FOOD and DRUGS Is Composed of Nine Volumes

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code of federal regulations Food andDrugs the FederalRegister as aSpecialEditionof Administration National ArchivesandRecords the OfficeofFederalRegister Published by Ancillaries With AS OFAPRIL1,1999 AND FUTUREEFFECT OF GENERALAPPLICABILITY A CODIFICATIONOFDOCUMENTS CONTAINING Revised asofApril1,1999 PART 1300TOEND 21 U.S. GOVERNMENT PRINTING OFFICE WASHINGTON : 1999

For sale by U.S. Government Printing Office Superintendent of Documents, Mail Stop: SSOP, Washington, DC 20402–9328 Table of Contents

Page Explanation ...... v

Title 21:

Chapter II—Drug Enforcement Administration, Department of Justice ...... 3

Chapter III—Office of National Drug Control Policy ...... 161

Finding Aids:

Table of CFR Titles and Chapters ...... 225

Alphabetical List of Agencies Appearing in the CFR ...... 243

List of CFR Sections Affected ...... 253

iii Cite this Code: CFR

To cite the regulations in this volume use title, part and section number. Thus, 21 CFR 1300.01 refers to title 21, part 1300, section 01.

iv Explanation

The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. The Code is divided into 50 titles which represent broad areas subject to Federal regulation. Each title is divided into chapters which usually bear the name of the issuing agency. Each chapter is further sub- divided into parts covering specific regulatory areas. Each volume of the Code is revised at least once each calendar year and issued on a quarterly basis approximately as follows: Title 1 through Title 16...... as of January 1 Title 17 through Title 27 ...... as of April 1 Title 28 through Title 41 ...... as of July 1 Title 42 through Title 50...... as of October 1 The appropriate revision date is printed on the cover of each volume. LEGAL STATUS The contents of the Federal Register are required to be judicially noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie evidence of the text of the original documents (44 U.S.C. 1510). HOW TO USE THE CODE OF FEDERAL REGULATIONS The Code of Federal Regulations is kept up to date by the individual issues of the Federal Register. These two publications must be used together to determine the latest version of any given rule. To determine whether a Code volume has been amended since its revision date (in this case, April 1, 1999), consult the ‘‘List of CFR Sections Affected (LSA),’’ which is issued monthly, and the ‘‘Cumulative List of Parts Affected,’’ which appears in the Reader Aids section of the daily Federal Register. These two lists will identify the Federal Register page number of the latest amendment of any given rule. EFFECTIVE AND EXPIRATION DATES Each volume of the Code contains amendments published in the Federal Reg- ister since the last revision of that volume of the Code. Source citations for the regulations are referred to by volume number and page number of the Federal Register and date of publication. Publication dates and effective dates are usually not the same and care must be exercised by the user in determining the actual effective date. In instances where the effective date is beyond the cut- off date for the Code a note has been inserted to reflect the future effective date. In those instances where a regulation published in the Federal Register states a date certain for expiration, an appropriate note will be inserted following the text. OMB CONTROL NUMBERS The Paperwork Reduction Act of 1980 (Pub. L. 96–511) requires Federal agencies to display an OMB control number with their information collection request.

v Many agencies have begun publishing numerous OMB control numbers as amendments to existing regulations in the CFR. These OMB numbers are placed as close as possible to the applicable recordkeeping or reporting requirements. OBSOLETE PROVISIONS Provisions that become obsolete before the revision date stated on the cover of each volume are not carried. Code users may find the text of provisions in effect on a given date in the past by using the appropriate numerical list of sections affected. For the period before January 1, 1986, consult either the List of CFR Sections Affected, 1949–1963, 1964–1972, or 1973–1985, published in seven separate volumes. For the period beginning January 1, 1986, a ‘‘List of CFR Sections Affected’’ is published at the end of each CFR volume. CFR INDEXES AND TABULAR GUIDES A subject index to the Code of Federal Regulations is contained in a separate volume, revised annually as of January 1, entitled CFR INDEX AND FINDING AIDS. This volume contains the Parallel Table of Statutory Authorities and Agency Rules (Table I), and Acts Requiring Publication in the Federal Register (Table II). A list of CFR titles, chapters, and parts and an alphabetical list of agencies publishing in the CFR are also included in this volume. An index to the text of ‘‘Title 3—The President’’ is carried within that volume. The Federal Register Index is issued monthly in cumulative form. This index is based on a consolidation of the ‘‘Contents’’ entries in the daily Federal Reg- ister. A List of CFR Sections Affected (LSA) is published monthly, keyed to the revision dates of the 50 CFR titles. REPUBLICATION OF MATERIAL There are no restrictions on the republication of material appearing in the Code of Federal Regulations. INQUIRIES For a legal interpretation or explanation of any regulation in this volume, contact the issuing agency. The issuing agency’s name appears at the top of odd–numbered pages. For inquiries concerning CFR reference assistance, call 202–523–5227 or write to the Director, Office of the Federal Register, National Archives and Records Administration, Washington, DC 20408 or e–mail [email protected]. SALES The Government Printing Office (GPO) processes all sales and distribution of the CFR. For payment by credit card, call 202–512–1800, M–F 8 a.m. to 4 p.m. e.s.t. or fax your order to 202–512–2233, 24 hours a day. For payment by check, write to the Superintendent of Documents, Attn: New Orders, P.O. Box 371954, Pittsburgh, PA 15250–7954. For GPO Customer Service call 202–512–1803. ELECTRONIC SERVICES The full text of the Code of Federal Regulations, the LSA (List of CFR Sections Affected), The United States Government Manual, the Federal Register, Public Laws, Weekly Compilation of Presidential Documents and the Privacy Act Com- pilation are available in electronic format at www.access.gpo.gov/nara (‘‘GPO Ac- cess’’). For more information, contact Electronic Information Dissemination Services, U.S. Government Printing Office. Phone 202–512–1530, or 888–293–6498 (toll–free). E–mail, [email protected].

vi The Office of the Federal Register also offers a free service on the National Archives and Records Administration’s (NARA) World Wide Web site for public law numbers, Federal Register finding aids, and related information. Connect to NARA’s web site at www.nara.gov/fedreg. The NARA site also contains links to GPO Access.

RAYMOND A. MOSLEY, Director, Office of the Federal Register. April 1, 1999.

vii

THIS TITLE

Title 21—FOOD AND DRUGS is composed of nine volumes. The parts in these volumes are arranged in the following order: Parts 1–99, 100–169, 170–199, 200–299, 300–499, 500–599, 600–799, 800–1299 and 1300–end. The first eight volumes, containing parts 1–1299, comprise Chapter I—Food and Drug Administration, Department of Health and Human Services. The ninth volume, containing part 1300 to end, includes Chapter II—Drug Enforcement Administration, Department of Justice, and Chapter III—Office of National Drug Control Policy. The contents of these volumes represent all current regulations codified under this title of the CFR as of April 1, 1999.

Redesignation tables for Chapter I—Food and Drug Administration appear in the Finding Aids section for the volumes containing parts 170–199 and 500–599.

For this volume, Ruth Reedy Green was Chief Editor. The Code of Federal Regulations publication program is under the direction of Frances D. McDonald, assisted by Alomha S. Morris.

ix x Title 21–Food and Drugs

(This book contains part 1300 to End)

EDITORIAL NOTE: Other regulations issued by the Department of Justice appear in title 4, title 8, and title 28.

Part

CHAPTER II—Drug Enforcement Administration, Depart- ment of Justice ...... 1301

CHAPTER III—Office of National Drug Control Policy ...... 1401

CROSS REFERENCES: U.S. Customs Service, Department of the Treasury: See Customs Duties, 19 CFR chapter I. Regulations of the Public Health Service, Department of Health and Human Services, applying to narcotic addicts: See Public Health, 42 CFR part 2.

CHAPTER II—DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE

Part Page 1300 Definitions ...... 5 1301 Registration of manufacturers, distributors, and dispensers of controlled substances ...... 12 1302 Labeling and packaging requirements for controlled substances ...... 40 1303 Quotas ...... 41 1304 Records and reports of registrants ...... 50 1305 Order forms ...... 62 1306 Prescriptions ...... 68 1307 Miscellaneous ...... 76 1308 Schedules of controlled substances ...... 79 1309 Registration of manufacturers, distributors, importers and exporters of list I chemicals ...... 97 1310 Records and reports of listed chemicals and certain machines ...... 107 1311 [Reserved] 1312 Importation and exportation of controlled substances ...... 117 1313 Importation and exportation of precursors and essential chemicals ...... 130 1314–1315 [Reserved] 1316 Administrative functions, practices, and procedures ...... 137

3 PART 1300—DEFINITIONS (xiii) Methandriol; (xiv) Methandrostenolone; Sec. (xv) Methenolone; 1300.01 Definitions relating to controlled (xvi) Methyltestosterone; substances. (xvii) Mibolerone; 1300.02 Definitions relating to listed chemi- (xviii) Nandrolone; cals. (xix) Norethandrolone; AUTHORITY: 21 U.S.C. 802, 871(b), 951, 958(f) (xx) Oxandrolone; SOURCE: 62 FR 13941, Mar. 24, 1997, unless (xxi) Oxymesterone; otherwise noted. (xxii) Oxymetholone; (xxiii) Stanolone; § 1300.01 Definitions relating to controlled substances. (xxiv) Stanozolol; (xxv) Testolactone; (a) Any term not defined in this part (xxvi) Testosterone; shall have the definition set forth in (xxvii) Trenbolone; and section 102 of the Act (21 U.S.C. 802), except that certain terms used in part (xxviii) Any salt, ester, or isomer of a 1316 of this chapter are defined at the drug or substance described or listed in beginning of each subpart of that part. this paragraph, if that salt, ester, or (b) As used in parts 1301 through 1308 isomer promotes muscle growth. Ex- and part 1312 of this chapter, the fol- cept such term does not include an an- lowing terms shall have the meanings abolic steroid which is expressly in- specified: tended for administration through im- (1) The term Act means the Con- plants to cattle or other nonhuman trolled Substances Act, as amended (84 species and which has been approved by Stat. 1242; 21 U.S.C. 801) and/or the Con- the Secretary of Health and Human trolled Substances Import and Export Services for such administration. If Act, as amended (84 Stat. 1285; 21 U.S.C. any person prescribes, dispenses, or dis- 951). tributes such steroid for human use, (2) The term Administration means such person shall be considered to have the Drug Enforcement Administration. prescribed, dispensed, or distributed an (3) The term Administrator means the anabolic steroid within the meaning of Administrator of the Drug Enforce- this paragraph. ment Administration. The Adminis- (5) The term basic class means, as to trator has been delegated authority controlled substances listed in Sched- under the Act by the Attorney General ules I and II: (28 CFR 0.100). (i) Each of the opiates, including its (4) The term anabolic steroid means isomers, esters, ethers, salts, and salts any drug or hormonal substance, of isomers, esters, and ethers whenever chemically and pharmacologically re- the existence of such isomers, esters, lated to testosterone (other than estro- ethers, and salts is possible within the gens, progestins, and corticosteroids) specific chemical designation, listed in that promotes muscle growth, and in- § 1308.11(b) of this chapter; cludes: (ii) Each of the opium derivatives, in- (i) Boldenone; cluding its salts, isomers, and salts of (ii) Chlorotestosterone (4- isomers whenever the existence of such chlortestosterone); salts, isomers, and salts of isomers is (iii) Clostebol; possible within the specific chemical (iv) designation, listed in § 1308.11(c) of this Dehydrochlormethyltestosterone; chapter; (v) Dihydrotestosterone (4- (iii) Each of the hallucinogenic sub- dihydrotestosterone); stances, including its salts, isomers, (vi) Drostanolone; and salts of isomers whenever the ex- (vii) Ethylestrenol; istence of such salts, isomers, and salts (viii) Fluoxymesterone; of isomers is possible within the spe- (ix) Formebulone (formebolone); cific chemical designation, listed in (x) Mesterolone; § 1308.11(d) of this chapter; (xi) Methandienone; (iv) Each of the following substances, (xii) Methandranone; whether produced directly or indirectly

5 § 1300.01 21 CFR Ch. II (4–1–99 Edition) by extraction from substances of vege- containers are stored or are used for table origin, or independently by shipment of controlled substances. means of chemical synthesis, or by a (7) The term compounder means any combination of extraction and chem- person engaging in maintenance or de- ical synthesis: toxification treatment who also mixes, (A) Opium, including raw opium, prepares, packages or changes the dos- opium extracts, opium fluid extracts, age form of a narcotic drug listed in powdered opium, granulated opium, de- Schedules II, III, IV or V for use in odorized opium and tincture of opium; maintenance or detoxification treat- (B) Apomorphine; ment by another narcotic treatment (C) Codeine; program. (D) Etorphine hydrochloride; (8) The term controlled substance has (E) Ethylmorphine; the meaning given in section 802(6) of (F) Hydrocodone; Title 21, United States Code (U.S.C.). (G) Hydromorphone; (9) The term customs territory of the (H) Metopon; United States means the several (I) Morphine; States, the District of Columbia, and (J) Oxycodone; Puerto Rico. (K) Oxymorphone; (10) The term detoxification treatment (L) Thebaine; means the dispensing, for a period of (M) Mixed alkaloids of opium listed time as specified below, of a narcotic in Section 1308.12(b)(2) of this chapter; drug or narcotic drugs in decreasing (N) Cocaine; and doses to an individual to alleviate ad- (O) Ecgonine; verse physiological or psychological ef- (v) Each of the opiates, including its fects incident to withdrawal from the isomers, esters, ethers, salts, and salts continuous or sustained use of a nar- of isomers, esters, and ethers whenever cotic drug and as a method of bringing the existence of such isomers, esters, the individual to a narcotic drug-free ethers, and salts is possible within the state within such period of time. There specific chemical designation, listed in are two types of detoxification treat- § 1308.12(c) of this chapter; and ment: Short-term detoxification treat- (vi) Methamphetamine, its salts, iso- ment and long-term detoxification mers, and salts of its isomers; treatment. (vii) Amphetamine, its salts, optical (i) Short-term detoxification treat- isomers, and salts of its optical iso- ment is for a period not in excess of 30 mers; days. (viii) Phenmetrazine and its salts; (ii) Long-term detoxification treat- (ix) Methylphenidate; ment is for a period more than 30 days (x) Each of the substances having a but not in excess of 180 days. depressant effect on the central nerv- (11) The term dispenser means an in- ous system, including its salts, iso- dividual practitioner, institutional mers, and salts of isomers whenever practitioner, pharmacy or pharmacist the existence of such salts, isomers, who dispenses a controlled substance. and salts of isomers is possible within (12) The term export means, with re- the specific chemical designation, list- spect to any article, any taking out or ed in § 1308.12(e) of this chapter. removal of such article from the juris- (6) The term commercial container diction of the United States (whether means any bottle, jar, tube, ampule, or or not such taking out or removal con- other receptacle in which a substance stitutes an exportation within the is held for distribution or dispensing to meaning of the customs and related an ultimate user, and in addition, any laws of the United States). box or package in which the receptacle (13) The term exporter includes every is held for distribution or dispensing to person who exports, or who acts as an an ultimate user. The term commercial export broker for exportation of, con- container does not include any package trolled substances listed in any sched- liner, package insert or other material ule. kept with or within a commercial con- (14) The term hearing means: tainer, nor any carton, crate, drum, or (i) In part 1301 of this chapter, any other package in which commercial hearing held for the granting, denial,

6 Drug Enforcement Administration, Justice § 1300.01 revocation, or suspension of a registra- manufactured or otherwise acquired by tion pursuant to sections 303, 304, and a registrant, whether in bulk, commer- 1008 of the Act (21 U.S.C. 823, 824 and cial containers, or contained in phar- 958). maceutical preparations in the posses- (ii) In part 1303 of this chapter, any sion of the registrant (including stocks hearing held regarding the determina- held by the registrant under separate tion of aggregate production quota or registration as a manufacturer, im- the issuance, adjustment, suspension, porter, exporter, or distributor). or denial of a procurement quota or an (21) The term isomer means the opti- individual manufacturing quota. cal isomer, except as used in § 1308.11(d) (iii) In part 1308 of this chapter, any and § 1308.12(b)(4) of this chapter. As hearing held for the issuance, amend- used in § 1308.11(d) of this chapter, the ment, or repeal of any rule issuable term isomer means the optical, posi- pursuant to section 201 of the Act (21 tional, or geometric isomer. As used in U.S.C. 811). § 1308.12(b)(4) of this chapter, the term (15) The term import means, with re- isomer means the optical or geometric spect to any article, any bringing in or isomer. introduction of such article into either (22) The term jurisdiction of the United the jurisdiction of the United States or States means the customs territory of the customs territory of the United the United States, the Virgin Islands, States, and from the jurisdiction of the the Canal Zone, Guam, American United States into the customs terri- Samoa, and the Trust Territories of tory of the United States (whether or the Pacific Islands. not such bringing in or introduction (23) The term label means any display constitutes an importation within the of written, printed, or graphic matter meaning of the tariff laws of the placed upon the commercial container United States). of any controlled substance by any (16) The term importer includes every manufacturer of such substance. person who imports, or who acts as an import broker for importation of, con- (24) The term labeling means all la- trolled substances listed in any sched- bels and other written, printed, or ule. graphic matter: (17) The term individual practitioner (i) Upon any controlled substance or means a physician, dentist, veteri- any of its commercial containers or narian, or other individual licensed, wrappers, or registered, or otherwise permitted, by (ii) Accompanying such controlled the United States or the jurisdiction in substance. which he/she practices, to dispense a (25) The term Long Term Care Facility controlled substance in the course of (LTCF) means a nursing home, retire- professional practice, but does not in- ment care, mental care or other facil- clude a pharmacist, a pharmacy, or an ity or institution which provides ex- institutional practitioner. tended health care to resident patients. (18) The term institutional practitioner (26) The term maintenance treatment means a hospital or other person (other means the dispensing for a period in ex- than an individual) licensed, reg- cess of twenty-one days, of a narcotic istered, or otherwise permitted, by the drug or narcotic drugs in the treat- United States or the jurisdiction in ment of an individual for dependence which it practices, to dispense a con- upon heroin or other morphine-like trolled substance in the course of pro- drug. fessional practice, but does not include (27) The term manufacture means the a pharmacy. producing, preparation, propagation, (19) The term interested person means compounding, or processing of a drug any person adversely affected or ag- or other substance or the packaging or grieved by any rule or proposed rule repackaging of such substance, or the issuable pursuant to section 201 of the labeling or relabeling of the commer- Act (21 U.S.C. 811). cial container of such substance, but (20) The term inventory means all fac- does not include the activities of a tory and branch stocks in finished form practitioner who, as an incident to his/ of a basic class of controlled substance her administration or dispensing such

7 § 1300.01 21 CFR Ch. II (4–1–99 Edition) substance in the course of his/her pro- (vi) Any compound, mixture, or prep- fessional practice, prepares, com- aration which contains any quantity of pounds, packages or labels such sub- any of the substances referred to in stance. The term manufacturer means a paragraphs (b)(31)(i) through (v) of this person who manufactures a drug or section. other substance, whether under a reg- (31) The term narcotic treatment pro- istration as a manufacturer or under gram means a program engaged in authority of registration as a re- maintenance and/or detoxification searcher or chemical analyst. treatment with narcotic drugs. (28) The term mid-level practitioner (32) The term net disposal means, for means an individual practitioner, other a stated period, the quantity of a basic than a physician, dentist, veterinarian, class of controlled substance distrib- or podiatrist, who is licensed, reg- uted by the registrant to another per- istered, or otherwise permitted by the son, plus the quantity of that basic United States or the jurisdiction in class used by the registrant in the pro- which he/she practices, to dispense a duction of (or converted by the reg- controlled substance in the course of istrant into) another basic class of con- professional practice. Examples of mid- trolled substance or a noncontrolled level practitioners include, but are not substance, plus the quantity of that limited to, health care providers such basic class otherwise disposed of by the as nurse practitioners, nurse midwives, registrant, less the quantity of that nurse anesthetists, clinical nurse spe- basic class returned to the registrant cialists and physician assistants who by any purchaser, and less the quantity are authorized to dispense controlled of that basic class distributed by the substances by the state in which they registrant to another registered manu- practice. facturer of that basic class for purposes other than use in the production of, or (29) The term name means the official conversion into, another basic class of name, common or usual name, chem- controlled substance or a noncon- ical name, or brand name of a sub- trolled substance or in the manufac- stance. ture of dosage forms of that basic class. (30) The term narcotic drug means any (33) The term pharmacist means any of the following whether produced di- pharmacist licensed by a State to dis- rectly or indirectly by extraction from pense controlled substances, and shall substances of vegetable origin or inde- include any other person (e.g., phar- pendently by means of chemical syn- macist intern) authorized by a State to thesis or by a combination of extrac- dispense controlled substances under tion and chemical synthesis: the supervision of a pharmacist li- (i) Opium, opiates, derivatives of censed by such State. opium and opiates, including their iso- (34) The term person includes any in- mers, esters, ethers, salts, and salts of dividual, corporation, government or isomers, esters, and ethers whenever governmental subdivision or agency, the existence of such isomers, esters, business trust, partnership, associa- ethers and salts is possible within the tion, or other legal entity. specific chemical designation. Such (35) The term prescription means an term does not include the isoquinoline order for medication which is dispensed alkaloids of opium. to or for an ultimate user but does not (ii) Poppy straw and concentrate of include an order for medication which poppy straw. is dispensed for immediate administra- (iii) Coca leaves, except coca leaves tion to the ultimate user. (e.g., an and extracts of coca leaves from which order to dispense a drug to a bed pa- cocaine, ecgonine and derivatives of ec- tient for immediate administration in gonine or their salts have been re- a hospital is not a prescription.) moved. (36) The term proceeding means all ac- (iv) Cocaine, its salts, optical and tions taken for the issuance, amend- geometric isomers, and salts of iso- ment, or repeal of any rule issued pur- mers. suant to section 201 of the Act (21 (v) Ecgonine, its derivatives, their U.S.C. 811), commencing with the pub- salts, isomers and salts of isomers. lication by the Administrator of the

8 Drug Enforcement Administration, Justice § 1300.02 proposed rule, amended rule, or repeal other legal entity which assists in ar- in the FEDERAL REGISTER. ranging an international transaction in (37) The term purchaser means any a listed chemical by— registered person entitled to obtain (i) Negotiating contracts; and execute order forms pursuant to (ii) Serving as an agent or inter- §§ 1305.04 and 1305.06. mediary; or (38) The term readily retrievable (iii) Fulfilling a formal obligation to means that certain records are kept by complete the transaction by bringing automatic data processing systems or together a buyer and seller, a buyer other electronic or mechanized record- and transporter, or a seller and trans- keeping systems in such a manner that porter, or by receiving any form of they can be separated out from all compensation for so doing. other records in a reasonable time and/ (5) The term chemical export means or records are kept on which certain transferring ownership or control, or items are asterisked, redlined, or in the sending or taking of threshold some other manner visually identifi- quantities of listed chemicals out of able apart from other items appearing the United States (whether or not such on the records. sending or taking out constitutes an (39) The terms register and registration exportation within the meaning of the refer only to registration required and Customs and related laws of the United permitted by sections 303 or 1007 of the States). Act (21 U.S.C. 823 or 957). (40) The term registrant means any (6) The term chemical exporter is a person who is registered pursuant to ei- regulated person who, as the principal ther section 303 or section 1008 of the party in interest in the export trans- Act (21 U.S.C. 823 or 958). action, has the power and responsi- (41) The term supplier means any reg- bility for determining and controlling istered person entitled to fill order the sending of the listed chemical out forms pursuant to § 1305.08 of this chap- of the United States. ter. (7) The term chemical import means with respect to a listed chemical, any § 1300.02 Definitions relating to listed bringing in or introduction of such list- chemicals. ed chemical into either the jurisdiction (a) Any term not defined in this part of the United States or into the Cus- shall have the definition set forth in toms territory of the United States section 102 of the Act (21 U.S.C. 802), (whether or not such bringing in or in- except that certain terms used in part troduction constitutes an importation 1316 of this chapter are defined at the within the meaning of the tariff laws of beginning of each subpart of that part. the United States). (b) As used in parts 1309, 1310, and (8) The term chemical importer is a 1313 of this chapter, the following regulated person who, as the principal terms shall have the meaning specified: party in interest in the import trans- (1) The term Act means the Con- action, has the power and responsi- trolled Substances Act, as amended (84 bility for determining and controlling Stat. 1242; 21 U.S.C. 801) and/or the Con- the bringing in or introduction of the trolled Substances Import and Export listed chemical into the United States. Act, as amended (84 Stat. 1285; 21 U.S.C. (9) The term chemical mixture means a 951) as amended. combination of two or more chemical (2) The term Administration means substances, at least one of which is not the Drug Enforcement Administration. a listed chemical, except that such (3) The term Administrator means the term does not include any combination Administrator of the Drug Enforce- of a listed chemical with another ment Administration. The Adminis- chemical that is present solely as an trator has been delegated authority impurity or which has been created to under the Act by the Attorney General evade the requirements of the Act. (28 CFR 0.100). (10) The term customs territory of the (4) The terms broker and trader mean United States means the several States, any individual, corporation, corporate the District of Columbia, and Puerto division, partnership, association, or Rico.

9 § 1300.02 21 CFR Ch. II (4–1–99 Edition)

(11) The term encapsulating machine or twice within the past twelve months means any manual, semi-automatic, or from a foreign supplier. The term also fully automatic equipment which may means that the regulated person has be used to fill shells or capsules with provided the Administration with the any powdered, granular, semi-solid, or following information in accordance liquid material. with the waiver of the 15-day advance (12) The term established business rela- notice requirements of § 1313.15 of this tionship with a foreign customer means chapter: the regulated person has exported a (i) The name, DEA registration num- listed chemical at least once within ber (where applicable), street address, the past six months, or twice within telephone number, telex number, and, the past twelve months to a foreign where available, the facsimile number manufacturer, distributor, or end user of the regulated person and of each for- of the chemical that has an established eign supplier; and business in the foreign country with a (ii) The frequency and number of fixed street address. A person or busi- transactions occurring during the pre- ness which functions as a broker or ceding 12 month period. intermediary is not a customer for pur- (14) The term hearing means any poses of this definition. The term also hearing held for the granting, denial, means that the regulated person has revocation, or suspension of a registra- provided the Administration with the tion pursuant to sections 303, 304, and following information in accordance 1008 of the Act (21 U.S.C. 823, 824 and with the waiver of 15-day advance no- 958). tice requirements of § 1313.24 of this (15) The term international transaction chapter: means a transaction involving the (i) The name and street address of shipment of a listed chemical across an the chemical exporter and of each reg- international border (other than a ular customer; United States border) in which a (ii) The telephone number, telex broker or trader located in the United number, contact person, and where States participates. available, the facsimile number for the (16) The term jurisdiction of the United chemical exporter and for each regular States means the customs territory of customer; the United States, the Virgin Islands, (iii) The nature of the regular cus- the Canal Zone, Guam, American tomer’s business (i.e., importer, ex- Samoa, and the Trust Territories of porter, distributor, manufacturer, the Pacific Islands. etc.), and if known, the use to which (17) The term listed chemical means the listed chemical or chemicals will any List I chemical or List II chemical. be applied; (18) The term List I chemical means a (iv) The duration of the business rela- chemical specifically designated by the tionship; Administrator in § 1310.02(a) of this (v) The frequency and number of chapter that, in addition to legitimate transactions occurring during the pre- uses, is used in manufacturing a con- ceding 12-month period; trolled substance in violation of the (vi) the amounts and the listed chem- Act and is important to the manufac- ical or chemicals involved in regulated ture of a controlled substance. transactions between the chemical ex- (19) The term List II chemical means a porter and regular customer; chemical, other than a List I chemical, (vii) The method of delivery (direct specifically designated by the Adminis- shipment or through a broker or for- trator in § 1310.02(b) of this chapter warding agent); and that, in addition to legitimate uses, is (viii) Other information that the used in manufacturing a controlled chemical exporter considers relevant substance in violation of the Act. for determining whether a customer is (20) The term name means the official a regular customer. name, common or usual name, chem- (13) The term established record as an ical name, or brand name of a sub- importer means that the regulated per- stance. son has imported a listed chemical at (21) The term person includes any in- least once within the past six months, dividual, corporation, government or

10 Drug Enforcement Administration, Justice § 1300.02 governmental subdivision or agency, (A) A domestic lawful distribution in business trust, partnership, associa- the usual course of business between tion, or other legal entity. agents or employees of a single regu- (22) The term readily retrievable lated person; in this context, agents or means that certain records are kept by employees means individuals under the automatic data processing systems or direct management and control of the other electronic or mechanized record- regulated person; keeping systems in such a manner that (B) A delivery of a listed chemical to they can be separated out from all or by a common or contract carrier for other records in a reasonable time and/ carriage in the lawful and usual course or records are kept on which certain of the business of the common or con- items are asterisked, redlined, or in tract carrier, or to or by a warehouse- some other manner visually identifi- man for storage in the lawful and usual able apart from other items appearing course of the business of the ware- on the records. houseman, except that if the carriage (23) The terms register and registration or storage is in connection with the refer only to registration required and distribution, importation, or expor- permitted by sections 303 or 1007 of the tation of a listed chemical to a third Act (21 U.S.C. 823 or 957). person, this paragraph does not relieve (24) The term registrant means any a distributor, importer, or exporter person who is registered pursuant to ei- from compliance with parts 1309, 1310, ther section 303 or section 1008 of the and 1313 of this chapter; Act (21 U.S.C. 823 or 958). (C) Any category of transaction or (25) The term regular customer means any category of transaction for a spe- a person with whom the regulated per- cific listed chemical or chemicals spec- son has an established business rela- ified by regulation of the Adminis- tionship for a specified listed chemical trator as excluded from this definition or chemicals that has been reported to as unnecessary for enforcement of the the Administration subject to the cri- Act; teria established in § 1300.02(b)(12). (D) Any transaction in a listed chem- (26) The term regular importer means, with respect to a listed chemical, a ical that is contained in a drug that person that has an established record may be marketed or distributed law- as an importer of that listed chemical fully in the United States under the that is reported to the Administrator. Federal Food, Drug, and Cosmetic Act unless— (27) The term regulated person means any individual, corporation, partner- (1)(i) The drug contains ephedrine or ship, association, or other legal entity its salts, optical isomers, or salts of op- who manufactures, distributes, im- tical isomers; or ports, or exports a listed chemical, a (ii) The Administrator has deter- tableting machine, or an encapsulating mined pursuant to the criteria in machine, or who acts as a broker or 1310.10 that the drug or group of drugs trader for an international transaction is being diverted to obtain the listed involving a listed chemical, tableting chemical for use in the illicit produc- machine, or encapsulating machine. tion of a controlled substance; and (28) The term regulated transaction (2) The quantity of ephedrine or means: other listed chemical contained in the (i) A distribution, receipt, sale, im- drug included in the transaction or portation, or exportation of a listed multiple transactions equals or exceeds chemical, or an international trans- the threshold established for that action involving shipment of a listed chemical. chemical, or if the Administrator es- (E) Any transaction in a chemical tablishes a threshold amount for a spe- mixture listed in § 1310.13 of this chap- cific listed chemical, a threshold ter. amount as determined by the Adminis- (ii) A distribution, importation, or trator, which includes a cumulative exportation of a tableting machine or threshold amount for multiple trans- encapsulating machine except that actions, of a listed chemical, except such term does not include a domestic that such term does not include: lawful distribution in the usual course

11 Pt. 1301 21 CFR Ch. II (4–1–99 Edition) of business between agents and employ- 1301.15 Additional information. ees of a single regulated person; in this 1301.16 Amendments to and withdrawal of context, agents or employees means in- applications. dividuals under the direct management 1301.17 Special procedures for certain appli- and control of the regulated person. cations. (29) The term retail distributor means 1301.18 Research protocols. a grocery store, general merchandise EXCEPTIONS TO REGISTRATION AND FEES store, drug store, or other entity or person whose activities as a distributor 1301.21 Exception from fees. relating to drug products containing 1301.22 Exemption of agents and employees; pseudoephedrine, phenylpropanola- affiliated practitioners. 1301.23 Exemption of certain military and mine, or ephedrine are limited almost other personnel. exclusively to sales for personal use, 1301.24 Exemption of law enforcement offi- both in number of sales and volume of cials. sales, either directly to walk-in cus- 1301.25 Registration regarding ocean ves- tomers or in face-to-face transactions sels, aircraft, and other entities. by direct sales. For the purposes of this 1301.26 Exemptions from import or export paragraph, sale for personal use means requirements for personal medical use. the distribution of below-threshold quantities in a single transaction to an ACTION ON APPLICATION FOR REGISTRATION: REVOCATION OR SUSPENSION OF REGISTRATION individual for legitimate medical use. Also for the purposes of this paragraph, 1301.31 Administrative review generally. a grocery store is an entity within 1301.32 Action on applications for research Standard Industrial Classification in Schedule I substances. (SIC) code 5411, a general merchandise 1301.33 Application for bulk manufacture of store is an entity within SIC codes 5300 Schedule I and II substances. through 5399 and 5499, and a drug store 1301.34 Application for importation of Schedule I and II substances. is an entity within SIC code 5912. 1301.35 Certificate of registration; denial of (30) The term tableting machine means registration. any manual, semi-automatic, or fully 1301.36 Suspension or revocation of registra- automatic equipment which may be tion; suspension of registration pending used for the compaction or molding of final order; extension of registration powdered or granular solids, or semi- pending final order. solid material, to produce coherent 1301.37 Order to show cause. solid tablets. HEARINGS [62 FR 13941, Mar. 24, 1997; 62 FR 15392, Apr. 1, 1997] 1301.41 Hearings generally. 1301.42 Purpose of hearing. 1301.43 Request for hearing or appearance; PART 1301—REGISTRATION OF waiver. MANUFACTURERS, DISTRIBUTORS, 1301.44 Burden of proof. AND DISPENSERS OF CON- 1301.45 Time and place of hearing. TROLLED SUBSTANCES 1301.46 Final order. MODIFICATION, TRANSFER, AND TERMINATION GENERAL INFORMATION OF REGISTRATION Sec. 1301.51 Modification in registration. 1301.01 Scope of this part 1301. 1301.52 Termination of registration; transfer 1301.02 Definitions. of registration; distribution upon dis- 1301.03 Information; special instructions. continuance of business. REGISTRATION SECURITY REQUIREMENTS 1301.11 Persons required to register. 1301.12 Separate registrations for separate 1301.71 Security requirements generally. locations. 1301.72 Physical security controls for non- 1301.13 Application for registration; time practitioners; narcotic treatment pro- for application; expiration date; registra- grams and compounders for narcotic tion for independent activities; applica- treatment programs; storage areas. tion forms, fees, contents and signature; 1301.73 Physical security controls for non- coincident activities. practitioners; compounders for narcotic 1301.14 Filing of application; acceptance for treatment programs; manufacturing and filing; defective applications. compounding areas.

12 Drug Enforcement Administration, Justice § 1301.12

1301.74 Other security controls for non- REGISTRATION practitioners; narcotic treatment programs and compounders for narcotic § 1301.11 Persons required to register. treatment programs. (a) Every person who manufactures, 1301.75 Physical security controls for practitioners. distributes, dispenses, imports, or ex- 1301.76 Other security controls for practi- ports any controlled substance or who tioners. proposes to engage in the manufacture, distribution, dispensing, importation EMPLOYEE SCREENING—NON-PRACTITIONERS or exportation of any controlled sub- 1301.90 Employee screening procedures. stance shall obtain a registration un- 1301.91 Employee responsibility to report less exempted by law or pursuant to drug diversion. §§ 1301.22–1301.26. Only persons actually 1301.92 Illicit activities by employees. engaged in such activities are required 1301.93 Sources of information for employee to obtain a registration; related or af- checks. filiated persons who are not engaged in such activities are not required to be AUTHORITY: 21 U.S.C. 821, 822, 823, 824, registered. (For example, a stockholder 871(b), 875, 877. or parent corporation of a corporation SOURCE: 36 FR 7778, Apr. 24, 1971, unless manufacturing controlled substances is otherwise noted. Redesignated at 38 FR 26609, not required to obtain a registration.) Sept. 24, 1973. (b) [Reserved]

GENERAL INFORMATION [62 FR 13945, Mar. 24, 1997]

§ 1301.01 Scope of this part 1301. § 1301.12 Separate registrations for separate locations. Procedures governing the registration of manufacturers, distributors, (a) A separate registration is re- dispensers, importers, and exporters of quired for each principal place of business or professional practice at one controlled substances pursuant to sec- general physical location where con- tions 301–304 and 1007–1008 of the Act (21 trolled substances are manufactured, U.S.C. 821–824 and 957–958) are set forth distributed, imported, exported, or dis- generally by those sections and specifi- pensed by a person. cally by the sections of this part. (b) The following locations shall be [62 FR 13945, Mar. 24, 1997] deemed not to be places where controlled substances are manufactured, § 1301.02 Definitions. distributed, or dispensed: Any term used in this part shall have (1) A warehouse where controlled substances are stored by or on behalf of the definition set forth in section 102 of a registered person, unless such sub- the Act (21 U.S.C. 802) or part 1300 of stances are distributed directly from this chapter. such warehouse to registered locations [62 FR 13945, Mar. 24, 1997] other than the registered location from which the substances were delivered or § 1301.03 Information; special instruc- to persons not required to register by tions. virtue of subsection 302(c)(2) or sub- Information regarding procedures section 1007(b)(1)(B) of the Act (21 under these rules and instructions U.S.C. 822(c)(2) or 957(b)(1)(B)); supplementing these rules will be fur- (2) An office used by agents of a reg- nished upon request by writing to the istrant where sales of controlled sub- Registration Unit, Drug Enforcement stances are solicited, made, or supervised but which neither contains such Administration, Department of Jus- substances (other than substances for tice, Post Office Box 28083, Central Sta- display purposes or lawful distribution tion, Washington, DC 20005. as samples only) nor serves as a dis- [36 FR 7778, Apr. 24, 1971. Redesignated at 38 tribution point for filling sales orders; FR 26609, Sept. 23, 1973, and amended at 51 and FR 5319, Feb. 13, 1986] (3) An office used by a practitioner (who is registered at another location)

13 § 1301.13 21 CFR Ch. II (4–1–99 Edition) where controlled substances are pre- the date on which the business activity scribed but neither administered nor is registered. otherwise dispensed as a regular part of (d) At the time a retail pharmacy, the professional practice of the practi- hospital/clinic, practitioner or teach- tioner at such office, and where no sup- ing institution is first registered, that plies of controlled substances are business activity shall be assigned to maintained. one of twelve groups, which shall cor- [62 FR 13945, Mar. 24, 1997] respond to the months of the year. The expiration date of the registrations of § 1301.13 Application for registration; all registrants within any group will be time for application; expiration the last day of the month designated date; registration for independent for that group. In assigning any of the activities; application forms, fees, above business activities to a group, contents and signature; coincident the Administration may select a group activities. the expiration date of which is not less (a) Any person who is required to be than 28 months nor more than 39 registered and who is not so registered months from the date such business ac- may apply for registration at any time. tivity was registered. After the initial No person required to be registered registration period, the registration shall engage in any activity for which shall expire 36 months from the initial registration is required until the appli- expiration date. cation for registration is granted and a (e) Any person who is required to be Certificate of Registration is issued by registered and who is not so registered, the Administrator to such person. shall make application for registration (b) Any person who is registered may for one of the following groups of con- apply to be reregistered not more than trolled substances activities, which are 60 days before the expiration date of deemed to be independent of each his/her registration, except that a bulk other. Application for each registration manufacturer of Schedule I or II con- shall be made on the indicated form, trolled substances or an importer of and shall be accompanied by the indi- Schedule I or II controlled substances cated fee. Fee payments shall be made may apply to be reregistered no more in the form of a personal, certified, or than 120 days before the expiration cashier’s check or money order made date of their registration. payable to the ‘‘Drug Enforcement Ad- (c) At the time a manufacturer, dis- ministration’’. The application fees are tributor, researcher, analytical lab, im- not refundable. Any person, when reg- porter, exporter or narcotic treatment istered to engage in the activities de- program is first registered, that business activity shall be assigned to one of scribed in each subparagraph in this twelve groups, which shall correspond paragraph, shall be authorized to en- to the months of the year. The expira- gage in the coincident activities de- tion date of the registrations of all reg- scribed without obtaining a registra- istrants within any group will be the tion to engage in such coincident ac- last date of the month designated for tivities, provided that, unless specifi- that group. In assigning any of the cally exempted, he/she complies with above business activities to a group, all requirements and duties prescribed the Administration may select a group by law for persons registered to engage the expiration date of which is less in such coincident activities. Any per- than one year from the date such busi- son who engages in more than one ness activity was registered. If the group of independent activities shall business activity is assigned to a group obtain a separate registration for each which has an expiration date less than group of activities, except as provided three months from the date of which in this paragraph under coincident ac- the business activity is registered, the tivities. A single registration to engage registration shall not expire until one in any group of independent activities year from that expiration date; in all listed below may include one or more other cases, the registration shall ex- controlled substances listed in the pire on the expiration date following schedules authorized in that group of

14 Drug Enforcement Administration, Justice § 1301.13 independent activities. A person reg- stances listed in Schedule I for which istered to conduct research with con- he/she has filed and had approved a re- trolled substances listed in Schedule I search protocol. may conduct research with any sub- (1)

Reg- Applica- istra- Business activity Controlled substances DEA application tion fee tion pe- Coincident activities allowed forms (dollars) riod (years)

(i) Manufacturing Schedules I through V NewÐ225 875 1 Schedules I through V: May distribute RenewalÐ225a 875 that substance or class for which registration was issued; may not distribute any substance or class for which not registered. Schedules II through V: May conduct chemical analysis and preclinical research (including quality control analysis) with substances listed in those schedules for which authorization as a manufacturer was issued. (ii) Distributing Schedules I through V NewÐ225 438 1 RenewalÐ225a 438 (iii) Dispensing or Schedules II through V NewÐ224 210 3 May conduct research and instruc- Instructing (In- RenewalÐ224a 210 tional activities with those sub- cludes Practitioner stances for which registration was Hospital/Clinic, granted, except that a mid-level Retail Pharmacy, practitioner may conduct such re- Teaching Institu- search only to the extent expressly tion) authorized under state statute. A pharmacist may manufacture an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in Schedule II through V in a proportion not exceeding 20 percent of the complete solution, compound, or mixture. (iv) Research Schedule I NewÐ225 70 1 A researcher may manufacture or im- RenewalÐ225a 70 port the basic class of substance or substances for which registration was issued, provided that such manufacture or import is set forth in the protocol required in Section 1301.18 and to distribute such class to persons registered or authorized to conduct research with such class of substance or registered or authorized to conduct chemical analysis with controlled substances. (v) Research Schedules II through V NewÐ225 70 1 May conduct chemical analysis with RenewalÐ225a 70 controlled substances in those schedules for which registration was issued; manufacture such substances if and to the extent that such manufacture is set forth in a statement filed with the application for registration or reregistration and provided that the manufacture is not for the purposes of dosage form development; import such substances for research purposes; distribute such substances to persons registered or authorized to conduct chemical analysis, instructional activities, or research with such substances, and to persons exempted from registration pursuant to Section 1301.24; and conduct instructional activities with controlled substances.

15 § 1301.13 21 CFR Ch. II (4–1–99 Edition)

Reg- Applica- istra- Business activity Controlled substances DEA application tion fee tion pe- Coincident activities allowed forms (dollars) riod (years)

(vi) Narcotic Treat- Narcotic Drugs in NewÐ363 70 1 ment Program (in- Schedules II through RenewalÐ363a 70 cluding V compounder) (vii) Importing Schedules I through V NewÐ225 438 1 May distribute that substance or class RenewalÐ225a 438 for which registration was issued; may not distribute any substance or class for which not registered. (viii) Exporting Schedules I through V NewÐ225 438 1 RenewalÐ225a 438 (ix) Chemical Anal- Schedules I through V NewÐ225 70 1 May manufacture and import con- ysis RenewalÐ225a 70 trolled substances for analytical or instructional activities; may distribute such substances to persons registered or authorized to conduct chemical analysis, instructional activities, or research with such substances and to persons exempted from registration pursuant to Sec- tion 1301.24; may export such substances to persons in other countries performing chemical analysis or enforcing laws relating to controlled substances or drugs in those countries; and may conduct instructional activities with controlled substances.

(2) DEA Forms 224, 225, and 363 may (g) Each application for registration be obtained at any area office of the to import or export controlled sub- Administration or by writing to the stances shall include the Administra- Registration Unit, Drug Enforcement tion Controlled Substances Code Num- Administration, Department of Jus- ber, as set forth in part 1308 of this tice, Post Office Box 28083, Central Sta- chapter, for each controlled substance tion, Washington, DC 20005. whose importation or exportation is to (3) DEA Forms 224a, 225a, and 363a be authorized by such registration. will be mailed, as applicable, to each Registration as an importer or ex- registered person approximately 60 porter shall not entitle a registrant to days before the expiration date of his/ import or export any controlled sub- her registration; if any registered per- stance not specified in such registra- son does not receive such forms within tion. 45 days before the expiration date of (h) Each application for registration his/her registration, he/she must to conduct research with any basic promptly give notice of such fact and request such forms by writing to the class of controlled substance listed in Registration Unit of the Administra- Schedule II shall include the Adminis- tion at the foregoing address. tration Controlled Substances Code (f) Each application for registration Number, as set forth in part 1308 of this to handle any basic class of controlled chapter, for each such basic class to be substance listed in Schedule I (except manufactured or imported as a coinci- to conduct chemical analysis with such dent activity of that registration. A classes), and each application for reg- statement listing the quantity of each istration to manufacture a basic class such basic class of controlled substance of controlled substance listed in Sched- to be imported or manufactured during ule II shall include the Administration the registration period for which appli- Controlled Substances Code Number, as cation is being made shall be included set forth in part 1308 of this chapter, with each such application. For pur- for each basic class to be covered by poses of this paragraph only, manufac- such registration. turing is defined as the production of a

16 Drug Enforcement Administration, Justice § 1301.16 controlled substance by synthesis, ex- cation will be returned to the applicant traction or by agricultural/horti- within 10 days following its receipt cultural means. with a statement of the reason for not (i) Each application shall include all accepting the application for filing. A information called for in the form, un- defective application may be corrected less the item is not applicable, in and resubmitted for filing at any time; which case this fact shall be indicated. the Administrator shall accept for fil- (j) Each application, attachment, or ing any application upon resubmission other document filed as part of an ap- by the applicant, whether complete or plication, shall be signed by the appli- not. cant, if an individual; by a partner of (d) Accepting an application for fil- the applicant, if a partnership; or by an ing does not preclude any subsequent officer of the applicant, if a corpora- request for additional information pur- tion, corporate division, association, suant to § 1301.15 and has no bearing on trust or other entity. An applicant may whether the application will be grant- authorize one or more individuals, who ed. would not otherwise be authorized to [62 FR 13948, Mar. 24, 1997] do so, to sign applications for the applicant by filing with the Registration § 1301.15 Additional information. Unit of the Administration a power of The Administrator may require an attorney for each such individual. The applicant to submit such documents or power of attorney shall be signed by a written statements of fact relevant to person who is authorized to sign appli- the application as he/she deems nec- cations under this paragraph and shall essary to determine whether the appli- contain the signature of the individual cation should be granted. The failure of being authorized to sign applications. the applicant to provide such docu- The power of attorney shall be valid ments or statements within a reason- until revoked by the applicant. able time after being requested to do so [62 FR 13946, Mar. 24, 1997] shall be deemed to be a waiver by the applicant of an opportunity to present § 1301.14 Filing of application; accept- such documents or facts for consider- ance for filing; defective applica- ation by the Administrator in granting tions. or denying the application. (a) All applications for registration shall be submitted for filing to the [62 FR 13948, Mar. 24, 1997] Registration Unit, Drug Enforcement § 1301.16 Amendments to and with- Administration, Department of Jus- drawal of applications. tice, Post Office Box 28083, Central Sta- tion, Washington, DC 20005. The appro- (a) An application may be amended priate registration fee and any required or withdrawn without permission of attachments must accompany the ap- the Administrator at any time before plication. the date on which the applicant re- (b) Any person required to obtain ceives an order to show cause pursuant more than one registration may submit to § 1301.37. An application may be all applications in one package. Each amended or withdrawn with permission application must be complete and of the Administrator at any time should not refer to any accompanying where good cause is shown by the ap- application for required information. plicant or where the amendment or (c) Applications submitted for filing withdrawal is in the public interest. are dated upon receipt. If found to be (b) After an application has been ac- complete, the application will be accepted for filing, the request by the ap- cepted for filing. Applications failing plicant that it be returned or the fail- to comply with the requirements of ure of the applicant to respond to offi- this part will not generally be accepted cial correspondence regarding the ap- for filing. In the case of minor defects plication, when sent by registered or as to completeness, the Administrator certified mail, return receipt re- may accept the application for filing quested, shall be deemed to be a with- with a request to the applicant for ad- drawal of the application. ditional information. A defective appli- [62 FR 13949, Mar. 24, 1997]

17 § 1301.17 21 CFR Ch. II (4–1–99 Edition)

§ 1301.17 Special procedures for cer- macy has been issued a valid State li- tain applications. cense. The transferee shall include (a) If, at the time of application for with his/her application the following registration of a new pharmacy, the affidavit: pharmacy has been issued a license from the appropriate State licensing Affidavit for Transfer of Pharmacy agency, the applicant may include with I, llllllllll, the his/her application an affidavit as to llllllllll (Title of officer, official, the existence of the State license in partner or other position) of the following form: llllllllll (Corporation, partnership, or sole proprietor), doing business as Affidavit for New Pharmacy llllllllll (Store name) hereby certify: llllllllll I, , the (1) That said company was issued a phar- llllllllll (Title of officer, official, macy permit No.llllllby the partner, or other position) of llllllllll (Board of Pharmacy of llllllllll (Corporation, partner- Licensing Agency) of the State of ship, or sole proprietor), doing business as llllll and a DEA Registration Number llllllllll (Store name) at llllllllll for a pharmacy located at llllllllll (Number and Street), llllllllll (Number and Street) llllllllll llllll (City) (State) llllll (City) llllll (State) llllll (Zip code), hereby certify that llllll (Zip Code); and said store was issued a pharmacy permit No. (2) That said company is acquiring the llll llllllll by the (Board of pharmacy business of llllllllll Pharmacy or Licensing Agency) of the State (Name of Seller) doing business llllll llllll of on (Date). asllllllllllwith DEA Registration This statement is submitted in order to ob- Number llllll on or about llllll tain a Drug Enforcement Administration (Date of Transfer) and that said company has registration number. I understand that if applied (or will apply on llllll (Date) any information is false, the Administration for a pharmacy permit from the board of may immediately suspend the registration pharmacy (or licensing agency) of the State for this store and commence proceedings to of llllll to do business as revoke under 21 U.S.C. 824(a) because of the llllllllll (Store name) at danger to public health and safety. I further llllllllll (Number and Street) understand that any false information con- llllllllll (City) llllll (State) tained in this affidavit may subject me per- llllll (Zip Code). sonally and the above-named corporation/ partnership/business to prosecution under 21 This statement is submitted in order U.S.C. 843, the penalties for conviction of to obtain a Drug Enforcement Admin- which include imprisonment for up to 4 istration registration number. years, a fine of not more than $30,000 or both. llllllllllllllllllllllll I understand that if a DEA registration Signature (Person who signs Application for number is issued, the pharmacy may acquire Registration) controlled substances but may not dispense State of lllllllllllllllllll them until a pharmacy permit or license is County of llllllllllllllllll issued by the State board of pharmacy or li- Subscribed to and sworn before me this censing agency. llll day of llll, 19lll. I understand that if any information is llllllllllllllllllllllll false, the Administration may immediately Notary Public suspend the registration for this store and commence proceedings to revoke under 21 (b) Whenever the ownership of a U.S.C. 824(a) because of the danger to public pharmacy is being transferred from one health and safety. I further understand that person to another, if the transferee any false information contained in this affi- owns at least one other pharmacy li- davit may subject me personally to prosecu- censed in the same State as the one the tion under 21 U.S.C. 843, the penalties for ownership of which is being trans- conviction of which include imprisonment ferred, the transferee may apply for for up to 4 years, a fine of not more than registration prior to the date of trans- $30,000 or both. fer. The Administrator may register llllllllllllllllllllllll the applicant and authorize him to ob- Signature (Person who signs Application for Registration) tain controlled substances at the time State of lllllllllllllllllll of transfer. Such registration shall not County of llllllllllllllllll authorize the transferee to dispense Subscribed to and sworn before me controlled substances until the phar- thisllday ofllllll, 19ll.

18 Drug Enforcement Administration, Justice § 1301.18 llllllllllllllllllllllll (vi) Statement of the security provi- Notary Public sions for storing the controlled sub- (c) The Administrator shall follow stances (in accordance with § 1301.75) the normal procedures for approving an and for dispensing the controlled sub- application to verify the statements in stances in order to prevent diversion. the affidavit. If the statements prove (vii) If the investigator desires to to be false, the Administrator may re- manufacture or import any controlled voke the registration on the basis of substance listed in paragraph (a)(2)(iii) section 304(a)(1) of the Act (21 U.S.C. of this section, a statement of the 824(a)(1)) and suspend the registration quantity to be manufactured or im- immediately by pending revocation on ported and the sources of the chemicals the basis of section 304(d) of the Act (21 to be used or the substance to be im- U.S.C. 824(d)). At the same time, the ported. Administrator may seize and place (3) Authority: under seal all controlled substances (i) Institutional approval. possessed by the applicant under sec- (ii) Approval of a Human Research tion 304(f) of the Act (21 U.S.C. 824(f)). Committee for human studies. Intentional misuse of the affidavit pro- (iii) Indication of an approved active cedure may subject the applicant to Notice of Claimed Investigational Ex- prosecution for fraud under section emption for a New Drug (number). 403(a)(4) of the Act (21 U.S.C. 843(a)(4)), (iv) Indication of an approved funded and obtaining controlled substances grant (number), if any. through registration by fraudulent (b) In the case of a clinical investiga- means may subject the applicant to tion with controlled substances listed prosecution under section 403(a)(3) of in Schedule I, the applicant shall sub- the Act (21 U.S.C. 843(a)(3)). The pen- mit three copies of a Notice of Claimed alties for conviction of either offense Investigational Exemption for a New include imprisonment for up to 4 years, Drug (IND) together with a statement a fine not exceeding $30,000 or both. of the security provisions (as proscribed in paragraph (a)(2)(vi) of this [62 FR 13949, Mar. 24, 1997] section for a research protocol) to, and have such submission approved by, the § 1301.18 Research protocols. Food and Drug Administration as re- (a) A protocol to conduct research quired in 21 U.S.C. 355(i) and § 130.3 of with controlled substances listed in this title. Submission of this Notice Schedule I shall be in the following and statement to the Food and Drug form and contain the following infor- Administration shall be in lieu of a re- mation where applicable: search protocol to the Administration (1) Investigator: as required in paragraph (a) of this sec- (i) Name, address, and DEA registration. The applicant, when applying for tion number; if any. registration with the Administration, (ii) Institutional affiliation. shall indicate that such notice has (iii) Qualifications, including a cur- been submitted to the Food and Drug riculum vitae and an appropriate bibli- Administration by submitting to the ography (list of publications). Administration with his/her DEA Form (2) Research project: 225 three copies of the following certifi- (i) Title of project. cate: (ii) Statement of the purpose. I hereby certify that on llllllllll (iii) Name of the controlled sub- (Date), pursuant to 21 U.S.C. 355(i) and 21 stances or substances involved and the CFR 130.3, I, llllllllll (Name and amount of each needed. Address of IND Sponsor) submitted a Notice (iv) Description of the research to be of Claimed Investigational Exemption for a conducted, including the number and New Drug (IND) to the Food and Drug Ad- species of research subjects, the dosage ministration for: to be administered, the route and llllllllllllllllllllllll method of administration, and the du- (Name of Investigational Drug). ration of the project. llllllllllllllllllllllll (v) Location where the research will (Date) be conducted. llllllllllllllllllllllll

19 § 1301.21 21 CFR Ch. II (4–1–99 Edition)

(Signature of Applicant). (1) Any hospital or other institution (c) In the event that the registrant which is operated by an agency of the desires to increase the quantity of a United States (including the U.S. controlled substance used for an ap- Army, Navy, Marine Corps., Air Force, proved research project, he/she shall and Coast Guard), of any State, or any political subdivision or agency thereof. submit a request to the Registration (2) Any individual practitioner who is Unit, Drug Enforcement Administra- required to obtain an individual reg- tion, Post Office Box 28083, Central istration in order to carry out his or Station, Washington, DC 20005, by reg- her duties as an official of an agency of istered mail, return receipt requested. the United States (including the U.S. The request shall contain the following Army, Navy, Marine Corps, Air Force, information: DEA registration number; and Coast Guard), of any State, or any name of the controlled substance or political subdivision or agency thereof. substances and the quantity of each (b) In order to claim exemption from authorized in the approved protocol; payment of a registration or rereg- and the additional quantity of each de- istration application fee, the registrant sired. Upon return of the receipt, the shall have completed the certification registrant shall be authorized to pur- on the appropriate application form, chase the additional quantity of the wherein the registrant’s superior (if controlled substance or substances the registrant is an individual) or offi- specified in the request. The Adminis- cer (if the registrant is an agency) cer- tration shall review the letter and for- tifies to the status and address of the ward it to the Food and Drug Adminis- registrant and to the authority of the tration together with the Administra- registrant to acquire, possess, or han- tion comments. The Food and Drug Ad- dle controlled substances. ministration shall approve or deny the (c) Exemption from payment of a reg- request as an amendment to the pro- istration or reregistration application tocol and so notify the registrant. Ap- fee does not relieve the registrant of proval of the letter by the Food and any other requirements or duties pre- Drug Administration shall authorize scribed by law. the registrant to use the additional quantity of the controlled substance in [62 FR 13950, Mar. 24, 1997] the research project. § 1301.22 Exemption of agents and em- (d) In the event the registrant desires ployees; affiliated practitioners. to conduct research beyond the vari- ations provided in the registrant’s ap- (a) The requirement of registration is proved protocol (excluding any in- waived for any agent or employee of a crease in the quantity of the controlled person who is registered to engage in substance requested for his/her re- any group of independent activities, if search project as outlined in paragraph such agent or employee is acting in the (c) of this section), he/she shall submit usual course of his/her business or em- three copies of a supplemental protocol ployment. in accordance with paragraph (a) of (b) An individual practitioner who is this section describing the new re- an agent or employee of another prac- search and omitting information in the titioner (other than a mid-level practi- supplemental protocol which has been tioner) registered to dispense con- stated in the original protocol. Supple- trolled substances may, when acting in mental protocols shall be processed and the normal course of business or em- approved or denied in the same manner ployment, administer or dispense as original research protocols. (other than by issuance of prescription) controlled substances if and to the ex- [62 FR 13949, Mar. 24, 1997] tent that such individual practitioner is authorized or permitted to do so by EXCEPTIONS TO REGISTRATION AND FEES the jurisdiction in which he or she practices, under the registration of the § 1301.21 Exemption from fees. employer or principal practitioner in (a) The Administrator shall exempt lieu of being registered him/herself. from payment of an application fee for (c) An individual practitioner who is registration or reregistration: an agent or employee of a hospital or

20 Drug Enforcement Administration, Justice § 1301.24 other institution may, when acting in cial duties. Such officials shall follow the normal course of business or em- procedures set forth in part 1306 of this ployment, administer, dispense, or pre- chapter regarding prescriptions, but scribe controlled substances under the shall state the branch of service or registration of the hospital or other in- agency (e.g., ‘‘U.S. Army’’ or ‘‘Public stitution which is registered in lieu of Health Service’’) and the service iden- being registered him/herself, provided tification number of the issuing official that: in lieu of the registration number re- (1) Such dispensing, administering or quired on prescription forms. The serv- prescribing is done in the usual course ice identification number for a Public of his/her professional practice; Health Service employee is his/her So- (2) Such individual practitioner is au- cial Security identification number. thorized or permitted to do so by the (b) The requirement of registration is jurisdiction in which he/she is prac- waived for any official or agency of the ticing; U.S. Army, Navy, Marine Corps, Air (3) The hospital or other institution Force, Coast Guard, or Public Health by whom he/she is employed has Service who or which is authorized to verified that the individual practi- import or export controlled substances tioner is so permitted to dispense, ad- in the course of his/her official duties. minister, or prescribe drugs within the (c) If any official exempted by this jurisdiction; section also engages as a private indi- (4) Such individual practitioner is vidual in any activity or group of ac- acting only within the scope of his/her tivities for which registration is re- employment in the hospital or institu- quired, such official shall obtain a reg- tion; istration for such private activities. (5) The hospital or other institution [62 FR 13951, Mar. 24, 1997] authorizes the individual practitioner to administer, dispense or prescribe § 1301.24 Exemption of law enforce- under the hospital registration and ment officials. designates a specific internal code (a) The requirement of registration is number for each individual practi- waived for the following persons in the tioner so authorized. The code number circumstances described in this sec- shall consist of numbers, letters, or a tion: combination thereof and shall be a suf- (1) Any officer or employee of the Ad- fix to the institution’s DEA registra- ministration, any officer of the U.S. tion number, preceded by a hyphen Customs Service, any officer or em- (e.g., APO123456–10 or APO123456–A12); ployee of the United States Food and and Drug Administration, and any other (6) A current list of internal codes Federal officer who is lawfully engaged and the corresponding individual prac- in the enforcement of any Federal law titioners is kept by the hospital or relating to controlled substances, other institution and is made available drugs or customs, and is duly author- at all times to other registrants and ized to possess or to import or export law enforcement agencies upon request controlled substances in the course of for the purpose of verifying the author- his/her official duties; and ity of the prescribing individual practi- (2) Any officer or employee of any tioner. State, or any political subdivision or [62 FR 13950, Mar. 24, 1997] agency thereof, who is engaged in the enforcement of any State or local law § 1301.23 Exemption of certain mili- relating to controlled substances and is tary and other personnel. duly authorized to possess controlled (a) The requirement of registration is substances in the course of his/her offi- waived for any official of the U.S. cial duties. Army, Navy, Marine Corps, Air Force, (b) Any official exempted by this sec- Coast Guard, Public Health Service, or tion may, when acting in the course of Bureau of Prisons who is authorized to his/her official duties, procure any con- prescribe, dispense, or administer, but trolled substance in the course of an not to procure or purchase, controlled inspection, in accordance with substances in the course of his/her offi- § 1316.03(d) of this chapter, or in the

21 § 1301.25 21 CFR Ch. II (4–1–99 Edition) course of any criminal investigation ports of the United States and any involving the person from whom the merchant vessel belonging to the U.S. substance was procured, and may pos- Government; sess any controlled substance and dis- (2) On board any aircraft operated by tribute any such substance to any an air carrier under a certificate of per- other official who is also exempted by mit issued pursuant to the Federal this section and acting in the course of Aviation Act of 1958 (49 U.S.C. 1301); his/her official duties. and (c) In order to enable law enforce- (3) In any other entity of fixed or ment agency laboratories, including transient location approved by the Ad- laboratories of the Administration, to ministrator as appropriate for applica- obtain and transfer controlled sub- tion of this section (e.g., emergency stances for use as standards in chem- kits at field sites of an industrial firm). ical analysis, such laboratories shall (b) A medical officer shall be: obtain annually a registration to con- (1) Licensed in a state as a physician; duct chemical analysis. Such labora- (2) Employed by the owner or oper- tories shall be exempted from payment ator of the vessel, aircraft or other en- of a fee for registration. Laboratory tity; and personnel, when acting in the scope of (3) Registered under the Act at either their official duties, are deemed to be of the following locations: officials exempted by this section and (i) The principal office of the owner within the activity described in section or operator of the vessel, aircraft or 515(d) of the Act (21 U.S.C. 885(d)). For other entity or purposes of this paragraph, laboratory (ii) At any other location provided activities shall not include field or that the name, address, registration other preliminary chemical tests by of- number and expiration date as they ap- ficials exempted by this section. pear on his/her Certificate of Registra- (d) In addition to the activities au- tion (DEA Form 223) for this location thorized under a registration to con- are maintained for inspection at said duct chemical analysis pursuant to principal office in a readily retrievable § 1301.13(e)(1)(ix), laboratories of the manner. Administration shall be authorized to (c) A registered medical officer may manufacture or import controlled sub- serve as medical officer for more than stances for any lawful purpose, to dis- one vessel, aircraft, or other entity tribute or export such substances to under a single registration, unless he/ any person, and to import and export she serves as medical officer for more such substances in emergencies with- than one owner or operator, in which out regard to the requirements of part case he/she shall either maintain a sep- 1312 of this chapter if a report con- arate registration at the location of cerning the importation or exportation the principal office of each such owner is made to the Drug Operations Section or operator or utilize one or more reg- of the Administration within 30 days of istrations pursuant to paragraph such importation or exportation. (b)(3)(ii) of this section. [62 FR 13951, Mar. 24, 1997] (d) If no medical officer is employed by the owner or operator of a vessel, or § 1301.25 Registration regarding ocean in the event such medical officer is not vessels, aircraft, and other entities. accessible and the acquisition of con- (a) If acquired by and dispensed under trolled substances is required, the mas- the general supervision of a medical of- ter or first officer of the vessel, who ficer described in paragraph (b) of this shall not be registered under the Act, section, or the master or first officer of may purchase controlled substances the vessel under the circumstances de- from a registered manufacturer or dis- scribed in paragraph (d) of this section, tributor, or from an authorized phar- controlled substances may be held for macy as described in paragraph (f) of stocking, be maintained in, and dis- this section, by following the procedure pensed from medicine chests, first aid outlined below: packets, or dispensaries: (1) The master or first officer of the (1) On board any vessel engaged in vessel must personally appear at the international trade or in trade between vendor’s place of business, present

22 Drug Enforcement Administration, Justice § 1301.25 proper identification (e.g., Seaman’s be documented, in triplicate, on a photographic identification card) and a record of sale in a format similar to written requisition for the controlled that outlined in paragraph (d)(4) of this substances. section. The vessel’s requisition shall (2) The written requisition must be be attached to copy 1 of the record of on the vessel’s official stationery or sale and filed with the controlled sub- purchase order form and must include stances records of the vendor, copy 2 of the name and address of the vendor, the record of sale shall be furnished to the name of the controlled substance, the officer of the vessel and retained description of the controlled substance aboard the vessel, copy 3 of the record (dosage form, strength and number or of sale shall be forwarded to the near- volume per container) number of con- est DEA Division Office within 15 days tainers ordered, the name of the vessel, after the end of the month in which the the vessel’s official number and coun- sale is made. try of registry, the owner or operator (4) The vendor’s record of sale should of the vessel, the port at which the vessel is located, signature of the vessel’s be similar to, and must include all the officer who is ordering the controlled information contained in, the below substances and the date of the requisi- listed format. tion. SALE OF CONTROLLED SUBSTANCES TO (3) The vendor may, after verifying VESSELS the identification of the vessel’s officer llllllllllll requisitioning the controlled sub- (Name of registrant) stances, deliver the control substances (Address of registrant) lllllllllll to that officer. The transaction shall (DEA registration number) lllllllll

Number of pack- Packages distrib- Line No. ages ordered Size of packages Name of product uted Date distributed

1 ...... 2 ...... 3 ......

FOOTNOTE: Line numbers may be continued according to needs of the vendor.

Number of lines completed lllllllll copy of the report to the Administra- Name of vessel lllllllllllllll tion. The medical officer need not be Vessel’s official number lllllllllll present when controlled substances are Vessel’s country of registry lllllllll dispensed, if the person who actually lllllll Owner or operator of the vessel dispensed the controlled substances is Name and title of vessel’s officer who pre- responsible to the medical officer to llll sented the requisition justify his/her actions. Signature of vessel’s officer who presented (f) Any registered pharmacy that the requisition llll wishes to distribute controlled sub- (e) Any medical officer described in stances pursuant to this section shall paragraph (b) of this section shall, in be authorized to do so, provided: addition to complying with all require- (1) The registered pharmacy notifies ments and duties prescribed for reg- the nearest Division Office of the Ad- istrants generally, prepare an annual ministration of its intention to so dis- report as of the date on which his/her tribute controlled substances prior to registration expires, which shall give the initiation of such activity. This no- in detail an accounting for each vessel, tification shall be by registered mail aircraft, or other entity, and a sum- and shall contain the name, address, mary accounting for all vessels, air- and registration number of the phar- craft, or other entities under his/her macy as well as the date upon which supervision for all controlled sub- such activity will commence; and stances purchased, dispensed or dis- (2) Such activity is authorized by posed of during the year. The medical state law; and officer shall maintain this report with (3) The total number of dosage units other records required to be kept under of all controlled substances distributed the Act and, upon request, deliver a by the pharmacy during any calendar

23 § 1301.26 21 CFR Ch. II (4–1–99 Edition) year in which the pharmacy is reg- (a) The controlled substance is in the istered to dispense does not exceed the original container in which it was dis- limitations imposed upon such dispensed to the individual; and tribution by § 1307.11(a)(4) and (b) of (b) The individual makes a declara- this chapter. tion to an appropriate official of the (g) Owners or operators of vessels, U.S. Customs Service stating: aircraft, or other entities described in (1) That the controlled substance is this section shall not be deemed to pos- possessed for his/her personal use, or sess or dispense any controlled sub- for an animal accompanying him/her; stance acquired, stored and dispensed and in accordance with this section. Addi- (2) The trade or chemical name and tionally, owners or operators of ves- the symbol designating the schedule of sels, aircraft, or other entities de- the controlled substance if it appears scribed in this section or in Article 32 on the container label, or, if such name of the Single Convention on Narcotic does not appear on the label, the name Drugs, 1961, or in Article 14 of the Con- and address of the pharmacy or practi- vention on Psychotropic Substances, tioner who dispensed the substance and the prescription number, if any; and 1971, shall not be deemed to import or (c) The importation of the controlled export any controlled substances pur- substance for personal medical use is chased and stored in accordance with authorized or permitted under other that section or applicable article. Federal laws and state law. (h) The Master of a vessel shall prepare a report for each calendar year [62 FR 13952, Mar. 24, 1997] which shall give in detail an accounting for all controlled substances pur- ACTION ON APPLICATION FOR REGISTRA- chased, dispensed, or disposed of during TION: REVOCATION OR SUSPENSION OF the year. The Master shall file this re- REGISTRATION port with the medical officer employed § 1301.31 Administrative review gen- by the owner or operator of his/her ves- erally. sel, if any, or, if not, he/she shall main- The Administrator may inspect, or tain this report with other records re- cause to be inspected, the establish- quired to be kept under the Act and, ment of an applicant or registrant, pur- upon request, deliver a copy of the re- suant to subpart A of part 1316 of this port to the Administration. chapter. The Administrator shall re- (i) Controlled substances acquired view the application for registration and possessed in accordance with this and other information gathered by the section shall not be distributed to per- Administrator regarding an applicant sons not under the general supervision in order to determine whether the ap- of the medical officer employed by the plicable standards of section 303 (21 owner or operator of the vessel, air- U.S.C. 823) or section 1008 (21 U.S.C. 958) craft, or other entity, except in accord- of the Act have been met by the appli- ance with § 1307.21 of this chapter. cant. [62 FR 13951, Mar. 24, 1997] [62 FR 13953, Mar. 24, 1997]

§ 1301.26 Exemptions from import or § 1301.32 Action on applications for reexport requirements for personal search in Schedule I substances. medical use. (a) In the case of an application for Any individual who has in his/her registration to conduct research with possession a controlled substance listed controlled substances listed in Sched- in schedules II, III, IV, or V, which he/ ule I, the Administrator shall process she has lawfully obtained for his/her the application and protocol and for- personal medical use, or for adminis- ward a copy of each to the Secretary of tration to an animal accompanying Health and Human Services (Secretary) him/her, may enter or depart the within 7 days after receipt. The Sec- United States with such substance not- retary shall determine the qualifica- withstanding sections 1002–1005 of the tions and competency of the applicant, Act (21 U.S.C. 952–955), providing the as well as the merits of the protocol following conditions are met: (and shall notify the Administrator of

24 Drug Enforcement Administration, Justice § 1301.34 his/her determination) within 21 days essing of an application or research after receipt of the application and protocol is delayed beyond the time complete protocol, except that in the limits imposed by this section, the ap- case of a clinical investigation, the plicant shall be so notified in writing. Secretary shall have 30 days to make such determination and notify the Ad- [62 FR 13953, Mar. 24, 1997] ministrator. The Secretary, in deter- § 1301.33 Application for bulk manu- mining the merits of the protocol, shall facture of Schedule I and II sub- consult with the Administrator as to stances. effective procedures to safeguard adequately against diversion of such con- (a) In the case of an application for trolled substances from legitimate registration or reregistration to manu- medical or scientific use. facture in bulk a basic class of con- (b) An applicant whose protocol is de- trolled substance listed in Schedule I fective shall be notified by the Sec- or II, the Administrator shall, upon the retary within 21 days after receipt of filing of such application, publish in such protocol from the Administrator the FEDERAL REGISTER a notice naming (or in the case of a clinical investiga- the applicant and stating that such ap- tion within 30 days), and he/she shall be plicant has applied to be registered as requested to correct the existing de- a bulk manufacturer of a basic class of fects before consideration shall be narcotic or nonnarcotic controlled sub- given to his/her submission. stance, which class shall be identified. (c) If the Secretary determines the A copy of said notice shall be mailed applicant qualified and competent and simultaneously to each person reg- the research protocol meritorious, he/ istered as a bulk manufacturer of that she shall notify the Administrator in basic class and to any other applicant writing of such determination. The Ad- therefor. Any such person may, within ministrator shall issue a certificate of 60 days from the date of publication of registration within 10 days after re- the notice in the FEDERAL REGISTER, ceipt of this notice, unless he/she deter- file with the Administrator written mines that the certificate of registra- comments on or objections to the tion should be denied on a ground spec- issuance of the proposed registration. ified in section 304(a) of the Act (21 (b) In order to provide adequate com- U.S.C. 824(a)). In the case of a supple- petition, the Administrator shall not mental protocol, a replacement certifi- be required to limit the number of cate of registration shall be issued by manufacturers in any basic class to a the Administrator. number less than that consistent with (d) If the Secretary determines that maintenance of effective controls the protocol is not meritorious and/or against diversion solely because a the applicant is not qualified or com- smaller number is capable of producing petent, he/she shall notify the Adminis- an adequate and uninterrupted supply. trator in writing setting forth the rea- (c) This section shall not apply to the sons for such determination. If the Ad- manufacture of basic classes of con- ministrator determines that grounds trolled substances listed in Schedules I exist for the denial of the application, or II as an incident to research or he/she shall within 10 days issue an chemical analysis as authorized in order to show cause pursuant to § 1301.13(e)(1). § 1301.37 and, if requested by the applicant, hold a hearing on the application [62 FR 13953, Mar. 24, 1997] pursuant to § 1301.41. If the grounds for denial of the application include a de- § 1301.34 Application for importation termination by the Secretary, the Sec- of Schedule I and II substances. retary or his duly authorized agent (a) In the case of an application for shall furnish testimony and documents registration or reregistration to import pertaining to his determination at such a controlled substance listed in Sched- hearing. ule I or II, under the authority of sec- (e) Supplemental protocols will be tion 1002(a)(2)(B) of the Act (21 U.S.C. processed in the same manner as origi- 952(a)(2)(B)), the Administrator shall, nal research protocols. If the proc- upon the filing of such application,

25 § 1301.34 21 CFR Ch. II (4–1–99 Edition) publish in the FEDERAL REGISTER a no- of establishments which can produce tice naming the applicant and stating an adequate and uninterrupted supply that such applicant has applied to be of these substances under adequately registered as an importer of a Schedule competitive conditions for legitimate I or II controlled substance, which sub- medical, scientific, research, and instance shall be identified. A copy of dustrial purposes; said notice shall be mailed simulta- (2) Compliance with applicable State neously to each person registered as a and local law; bulk manufacturer of that controlled (3) Promotion of technical advances substance and to any other applicant in the art of manufacturing these sub- therefor. Any such person may, within stances and the development of new 30 days from the date of publication of substances; the notice in the FEDERAL REGISTER, (4) Prior conviction record of appli- file written comments on or objections cant under Federal and State laws re- to the issuance of the proposed reg- lating to the manufacture, distribu- istration, and may, at the same time, tion, or dispensing of such substances; file a written request for a hearing on (5) Past experience in the manufac- the application pursuant to § 1301.43. If ture of controlled substances, and the a hearing is requested, the Adminis- existence in the establishment of effec- trator shall hold a hearing on the ap- tive control against diversion; plication in accordance with § 1301.41. Notice of the hearing shall be published (6) That the applicant will be permitted to import only: in the FEDERAL REGISTER, and shall be mailed simultaneously to the applicant (i) Such amounts of crude opium, and to all persons to whom notice of poppy straw, concentrate of poppy the application was mailed. Any such straw, and coca leaves as the Adminis- person may participate in the hearing trator finds to be necessary to provide by filing a notice of appearance in ac- for medical, scientific, or other legiti- cordance with § 1301.43 of this chapter. mate purposes; or Notice of the hearing shall contain a (ii) Such amounts of any controlled summary of all comments and objec- substances listed in Schedule I or II as tions filed regarding the application the Administrator shall find to be nec- and shall state the time and place for essary to provide for the medical, sci- the hearing, which shall not be less entific, or other legitimate needs of the than 30 days after the date of publica- United States during an emergency in tion of such notice in the FEDERAL which domestic supplies of such sub- REGISTER. A hearing pursuant to this stances are found by the Administrator section may be consolidated with a to be inadequate; or hearing held pursuant to § 1301.35 or (iii) Such amounts of any controlled § 1301.36 of this part. substance listed in Schedule I or II as (b) The Administrator shall register the Administrator shall find to be nec- an applicant to import a controlled essary to provide for the medical, sci- substance listed in Schedule I or II if entific, or other legitimate needs of the he/she determines that such registra- United States in any case in which the tion is consistent with the public inter- Administrator finds that competition est and with U.S. obligations under among domestic manufacturers of the international treaties, conventions, or controlled substance is inadequate and protocols in effect on May 1, 1971. In will not be rendered adequate by the determining the public interest, the registration of additional manufactur- following factors shall be considered: ers under section 303 of the Act (21 (1) Maintenance of effective controls U.S.C. 823); or against diversion of particular con- (iv) Such limited quantities of any trolled substances and any controlled controlled substance listed in Schedule substance in Schedule I or II com- I or II as the Administrator shall find pounded therefrom into other than le- to be necessary for scientific, analyt- gitimate medical, scientific research, ical or research uses; and or industrial channels, by limiting the (7) Such other factors as may be rel- importation and bulk manufacture of evant to and consistent with the public such controlled substances to a number health and safety.

26 Drug Enforcement Administration, Justice § 1301.35

(c) In determining whether the appli- (5) Such other factors as may be rel- cant can and will maintain effective evant to the determinations required controls against diversion within the under this paragraph. meaning of paragraph (b) of this sec- (e) In considering the scope of the do- tion, the Administrator shall consider mestic market, consideration shall be among other factors: given to substitute products which are (1) Compliance with the security re- reasonably interchangeable in terms of quirements set forth in §§ 1301.71– price, quality and use. 1301.76; and (f) The fact that the number of exist- (2) Employment of security proce- ing manufacturers is small shall not dures to guard against in-transit losses demonstrate, in and of itself, that ade- within and without the jurisdiction of quate competition among them does the United States. not exist. (d) In determining whether competition among the domestic manufactur- [62 FR 13953, Mar. 24, 1997] ers of a controlled substance is adequate within the meaning of para- § 1301.35 Certificate of registration; graphs (b)(1) and (b)(6)(iii) of this sec- denial of registration. tion, as well as section 1002(a)(2)(B) of (a) The Administrator shall issue a the Act (21 U.S.C. 952(a)(2)(B)), the Ad- Certificate of Registration (DEA Form ministrator shall consider: 223) to an applicant if the issuance of (1) The extent of price rigidity in the registration or reregistration is re- light of changes in: quired under the applicable provisions (i) raw materials and other costs and of sections 303 or 1008 of the Act (21 (ii) conditions of supply and demand; U.S.C. 823 and 958). In the event that (2) The extent of service and quality the issuance of registration or rereg- competition among the domestic man- istration is not required, the Adminis- ufacturers for shares of the domestic trator shall deny the application. Be- market including: fore denying any application, the Ad- (i) Shifts in market shares and ministrator shall issue an order to (ii) Shifts in individual customers show cause pursuant to § 1301.37 and, if among domestic manufacturers; requested by the applicant, shall hold a (3) The existence of substantial dif- hearing on the application pursuant to ferentials between domestic prices and § 1301.41. the higher of prices generally pre- (b) If in response to a show cause vailing in foreign markets or the prices order a hearing is requested by an ap- at which the applicant for registration plicant for registration or reregistra- to import is committed to undertake tion to manufacture in bulk a basic to provide such products in the domes- class of controlled substance listed in tic market in conformity with the Act. Schedule I or II, notice that a hearing In determining the existence of sub- has been requested shall be published stantial differentials hereunder, appro- in the FEDERAL REGISTER and shall be priate consideration should be given to any additional costs imposed on domes- mailed simultaneously to the applicant tic manufacturers by the requirements and to all persons to whom notice of of the Act and such other cost-related the application was mailed. Any person and other factors as the Administrator entitled to file comments or objections may deem relevant. In no event shall to the issuance of the proposed reg- an importer’s offering prices in the istration pursuant to § 1301.33(a) may United States be considered if they are participate in the hearing by filing no- lower than those prevailing in the for- tice of appearance in accordance with eign market or markets from which § 1301.43. Such persons shall have 30 the importer is obtaining his/her sup- days to file a notice of appearance after ply; the date of publication of the notice of (4) The existence of competitive re- a request for a hearing in the FEDERAL straints imposed upon domestic manu- REGISTER. facturers by governmental regulations; (c) The Certificate of Registration and (DEA Form 223) shall contain the

27 § 1301.36 21 CFR Ch. II (4–1–99 Edition) name, address, and registration num- the registrant, shall hold a hearing ber of the registrant, the activity au- pursuant to § 1301.41. thorized by the registration, the sched- (e) The Administrator may suspend ules and/or Administration Controlled any registration simultaneously with Substances Code Number (as set forth or at any time subsequent to the serv- in part 1308 of this chapter) of the con- ice upon the registrant of an order to trolled substances which the registrant show cause why such registration is authorized to handle, the amount of should not be revoked or suspended, in fee paid (or exemption), and the expira- any case where he/she finds that there tion date of the registration. The reg- is an imminent danger to the public istrant shall maintain the certificate health or safety. If the Administrator of registration at the registered loca- so suspends, he/she shall serve with the tion in a readily retrievable manner order to show cause pursuant to and shall permit inspection of the cer- § 1301.37 an order of immediate suspen- tificate by any official, agent or em- sion which shall contain a statement of ployee of the Administration or of any his findings regarding the danger to Federal, State, or local agency engaged public health or safety. in enforcement of laws relating to con- (f) Upon service of the order of the trolled substances. Administrator suspending or revoking [62 FR 13954, Mar. 24, 1997] registration, the registrant shall immediately deliver his/her Certificate of § 1301.36 Suspension or revocation of Registration, any order forms, and any registration; suspension of registra- import or export permits in his/her pos- tion pending final order; extension session to the nearest office of the Ad- of registration pending final order. ministration. The suspension or rev- (a) For any registration issued under ocation of a registration shall suspend section 303 of the Act (21 U.S.C. 823), or revoke any individual manufac- the Administrator may: turing or procurement quota fixed for (1) Suspend the registration pursuant the registrant pursuant to part 1303 of to section 304(a) of the Act (21 U.S.C. this chapter and any import or export 824(a)) for any period of time. permits issued to the registrant pursu- (2) Revoke the registration pursuant ant to part 1312 of this chapter. Also, to section 304(a) of the Act (21 U.S.C. upon service of the order of the Admin- 824(a)). istrator revoking or suspending reg- (b) For any registration issued under istration, the registrant shall, as in- section 1008 of the Act (21 U.S.C. 958), structed by the Administrator: the Administrator may: (1) Suspend the registration pursuant (1) Deliver all controlled substances to section 1008(d) of the Act (21 U.S.C. in his/her possession to the nearest of- 958(d)) for any period of time. fice of the Administration or to au- (2) Revoke the registration pursuant thorized agents of the Administration; to section 1008(d) of the Act (21 U.S.C. or 958(d)) if he/she determines that such (2) Place all controlled substances in registration is inconsistent with the his/her possession under seal as de- public interest as defined in section scribed in sections 304(f) or 1008(d)(6) of 1008 or with the United States obliga- the Act (21 U.S.C. 824(f) or 958(d)(6)). tions under international treaties, con- (g) In the event that revocation or ventions, or protocols in effect on Oc- suspension is limited to a particular tober 12, 1984. controlled substance or substances, the (c) The Administrator may limit the registrant shall be given a new Certifi- revocation or suspension of a registra- cate of Registration for all substances tion to the particular controlled sub- not affected by such revocation or sus- stance, or substances, with respect to pension; no fee shall be required to be which grounds for revocation or sus- paid for the new Certificate of Reg- pension exist. istration. The registrant shall deliver (d) Before revoking or suspending the old Certificate of Registration and, any registration, the Administrator if appropriate, any order forms in his/ shall issue an order to show cause pur- her possession to the nearest office of suant to § 1301.37 and, if requested by the Administration. The suspension or

28 Drug Enforcement Administration, Justice § 1301.37 revocation of a registration, when lim- istration under the circumstances con- ited to a particular basic class or class- templated in this section even though es of controlled substances, shall sus- the registrant failed to apply for rereg- pend or revoke any individual manu- istration at least 45 days before expira- facturing or procurement quota fixed tion of the existing registration, with for the registrant for such class or or without request by the registrant, if classes pursuant to part 1303 of this the Administrator finds that such ex- chapter and any import or export per- tension is not inconsistent with the mits issued to the registrant for such public health and safety. class or classes pursuant to part 1312 of this chapter. Also, upon service of the [62 FR 13955, Mar. 24, 1997] order of the Administrator revoking or suspending registration, the registrant § 1301.37 Order to show cause. shall, as instructed by the Adminis- (a) If, upon examination of the appli- trator: cation for registration from any appli- (1) Deliver to the nearest office of the cant and other information gathered Administration or to authorized agents by the Administration regarding the of the Administration all of the par- applicant, the Administrator is unable ticular controlled substance or sub- to make the determinations required stances affected by the revocation or by the applicable provisions of section suspension which are in his/her posses- 303 and/or section 1008 of the Act (21 sion; or U.S.C. 823 and 958) to register the appli- (2) Place all of such substances under seal as described in sections 304(f) or cant, the Administrator shall serve 958(d)(6) of the Act (21 U.S.C. 824(f) or upon the applicant an order to show 958(d)(6)). cause why the registration should not (h) Any suspension shall continue in be denied. effect until the conclusion of all pro- (b) If, upon information gathered by ceedings upon the revocation or sus- the Administration regarding any reg- pension, including any judicial review istrant, the Administrator determines thereof, unless sooner withdrawn by that the registration of such registrant the Administrator or dissolved by a is subject to suspension or revocation court of competent jurisdiction. Any pursuant to section 304 or section 1008 registrant whose registration is sus- of the Act (21 U.S.C. 824 and 958), the pended under paragraph (e) of this sec- Administrator shall serve upon the reg- tion may request a hearing on the rev- istrant an order to show cause why the ocation or suspension of his/her reg- registration should not be revoked or istration at a time earlier than speci- suspended. fied in the order to show cause pursu- (c) The order to show cause shall call ant to § 1301.37. This request shall be upon the applicant or registrant to ap- granted by the Administrator, who pear before the Administrator at a shall fix a date for such hearing as time and place stated in the order, early as reasonably possible. which shall not be less than 30 days (i) In the event that an applicant for after the date of receipt of the order. reregistration (who is doing business The order to show cause shall also con- under a registration previously granted tain a statement of the legal basis for and not revoked or suspended) has applied for reregistration at least 45 days such hearing and for the denial, revoca- before the date on which the existing tion, or suspension of registration and registration is due to expire, and the a summary of the matters of fact and Administrator has issued no order on law asserted. the application on the date on which (d) Upon receipt of an order to show the existing registration is due to ex- cause, the applicant or registrant pire, the existing registration of the must, if he/she desires a hearing, file a applicant shall automatically be ex- request for a hearing pursuant to tended and continue in effect until the § 1301.43. If a hearing is requested, the date on which the Administrator so Administrator shall hold a hearing at issues his/her order. The Administrator the time and place stated in the order, may extend any other existing reg- pursuant to § 1301.41.

29 § 1301.41 21 CFR Ch. II (4–1–99 Edition)

(e) When authorized by the Adminis- registration in the FEDERAL REGISTER trator, any agent of the Administra- in the case of § 1301.34), file with the tion may serve the order to show Administrator a written request for a cause. hearing in the form prescribed in [62 FR 13955, Mar. 24, 1997] § 1316.47 of this chapter. (b) Any person entitled to participate HEARINGS in a hearing pursuant to § 1301.34 or § 1301.35(b) and desiring to do so shall, § 1301.41 Hearings generally. within 30 days of the date of publica- (a) In any case where the Adminis- tion of notice of the request for a hear- trator shall hold a hearing on any reg- ing in the FEDERAL REGISTER, file with istration or application therefor, the the Administrator a written notice of procedures for such hearing shall be intent to participate in such hearing in governed generally by the adjudication the form prescribed in § 1316.48 of this procedures set forth in the Administra- chapter. Any person filing a request for tive Procedure Act (5 U.S.C. 551–559) and specifically by sections 303, 304, a hearing need not also file a notice of and 1008 of the Act (21 U.S.C. 823–824 appearance. and 958), by §§ 1301.42–1301.46 of this (c) Any person entitled to a hearing part, and by the procedures for admin- or to participate in a hearing pursuant istrative hearings under the Act set to § 1301.32 or §§ 1301.34–1301.36 may, forth in §§ 1316.41–1316.67 of this chap- within the period permitted for filing a ter. request for a hearing or a notice of ap- (b) Any hearing under this part shall pearance, file with the Administrator a be independent of, and not in lieu of, waiver of an opportunity for a hearing criminal prosecutions or other pro- or to participate in a hearing, together ceedings under the Act or any other with a written statement regarding law of the United States. such person’s position on the matters [62 FR 13956, Mar. 24, 1997] of fact and law involved in such hearing. Such statement, if admissible, § 1301.42 Purpose of hearing. shall be made a part of the record and If requested by a person entitled to a shall be considered in light of the lack hearing, the Administrator shall hold a of opportunity for cross-examination in hearing for the purpose of receiving determining the weight to be attached factual evidence regarding the issues to matters of fact asserted therein. involved in the denial, revocation, or (d) If any person entitled to a hearing suspension of any registration, and the or to participate in a hearing pursuant granting of any application for reg- to § 1301.32 or §§ 1301.34–1301.36 fails to istration to import or to manufacture file a request for a hearing or a notice in bulk a basic class of controlled sub- of appearance, or if such person so files stance listed in Schedule I or II. Exten- and fails to appear at the hearing, such sive argument should not be offered person shall be deemed to have waived into evidence but rather presented in the opportunity for a hearing or to par- opening or closing statements of coun- ticipate in the hearing, unless such sel or in memoranda or proposed find- person shows good cause for such fail- ings of fact and conclusions of law. ure. [62 FR 13956, Mar. 24, 1997] (e) If all persons entitled to a hearing or to participate in a hearing waive or § 1301.43 Request for hearing or appearance; waiver. are deemed to waive their opportunity for the hearing or to participate in the (a) Any person entitled to a hearing hearing, the Administrator may cancel pursuant to § 1301.32 or §§ 1301.34–1301.36 the hearing, if scheduled, and issue his/ and desiring a hearing shall, within 30 her final order pursuant to § 1301.46 days after the date of receipt of the without a hearing. order to show cause (or the date of publication of notice of the application for [62 FR 13956, Mar. 24, 1997]

30 Drug Enforcement Administration, Justice § 1301.51

§ 1301.44 Burden of proof. thereafter it may be moved to a dif- (a) At any hearing on an application ferent place and may be continued to manufacture any controlled sub- from day to day or recessed to a later stance listed in Schedule I or II, the ap- day without notice other than an- plicant shall have the burden of prov- nouncement thereof by the presiding ing that the requirements for such reg- officer at the hearing. istration pursuant to section 303(a) of [62 FR 13956, Mar. 24, 1997] the Act (21 U.S.C. 823(a)) are satisfied. Any other person participating in the § 1301.46 Final order. hearing pursuant to § 1301.35(b) shall As soon as practicable after the pre- have the burden of proving any propo- siding officer has certified the record sitions of fact or law asserted by such to the Administrator, the Adminis- person in the hearing. trator shall issue his/her order on the (b) At any hearing on the granting or granting, denial, revocation, or suspen- denial of an applicant to be registered sion of registration. In the event that to conduct a narcotic treatment pro- an application for registration to im- gram or as a compounder, the appli- port or to manufacture in bulk a basic cant shall have the burden of proving class of any controlled substance listed that the requirements for each reg- in Schedule I or II is granted, or any istration pursuant to section 303(g) of application for registration is denied, the Act (21 U.S.C. 823(g)) are satisfied. or any registration is revoked or sus- (c) At any hearing on the granting or pended, the order shall include the denial of an application to be reg- findings of fact and conclusions of law istered to import or export any con- upon which the order is based. The trolled substance listed in Schedule I order shall specify the date on which it or II, the applicant shall have the bur- shall take effect. The Administrator den of proving that the requirements shall serve one copy of his/her order for such registration pursuant to sec- upon each party in the hearing. tions 1008(a) and (d) of the Act (21 U.S.C. 958 (a) and (d)) are satisfied. Any [62 FR 13956, Mar. 24, 1997] other person participating in the hear- MODIFICATION, TRANSFER AND ing pursuant to § 1301.34 shall have the TERMINATION OF REGISTRATION burden of proving any propositions of fact or law asserted by him/her in the § 1301.51 Modification in registration. hearings. (d) At any other hearing for the de- Any registrant may apply to modify nial of a registration, the Administra- his/her registration to authorize the tion shall have the burden of proving handling of additional controlled sub- that the requirements for such reg- stances or to change his/her name or istration pursuant to section 303 or sec- address, by submitting a letter of re- tion 1008(c) and (d) of the Act (21 U.S.C. quest to the Registration Unit, Drug 823 or 958(c) and (d)) are not satisfied. Enforcement Administration, Depart- (e) At any hearing for the revocation ment of Justice, Post Office Box 28083, or suspension of a registration, the Ad- Central Station, Washington, DC 20005. ministration shall have the burden of The letter shall contain the reg- proving that the requirements for such istrant’s name, address, and registra- revocation or suspension pursuant to tion number as printed on the certifi- section 304(a) or section 1008(d) of the cate of registration, and the substances Act (21 U.S.C. 824(a) or 958(d)) are satis- and/or schedules to be added to his/her fied. registration or the new name or address and shall be signed in accordance [62 FR 13956, Mar. 24, 1997] with § 1301.13(j). If the registrant is seeking to handle additional controlled § 1301.45 Time and place of hearing. substances listed in Schedule I for the The hearing will commence at the purpose of research or instructional ac- place and time designated in the order tivities, he/she shall attach three cop- to show cause or notice of hearing pub- ies of a research protocol describing lished in the FEDERAL REGISTER (unless each research project involving the ad- expedited pursuant to § 1301.36(h)) but ditional substances, or two copies of a

31 § 1301.52 21 CFR Ch. II (4–1–99 Edition) statement describing the nature, ex- or with respect to controlled substance tent, and duration of such instruc- (by transferring such business activi- tional activities, as appropriate. No fee ties to another person) shall submit in shall be required to be paid for the person or by registered or certified modification. The request for modifica- mail, return receipt requested, to the tion shall be handled in the same man- Special Agent in Charge in his/her ner as an application for registration. area, at least 14 days in advance of the If the modification in registration is date of the proposed transfer (unless approved, the Administrator shall issue the Special Agent in Charge waives a new certificate of registration (DEA this time limitation in individual in- Form 223) to the registrant, who shall stances), the following information: maintain it with the old certificate of (1) The name, address, registration registration until expiration. number, and authorized business activ- [62 FR 13956, Mar. 24, 1997] ity of the registrant discontinuing the business (registrant-transferor); § 1301.52 Termination of registration; (2) The name, address, registration transfer of registration; distribution number, and authorized business activ- upon discontinuance of business. ity of the person acquiring the business (a) Except as provided in paragraph (registrant-transferee); (b) of this section, the registration of (3) Whether the business activities any person shall terminate if and when will be continued at the location reg- such person dies, ceases legal exist- istered by the person discontinuing ence, or discontinues business or pro- business, or moved to another location fessional practice. Any registrant who (if the latter, the address of the new lo- ceases legal existence or discontinues cation should be listed); business or professional practice shall (4) Whether the registrant-transferor notify the Administrator promptly of has a quota to manufacture or procure such fact. any controlled substance listed in (b) No registration or any authority Schedule I or II (if so, the basic class or conferred thereby shall be assigned or class of the substance should be indi- otherwise transferred except upon such cated); and conditions as the Administration may (5) The date on which the transfer of specifically designate and then only controlled substances will occur. pursuant to written consent. Any per- (e) Unless the registrant-transferor is son seeking authority to transfer a reg- informed by the Special Agent in istration shall submit a written re- Charge, before the date on which the quest, providing full details regarding transfer was stated to occur, that the the proposed transfer of registration, transfer may not occur, the registrant- to the Deputy Assistant Administrator, transferor may distribute (without Office of Diversion Control, Drug En- being registered to distribute) con- forcement Administration, Department trolled substances in his/her possession of Justice, Washington, DC 20537. to the registrant-transferee in accord- (c) Any registrant desiring to dis- ance with the following: continue business activities altogether (1) On the date of transfer of the con- or with respect to controlled sub- trolled substances, a complete inven- stances (without transferring such tory of all controlled substances being business activities to another person) transferred shall be taken in accord- shall return for cancellation his/her ance with § 1304.11 of this chapter. This certificate of registration, and any inventory shall serve as the final in- unexecuted order forms in his/her pos- ventory of the registrant-transferor session, to the Registration Unit, Drug and the initial inventory of the reg- Enforcement Administration, Depart- istrant-transferee, and a copy of the in- ment of Justice, Post Office Box 28083, ventory shall be included in the records Central Station, Washington, DC 20005. of each person. It shall not be nec- Any controlled substances in his/her essary to file a copy of the inventory possession may be disposed of in ac- with the Administration unless re- cordance with § 1307.21 of this chapter. quested by the Special Agent in (d) Any registrant desiring to dis- Charge. Transfers of any substances continue business activities altogether listed in Schedule I or II shall require

32 Drug Enforcement Administration, Justice § 1301.71 the use of order forms in accordance may be deemed sufficient by the Ad- with part 1305 of this chapter. ministrator after evaluation of the (2) On the date of transfer of the con- overall security system and needs of trolled substances, all records required the applicant or registrant. In evalu- to be kept by the registrant-transferor ating the overall security system of a with reference to the controlled sub- registrant or applicant, the Adminis- stances being transferred, under part trator may consider any of the fol- 1304 of this chapter, shall be trans- lowing factors as he may deem relevant ferred to the registrant-transferee. Re- to the need for strict compliance with sponsibility for the accuracy of records security requirements: prior to the date of transfer remains (1) The type of activity conducted with the transferor, but responsibility (e.g., processing of bulk chemicals, pre- for custody and maintenance shall be paring dosage forms, packaging, label- upon the transferee. ing, cooperative buying, etc.); (3) In the case of registrants required (2) The type and form of controlled to make reports pursuant to part 1304 substances handled (e.g., bulk liquids of this chapter, a report marked or dosage units, usable powders or non- ‘‘Final’’ will be prepared and submitted usable powders); by the registrant-transferor showing (3) The quantity of controlled sub- the disposition of all the controlled stances handled; substances for which a report is re- (4) The location of the premises and quired; no additional report will be re- the relationship such location bears on quired from him, if no further trans- security needs; actions involving controlled substances (5) The type of building construction are consummated by him. The initial comprising the facility and the general report of the registrant-transferee characteristics of the building or build- shall account for transactions begin- ings; ning with the day next succeeding the (6) The type of vault, safe, and secure date of discontinuance or transfer of enclosures or other storage system business by the transferor-registrant (e.g., automatic storage and retrieval and the substances transferred to him system) used; shall be reported as receipts in his/her (7) The type of closures on vaults, initial report. safes, and secure enclosures; [62 FR 13957, Mar. 24, 1997] (8) The adequacy of key control systems and/or combination lock control SECURITY REQUIREMENTS systems; (9) The adequacy of electric detection § 1301.71 Security requirements gen- and alarm systems, if any including erally. use of supervised transmittal lines and (a) All applicants and registrants standby power sources; shall provide effective controls and (10) The extent of unsupervised public procedures to guard against theft and access to the facility, including the diversion of controlled substances. In presence and characteristics of perim- order to determine whether a reg- eter fencing, if any; istrant has provided effective controls (11) The adequacy of supervision over against diversion, the Administrator employees having access to manufac- shall use the security requirements set turing and storage areas; forth in §§ 1301.72–1301.76 as standards (12) The procedures for handling busi- for the physical security controls and ness guests, visitors, maintenance per- operating procedures necessary to pre- sonnel, and nonemployee service per- vent diversion. Materials and construc- sonnel; tion which will provide a structural (13) The availability of local police equivalent to the physical security protection or of the registrant’s or ap- controls set forth in §§ 1301.72, 1301.73 plicant’s security personnel, and; and 1301.75 may be used in lieu of the (14) The adequacy of the registrant’s materials and construction described or applicant’s system for monitoring in those sections. the receipt, manufacture, distribution, (b) Substantial compliance with the and disposition of controlled sub- standards set forth in §§ 1301.72–1301.76 stances in its operations.

33 § 1301.72 21 CFR Ch. II (4–1–99 Edition)

(c) When physical security controls viously approved by the Administra- become inadequate as a result of a con- tion. trolled substance being transferred to a [36 FR 18729, Sept. 21, 1971. Redesignated at different schedule, or as a result of a 38 FR 26609, Sept. 24, l973, and amended at 46 noncontrolled substance being listed on FR 28841, May 29, 1981; 47 FR 41735, Sept. 22, any schedule, or as a result of a signifi- 1982; 51 FR 5319, Feb. 13, 1986] cant increase in the quantity of controlled substances in the possession of § 1301.72 Physical security controls for non-practitioners; narcotic treat- the registrant during normal business ment programs and compounders operations, the physical security con- for narcotic treatment programs; trols shall be expanded and extended storage areas. accordingly. A registrant may adjust (a) Schedules I and II. Raw materials, physical security controls within the bulk materials awaiting further proc- requirements set forth in §§ 1301.72– essing, and finished products which are 1301.76 when the need for such controls controlled substances listed in Sched- decreases as a result of a controlled ule I or II shall be stored in one of the substance being transferred to a dif- following secure storage areas: ferent schedule, or a result of a con- (1) Where small quantities permit, a trolled substance being removed from safe or steel cabinet; control, or as a result of a significant (i) Which safe or steel cabinet shall decrease in the quantity of controlled have the following specifications or the substances in the possession of the reg- equivalent: 30 man-minutes against istrant during normal business oper- surreptitious entry, 10 man-minutes ations. against forced entry, 20 man-hours (d) Any registrant or applicant desir- against lock manipulation, and 20 man- ing to determine whether a proposed hours against radiological techniques; security system substantially complies (ii) Which safe or steel cabinet, if it with, or is the structural equivalent of, weighs less than 750 pounds, is bolted the requirements set forth in §§ 1301.72– or cemented to the floor or wall in such 1301.76 may submit any plans, blue- a way that it cannot be readily removed; and prints, sketches or other materials re- (iii) Which safe or steel cabinet, if garding the proposed security system necessary, depending upon the quan- either to the Special Agent in Charge tities and type of controlled substances in the region in which the system will stored, is equipped with an alarm sys- be used, or to the Diversion Operations tem which, upon attempted unauthor- Section, Drug Enforcement Adminis- ized entry, shall transmit a signal di- tration, Department of Justice, Wash- rectly to a central protection company ington, DC 20537. or a local or State police agency which (e) Physical security controls of loca- has a legal duty to respond, or a 24- tions registered under the Harrison hour control station operated by the Narcotic Act or the Narcotics Manufac- registrant, or such other protection as turing Act of 1960 on April 30, 1971, the Administrator may approve. shall be deemed to comply substan- (2) A vault constructed before, or tially with the standards set forth in under construction on, September 1, §§ 1301.72, 1301.73 and 1301.75. Any new 1971, which is of substantial construc- facilities or work or storage areas con- tion with a steel door, combination or structed or utilized for controlled sub- key lock, and an alarm system; or stances, which facilities or work or (3) A vault constructed after Sep- storage areas have not been previously tember 1, 1971: approved by the Administration, shall (i) The walls, floors, and ceilings of not necessarily be deemed to comply which vault are constructed of at least substantially with the standards set 8 inches of reinforced concrete or other forth in §§ 1301.72, 1301.73 and 1301.75, substantial masonry, reinforced 1 notwithstanding that such facilities or vertically and horizontally with ⁄2-inch steel rods tied 6 inches on center, or work or storage areas have physical se- the structural equivalent to such rein- curity controls similar to those pre- forced walls, floors, and ceilings;

34 Drug Enforcement Administration, Justice § 1301.72

(ii) The door and frame unit of which (i) Has an electronic alarm system as vault shall conform to the following described in paragraph (b)(4)(v) of this specifications or the equivalent: 30 section, man-minutes against surreptitious (ii) Is equipped with self-closing, self- entry, 10 man-minutes against forced locking doors constructed of substan- entry, 20 man-hours against lock ma- tial material commensurate with the nipulation, and 20 man-hours against type of building construction, provided, radiological techniques; however, a door which is kept clored (iii) Which vault, if operations re- and locked at all times when not in use quire it to remain open for frequent ac- and when in use is kept under direct cess, is equipped with a ‘‘day-gate’’ observation of a responsible employee which is self-closing and self-locking, or agent of the registrant is permitted or the equivalent, for use during the in lieu of a self-closing, self-locking hours of operation in which the vault door. Doors may be sliding or hinged. door is open; Regarding hinged doors, where hinges are mounted on the outside, such (iv) The walls or perimeter of which hinges shall be sealed, welded or other- vault are equipped with an alarm, wise constructed to inhibit removal. which upon unauthorized entry shall Locking devices for such doors shall be transmit a signal directly to a central either of the multiple-position com- station protection company, or a local bination or key lock type and: or State police agency which has a (a) In the case of key locks, shall re- legal duty to respond, or a 24-hour con- quire key control which limits access trol station operated by the registrant, to a limited number of employees, or; or such other protection as the Admin- (b) In the case of combination locks, istrator may approve, and, if nec- the combination shall be limited to a essary, holdup buttons at strategic minimum number of employees and points of entry to the perimeter area of can be changed upon termination of the vault; employment of an employee having (v) The door of which vault is knowledge of the combination; equipped with contact switches; and (4) A cage, located within a building (vi) Which vault has one of the fol- on the premises, meeting the following lowing: Complete electrical lacing of specifications: the walls, floor and ceilings; sensitive (i) Having walls constructed of not ultrasonic equipment within the vault; less than No. 10 gauge steel fabric a sensitive sound accumulator system; mounted on steel posts, which posts or such other device designed to detect are: illegal entry as may be approved by the (a) At least one inch in diameter; Administration. (b) Set in concrete or installed with (b) Schedules III, IV and V. Raw mate- lag bolts that are pinned or brazed; and rials, bulk materials awaiting further (c) Which are placed no more than processing, and finished products which ten feet apart with horizontal one and are controlled substances listed in one-half inch reinforcements every Schedules III, IV and V shall be stored sixty inches; in the following secure storage areas: (ii) Having a mesh construction with (1) A safe or steel cabinet as de- openings of not more than two and one- scribed in paragraph (a)(1) of this sec- half inches across the square, tion; (iii) Having a ceiling constructed of (2) A vault as described in paragraph the same material, or in the alter- (a)(2) or (3) of this section equipped native, a cage shall be erected which with an alarm system as described in reaches and is securely attached to the paragraph (b)(4)(v) of this section; structural ceiling of the building. A (3) A building used for storage of lighter gauge mesh may be used for the Schedules III through V controlled sub- ceilings of large enclosed areas if walls stances with perhmeter security which are at least 14 feet in height, limits access during working hours and (iv) Is equipped with a door con- provides security after working hours structed of No. 10 gauge steel fabric on and meets the following specifications: a metal door frame in a metal door

35 § 1301.73 21 CFR Ch. II (4–1–99 Edition) flange, and in all other respects con- in process), the controlled substances forms to all the requirements of 21 CFR may be stored separately, provided 1301.72(b)(3)(ii), and that each storage area complies with (v) Is equipped with an alarm system the requirements set forth in this sec- which upon unauthorized entry shall tion. transmit a signal directly to a central (d) Accessibility to storage areas. The station protection agency or a local or controlled substances storage areas state police agency, each having a shall be accessible only to an absolute legal duty to respond, or to a 24-hour minimum number of specifically au- control station operated by the reg- thorized employees. When it is nec- istrant, or to such other source of pro- essary for employee maintenance per- tection as the Administrator may ap- sonnel, nonemployee maintenance per- prove; (5) An enclosure of masonry or other sonnel, business guests, or visitors to material, approved in writing by the be present in or pass through con- Administrator as providing security trolled substances storage areas, the comparable to a cage; registrant shall provide for adequate (6) A building or enclosure within a observation of the area by an employee building which has been inspected and specifically authorized in writing. approved by DEA or its predecessor [36 FR 18730, Sept. 21, 1971, as amended at 37 agency, BNDD, and continues to pro- FR 15919, Aug. 8, 1972. Redesignated at 38 FR vide adequate security against the di- 26609, Sept. 24, l973] version of Schedule III through V controlled substances, of which fact writ- EDITORIAL NOTE: For FEDERAL REGISTER ci- ten acknowledgment has been made by tations affecting § 1301.72, see the List of CFR Sections Affected in the Finding Aids sec- the Special Agent in Charge of DEA for tion of this volume. the area in which such building or enclosure is situated; § 1301.73 Physical security controls for (7) Such other secure storage areas as non-practitioners; compounders for may be approved by the Administrator narcotic treatment programs; man- after considering the factors listed in ufacturing and compounding areas. § 1301.71(b), (1) through (14); All manufacturing activities (includ- (8)(i) Schedule III through V con- ing processing, packaging and labeling) trolled substances may be stored with Schedules I and II controlled sub- involving controlled substances listed stances under security measures pro- in any schedule and all activities of vided by 21 CFR 1301.72(a); compounders shall be conducted in ac- (ii) Non-controlled drugs, substances cordance with the following: and other materials may be stored with (a) All in-process substances shall be Schedule III through V controlled sub- returned to the controlled substances stances in any of the secure storage storage area at the termination of the areas required by 21 CFR 1301.72(b), process. If the process is not termi- provided that permission for such stor- nated at the end of a workday (except age of non-controlled items is obtained where a continuous process or other in advance, in writing, from the Spe- normal manufacturing operation cial Agent in Charge of DEA for the should not be interrupted), the proc- area in which such storage area is situ- essing area or tanks, vessels, bins or ated. Any such permission tendered bulk containers containing such sub- must be upon the Special Agent in stances shall be securely locked, with Charge’s written determination that adequate security for the area or build- such non-segregated storage does not ing. If such security requires an alarm, diminish security effectiveness for such alarm, upon unauthorized entry, Schedules III through V controlled sub- shall transmit a signal directly to a stances. central station protection company, or (c) Multiple storage areas. Where sev- local or state police agency which has eral types or classes of controlled substances are handled separately by the a legal duty to respond, or a 24-hour registrant or applicant for different control station operated by the reg- purposes (e.g., returned goods, or goods istrant.

36 Drug Enforcement Administration, Justice § 1301.74

(b) Manufacturing activities with usual size, orders deviating substan- controlled substances shall be con- tially from a normal pattern, and or- ducted in an area or areas of clearly de- ders of unusual frequency. fined limited access which is under sur- (c) The registrant shall notify the veillance by an employee or employees Field Division Office of the Adminis- designated in writing as responsible for tration in his area of any theft or sig- the area. ‘‘Limited access’’ may be pro- nificant loss of any controlled sub- vided, in the absence of physical divid- stances upon discovery of such theft or ers such as walls or partitions, by traf- loss. The supplier shall be responsible fic control lines or restricted space des- for reporting in-transit losses of con- ignation. The employee designated as trolled substances by the common or responsible for the area may be en- contract carrier selected pursuant to gaged in the particular manufacturing § 1301.74(e), upon discovery of such theft operation being conducted: Provided, or loss. The registrant shall also com- That he is able to provide continuous plete DEA Form 106 regarding such surveillance of the area in order that unauthorized persons may not enter or theft or loss. Thefts must be reported leave the area without his knowledge. whether or not the controlled sub- (c) During the production of con- stances are subsequently recovered trolled substances, the manufacturing and/or the responsible parties are iden- areas shall be accessible to only those tified and action taken against them. employees required for efficient oper- (d) The registrant shall not dis- ation. When it is necessary for em- tribute any controlled substance listed ployee maintenance personnel, non- in Schedules II through V as a com- employee maintenance personnel, busi- plimentary sample to any potential or ness guests, or visitors to be present in current customer (1) without the prior or pass through manufacturing areas written request of the customer, (2) to during production of controlled sub- be used only for satisfying the legiti- stances, the registrant shall provide for mate medical needs of patients of the adequate observation of the area by an customer, and (3) only in reasonable employee specifically authorized in quantities. Such request must contain writing. the name, address, and registration [36 FR 18731, Sept. 21, 1971. Redesignated at number of the customer and the name 38 FR 26609, Sept. 24, l973 and amended at 39 and quantity of the specific controlled FR 37984, Oct. 25, 1974] substance desired. The request shall be preserved by the registrant with other § 1301.74 Other security controls for records of distribution of controlled non-practitioners; narcotic treat- substances. In addition, the requirement programs and compounders for narcotic treatment programs. ments of part 1305 of the chapter shall be complied with for any distribution (a) Before distributing a controlled of a controlled substance listed in substance to any person who the reg- Schedule II. For purposes of this para- istrant does not know to be registered graph, the term ‘‘customer’’ includes a to possess the controlled substance, the person to whom a complimentary sam- registrant shall make a good faith in- ple of a substance is given in order to quiry either with the Administration or with the appropriate State con- encourage the prescribing or recom- trolled substances registration agency, mending of the substance by the per- if any, to determine that the person is son. registered to possess the controlled (e) When shipping controlled sub- substance. stances, a registrant is responsible for (b) The registrant shall design and selecting common or contract carriers operate a system to disclose to the reg- which provide adequate security to istrant suspicious orders of controlled guard against in-transit losses. When substances. The registrant shall inform storing controlled substances in a pub- the Field Division Office of the Admin- lic warehouse, a registrant is respon- istration in his area of suspicious or- sible for selecting a warehouseman ders when discovered by the registrant. which will provide adequate security to Suspicious orders include orders of un- guard against storage losses; wherever

37 § 1301.75 21 CFR Ch. II (4–1–99 Edition) possible, the registrant shall store con- lished by the Secretary of Health and trolled substances in a public ware- Human Services (after consultation house which complies with the require- with the Administration) respecting ments set forth in § 1301.72. In addition, the quantities of narcotic drugs which the registrant shall employ pre- may be provided to persons enrolled in cautions (e.g., assuring that shipping a narcotic treatment program for unsu- containers do not indicate that con- pervised use. tents are controlled substances) to (l) DEA may exercise discretion re- guard against storage or in-transit garding the degree of security required losses. in narcotic treatment programs based (f) When distributing controlled sub- on such factors as the location of a pro- stances through agents (e.g., gram, the number of patients enrolled detailmen), a registrant is responsible for providing and requiring adequate in a program and the number of physi- security to guard against theft and di- cians, staff members and security version while the substances are being guards. Similarly, such factors will be stored or handled by the agent or taken into consideration when evalu- agents. ating existing security or requiring (g) Before the initial distribution of new security at a narcotic treatment carfentanil etorphine hydrochloride program. and/or diprenorphine to any person, the [36 FR 7778, Apr. 24, 1971; 36 FR 13386, July 21, registrant must verify that the person 1971, as amended at 36 FR 18731, Sept. 21, is authorized to handle the sub- 1971. Redesignated at 38 FR 26609, Sept. 24, stances(s) by contacting the Drug En- l973] forcement Administration. (h) The acceptance of delivery of nar- EDITORIAL NOTE: For FEDERAL REGISTER ci- cotic substances by a narcotic treat- tations affecting § 1301.74, see the List of CFR Sections Affected in the Finding Aids sec- ment program shall be made only by a tion of this volume. licensed practitioner employed at the facility or other authorized individuals § 1301.75 Physical security controls for designated in writing. At the time of practitioners. delivery, the licensed practitioner or other authorized individual designated (a) Controlled substances listed in in writing (excluding persons currently Schedule I shall be stored in a securely or previously dependent on narcotic locked, substantially constructed cabi- drugs), shall sign for the narcotics and net. place his specific title (if any) on any (b) Controlled substances listed in invoice. Copies of these signed invoices Schedules II, III, IV, and V shall be shall be kept by the distributor. stored in a securely locked, substan- (i) Narcotics dispensed or adminis- tially constructed cabinet. However, tered at a narcotic treatment program pharmacies and institutional practi- will be dispensed or administered di- tioners may disperse such substances rectly to the patient by either (1) the throughout the stock of noncontrolled licensed practitioner, (2) a registered substances in such a manner as to ob- nurse under the direction of the li- struct the theft or diversion of the con- censed practitioner, (3) a licensed prac- trolled substances. tical nurse under the direction of the (c) This section shall also apply to licensed practitioner, or (4) a phar- nonpractitioners authorized to conduct macist under the direction of the li- research or chemical analysis under censed practitioner. another registration. (j) Persons enrolled in a narcotic (d) Carfentanil etorphine hydro- treatment program will be required to chloride and diprenorphine shall be wait in an area physically separated stored in a safe or steel cabinet equiva- from the narcotic storage and dispensing area. This requirement will be lent to a U.S. Government Class V se- enforced by the program physician and curity container. employees. [39 FR 3674, Jan. 29, 1974, as amended at 39 (k) All narcotic treatment programs FR 17838, May 21, 1974; 54 FR 33674, Aug. 16, must comply with standards estab- 1989; 62 FR 13957, Mar. 24, 1997]

38 Drug Enforcement Administration, Justice § 1301.91

§ 1301.76 Other security controls for ployer’s comprehensive employee practitioners. screening program: (a) The registrant shall not employ, Question. Within the past five years, have as an agent or employee who has access you been convicted of a felony, or within the to controlled substances, any person past two years, of any misdemeanor or are who has been convicted of a felony of- you presently formally charged with com- mitting a criminal offense? (Do not include fense relating to controlled substances any traffic violations, juvenile offenses or or who, at any time, had an application military convictions, except by general for registration with the DEA denied, court-martial.) If the answer is yes, furnish had a DEA registration revoked or has details of conviction, offense, location, date surrendered a DEA registration for and sentence. cause. For purposes of this subsection, Question. In the past three years, have you the term ‘‘for cause’’ means a sur- ever knowingly used any narcotics, amphet- render in lieu of, or as a consequence amines or barbiturates, other than those pre- of, any federal or state administrative, scribed to you by a physician? If the answer civil or criminal action resulting from is yes, furnish details. an investigation of the individual’s Advice. An authorization, in writing, that allows inquiries to be made of courts and law handling of controlled substances. enforcement agencies for possible pending (b) The registrant shall notify the charges or convictions must be executed by a Field Division Office of the Adminis- person who is allowed to work in an area tration in his area of the theft or sig- where access to controlled substances clear- nificant loss of any controlled sub- ly exists. A person must be advised that any stances upon discovery of such loss or false information or omission of information will jeopardize his or her position with re- theft. The registrant shall also com- spect to employment. The application for plete DEA (or BND) Form 106 regarding employment should inform a person that in- such loss or theft. formation furnished or recovered as a result (c) Whenever the registrant distrib- of any inquiry will not necessarily preclude utes a controlled substance (without employment, but will be considered as part being registered as a distributor, as of an overall evaluation of the person’s qualifications. The maintaining of fair em- permitted in § 1301.13(e)(1) and/or ployment practices, the protection of the §§ 1307.11–1307.12) he/she shall comply person’s right of privacy, and the assurance with the requirements imposed on non- that the results of such inquiries will be practitioners in § 1301.74 (a), (b), and (e). treated by the employer in confidence will be explained to the employee. [36 FR 7778, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971; 37 FR 15919, Aug. 8, [40 FR 17143, Apr. 17, 1975] 1972. Redesignated at 38 FR 26609, Sept. 24, l973; 47 FR 41735, Sept. 22, 1982; 56 FR 36728, § 1301.91 Employee responsibility to Aug. 1, 1991; 62 FR 13957, Mar. 24, 1997] report drug diversion. Reports of drug diversion by fellow EMPLOYEE SCREENING—NON- employees is not only a necessary part PRACTITIONERS of an overall employee security program but also serves the public inter- § 1301.90 Employee screening proce- est at large. It is, therefore, the posi- dures. tion of DEA that an employee who has It is the position of DEA that the ob- knowledge of drug diversion from his taining of certain information by non- employer by a fellow employee has an practitioners is vital to fairly assess obligation to report such information the likelihood of an employee commit- to a responsible security official of the ting a drug security breach. The need employer. The employer shall treat to know this information is a matter of such information as confidential and business necessity, essential to overall shall take all reasonable steps to pro- controlled substances security. In this tect the confidentiality of the informa- regard, it is believed that conviction of tion and the identity of the employee crimes and unauthorized use of con- furnishing information. A failure to re- trolled substances are activities that port information of drug diversion will are proper subjects for inquiry. It is, be considered in determining the feasi- therefore, assumed that the following bility of continuing to allow an em- questions will become a part of an employee to work in a drug security area.

39 § 1301.92 21 CFR Ch. II (4–1–99 Edition)

The employer shall inform all employ- 1302.06 Sealing of controlled substances. ees concerning this policy. 1302.07 Labeling and packaging requirements for imported and exported sub- [40 FR 17143, Apr. 17, 1975] stances. § 1301.92 Illicit activities by employ- AUTHORITY: 21 U.S.C. 821, 825, 871(b), 958(e). ees. SOURCE: 36 FR 7785, Apr. 24, 1971, unless It is the position of DEA that em- otherwise noted. Redesignated at 38 FR 26609, ployees who possess, sell, use or divert Sept. 24, 1973. controlled substances will subject themselves not only to State or Fed- § 1302.01 Scope of part 1302. eral prosecution for any illicit activ- Requirements governing the labeling ity, but shall also immediately become and packaging of controlled substances the subject of independent action re- pursuant to sections 1305 and 1008(d) of garding their continued employment. the Act (21 U.S.C. 825 and 958(d)) are set The employer will assess the serious- forth generally by those sections and ness of the employee’s violation, the specifically by the sections of this part. position of responsibility held by the employee, past record of employment, [36 FR 13386, July 21, 1971. Redesignated at 38 etc., in determining whether to sus- FR 26609, Sept. 24, l973] pend, transfer, terminate or take other action against the employee. § 1302.02 Definitions. [40 FR 17143, Apr. 17, 1975] Any term contained in this part shall have the definition set forth in section § 1301.93 Sources of information for 102 of the Act (21 U.S.C. 802) or part employee checks. 1300 of this chapter. DEA recommends that inquiries con- [62 FR 13958, Mar. 24, 1997] cerning employees’ criminal records be made as follows: § 1302.03 Symbol required; exceptions. Local inquiries. Inquiries should be made by (a) Each commercial container of a name, date and place of birth, and other controlled substance (except for a con- identifying information, to local courts and trolled substance excepted by the Ad- law enforcement agencies for records of pending charges and convictions. Local prac- ministrator pursuant to § 1308.31 of this tice may require such inquiries to be made in chapter) shall have printed on the label person, rather than by mail, and a copy of an the symbol designating the schedule in authorization from the employee may be re- which such controlled substance is list- quired by certain law enforcement agencies. ed. Each such commercial container, if DEA inquiries. Inquiries supplying identi- it otherwise has no label, must bear a fying information should also be furnished to label complying with the requirement DEA Field Division Offices along with written consent from the concerned individual of this part. for a check of DEA files for records of con- (b) Each manufacturer shall print victions. The Regional check will result in a upon the labeling of each controlled national check being made by the Field Divi- substance distributed by him the sym- sion Office. bol designating the schedule in which [40 FR 17143, Apr. 17, 1975, as amended at 47 such controlled substance is listed. FR 41735, Sept. 22, 1982] (c) The following symbols shall designate the schedule corresponding PART 1302—LABELING AND PACK- thereto: AGING REQUIREMENTS FOR CONTROLLED SUBSTANCES Schedule Schedule I ...... CI or C±I. Sec. Schedule II ...... CII or C±II. 1302.01 Scope of part 1302. Schedule III ...... CIII or C±III. 1302.02 Definitions. Schedule IV ...... CIV or C±IV. 1302.03 Symbol required; exceptions. Schedule V ...... CV or C±V. 1302.04 Location and size of symbol on label and labeling. The word ‘‘schedule’’ need not be used. 1302.05 Effective dates of labeling require- No distinction need be made between ments. narcotic and nonnarcotic substances.

40 Drug Enforcement Administration, Justice Pt. 1303

(d) The symbol is not required on a curely affixed to the stopper, cap, lid, carton or wrapper in which a commer- covering, or wrapper or such container cial container is held if the symbol is a seal to disclose upon inspection any easily legible through such carton or tampering or opening of the container. wrapper. [62 FR 13958, Mar. 24, 1997] (e) The symbol is not required on a commercial container too small or oth- § 1302.07 Labeling and packaging re- erwise unable to accommodate a label, quirements for imported and ex- if the symbol is printed on the box or ported substances. package from which the commercial (a) The symbol requirements of container is removed upon dispensing §§ 1302.03–1302.05 apply to every com- to an ultimate user. mercial container containing, and to (f) The symbol is not required on a all labeling of, controlled substances commercial container containing, or imported into the jurisdiction of and/or on the labeling of, a controlled sub- the customs territory of the United stance being utilized in clinical re- States. search involving blind and double blind (b) The symbol requirements of studies. §§ 1302.03–1302.05 do not apply to any [36 FR 7785, Apr. 24, 1971, as amended at 36 commercial containers containing, or FR 18731, Sept. 21, 1971. Redesignated at 38 any labeling of, a controlled substance FR 26609, Sept. 24, 1973] intended for export from the jurisdiction of the United States. § 1302.04 Location and size of symbol (c) The sealing requirements of on label and labeling. § 1302.06 apply to every bottle, multiple The symbol shall be prominently lo- dose vial, or other commercial con- cated on the label or the labeling of the tainer of any controlled substance list- commercial container and/or the panel ed in schedule I or II, or any narcotic of the commercial container normally controlled substance listed in schedule displayed to dispensers of any con- III or IV, imported into, exported from, trolled substance. The symbol on labels or intended for export from, the juris- shall be clear and large enough to af- diction of and/or the customs territory ford easy identification of the schedule of the United States. of the controlled substance upon in- [62 FR 13958, Mar. 24, 1997] spection without removal from the dispenser’s shelf. The symbol on all other labeling shall be clear and large PART 1303—QUOTAS enough to afford prompt identification of the controlled substance upon in- GENERAL INFORMATION spection of the labeling. Sec. 1303.01 Scope of part 1303. [62 FR 13958, Mar. 24, 1997] 1303.02 Definitions.

§ 1302.05 Effective dates of labeling re- AGGREGATE PRODUCTION AND PROCUREMENT quirements. QUOTAS All labels on commercial containers 1303.11 Aggregate production quotas. of, and all labeling of, a controlled sub- 1303.12 Procurement quotas. stance which either is transferred to 1303.13 Adjustments of aggregate produc- another schedule or is added to any tion quotas. schedule shall comply with the require- INDIVIDUAL MANUFACTURING QUOTAS ments of § 1302.03, on or before the effective date established in the final 1303.21 Individual manufacturing quotas. 1303.22 Procedure for applying for individual order for the transfer or addition. manufacturing quotas. [62 FR 13958, Mar. 24, 1997] 1303.23 Procedure for fixing individual manufacturing quotas. § 1302.06 Sealing of controlled sub- 1303.24 Inventory allowance. stances. 1303.25 Increase in individual manufacturing quotas. On each bottle, multiple dose vial, or 1303.26 Reduction in individual manufac- other commercial container of any turing quotas. controlled substance, there shall be se- 1303.27 Abandonment of quota.

41 § 1303.01 21 CFR Ch. II (4–1–99 Edition)

HEARINGS (4) Projected demand for such class 1303.31 Hearings generally. as indicated by procurement quotas re- 1303.32 Purpose of hearing. quested pursuant to § 1303.12; and 1303.33 Waiver or modification of rules. (5) Other factors affecting medical, 1303.34 Request for hearing or appearance; scientific, research, and industrial waiver. 1303.35 Burden of proof. needs in the United States and lawful 1303.36 Time and place of hearing. export requirements, as the Adminis- 1303.37 Final order. trator finds relevant, including changes in the currently accepted med- AUTHORITY: 21 U.S.C. 821, 826, 871(b). ical use in treatment with the class or GENERAL INFORMATION the substances which are manufactured from it, the economic and physical § 1303.01 Scope of part 1303. availability of raw materials for use in Procedures governing the establish- manufacturing and for inventory pur- ment of production and manufacturing poses, yield and stability problems, po- quotas on basic classes of controlled tential disruptions to production (in- substances listed in schedules I and II cluding possible labor strikes), and re- pursuant to section 306 of the Act (21 cent unforeseen emergencies such as U.S.C. 826) are governed generally by floods and fires. that section and specifically by the (c) The Administrator shall, on or be- sections of this part. fore May 1 of each year, publish in the [36 FR 7786, Apr. 24, 1971. Redesignated at 38 FEDERAL REGISTER, general notice of FR 26609, Sept. 24, 1973] an aggregate production quota for any basic class determined by him under § 1303.02 Definitions. this section. A copy of said notice shall Any term contained in this part shall be mailed simultaneously to each per- have the definition set forth in section son registered as a bulk manufacturer 102 of the Act (21 U.S.C. 802) or part of the basic class. The Administrator 1300 of this chapter. shall permit any interested person to file written comments on or objections [62 FR 13958, Mar. 24, 1997] to the proposal and shall designate in AGGREGATE PRODUCTION AND the notice the time during which such PROCUREMENT QUOTAS filings may be made. The Adminis- trator may, but shall not be required § 1303.11 Aggregate production quotas. to, hold a public hearing on one or (a) The Administrator shall deter- more issues raised by the comments mine the total quantity of each basic and objections filed with him. In the class of controlled substance listed in event the Administrator decides to Schedule I or II necessary to be manu- hold such a hearing, he shall publish factured during the following calendar notice of the hearing in the FEDERAL year to provide for the estimated med- REGISTER, which notice shall summa- ical, scientific, research and industrial rize the issues to be heard and shall set needs of the United States, for lawful the time for the hearing which shall export requirements, and for the estab- nnt be less than 30 days after the date lishment and maintenance of reserve of publication of the notice. After con- stocks. sideration of any comments or objec- (b) In making his determinations, the tions, or after a hearing if one is or- Administrator shall consider the fol- dered by the Administrator, the Ad- lowing factors: ministrator shall issue and publish in (1) Total net disposal of the class by the FEDERAL REGISTER his final order all manufacturers during the current determining the aggregate production and 2 preceding years; quota for the basic class of controlled (2) Trends in the national rate of net substance. The order shall include the disposal of the class; findings of fact and conclusions of law (3) Total actual (or estimated) inven- upon which the order is based. The tories of the class and of all substances order shall specify the date on which it manufactured from the class, and shall take effect. A copy of said order trends in inventory accumulation; shall be mailed simultaneously to each

42 Drug Enforcement Administration, Justice § 1303.12 person registered as a bulk manufac- basic class of controlled substance list- turer of the basic class. ed in Schedule I or II, the applicant [36 FR 7786, Apr. 24, 1971, as amended at 37 shall also state the quantity of the FR 15919, Aug. 8, 1972. Redesignated at 38 FR other basic class which the applicant 26609, Sept. 24, 1973] has applied to manufacture pursuant to § 1303.22 and the quantity of the first § 1303.12 Procurement quotas. basic class necessary to manufacture a (a) In order to determine the esti- specified unit of the second basic class. mated needs for, and to insure an ade- DEA Form 250 shall be filed on or be- quate and uninterrupted supply of, fore April 1 of the year preceding the basic classes of controlled substances calendar year for which the procure- listed in Schedules I and II (except raw ment quota is being applied. Copies of opium being imported by the registrant DEA Form 250 may be obtained from, pursuant to an import permit) the Ad- and shall be filed with, the Drug & ministrator shall issue procurement Chemical Evaluation Section, Drug En- quotas authorizing persons to procure forcement Administration, Department and use quantities of each basic class of Justice, Washington, DC 20537. of such substances for the purpose of (c) The Administrator shall, on or be- manufacturing such class into dosage fore July 1 of the year preceding the forms or into other substances. calendar year during which the quota (b) Any person who is registered to shall be effective, issue to each quali- manufacture controlled substances fied applicant a procurement quota au- listed in any schedule and who desires thorizing him to procure and use: to use during the next calendar year (1) All quantities of such class nec- any basic class of controlled substances essary to manufacture all quantities of listed in Schedule I or II (except raw other basic classes of controlled sub- opium being imported by the registrant stances listed in Schedules I and II pursuant to an import permit) for pur- which the applicant is authorized to poses of manufacturing, shall apply on manufacture pursuant to § 1303.23; and DEA Form 250 for a procurement quota for such basic class. A separate applica- (2) Such other quantities of such tion must be made for each basic class class as the applicant has applied to desired to be procured or used. The ap- procure and use and are consistent plicant shall state whether he intends with his past use, his estimated needs, to manufacture the basic class himself and the total quantity of such class or purchase it from another manufac- that will be produced. turer. The applicant shall state sepa- (d) Any person to whom a procure- rately each purpose for which the basic ment quota has been issued may at any class is desired, the quantity desired time request an adjustment in the for that purpose during the next cal- quota by applying to the Adminis- endar year, and the quantities used and trator with a statement showing the estimated to be used, if any, for that need for the adjustment. Such applica- purpose during the current and pre- tion shall be filed with the Drug & ceding 2 calendar years. If the purpose Chemical Evaluation Section, Drug En- is to manufacture the basic class into forcement Administration, Department dosage form, the applicant shall state of Justice, Washington, DC 20537. The the official name, common or usual Administrator shall increase or de- name, chemical name, or brand name crease the procurement quota of such of that form. If the purpose is to manu- person if and to the extent that he facture another substance, the appli- finds, after considering the factors enu- cant shall state the official name, com- merated in paragraph (c) of this section mon or usual name, chemical name, or and any occurrences since the issuance brand name of the substance, and, if a of the procurement quota, that the controlled substance listed in any need justifies an adjustment. schedule, the schedule number and Ad- (e) The following persons need not ministration Controlled Substances obtain a procurement quota: Code Number, as set forth in part 1308 (1) Any person who is registered to of this chapter, of the substance. If the manufacture a basic class of controlled purpose is to manufacture another substance listed in Schedule I or II and

43 § 1303.13 21 CFR Ch. II (4–1–99 Edition) who uses all of the quantity he manu- current calendar year; and the signa- factures in the manufacture of a sub- ture of the individual who signed the stance not controlled under the Act; DEA Form 222 to which the certifi- (2) Any person who is registered or cation applies. authorized to conduct chemical anal- [36 FR 7786, Apr. 24, 1971, as amended at 36 ysis with controlled substances (for FR 13386, July 21, 1971; 36 FR 18731, Sept. 21, controlled substances to be used in 1971; 37 FR 15919, Aug. 8, 1972. Redesignated such analysis only); and at 38 FR 26609, Sept. 24, 1973] (3) Any person who is registered to EDITORIAL NOTE: For FEDERAL REGISTER ci- conduct research with a basic class of tations affecting § 1303.12, see the List of CFR controlled substance listed in Schedule Sections Affected in the Finding Aids sec- I or II and who is authorized to manu- tion of this volume. facture a quantity of such class pursuant to § 1301.13 of this chapter. § 1303.13 Adjustments of aggregate (f) Any person to whom a procure- production quotas. ment quota has been issued, author- (a) The Administrator may at any izing that person to procure and use a time increase or reduce the aggregate quantity of a basic class of controlled production quota for a basic class of substances listed in Schedules I or II controlled substance listed in Schedule during the current calendar year, shall, I or II which he has previously fixed at or before the time of giving an order pursuant to § 1303.11. to another manufacturer requiring the (b) In determining to adjust the ag- distribution of a quantity of such basic gregate production quota, the Adminis- class, certify in writing to such other trator shall consider the following fac- manufacturer that the quantity of such tors: basic class ordered does not exceed the (1) Changes in the demand for that person’s unused and available procure- class, changes in the national rate of ment quota of such basic class for the net disposal of the class, and changes current calendar year. The written cer- in the rate of net disposal of the class tification shall be executed by the by registrants holding individual man- same individual who signed the DEA ufacturing quotas for that class; Form 222 transmitting the order. Man- (2) Whether any increased demand for ufacturers shall not fill an order from that class, the national and/or indi- persons required to apply for a procure- vidual rates of net disposal of that ment quota under paragraph (b) of this class are temporary, short term, or section unless the order is accompanied long term; by a certification as required under (3) Whether any increased demand for this section. The certification required that class can be met through existing by this section shall contain the fol- inventories, increased individual man- lowing: The date of the certification; ufacturing quotas, or increased impor- the name and address of the bulk man- tation, without increasing the aggre- ufacturer to whom the certification is gate production quota, taking into ac- directed; a reference to the number of count production delays and the prob- the DEA Form 222 to which the certifi- ability that other individual manufac- cation applies; the name of the person turing quotas may be suspended pursu- giving the order to which the certifi- ant to § 1303.24(b); cation applies; the name of the basic (4) Whether any decreased demand class specified in the DEA Form 222 to for that class will result in excessive which the certification applies; the ap- inventory accumulation by all persons propriate schedule within which is list- registered to handle that class (included the basic class specified in the DEA ing manufacturers, distributors, practi- Form 222 to which the certification ap- tioners, importers, and exporters), not- plies; a statement that the quantity withstanding the possibility that indi- (expressed in grams) of the basic class vidual manufacturing quotas may be specified in the DEA Form 222 to which suspended pursuant to § 1303.24(b) or the certification applies does not ex- abandoned pursuant to § 1303.27; ceed the unused and available procure- (5) Other factors affecting medical, ment quota of such basic class, issued scientific, research, and industrial to the person giving the order, for the needs in the United States and lawful

44 Drug Enforcement Administration, Justice § 1303.22 export requirements, as the Adminis- INDIVIDUAL MANUFACTURING QUOTAS trator finds relevant, including changes in the currently accepted med- § 1303.21 Individual manufacturing ical use in treatment with the class or quotas. the substances which are manufactured (a) The Administrator shall, on or be- from it, the economic and physical fore July 1 of each year, fix for and availability of raw materials for use in issue to each person who is registered manufacturing and for inventory pur- to manufacture a basic class of con- poses, yield and stability problems, po- trolled substance listed in Schedule I tential disruptions to production (in- or II, and who applies for a manufac- cluding possible labor strikes), and re- turing quota, an individual manufac- cent unforeseen emergencies such as turing quota authorizing that person to floods and fires. manufacture during the next calendar (c) The Administrator in the event he year a quantity of that basic class. Any determines to increase or reduce the manufacturing quota fixed and issued aggregate production quota for a basic by the Administrator shall be subject class of controlled substance, shall to his authority to reduce or limit it at publish in the FEDERAL REGISTER gen- a later date pursuant to § 1303.26 and to eral notice of an adjustment in the ag- his authority to revoke or suspend it at gregate production quota for that class any time pursuant to §§ 1301.36 of this determined by him under this section. chapter. A copy of said notice shall be mailed (b) No individual manufacturing simultaneously to each person reg- quota shall be required for registrants istered as a bulk manufacturer of the listed in § 1303.12(e). basic class. The Administrator shall [36 FR 7786, Apr. 24, 1971. Redesignated at 38 permit any interested person to file FR 26609, Sept. 24, 1973, as amended at 62 FR written comments on or objections to 13958, Mar. 24, 1997] the proposal and shall designate in the notice the time during which such fil- § 1303.22 Procedure for applying for ings may be made. The Administrator individual manufacturing quotas. may, but shall not be required to, hold Any person who is registered to man- a public hearing on one or more issues ufacture any basic class of controlled raised by the comments and objections substance listed in Schedule I or II and filed with him. In the event the Admin- who desires to manufacture a quantity istrator decides to hold such a hearing, of such class shall apply on DEA Form he shall publish notice of the hearing 189 for a manufacturing quota for such in the FEDERAL REGISTER, which notice quantity of such class. Copies of DEA shall summarize the issues to be heard Form 189 may be obtained from, and and shall set the time for the hearing, shall be filed (on or before May 1 of the which shall not be less than 10 days year preceding the calendar year for after the date of publication of the no- which the manufacturing quota is tice. After consideration of any com- being applied) with, the Drug & Chem- ments or objections, or after a hearing ical Evaluation Section, Drug Enforce- if one is ordered by the Administrator, ment Administration, Department of the Administrator shall issue and pub- Justice, Washington, D.C. 20537. A sep- lish in the FEDERAL REGISTER his final arate application must be made for order determining the aggregate pro- each basic class desired to be manufac- duction for the basic class of controlled tured. The applicant shall state: substance. The order shall include the (a) The name and Administration findings of fact and conclusions of law Controlled Substances Code Number, as upon which the order is based. The set forth in part 1308 of this chapter, of order shall specify the date on which it the basic class. shall take effect. A copy of said order (b) For the basic class in each of the shall be mailed simultaneously to each current and preceding 2 calendar years, person registered as a bulk manufac- (1) The authorized individual manu- turer of the basic class. facturing quota, if any; [37 FR 15919, Aug. 8, 1972. Redesignated at 38 (2) The actual or estimated quantity FR 26609, Sept. 24, 1973] manufactured;

45 § 1303.23 21 CFR Ch. II (4–1–99 Edition)

(3) The actual or estimated net dis- tential disruptions to production (in- posal; cluding possible labor strikes), and re- (4) The actual or estimated inventory cent unforeseen emergencies such as allowance pursuant to § 1303.24; and floods and fires. (5) The actual or estimated inventory (b) In fixing individual manufac- as of December 31; turing quotas for a basic class of con- (c) For the basic class in the next cal- trolled substance listed in Schedule I endar year, or II, the Administrator shall allocate (1) The desired individual manufac- to each applicant who is not currently turing quota; and manufacturing such class a quota equal (2) Any additional factors which the to 100 percent of the reasonably esti- applicant finds relevant to the fixing of mated net disposal of that applicant his individual manufacturing quota, infor the next calendar year, as deter- cluding the trend of (and recent changes in) his and the national rates mined by the Administrator, ad- of net disposal, his production cycle justed— and current inventory position, the (1) By the amount necessary to pro- econolic and physical availability of vide the applicant his estimated inven- raw materials for use in manufacturing tory allowance for the next calendar and for inventory purposes, yield and year, pursuant to § 1303.24, and stability problems, potential disrup- (2) By any other factors which the tions to production (including possible Administrator deems relevant to the labor strikes) and recent unforeseen fixing of the individual manufacturing emergencies such as floods and fires. quota of the applicant, including the [36 FR 7786, Apr. 24, 1971, as amended at 36 trend of (and recent changes in) the na- FR 13386, July 21, 1971; 37 FR 15920, Aug. 8, tional rate of net disposal, his produc- 1972. Redesignated at 38 FR 26609, Sept. 24, tion cycle and current inventory posi- 1973, and amended at 46 FR 28841, May 29, tion, the economic and physical avail- 1981; 51 FR 5319, Feb. 13, 1986; 62 FR 13958, ability of raw materials for use in man- Mar. 24, 1997] ufacturing and for inventory purposes, § 1303.23 Procedure for fixing indi- yield and stability problems, potential vidual manufacturing quotas. disruptions to production (including possible labor strikes), and recent un- (a) In fixing individual manufacturing quotas for a basic class of con- foreseen emergencies such as floods trolled substance listed in Schedule I and fires. or II, the Administrator shall allocate (c) The Administrator shall, on or be- to each applicant who is currently fore March 1 of each year, adjust the manufacturing such class a quota equal individual manufacturing quota allo- to 100 percent of the estimated net dis- cated for that year to each applicant in posal of that applicant for the next cal- paragraph (a) of this section by the endar year, adjusted— amount necessary to increase or reduce (1) By the amount necessary to in- the actual inventory of the applicant crease or reduce the estimated inven- to December 31 of the preceding year to tory of the applicant on December 31 of his estimated inventory allowance for the current year to his estimated in- the current calendar year, pursuant to ventory allowance for the next cal- § 1303.24. endar year, pursuant to § 1303.24, and (2) By any other factors which the [36 FR 7786, Apr. 24, 1971, as amended at 37 Administrator deems relevant to the FR 15920, Aug. 8, 1972. Redesignated at 38 FR fixing of the individual manufacturing 26609, Sept. 24, 1973] quota of the applicant, including the § 1303.24 Inventory allowance. trend of (and recent changes in) his and the national rates of net disposal, his (a) For the purpose of determining production cycle and current inventory individual manufacturing quotas pur- position, the economic and physical suant to § 1303.23, each registered man- availability of raw materials for use in ufacturer shall be allowed as a part of manufacturing and for inventory pur- such quota an amount sufficient to poses, yield and stability problems, po- maintain an inventory equal to,

46 Drug Enforcement Administration, Justice § 1303.26

(1) For current manufacturers, 50 per- estimated net disposal, inventory and cent of his average estimated net dis- other requirements during the remain- posal for the current calendar year and der of such calendar year. the last preceding calendar year; or (b) The Administrator, in passing (2) For new manufacturers, 50 percent upon a registrant’s application for an of his reasonably estimated net dis- increase in his individual manufac- posal for the next calendar year as de- turing quota, shall take into consider- termined by the Administrator. ation any occurrences since the filing (b) During each calendar year each of such registrant’s initial quota appli- registered manufacturer shall be al- cation that may require an increased lowed to maintain an inventory of a manufacturing rate by such registrant basic class not exceeding 65 percent of his estimated net disposal of that class during the balance of the calendar for that year, as determined at the year. In passing upon such application time his quota for that year was deter- the Administrator may also take into mined. At any time the inventory of a consideration the amount, if any, by basic class held by a manufacturer ex- which his determination of the total ceeds 65 percent of his estimated net quantity for the basic class of con- disposal, his quota for that class is trolled substance to be manufactured automatically suspended and shall re- under § 1303.11 exceeds the aggregate of main suspended until his inventory is all the individual manufacturing less than 60 percent of his estimated quotas for the basic class of controlled net disposal. The Administrator may, substance, and the equitable distribu- upon application and for good cause tion of such excess among other reg- shown, permit a manufacturer whose istrants. quota is, or is likely to be, suspended [36 FR 7786, Apr. 24, 1971, as amended at 36 pursuant to this paragraph to continue FR 13386, July 21, 1971. Redesignated at 38 FR manufacturing and to accumulate an 26609, Sept. 24, 1973] inventory in excess of 65 percent of his estimated net disposal, upon such con- § 1303.26 Reduction in individual man- ditions and within such limitations as ufacturing quotas. the Administrator may find necessary The Administrator may at any time or desirable. (c) If, during a calendar year, a reg- reduce an individual manufacturing istrant has manufactured the entire quota for a basic class of controlled quantity of a basic class allocated to substance listed in Schedule I or II him under an individual manufacturing which he has previously fixed in order quota, and his inventory of that class to prevent the aggregate of the indi- is less than 40 percent of his estimated vidual manufacturing quotas and im- net disposal of that class for that year, port permits outstanding or to be the Administrator may, upon applica- granted from exceeding the aggregate tion pursuant to § 1303.25, increase the production quota which has been estab- quota of such registrant sufficiently to lished for that class pursuant of allow restoration of the inventory to 50 § 1303.11, as adjusted pursuant to percent of the estimated net disposal § 1303.13. If a quota assigned to a new for that year. manufacturer pursuant to § 1303.23(b), or if a quota assigned to any manufac- [36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. Redesignated at 38 FR turer is increased pursuant to 26609, Sept. 24, 1973] § 1303.24(c), or if an import permit issued to an importer pursuant to part § 1303.25 Increase in individual manu- 1312 of this chapter, causes the total facturing quotas. quantity of a basic class to be manu- (a) Any registrant who holds an indi- factured and imported during the year vidual manufacturing quota for a basic to exceed the aggregate production class of controlled substance listed in quota which has been established for Schedule I or II may file with the Ad- that class pursuant to § 1303.11, as administrator an application on Adminis- justed pursuant to § 1303.13, the Admin- tration Form 189 for an increase in istrator may proportionately reduce such quota in order for him to meet his the individual manufacturing quotas

47 § 1303.27 21 CFR Ch. II (4–1–99 Edition) and import permits of all other reg- or denial of a procurement quota pur- istrants to keep the aggregate produc- suant to § 1303.12, or the issuance, ad- tion quota within the limits originally justment, suspension, or denial of an established, or, alternatively, the Ad- individual manufacturing quota pursu- ministrator may reduce the individual ant to §§ 1303.21–1303.27, the procedures manufacturing quota of any registrant for such hearing shall be governed gen- whose quota is suspended pursuant to erally by the adjudication procedures § 1303.24(b) or § 1301.36 of this chapter, or set forth in the Administrative Proce- is abandoned pursuant to § 1303.27. dures Act (5 U.S.C. 551–559) and specifically by section 306 of the Act (21 [36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR U.S.C. 826), by §§ 1303.32–1303.37, and by 26609, Sept. 24, 1973, as amended at 62 FR the procedures for administrative hear- 13958, Mar. 24, 1997] ings under the Act set forth in §§ 1316.41–1316.67 of this chapter. § 1303.27 Abandonment of quota. [36 FR 7786, Apr. 24, 1971, as amended at 37 Any manufacturer assigned an indi- FR 15920, Aug. 8, 1972. Redesignated at 38 FR vidual manufacturing quota for any 26609, Sept. 24, 1973] basic class pursuant to § 1303.23 may at any time abandon his right to manu- § 1303.32 Purpose of hearing. facture all or any part of such quota by (a) The Administrator may, in his filing with the Drug & Chemical Eval- sole discretion, hold a hearing for the uation Section a written notice of such purpose of receiving factual evidence abandonment, stating the name and regarding any one or more issues (to be Administration Controlled Substances specified by him) involved in the deter- Code Number, as set forth in part 1308 mination or adjustment of any aggre- of this chapter, of the substance and gate production quota. the amount which he has chosen not to (b) If requested by a person applying manufacture. The Administrator may, for or holding a procurement quota or in his discretion, allocate such amount an individual manufacturing quota, the among the other manufacturers in pro- Administrator shall hold a hearing for portion to their respective quotas. the purpose of receiving factual evi- [36 FR 7786, Apr. 24, 1971, as amended at 36 dence regarding the issues involved in FR 13386, July 21, 1971. Redesignated at 38 FR the issuance, adjustment, suspension, 26609, Sept. 24, 1973, and amended at 46 FR or denial of such quota to such person, 28841, May 29, 1981; 51 FR 5319, Feb. 13, 1986; but the Administrator need not hold a 62 FR 13958, Mar. 24, 1997] hearing on the suspension of a quota HEARINGS pursuant to § 1301.36 of this chapter separate from a hearing on the suspension § 1303.31 Hearings generally. of registration pursuant to those sec- (a) In any case where the Adminis- tions. trator shall hold a hearing regarding (c) Extensive argument should not be the determination of an aggregate pro- offered into evidence but rather pre- duction quota pursuant to § 1303.11(c), sented in opening or closing state- or regarding the adjustment of an ag- ments of counsel or in memoranda or gregate production quota pursuant to proposed findings of fact and conclu- § 1303.13(c), the procedures for such sions of law. hearing shall be governed generally by [36 FR 7786, Apr. 24, 1971, as amended at 37 the rule making procedures set forth in FR 15920, Aug. 8, 1972. Redesignated at 38 FR the Administrative Procedure Act (5 26609, Sept. 24, 1973, as amended at 62 FR U.S.C. 551–559) and specifically by sec- 13958, Mar. 24, 1997] tion 306 of the Act (21 U.S.C. 826), by §§ 1303.32–1303.37, and by the procedures § 1303.33 Waiver or modification of for administrative hearings under the rules. Act set forth in §§ 1316.41–1316.67 of this The Administrator or the presiding chapter. officer (with respect to matters pend- (b) In any case where the Adminis- ing before him) may modify or waive trator shall hold a hearing regarding any rule in this part by notice in ad- the issuance, adjustment, suspension, vance of the hearing, if he determines

48 Drug Enforcement Administration, Justice § 1303.36 that no party in the hearing will be un- (d) If any person entitled to a hearing duly prejudiced and the ends of justice or to participate in a hearing pursuant will thereby be served. Such notice of to paragraph (b) of this section, fails to modification or waiver shall be made a file a request for a hearing or notice of part of the record of the hearing. appearance, or if he so files and fails to [36 FR 7786, Apr. 24,1971. Redesignated at 38 appear at the hearing, he shall be FR 26609, Sept. 24, 1973] deemed to have waived his opportunity for the hearing or to participate in the § 1303.34 Request for hearing or ap- hearing, unless he shows good cause for pearance; waiver. such failure. (a) Any applicant or registrant who (e) If all persons entitled to a hearing desires a hearing on the issuance, ad- or to participate in a hearing waive or justment, suspension, or denial of his are deemed to waive their opportunity procurement and/or individual manu- for the hearing or to participate in the facturing quota shall, within 30 days hearing, the Administrator may cancel after the date of receipt of the the hearing, if scheduled, and issue his issuance, adjustment, suspension, or final order pursuant to § 1303.37 without denial of such quota, file with the Ad- a hearing. ministrator a written request for a hearing in the form prescribed in [36 FR 7786, Apr. 24, 1971, as amended at 36 § 1316.47 of this chapter. Any interested FR 18731, Sept. 21, 1971; 37 FR 15920, Aug. 8, person who desires a hearing on the de- 1972. Redesignated at 38 FR 26609, Sept. 24, termination of an aggregate production 1973] quota shall, within the time prescribed in § 1303.11(c), file with the Adminis- § 1303.35 Burden of proof. trator a written request for a hearing (a) At any hearing regarding the de- in the form prescribed in § 1316.47 of termination or adjustment of an aggre- this chapter, including in the request a gate production quota, each interested statement of the grounds for a hearing. person participating in the hearing (b) Any interested person who desires shall have the burden of proving any to participate in a hearing on the de- propositions of fact or law asserted by termination or adjustment of an aggre- him in the hearing. gate production quota, which hearing (b) At any hearing regarding the is ordered by the Administrator pursu- issuance, adjustment, suspension, or ant to § 1303.11(c) or § 1303.13(c) may do denial of a procurement or individual so by filing with the Administrator, manufacturing quota, the Administra- within 30 days of the date of publication shall have the burden of proving tion of notice of the hearing in the that the requirements of this part for FEDERAL REGISTER, a written notice of such issuance, adjustment, suspension, his intention to participate in such or denial are satisfied. hearing in the form prescribed in § 1316.48 of this chapter. [36 FR 7786, Apr. 24, 1971, as amended at 37 (c) Any person entitled to a hearing FR 15920, Aug. 8, 1972. Redesignated at 38 FR or to participate in a hearing pursuant 26609, Sept. 24, 1973, as amended at 62 FR to paragraph (b) of this section, may, 13958, Mar. 24, 1997] within the period permitted for filing a § 1303.36 Time and place of hearing. request for a hearing of notice of appearance, file with the Administrator a (a) If any applicant or registrant re- waiver of an opportunity for a hearing quests a hearing on the issuance, ad- or to participate in a hearing, together justment, suspension, or denial of his with a written statement regarding his procurement and/or individual manu- position on the matters of fact and law facturing quota pursuant to § 1303.34, involved in such hearing. Such state- the Administrator shall hold such ment, if admissible, shall be made a hearing. Notice of the hearing shall be part of the record and shall be consid- given to the applicant or registrant of ered in light of the lack of opportunity the time and place at least 30 days for cross-examination in determining prior to the hearing, unless the appli- the weight to be attached to matters of cant or registrant waives such notice fact asserted therein. and requests the hearing be held at an

49 § 1303.37 21 CFR Ch. II (4–1–99 Edition) earlier time, in which case the Admin- 1304.22 Records for manufacturers, distribu- istrator shall fix a date for such hear- tors, dispensers, researchers, importers, ing as early as reasonably possible. and exporters. 1304.23 Records for chemical analysts. (b) The hearing will commence at the 1304.24 Records for maintenance treatment place and time designated in the notice programs and detoxification treatment given pursuant to paragraph (a) of this programs. section or in the notice of hearing pub- 1304.25 Records for treatment programs lished in the FEDERAL REGISTER pursu- which compound narcotics for treatment ant to § 1303.11(c) or § 1303.13 (c), but programs and other locations. thereafter it may be moved to a dif- REPORTS ferent place and may be continued from day to day or recessed to a later 1304.31 Reports from manufacturers importing narcotic raw material. day without notice other than an- 1304.32 Reports of manufacturers importing nouncement thereof by the presiding coca leaves. officer at the hearing. 1304.33 Reports to ARCOS. [36 FR 7786, Apr. 24, 1971, as amended at 37 AUTHORITY: 21 U.S.C. 821, 827, 871(b), 958(e), FR 15920, Aug. 8, 1972. Redesignated at 38 FR 965, unless otherwise noted. 26609, Sept. 24, 1973] GENERAL INFORMATION § 1303.37 Final order. § 1304.01 Scope of part 1304. As soon as practicable after the presiding officer has certified the record Inventory and other records and re- to the Administrator, the Adminis- ports required under section 307 or sec- trator shall issue his order on the de- tion 1008(d) of the Act (21 U.S.C. 827 and termination or adjustment of the ag- 958(d)) shall be in accordance with, and gregate production quota or on the contain the information required by, issuance, adjustment, suspension, or those sections and by the sections of denial of the procurement quota or in- this part. dividual manufacturing quota, as case [36 FR 7789, Apr. 24, 1971. Redesignated at 38 may be. The order shall include the FR 26609, Sept. 24, 1973] findings of fact and conclusions of law upon which the order is based. The § 1304.02 Definitions. order shall specify the date on which it Any term contained in this part shall shall take effect. The Administrator have the definition set forth in section shall serve one copy of his order upon 102 of the Act (21 U.S.C. 802) or part each party in the hearing. 1300 of this chapter. [36 FR 7786, Apr. 24, 1971, as amended at 37 [62 FR 13958, Mar. 24, 1997] FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973] § 1304.03 Persons required to keep records and file reports. PART 1304—RECORDS AND (a) Each registrant shall maintain REPORTS OF REGISTRANTS the records and inventories and shall file the reports required by this part, GENERAL INFORMATION except as exempted by this section. Any registrant who is authorized to Sec. conduct other activities without being 1304.01 Scope of part 1304. registered to conduct those activities, 1304.02 Definitions. either pursuant to § 1301.22(b) of this 1304.03 Persons required to keep records and file reports. chapter or pursuant to §§ 1307.11–1307.15 1304.04 Maintenance of records and inven- of this chapter, shall maintain the tories. records and inventories and shall file the reports required by this part for INVENTORY REQUIREMENTS persons registered to conduct such ac- 1304.11 Inventory requirements. tivities. This latter requirement should not be construed as requiring stocks of CONTINUING RECORDS controlled substances being used in 1304.21 General requirements for continuing various activities under one registra- records. tion to be stored separately, nor that

50 Drug Enforcement Administration, Justice § 1304.03 separate records are required for each Schedules II, III, IV and V which are activity. The intent of the Administra- administered in the lawful course of tion is to permit the registrant to keep professional practice unless the practi- one set of records which are adapted by tioner regularly engages in the dis- the registrant to account for controlled pensing or administering of controlled substances used in any activity. Also, substances and charges patients, either the Administration does not wish to separately or together with charges for acquire separate stocks of the same other professional services, for sub- substance to be purchased and stored stances so dispensed or administered. for separate activities. Otherwise, Records are required to be kept for there is no advantage gained by per- controlled substances administered in mitting several activities under one the course of maintenance or detoxi- registration. Thus, when a researcher fication treatment of an individual. manufactures a controlled item, he must keep a record of the quantity (e) Each registered mid-level practi- manufactured; when he distributes a tioner shall maintain in a readily re- quantity of the item, he must use and trievable manner those documents re- keep invoices or order forms to docu- quired by the state in which he/she ment the transfer; when he imports a practices which describe the conditions substance, he keeps as part of his and extent of his/her authorization to records the documentation required of dispense controlled substances and an importer; and when substances are shall make such documents available used in chemical analysis, he need not for inspection and copying by author- keep a record of this because such a ized employees of the Administration. record would not be required of him Examples of such documentation in- under a registration to do chemical clude protocols, practice guidelines or analysis. All of these records may be practice agreements. maintained in one consolidated record (f) Registered persons using any con- system. Similarly, the researcher may trolled substances while conducting store all of his controlled items in one preclinical research, in teaching at a place, and every two years take inven- registered establishment which main- tory of all items on hand, regardless of tains records with respect to such sub- whether the substances were manufac- stances or conducting research in con- tured by him, imported by him, or pur- formity with an exemption granted chased domestically by him, of whether the substances will be administered to under section 505(i) or 512(j) of the Fed- subjects, distributed to other research- eral Food, Drug, and Cosmetic Act (21 ers, or destroyed during chemical anal- U.S.C. 355(i) or 360b(j)) at a registered ysis. establishment which maintains records (b) A registered individual practi- in accordance with either of those sec- tioner is required to keep records, as tions, are not required to keep records described in § 1304.04, of controlled sub- if he/she notifies the Administration of stances in Schedules II, III, IV, and V the name, address, and registration which are dispensed, other than by pre- number of the establishment maintain- scribing or administering in the lawful ing such records. This notification course of professional practice. shall be given at the time the person (c) A registered individual practi- applies for registration or reregistra- tioner is not required to keep records tion and shall be made in the form of of controlled substances in Schedules an attachment to the application, II, III, IV, and V which are prescribed which shall be filed with the applica- in the lawful course of professional tion. practice, unless such substances are [36 FR 7790, Apr. 24, 1971, as amended at 36 prescribed in the course of mainte- FR 18731, Sept. 21, 1971; 37 FR 15920, Aug. 8, nance or detoxification treatment of an 1972. Redesignated at 38 FR 26609, Sept. 24, individual. 1973, and amended at 50 FR 40523, Oct. 4, 1985; (d) A registered individual practi- 51 FR 5320, Feb. 13, 1986; 51 FR 26154, July 21, tioner is not required to keep records 1986; 58 FR 31175, June 1, 1993; 62 FR 13958, of controlled substances listed in Mar. 24, 1997]

51 § 1304.04 21 CFR Ch. II (4–1–99 Edition)

§ 1304.04 Maintenance of records and provided to make the records under- inventories. standable. (a) Every inventory and other records (3) The registrant agrees to deliver required to be kept under this part all or any part of such records to the shall be kept by the registrant and be registered location within two business available, for at least 2 years from the days upon receipt of a written request date of such inventory or records, for from the Administration for such inspection and copying by authorized records, and if the Administration employees of the Administration, ex- chooses to do so in lieu of requiring de- cept that financial and shipping livery of such records to the registered records (such as invoices and packing location, to allow authorized employ- slips but not executed order forms sub- ees of the Administration to inspect ject to § 1305.13 of this chapter) may be such records at the central location kept at a central location, rather than upon request by such employees with- at the registered location, if the reg- out a warrant of any kind. istrant has notified the Administration (4) In the event that a registrant fails of his intention to keep central to comply with these conditions, the records. Written notification must be Special Agent in Charge may cancel submitted by registered or certified such central recordkeeping authoriza- mail, return receipt requested, in trip- tion, and all other central record- licate, to the Special Agent in Charge keeping authorizations held by the reg- of the Administration in the area in istrant without a hearing or other pro- which the registrant is located. Unless cedures. In the event of a cancellation the registrant is informed by the Spe- of central recordkeeping authoriza- cial Agent in Charge that permission tions under this paragraph the reg- to keep central records is denied, the istrant shall, within the time specified registrant may maintain central by the Special Agent in Charge, comply records commencing 14 days after re- with the requirements of this section ceipt of his notification by the Special that all records be kept at the reg- Agent in Charge. istered location. All notifications must include: (c) Registrants need not notify the (1) The nature of the records to be Special Agent in Charge or obtain cen- kept centrally. tral recordkeeping approval in order to (2) The exact location where the maintain records on an in-house com- records will be kept. puter system. (3) The name, address, DEA registra- (d) ARCOS participants who desire tion number and type of DEA registra- authorization to report from other tion of the registrant whose records are than their registered locations must being maintained centrally. obtain a separate central reporting (4) Whether central records will be identifier. Request for central report- maintained in a manual, or computer ing identifiers will be submitted to: readable form. ARCOS Unit, P.O. Box 28293, Central (b) All registrants that are author- Station, Washington, DC 20005. ized to maintain a central record- (e) All central recordkeeping permits keeping system shall be subject to the previously issued by the Administra- following conditions: tion expired September 30, 1980. (1) The records to be maintained at (f) Each registered manufacturer, dis- the central record location shall not tributor, importer, exporter, narcotic include executed order forms, prescrip- treatment program and compounder tions and/or inventories which shall be for narcotic treatment program shall maintained at each registered location. maintain inventories and records of (2) If the records are kept on micro- controlled substances as follows: film, computer media or in any form (1) Inventories and records of con- requiring special equipment to render trolled substances listed in Schedules I the records easily readable, the reg- and II shall be maintained separately istrant shall provide access to such from all of the records of the reg- equipment with the records. If any istrant; and code system is used (other than pricing (2) Inventories and records of con- information), a key to the code shall be trolled substances listed in Schedules

52 Drug Enforcement Administration, Justice § 1304.11

III, IV, and V shall be maintained ei- (21 U.S.C. 821 and 871(b); 28 CFR 0.100) ther separately from all other records [36 FR 7790, Apr. 24, 1971, as amended at 36 of the registrant or in such form that FR 13386, July 21, 1971. Redesignated at 38 FR the information required is readily re- 26609, Sept. 24, l973, and amended at 39 FR trievable from the ordinary business 37985, Oct. 25, 1974; 45 FR 44266, July 1, 1980; records of the registrant. 47 FR 41735, Sept. 22, 1982; 51 FR 5320, Feb. 13, 1986; 62 FR 13959, Mar. 24, 1997] (g) Each registered individual practitioner required to keep records and in- INVENTORY REQUIREMENTS stitutional practitioner shall maintain inventories and records of controlled § 1304.11 Inventory requirements. substances in the manner prescribed in (a) General requirements. Each inven- paragraph (f) of this section. tory shall contain a complete and accu- (h) Each registered pharmacy shall rate record of all controlled substances maintain the inventories and records of on hand on the date the inventory is controlled substances as follows: taken, and shall be maintained in writ- (1) Inventories and records of all con- ten, typewritten, or printed form at trolled substances listed in Schedules I the registered location. An inventory and II shall be maintained separately taken by use of an oral recording de- from all other records of the pharmacy, vice must be promptly transcribed. and prescriptions for such substances Controlled substances shall be deemed shall be maintained in a separate pre- to be ‘‘on hand’’ if they are in the pos- scription file; and session of or under the control of the (2) Inventories and records of con- registrant, including substances re- trolled substances listed in Schedules turned by a customer, ordered by a cus- III, IV, and V shall be maintained ei- tomer but not yet invoiced, stored in a ther separately from all other records warehouse on behalf of the registrant, of the pharmacy or in such form that and substances in the possession of em- the information required is readily re- ployees of the registrant and intended trievable from ordinary business for distribution as complimentary sam- records of the pharmacy, and prescrip- ples. A separate inventory shall be tions for such substances shall be made for each registered location and maintained either in a separate pre- each independent activity registered, scription file for controlled substances except as provided in paragraph (e)(4) listed in Schedules III, IV, and V only of this section. In the event controlled substances in the possession or under or in such form that they are readily the control of the registrant are stored retrievable from the other prescription at a location for which he/she is not records of the pharmacy. Prescriptions registered, the substances shall be in- will be deemed readily retrievable if, at cluded in the inventory of the reg- the time they are initially filed, the istered location to which they are sub- face of the prescription is stamped in ject to control or to which the person red ink in the lower right corner with possessing the substance is responsible. the letter ‘‘C’’ no less than 1 inch high The inventory may be taken either as and filed either in the prescription file of opening of business or as of the close for controlled substances listed in of business on the inventory date and Schedules I and II or in the usual con- it shall be indicated on the inventory. secutively numbered prescription file (b) Initial inventory date. Every person for non-controlled substances. How- required to keep records shall take an ever, if a pharmacy employs an ADP inventory of all stocks of controlled system or other electronic record- substances on hand on the date he/she keeping system for prescriptions which first engages in the manufacture, dis- permits identification by prescription tribution, or dispensing of controlled number and retrieval of original docu- substances, in accordance with para- ments by prescriber’s name, patient’s graph (e) of this section as applicable. name, drug dispensed, and date filled, In the event a person commences busi- then the requirement to mark the hard ness with no controlled substances on copy prescription with a red ‘‘C’’ is hand, he/she shall record this fact as waived. the initial inventory.

53 § 1304.11 21 CFR Ch. II (4–1–99 Edition)

(c) Biennial inventory date. After the other appropriate identifying number; initial inventory is taken, the reg- and istrant shall take a new inventory of (C) The physical form which the sub- all stocks of controlled substances on stance is to take upon completion of hand at least every two years. The bi- the manufacturing process (e.g., granu- ennial inventory may be taken on any lations, tablets, capsules, or solutions), date which is within two years of the identified by the batch number or previous biennial inventory date. other appropriate identifying number, (d) Inventory date for newly controlled and if possible the finished form of the substances. On the effective date of a substance (e.g., 10-milligram tablet or rule by the Administrator pursuant to 10-milligram concentration per fluid §§ 1308.45, 1308.46, or 1308.47 of this chap- ounce or milliliter) and the number or ter adding a substance to any schedule volume thereof. of controlled substances, which sub- (iii) For each controlled substance in stance was, immediately prior to that finished form the inventory shall in- date, not listed on any such schedule, clude: every registrant required to keep (A) The name of the substance; records who possesses that substance (B) Each finished form of the sub- shall take an inventory of all stocks of stance (e.g., 10-milligram tablet or 10- the substance on hand. Thereafter, milligram concentration per fluid such substance shall be included in ounce or milliliter); each inventory made by the registrant (C) The number of units or volume of pursuant to paragraph (c) of this sec- each finished form in each commercial tion. container (e.g., 100-tablet bottle or 3- (e) Inventories of manufacturers, dis- milliliter vial); and tributors, dispensers, researchers, import- (D) The number of commercial con- ers, exporters and chemical analysts. tainers of each such finished form (e.g. Each person registered or authorized four 100-tablet bottles or six 3-milli- (by § 1301.13 or §§ 1307.11–1307.13 of this liter vials). chapter) to manufacture, distribute, (iv) For each controlled substance dispense, import, export, conduct re- not included in paragraphs (e)(1) (i), (ii) search or chemical analysis with con- or (iii) of this section (e.g., damaged, trolled substances and required to keep defective or impure substances await- records pursuant to § 1304.03 shall ining disposal, substances held for qual- clude in the inventory the information ity control purposes, or substances listed below. maintained for extemporaneous (1) Inventories of manufacturers. Each compoundings) the inventories shall person registered or authorized to man- include: ufacture controlled substances shall in- (A) The name of the substance; clude the following information in the (B) The total quantity of the sub- inventory: stance to the nearest metric unit (i) For each controlled substance in weight or the total number of units of bulk form to be used in (or capable of finished form; and use in) the manufacture of the same or (C) The reason for the substance other controlled or non-controlled sub- being maintained by the registrant and stances in finished form, the inventory whether such substance is capable of shall include: use in the manufacture of any con- (A) The name of the substance and trolled substance in finished form. (B) The total quantity of the sub- (2) Inventories of distributors. Each stance to the nearest metric unit person registered or authorized to dis- weight consistent with unit size. tribute controlled substances shall in- (ii) For each controlled substance in clude in the inventory the same infor- the process of manufacture on the in- mation required of manufacturers pur- ventory date, the inventory shall in- suant to paragraphs (e)(1) (iii) and (iv) clude: of this section. (A) The name of the substance; (3) Inventories of dispensers and re- (B) The quantity of the substance in searchers. Each person registered or au- each batch and/or stage of manufac- thorized to dispense or conduct re- ture, identified by the batch number or search with controlled substances shall

54 Drug Enforcement Administration, Justice § 1304.22 include in the inventory the same instances received as evidentiary mate- formation required of manufacturers rials for analysis. pursuant to paragraphs (e)(1) (iii) and (iv) of this section. In determining the [62 FR 13959, Mar. 24, 1997] number of units of each finished form CONTINUING RECORDS of a controlled substance in a commercial container which has been opened, § 1304.21 General requirements for the dispenser shall do as follows: continuing records. (i) If the substance is listed in Sched- (a) Every registrant required to keep ule I or II, make an exact count or records pursuant to § 1304.03 shall main- measure of the contents, or tain on a current basis a complete and (ii) If the substance is listed in accurate record of each such substance Schedule III, IV or V, make an esti- manufactured, imported, received, mated count or measure of the con- sold, delivered, exported, or otherwise tents, unless the container holds more disposed of by him/her, except that no than 1,000 tablets or capsules in which registrant shall be required to main- case he/she must make an exact count tain a perpetual inventory. of the contents. (4) Inventories of importers and export- (b) Separate records shall be main- ers. Each person registered or author- tained by a registrant for each reg- ized to import or export controlled sub- istered location except as provided in stances shall include in the inventory § 1304.04 (a). In the event controlled the same information required of man- substances are in the possession or ufacturers pursuant to paragraphs under the control of a registrant at a (e)(1) (iii) and (iv) of this section. Each location for which he is not registered, such person who is also registered as a the substances shall be included in the manufacturer or as a distributor shall records of the registered location to include in his/her inventory as an im- which they are subject to control or to porter or exporter only those stocks of which the person possessing the sub- controlled substances that are actually stance is responsible. separated from his stocks as a manu- (c) Separate records shall be main- facturer or as a distributor (e.g., in tained by a registrant for each inde- transit or in storage for shipment). pendent activity for which he/she is (5) Inventories of chemical analysts. registered, except as provided in Each person registered or authorized to § 1304.22(d). conduct chemical analysis with con- (d) In recording dates of receipt, im- trolled substances shall include in his portation, distribution, exportation, or inventory the same information re- other transfers, the date on which the quired of manufacturers pursuant to controlled substances are actually re- paragraphs (e)(1) (iii) and (iv) of this ceived, imported, distributed, exported, section as to substances which have or otherwise transferred shall be used been manufactured, imported, or re- as the date of receipt or distribution of ceived by such person. If less than 1 any documents of transfer (e.g., in- kilogram of any controlled substance voices or packing slips). (other than a hallucinogenic controlled [36 FR 7792, Apr. 24, 1971, as amended at 36 substance listed in Schedule I), or less FR 13386, July 21, 1971. Redesignated at 38 FR than 20 grams of a hallucinogenic sub- 26609, Sept. 24, 1973, as amended at 62 FR stance listed in Schedule I (other than 13960, Mar. 24, 1997] lysergic acid diethylamide), or less than 0.5 gram of lysergic acid § 1304.22 Records for manufacturers, diethylamide, is on hand at the time of distributors, dispensers, research- inventory, that substance need not be ers, importers and exporters. included in the inventory. Laboratories Each person registered or authorized of the Administration may possess up (by § 1301.13(e) or §§ 1307.11–1307.13 of to 150 grams of any hallucinogenic sub- this chapter) to manufacture, dis- stance in Schedule I without regard to tribute, dispense, import, export or a need for an inventory of those sub- conduct research with controlled substances. No inventory is required of stances shall maintain records with the known or suspected controlled sub- information listed below.

55 § 1304.22 21 CFR Ch. II (4–1–99 Edition)

(a) Records for manufacturers. Each the information required in paragraph person registered or authorized to man- (a)(1)(v) of this section; ufacture controlled substances shall (vii) The quantity distributed in bulk maintain records with the following inform to other persons, including the formation: date and quantity of each distribution (1) For each controlled substance in and the name, address, and registration bulk form to be used in, or capable of number of each person to whom a dis- use in, or being used in, the manufac- tribution was made; ture of the same or other controlled or (viii) The quantity exported directly noncontrolled substances in finished by the registrant (under a registration form, as an exporter), including the date, (i) The name of the substance; quantity, and export permit or declara- (ii) The quantity manufactured in tion number of each exportation; bulk form by the registrant, including (ix) The quantity distributed or dis- the date, quantity and batch or other posed of in any other manner by the identifying number of each batch man- registrant (e.g., by distribution of com- ufactured; plimentary samples or by destruction), (iii) The quantity received from including the date and manner of dis- other persons, including the date and tribution or disposal, the name, ad- quantity of each receipt and the name, dress, and registration number of the address, and registration number of the person to whom distributed, and the other person from whom the substance quantity distributed or disposed; and was received; (x) The originals of all written cer- (iv) The quantity imported directly tifications of available procurement by the registrant (under a registration quotas submitted by other persons (as as an importer) for use in manufacture required by § 1303.12(f) of this chapter) by him/her, including the date, quan- relating to each order requiring the tity, and import permit or declaration distribution of a basic class of con- number for each importation; trolled substance listed in Schedule I (v) The quantity used to manufacture or II. the same substance in finished form, including: (2) For each controlled substance in (A) The date and batch or other iden- finished form, tifying number of each manufacture; (i) The name of the substance; (B) The quantity used in the manu- (ii) Each finished form (e.g., 10-milli- facture; gram tablet or 10-milligram concentra- (C) The finished form (e.g., 10-milli- tion per fluid ounce or milliliter) and gram tablets or 10-milligram con- the number of units or volume of fin- centration per fluid ounce or milli- ished form in each commercial con- liter); tainer (e.g., 100-tablet bottle or 3-milli- (D) The number of units of finished liter vial); form manufactured; (iii) The number of containers of (E) The quantity used in quality con- each such commercial finished form trol; manufactured from bulk form by the (F) The quantity lost during manu- registrant, including the information facturing and the causes therefore, if required pursuant to paragraph known; (a)(1)(v) of this section; (G) The total quantity of the sub- (iv) The number of units of finished stance contained in the finished form; forms and/or commercial containers (H) The theoretical and actual yields; acquired from other persons, including and the date of and number of units and/or (I) Such other information as is nec- commercial containers in each acquisi- essary to account for all controlled tion to inventory and the name, ad- substances used in the manufacturing dress, and registration number of the process; person from whom the units were ac- (vi) The quantity used to manufac- quired; ture other controlled and noncon- (v) The number of units of finished trolled substances, including the name forms and/or commercial containers of each substance manufactured and imported directly by the person (under

56 Drug Enforcement Administration, Justice § 1304.23 a registration or authorization to im- with controlled substances shall main- port), including the date of, the num- tain records with the same information ber of units and/or commercial con- required of manufacturers pursuant to tainers in, and the import permit or paragraph (a)(2) (i), (ii), (iv), (vii), and declaration number for, each importa- (ix) of this section. In addition, records tion; shall be maintained of the number of (vi) The number of units and/or com- units or volume of such finished form mercial containers manufactured by dispensed, including the name and ad- the registrant from units in finished dress of the person to whom it was dis- form received from others or imported, pensed, the date of dispensing, the including: number of units or volume dispensed, (A) The date and batch or other iden- and the written or typewritten name or tifying number of each manufacture; initials of the individual who dispensed (B) The operation performed (e.g., re- or administered the substance on be- packaging or relabeling); half of the dispenser. (C) The number of units of finished (d) Records for importers and exporters. form used in the manufacture, the Each person registered or authorized to number manufactured and the number import or export controlled substances lost during manufacture, with the shall maintain records with the same causes for such losses, if known; and information required of manufacturers (D) Such other information as is nec- pursuant to paragraphs (a)(2) (i), (iv), essary to account for all controlled (v) and (vii) of this section. In addition, substances used in the manufacturing the quantity disposed of in any other process; manner by the registrant (except quan- (vii) The number of commercial con- tities used in manufacturing by an im- tainers distributed to other persons, in- porter under a registration as a manu- cluding the date of and number of con- facturer), which quantities are to be re- tainers in each reduction from inven- corded pursuant to paragraphs (a)(1) tory, and the name, address, and reg- (iv) and (v) of this section; and the istration number of the person to quantity (or number of units or volume whom the containers were distributed; in finished form) exported, including (viii) The number of commercial con- the date, quantity (or number of units tainers exported directly by the reg- or volume), and the export permit or istrant (under a registration as an ex- declaration number for each expor- porter), including the date, number of tation, but excluding all quantities containers and export permit or dec- (and number of units and volumes) laration number for each exportation; manufactured by an exporter under a and registration as a manufacturer, which (ix) The number of units of finished quantities (and numbers of units and forms and/or commercial containers volumes) are to be recorded pursuant distributed or disposed of in any other to paragraphs (a)(1)(xiii) or (a)(2)(xiii) manner by the registrant (e.g., by dis- of this section. tribution of complimentary samples or [62 FR 13960, Mar. 24, 1997] by destruction), including the date and manner of distribution or disposal, the § 1304.23 Records for chemical ana- name, address, and registration num- lysts. ber of the person to whom distributed, (a) Each person registered or author- and the quantity in finished form dis- ized (by § 1301.22(b) of this chapter) to tributed or disposed. conduct chemical analysis with con- (b) Records for distributors. Each per- trolled substances shall maintain son registered or authorized to dis- records with the following information tribute controlled substances shall (to the extent known and reasonably maintain records with the same infor- ascertainable by him) for each con- mation required of manufacturers pur- trolled substance: suant to paragraphs (a)(2) (i), (ii), (iv), (1) The name of the substance; (v), (vii), (viii) and (ix) of this section. (2) The form or forms in which the (c) Records for dispensers and research- substance is received, imported, or ers. Each person registered or author- manufactured by the registrant (e.g., ized to dispense or conduct research powder, granulation, tablet, capsule, or

57 § 1304.24 21 CFR Ch. II (4–1–99 Edition) solution) and the concentration of the (b) The records required by paragraph substance in such form (e.g., C.P., (a) of this section will be maintained in U.S.P., N.F., 10-milligram tablet or 10- a dispensing log at the narcotic treat- milligram concentration per milli- ment program site and will be main- liter); tained in compliance with § 1304.22 (3) The total number of the forms re- without reference to § 1304.03. ceived, imported or manufactured (e.g., (c) All sites which compound a bulk 100 tablets, thirty 1-milliliter vials, or narcotic solution from bulk narcotic 10 grams of powder), including the date powder to liquid for on-site use must and quantity of each receipt, importa- keep a separate batch record of the tion, or manufacture and the name, ad- compounding. dress, and registration number, if any, (d) Records of identity, diagnosis, of the person from whom the substance prognosis, or treatment of any patients was received; which are maintained in connection (4) The quantity distributed, ex- with the performance of a narcotic ported, or destroyed in any manner by treatment program shall be confiden- the registrant (except quantities used tial, except that such records may be in chemical analysis or other labora- disclosed for purposes and under the tory work), including the date and circumstances authorized by part 310 manner of distribution, exportation, or and 42 CFR part 2. destruction, and the name, address, and registration number, if any, of [39 FR 37985, Oct. 25, 1974. Redesignated and each person to whom the substance was amended at 62 FR 13961, Mar. 24, 1997] distributed or exported. (b) Records of controlled substances § 1304.25 Records for treatment pro- used in chemical analysis or other lab- grams which compound narcotics for treatment programs and other oratory work are not required. locations. (c) Records relating to known or suspected controlled substances received Each person registered or authorized as evidentiary material for analysis are by § 1301.22 of this chapter to compound not required under paragraph (a) of narcotic drugs for off-site use in a nar- this section. cotic treatment program shall maintain records which include the fol- [36 FR 7793, Apr. 24, 1971, as amended at 36 lowing information for each narcotic FR 13386, July 21, 1971; 36 FR 18732, Sept. 21, drug: 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and further redesignated at 62 FR 13961, (a) For each narcotic controlled sub- Mar. 24, 1997] stance in bulk form to be used in, or capable of use in, or being used in, the § 1304.24 Records for maintenance compounding of the same or other non- treatment programs and detoxifica- controlled substances in finished form: tion treatment programs. (1) The name of the substance; (a) Each person registered or author- (2) The quantity compounded in bulk ized (by § 1301.22 of this chapter) to form by the registrant, including the maintain and/or detoxify controlled date, quantity and batch or other iden- substance users in a narcotic treat- tifying number of each batch comment program shall maintain records pounded; with the following information for each (3) The quantity received from other narcotic controlled substance: persons, including the date and quan- (1) Name of substance; tity of each receipt and the name, ad- (2) Strength of substance; dress and registration number of the (3) Dosage form; other person from whom the substance (4) Date dispensed; was received; (5) Adequate identification of patient (4) The quantity imported directly by (consumer); the registrant (under a registration as (6) Amount consumed; an importer) for use in compounding by (7) Amount and dosage form taken him, including the date, quantity and home by patient; and import permit or declaration number (8) Dispenser’s initials. of each importation;

58 Drug Enforcement Administration, Justice § 1304.25

(5) The quantity used to compound pounded from bulk form by the reg- the same substance in finished form, istrant, including the information re- including: quired pursuant to paragraph (a)(5) of (i) The date and batch or other iden- this section; tifying number of each compounding; (4) The number of units of finished (ii) The quantity used in the com- forms and/or commercial containers re- pound; ceived from other persons, including (iii) The finished form (e.g., 10-milli- the date of and number of units and/or gram tablets or 10-milligram con- commercial containers in each receipt centration per fluid ounce or milliliter; and the name, address and registration (iv) The number of units of finished number of the person from whom the form compounded; units were received; (v) The quantity used in quality con- (5) The number of units of finished trol; forms and/or commercial containers (vi) The quantity lost during imported directly by the person (under compounding and the causes therefore, if known; a registration or authorization to im- (vii) The total quantity of the sub- port), including the date of, the num- stance contained in the finished form; ber of units and/or commercial con- (viii) The theoretical and actual tainers in, and the import permit or yields; and declaration number for, each importa- (ix) Such other information as is nection; essary to account for all controlled (6) The number of units and/or com- substances used in the compounding mercial containers compounded by the process; registrant from units in finished form (6) The quantity used to manufacture received from others or imported, in- other controlled and non-controlled cluding: substances; including the name of each (i) The date and batch or other iden- substance manufactured and the infor- tifying number of each compounding; mation required in paragraph (a)(5) of (ii) The operation performed (e.g., re- this section; packaging or relabeling); (7) The quantity distributed in bulk (iii) The number of units of finished form to other programs, including the form used in the compound, the num- date and quantity of each distribution ber compounded and the number lost and the name, address and registration during compounding, with the causes number of each program to whom a dis- for such losses, if known; and tribution was made; (iv) Such other information as is nec- (8) The quantity exported directly by essary to account for all controlled the registrant (under a registration as substances used in the compounding an exporter), including the date, quan- process; tity, and export permit or declaration (7) The number of containers distrib- number of each exploration; and uted to other programs, including the (9) The quantity disposed of by de- date, the number of containers in each struction, including the reason, date distribution, and the name, address and and manner of destruction. All other destruction of narcotic controlled sub- registration number of the program to stances will comply with § 1307.22. whom the containers were distributed; (b) For each narcotic controlled sub- (8) The number of commercial con- stance in finished form: tainers exported directly by the reg- (1) The name of the substance; istrant (under a registration as an ex- (2) Each finished form (e.g., 10-milli- porter), including the date, number of gram tablet or 10 milligram concentra- containers and export permit or dec- tion per fluid ounce or milliliter) and laration number for each exportation; the number of units or volume or fin- and ished form in each commercial con- (9) The number of units of finished tainer (e.g., 100-tablet bottle or 3-milli- forms and/or commercial containers liter vial); destroyed in any manner by the reg- (3) The number of containers of each istrant, including the reason, the date such commercial finished form com- and manner of destruction. All other

59 § 1304.31 21 CFR Ch. II (4–1–99 Edition) destruction of narcotic controlled sub- (5) Quantity sold; stances will comply with § 1307.22. (6) Quantity returned to conversion processes for reworking; [39 FR 37985, Oct. 25, 1974. Redesignated at 62 FR 13961, Mar. 24, 1997] (7) Quantity used for conversion; (8) Quantity placed in process; REPORTS (9) Other dispositions; (10) Losses on reweighing and § 1304.31 Reports from manufacturers (11) Ending inventory. importing narcotic raw material. (d) The following information shall (a) Every manufacturer which im- be submitted for importation of each ports or manufactures from narcotic narcotic raw material: raw material (opium, poppy straw, and (1) Import permit number; concentrate of poppy straw) shall sub- (2) Date shipment arrived at the mit information which accounts for the United States port of entry; importation and for all manufacturing (3) Actual quantity shipped; operations performed between importa- (4) Assay (percent) of morphine, co- tion and the production in bulk or fin- deine and thebaine and ished marketable products, standard- (5) Quantity shipped, expressed as an- ized in accordance with the U.S. Phar- hydrous morphine alkaloid. macopeia, National Formulary or other (e) Upon importation of crude opium, recognized medical standards. Reports samples will be selected and assays shall be signed by the authorized offi- made by the importing manufacturer cial and submitted quarterly on com- in the manner and according to the pany letterhead to the Drug Enforce- method specified in the U.S. Pharma- ment Administration, Drug and Chem- copoeia. Where final assay data is not ical Evaluation Section, Washington, determined at the time of rendering re- D.C. 20537, on or before the 15th day of port, the report shall be made on the the month immediately following the basis of the best data available, subject period for which it is submitted. to adjustment, and the necessary ad- (b) The following information shall justing entries shall be made on the be submitted for each type of narcotic next report. raw material (quantities are expressed (f) Where factory procedure is such as grams of anhydrous morphine alka- that partial withdrawals of opium are loid): made from individual containers, there (1) Beginning inventory; shall be attached to each container a (2) Gains on reweighing; stock record card on which shall be (3) Imports; kept a complete record of all with- (4) Other receipts; drawals therefrom. (5) Quantity put into process; (g) All in-process inventories should (6) Losses on reweighing; be expressed in terms of end-products (7) Other dispositions and and not precursors. Once precursor ma- (8) Ending inventory. terial has been changed or placed into (c) The following information shall process for the manufacture of a speci- be submitted for each narcotic raw ma- fied end-product, it must no longer be terial derivative including morphine, accounted for as precursor stocks codeine, thebaine, oxycodone, available for conversion or use, but hydrocodone, medicinal opium, manu- rather as end-product in-process inven- facturing opium, crude alkaloids and tories. other derivatives (quantities are ex- [62 FR 13961, Mar. 24, 1997] pressed as grams of anhydrous base or anhydrous morphine alkaloid for man- § 1304.32 Reports of manufacturers im- ufacturing opium and medicinal porting coca leaves. opium): (a) Every manufacturer importing or (1) Beginning inventory; manufacturing from raw coca leaves (2) Gains on reweighing; shall submit information accounting (3) Quantity extracted from narcotic for the importation and for all manu- raw material; facturing operations performed be- (4) Quantity produced/manufactured/ tween the importation and the manu- synthesized; facture of bulk or finished products

60 Drug Enforcement Administration, Justice § 1304.33 standardized in accordance with U.S. mined at the time of submission, the Pharmacopoeia, National Formulary, report shall be made on the basis of the or other recognized standards. The re- best data available, subject to adjust- ports shall be submitted quarterly on ment, and the necessary adjusting en- company letterhead to the Drug En- tries shall be made on the next report. forcement Administration, Drug and (e) Where factory procedure is such Chemical Evaluation Section, Wash- that partial withdrawals of medicinal ington, DC 20537, on or before the 15th coca leaves are made from individual day of the month immediately fol- containers, there shall be attached to lowing the period for which it is sub- the container a stock record card on mitted. which shall be kept a complete record (b) The following information shall of withdrawals therefrom. be submitted for raw coca leaf, ecgo- (f) All in-process inventories should nine, ecgonine for conversion or fur- be expressed in terms of end-products ther manufacture, benzoylecgonine, and not precursors. Once precursor ma- manufacturing coca extracts (list for terial has been changed or placed into tinctures and extracts; and others sep- process for the manufacture of a speci- arately), other crude alkaloids and fied end-product, it must no longer be other derivatives (quantities should be accounted for as precursor stocks reported as grams of actual quantity available for conversion or use, but involved and the cocaine alkaloid con- rather as end-product in-process inven- tent or equivalency): tories. (1) Beginning inventory; (2) Imports; [62 FR 13962, Mar. 24, 1997] (3) Gains on reweighing; (4) Quantity purchased; § 1304.33 Reports to ARCOS. (5) Quantity produced; (a) Reports generally. All reports re- (6) Other receipts; quired by this section shall be filed (7) Quantity returned to processes for with the ARCOS Unit, PO 28293, Cen- reworking; tral Station, Washington, DC 20005 on (8) Material used in purification for DEA Form 333, or on media which con- sale; tains the data required by DEA Form (9) Material used for manufacture or 333 and which is acceptable to the production; ARCOS Unit. (10) Losses on reweighing; (b) Frequency of reports. Acquisition/ (11) Material used for conversion; Distribution transaction reports shall (12) Other dispositions and be filed every quarter not later than (13) Ending inventory. the 15th day of the month succeeding (c) The following information shall the quarter for which it is submitted; be submitted for importation of coca except that a registrant may be given leaves: permission to file more frequently (but (1) Import permit number; not more frequently than monthly), de- (2) Date the shipment arrived at the pending on the number of transactions United States port of entry; being reported each time by that reg- (3) Actual quantity shipped; istrant. Inventories shall provide data (4) Assay (percent) of cocaine alka- on the stocks of each reported con- loid and trolled substance on hand as of the (5) Total cocaine alkaloid content. close of business on December 31 of (d) Upon importation of coca leaves, each year, indicating whether the sub- samples will be selected and assays stance is in storage or in process of made by the importing manufacturer manufacturing. These reports shall be in accordance with recognized chem- filed not later than January 15 of the ical procedures. These assays shall following year. Manufacturing trans- form the basis of accounting for such action reports shall be filed annually coca leaves, which shall be accounted for each calendar year not later than for in terms of their cocaine alkaloid January 15 of the following year, ex- content or equivalency or their total cept that a registrant may be given anhydrous coca alkaloid content. permission to file more frequently (but Where final assay data is not deter- not more frequently than quarterly).

61 Pt. 1305 21 CFR Ch. II (4–1–99 Edition)

(c) Persons reporting. For controlled of the product containing the con- substances in Schedules I, II or nar- trolled substance for which the report cotic controlled substances in Schedule is being made. For this purpose, per- III, each person who is registered to sons filing reports shall utilize the Na- manufacture in bulk or dosage form, or tional Drug Code Number assigned to to package, repackage, label or relabel, the product under the National Drug and each person who is registered to Code System of the Food and Drug Ad- distribute shall report acquisition/dis- ministration. tribution transactions. In addition to (e) Transactions reported. Acquisition/ reporting acquisition/distribution distribution transaction reports shall transactions, each person who is reg- provide data on each acquisition to in- istered to manufacture controlled sub- ventory (identifying whether it is, e.g., stances in bulk or dosage form shall re- by purchase or transfer, return from a port manufacturing transactions on customer, or supply by the Federal controlled substances in Schedules I Government) and each reduction from and II, each narcotic controlled sub- inventory (identifying whether it is, stance listed in Schedules III, IV, and e.g., by sale or transfer, theft, destruc- V, and on each psychotropic controlled tion or seizure by Government agen- substance listed in Schedules III and IV cies). Manufacturing reports shall pro- as identified in paragraph (d) of this vide data on material manufactured, section. manufacture from other material, use (d) Substances covered. (1) Manufac- in manufacturing other material and turing and acquisition/distribution use in producing dosage forms. transaction reports shall include data (f) Exceptions. A registered institu- on each controlled substance listed in tional practitioner who repackages or Schedules I and II and on each narcotic relabels exclusively for distribution or controlled substance listed in Schedule who distributes exclusively to (for dis- III (but not on any material, com- pensing by) agents, employees, or af- pound, mixture or preparation con- filiated institutional practitioners of taining a quantity of a substance hav- the registrant may be exempted from ing a stimulant effect on the central filing reports under this section by ap- nervous system, which material, complying to the ARCOS Unit of the Ad- pound, mixture or preparation is listed ministration. in Schedule III or on any narcotic controlled substance listed in Schedule V). (Approved by the Office of Management and Budget under control number 1117–0003) Additionally, reports on manufacturing [62 FR 13962, Mar. 24, 1997] transactions shall include the following psychotropic controlled substances listed in Schedules III and IV: PART 1305—ORDER FORMS (i) Schedule III (A) Benzphetamine; Sec. (B) Cyclobarbital; 1305.01 Scope of part 1305. (C) Methyprylon; and 1305.02 Definitions. 1305.03 Distributions requiring order forms. (D) Phendimetrazine. 1305.04 Persons entitled to obtain and exe- (ii) Schedule IV cute order forms. (A) Barbital; 1305.05 Procedure for obtaining order forms. (B) Diethylpropion (Amfepramone); 1305.06 Procedure for executing order forms. (C) Ethchlorvynol; 1305.07 Power of attorney. (D) Ethinamate; 1305.08 Persons entitled to fill order forms. (E) Lefetamine (SPA); 1305.09 Procedure for filling order forms. (F) Mazindol; 1305.10 Procedure for endorsing order forms. (G) Meprobamate; 1305.11 Unaccepted and defective order (H) Methylphenobarbital; forms. (I) Phenobarbital; 1305.12 Lost and stolen order forms. 1305.13 Preservation of order forms. (J) Phentermine; and 1305.14 Return of unused order forms. (K) Pipradrol. 1305.15 Cancellation and voiding of order (2) Data shall be presented in such a forms. manner as to identify the particular 1305.16 Special procedure for filling certain form, strength, and trade name, if any, order forms.

62 Drug Enforcement Administration, Justice § 1305.05

AUTHORITY: 21 U.S.C. 821, 828, 871(b), unless § 1305.05 Procedure for obtaining otherwise noted. order forms. SOURCE: 36 FR 7796, Apr. 24, 1971, unless (a) Order Forms are issued in mailing otherwise noted. Redesignated at 38 FR 26609, envelopes containing either seven or Sept. 24, 1973. fourteen forms, each form containing § 1305.01 Scope of part 1305. an original duplicate and triplicate copy (respectively, Copy 1, Copy 2, and Procedures governing the issuance, Copy 3). A limit, which is based on the use, and preservation of order forms business activity of the registrant, will pursuant to section 1308 of the Act (21 be imposed on the number of order U.S.C. 828) are set forth generally by forms which will be furnished on any that section and specifically by the requisition unless additional forms are sections of this part. specifically requested and a reasonable need for such additional forms is § 1305.02 Definitions. shown. Any term contained in this part shall (b) Any person applying for a reg- have the definition set forth in section istration which would entitle him/her 102 of the Act (21 U.S.C. 802) or part to obtain order forms may requisition 1300 of this chapter. such forms by so indicating on the ap- [62 FR 13963, Mar. 24, 1997] plication form; order forms will be supplied upon the registration of the appli- § 1305.03 Distributions requiring order cant. Any person holding a registration forms. entitling him/her to obtain order forms An order form (DEA Form 222) is re- may requisition such forms for the quired for each distribution of a Sched- first time by contacting any Division ule I or II controlled substance except Office or the Registration Unit of the to persons exempted from registration Administration. Any person already under part 1301 of this chapter; which holding order forms may requisition are exported from the United States in additional forms on DEA Form 222a conformity with the Act; or for deliv- which is mailed to a registrant ap- ery to a registered analytical labora- proximately 30 days after each ship- tory, or its agent approved by DEA. ment of order forms to that registrant or by contacting any Division Office or [62 FR 13963, Mar. 24, 1997] the Registration Unit of the Adminis- tration. All requisition forms (DEA § 1305.04 Persons entitled to obtain Form 222a) shall be submitted to the and execute order forms. Registration Unit, Drug Enforcement (a) Order forms may be obtained only Administration, Department of Jus- by persons who are registered under tice, Post Office Box 28083, Central Sta- section 303 of the Act (21 U.S.C. 823) to tion, Washington, DC 20005. handle controlled substances listed in (c) Each requisition shall show the Schedules I and II, and by persons who name, address, and registration num- are registered under section 1008 of the ber of the registrant and the number of Act (21 U.S.C. 958) to export such sub- books of order forms desired. Each req- stances. Persons not registered to han- uisition shall be signed and dated by dle controlled substances listed in the same person who signed the most Schedule I or II and persons registered recent application for registration or only to import controlled substances for reregistration, or by any person au- listed in any schedule are not entitled thorized to obtain and execute order to obtain order forms. forms by a power of attorney pursuant (b) An order form may be executed to § 1305.07. only on behalf of the registrant named (d) Order forms will be serially num- thereon and only if his/her registration bered and issued with the name, ad- as to the substances being purchased dress and registration number of the has not expired or been revoked or sus- registrant, the authorized activity and pended. schedules of the registrant. This infor- [36 FR 7796, Apr. 24, 1971. Redesignated at 38 mation cannot be altered or changed FR 26609, Sept. 24, 1973, as amended at 62 FR by the registrant; any errors must be 13964, Mar. 24, 1997] corrected by the Registration Unit of

63 § 1305.06 21 CFR Ch. II (4–1–99 Edition) the Administration by returning the vidual. The power of attorney shall be forms with notification of the error. signed by the same person who signed the most recent application for reg- [36 FR 7796, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21, 1971. Redesignated at 38 istration or reregistration and by the FR 26609, Sept. 24, 1973, and amended at 51 individual being authorized to obtain FR 5319, Feb. 13, 1986; 53 FR 4963, Feb. 19, and execute order forms. The power of 1988; 62 FR 13964, Mar. 24, 1997] attorney shall be filed with the executed order forms of the purchaser, and § 1305.06 Procedure for executing shall be retained for the same period as order forms. any order form bearing the signature of (a) Order forms shall be prepared and the attorney. The power of attorney executed by the purchaser simulta- shall be available for inspection to- neously in triplicate by means of gether with other order form records. interleaved carbon sheets which are Any power of attorney may be revoked part of the DEA Form 222. Order forms at any time by executing a notice of shall be prepared by use of a type- revocation, signed by the person who writer, pen, or indelible pencil. signed (or was authorized to sign) the (b) Only one item shall be entered on power of attorney or by a successor, each numbered line. An item shall con- whoever signed the most recent appli- sist of one or more commercial or bulk cation for registration or reregistra- containers of the same finished or bulk tion, and filing it with the power of at- form and quantity of the same sub- torney being revoked. The form for the stance. The number of lines completed power of attorney and notice of revoca- shall be noted on that form at the bot- tion shall be similar to the following: tom of the form, in the space provided. Order forms for carfentanil, etorphine Power of Attorney for DEA Order Forms hydrochloride, and diprenorphine shall lllll (Name of registrant) contain only these substances. lllll (Address of registrant) (c) The name and address of the sup- lllll (DEA registration number) plier from whom the controlled sub- I, lllll (name of person granting stances are being ordered shall be en- power), the undersigned, who is authorized tered on the form. Only one supplier to sign the current application for registra- may be listed on any form. tion of the above-named registrant under the (d) Each order form shall be signed Controlled Substances Act or Controlled and dated by a person authorized to Substances Import and Export Act, have made, constituted, and appointed, and by sign an application for registration. these presents, do make, constitute, and ap- The name of the purchaser, if different point lllll (name of attorney-in-fact), from the individual signing the order my true and lawful attorney for me in my form, shall also be inserted in the sig- name, place, and stead, to execute applica- nature space. Unexecuted order forms tions for books of official order forms and to may be kept and may be executed at a sign such order forms in requisition for location other than the registered loca- Schedule I and II controlled substances, in tion printed on the form, provided that accordance with section 308 of the Controlled all unexecuted forms are delivered Substances Act (21 U.S.C. 828) and part 1305 of Title 21 of the Code of Federal Regula- promptly to the registered location tions. I hereby ratify and confirm all that upon an inspection of such location by said attorney shall lawfully do or cause to be any officer authorized to make inspec- done by virtue hereof. tions, or to enforce, any Federal, State, llllllllllllllllllllllll or local law regarding controlled sub- (Signature of person granting power) stances. I, lllll (name of attorney-in-fact), [62 FR 13963, Mar. 24, 1997] hereby affirm that I am the person named herein as attorney-in-fact and that the sig- § 1305.07 Power of attorney. nature affixed hereto is my signature. llllllllllllllllllllllll Any purchaser may authorize one or (Signature of attorney-in-fact) more individuals, whether or not lo- Witnesses: cated at the registered location of the 1. lllll. purchaser, to obtain and execute order 2. lllll. forms on his/her behalf by executing a Signed and dated on the lll day of power of attorney for each such indi- lllll, (year), at lllll.

64 Drug Enforcement Administration, Justice § 1305.09

Notice of Revocation chemical analysis, instructional activi- The foregoing power of attorney is hereby ties, or research with such substances revoked by the undersigned, who is author- pursuant to the order form of the lat- ized to sign the current application for reg- ter person, if such distribution is for istration of the above-named registrant the purpose of furthering such chem- under the Controlled Substances Act of the ical analysis, instructional activities, Controlled Substances Import and Export or research. Act. Written notice of this revocation has been given to the attorney-in-fact lllll (e) A person registered as a this same day. compounder of narcotic substances for llllllllllllllllllllllll use at off-site locations in conjunction (Signature of person revoking power) with a narcotic treatment program at Witnesses: the compounding location, who is au- 1. lllll. thorized to handle Schedule II nar- 2. lllll. cotics, is authorized to fill order forms lll Signed and dated on the day of for distribution of narcotic drugs to lllll, (year), at lllll. off-site narcotic treatment programs [62 FR 13963, Mar. 24, 1997] only. § 1305.08 Persons entitled to fill order [36 FR 7796, Apr. 24, 1971, as amended at 36 forms. FR 13386, July 21, 1971; 36 FR 18732, Sept. 21, An order form may be filled only by 1971; 37 FR 15921, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973] a person registered as a manufacturer or distributor of controlled substances EDITORIAL NOTE: For FEDERAL REGISTER ci- listed in Schedule I or II under section tations affecting § 1305.08, see the List of CFR 303 of the Act (21 U.S.C. 823) or as an Sections Affected in the Finding Aids sec- importer of such substances under section of this volume. tion 1008 of the Act (21 U.S.C. 958), ex- § 1305.09 Procedure for filling order cept for the following: forms. (a) A person registered to dispense such substances under section 303 of (a) The purchaser shall submit Copy 1 the Act, or to export such substances and Copy 2 of the order form to the under section 1008 of the Act, if he/she supplier, and retain Copy 3 in his own is discontinuing business or if his/her files. registration is expiring without rereg- (b) The supplier shall fill the order, if istration, may dispose of any con- possible and if he/she desires to do so, trolled substances listed in Schedule I and record on Copies 1 and 2 the num- or II in his/her possession pursuant to ber of commercial or bulk containers order forms in accordance with § 1307.14 furnished on each item and the date on of this chapter; which such containers are shipped to (b) A person who has obtained any the purchaser. If an order cannot be controlled substance in Schedule I or II filled in its entirety, it may be filled in by order form may return such subpart and the balance supplied by addi- stance, or portion thereof, to the per- tional shipments within 60 days fol- son from whom he obtained the sub- lowing the date of the order form. No stance or the manufacturer of the sub- order form shall be valid more than 60 stance pursuant to the order form of days after its execution by the pur- the latter person; chaser, except as specified in paragraph (c) A person registered to dispense (f) of this section. such substances may distribute such (c) The controlled substances shall substances to another dispenser pursu- only be shipped to the purchaser and at ant to, and only in the circumstances the location printed by the Adminis- described in, § 1307.11 of this chapter; tration on the order form, except as and specified in paragraph (f) of this sec- (d) A person registered or authorized tion. to conduct chemical analysis or re- (d) The supplier shall retain Copy 1 of search with controlled substances may the order form for his/her own files and distribute a controlled substance listed forward Copy 2 to the Special Agent in in Schedule I or II to another person Charge of the Drug Enforcement Ad- registered or authorized to conduct ministration in the area in which the

65 § 1305.10 21 CFR Ch. II (4–1–99 Edition) supplier is located. Copy 2 shall be for- where the name of the supplier is re- warded at the close of the month dur- quested on the reporting form, the sec- ing which the order is filled; if an order ond supplier shall record the name, ad- is filled by partial shipments, Copy 2 dress and registration number of the shall be forwarded at the close of the first supplier. month during which the final shipment is made or during which the 60-day va- [36 FR 7796, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR lidity period expires. 13964, Mar. 24, 1997] (e) The purchaser shall record on Copy 3 of the order form the number of § 1305.11 Unaccepted and defective commercial or bulk containers fur- order forms. nished on each item and the dates on (a) No order form shall be filled if it: which such containers are received by (1) Is not complete, legible, or prop- the purchaser. erly prepared, executed, or endorsed; or (f) Order forms submitted by registered procurement officers of the De- (2) Shows any alteration, erasure, or fense Personnel Support Center of De- change of any description. fense Supply Agency for delivery to (b) If an order form cannot be filled armed services establishments within for any reason under this section, the the United States may be shipped to lo- supplier shall return Copies 1 and 2 to cations other than the location printed the purchaser with a statement as to on the order form, and in partial ship- the reason (e.g., illegible or altered). A ments at different times not to exceed supplier may for any reason refuse to six months from the date of the order, accept any order and if a supplier re- as designated by the procurement offi- fuses to accept the order, a statement cer when submitting the order. that the order is not accepted shall be sufficient for purposes of this para- [36 FR 7796, Apr. 24, 1971, as amended at 36 graph. FR 18732, Sept. 21, 1971. Redesignated at 38 (c) When received by the purchaser, FR 26609, Sept. 24, 1973, and amended at 47 FR 41735, Sept. 22, 1982; 62 FR 13964, Mar. 24, Copies 1 and 2 of the order form and the 1997] statement shall be attached to Copy 3 and retained in the files of the pur- § 1305.10 Procedure for endorsing chaser in accordance with § 1305.13. A order forms. defective order form may not be cor- (a) An order form made out to any rected; it must be replaced by a new supplier who cannot fill all or a part of order form in order for the order to be the order within the time limitation filled. set forth in § 1305.09 may be endorsed to another supplier for filling. The en- § 1305.12 Lost and stolen order forms. dorsement shall be made only by the (a) If a purchaser ascertains that an supplier to whom the order form was unfilled order form has been lost, he first made, shall state (in the spaces shall execute another in triplicate and provided on the reverse sides of Copies a statement containing the serial num- 1 and 2 of the order form) the name and ber and date of the lost form, and stat- address of the second supplier, and ing that the goods covered by the first shall be signed by a person authorized order form were not received through to obtain and execute order forms on loss of that order form. Copy 3 of the behalf of the first supplier. The first second form and a copy of the state- supplier may not fill any part of an ment shall be retained with Copy 3 of order on an endorsed form. The second the order form first executed. A copy of supplier shall fill the order, if possible the statement shall be attached to Cop- and if he/she desires to do so, in accord- ies 1 and 2 of the second order form ance with § 1305.09 (b), (c), and (d), in- sent to the supplier. If the first order cluding shipping all substances di- form is subsequently received by the rectly to the purchaser. supplier to whom it was directed, the (b) Distributions made on endorsed supplier shall mark upon the face order forms shall be reported by the thereof ‘‘Not accepted’’ and return Cop- second supplier in the same manner as ies 1 and 2 to the purchaser, who shall all other distributions except that attach it to Copy 3 and the statement.

66 Drug Enforcement Administration, Justice § 1305.15

(b) Whenever any used or unused to § 1305.06(d)) at the registered loca- order forms are stolen or lost (other- tion printed on the order form. wise than in the course of trans- (d) The supplier of carfentanil mission) by any purchaser or supplier, etorphine hydrochloride and he/she shall immediately upon dis- diprenorphine shall maintain order covery of such theft or loss, report the forms for these substances separately same to the Special Agent in Charge of from all other order forms and records the Drug Enforcement Administration required to be maintained by the reg- in the Divisional Office responsible for istrant. the area in which the registrant is lo- [36 FR 7796, Apr. 24, 1971. Redesignated at 38 cated, stating the serial number of FR 26609, Sept. 24, 1973, and amended at 39 each form stolen or lost. If the theft or FR 17839, May 21, 1974; 54 FR 33674, Aug. 16, loss includes any original order forms 1989; 62 FR 13964, Mar. 24, 1997] received from purchasers and the supplier is unable to state the serial num- § 1305.14 Return of unused order forms. bers of such order forms, he/she shall report the date or approximate date of If the registration of any purchaser receipt thereof and the names and ad- terminates (because the purchaser dies, dresses of the purchasers. If an entire ceases legal existence, discontinues book of order forms is lost or stolen, business or professional practice, or and the purchaser is unable to state changes his name or address as shown the serial numbers of the order forms on his registration) or is suspended or contained therein, he/she shall report, revoked pursuant to § 1301.36 of this in lieu of the numbers of the forms con- chapter as to all controlled substances listed in Schedules I and II for which tained in such book, the date or ap- he/she is registered, he/she shall return proximate date of issuance thereof. If all unused order forms for such sub- any unused order form reported stolen stance to the nearest office of the Ad- or lost is subsequently recovered or ministration. found, the Special Agent in Charge of the Drug Enforcement Administration [36 FR 7796, Apr. 24, 1971, as amended at 36 in the Divisional Office responsible for FR 18732, Sept. 21, 1971. Redesignated at 38 the area in which the registrant is lo- FR 26609, Sept. 24, 1973, as amended at 62 FR cated shall immediately be notified. 13964, Mar. 24, 1997] [36 FR 7796, Apr. 24, 1971, as amended at 36 § 1305.15 Cancellation and voiding of FR 13386, July 21, 1971. Redesignated at 38 FR order forms. 26609, Sept. 24, 1973, and amended at 51 FR (a) A purchaser may cancel part or 5319, Feb. 13, 1986; 62 FR 13964, Mar. 24, 1997] all of an order on an order form by notifying the supplier in writing of such § 1305.13 Preservation of order forms. cancellation. The supplier shall indi- (a) The purchaser shall retain Copy 3 cate the cancellation on Copies 1 and 2 of each order form which has been of the order form by drawing a line filled. He/She shall also retain in his through the canceled items and print- files all copies of each unaccepted or ing ‘‘canceled’’ in the space provided defective order form and each state- for number of items shipped. ment attached thereto. (b) A supplier may void part or all of (b) The supplier shall retain Copy 1 of an order on an order form by notifying each order form which he/she has filled. the purchaser in writing of such void- (c) Order forms must be maintained ing. The supplier shall indicate the separately from all other records of the voiding in the manner prescribed for registrant. Order forms are required to cancellation in paragraph (a) of this be kept available for inspection for a section. period of 2 years. If a purchaser has (c) No cancellation or voiding per- several registered locations, he/she mitted by this section shall affect in must retain Copy 3 of the executed any way contract rights of either the order forms and any attached state- purchaser or the supplier. ments or other related documents (not [36 FR 7796, Apr. 24, 1971, as amended at 36 including unexecuted order forms FR 13386, July 21, 1971. Redesignated at 38 FR which may be kept elsewhere pursuant 26609, Sept. 24, 1973]

67 § 1305.16 21 CFR Ch. II (4–1–99 Edition)

§ 1305.16 Special procedure for filling 1306.25 Transfer between pharmacies of certain order forms. presription information for Schedules III, IV, and V controlled substances for refill (a) The purchaser of carfentanil purposes. etorphine hydrochloride or 1306.26 Dispensing without prescription. diprenorphine shall submit copy 1 and 2 of the order form to the supplier and AUTHORITY: 21 U.S.C. 821, 829, 871(b), unless otherwise noted. retain copy 3 in his own files. (b) The supplier, if he/she determines SOURCE: 36 FR 7799, Apr. 24, 1971; 36 FR that the purchaser is a veterinarian en- 13386, July 21, 1971, unless otherwise noted. gaged in zoo and exotic animal prac- Redesignated at 38 FR 26609, Sept. 24, 1973. tice, wildlife management programs GENERAL INFORMATION and/or research and authorized by the Administrator to handle these sub- § 1306.01 Scope of part 1306. stances shall fill the order in accordance with the procedures set forth in Rules governing the issuance, filling § 1305.09 except that: and filing of prescriptions pursuant to (1) Order forms for carfentanil section 309 of the Act (21 U.S.C. 829) are etorphine hydrochloride and set forth generally in that section and diprenorphine shall only contain these specifically by the sections of this part. substances in reasonable quantities and § 1306.02 Definitions. (2) The substances shall only be Any term contained in this part shall shipped to the purchaser at the loca- have the definition set forth in section tion printed by the Administration 102 of the Act (21 U.S.C. 802) or part upon the order form under secure con- 1300 of this chapter. ditions using substantial packaging material with no markings on the out- [62 FR 13964, Mar. 24, 1997] side which would indicate the content. § 1306.03 Persons entitled to issue pre- [39 FR 17839, May 21, 1974, as amended at 54 scriptions. FR 33674, Aug. 16, 1989; 62 FR 13964, Mar. 24, (a) A prescription for a controlled 1997] substance may be issued only by an individual practitioner who is: PART 1306—PRESCRIPTIONS (1) authorized to prescribe controlled substances by the jurisdiction in which GENERAL INFORMATION he is licensed to practice his profession Sec. and 1306.01 Scope of part 1306. (2) either registered or exempted 1306.02 Definitions. from registration pursuant to 1306.03 Persons entitled to issue prescrip- §§ 1301.22(c) and 1301.23 of this chapter. tions. 1306.04 Purpose of issue of prescription. (b) A prescription issued by an indi- 1306.05 Manner of issuance of prescriptions. vidual practitioner may be commu- 1306.06 Persons entitled to fill prescriptions. nicated to a pharmacist by an em- 1306.07 Administering or dispensing of nar- ployee or agent of the individual prac- cotic drugs. titioner. CONTROLLED SUBSTANCES LISTED IN SCHEDULE [36 FR 7799, Apr. 24, 1971, as amended at 36 II FR 18732, Sept. 21, 1971. Redesignated at 38 1306.11 Requirement of prescription. FR 26609, Sept. 24, 1973, as amended at 62 FR 1306.12 Refilling prescriptions. 13966, Mar. 24, 1997] 1306.13 Partial filling of prescriptions. 1306.14 Labeling of substances and filling of § 1306.04 Purpose of issue of prescrip- prescriptions. tion.

CONTROLLED SUBSTANCES LISTED IN (a) A prescription for a controlled SCHEDULES III, IV, AND V substance to be effective must be issued for a legitimate medical purpose 1306.21 Requirement of prescription. 1306.22 Refilling of prescriptions. by an individual practitioner acting in 1306.23 Partial filling of prescriptions. the usual course of his professional 1306.24 Labeling of substances and filling of practice. The responsibility for the prescriptions. proper prescribing and dispensing of

68 Drug Enforcement Administration, Justice § 1306.07 controlled substances is upon the pre- prescription not prepared in the form scribing practitioner, but a cor- prescribed by these regulations. responding responsibility rests with (b) An individual practitioner ex- the pharmacist who fills the prescrip- empted from registration under tion. An order purporting to be a pre- § 1301.22(c) of this chapter shall include scription issued not in the usual course on all prescriptions issued by him or of professional treatment or in legiti- her the registration number of the hos- mate and authorized research is not a pital or other institution and the spe- prescription within the meaning and cial internal code number assigned to intent of section 309 of the Act (21 him or her by the hospital or other in- U.S.C. 829) and the person knowingly stitution as provided in § 1301.22(c) of filling such a purported prescription, as this chapter, in lieu of the registration well as the person issuing it, shall be number of the practitioner required by subject to the penalties provided for this section. Each written prescription violations of the provisions of law re- shall have the name of the physician lating to controlled substances. stamped, typed, or handprinted on it, (b) A prescription may not be issued as well as the signature of the physi- in order for an individual practitioner cian. to obtain controlled substances for sup- (c) An official exempted from reg- plying the individual practitioner for istration under § 1301.22(c) shall include the purpose of general dispensing to pa- on all prescriptions issued by him his tients. branch of service or agency (e.g., ‘‘U.S. (c) A prescription may not be issued Army’’ or ‘‘Public Health Service’’) and for the dispensing of narcotic drugs his service identification number, in listed in any schedule for ‘‘detoxifica- lieu of the registration number of the tion treatment’’ or ‘‘maintenance practitioner required by this section. The service identification number for a treatment’’ as defined in Section 102 of Public Health Service employee is his the Act (21 U.S.C. 802). Social Security identification number. [36 FR 7799, Apr. 24, 1971. Redesignated at 38 Each prescription shall have the name FR 26609, Sept. 24, 1973, and amended at 39 of the officer stamped, typed, or FR 37986, Oct. 25, 1974] handprinted on it, as well as the signature of the officer. § 1306.05 Manner of issuance of prescriptions. [36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18733, Sept. 21, 1971. Redesignated at 38 (a) All prescriptions for controlled FR 26609, Sept. 24, 1973, and amended at 56 substances shall be dated as of, and FR 25026, June 3, 1991; 60 FR 36641, July 18, signed on, the day when issued and 1995; 62 FR 13966, Mar. 24, 1997] shall bear the full name and address of the patient, the drug name, strength, § 1306.06 Persons entitled to fill pre- dosage form, quantity prescribed, di- scriptions. rections for use and the name, address A prescription for controlled sub- and registration number of the practi- stances may only be filled by a phar- tioner. A practitioner may sign a pre- macist acting in the usual course of his scription in the same manner as he professional practice and either reg- would sign a check or legal document istered individually or employed in a (e.g., J.H. Smith or John H. Smith). registered pharmacy or registered in- Where an oral order is not permitted, stitutional practitioner. prescriptions shall be written with ink or indelible pencil or typewriter and § 1306.07 Administering or dispensing shall be manually signed by the practi- of narcotic drugs. tioner. The prescriptions may be pre- (a) The administering or dispensing pared by the secretary or agent for the directly (but not prescribing) of nar- signature of a practitioner, but the pre- cotic drugs listed in any schedule to a scribing practitioner is responsible in narcotic drug dependent person for case the prescription does not conform ‘‘detoxification treatment’’ or ‘‘main- in all essential respects to the law and tenance treatment’’ as defined in sec- regulations. A corresponding liability tion 102 of the Act (21 U.S.C. 802) shall rests upon the pharmacist who fills a be deemed to be within the meaning of

69 § 1306.11 21 CFR Ch. II (4–1–99 Edition) the term ‘‘in the course of his profes- presented to the pharmacist for review sional practice or research’’ in section prior to the actual dispensing of the 308(e) and section 102(20) of the Act (21 controlled substance, except as noted U.S.C. 828 (e)): Provided, That the prac- in paragraph (e), (f), or (g) of this sec- titioner is separately registered with tion. The original prescription shall be the Attorney General as required by maintained in accordance with section 303(g) of the Act (21 U.S.C. § 1304.04(h) of this chapter. 823(g)) and then thereafter complies (b) An individual practitioner may with the regulatory standards imposed administer or dispense directly a con- relative to treatment qualification, se- trolled substance listed in Schedule II curity, records and unsupervised use of in the course of his professional prac- drugs pursuant to such Act. tice without a prescription, subject to (b) Nothing in this section shall pro- § 1306.07. hibit a physician who is not specifi- (c) An institutional practitioner may cally registered to conduct a narcotic administer or dispense directly (but treatment program from administering not prescribe) a controlled substance (but not prescribing) narcotic drugs to listed in Schedule II only pursuant to a a person for the purpose of relieving written prescription signed by the pre- acute withdrawal symptoms when nec- scribing individual practitioner or to essary while arrangements are being an order for medication made by an in- made for referral for treatment. Not dividual practitioner which is dis- more than one day’s medication may pensed for immediate administration be administered to the person or for to the ultimate user. the person’s use at one time. Such (d) In the case of an emergency situa- emergency treatment may be carried tion, as defined by the Secretary in out for not more than three days and § 290.10 of this title, a pharmacist may may not be renewed or extended. dispense a controlled substance listed (c) This section is not intended to im- in Schedule II upon receiving oral au- pose any limitations on a physician or thorization of a prescribing individual authorized hospital staff to administer practitioner, provided that: or dispense narcotic drugs in a hospital (1) The quantity prescribed and dis- to maintain or detoxify a person as an pensed is limited to the amount ade- incidental adjunct to medical or sur- quate to treat the patient during the gical treatment of conditions other emergency period (dispensing beyond than addiction, or to administer or dis- the emergency period must be pursuant pense narcotic drugs to persons with to a written prescription signed by the intractable pain in which no relief or prescribing individual practitioner); cure is possible or none has been found (2) The prescription shall be imme- after reasonable efforts. diately reduced to writing by the phar- [39 FR 37986, Oct. 25, 1974] macist and shall contain all information required in § 1306.05, except for the CONTROLLED SUBSTANCES LISTED IN signature of the prescribing individual SCHEDULE II practitioner; (3) If the prescribing individual prac- § 1306.11 Requirement of prescription. titioner is not known to the phar- (a) A pharmacist may dispense di- macist, he must make a reasonable ef- rectly a controlled substance listed in fort to determine that the oral author- Schedule II, which is a prescription ization came from a registered indi- drug as determined under the Federal vidual practitioner, which may include Food, Drug, and Cosmetic Act, only a callback to the prescribing individual pursuant to a written prescription practitioner using his phone number as signed by the practitioner, except as listed in the telephone directory and/or provided in paragraph (d) of this sec- other good faith efforts to insure his tion. A prescription for a Schedule II identity; and controlled substance may be trans- (4) Within 7 days after authorizing an mitted by the practitioner or the prac- emergency oral prescription, the pre- titioner’s agent to a pharmacy via fac- scribing individual practitioner shall simile equipment, provided that the cause a written prescription for the original written, signed prescription is emergency quantity prescribed to be

70 Drug Enforcement Administration, Justice § 1306.13 delivered to the dispensing pharmacist. patient. The facsimile serves as the In addition to conforming to the re- original written prescription for pur- quirements of § 1306.05, the prescription poses of this paragraph (g) and it shall shall have written on its face ‘‘Author- be maintained in accordance with ization for Emergency Dispensing,’’ § 1304.04(h) of this chapter. and the date of the oral order. The [36 FR 7799, Apr. 24, 1971, as amended at 36 written prescription may be delivered FR 18733, Sept. 21, 1971. Redesignated at 38 to the pharmacist in person or by mail, FR 26609, Sept. 24, 1973 and amended at 53 FR but if delivered by mail it must be 4964, Feb. 19, 1988; 59 FR 26111, May 19, 1994; postmarked within the 7 day period. 59 FR 30832, June 15, 1994; 62 FR 13964, Mar. Upon receipt, the dispensing phar- 24, 1997] macist shall attach this prescription to the oral emergency prescription which § 1306.12 Refilling prescriptions. had earlier been reduced to writing. The refilling of a prescription for a The pharmacist shall notify the near- controlled substance listed in Schedule est office of the Administration if the II is prohibited. prescribing individual practitioner fails to deliver a written prescription § 1306.13 Partial filling of prescrip- to him; failure of the pharmacist to do tions. so shall void the authority conferred (a) The partial filling of a prescrip- by this paragraph to dispense without tion for a controlled substance listed in a written prescription of a prescribing Schedule II is permissible, if the phar- individual practitioner. macist is unable to supply the full (e) A prescription prepared in accord- quantity called for in a written or ance with § 1306.05 written for a Sched- emergency oral prescription and he ule II narcotic substance to be com- makes a notation of the quantity sup- pounded for the direct administration plied on the face of the written pre- to a patient by parenteral, intra- scription (or written record of the venous, intramuscular, subcutaneous emergency oral prescription). The re- or intraspinal infusion may be trans- maining portion of the prescription mitted by the practitioner or the prac- may be filled within 72 hours of the titioner’s agent to the pharmacy by first partial filling; however, if the re- facsimile. The facsimile serves as the maining portion is not or cannot be original written prescription for pur- filled within the 72-hour period, the poses of this paragraph (e) and it shall pharmacist shall so notify the pre- be maintained in accordance with scribing individual practitioner. No § 1304.04(h) of this chapter. further quantity may be supplied be- (f) A prescription prepared in accord- yond 72 hours without a new prescrip- ance with § 1306.05 written for Schedule tion. II substance for a resident of a Long (b) A prescription for a Schedule II Term Care Facility may be trans- controlled substance written for a pa- mitted by the practitioner or the prac- tient in a Long Term Care Facility titioner’s agent to the dispensing phar- (LTCF) or for a patient with a medical macy by facsimile. The facsimile diagnosis documenting a terminal ill- serves as the original written prescrip- ness may be filled in partial quantities tion for purposes of this paragraph (f) to include individual dosage units. If and it shall be maintained in accord- there is any question whether a patient ance with § 1304.04(h). may be classified as having a terminal (g) A prescription prepared in accord- illness, the pharmacist must contact ance with § 1306.05 written for a Sched- the practitioner prior to partially fill- ule II narcotic substance for a patient ing the prescription. Both the phar- residing in a hospice certified by Medi- macist and the prescribing practitioner care under Title XVIII or licensed by have a corresponding responsibility to the state may be transmitted by the assure that the controlled substance is practitioner or the practitioner’s agent for a terminally ill patient. The phar- to the dispensing pharmacy by fac- macist must record on the prescription simile. The practitioner or the practi- whether the patient is ‘‘terminally ill’’ tioner’s agent will note on the pre- or an ‘‘LTCF patient.’’ A prescription scription that the patient is a hospice that is partially filled and does not

71 § 1306.14 21 CFR Ch. II (4–1–99 Edition) contain the notation ‘‘terminally ill’’ § 1306.14 Labeling of substances and or ‘‘LTCF patient’’ shall be deemed to filling of prescriptions. have been filled in violation of the Act. (a) The pharmacist filling a written For each partial filling, the dispensing or emergency oral prescription for a pharmacist shall record on the back of controlled substance listed in Schedule the prescription (or on another appro- II shall affix to the package a label priate record, uniformly maintained, showing date of filling, the pharmacy and readily retrievable) the date of the name and address, the serial number of partial filling, quantity dispensed, re- the prescription, the name of the pa- maining quantity authorized to be dis- tient, the name of the prescribing prac- pensed, and the identification of the titioner, and directions for use and dispensing pharmacist. The total quan- cautionary statements, if any, con- tity of Schedule II controlled sub- tained in such prescription or required stances dispensed in all partial fillings by law. must not exceed the total quantity pre- (b) The requirements of paragraph (a) scribed. Schedule II prescriptions for of this section do not apply when a patients in a LTCF or patients with a controlled substance listed in Schedule medical diagnosis documenting a ter- II is prescribed for administration to minal illness shall be valid for a period an ultimate user who is institutional- not to exceed 60 days from the issue ized: Provided, That: date unless sooner terminated by the (1) Not more than 7-day supply of the discontinuance of medication. controlled substance listed in Schedule II is dispensed at one time; (c) Information pertaining to current (2) The controlled substance listed in Schedule II prescriptions for patients Schedule II is not in the possession of in a LTCF or for patients with a med- the ultimate user prior to the adminis- ical diagnosis documenting a terminal tration; illness may be maintained in a comput- (3) The institution maintains appro- erized system if this system has the ca- priate safeguards and records regarding pability to permit: the proper administration, control, dis- (1) Output (display or printout) of the pensing, and storage of the controlled original prescription number, date of substance listed in Schedule II; and issue, identification of prescribing indi- (4) The system employed by the phar- vidual practitioner, identification of macist in filling a prescription is ade- patient, address of the LTCF or address quate to identify the supplier, the of the hospital or residence of the pa- product, and the patient, and to set tient, identification of medication au- forth the directions for use and cau- thorized (to include dosage, form, tionary statements, if any, contained strength and quantity), listing of the in the prescription or required by law. partial fillings that have been dis- (c) All written prescriptions and pensed under each prescription and the written records of emergency oral pre- information required in § 1306.13(b). scriptions shall be kept in accordance (2) Immediate (real time) updating of with requirements of § 1304.04(h) of this the prescription record each time a chapter. partial filling of the prescription is [36 FR 13368, July 21, 1971, as amended at 37 conducted. FR 15921, Aug. 8, 1972. Redesignated at 38 FR (3) Retrieval of partially filled Sched- 26609, Sept. 24, 1973, as amended at 62 FR ule II prescription information is the 13965, Mar. 24, 1997] same as required by § 1306.22(b) (4) and CONTROLLED SUBSTANCES LISTED IN (5) for Schedule III and IV prescription SCHEDULES III, IV, AND V refill information. (21 U.S.C. 801, et seq.) § 1306.21 Requirement of prescription. [36 FR 7799, Apr. 24, 1971. Redesignated at 38 (a) A pharmacist may dispense di- FR 26609, Sept. 24, 1973, and amended at 45 rectly a controlled substance listed in FR 54330, July 15, 1980; 56 FR 25027, June 3, Schedule III, IV, or V which is a pre- 1991; 62 FR 13965, Mar. 24, 1997] scription drug as determined under the Federal Food, Drug, and Cosmetic Act,

72 Drug Enforcement Administration, Justice § 1306.22 only pursuant to either a written pre- substance, the date filled or refilled, scription signed by a practitioner or a the quantity dispensed, initials of the facsimile of a written, signed prescrip- dispensing pharmacist for each refill, tion transmitted by the practitioner or and the total number of refills for that the practitioner’s agent to the phar- prescription. If the pharmacist merely macy or pursuant to an oral prescrip- initials and dates the back of the pre- tion made by an individual practitioner scription it shall be deemed that the and promptly reduced to writing by the full face amount of the prescription has pharmacist containing all information been dispensed. The prescribing practi- required in § 1306.05, except for the sig- tioner may authorize additional refills nature of the practitioner. of Schedule III or IV controlled sub- (b) An individual practitioner may stances on the original prescription administer or dispense directly a con- through an oral refill authorization trolled substance listed in Schedule III, transmitted to the pharmacist pro- IV, or V in the course of his/her profes- vided the following conditions are met: sional practice without a prescription, (1) The total quantity authorized, in- subject to § 1306.07. cluding the amount of the original pre- (c) An institutional practitioner may scription, does not exceed five refills administer or dispense directly (but nor extend beyond six months from the not prescribe) a controlled substance date of issue of the original prescrip- listed in Schedule III, IV, or V only tion. pursuant to a written prescription (2) The pharmacist obtaining the oral signed by an individual practitioner, or authorization records on the reverse of pursuant to a facsimile of a written the original prescription the date, prescription or order for medication quantity of refill, number of additional transmitted by the practitioner or the refills authorized, and initials the pre- practitioner’s agent to the institu- scription showing who received the au- tional practitioner-pharmacist, or pur- thorization from the prescribing prac- suant to an oral prescription made by titioner who issued the original pre- an individual practitioner and prompt- scription. ly reduced to writing by the phar- (3) The quantity of each additional macist (containing all information re- refill authorized is equal to or less than quired in Section 1306.05 except for the the quantity authorized for the initial signature of the individual practi- filling of the original prescription. tioner), or pursuant to an order for (4) The prescribing practitioner must medication made by an individual execute a new and separate prescrip- practitioner which is dispensed for im- tion for any additional quantities be- mediate administration to the ulti- yond the five refill, six-month limita- mate user, subject to § 1306.07. tion. [62 FR 13965, Mar. 24, 1997] (b) As an alternative to the procedures provided by subsection (a), an § 1306.22 Refilling of prescriptions. automated data processing system may (a) No prescription for a controlled be used for the storage and retrieval of substance listed in Schedule III or IV refill information for prescription or- shall be filled or refilled more than six ders for controlled substances in months after the date on which such Schedule III and IV, subject to the fol- prescription was issued and no such lowing conditions: prescription authorized to be refilled (1) Any such proposed computerized may be refilled more than five times. system must provide on-line retrieval Each refilling of a prescription shall be (via CRT display or hard-copy print- entered on the back of the prescription out) of original prescription order in- or on another appropriate document. If formation for those prescription orders entered on another document, such as which are currently authorized for re- a medication record, the document filling. This shall include, but is not must be uniformly maintained and limited to, data such as the original readily retrievable. The following in- prescription number, date of issuance formation must be retrievable by the of the original prescription order by prescription number consisting of the the practitioner, full name and address name and dosage form of the controlled of the patient, name, address, and DEA

73 § 1306.22 21 CFR Ch. II (4–1–99 Edition) registration number of the practi- the manner previously described) each tioner, and the name, strength, dosage day, attesting to the fact that the refill form, quantity of the controlled sub- information entered into the computer stance prescribed (and quantity dis- that day has been reviewed by him and pensed if different from the quantity is correct as shown. Such a book or file prescribed), and the total number of re- must be maintained at the pharmacy fills authorized by the prescribing prac- employing such a system for a period titioner. of two years after the date of dis- (2) Any such proposed computerized pensing the appropriately authorized system must also provide on-line re- refill. trieval (via CRT display or hard-copy (4) Any such computerized system printout) of the current refill history shall have the capability of producing a for Schedule III or IV controlled sub- printout of any refill data which the stance prescription orders (those au- user pharmacy is responsible for main- thorized for refill during the past six taining under the Act and its imple- months.) This refill history shall in- menting regulations. For example, this clude, but is not limited to, the name would include a refill-by-refill audit of the controlled substance, the date of trail for any specified strength and dos- refill, the quantity dispensed, the iden- age form of any controlled substance tification code, or name or initials of (by either brand or generic name or the dispensing pharmacist for each re- both). Such a printout must include fill and the total number of refills dis- name of the prescribing practitioner, pensed to date for that prescription name and address of the patient, quan- order. tity dispensed on each refill, date of (3) Documentation of the fact that dispensing for each refill, name or the refill information entered into the identification code of the dispensing computer each time a pharmacist re- pharmacist, and the number of the fills an original prescription order for a original prescription order. In any Schedule III or IV controlled substance computerized system employed by a is correct must be provided by the indi- user pharmacy the central record- vidual pharmacist who makes use of keeping location must be capable of such a system. If such a system pro- sending the printout to the pharmacy vides a hard-copy printout of each within 48 hours, and if a DEA Special day’s controlled substance prescription Agent or Diversion Investigator re- order refill data, that printout shall be quests a copy of such printout from the verified, dated, and signed by the indi- user pharmacy, it must, if requested to vidual pharmacist who refilled such a do so by the Agent or Investigator, prescription order. The individual verify the printout transmittal capa- pharmacist must verify that the data bility of its system by documentation indicated is correct and then sign this (e.g., postmark). document in the same manner as he (5) In the event that a pharmacy would sign a check or legal document which employs such a computerized (e.g., J. H. Smith, or John H. Smith). system experiences system down-time, This document shall be maintained in a the pharmacy must have an auxiliary separate file at that pharmacy for a pe- procedure which will be used for docu- riod of two years from the dispensing mentation of refills os Schedule III and date. This printout of the day’s con- IV controlled substance prescription trolled substance prescription order re- orders. This auxiliary procedure must fill data must be provided to each phar- insure that refills are authorized by macy using such a computerized sys- the original prescription order, that tem within 72 hours of the date on the maximum number of refills has not which the refill was dispensed. It must been exceeded, and that all of the ap- be verified and signed by each phar- propriate data is retained for on-line macist who is involved with such dis- data entry as soon as the computer sys- pensing. In lieu of such a printout, the tem is available for use again. pharmacy shall maintain a bound log (c) When filing refill information for book, or separate file, in which each in- original prescription orders for Sched- dividual pharmacist involved in such ule III or IV controlled substances, a dispensing shall sign a statement (in pharmacy may use only one of the two

74 Drug Enforcement Administration, Justice § 1306.25 systems described in paragraphs (a) or and storage of the controlled substance (b) of this section. listed in Schedule III, IV, or V; and (4) The system employed by the phar- [36 FR 7799, Apr. 24, 1971; 36 FR 13386, July 21, macist in filling a prescription is ade- 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 42 FR 28878, June 6, quate to identify the supplier, the 1977; 45 FR 44266, July 1, 1980; 52 FR 3605, Feb. product and the patient, and to set 5, 1987; 62 FR 13966, Mar. 24, 1997] forth the directions for use and cautionary statements, if any, contained § 1306.23 Partial filling of prescrip- in the prescription or required by law. tions. (c) All prescriptions for controlled The partial filling of a prescription substances listed in Schedules III, IV, for a controlled substance listed in and V shall be kept in accordance with Schedule III, IV, or V is permissible, § 1304.04(h) of this chapter. provided that: [62 FR 13965, Mar. 24, 1997] (a) Each partial filling is recorded in the same manner as a refilling, § 1306.25 Transfer between pharmacies (b) The total quantity dispensed in of prescription information for all partial fillings does not exceed the Schedules III, IV, and V controlled substances for refill purposes. total quantity prescribed, and (c) No dispensing occurs after 6 (a) The transfer of original prescrip- months after the date on which the tion information for a controlled sub- prescription was issued. stance listed in Schedules III, IV or V for the purpose of refill dispensing is [36 FR 18733, Sept. 21, 1971. Redesignated at permissible between pharmacies on a 38 FR 26609, Sept. 24, 1973, and amended at 51 one time basis only. However, phar- FR 5320, Feb. 13, 1986; 62 FR 13965, Mar. 24, macies electronically sharing a real- 1997] time, on-line database may transfer up § 1306.24 Labeling of substances and to the maximum refills permitted by filing of prescriptions. law and the prescriber’s authorization. Transfers are subject to the following (a) The pharmacist filling a prescrip- requirements: tion for a controlled substance listed in (1) The transfer is communicated di- Schedule III, IV, or V shall affix to the rectly between two licensed phar- package a label showing the pharmacy macists and the transferring phar- name and address, the serial number macist records the following informa- and date of initial filling, the name of tion: the patient, the name of the practi- (i) Write the word ‘‘VOID’’ on the tioner issuing the prescription, and di- face of the invalidated prescription. rections for use and cautionary state- (ii) Record on the reverse of the in- ments, if any, contained in such pre- validated prescription the name, ad- scription as required by law. dress and DEA registration number of (b) The requirements of paragraph (a) the pharmacy to which it was trans- of this section do not apply when a ferred and the name of the pharmacist controlled substance listed in Schedule receiving the prescription information. III, IV, or V is prescribed for adminis- (iii) Record the date of the transfer tration to an ultimate user who is in- and the name of the pharmacist trans- stitutionalized: Provided, That: ferring the information. (1) Not more than a 34-day supply or (b) The pharmacist receiving the 100 dosage units, whichever is less, of transferred prescription information the controlled substance listed in shall reduce to writing the following: Schedule III, IV, or V is dispensed at (1) Write the word ‘‘transfer’’ on the one time; face of the transferred prescription. (2) The controlled substance listed in (2) Provide all information required Schedule III, IV, or V is not in the pos- to be on a prescription pursuant to 21 session of the ultimate user prior to CFR 1306.05 and include: administration; (i) Date of issuance of original pre- (3) The institution maintains appro- scription; priate safeguards and records the prop- (ii) Original number of refills author- er administration, control, dispensing, ized on original prescription;

75 § 1306.26 21 CFR Ch. II (4–1–99 Edition)

(iii) Date of original dispensing; trolled substance may be dispensed at (iv) Number of valid refills remaining retail to the same purchaser in any and date(s) and locations of previous given 48-hour period; refill(s); (c) The purchaser is at least 18 years (v) Pharmacy’s name, address, DEA of age; registration number and prescription (d) The pharmacist requires every number from which the prescription in- purchaser of a controlled substance formation was transferred; under this section not known to him to (vi) Name of pharmacist who trans- furnish suitable identification (includ- ferred the prescription. ing proof of age where appropriate); (vii) Pharmacy’s name, address, DEA (e) A bound record book for dis- registration number and prescription pensing of controlled substances under number from which the prescription this section is maintained by the phar- was originally filled; macist, which book shall contain the (3) The original and transferred pre- name and address of the purchaser, the scription(s) must be maintained for a name and quantity of controlled sub- period of two years from the date of stance purchased, the date of each pur- last refill. chase, and the name or initials of the (c) Pharmacies electronically access- pharmacist who dispensed the sub- ing the same prescription record must stance to the purchaser (the book shall satisfy all information requirements of be maintained in accordance with the a manual mode for prescription recordkeeping requirement of § 1304.04 transferral. of this chapter); and (d) The procedure allowing the trans- (f) A prescription is not required for fer of prescription information for re- distribution or dispensing of the sub- fill purposes is permissible only if al- stance pursuant to any other Federal, lowable under existing state or other State or local law. applicable law. [36 FR 7799, Apr. 24, 1971, as amended at 36 [46 FR 48919, Oct. 5, 1981. Redesignated and FR 18733, Sept. 21, 1971. Redesignated at 38 amended at 62 FR 13966, Mar. 24, 1997] FR 26609, Sept. 24, 1973, and further redesigated and amended at 62 FR 13966, Mar. § 1306.26 Dispensing without prescrip- 24, 1997] tion. A controlled substance listed in PART 1307—MISCELLANEOUS Schedules II, III, IV, or V which is not a prescription drug as determined Sec. under the Federal Food, Drug, and Cos- GENERAL INFORMATION metic Act, may be dispensed by a pharmacist without a prescription to a pur- 1307.01 Definitions. 1307.02 Application of State law and other chaser at retail, provided that: Federal law. (a) Such dispensing is made only by a 1307.03 Exceptions to regulations. pharmacist (as defined in part 1300 of this chapter), and not by a nonphar- SPECIAL EXCEPTIONS FOR MANUFACTURE AND macist employee even if under the su- DISTRIBUTION OF CONTROLLED SUBSTANCES pervision of a pharmacist (although 1307.11 Distribution by dispenser to another after the pharmacist has fulfilled his practitioner. professional and legal responsibilities 1307.12 Distribution to supplier. set forth in this section, the actual 1307.13 Incidental manufacture of controlled substances. cash, credit transaction, or delivery, may be completed by a nonphar- DISPOSAL OF CONTROLLED SUBSTANCES macist); 1307.21 Procedure for disposing of controlled (b) Not more than 240 cc. (8 ounces) of substances. any such controlled substance con- 1307.22 Disposal of controlled substances by taining opium, nor more than 120 cc. (4 the Administration. ounces) of any other such controlled SPECIAL EXEMPT PERSONS substance nor more than 48 dosage units of any such controlled substance 1307.31 Native American Church. containing opium, nor more than 24 AUTHORITY: 21 U.S.C. 821, 822(d), 871(b), un- dosage units of any other such con- less otherwise noted.

76 Drug Enforcement Administration, Justice § 1307.12

SOURCE: 36 FR 7801, Apr. 24, 1971, unless purpose of general dispensing by the otherwise noted. Redesignated at 38 FR 26609, practitioner to his or its patients: Pro- Sept. 24, 1973. vided, That: GENERAL INFORMATION (1) The practitioner to whom the controlled substance is to be distributed is § 1307.01 Definitions. registered under the Act to dispense that controlled substance; Any term contained in this part shall have the definition set forth in section (2) The distribution is recorded by 102 of the Act (21 U.S.C. 802) or part the distributing practitioner in accord- 1300 of this chapter. ance with § 1304.22(c) of this chapter and by the receiving practitioner in ac- [62 FR 13966, Mar. 24, 1997] cordance with § 1304.22(c) of this chapter; § 1307.02 Application of State law and (3) If the substance is listed in Sched- other Federal law. ule I or II, an order form is used as re- Nothing in this chapter shall be con- quired in part 1305 of this chapter; strued as authorizing or permitting (4) The total number of dosage units any person to do any act which such of all controlled substances distributed person is not authorized or permitted by the practitioner pursuant to this to do under other Federal laws or obli- section and § 1301.25 of this chapter dur- gations under international treaties, ing each calendar year in which the conventions or protocols, or under the practitioner is registered to dispense law of the State in which he/she desires does not exceed 5 percent of the total to do such act nor shall compliance number of dosage units of all con- with such parts be construed as compli- trolled substances distributed and dis- ance with other Federal or State laws pensed by the practitioner during the unless expressly provided in such other same calendar year. laws. (b) If, during any calendar year in [62 FR 13966, Mar. 24, 1997] which the practitioner is registered to dispense, the practitioner has reason to § 1307.03 Exceptions to regulations. believe that the total number of dosage Any person may apply for an excep- units of all controlled substances tion to the application of any provision which will be distributed by him pursu- of this chapter by filing a written re- ant to this section and § 1301.25 of this quest stating the reasons for such ex- chapter will exceed 5 percent of the ception. Requests shall be filed with total number of dosage units of all con- the Administrator, Drug Enforcement trolled substances distributed and dis- Administration, Department of Jus- pensed by him during that calendar tice, Washington, DC 20537. The Admin- year, the practitioner shall obtain a istrator may grant an exception in his registration to distribute controlled discretion, but in no case shall he/she substances. be required to grant an exception to [36 FR 18733, Sept. 21, 1971. Redesignated at any person which is otherwise required 38 FR 26609, Sept. 24, 1973, and amended at 50 by law or the regulations cited in this FR 31590, Aug. 5, 1985; 62 FR 13967, Mar. 24, section. 1997]

[62 FR 13966, Mar. 24, 1997] § 1307.12 Distribution to supplier. SPECIAL EXCEPTIONS FOR MANUFACTURE Any person lawfully in possession of AND DISTRIBUTION OF CONTROLLED a controlled substance listed in any SUBSTANCES schedule may distribute (without being registered to distribute) that substance § 1307.11 Distribution by dispenser to to the person from whom he obtained it another practitioner. or to the manufacturer of the sub- (a) A practitioner who is registered stance, provided that a written record to dispense a controlled substance may is maintained which indicates the date distribute (without being registered to of the transaction, the name, form and distribute) a quantity of such sub- quantity of the substance, the name, stance to another practitioner for the address, and registration number, if

77 § 1307.13 21 CFR Ch. II (4–1–99 Edition) any, of the person making the distribu- (1) If the person is a registrant, he/ tion, and the name, address, and reg- she shall list the controlled substance istration number, if known, of the sup- or substances which he/she desires to plier or manufacturer. In the case of dispose of on DEA Form 41, and submit returning a controlled substance listed three copies of that form to the Special in Schedule I or II, an order form shall Agent in Charge in his/her area; or be used in the manner prescribed in (2) If the person is not a registrant, part 1305 of this chapter and be main- he/she shall submit to the Special tained as the written record of the Agent in Charge a letter stating: transaction. Any person not required (i) The name and address of the per- to register pursuant to sections 302(c) son; or 1007(b)(1) of the Act (21 U.S.C. 823(c) (ii) The name and quantity of each or 957(b)(1)) shall be exempt from main- controlled substance to be disposed of; taining the records required by this (iii) How the applicant obtained the section. substance, if known; and (iv) The name, address, and registra- [36 FR 7801, Apr. 24, 1971, as amended at 36 tion number, if known, of the person FR 18733, Sept. 21, 1971. Redesignated at 38 who possessed the controlled sub- FR 26609, Sept. 24, 1973, and further redesignated at 62 FR 13967, Mar. 24, 1997] stances prior to the applicant, if known. § 1307.13 Incidental manufacture of (b) The Special Agent in Charge shall controlled substances. authorize and instruct the applicant to dispose of the controlled substance in Any registered manufacturer who, in- one of the following manners: cidentally but necessarily, manufac- (1) By transfer to person registered tures a controlled substance as a result under the Act and authorized to pos- of the manufacture of a controlled sub- sess the substance; stance or basic class of controlled sub- (2) By delivery to an agent of the Ad- stance for which he is registered and ministration or to the nearest office of has been issued an individual manufac- the Administration; turing quota pursuant to part 1303 of (3) By destruction in the presence of this chapter (if such substance or class an agent of the Administration or is listed in Schedule I or II) shall be ex- other authorized person; or empt from the requirement of registra- (4) By such other means as the Spe- tion pursuant to part 1301 of this cial Agent in Charge may determine to chapter and, if such incidentally manu- assure that the substance does not be- factured substance is listed in Schedule come available to unauthorized per- I or II, shall be exempt from the re- sons. quirement of an individual manufac- (c) In the event that a registrant is turing quota pursuant to part 1303 of required regularly to dispose of con- this chapter, if such substances are dis- trolled substances, the Special Agent posed of in accordance with § 1307.21. in Charge may authorize the registrant [36 FR 7801, Apr. 24, 1971. Redesignated at 38 to dispose of such substances, in ac- FR 26609, Sept. 24, 1973, and further redesig- cordance with paragraph (b) of this sec- nated at 62 FR 13967, Mar. 24, 1997] tion, without prior approval of the Ad- ministration in each instance, on the DISPOSAL OF CONTROLLED SUBSTANCES condition that the registrant keep records of such disposals and file peri- § 1307.21 Procedure for disposing of odic reports with the Special Agent in controlled substances. Charge summarizing the disposals (a) Any person in possession of any made by the registrant. In granting controlled substance and desiring or re- such authority, the Special Agent in quired to dispose of such substance Charge may place such conditions as he may request assistance from the Spe- deems proper on the disposal of con- cial Agent in Charge of the Adminis- trolled substances, including the meth- tration in the area in which the person od of disposal and the frequency and is located for authority and instruc- detail of reports. tions to dispose of such substance. The (d) This section shall not be con- request should be made as follows: strued as affecting or altering in any

78 Drug Enforcement Administration, Justice § 1308.01 way the disposal of controlled sub- 1308.03 Administration Controlled Sub- stances through procedures provided in stances Code Number. laws and regulations adopted by any SCHEDULES State. 1308.11 Schedule I. [36 FR 7801, Apr. 24, 1971, as amended at 37 1308.12 Schedule II. FR 15922, Aug. 8, 1972. Redesignated at 38 FR 1308.13 Schedule III. 26609, Sept. 24, 1973, and amended at 47 FR 1308.14 Schedule IV. 41735, Sept. 22, 1982; 62 FR 13967, Mar. 24, 1997] 1308.15 Schedule V.

§ 1307.22 Disposal of controlled sub- EXCLUDED NONNARCOTIC SUBSTANCES stances by the Administration. 1308.21 Application for exclusion of a non- Any controlled substance delivered narcotic substance. to the Administration under § 1307.21 or 1308.22 Excluded substances. forfeited pursuant to section 511 of the EXEMPT CHEMICAL PREPARATIONS Act (21 U.S.C. 881) may be delivered to any department, bureau, or other agen- 1308.23 Exemption of certain chemical prep- cy of the United States or of any State arations; application. upon proper application addressed to 1308.24 Exemption chemical preparations. the Administrator, Drug Enforcement EXCLUDED VETERINARY ANABOLIC STEROID Administration, Department of Jus- IMPLANT PRODUCTS tice, Washington, DC 20537 The applica- 1308.25 Exclusion of a veterinary anabolic tion shall show the name, address, and steroid implant product; application. official title of the person or agency to 1308.26 Excluded veterinary anabolic steroid whom the controlled drugs are to be implant products. delivered, including the name and quantity of the substances desired and EXEMPTED PRESCRIPTION PRODUCTS the purpose for which intended. The de- 1308.31 Application for exemption of a non- livery of such controlled drugs shall be narcotic prescription product. ordered by the Administrator, if, in his 1308.32 Exempted prescription products. opinion, there exists a medical or sci- EXEMPT ANABOLIC STEROID PRODUCTS entific need therefor. 1308.33 Exemption of certain anabolic ster- [38 FR 7801, Apr. 24, 1971. Redesignated at 38 oid products; application. FR 26609, Sept. 24, 1973, as amended at 62 FR 1308.34 Exempt anabolic steroid products. 13967, Mar. 24, 1997] HEARINGS SPECIAL EXEMPT PERSONS 1308.41 Hearings generally. 1308.42 Purpose of hearing. § 1307.31 Native American Church. 1308.43 Initiation of proceedings for rule- The listing of peyote as a controlled making. substance in Schedule I does not apply 1308.44 Request for hearing or appearance; to the nondrug use of peyote in bona waiver. fide religious ceremonies of the Native 1308.45 Final order. 1308.46 Control required under international American Church, and members of the treaty. Native American Church so using pe- 1308.47 Control of immediate precursors. yote are exempt from registration. Any 1308.49 Emergency scheduling. person who manufactures peyote for or AUTHORITY: 21 U.S.C. 811, 812, 871(b), unless distributes peyote to the Native Amer- otherwise noted. ican Church, however, is required to obtain registration annually and to SOURCE: 38 FR 8254, Mar. 30, 1973, unless comply with all other requirements of otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973. law. GENERAL INFORMATION PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES § 1308.01 Scope of part 1308. Schedules of controlled substances GENERAL INFORMATION established by section 202 of the Act (21 Sec. U.S.C. 812), as they are changed, up- 1308.01 Scope of part 1308. dated, and republished from time to 1308.02 Definitions. time, are set forth in this part.

79 § 1308.02 21 CFR Ch. II (4–1–99 Edition)

§ 1308.02 Definitions. designated, listed in this section. Each Any term contained in this part shall drug or substance has been assigned have the definition set forth in section the DEA Controlled Substances Code 102 of the Act (21 U.S.C. 802) or part Number set forth opposite it. (b) Opiates. Unless specifically ex- 1300 of this chapter. cepted or unless listed in another [62 FR 13967, Mar. 24, 1997] schedule, any of the following opiates, including their isomers, esters, ethers, § 1308.03 Administration Controlled salts, and salts of isomers, esters and Substances Code Number. ethers, whenever the existence of such (a) Each controlled substance, or isomers, esters, ethers and salts is pos- basic class thereof, has been assigned sible within the specific chemical des- an ‘‘Administration Controlled Sub- ignation (for purposes of paragraph stances Code Number’’ for purposes of (b)(34) only, the term isomer includes identification of the substances or the optical and geometric isomers): class on certain Certificates of Reg- (1) Acetyl-alpha-methylfentanyl (N-[1-(1-methyl-2- istration issued by the Administration phenethyl)-4-piperidinyl]-N-phenylacetamide) ...... 9815 pursuant to §§ 1301.35 of this chapter (2) Acetylmethadol ...... 9601 (3) Allylprodine ...... 9602 and on certain order forms issued by (4) Alphacetylmethadol (except levo- the Administration pursuant to alphacetylmethadol also known as levo-alpha- § 1305.05(d) of this chapter. Applicants acetylmethadol, levomethadyl acetate, or LAAM) ..... 9603 (5) Alphameprodine ...... 9604 for procurement and/or individual man- (6) Alphamethadol ...... 9605 ufacturing quotas must include the ap- (7) Alpha-methylfentanyl (N-[1-(alpha-methyl-beta- propriate code number on the applica- phenyl)ethyl-4-piperidyl] propionanilide; 1-(1-methyl- 2-phenylethyl)-4-(N-propanilido) piperidine) ...... 9814 tion as required in §§ 1303.12(b) and (8) Alpha-methylthiofentanyl (N-[1-methyl-2-(2- 1303.22(a) of this chapter. Applicants thienyl)ethyl-4-piperidinyl]-N-phenylpropanamide) ..... 9832 for import and export permits must in- (9) Benzethidine ...... 9606 clude the appropriate code number on (10) Betacetylmethadol ...... 9607 (11) Beta-hydroxyfentanyl (N-[1-(2-hydroxy-2- the application as required in phenethyl)-4-piperidinyl]-N-phenylpropanamide) ...... 9830 §§ 1312.12(a) and 1312.22(a) of this chap- (12) Beta-hydroxy-3-methylfentanyl (other name: N-[1- ter. Authorized registrants who desire (2-hydroxy-2-phenethyl)-3-methyl-4-piperidinyl]-N- phenylpropanamide ...... 9831 to import or export a controlled sub- (13) Betameprodine ...... 9608 stance for which an import or export (14) Betamethadol ...... 9609 permit is not required must include the (15) Betaprodine ...... 9611 (16) Clonitazene ...... 9612 appropriate Administration Controlled (17) Dextromoramide ...... 9613 Substances Code Number beneath or (18) Diampromide ...... 9615 beside the name of each controlled sub- (19) Diethylthiambutene ...... 9616 stance listed on the DEA Form 236 (20) Difenoxin ...... 9168 (21) Dimenoxadol ...... 9617 (Controlled Substance Import/Export (22) Dimepheptanol ...... 9618 Declaration) which is executed for such (23) Dimethylthiambutene ...... 9619 importation or exportation as required (24) Dioxaphetyl butyrate ...... 9621 (25) Dipipanone ...... 9622 in §§ 1312.18(c) and 1312.27(b) of this (26) Ethylmethylthiambutene ...... 9623 chapter. (27) Etonitazene ...... 9624 (b) Except as stated in paragraph (a) (28) Etoxeridine ...... 9625 (29) Furethidine ...... 9626 of this section, no applicant or reg- (30) Hydroxypethidine ...... 9627 istrant is required to use the Adminis- (31) Ketobemidone ...... 9628 tration Controlled Substances Code (32) Levomoramide ...... 9629 Number for any purpose. (33) Levophenacylmorphan ...... 9631 (34) 3-Methylfentanyl (N-[3-methyl-1-(2-phenylethyl)-4- [38 FR 8254, Mar. 30, 1973. Redesignated at 38 piperidyl]-N-phenylpropanamide) ...... 9813 FR 26609, Sept. 24, 1973 and amended at 51 FR (35) 3-methylthiofentanyl (N-[(3-methyl-1-(2- thienyl)ethyl-4-piperidinyl]-N-phenylpropanamide) ..... 9833 15318, Apr. 23, 1986; 62 FR 13968, Mar. 24, 1997] (36) Morpheridine ...... 9632 (37) MPPP (1-methyl-4-phenyl-4-propionoxypiperidine) 9661 SCHEDULES (38) Noracymethadol ...... 9633 (39) Norlevorphanol ...... 9634 § 1308.11 Schedule I. (40) Normethadone ...... 9635 (41) Norpipanone ...... 9636 (a) Schedule I shall consist of the (42) Para-fluorofentanyl (N-(4-fluorophenyl)-N-[1-(2- drugs and other substances, by what- phenethyl)-4-piperidinyl] propanamide ...... 9812 (43) PEPAP (1-(-2-phenethyl)-4-phenyl-4- ever official name, common or usual acetoxypiperidine ...... 9663 name, chemical name, or brand name (44) Phenadoxone ...... 9637

80 Drug Enforcement Administration, Justice § 1308.11

(45) Phenampromide ...... 9638 Some trade or other names: 2-(4-bromo-2,5- (46) Phenomorphan ...... 9647 dimethoxyphenyl)-1-aminoethane; alpha- (47) Phenoperidine ...... 9641 desmethyl DOB; 2C-B, Nexus. (48) Piritramide ...... 9642 (4) 2,5-dimethoxyamphetamine ...... 7396 (49) Proheptazine ...... 9643 Some trade or other names: 2,5-dimethoxy-α- (50) Properidine ...... 9644 methylphenethylamine; 2,5-DMA (51) Propiram ...... 9649 (5) 2,5-dimethoxy-4-ethylamphet-amine ...... 7399 (52) Racemoramide ...... 9645 Some trade or other names: DOET (53) Thiofentanyl (N-phenyl-N-[1-(2-thienyl)ethyl-4- (6) 4-methoxyamphetamine ...... 7411 piperidinyl]-propanamide ...... 9835 Some trade or other names: 4-methoxy-α- (54) Tilidine ...... 9750 methylphenethylamine; (55) Trimeperidine ...... 9646 paramethoxyamphetamine, PMA (c) Opium derivatives. Unless specifi- (7) 5-methoxy-3,4-mdthylenedioxy-amphetamine ...... 7401 (8) 4-methyl-2,5-dimethoxy-amphetamine ...... 7395 cally excepted or unless listed in an- Some trade and other names: 4-methyl-2,5- other schedule, any of the following dimethoxy-α-methylphenethylamine; ``DOM''; and opium derivatives, its salts, isomers, ``STP'' and salts of isomers whenever the ex- (9) 3,4-methylenedioxy amphetamine ...... 7400 istence of such salts, isomers, and salts (10) 3,4-methylenedioxymethamphetamine (MDMA) .... 7405 (11) 3,4-methylenedioxy-N-ethylamphetamine (also of isomers is possible within the spe- known as N-ethyl-alpha-methyl- cific chemical designation: 3,4(methylenedioxy)phenethylamine, N-ethyl MDA, (1) Acetorphine ...... 9319 MDE, MDEA ...... 7404 (2) Acetyldihydrocodeine ...... 9051 (12) N-hydroxy-3,4-methylenedioxyamphetamine (also (3) Benzylmorphine ...... 9052 known as N-hydroxy-alpha-methyl- (4) Codeine methylbromide ...... 9070 3,4(methylenedioxy)phenethylamine, and N-hydroxy MDA ...... 7402 (5) Codeine-N-Oxide ...... 9053 (6) Cyprenorphine ...... 9054 (13) 3,4,5-trimethoxy amphetamine ...... 7390 (7) Desomorphine ...... 9055 (14) Bufotenine ...... 7433 (8) Dihydromorphine ...... 9145 Some trade and other names: 3-(β (9) Drotebanol ...... 9335 -Dimethylaminoethyl)-5-hydroxyindole; 3-(2- (10) Etorphine (except hydrochloride salt) ...... 9056 dimethylaminoethyl)-5-indolol; N, N- (11) Heroin ...... 9200 dimethylserotonin; 5-hydroxy-N,N- (12) Hydromorphinol ...... 9301 dimethyltryptamine; mappine (13) Methyldesorphine ...... 9302 (15) Diethyltryptamine ...... 7434 (14) Methyldihydromorphine ...... 9304 Some trade and other names: N,N- (15) Morphine methylbromide ...... 9305 Diethyltryptamine; DET (16) Morphine methylsulfonate ...... 9306 (16) Dimethyltryptamine ...... 7435 (17) Morphine-N-Oxide ...... 9307 Some trade or other names: DMT (18) Myrophine ...... 9308 (17) Ibogaine ...... 7260 (19) Nicocodeine ...... 9309 Some trade and other names: 7-Ethyl- (20) Nicomorphine ...... 9312 6,6β,7,8,9,10,12,13-octahydro-2-methoxy-6,9- (21) Normorphine ...... 9313 methano-5H-pyrido [1′, 2′:1,2] azepino [5,4-b] (22) Pholcodine ...... 9314 indole; Tabernanthe iboga (23) Thebacon ...... 9315 (18) Lysergic acid diethylamide ...... 7315 (19) Marihuana ...... 7360 (d) Hallucinogenic substances. Unless (20) Mescaline ...... 7381 specifically excepted or unless listed in (21) ParahexylÐ7374; some trade or other names: 3- another schedule, any material, com- Hexyl-1-hydroxy-7,8,9,10-tetrahydro-6,6,9-trimethyl- pound, mixture, or preparation, which 6H-dibenzo[b,d]pyran; Synhexyl. contains any quantity of the following (22) Peyote ...... 7415 Meaning all parts of the plant presently classified hallucinogenic substances, or which botanically as Lophophora williamsii Lemaire, contains any of its salts, isomers, and whether growing or not, the seeds thereof, any salts of isomers whenever the existence extract from any part of such plant, and every compound, manufacture, salts, derivative, mixture, of such salts, isomers, and salts of iso- or preparation of such plant, its seeds or extracts mers is possible within the specific (Interprets 21 USC 812(c), Schedule I(c) (12)) chemical designation (for purposes of (23) N-ethyl-3-piperidyl benzilate ...... 7482 this paragraph only, the term ‘‘isomer’’ (24) N-methyl-3-piperidyl benzilate ...... 7484 includes the optical, position and geo- (25) Psilocybin ...... 7437 metric isomers): (26) Psilocyn ...... 7438 (27) Tetrahydrocannabinols ...... 7370 (1) Alpha-ethyltryptamine ...... 7249 Some trade or other names: etryptamine; Monase; α-ethyl-1H-indole-3-ethanamine; 3-(2-aminobutyl) indole; α-ET; and AET. (2) 4-bromo-2,5-dimethoxy-amphetamine ...... 7391 Some trade or other names: 4-bromo-2,5- dimethoxy-α-methylphenethylamine; 4-bromo-2,5- DMA (3) 4-Bromo-2,5-dimethoxyphenethylamine ...... 7392 81 § 1308.12 21 CFR Ch. II (4–1–99 Edition)

Synthetic equivalents of the substances contained in (5) (±)cis-4-methylaminorex ((±)cis-4,5-dihydro-4-meth- the plant, or in the resinous extractives of Can- yl-5-phenyl-2-oxazolamine) ...... 1590 nabis, sp. and/or synthetic substances, deriva- (6) N-ethylamphetamine ...... 1475 tives, and their isomers with similar chemical (7) N,N-dimethylamphetamine (also known as N,N- structure and pharmacological activity such as the alpha-trimethyl-benzeneethanamine; N,N-alpha- following: trimethylphenethylamine) ...... 1480 ∆1 cis or trans tetrahydrocannabinol, and their optical isomers (g) Temporary listing of substances sub- ∆6 cis or trans tetrahydrocannabinol, and their opti- ject to emergency scheduling. Any mate- cal isomers rial, compound, mixture or preparation ∆ 3,4 cis or trans tetrahydrocannabinol, and its opti- which contains any quantity of the fol- cal isomers (Since nomenclature of these substances is not lowing substances: internationally standardized, compounds of these (1) N-[1-benzyl-4-piperidyl]-N-phenylpropanamide structures, regardless of numerical designation of (benzylfentanyl), its optical isomers, salts and salts atomic positions covered.) of isomers ...... 9818 (28) Ethylamine analog of phencyclidine ...... 7455 (2) N-[1-(2-thienyl)methyl-4-piperidyl]-N- Some trade or other names: N-ethyl-1- phenylpropanamide (thenylfentanyl), its optical phenylcyclohexylamine, (1- isolers, salts and salts of isomers ...... 9834 phenylcyclohexyl)ethylamine, N-(1- phenylcyclohexyl)ethylamine, cyclohexamine, PCE [39 FR 22141, June 20, 1974] (29) Pyrrolidine analog of phencyclidine ...... 7458 Some trade or other names: 1-(1-phenylcyclohexyl)- EDITORIAL NOTE: For FEDERAL REGISTER ci- pyrrolidine, PCPy, PHP tations affecting § 1308.11, see the List of CFR (30) Thiophene analog of phencyclidine ...... 7470 Sections Affected in the Finding Aids sec- Some trade or other names: 1-[1-(2-thienyl)- tion of this volume. cyclohexyl]-piperidine, 2-thienylanalog of phencyclidine, TPCP, TCP § 1308.12 Schedule II. (31) 1-[1-(2-thienyl)cyclohexyl]pyrrolidine ...... 7473 Some other names: TCPy (a) Schedule II shall consist of the (e) Depressants. Unless specifically drugs and other substances, by what- excepted or unless listed in another ever official name, common or usual schedule, any material, compound, name, chemical name, or brand name mixture, or preparation which contains designated, listed in this section. Each any quantity of the following sub- drug or substance has been assigned stances having a depressant effect on the Controlled Substances Code Num- the central nervous system, including ber set forth opposite it. its salts, isomers, and salts of isomers (b) Substances, vegetable origin or whenever the existence of such salts, chemical synthesis. Unless specifically isomers, and salts of isomers is possible excepted or unless listed in another within the specific chemical designa- schedule, any of the following sub- tion: stances whether produced directly or (1) Mecloqualone ...... 2572 indirectly by extraction from sub- (2) Methaqualone ...... 2565 stances of vegetable origin, or independently by means of chemical syn- (f) Stimulants. Unless specifically ex- thesis, or by a combination of extrac- cepted or unless listed in another tion and chemical synthesis: schedule, any material, compound, (1) Opium and opiate, and any salt, mixture, or preparation which contains compound, derivative, or preparation any quantity of the following sub- of opium or opiate excluding stances having a stimulant effect on apomorphine, thebaine-derived the central nervous system, including butorphanol, dextrorphan, nalbuphine, its salts, isomers, and salts of isomers: nalmefene, naloxone, and naltrexone, (1) Aminorex (Some other names: aminoxaphen; 2- and their respective salts, but includ- amino-5-phenyl-2-oxazoline; or 4,5-dihydro-5- phenly-2-oxazolamine) ...... 1585 ing the following: (2) Cathinone ...... 1235 (1) Raw opium ...... 9600 Some trade or other names: 2-amino-1-phenyl-1- (2) Opium extracts ...... 9610 propanone, alpha-aminopropiophenone, 2- (3) Opium fluid ...... 9620 aminopropiophenone, and norephedrone (4) Powdered opium ...... 9639 (3) Fenethylline ...... 1503 (5) Granulated opium ...... 9640 (4) Methcathinone (Some other names: 2- (6) Tincture of opium ...... 9630 (methylamino)-propiophenone; alpha- (7) Codeine ...... 9050 (methylamino)propiophenone; 2-(methylamino)-1- (8) Ethylmorphine ...... 9190 phenylpropan-1-one; alpha-N- (9) Etorphine hydrochloride ...... 9059 methylaminopropiophenone; monomethylpropion; (10) Hydrocodone ...... 9193 ephedrone; N-methylcathinone; methylcathinone; (11) Hydromorphone ...... 9150 AL±464; AL±422; AL±463 and UR1432), its salts, (12) Metopon ...... 9260 optical isomers and salts of optical isomers ...... 1237 (13) Morphine ...... 9300 82 Drug Enforcement Administration, Justice § 1308.12

(14) Oxycodone ...... 9143 (20) Pethidine-Intermediate-B, ethyl-4- (15) Oxymorphone ...... 9652 phenylpiperidine-4-carboxylate ...... 9233 (16) Thebaine ...... 9333 (21) Pethidine-Intermediate-C, 1-methyl-4- phenylpiperidine-4-carboxylic acid ...... 9234 (2) Any salt, compound, derivative, or (22) Phenazocine ...... 9715 preparation thereof which is chemi- (23) Piminodine ...... 9730 cally equivalent or identical with any (24) Racemethorphan ...... 9732 (25) Racemorphan ...... 9733 of the substances referred to in para- (26) Remifentanil ...... 9739 graph (b) (1) of this section, except that (27) Sufentanil ...... 9740 these substances shall not include the isoquinoline alkaloids of opium. (d) Stimulants. Unless specifically excepted or unless listed in another (3) Opium poppy and poppy straw. schedule, any material, compound, (4) Coca leaves (9040) and any salt, mixture, or preparation which contains compound, derivative or preparation of any quantity of the following sub- coca leaves (including cocaine (9041) stances having a stimulant effect on and ecgonine (9180) and their salts, iso- the central nervous system: mers, derivatives and salts of isomers (1) Amphetamine, its salts, optical isomers, and salts and derivatives), and any salt, com- of its optical isomers ...... 1100 pound, derivative, or preparation (2) Methamphetamine, its salts, isomers, and salts of thereof which is chemically equivalent its isomers ...... 1105 or identical with any of these sub- (3) Phenmetrazine and its salts ...... 1631 stances, except that the substances (4) Methylphenidate ...... 1724 shall not include decocainized coca (e) Depressants. Unless specifically leaves or extraction of coca leaves, excepted or unless listed in another whhch extractions do not contain co- schedule, any material, compound, caine or ecgonine. mixture, or preparation which contains (5) Concentrate of poppy straw (the any quantity of the following sub- crude extract of poppy straw in either stances having a depressant effect on liquid, solid or powder form which con- the central nervous system, including tains the phenanthrene alkaloids of the its salts, isomers, and salts of isomers opium poppy), 9670. whenever the existence of such salts, (c) Opiates. Unless specifically ex- isomers, and salts of isomers is possible cepted or unless in another schedule within the specific chemical designa- any of the following opiates, including tion: its isomers, esters, ethers, salts and (1) Amobarbital ...... 2125 salts of isomers, esters and ethers (2) Glutethimide ...... 2550 (3) Pentobarbital ...... 2270 whenever the existence of such iso- (4) Phencyclidine ...... 7471 mers, esters, ethers, and salts is pos- (5) Secobarbital ...... 2315 sible within the specific chemical des- (f) Hallucinogenic substances. ignation, dextrorphan and (1) Dronabinol (synthetic) in sesame oil and encap- levopropoxyphene excepted: sulated in a soft gelatin capsule in a U.S. Food and (1) Alfentanil ...... 9737 Drug Administration approved drug product ...... 7369 (2) Alphaprodine ...... 9010 [Some other names for dronabinol: (6aR-trans)- (3) Anileridine ...... 9020 6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl- (4) Bezitramide ...... 9800 6H-dibenzo[b,d]pyran-1-ol, or (-)-delta-9-(trans)- (5) Bulk dextropropoxyphene (non-dosage forms) ...... 9273 tetrahydrocannabinol] (6) Carfentanil ...... 9743 (2) Nabilone ...... 7379 (7) Dihydrocodeine ...... 9120 [Another name for nabilone: (±)-trans-3-(1,1- (8) Diphenoxylate ...... 9170 dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hy- (9) Fentanyl ...... 9801 droxy-6,6-dimethyl-9H-dibenzo[b,d]pyran-9-one] (10) Isomethadone ...... 9226 (11) Levo-alphacetylmethadol ...... 9648 (g) Immediate precursors. Unless spe- [Some other names: levo-alpha-acetylmethadol, cifically excepted or unless listed in levomethadyl acetate, LAAM] another schedule, any material, com- (12) Levomethorphan ...... 9210 (13) Levorphanol ...... 9220 pound, mixture, or preparation which (14) Metazocine ...... 9240 contains any quantity of the following (15) Methadone ...... 9250 substances: (16) Methadone-Intermediate, 4-cyano-2- (1) Immediate precursor to amphet- dimethylamino-4,4-diphenyl butane ...... 9254 (17) Moramide-Intermediate, 2-methyl-3-morpholino-1, amine and methamphetamine: 1-diphenylpropane-carboxylic acid ...... 9802 (i) Phenylacetone ...... 8501 (18) Pethidine (meperidine) ...... 9230 Some trade or other names: phenyl-2-propanone; (19) Pethidine-Intermediate-A, 4-cyano-1-methyl-4- P2P; benzyl methyl ketone; methyl benzyl ke- phenylpiperidine ...... 9232 tone; 83 § 1308.13 21 CFR Ch. II (4–1–99 Edition)

(2) Immediate precursors to or any salt of any of these drugs and approved by phencyclidine (PCP): the Food and Drug Administration for marketing only as a suppository. (i) 1-phenylcyclohexylamine ...... 7460 (3) Any substance which contains any quantity of a (ii) 1-piperidinocyclohexanecarbonitrile (PCC) ...... 8603 derivative of barbituric acid or any salt thereof ...... 2100 (4) Chlorhexadol ...... 2510 [39 FR 22142, June 20, 1974] (5) Lysergic acid ...... 7300 (6) Lysergic acid amide ...... 7310 EDITORIAL NOTE: For FEDERAL REGISTER ci- (7) Methyprylon ...... 2575 tations affecting § 1308.12, see the List of CFR (8) Sulfondiethylmethane ...... 2600 Sections Affected in the Finding Aids sec- (9) Sulfonethylmethane ...... 2605 tion of this volume. (10) Sulfonmethane ...... 2610 (11) Tiletamine and zolazepam or any salt thereof ...... 7295 Some trade or other names for a tiletamine- § 1308.13 Schedule III. zolazepam combination product: (a) Schedule III shall consist of the Telazol.. Some trade or other names for tiletamine: drugs and other substances, by what- 2-(ethylamino)-2-(2-thienyl)-cyclohexanone.. ever official name, common or usual Some trade or other names for zolazepam: name, chemical name, or brand name 4-(2-fluorophenyl)-6,8-dihydro-1,3,8- trimethylpyrazolo-[3,4-e] [1,4]-diazepin- designated, listed in this section. Each 7(1H)-one, flupyrazapon.. drug or substance has been assigned the DEA Controlled Substances Code (d) Nalorphine 9400. Number set forth opposite it. (e) Narcotic Drugs. Unless specifically (b) Stimulants. Unless specifically ex- excepted or unless listed in another cepted or unless listed in another schedule, any material, compound, schedule, any material, compound, mixture, or preparation containing any mixture, or preparation which contains of the following narcotic drugs, or any quantity of the following sub- their salts calculated as the free anhy- stances having a stimulant effect on drous base or alkaloid, in limited quan- the central nervous sxstem, including tities as set forth below: its salts, isomers (whether optical, po- (1) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage sition, or geometric), and salts of such unit, with an equal or greater quantity of an isomers whenever the existence of such isoquinoline alkaloid of opium ...... 9803 salts, isomers, and salts of isomers is (2) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage possible within the specific chemical unit, with one or more active, nonnarcotic ingredi- designation: ents in recognized therapeutic amounts ...... 9804 (1) Those compounds, mixtures, or preparations in (3) Not more than 300 milligrams of dihydrocodeinone dosage unit form containing any stimulant sub- (hydrocodone) per 100 milliliters or not more than stances listed in schedule II which compounds, mix- 15 milligrams per dosage unit, with a fourfold or tures, or preparations were listed on August 25, greater quantity of an isoquinoline alkaloid of opium 9805 1971, as excepted compounds under § 1308.32, and (4) Not more than 300 milligrams of dihydrocodeinone any other drug of the quantitative composition (hydrocodone) per 100 milliliters or not more than shown in that list for those drugs or which is the 15 milligrams per dosage unit, with one or more ac- same except that it contains a lesser quantity of tive nonnarcotic ingredients in recognized thera- controlled substances ...... 1405 peutic amounts ...... 9806 (2) Benzphetamine ...... 1228 (5) Not more than 1.8 grams of dihydrocodeine per (3) Chlorphentermine ...... 1645 100 milliliters or not more than 90 milligrams per (4) Clortermine ...... 1647 dosage unit, with one or more active nonnarcotic in- (5) Phendimetrazine ...... 1615 gredients in recognized therapeutic amounts ...... 9807 (6) Not more than 300 milligrams of ethylmorphine per (c) Depressants. Unless specifically 100 milliliters or not more than 15 milligrams per excepted or unless listed in another dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts ...... 9808 schedule, any material, compound, (7) Not more than 500 milligrams of opium per 100 mixture, or preparation which contains milliliters or per 100 grams or not more than 25 milli- any quantity of the following sub- grams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic stances having a depressant effect on amounts ...... 9809 the central nervous system: (8) Not more than 50 milligrams of morphine per 100 (1) Any compound, mixture or preparation containing: milliliters or per 100 grams, with one or more active, (i) Amobarbital ...... 2126 nonnarcotic ingredients in recognized therapeutic (ii) Secobarbital ...... 2316 amounts ...... 9810 (iii) Pentobarbital ...... 2271 or any salt thereof and one or more other active (f) Anabolic steroids. Unless specifi- medicinal ingredients which are not listed in any cally excepted or unless listed in an- schedule. other schedule, any material, com- (2) Any suppository dosage form containing: pound, mixture, or preparation con- (i) Amobarbital ...... 2126 (ii) Secobarbital ...... 2316 taining any quantity of the following (iii) Pentobarbital ...... 2271 substances, including its salts, isomers, 84 Drug Enforcement Administration, Justice § 1308.14 and salts of isomers whenever the ex- (19) Fludiazepam ...... 2759 istence of such salts of isomers is pos- (20) Flunitrazepam ...... 2763 (21) Flurazepam ...... 2767 sible within the specific chemical des- (22) Halazepam ...... 2762 ignation: (23) Haloxazolam ...... 2771 (24) Ketazolam ...... 2772 (1) Anabolic Steroids ...... 4000 (25) Loprazolam ...... 2773 (26) Lorazepam ...... 2885 [39 FR 22142, June 20, 1974, as amended at 41 (27) Lormetazepam ...... 2774 FR 43401, Oct. 1, 1976; 43 FR 3359, Jan. 25, 1978; (28) Mebutamate ...... 2800 (29) Medazepam ...... 2836 44 FR 40888, July 13, l979; 46 FR 52334, Oct. 27, (30) Meprobamate ...... 2820 1981; 51 FR 5320, Feb. 13, 1986; 52 FR 2222, Jan. (31) Methohexital ...... 2264 21, 1987; 52 FR 5952, Feb. 27, 1987; 56 FR 5754, (32) Methylphenobarbital (mephobarbital) ...... 2250 Feb. 13, 1991; 56 FR 11932, Mar. 21, 1991; 62 FR (33) Midazolam ...... 2884 13968, Mar. 24, 1997] (34) Nimetazepam ...... 2837 (35) Nitrazepam ...... 2834 (36) Nordiazepam ...... 2838 § 1308.14 Schedule IV. (37) Oxazepam ...... 2835 (a) Schedule IV shall consist of the (38) Oxazolam ...... 2839 (39) Paraldehyde ...... 2585 drugs and other substances, by what- (40) Petrichloral ...... 2591 ever official name, common or usual (41) Phenobarbital ...... 2285 name, chemical name, or brand name (42) Pinazepam ...... 2883 (43) Prazepam ...... 2764 designated, listed in this section. Each (44) Quazepam ...... 2881 drug or substance has been assigned (45) Temazepam ...... 2925 the DEA Controlled Substances Code (46) Tetrazepam ...... 2886 (47) Triazolam ...... 2887 Number set forth opposite it. (48) Zolpidem ...... 2783 (b) Narcotic drugs. Unless specifically excepted or unless listed in another (d) Fenfluramine. Any material, com- schedule, any material, compound, pound, mixture, or preparation which mixture, or preparation containing any contains any quantity of the following of the following narcotic drugs, or substances, including its salts, isomers their salts calculated as the free anhy- (whether optical, position, or geo- drous base or alkaloid, in limited quan- metric), and salts of such isomers, tities as set forth below: whenever the existence of such salts, (1) Not more than 1 milligram of difenoxin and not less isomers, and salts of isomers is pos- than 25 micrograms of atropine sulfate per dosage sible: unit ...... 9167 (1) Fenfluramine ...... 1670 (2) Dextropropoxyphene (alpha-(∂)-4-dimethylamino- 1,2-diphenyl-3-methyl-2-propionoxybutane) ...... 9278 (e) Stimulants. Unless specifically excepted or unless listed in another (c) Depressants. Unless specifically excepted or unless listed in another schedule, any material, compound, schedule, any material, compound, mixture, or preparation which contains mixture, or preparation which contains any quantity of the following sub- any quantity of the following substances having a stimulant effect on stances, including its salts, isomers, the central nervous system, including and salts of isomers whenever the ex- its salts, isomers and salts of isomers: (1) Cathine ((∂)-norpseudoephedrine) ...... 1230 istence of such salts, isomers, and salts (2) Diethylpropion ...... 1610 of isomers is possible within the spe- (3) Fencamfamin ...... 1760 cific chemical designation: (4) Fenproporex ...... 1575 (5) Mazindol ...... 1605 (1) Alprazolam ...... 2882 (6) Mefenorex ...... 1580 (2) Barbital ...... 2145 (7)Modafinil ...... 1680 (3) Bromazepam ...... 2748 (8) Pemoline (including organometallic complexes and (4) Camazepam ...... 2749 chelates thereof) ...... 1530 (5) Chloral betaine ...... 2460 (9) Phentermine ...... 1640 (6) Chloral hydrate ...... 2465 (10) Pipradrol ...... 1750 (7) Chlordiazepoxide ...... 2744 (11) Sibutramine ...... 1675 (8) Clobazam ...... 2751 (12) SPA ((-)-1-dimethylamino- 1,2-diphenylethane) .... 1635 (9) Clonazepam ...... 2737 (10) Clorazepate ...... 2768 (f) Other substances. Unless specifi- (11) Clotiazepam ...... 2752 (12) Cloxazolam ...... 2753 cally excepted or unless listed in an- (13) Delorazepam ...... 2754 other schedule, any material, com- (14) Diazepam ...... 2765 pound, mixture or preparation which (15) Estazolam ...... 2756 contains any quantity of the following (16) Ethchlorvynol ...... 2540 (17) Ethinamate ...... 2545 substances, including its salts: (18) Ethyl loflazepate ...... 2758 (1) Pentazocine ...... 9709 85 § 1308.15 21 CFR Ch. II (4–1–99 Edition)

(2) Butorphanol (including its optical isomers) ...... 9720 contains any quantity of the following substances having a stimulant effect [39 FR 22143, June 20, 1974] on the central nervous system, includ- EDITORIAL NOTE: For FEDERAL REGISTER ci- ing its salts, isomers and salts of iso- tations affecting § 1308.14, see the List of CFR mers: Sections Affected in the Finding Aids section of this volume. (1) Pyrovalerone ...... 1485. (2) [Reserved] § 1308.15 Schedule V. [39 FR 22143, June 20, 1974, as amended at 43 (a) Schedule V shall consist of the FR 38383, Aug. 28, 1978; 44 FR 40888, July 13, drugs and other substances, by what- 1979; 47 FR 49841, Nov. 3, 1982; 50 FR 8108, Feb. ever official name, common or usual 28, 1985; 52 FR 5952, Feb. 27, 1987; 53 FR 10870, name, chemical name, or brand name Apr. 4, 1988; 56 FR 61372, Dec. 3, 1991] designated, listed in this section. EXCLUDED NONNARCOTIC SUBSTANCES (b) Narcotic drugs. Unless specifically excepted or unless listed in another § 1308.21 Application for exclusion of a schedule, any material, compound, nonnarcotic substance. mixture, or preparation containing any (a) Any person seeking to have any of the following narcotic drugs and nonnarcotic substance which may, their salts, as set forth below: under the Federal Food, Drug, and Cos- (1) Buprenorphine ...... 9064 metic Act (21 U.S.C. 301), be lawfully (c) Narcotic drugs containing non-nar- sold over the counter without a pre- cotic active medicinal ingredients. Any scription, excluded from any schedule, compound, mixture, or preparation pursuant to section 201(g) (1) of the Act containing any of the following nar- (21 U.S.C. 811 (g) (1)), may apply to the cotic drugs, or their salts calculated as Administrator, Drug Enforcement Ad- the free anhydrous base or alkaloid, in ministration, Department of Justice, limited quantities as set forth below, Washington, DC 20537. which shall include one or more non- (b) An application for an exclusion narcotic active medicinal ingredients under this section shall contain the fol- in sufficient proportion to confer upon lowing information: the compound, mixture, or preparation (1) The name and address of the ap- valuable medicinal qualities other than plicant; those possessed by narcotic drugs (2) The name of the substance for alone: which exclusion is sought; and (1) Not more than 200 milligrams of (3) The complete quantitative com- codeine per 100 milliliters or per 100 position of the substance. grams. (c) Within a reasonable period of (2) Not more than 100 milligrams of time after the receipt of an application dihydrocodeine per 100 milliliters or for an exclusion under this section, the per 100 grams. Administrator shall notify the appli- (3) Not more than 100 milligrams of cant of his acceptance or nonaccept- ethylmorphine per 100 milliliters or per ance of his application, and if not ac- 100 grams. cepted, the reason therefore. The Ad- (4) Not more than 2.5 milligrams of ministrator need not accept an applica- diphenoxylate and not less than 25 tion for filing if any of the require- micrograms of atropine sulfate per dos- ments prescribed in paragraph (b) of age unit. this section is lacking or is not set (5) Not more than 100 milligrams of forth as to be readily understood. If the opium per 100 milliliters or per 100 applicant desires, he may amend the grams. application to meet the requirements (6) Not more than 0.5 milligram of of paragraph (b) of this section. If the difenoxin and not less than 25 application is accepted for filing, the micrograms of atropine sulfate per dos- Administrator shall issue and publish age unit. in the FEDERAL REGISTER his order on (d) Stimulants. Unless specifically ex- the application, which shall include a empted or excluded or unless listed in reference to the legal authority under another schedule, any material, com- which the order is issued and the find- pound, mixture, or preparation which ings of fact and conclusions of law 86 Drug Enforcement Administration, Justice § 1308.23 upon which the order is based. This (d) The Administrator may at any order shall specify the date on which it time revoke any exclusion granted pur- shall take effect. The Administrator suant to section 201(g) of the Act (21 shall permit any interested person to U.S.C. 811(g)) by following the proce- file written comments on or objections dures set forth in paragraph (c) of this to the order within 60 days of the date section for handling an application for of publication of his order in the FED- an exclusion which has been accepted ERAL REGISTER. If any such comments for filing. or objections raise significant issues regarding any finding of fact or conclu- § 1308.22 Excluded substances. sion of law upon which the order is based, the Administrator shall imme- The following nonnarcotic substances diately suspend the effectiveness of the which may, under the Federal Food, order until he may reconsider the ap- Drug, and Cosmetic Act (21 U.S.C. 301), plication in light of the comments and be lawfully sold over the counter with- objections filed. Thereafter, the Ad- out a prescription, are excluded from ministrator shall reinstate, revoke, or all schedules pursuant to section 201(g) amend his original order as he deter- (1) of the Act (21 U.S.C. 811(g) (1)): mines appropriate.

EXCLUDED NONNARCOTIC PRODUCTS

(mg or mg/ Company Trade name NDC code Form Controlled substance ml)

Bioline Laboratories ...... Theophed ...... 00719±1945 TB Phenobarbital ...... 8.00 Goldline Laboratories ...... Guiaphed Elixir ...... 00182±1377 EL Phenobarbital ...... 4.00 Goldline Laboratories ...... Tedrigen Tablets ...... 00182±0134 TB Phenobarbital ...... 8.00 Hawthorne Products Inc .... Choate's Leg Freeze ...... LQ Chloral hydrate ...... 246.67 Parke-Davis & Co ...... Tedral ...... 00071±0230 TB Phenobarbital ...... 8.00 Parke-Davis & Co ...... Tedral Elixir ...... 00071±0242 EX Phenobarbital ...... 40.00 Parke-Davis & Co ...... Tedral S.A...... 00071±0231 TB Phenobarbital ...... 8.00 Parke-Davis & Co ...... Tedral Suspension ...... 00071±0237 SU Phenobarbital ...... 80.00 Parmed Pharmacy ...... Asma-Ese ...... 00349±2018 TB Phenobarbital ...... 8.10 Rondex Labs ...... Azma-Aids ...... 00367±3153 TB Phenobarbital ...... 8.00 Smith Kline Consumer ...... Benzedrex ...... 49692±0928 IN Propylhexedrine ...... 250.00 Sterling Drug, Inc ...... Bronkolixir ...... 00057±1004 EL Phenobarbital ...... 0.80 Sterling Drug, Inc ...... Bronkotabs ...... 00057±1005 TB Phenobarbital ...... 8.00 Vicks Chemical Co ...... Vicks Inhaler ...... 23900±0010 IN I-Desoxyephedrine ...... 113.00 White Hall Labs ...... Primatene (P-tablets) ...... 00573±2940 TB Phenobarbital ...... 8.00

[38 FR 8255, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, l973, and amended at 41 FR 16553, Apr. 20, 1976; 41 FR 53477, Dec. 7, 1976; 46 FR 51603, Oct. 21, 1981; 47 FR 45867, Oct. 14, 1982; 54 FR 2100, Jan. 19, 1989; 55 FR 12162, Mar. 30, 1990; 62 FR 13968, Mar. 24, 1997]

EXEMPT CHEMICAL PREPARATIONS form or concentration that the packaged quantity does not present any sig- § 1308.23 Exemption of certain chem- nificant potential for abuse (the type of ical preparations; application. packaging and the history of abuse of (a) The Administrator may, by regu- the same or similar preparations may lation, exempt from the application of be considered in determining the po- all or any part of the Act any chemical tential for abuse of the preparation or preparation or mixture containing one mixture); or or more controlled substances listed in (2) Contains either a narcotic or non- any schedule, which preparation or narcotic controlled substance and one mixture is intended for laboratory, in- or more adulterating or denaturing dustrial, educational, or special re- agents in such a manner, combination, search purposes and not for general ad- quantity, proportion, or concentration, ministration to a human being or other that the preparation or mixture does animal, if the preparation or mixture not present any potential for abuse. If either: the preparation or mixture contains a (1) Contains no narcotic controlled narcotic controlled substance, the substance and is packaged in such a

87 § 1308.23 21 CFR Ch. II (4–1–99 Edition) preparation or mixture must be formu- deemed by the applicant to be a trade lated in such a manner that it incor- secret or otherwise confidential and en- porates methods of denaturing or other titled to protection under subsection means so that the preparation or mix- 402(a)(8) of the Act (21 U.S.C. 842(a) (8)) ture is not liable to be abused or have or any other law restricting public dis- ill effects, if abused, and so that the closure of information. narcotic substance cannot in practice (d) The Administrator may require be removed. the applicant to submit such docu- (b) Any person seeking to have any ments or written statements of fact preparation or mixture containing a relevant to the application as he deems controlled substance and one or more necessary to determine whether the ap- noncontrolled substances exempted plication should be granted. from the application of all or any part (e) Within a reasonable period of of the Act, pursuant to paragraph (a) of time after the receipt of an application this section, may apply to the Admin- for an exemption under this section, istrator, Drug Enforcement Adminis- the Administrator shall notify the ap- tration, Department of Justice, Wash- plicant of his acceptance or nonaccept- ington, DC 20537. ance of his application, and if not ac- (c) An application for an exemption cepted, the reason therefor. The Ad- under this section shall contain the fol- ministrator need not accept an applica- lowing information: tion for filing if any of the require- (1) The name, address, and registra- ments prescribed in paragraph (c) or re- tion number, if any, of the applicant; quested pursuant to paragraph (d) is (2) The name, address, and registra- lacking or is not set forth as to be tion number, if any, of the manufacturer or importer of the preparation or readily understood. If the applicant de- mixture, if not the applicant; sires, he may amend the application to (3) The exact trade name or other meet the requirements of paragraphs designation of the preparation or mix- (c) and (d) of this section. If the appli- ture; cation is accepted for filing, the Ad- (4) The complete qualitative and ministrator shall issue and publish in quantitative composition of the prepa- the FEDERAL REGISTER his order on the ration or mixture (including all active application, which shall include a ref- and inactive ingredients and all con- erence to the legal authority under trolled and noncontrolled substances); which the order is based. This order (5) The form of the immediate con- shall specify the date on which it shall tainer in which the preparation or mix- take effect. The Administrator shall ture will be distributed with sufficient permit any interested person to file descriptive detail to identify the prepa- written comments on or objections to ration or mixture (e.g., bottle, packet, the order within 60 days of the date of vial, soft plastic pillow, agar gel plate, publication of his order in the FEDERAL etc.); REGISTER. If any such comments or ob- (6) The dimensions or capacity of the jections raise significant issues regard- immediate container of the prepara- ing any finding of fact or conclusion of tion or mixture; law upon which the order is based, the (7) The label and labeling, as defined Administrator shall immediately sus- in part 1300 of this chapter, of the im- pend the effectiveness of the order mediate container and the commercial until he may reconsider the application containers, if any, of the preparation in light of the comments and objec- or mixture; tions filed. Thereafter, the Adminis- (8) A brief statement of the facts trator shall reinstate, revoke, or which the applicant believes justify the amend his original order as he deter- granting of an exemption under this mines appropriate. paragraph, including information on (f) The Administrator may at any the use to which the preparation or time revoke or modify any exemption mixture will be put; granted pursuant to this section by fol- (9) The date of the application; and lowing the procedures set forth in para- (10) Which of the information sub- graph (e) of this section for handling an mitted on the application, if any, is application for an exemption which has

88 Drug Enforcement Administration, Justice § 1308.24 been accepted for filing. The Adminis- label and labeling must also include in trator may also modify or revoke the a prominent manner the statement criteria by which exemptions are ‘‘For industrial use only’’ or ‘‘For granted (and thereby modify or revoke chemical use only’’ or ‘‘For in vitro use all preparations and mixtures granted only—not for human or animal use’’ or under the old criteria) and modify the ‘‘Diagnostic reagent—for professional scope of exemptions at any time. use only’’ or a comparable statement warning the person reading it that [38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 46 human or animal use is not intended. FR 28841, May 29, 1981; 62 FR 13968, Mar. 24, The symbol designating the schedule of 1997] the controlled substance is not required on either the label or the label- § 1308.24 Exempt chemical prepara- ing of the exempt chemical preparations. tion, nor is it necessary to list all in- (a) The chemical preparations and gredients of the preparation. mixtures approved pursuant to § 1308.23 (d) Records and reports: Any person are exempt from application of sec- who manufactures an exempt chemical tions 302, 303, 305, 306, 307, 308, 309, 1002, preparation or mixture must keep com- 1003 and 1004 of the Act (21 U.S.C. 822– plete and accurate records and file all 823, 825–829, 952–954) and § 1301.74 of this reports required under part 1304 of this chapter, to the extent described in chapter regarding all controlled subparagraphs (b) to (h) of this section. stances being used in the manufac- Substances set forth in paragraph (j) of turing process until the preparation or this section shall be exempt from the mixture is in the form described in application of sections 305, 306, 307, 308, paragraph (i) of this section. In lieu of 309, 1002, 1003 and 1004 of the Act (21 records and reports required under part U.S.C. 825–829, 952–954) and §§ 1301.71— 1304 of this chapter regarding exempt 1301.73 and 1301.74 (a), (b), (d), (e) and (f) chemical preparations, the manufac- of this chapter to the extent as herein- turer need only record the name, ad- after may be provided. dress, and registration number, if any, (b) Registration and security: Any of each person to whom the manufac- person who manufactures an exempt turer distributes any exempt chemical chemical preparation or mixture must preparation. Each importer or exporter be registered under the Act and comply of an exempt narcotic chemical prepa- with all relevant security requirements ration must submit a semiannual re- regarding controlled substances being port of the total quantity of each sub- used in the manufacturing process stance imported or exported in each until the preparation or mixture is in calendar half-year within 30 days of the the form described in paragraph (i) of close of the period to the Drug and this section. Any other person who Chemical Evaluation Section, Drug En- handles an exempt chemical prepara- forcement Administration, Department tion after it is in the form described in of Justice, Washington, DC 20537. Any paragraph (i) of this section is not re- other person who handles an exempt quired to be registered under the Act chemical preparation after it is in the to handle that preparation, and the form described in paragraph (i) of this preparation is not required to be stored section is not required to maintain in accordance with security require- records or file reports. ments regarding controlled substances. (e) Quotas, order forms, prescrip- (c) Labeling: In lieu of the require- tions, import, export, and trans- ments set forth in part 1302 of this shipment requirements: Once an ex- chapter, the label and the labeling of empt chemical preparation is in the an exempt chemical preparation must form described in paragraph (i) of this be prominently marked with its full section, the requirements regarding trade name or other description and quotas, order forms, prescriptions, im- the name of the manufacturer or support permits and declarations, export plier as set forth in paragraph (i) of permit and declarations, and trans- this section, in such a way that the shipment and intransit permits and product can be readily identified as an declarations do not apply. These re- exempt chemical preparation. The quirements do apply, however, to any

89 § 1308.25 21 CFR Ch. II (4–1–99 Edition) controlled substances used in manufac- EXCLUDED VETERINARY ANABOLIC turing the exempt chemical prepara- STEROID IMPLANT PRODUCTS tion before it is in the form described in paragraph (i) of this section. § 1308.25 Exclusion of a veterinary an- (f) Criminal penalties: No exemption abolic steroid implant product; ap- granted pursuant to § 1308.23 affects the plication. criminal liability for illegal manufac- (a) Any person seeking to have any ture, distribution, or possession of con- anabolic steroid product, which is ex- trolled substances contained in the expressly intended for administration empt chemical preparation. Distribu- through implants to cattle or other tion, possession, and use of an exempt nonhuman species and which has been chemical preparation are lawful for approved by the Secretary of Health registrants and nonregistrants only as and Human Services for such adminis- long as such distribution, possession, tration, identified as being excluded or use is intended for laboratory, in- from any schedule, pursuant to section dustrial, or educational purposes and 102(41)(B)(i) of the Act (21 U.S.C. not for immediate or subsequent administration to a human being or other 802(41)(B)(i)), may apply to the Admin- animal. istrator, Drug Enforcement Adminis- (g) Bulk materials: For materials ex- tration, Department of Justice, Wash- empted in bulk quantities, the Admin- ington, DC 20537. istrator may prescribe requirements (b) An application for any exclusion other than those set forth in para- under this section shall be submitted graphs (b) through (e) of this section on in triplicate and contain the following a case-by-case basis. information: (h) Changes in chemical preparations: (1) The name and address of the ap- Any change in the quantitative or plicant; qualitative composition of the prepara- (2) The name of the product; tion or mixture after the date of appli- (3) The chemical structural formula cation, or change in the trade name or or description for any anabolic steroid other designation of the preparation or contained in the product; mixture, set forth in paragraph (i) of (4) A complete description of dosage this section, requires a new application and quantitative composition of the for exemption. dosage form;. (i) A listing of exempt chemical prep- (5) The conditions of use including arations may be obtained by submit- whether or not Federal law restricts ting a written request to the Drug and this product to use by or on the order Chemical Evaluation Section, Drug En- of a licensed veterinarian; forcement Administration, Wash- ington, DC 20537. (6) A description of the delivery sys- (j) The following substances are des- tem in which the dosage form will be ignated as exempt chemical prepara- distributed with sufficient detail to tions for the purposes set forth in this identify the product (e.g. 20 cartridge section. brown plastic belt); (1) Chloral. When packaged in a (7) The label and labeling of the im- sealed, oxygen-free environment, under mediate container and the commercial nitrogen pressure, safeguarded against containers, if any, of the product;. exposure to the air. (8) The name and address of the man- (2) EmitR Phenobarbital Enzyme Rea- ufacturer of the dosage form if dif- gent B. In one liter quantities each ferent from that of the applicant; and with a 5 ml. retention sample for re- (9) Evidence that the product has packaging as an exempt chemical prep- been approved by the Secretary of aration only. Health and Human Services for admin- [38 FR 8255, Mar. 30, 1973] istration through implant to cattle or other nonhuman species. EDITORIAL NOTE: For FEDERAL REGISTER ci- (c) Within a reasonable period of tations affecting § 1308.24, see the List of CFR Sections Affected in the Finding Aids sec- time after the receipt of an application tion of this volume. for an exclusion under this section, the

90 Drug Enforcement Administration, Justice § 1308.31

Administrator shall notify the appli- products may be obtained by submit- cant of his acceptance or nonaccept- ting a written request to the Drug and ance of the application, and if not ac- Chemical Evaluation Section, Drug En- cepted, the reason therefore. The Ad- forcement Administration, Washington ministrator need not accept an applica- DC 20537. tion for filing if any of the require- (b) In accordance with section ments prescribed in paragraph (b) of 102(41)(B)(ii) of the Act (21 U.S.C. this section is lacking or is not set 802(41)(B)(ii)) if any person prescribes, forth as to be readily understood. The dispenses, or distributes a product list- applicant may amend the application ed in paragraph (a) of this section for to meet the requirements of paragraph human use, such person shall be con- (b) of this section. If the application is sidered to have prescribed, dispensed, accepted for filing, the Administrator or distributed an anabolic steroid with- shall issue and have published in the in the meaning of section 102(41)(A) of FEDERAL REGISTER his order on the ap- the Act (21 U.S.C. 802(41)(A)). plication, which shall include a reference to the legal authority under [56 FR 42936, Aug. 30, 1991, as amended at 57 which the order is issued and the find- FR 19534, May 7, 1992; 58 FR 15088, Mar. 19, 1993; 62 FR 13967, Mar. 24, 1997] ings of fact and conclusions of law upon which the order is based. This EXEMPTED PRESCRIPTION PRODUCTS order shall specify the date on which it will take effect. The Administrator § 1308.31 Application for exemption of shall permit any interested person to a nonnarcotic prescription product. file written comments on or objections (a) Any person seeking to have any to the order within 60 days of the date compound, mixture, or preparation of publication in the FEDERAL REG- containing any nonnarcotic controlled ISTER. If any such comments or objec- substance listed in § 1308.12(e), or in tions raise significant issues regarding § 1308.13 (b) or (c), or in § 1308.14, or in any finding of fact or conclusion of law § 1308.15, exempted from application of upon which the order is based, the Ad- all or any part of the Act pursuant to ministrator shall immediately suspend section 201(g)(3)(A), of the Act (21 the effectiveness of the order until he U.S.C. 811(g)(3)(A). may apply to the may reconsider the application in light Administrator, Drug Enforcement Ad- of the comments and objections filed. ministration, Washington, DC 20537, for Thereafter, the Administrator shall re- such exemption. instate, revoke, or amend his original (b) An application for an exemption order as he determines appropriate. under this section shall contain the fol- (d) The Administrator may at any lowing information: time revoke or modify any designation (1) The complete quantitative com- of excluded status granted pursuant to position of the dosage form. this section by following the proce- (2) Description of the unit dosage dures set forth in paragraph (c) of this form together with complete labeling. section for handling an application for (3) A summary of the pharmacology an exclusion which has been accepted of the product including animal inves- for filing. tigations and clinical evaluations and [56 FR 42936, Aug. 30, 1991] studies, with emphasis on the psychic and/or physiological dependence liabil- § 1308.26 Excluded veterinary anabolic ity (this must be done for each of the steroid implant products. active ingredients separately and for (a) Products containing an anabolic the combination product). steroid, that are expressly intended for (4) Details of synergisms and antag- administration through implants to onisms among ingredients. cattle or other nonhuman species and (5) Deterrent effects of the noncon- which have been approved by the Sec- trolled ingredients. retary of Health and Human Services (6) Complete copies of all literature for such administration are excluded in support of claims. from all schedules pursuant to section (7) Reported instances of abuse. 102(41)(B)(I) of the Act (21 U.S.C. (8) Reported and anticipated adverse 802(41)(B)(I)). A listing of the excluded effects.

91 § 1308.32 21 CFR Ch. II (4–1–99 Edition)

(9) Number of dosage units produced an exemption which has been accepted for the past 2 years. for filing. (c) Within a reasonable period of [38 FR 8254, Mar. 30, 1973. Redesignated at 38 time after the receipt of an application FR 26609, Sept. 24, 1973, as amended at 44 FR for an exemption under this section, 18968, Mar. 30, 1979; 52 FR 9803, Mar. 27, 1987] the Administrator shall notify the applicant of his acceptance or non-ac- § 1308.32 Exempted prescription prod- ceptance of the application, and if not ucts. accepted, the reason therefor. The Ad- The compounds, mixtures, or prep- ministrator need not accept an applica- arations that contain a nonnarcotic tion for filing if any of the require- controlled substance listed in ments prescribed in paragraph (b) of § 1308.12(e) or in § 1308.13 (b) or (c) or in this section is lacking or is not set § 1308.14 or in § 1308.15 listed in the forth so as to be readily understood. If Table of Exempted Prescription Prod- the applicant desires, he may amend ucts have been exempted by the Ad- the application to meet the require- ministrator from the application of ments of paragraph (b) of this section. sections 302 through 305, 307 through If accepted for filing, the Adminis- 309, 1002 through 1004 of the Act (21 trator shall publish in the FEDERAL U.S.C. 822–825, 827–829, and 952–954) and REGISTER general notice of this pro- §§ 1301.13, 1301.22, and §§ 1301.71 through posed rulemaking in granting or deny- 1301.76 of this chapter for administra- ing the application. Such notice shall tive purposes only. An exception to the include a reference to the legal author- above is that those products containing ity under which the rule is proposed, a butalbital shall not be exempt from the statement of the proposed rule grant- requirement of 21 U.S.C. 952–954 con- ing or denying an exemption, and, in cerning importation, exportation, the discretion of the Administrator, a transshipment and in-transit shipment summary of the subjects and issues in- of controlled substances. Any deviation volved. The Administrator shall permit from the quantitative composition of any interested person to file written any of the listed drugs shall require a comments on or objections to the pro- petition of exemption in order for the posal and shall designate in the notice product to be exempted. A listing of of proposed rule making the time dur- the Exempted Prescription Products ing which such filings may be made. may be obtained by submitting a writ- After consideration of the application ten request to the Drug and Chemical and any comments on or objections to Evaluation Section, Drug Enforcement his proposed rulemaking, the Adminis- Administration, Washington, DC 20537. trator shall issue and publish in the FEDERAL REGISTER his final order on [62 FR 13967, Mar. 24, 1997] the application, which shall set forth the findings of fact and conclusions of EXEMPT ANABOLIC STEROID PRODUCTS law upon which the order is based. This order shall specify the date on which it § 1308.33 Exemption of certain ana- shall take effect, which shall not be bolic steroid products; application. less than 30 days from the date of pub- (a) The Administrator, upon the rec- lication in the FEDERAL REGISTER un- ommendation of the Secretary of less the Administrator finds that con- Health and Human Services, may, by ditions of public health or safety neces- regulation, exempt from the applica- sitate an earlier effective date, in tion of all or any part of the Act any which event the Administrator shall compound, mixture, or preparation specify in the order his findings as to containing an anabolic steroid as de- such conditions. fined in part 1300 of this chapter if, be- (d) The Administrator may revoke cause of its concentration, preparation, any exemption granted pursuant to mixture or delivery system, it has no section 201(g)(3)(A) of the Act (21 U.S.C. significant potential for abuse (Pub. L. 811(g)(3)(A)) by following the proce- 101–647 section 1903(a)). dures set forth in paragraph (c) of this (b) Any person seeking to have any section for handling an application for compound, mixture, or preparation

92 Drug Enforcement Administration, Justice § 1308.34 containing an anabolic steroid as de- Human Services his recommendation, fined in part 1300 of this chapter ex- as to whether such product which con- empted from the application of all or tains an anabolic steroid should be con- any part of the Act, pursuant to para- sidered for exemption from certain por- graph (a) of this section, may apply to tions of the Controlled Substances Act. the Administrator, Drug Enforcement On receipt of the recommendation of Administration, Department of Jus- the Secretary, the Administrator shall tice, Washington, DC 20537. make a determination as to whether (c) An application for an exemption the evidence submitted or otherwise under this section shall be submitted available sufficiently establishes that in triplicate and contain the following the product possesses no significant po- information: tential for abuse. The Administrator (1) The name and address of the ap- shall issue and publish in the FEDERAL plicant; REGISTER his order on the application, (2) The name of the product; which shall include a reference to the (3) The chemical structural formula legal authority under which the order or description for any anabolic steroid is issued, and the findings of fact and contained in the product; conclusions of law upon which the (4) The complete description of dos- order is based. This order shall specify age and quantitative composition of the date on which it will take effect. the dosage form; The Administrator shall permit any in- (5) A description of the delivery sys- terested person to file written com- tem, if applicable; ments on or objections to the order (6) The indications and conditions for within 60 days of the date of publica- use in which species, including whether tion of his order in the FEDERAL REG- or not this product is a prescription ISTER. If any such comments or objec- drug; tions raise significant issues regarding (7) Information to facilitate identi- any finding of fact or conclusion of law fication of the dosage form, such as upon which the order is based, the Ad- shape, color, coating, and scoring; ministrator shall immediately suspend (8) The label and labeling of the im- the effectiveness of the order until he mediate container and the commercial may reconsider the application in light containers, if any, of the product; of the comments and objections filed. (9) The units in which the dosage Thereafter, the Administrator shall re- form is ordinarily available; and instate, revoke, or amend his original (10) The facts which the applicant be- order as he determines appropriate. lieves justify: (e) The Administrator may revoke (i) A determination that the product any exemption granted pursuant to has no significant potential for abuse section 1903(a) of Public Law 101–647 by and following the procedures set forth in (ii) a granting of an exemption under paragraph (d) of this section for han- this section. dling an application for an exemption (d) Within a reasonable period of which has been accepted for filing. time after the receipt of the application for an exemption under this sec- [56 FR 42936, Aug. 30, 1991; 57 FR 10815, Mar. tion, the Administrator shall notify 31, 1992, as amended at 62 FR 13968, Mar. 24, the applicant of his acceptance or non- 1997] acceptance of the application, and if not accepted, the reason therefor. The § 1308.34 Exempt anabolic steroid Administrator need not accept an ap- products. plication for filing if any of the re- The list of compounds, mixtures, or quirements prescribed in paragraph (c) preparations that contain an anabolic of this section is lacking or is not set steroid that have been exempted by the forth so as to be readily understood. Administrator from application of sec- The applicant may amend the applications 302 through 309 and 1002 through tion to meet the requirements of para- 1004 of the Act (21 U.S.C. 822–829 and graph (c) of this section. If accepted for 952–954) and §§ 1301.13, 1301.22, and filing, the Administrator will request 1301.71 through 1301.76 of this chapter from the Secretary for Health and for administrative purposes only may

93 § 1308.41 21 CFR Ch. II (4–1–99 Edition) be obtained by submitting a written re- ADMINISTRATOR, DRUG ENFORCEMENT quest to the Drug and Chemical Eval- ADMINISTRATION uation Section, Drug Enforcement Ad- Department of Justice, ministration, Washington, DC 20537. Washington, DC 20537. DEAR SIR: The undersigned ——————— [62 FR 13967, Mar. 24, 1997] hereby petitions the Administrator to initiate proceedings for the issuance (amend- HEARINGS ment or repeal) of a rule or regulation pursuant to section 201 of the Controlled Sub- § 1308.41 Hearings generally. stances Act. In any case where the Administrator Attached hereto and constituting a part of this petition are the following: shall hold a hearing on the issuance, (A) The proposed rule in the form proposed amendment, or repeal of rules pursuant by the petitioner. (If the petitioner seeks the to section 201 of the Act, the proce- amendment or repeal of an existing rule, the dures for such hearing and accom- existing rule, together with a reference to panying proceedings shall be governed the section in the Code of Federal Regula- generally by the rulemaking proce- tions where it appears, should be included.) dures set forth in the Administrative (B) A statement of the grounds which the Procedure Act (5 U.S.C. 551–559) and petitioner relies for the issuance (amendment or repeal) of the rule. (Such grounds specifically by section 201 of the Act (21 shall include a reasonably concise statement U.S.C. 811), by §§ 1308.42–1308.51, and by of the facts relied upon by the petitioner, in- §§ 1316.41–1316.67 of this chapter. cluding a summary of any relevant medical or scientific evidence known to the peti- § 1308.42 Purpose of hearing. tioner.) If requested by any interested person All notices to be sent regarding this peti- after proceedings are initiated pursu- tion should be addressed to: ant to § 1308.43, the Administrator shall llllllllllllllllllllllll hold a hearing for the purpose of re- (Name) ceiving factual evidence and expert opinion regarding the issues involved llllllllllllllllllllllll in the issuance, amendment or repeal (Street Address) of a rule issuable pursuant to section 201(a) of the Act (21 U.S.C. 811(a)). Ex- llllllllllllllllllllllll tensive argument should not be offered (City and State) into evidence but rather presented in opening or closing statements of coun- Respectfully yours, sel or in memoranda or proposed find- llllllllllllllllllllllll ings of fact and conclusions of law. Ad- ditional information relating to hear- (Signature of petitioner) ings to include waivers or modification of rules, request for hearing, burden of (c) Within a reasonable period of proof, time and place, and final order time after the receipt of a petition, the are set forth in part 1316 of this chap- Administrator shall notify the peti- ter. tioner of his acceptance or nonaccept- ance of the petition, and if not accept- [62 FR 13968, Mar. 24, 1997] ed, the reason therefor. The Adminis- trator need not accept a petition for § 1308.43 Initiation of proceedings for rulemaking. filing if any of the requirements prescribed in paragraph (b) of this section (a) Any interested person may sub- is lacking or is not set forth so as to be mit a petition to initiate proceedings readily understood. If the petitioner for the issuance, amendment, or repeal desires, he may amend the petition to of any rule or regulation issuable pur- meet the requirements of paragraph (b) suant to the provisions of section 201 of of this section. If accepted for filing, a the Act. petition may be denied by the Adminis- (b) Petitions shall be submitted in trator within a reasonable period of quintuplicate to the Administrator in time thereafter if he finds the grounds the following form: upon which the petitioner relies are llllllllllllllllllllllll not sufficient to justify the initiation (Date) of proceedings.

94 Drug Enforcement Administration, Justice § 1308.44

(d) The Administrator shall, before (g) The Administrator may permit initiating proceedings for the issuance, any interested persons to file written amendment, or repeal of any rule ei- comments on or objections to the pro- ther to control a drug or other sub- posal and shall designate in the notice stance, or to transfer a drug or other of proposed rule making the time dur- substance from one schedule to an- ing which such filings may be made. other, or to remove a drug or other [38 FR 8254, Mar. 30, 1973. Redesignated at 38 substance entirely from the schedules, FR 26609, Sept. 24, 1973, and further redesig- and after gathering the necessary data, nated and amended at 62 FR 13968, Mar. 24, request from the Secretary a scientific 1997] and medical evaluation and the Sec- retary’s recommendations as to wheth- § 1308.44 Request for hearing or appearance; waiver. er such drug or other substance should be so controlled, transferred, or re- (a) Any interested person desiring a moved as a controlled substance. The hearing on a proposed rulemaking, recommendations of the Secretary to shall, within 30 days after the date of the Administrator shall be binding on publication of notice of the proposed the Administrator as to such scientific rulemaking in the FEDERAL REGISTER, and medical matters, and if the Sec- file with the Administrator a written retary recommends that a drug or request for a hearing in the form pre- other substance not be controlled, the scribed in § 1316.47 of this chapter. Administrator shall not control that (b) Any interested person desiring to drug or other substance. participate in a hearing pursuant to § 1308.41 shall, within 30 days after the (e) If the Administrator determines date of publication of the notice of that the scientific and medical evalua- hearing in the FEDERAL REGISTER, file tion and recommendations of the Sec- with the Administrator a written no- retary and all other relevant data con- tice of his intention to participate in stitute substantial evidence of poten- such hearing in the form prescribed in tial for abuse such as to warrant con- § 1316.48 of this chapter. Any person fil- trol or additional control over the drug ing a request for a hearing need not or other substance, or substantial evi- also file a notice of appearance; the re- dence that the drug or other sub- quest for a hearing shall be deemed to stances should be subjected to lesser be a notice of appearance. control or removed entirely from the (c) Any interested person may, with- schedules, he shall initiate proceedings in the period permitted for filing a re- for control, transfer, or removal as the quest for a hearing, file with the Ad- case may be. ministrator a waiver of an opportunity (f) If and when the Administrator de- for a hearing or to participate in a termines to initiate proceedings, he hearing, together with a written state- shall publish in the FEDERAL REGISTER ment regarding his position on the general notice of any proposed rule matters of fact and law involved in making to issue, amend, or repeal any such hearing. Such statement, if ad- rule pursuant to section 201 of the Act. missible, shall be made a part of the Such published notice shall include a record and shall be considered in light statement of the time, place, and na- of the lack of opportunity for cross-ex- ture of any hearings on the proposal in amination in determining the weight the event a hearing is requested pursu- to be attached to matters of fact as- ant to § 1308.44. Such hearings may not serted therein. be commenced until after the expira- (d) If any interested person fails to tion of at least 30 days from the date file a request for a hearing; or if he so the general notice is published in the files and fails to appear at the hearing, FEDERAL REGISTER. Such published no- he shall be deemed to have waived his tice shall also include a reference to opportunity for the hearing or to par- the legal authority under which the ticipate in the hearing, unless he shows rule is proposed, a statement of the good cause for such failure. proposed rule, and, in the discretion of (e) If all interested persons waive or the Administrator, a summary of the are deemed to waive their opportunity subjects and issues involved. for the hearing or to participate in the

95 § 1308.45 21 CFR Ch. II (4–1–99 Edition) hearing, the Administrator may cancel specify in the order his findings as to the hearing, if scheduled, and issue his such conditions. final order pursuant to § 1308.45 without [38 FR 8254, Mar. 30, 1973. Redesignated at 38 a hearing. FR 26609, Sept. 24, 1973, and further redesig- [38 FR 8254, Mar. 30, 1973. Redesignated at 38 nated at 62 FR 13968, Mar. 24, 1997] FR 26609, Sept. 24, 1973, and further redesignated and amended at 62 FR 13968, Mar. 24, § 1308.47 Control of immediate precur- 1997] sors. Pursuant to section 201(e) of the Act § 1308.45 Final order. (21 U.S.C. 811(e)), the Administrator As soon as practicable after the pre- may, without regard to the findings residing officer has certified the record quired by subsection 201(a) or 202 (b) of to the Administrator, the Adminis- the Act (21 U.S.C. 811(a) or 812(b)) and trator shall cause to be published in without regard to the procedures pre- the FEDERAL REGISTER his order in the scribed by § 1308.41 or subsections 201 proceeding, which shall set forth the (a) and (b) of the Act (21 U.S.C. 811(a) final rule and the findings of fact and and (b)), issue and publish in the FED- conclusions of law upon which the rule ERAL REGISTER an order controlling an is based. This order shall specify the immediate precursor. The order shall date on which it shall take effect, designate the schedule in which the im- which shall not be less than 30 days mediate precursor is to be placed, from the date of publication in the which shall be the same schedule in FEDERAL REGISTER unless the Adminis- which the controlled substance of trator finds that conditions of public which it is an immediate precursor is health or safety necessitate an earlier placed or any other schedule with a effective date, in which event the Ad- higher numerical designation. An order ministrator shall specify in the order controlling an immediate precursor his findings as to such conditions. shall become effective 30 days from the date of publication in the FEDERAL [38 FR 8254, Mar. 30, 1973. Redesignated at 38 REGISTER, unless the Administrator FR 26609, Sept. 24, 1973, and further redesignated at 62 FR 13968, Mar. 24, 1997] finds that conditions of public health or safety necessitate an earlier effec- § 1308.46 Control required under inter- tive date, in which event the Adminis- national treaty. trator shall specify in the order his findings as to such conditions. Pursuant to section 201(d) of the Act (21 U.S.C. 811(d) ), where control of a [38 FR 8254, Mar. 30, 1973. Redesignated at 38 substance is required by U.S. obliga- FR 26609, Sept. 24, 1973, and further redesig- tions under international treaties, con- nated at 62 FR 13968, Mar. 24, 1997] ventions, or protocols in effect on May 1, 1971, the Administrator shall issue § 1308.49 Emergency scheduling. and publish in the FEDERAL REGISTER Pursuant to 21 U.S.C. 811(h) and with- an order controlling such substance out regard to the requirements of 21 under the schedule he deems most ap- U.S.C. 811(b) relating to the scientific propriate to carry out obligations. and medical evaluation of the Sec- Issuance of such an order shall be with- retary of Health and Human Services, out regard to the findings required by the Administrator may place a sub- subsections 201(a) or 202(b) of the Act stance into Schedule I on a temporary (21 U.S.C. 811(a) or 812(b)) and without basis, if he determines that such action regard to the procedures prescribed by is necessary to avoid an imminent haz- § 1308.41 or subsections 201 (a) and (b) of ard to the public safety. An order the Act (21 U.S.C. 811 (a) and (b)). An issued under this section may not be order controlling a substance shall be- effective before the expiration of 30 come effective 30 days from the date of days from: publication in the FEDERAL REGISTER, (a) The date of publication by the Ad- unless the Administrator finds that ministrator of a notice in the FEDERAL conditions of public health or safety REGISTER of his intention to issue such necessitate an earlier effective date, in order and the grounds upon which such which event the Administrator shall order is to be issued, and

96 Drug Enforcement Administration, Justice § 1309.02

(b) The date the Administrator has 1309.35 Additional information. transmitted notification to the Sec- 1309.36 Amendments to and withdrawals of retary of Health and Human Services applications. of his intention to issue such order. An ACTION ON APPLICATIONS FOR REGISTRATION: order issued under this section shall be REVOCATION OR SUSPENSION OF REGISTRATION vacated upon the conclusion of a subsequent rulemaking proceeding initiated 1309.41 Administrative review generally. 1309.42 Certificate of registration; denial of under section 201(a) (21 U.S.C. 811(a)) registration. with respect to such substance or at 1309.43 Suspension or revocation of registra- the end of one year from the effective tion. date of the order scheduling the sub- 1309.44 Suspension of registration pending stance, except that during the pend- final order. ency of proceedings under section 1309.45 Extension of registration pending 201(a) (21 U.S.C. 811(a)) with respect to final order. the substance, the Administrator may 1309.46 Order to show cause. extend the temporary scheduling for up HEARINGS to six months. 1309.51 Hearings generally. [51 FR 15318, Apr. 23, 1986. Redesignated and 1309.52 Purpose of hearing. amended at 62 FR 13968, Mar. 24, 1997] 1309.53 Request for hearing or appearance; waiver. PART 1309—REGISTRATION OF 1309.54 Burden of proof. MANUFACTURERS, DISTRIBUTORS, 1309.55 Time and place of hearing. IMPORTERS AND EXPORTERS OF MODIFICATION, TRANSFER AND TERMINATION LIST I CHEMICALS OF REGISTRATION 1309.61 Modification in registration. GENERAL INFORMATION 1309.62 Termination of registration. Sec. 1309.63 Transfer of registration. 1309.01 Scope of part 1309. 1309.02 Definitions. SECURITY REQUIREMENTS 1309.03 Information; special instructions. 1309.71 General security requirements. FEES FOR REGISTRATION AND REREGISTRATION 1309.72 Felony conviction; employer responsibilities. 1309.11 Fee amounts. 1309.73 Employee responsibility to report di- 1309.12 Time and method of payment; re- version. fund. AUTHORITY: 21 U.S.C. 821, 822, 823, 824, 830, REQUIREMENTS FOR REGISTRATION 871(b), 875, 877, 958.

1309.21 Persons required to register. SOURCE: 60 FR 32454, June 22, 1995, unless 1309.22 Separate registration for inde- otherwise noted. pendent activities. 1309.23 Separate registration for separate GENERAL INFORMATION locations. 1309.24 Exemption of agents and employees. § 1309.01 Scope of part 1309. 1309.25 Exemption of certain controlled substance registrants. Procedures governing the registra- 1309.26 Exemption of law enforcement offi- tion of manufacturers, distributors, cials. importers and exporters of List I 1309.27 Exemption of certain manufacturers. chemicals pursuant to Sections 102, 302, 1309.28 Exemption of distributors of regu- 303, 1007 and 1008 of the Act (21 U.S.C. lated prescription drug products. 802, 822, 823, 957 and 958) are set forth 1309.29 Exemption of retail distributors of generally by those sections and specifi- regulated drug products. cally by the sections of this part. APPLICATION FOR REGISTRATION § 1309.02 Definitions. 1309.31 Time for application for registration; expiration date. Any term used in this part shall have 1309.32 Application forms; contents, signa- the definition set forth in section 102 of ture. the Act (21 U.S.C. 802) or part 1300 of 1309.33 Filing of application; joint filings. this chapter. 1309.34 Acceptance for filing; defective applications. [62 FR 13968, Mar. 24, 1997]

97 § 1309.03 21 CFR Ch. II (4–1–99 Edition)

§ 1309.03 Information; special instruc- able to ‘‘Drug Enforcement Adminis- tions. tration.’’ Payments made in the form Information regarding procedures of stamps, foreign currency, or third under these rules and instructions party endorsed checks will not be ac- supplementing these rules will be fur- cepted. These application fees are not nished upon request by writing to the refundable. Drug Enforcement Administration, [60 FR 32454, June 22, 1995; 60 FR 35264, July Chemical Operations Section, Office of 6, 1995] Diversion Control, Washington, D.C. 20537. REQUIREMENTS FOR REGISTRATION

FEES FOR REGISTRATION AND § 1309.21 Persons required to register. REREGISTRATION (a) Every person who distributes, imports, or exports any List I chemical, § 1309.11 Fee amounts. other than those List I chemicals con- (a) For each initial registration to tained in a product exempted under manufacture for distribution, dis- § 1310.01(b)(28)(i)(D) of this chapter, or tribute, import, or export, the appli- who proposes to engage in the distribu- cant shall pay a fee of $595 for a annual tion, importation, or exportation of registration. any List I chemical, shall obtain annu- (b) For each reregistration to manually a registration specific to the List facture for distribution, distribute, im- I chemicals to be handled, unless export, or export, the registrant shall pay empted by law or pursuant to §§ 1309.24 a fee of $477 for an annual registration. through 1309.28 of this part. Only per- (c) For each initial registration to sons actually engaged in such activi- conduct business as a retail distributor ties are required to obtain a registra- the applicant shall pay an application tion; related or affiliated persons who processing fee of $7 and an investiga- are not engaged in such activities are tion fee of $248, for an annual registra- not required to be registered. (For ex- tion. ample, a stockholder or parent cor- (d) For each reregistration to con- poration of a corporation distributing duct business as a retail distributor the List I chemicals is not required to ob- registrant shall pay a fee of $116. tain a registration.) (b) Every person who distributes or § 1309.12 Time and method of pay- exports a List I chemical they have ment; refund. manufactured, other than a List I (a) For each application for registra- chemical contained in a product ex- tion or reregistration to manufacture empted under § 1310.01(b)(28)(i)(D) of for distribution, distribute, import, or this chapter, or proposes to distribute export, the applicant shall pay the fee or export a List I chemical they have when the application for registration manufactured, shall obtain annually a or reregistration is submitted for fil- registration specific to the List I ing. chemicals to be handled, unless ex- (b) For retail the distributor initial empted by law or pursuant to §§ 1309.24 applications, the applicant shall pay through 1309.28 of this part. the application processing fee when the [61 FR 32926, June 26, 1996, as amended at 62 application for registration is sub- FR 13968, Mar. 24, 1997] mitted for filing. The investigation fee shall be paid within 30 days after DEA § 1309.22 Separate registration for notifies the applicant that the independent activities. preregistration investigation has been (a) The following groups of activities scheduled. are deemed to be independent of each (c) For retail distributor reregistra- other: tion applications, the registrant shall (1) Retail distributing of List I pay the fee when the application for re- chemicals; registration is submitted for filing. (2) Non-Retail distributing of List I (d) Payments should be made in the chemicals; form of a personal, certified, or cash- (3) Importing List I chemicals; and ier’s check or money order made pay- (4) Exporting List I chemicals.

98 Drug Enforcement Administration, Justice § 1309.26

(b) Every person who engages in more manufacture, distribute or dispense a than one group of independent activi- controlled substance. ties shall obtain a separate registra- (b) The requirement of registration is tion for each group of activities, unless waived for any person who imports or otherwise exempted by the Act or exports a product containing a List I §§ 1309.24 through 1309.28 of this part, chemical that is regulated pursuant to except that a person registered to im- § 1310.01(b)(28)(i)(D), if that person is port any List I chemical shall be au- registered with the Administration to thorized to distribute that List I chem- engage in the same activity with a con- ical after importation, but no other trolled substance. chemical that the person is not reg- (c) The Administrator may, upon istered to import. finding that continuation of the waiver would not be in the public interest, [60 FR 32454, June 22, 1995, as amended at 61 FR 32926, June 26, 1996] suspend or revoke a person’s waiver pursuant to the procedures set forth in § 1309.23 Separate registration for sep- §§ 1309.43 through 1309.46 and 1309.51 arate locations. through 1309.57. In considering the rev- (a) A separate registration is re- ocation or suspension of a person’s quired for each principal place of busi- waiver, the Administrator shall also ness at one general physical location consider whether action to revoke or where List I chemicals are distributed, suspend the person’s controlled sub- imported, or exported by a person. stance registration pursuant to 21 (b) The following locations shall be U.S.C. 824 is warranted. deemed to be places not subject to the (d) Any person exempted from the registration requirement: registration requirement under this (1) A warehouse where List I chemi- section shall comply with the security cals are stored by or on behalf of a reg- requirements set forth in Sections istered person, unless such chemicals 1309.71–1309.73 and the recordkeeping are distributed directly from such and reporting requirements set forth warehouse to locations other than the under Parts 1310 and 1313 of this chap- registered location from which the ter. chemicals were originally delivered; [60 FR 32454, June 22, 1995, as amended at 62 and FR 13968, Mar. 24, 1997] (2) An office used by agents of a registrant where sales of List I chemicals § 1309.26 Exemption of law enforce- are solicited, made, or supervised but ment officials. which neither contains such chemicals (a) The requirement of registration is (other than chemicals for display pur- waived for the following persons in the poses) nor serves as a distribution circumstances described in this sec- point for filling sales orders. tion: (1) Any officer or employee of the Ad- § 1309.24 Exemption of agents and em- ministration, any officer of the U.S. ployees. Customs Service, any officer or em- The requirement of registration is ployee of the United States Food and waived for any agent or employee of a Drug Administration, any other Fed- person who is registered to engage in eral officer who is lawfully engaged in any group of independent activities, if the enforcement of any Federal law re- such agent or employee is acting in the lating to listed chemicals, controlled usual course of his or her business or substances, drugs or customs, and is employment. duly authorized to possess and distribute List I chemicals in the course § 1309.25 Exemption of certain con- of official duties; and trolled substance registrants. (2) Any officer or employee of any (a) The requirement of registration is State, or any political subdivision or waived for any person who distributes agency thereof, who is engaged in the a product containing a List I chemical enforcement of any State or local law that is regulated pursuant to relating to listed chemicals and con- § 1310.01(b)(28)(i)(D), if that person is trolled substances and is duly author- registered with the Administration to ized to possess and distribute List I

99 § 1309.27 21 CFR Ch. II (4–1–99 Edition) chemicals in the course of his official an individual for legitimate medical duties. use. (b) Any official exempted by this sec- [62 FR 53960, Oct. 17, 1997] tion may, when acting in the course of official duties, possess any List I chem- APPLICATION FOR REGISTRATION ical and distribute any such chemical to any other official who is also ex- § 1309.31 Time for application for reg- empted by this section and acting in istration; expiration date. the course of official duties. (a) Any person who is required to be registered and who is not so registered § 1309.27 Exemption of certain manufacturers. may apply for registration at any time. No person required to be registered The requirement of registration is shall engage in any activity for which waived for any manufacturer of a List registration is required until the appli- I chemical, if that chemical is pro- cation for registration is approved and duced solely for internal consumption a Certificate of Registration is issued by the manufacturer and there is no by the Administrator to such person. subsequent distribution or exportation (b) Any person who is registered may of the List I chemical. apply to be reregistered not more than § 1309.28 Exemption of distributors of 60 days before the expiration date of regulated prescription drug prod- his registration. ucts. (c) At the time a person is first reg- (a) The requirement of registration is istered, that person shall be assigned waived for any person who distributes to one of twelve groups, which shall a prescription drug product containing correspond to the months of the year. a List I chemical that is regulated pur- The expiration date of the registra- suant to § 1310.01(f)(1)(iv) of this chap- tions of all registrants within any ter. group will be the last day of the month (b) If any person exempted by this designated for that group. In assigning section also engages in the distribu- any of the above persons to a group, tion, importation or exportation of a the Administration may select a group List I chemical, other than as de- the expiration date of which is less scribed in paragraph (a) of this section, than one year from the date such busi- the person shall obtain a registration ness activity was registered. If the per- for such activities, as required by son is assigned to a group which has an § 1309.21 of this part. expiration date less than eleven (c) The Administrator may, upon months from the date of which the per- finding that continuation of the waiver son is registered, the registration shall granted in paragraph (a) of this section not expire until one year from that ex- would not be in the public interest, piration date; in all other cases, the suspend or revoke a person’s waiver registration shall expire on the expira- pursuant to the procedures set forth in tion date following the date on which §§ 1309.43 through 1309.46 and 1309.51 the person is registered. through 1309.57 of this part. § 1309.32 Application forms; contents; [61 FR 32926, June 26, 1996] signature. § 1309.29 Exemption of retail distribu- (a) Any person who is required to be tors of regulated drug products. registered pursuant to § 1309.21 and is The requirement of registration is not so registered, shall apply on DEA waived for any retail distributor whose Form 510. activities with respect to List I chemi- (b) Any person who is registered pur- cals are restricted to the distribution suant to Section 1309.21, shall apply for of below-threshold quantities of a drug reregistration on DEA Form 510a. product that contains a List I chemical (c) DEA Form 510 may be obtained at that is regulated pursuant to any divisional office of the Administra- § 1300.02(b)(28)(1)(D) of this chapter to tion or by writing to the Registration

100 Drug Enforcement Administration, Justice § 1309.36

Unit, Drug Enforcement Administra- ton, Virginia 22202–2427. The appro- tion, Department of Justice, Post Of- priate registration fee and any required fice Box 28083, Central Station, Wash- attachments must accompany the ap- ington, DC 20005. DEA Form 510a will plication. be mailed to each List I chemical reg- (b) Any person required to obtain istrant approximately 60 days before more than one registration may submit the expiration date of his or her reg- all applications in one package. Each istration; if any registered person does application must be complete and must not receive such forms within 45 days not refer to any accompanying applica- before the expiration date of the reg- tion for required information. istration, notice must be promptly given of such fact and DEA Form 510a § 1309.34 Acceptance for filing; defec- must be requested by writing to the tive applications. Registration Unit of the Administra- (a) Applications submitted for filing tion at the foregoing address. are dated upon receipt. If found to be (d) Each application for registration complete, the application will be ac- shall include the Administration cepted for filing. Applications failing Chemical Code Number, as set forth in to comply with the requirements of § 1310.02 of this chapter, for each List I this part will not generally be accepted chemical to be distributed, imported, for filing. In the case of minor defects or exported. as to completeness, the Administrator (e) Registration shall not entitle a may accept the application for filing person to engage in any activity with with a request to the applicant for ad- any List I chemical not specified in his ditional information. A defective appli- or her application. cation will be returned to the applicant (f) Each application shall include all within 10 days of receipt with a state- information called for in the form, un- ment of the reason for not accepting less the item is not applicable, in the application for filing. A defective which case this fact shall be indicated. application may be corrected and re- (g) Each application, attachment, or submitted for filing at any time. other document filed as part of an ap- (b) Accepting an application for fil- plication, shall be signed by the appli- ing does not preclude any subsequent cant, if an individual; by a partner of request for additional information pur- the applicant, if a partnership; or by an suant to § 1309.35 and has no bearing on officer of the applicant, if a corpora- whether the application will be grant- tion, corporate division, association, ed. trust or other entity. An applicant may authorize one or more individuals, who § 1309.35 Additional information. would not otherwise be authorized to do so, to sign applications for the ap- The Administrator may require an plicant by filing with the application applicant to submit such documents or or other document a power of attorney written statements of fact relevant to for each such individual. The power of the application as he deems necessary attorney shall be signed by a person to determine whether the application who is authorized to sign applications should be granted. The failure of the under this paragraph and shall contain applicant to provide such documents or the signature of the individual being statements within a reasonable time authorized to sign the application or after being requested to do so shall be other document. The power of attorney deemed to be a waiver by the applicant shall be valid until revoked by the ap- of an opportunity to present such docu- plicant. ments or facts for consideration by the Administrator in granting or denying § 1309.33 Filing of application; joint fil- the application. ings. (a) All applications for registration § 1309.36 Amendments to and with- shall be submitted for filing to the drawals of applications. Registration Unit, Drug Enforcement (a) An application may be amended Administration, Chemical Registra- or withdrawn without permission of tion/ODC, Post Office Box 2427, Arling- the Administration at any time before

101 § 1309.41 21 CFR Ch. II (4–1–99 Edition) the date on which the applicant re- ber of the registrant, the activity au- ceives an order to show cause pursuant thorized by the registration, the to § 1309.46. An application may be amount of fee paid, and the expiration amended or withdrawn with permission date of the registration. The registrant of the Administrator at any time shall maintain the certificate of reg- where good cause is shown by the ap- istration at the registered location in a plicant or where the amendment or readily retrievable manner and shall withdrawal is in the public interest. permit inspection of the certificate by (b) After an application has been ac- any official, agent or employee of the cepted for filing, the request by the ap- Administration or of any Federal, plicant that it be returned or the fail- State, or local agency engaged in en- ure of the applicant to respond to offi- forcement of laws relating to List I cial correspondence regarding the ap- chemicals or controlled substances. plication, including a request that the applicant submit the required fee, § 1309.43 Suspension or revocation of when sent by registered or certified registration. mail, return receipt requested, shall be (a) The Administrator may suspend deemed to be a withdrawal of the appli- any registration pursuant to section cation. 304(a) of the Act (21 U.S.C. 824(a)) for any period of time he determines. ACTION ON APPLICATIONS FOR REGISTRA- (b) The Administrator may revoke TION: REVOCATION OR SUSPENSION OF any registration pursuant to section REGISTRATION 304(a) of the Act (21 U.S.C. 824(a)). § 1309.41 Administrative review gen- (c) Before revoking or suspending any erally. registration, the Administrator shall The Administrator may inspect, or issue an order to show cause pursuant cause to be inspected, the establish- to Section 1309.46 and, if requested by ment of an applicant or registrant, pur- the registrant, shall hold a hearing suant to subpart A of part 1316 of this pursuant to Section 1309.51. Notwith- chapter. The Administrator shall re- standing the requirements of this Sec- view the application for registration tion, however, the Administrator may and other information gathered by the suspend any registration pending a Administrator regarding an applicant final order pursuant to § 1309.44. in order to determine whether the ap- (d) Upon service of the order of the plicable standards of Section 303 of the Administrator suspending or revoking Act (21 U.S.C. 823) have been met by registration, the registrant shall im- the applicant. mediately deliver his or her Certificate of Registration to the nearest office of § 1309.42 Certificate of registration; the Administration. Also, upon service denial of registration. of the order of the Administrator re- (a) The Administrator shall issue a voking or suspending registration, the Certificate of Registration (DEA Form registrant shall, as instructed by the 511) to an applicant if the issuance of Administrator: registration or reregistration is re- (1) Deliver all List I chemicals in his quired under the applicable provisions or her possession that were obtained of section 303 of the Act (21 U.S.C. 823). under the authority of a registration or In the event that the issuance of reg- an exemption from registration grant- istration or reregistration is not re- ed by the Administrator by regulation, quired, the Administrator shall deny to the nearest office of the Administra- the application. Before denying any ap- tion or to authorized agents of the Ad- plication, the Administrator shall issue ministration; or an order to show cause pursuant to (2) Place all such List I chemicals in Section 1309.46 and, if requested by the his or her possession under seal as de- applicant, shall hold a hearing on the scribed in section 304(f) of the Act (21 application pursuant to § 1309.51. U.S.C. 824(f)). (b) The Certificate of Registration (e) In the event that revocation or (DEA Form 511) shall contain the suspension is limited to a particular name, address, and registration num- chemical or chemicals, the registrant

102 Drug Enforcement Administration, Justice § 1309.45 shall be given a new Certificate of Reg- under the authority of a registration or istration for all substances not affected an exemption from registration grant- by such revocation or suspension; no ed by the Administrator by regulation, fee shall be required for the new Cer- which are affected by the revocation or tificate of Registration. The registrant suspension; or shall deliver the old Certificate of Reg- (2) Place all of such chemicals under istration to the nearest office of the seal as described in section 304(f) of the Administration. Also, upon service of Act (21 U.S.C. 824(f)). the order of the Administrator revok- (c) Any suspension shall continue in ing or suspending registration with respect to a particular chemical or effect until the conclusion of all pro- chemicals, the registrant shall, as in- ceedings upon the revocation or sus- structed by the Administrator: pension, including any judicial review (1) Deliver to the nearest office of the thereof, unless sooner withdrawn by Administration or to authorized agents the Administrator or dissolved by a of the Administration all of the par- court of competent jurisdiction. Any ticular chemical or chemicals in his or registrant whose registration is sus- her possession that were obtained pended under this section may request under the authority of a registration or a hearing on the revocation or suspen- an exemption from registration grant- sion of his registration at a time ear- ed by the Administrator by regulation, lier than specified in the order to show which are affected by the revocation or cause pursuant to Section 1309.46, suspension; or which request shall be granted by the (2) Place all of such chemicals under Administrator, who shall fix a date for seal as described in section 304(f) of the such hearing as early as reasonably Act (21 U.S.C. 824(f)). possible. [60 FR 32454, June 22, 1995, as amended at 62 [60 FR 32454, June 22, 1995, as amended at 62 FR 5916, Feb. 10, 1997] FR 5916, Feb. 10, 1997] § 1309.44 Suspension of registration pending final order. § 1309.45 Extension of registration pending final order. (a) The Administrator may suspend any registration simultaneously with In the event that an applicant for re- or at any time subsequent to the serv- registration (who is doing business ice upon the registrant of an order to under a registration previously granted show cause why such registration and not revoked or suspended) has ap- should not be revoked or suspended, in plied for reregistration at least 45 days any case where he finds that there is before the date on which the existing an imminent danger to the public registration is due to expire, and the health or safety. If the Administrator Administrator has issued no order on so suspends, he shall serve with the the application on the date on which order to show cause pursuant to the existing registration is due to ex- § 1309.46 an order of immediate suspen- pire, the existing registration of the sion that shall contain a statement of applicant shall automatically be ex- his findings regarding the danger to tended and continue in effect until the public health or safety. date on which the Administrator so (b) Upon service of the order of im- issues his order. The Administrator mediate suspension, the registrant may extend any other existing reg- shall promptly return his Certificate of istration under the circumstances con- Registration to the nearest office of the Administration. Also, upon service templated in this section even though of the order of immediate suspension, the registrant failed to apply for rereg- the registrant shall, as instructed by istration at least 45 days before expira- the Administrator: tion of the existing registration, with (1) Deliver to the nearest office of the or without request by the registrant, if Administration or to authorized agents the Administrator finds that such ex- of the Administration all of the par- tension is not inconsistent with the ticular chemical or chemicals in his or public health and safety. her possession that were obtained

103 § 1309.46 21 CFR Ch. II (4–1–99 Edition)

§ 1309.46 Order to show cause. of the Act (21 U.S.C. 823–824), by (a) If, upon examination of the appli- §§ 1309.52 through 1309.57, and by the cation for registration from any appli- procedures for administrative hearings cant and other information gathered under the Act set forth in §§ 1316.41 by the Administration regarding the through 1316.67 of this chapter. applicant, the Administrator is unable (b) Any hearing under this part shall to make the determinations required be independent of, and not in lieu of, by the applicable provisions of section criminal prosecutions or other pro- 303 of the Act (21 U.S.C. 823) to register ceedings under the Act or any other the applicant, the Administrator shall law of the United States. serve upon the applicant an order to show cause why the application for reg- § 1309.52 Purpose of hearing. istration should not be denied. If requested by a person entitled to a (b) If, upon information gathered by hearing, the Administrator shall hold a the Administration regarding any reg- hearing for the purpose of receiving istrant, the Administrator determines factual evidence regarding the issues that the registration of such registrant involved in the denial, revocation, or is subject to suspension or revocation suspension of any registration. Exten- pursuant to section 304 of the Act (21 sive argument should not be offered U.S.C. 824), the Administrator shall into evidence but rather presented in serve upon the registrant an order to opening or closing statements of coun- show cause why the registration should sel or in memoranda or proposed find- not be revoked or suspended. ings of fact and conclusions of law. (c) The order to show cause shall call upon the applicant or registrant to ap- § 1309.53 Request for hearing or appear before the Administrator at a pearance; waiver. time and place stated in the order, (a) Any person entitled to a hearing which shall not be less than 30 days pursuant to §§ 1309.42 and 1309.43 and de- after the date of receipt of the order. siring a hearing shall, within 30 days The order to show cause shall also con- after the date of receipt of the order to tain a statement of the legal basis for show cause, file with the Adminis- such hearing and for the denial, revoca- trator a written request for a hearing tion, or suspension of registration and in the form prescribed in § 1316.47 of a summary of the matters of fact and this chapter. law asserted. (d) Upon Receipt of an order to show (b) Any person entitled to a hearing cause, the applicant or registrant pursuant to §§ 1309.42 and 1309.43 may, must, if he desires a hearing, file a re- within the period permitted for filing a quest for a hearing pursuant to request for a hearing, file with the Ad- § 1309.54. If a hearing is requested, the ministrator a waiver of an opportunity Administrator shall hold a hearing at for a hearing, together with a written the time and place stated in the order, statement regarding his position on pursuant to § 1309.51. the matters of fact and law involved in (e) When authorized by the Adminis- such hearing. Such statement, if ad- trator, any agent of the Administra- missible, shall be made a part of the tion may serve the order to show record and shall be considered in light cause. of the lack of opportunity for cross-examination in determining the weight HEARINGS to be attached to matters of fact asserted therein. § 1309.51 Hearings generally. (c) If any person entitled to a hearing (a) In any case where the Adminis- pursuant to §§ 1309.42 and 1309.43 fails to trator shall hold a hearing on any reg- file a request for a hearing, or if he so istration or application therefore, the files and fails to appear at the hearing, procedures for such hearing shall be he shall be deemed to have waived his governed generally by the adjudication opportunity for the hearing, unless he procedures set forth in the Administra- shows good cause for such failure. tive Procedure Act (5 U.S.C. 551–559) (d) If any person entitled to a hearing and specifically by sections 303 and 304 waives or is deemed to waive his or her

104 Drug Enforcement Administration, Justice § 1309.71 opportunity for the hearing, the Ad- § 1309.32(g). No fee shall be required to ministrator may cancel the hearing, if be paid for the modification. The re- scheduled, and issue his final order pur- quest for modification shall be handled suant to § 1309.57 without a hearing. in the same manner as an application for registration. If the modification in [60 FR 32454, June 22, 1995. Redesignated at 62 FR 13968, Mar. 24, 1997] registration is approved, the Adminis- trator shall issue a new certificate of § 1309.54 Burden of proof. registration (DEA Form 511) to the registrant, who shall maintain it with the (a) At any hearing for the denial of a old certificate of registration until ex- registration, the Administration shall piration. have the burden of proving that the requirements for such registration pursu- § 1309.62 Termination of registration. ant to section 303 of the Act (21 U.S.C. 823) are not satisfied. (a) The registration of any person (b) At any hearing for the revocation shall terminate if and when such per- or suspension of a registration, the Ad- son dies, ceases legal existence, or dis- ministration shall have the burden of continues business or professional proving that the requirements for such practice. Any registrant who cases revocation or suspension pursuant to legal existence or discontinues busi- section 304(a) of the Act (21 U.S.C. ness or professional practice shall 824(a)) are satisfied. promptly notify the Special Agent in Charge of the Administration in the [60 FR 32454, June 22, 1995. Redesignated at 62 area in which the person is located of FR 13968, Mar. 24, 1997] such fact and seek authority and instructions to dispose of any List I § 1309.55 Time and place of hearing. chemicals obtained under the author- The hearing will commence at the ity of that registration. place and time designated in the order (b) The Special Agent in Charge shall to show cause or notice of hearing pub- authorize and instruct the person to lished in the FEDERAL REGISTER (unless dispose of the List I chemical in one of expedited pursuant to Section the following manners: 1309.44(c)) but thereafter it may be (1) By transfer to person registered moved to a different place and may be under the Act and authorized to pos- continued from day to day or recessed sess the substances; to a later day without notice other (2) By delivery to an agent of the Ad- than announcement thereof by the pre- ministration or to the nearest office of siding officer at the hearing. the Administration; [60 FR 32454, June 22, 1995. Redesignated at 62 (3) By such other means as the Spe- FR 13968, Mar. 24, 1997] cial Agent in Charge may determine to assure that the substance does not be- MODIFICATION, TRANSFER AND come available to unauthorized per- TERMINATION OF REGISTRATION sons.

§ 1309.61 Modification in registration. [60 FR 32454, June 22, 1995, as amended at 62 FR 5916, Feb. 10, 1997] Any registrant may apply to modify his or her registration to authorize the § 1309.63 Transfer of registration. handling of additional List I chemicals No registration or any authority con- or to change his or her name or ad- ferred thereby shall be assigned or oth- dress, by submitting a letter of request erwise transferred except upon such to the Drug Enforcement Administra- conditions as the Administrator may tion, Chemical Registration/ODC, Post specifically designate and then only Office Box 2427, Arlington, Virginia pursuant to his written consent. 22202–2427. The letter shall contain the registrant’s name, address, and reg- SECURITY REQUIREMENTS istration number as printed on the certificate of registration, and the List I § 1309.71 General security require- chemicals to be added to his registra- ments. tion or the new name or address and (a) All applicants and registrants shall be signed in accordance with shall provide effective controls and

105 § 1309.72 21 CFR Ch. II (4–1–99 Edition) procedures to guard against theft and and procedures will be used, or to the diversion of List I chemicals. Specific Chemical Operations Section Office of attention shall be paid to storage of Diversion Control, Drug Enforcement and controlling access to List I chemi- Administration, Washington, D.C. cals as follows: 20537. (1) Chemicals shall be stored in containers sealed in such a manner as to [60 FR 32454, June 22, 1995, as amended at 62 indicate any attempts at tampering FR 13968, Mar. 24, 1997] with the container. Where chemicals § 1309.72 Felony conviction; employer cannot be stored in sealed containers, responsibilities. access to the chemicals should be controlled through physical means or (a) The registrant shall exercise cau- through human or electronic moni- tion in the consideration of employ- toring. ment of persons who will have access (2) In retail settings open to the pub- to listed chemicals, who have been con- lic where drugs containing List I victed of a felony offense relating to chemicals that are regulated pursuant controlled substances or listed chemi- to § 1310.01(b)(28)(i)(D) are distributed, cals, or who have, at any time, had an such drugs will be stocked behind a application for registration with the counter where only employees have ac- DEA denied, had a DEA registration re- cess. voked, or surrendered a DEA registra- (b) In evaluating the effectiveness of tion for cause. (For purposes of this security controls and procedures, the subsection, the term ‘‘for cause’’ means Administrator shall consider the fol- a surrender in lieu of, or as a con- lowing factors: sequence of, any Federal or State ad- (1) The type, form, and quantity of ministrative, civil or criminal action List I chemicals handled; resulting from an investigation of the (2) The location of the premises and individual’s handling of controlled sub- the relationship such location bears on stances or listed chemicals.) The reg- the security needs; istrant should be aware of the cir- (3) The type of building construction cumstances regarding the action comprising the facility and the general against the potential employee and the characteristics of the building or build- rehabilitative efforts following the ac- ings; tion. The registrant shall assess the (4) The availability of electronic de- risks involved in employing such per- tection and alarm systems; sons, including the potential for action (5) the extent of unsupervised public against the registrant pursuant to access to the facility; § 1309.43, If such person is found to have (6) The adequacy of supervision over diverted listed chemicals, and, in the employees having access to List I event of employment, shall institute chemicals; procedures to limit the potential for (7) The procedures for handling business guests, visitors, maintenance per- diversion of List I chemicals. sonnel, and nonemployee service per- (b) It is the position of DEA that em- sonnel in areas where List I chemicals ployees who possess, sell, use or divert are processed or stored; listed chemicals or controlled sub- (8) The adequacy of the registrant’s stances will subject themselves not or applicant’s systems for monitoring only to State or Federal prosecution the receipt, distribution, and disposi- for any illicit activity, but shall also tion of List I chemicals in its oper- immediately become the subject of ations. independent action regarding their (c) Any registrant or applicant desir- continued employment. The employer ing to determine whether a proposed will assess the seriousness of the em- system of security controls and proce- ployee’s violation, the position of re- dures is adequate may submit mate- sponsibility held by the employee, past rials and plans regarding the proposed record of employment, etc., in deter- security controls and procedures either mining whether to suspend, transfer, to the Special Agent in Charge in the terminate or take other action against region in which the security controls the employee.

106 Drug Enforcement Administration, Justice § 1310.02

§ 1309.73 Employee responsibility to § 1310.01 Definitions. report diversion. Any term used in this part shall have Reports of listed chemical diversion the definition set forth in section 102 of by fellow employees is not only a nec- the Act (21 U.S.C. 802) or part 1300 of essary part of an overall employee se- this chapter. curity program but also serves the pub- [62 FR 13968, Mar. 24, 1997] lic interest at large. It is, therefore, the position of DEA that an employee § 1310.02 Substances covered. who has knowledge of diversion from The following chemicals have been his employer by a fellow employee has specifically designated by the Adminis- an obligation to report such informa- trator of the Drug Enforcement Admin- tion to a responsible security official of istration as the listed chemicals sub- the employer. The employer shall treat ject to the provisions of this part and such information as confidential and parts 1309 and 1313 of this chapter. Each shall take all reasonable steps to pro- chemical has been assigned the DEA tect the confidentiality of the informa- Chemical Code Number set forth oppo- tion and the identity of the employee site it. furnishing information. A failure to re- (a) List I chemicals port information of chemical diversion will be considered in determining the (1) Anthranilic acid, its esters, and its feasibility of continuing to allow an salts ...... 8530 employee to work in an area with ac- (2) Benzyl cyanide...... 8735 cess to chemicals. The employer shall (3) Ephedrine, its salts, optical isomers, and salts of optical isomers inform all employees concerning this ...... 8113 policy. (4) Ergonovine and its salts ...... 8675 (5) Ergotamine and its salts...... 8676 PART 1310—RECORDS AND RE- (6) N-Acetylanthranilic acid, its esters, and its salts...... 8522 PORTS OF LISTED CHEMICALS (7) Norpseudoephedrine, its salts, opti- AND CERTAIN MACHINES cal isomers, and salts of optical isomers ...... 8317 Sec. (8) Phenylacetic acid, its esters, and 1310.01 Definitions. its salts...... 8791 1310.02 Substances covered. (9) Phenylpropanolamine, its salts, optical isomers, and salts of optical 1310.03 Persons required to keep records and isomers ...... 1225 file reports. (10) Piperidine and its salts ...... 2704 1310.04 Maintenance of records. (11) Pseudoephedrine, its salts, optical 1310.05 Reports. isomers, and salts of optical iso- 1310.06 Content of records and reports. mers...... 8112 1310.07 Proof of identity. (12) 3,4-Methylenedioxyphenyl-2- 1310.08 Excluded transactions. propanone ...... 8502 1310.09 Temporary exemption from registra- (13) Methylamine and its salts...... 8520 tion. (14) Ethylamine and its salts ...... 8678 1310.10 Removal of the exemption of drugs (15) Propionic anhydride...... 8328 distributed under the Food, Drug and (16) Isosafrole...... 8704 Cosmetic Act. (17) Safrole...... 8323 1310.11 Reinstatement of exemption for drug (18) Piperonal...... 8750 products distributed under the Food, (19) N-Methylephedrine, its salts, opti- Drug and Cosmetic Act. cal isomers, and salts of optical 1310.14 Exemption of drug products con- isomers (N-Methylephedrine) ...... 8115 taining ephedrine and therapeutically (20) N-Methylpseudoephedrine, its significant quantities of another active salts, optical isomers, and salts of medicinal ingredient. optical isomers ...... 8119 (21) Hydriodic Acid ...... 6695 1310.15 Exempt drug products containing (22) Benzaldehyde...... 8256 ephedrine and therapeutically significant (23) Nitroethane ...... 6724 quantities of another active medicinal ingredient. (b) List II chemicals: (1) Acetic anhydride...... 8519 AUTHORITY: 21 U.S.C. 802, 830, 871(b). (2) Acetone...... 6532 SOURCE: 54 FR 31665, Aug. 1, 1989, unless (3) Benzyl chloride ...... 8570 otherwise noted. (4) Ethyl ether ...... 6584

107 § 1310.03 21 CFR Ch. II (4–1–99 Edition)

(5) Potassium permanganate ...... 6579 shall permit any interested person to (6) 2-Butanone (or Methyl Ethyl Ke- file written comments regarding the tone or MEK) ...... 6714 proposal within 30 days of the date of (7) Toluene ...... 6594 (8) Hydrochloric acid ...... 6545 publication of his order in the FEDERAL (9) Sulfuric acid ...... 6552 REGISTER. The Administrator will con- (10) Methyl Isobutyl Ketone (MIBK) sider any comments filed by interested ...... 6715 persons and publish a final rule in ac- (c) The Administrator may add or de- cordance with his decision in the mat- lete a substance as a listed chemical by ter. publishing a final rule in the FEDERAL [54 FR 31665, Aug. 1, 1989, as amended at 56 REGISTER following a proposal which FR 48733, Sept. 26, 1991; 57 FR 43615, Sept. 22, shall be published at least 30 days prior 1992; 60 FR 19510, Apr. 19, 1995; 60 FR 32460, to the final rule. June 22, 1995; 62 FR 5917, Feb. 10, 1997] (d) Any person may petition the Ad- ministrator to have any substance § 1310.03 Persons required to keep added or deleted from paragraphs (a) or records and file reports. (b) of this section. (a) Each regulated person who en- (e) Any petition under this section gages in a regulated transaction in- shall contain the following informa- volving a listed chemical, a tableting tion: machine, or an encapsulating machine (1) The name and address of the peti- shall keep a record of the transaction tioner; as specified by § 1310.04 and file reports (2) The name of the chemical to as specified by § 1310.05. However, a which the petition pertains; non-regulated person who acquires list- (3) The name and address of the man- ed chemicals for internal consumption ufacturer(s) of the chemical (if known); or ‘‘end use’’ and becomes a regulated (4) A complete statement of the facts person by virtue of infrequent or rare which the petitioner believes justifies distribution of a listed chemical from the addition or deletion of the sub- inventory, shall not be required to stance from paragraphs (a) or (b) of maintain receipt records of listed this section; chemicals under this section. (5) The date of the petition. (b) Each regulated person who manu- (f) The Administrator may require factures a List I or List II chemical the petitioner to submit such docu- shall file reports regarding such manu- ments or written statements of fact facture as specified in Section 1310.05. relevant to the petition as he deems necessary in making a determination. [54 FR 31665, Aug. 1, 1989, as amended at 56 (g) Within a reasonable period of FR 8277, Feb. 28, 1991; 61 FR 14023, Mar. 29, time after the receipt of the petition, 1996] the Administrator shall notify the pe- § 1310.04 Maintenance of records. titioner of his decision and the reason therefor. The Administrator need not (a) Every record required to be kept accept a petition if any of the require- subject to § 1310.03 for a List I chem- ments prescribed in paragraph (e) of ical, a tableting machine, or an encap- this section or requested pursuant to sulating machine shall be kept by the paragraph (f) of this section are lack- regulated person for 2 years after the ing or are not clearly set forth as to be date of the transaction. readily understood. If the petitioner (b) Every record required to be kept desires, he may amend and resubmit subject to Section 1310.03 for List II the petition to meet the requirements chemical shall be kept by the regulated of paragraphs (e) and (f) of this section. person for two years after the date of (h) If a petition is granted or the Ad- the transaction. ministrator, upon his own motion, pro- (c) A record under this section shall poses to add or delete substances as be kept at the regulated person’s place listed chemicals as set forth in para- of business where the transaction oc- graph (c) of this section, he shall issue curred, except that records may be and publish in the FEDERAL REGISTER a kept at a single, central location of the proposal to add or delete a substance as regulated person if the regulated per- a listed chemical. The Administrator son has notified the Administration of

108 Drug Enforcement Administration, Justice § 1310.04 the intention to do so. Written notifi- devise a system to detect any party cation must be submitted by registered purchasing from several individual lo- or certified mail, return receipt re- cations of the regulated person thereby quested, to the Special Agent in Charge seeking to avoid the application of the of the DEA Divisional Office for the cumulative threshold or evading the area in which the records are required requirements of the Act. to be kept. (f) For those listed chemicals for (d) The records required to be kept which thresholds have been estab- under this section shall be readily re- lished, the quantitative threshold or trievable and available for inspection the cumulative amount for multiple and copying by authorized employees transactions within a calendar month, of the Administration under the provi- to be utilized in determining whether a sions of 21 U.S.C. 880. receipt, sale, importation or expor- (e) The regulated person with more tation is a regulated transaction is as than one place of business where follows: records are required to be kept shall (1) List I Chemicals:

Chemical Threshold by base weight

(i) Anthranilic acid and its salts ...... 30 kilograms. (ii) Benzyl cyanide ...... 1 kilogram. (iii) Ergonovine and its salts ...... 10 grams. (iv) Ergotamine and its salts ...... 20 grams. (v) N-Acetylanthranilic acid and its salts ...... 40 kilograms (vi) Norpseudoephedrine, its salts, optical isomers, and salts of optical isomers ...... 2.5 kilograms. (vii) Phenylacetic acid and its salts ...... 1 kilogram. (viii) Phenylpropanolamine, its salts, optical isomers, and salts of optical isomers ...... 2.5 kilograms. (ix) Piperidine and its salts ...... 500 grams. (x) Pseudoephedrine, its salts, optical isomers, and salts of optical isomers ...... 1 kilogram (xi) 3, 4-Methylenedioxyphenyl-2-propanone ...... 4 kilograms. (xii) Methylamine and its salts ...... 1 kilogram. (xiii) Ethylamine and its salts ...... 1 kilogram. (xiv) Propionic anhydride ...... 1 gram. (xv) Isosafrole ...... 4 kilograms. (xvi) Safrole ...... 4 kilograms. (xvii) Piperonal ...... 4 kilograms. (xviii) N-Methylephedrine, its salts, optical isomers, and salts of optical isomers ...... 1 kilogram. (xix) N-Methylpseudoephedrine, its salts, optical isomers, and salts of optical isomers ...... 1 kilogram. (xx) Hydriotic acid (57%) ...... 1.7 kilograms (or 1 liter by volume). (xxi) Benzaldehyde ...... 4 Kilograms. (xxii) Nitroethane ...... 2.5 Kilograms.

(2) List II Chemicals: (i) Imports and Exports

Chemical Threshold by volume Threshold by weight

(A) Acetic anhydride ...... 250 gallons ...... 1,023 kilograms. (B) Acetone ...... 500 gallons ...... 1,500 kilograms. (C) Benzyl chloride ...... N/A ...... 4 kilograms. (D) Ethyl ether ...... 500 gallons ...... 1,364 kilograms. (E) Potassium permanganate ...... N/A ...... 500 kilograms. (F) 2-Butanone (MEK) ...... 500 gallons ...... 1,455 kilograms. (G) Toluene ...... 500 gallons ...... 1,591 kilograms.

(ii) Domestic Sales

Chemical Threshold by volume Threshold by weight

(A) Acetic anhydride ...... 250 gallons ...... 1,023 kilograms. (B) Acetone ...... 50 gallons ...... 150 kilograms. (C) Benzyl chloride ...... N/A ...... 1 kilogram. (D) Ethyl ether ...... 50 gallons ...... 135.8 kilograms. (E) Potassium permanganate ...... N/A ...... 55 kilograms. (F) 2-Butanone (MEK) ...... 50 gallons ...... 145 kilograms.

109 § 1310.05 21 CFR Ch. II (4–1–99 Edition)

Chemical Threshold by volume Threshold by weight

(G) Toluene ...... 50 gallons ...... 159 kilograms.

(iii) The cumulative threshold is not chemical will be used in violation of applicable to domestic sales of Ace- this part. tone, 2-Butanone (MEK), and Toluene. (2) Any proposed regulated trans- (iv) Exports, transshipments and action with a person whose description international transactions to Des- or other identifying characteristic the ignated Countries set forth in Administration has previously fur- § 1310.08(b) nished to the regulated person. (v) Export and International Trans- (3) Any unusual or excessive loss or actions to Designated Countries, and disappearance of a listed chemical Importations for Transshipment or under the control of the regulated per- Transfer to Designated Countries son. The regulated person responsible for reporting a loss in-transit is the Threshold by Threshold by supplier. Chemical volume weight (4) Any domestic regulated trans- (A) Methyl Isobutyl 500 gallons ...... 1523 kilograms. action in a tableting machine or an en- Ketone (MIBK). capsulating machine. (B) Reserved. (b) Each report submitted pursuant (g) For listed chemicals for which no to paragraph (a) of this section shall, thresholds have been established, the whenever possible, be made orally to size of the transaction is not a factor the DEA Divisional Office for the area in determining whether the trans- in which the regulated person making action meets the definition of a regu- the report is located at the earliest lated transaction as set forth in practicable opportunity after the regu- § 1310.01(f). All such transactions, related person becomes aware of the cir- gardless of size, are subject to record- cumstances involved and as much in keeping and reporting requirements as advance of the conclusion of the trans- set forth in this part 1310 and notifica- action as possible. Written reports of tion provisions as set forth in part 1313 transactions listed in paragraphs (a)(1), of this chapter. (a)(3) and (a)(4) of this section will subsequently be filed as set forth in (1) Listed Chemicals For Which No § 1310.06 within 15 days after the regu- Thresholds Have Been Established: lated person becomes aware of the cir- (i) Ephedrine, its salts, optical iso- cumstances of the event. A transaction mers, and salts of optical isomers may not be completed with a person (ii) [Reserved] whose description or identifying char- (2) [Reserved] acteristic has previously been fur- [54 FR 31665, Aug. 1, 1989, as amended at 56 nished to the regulated person by the FR 48733, Sept. 26, 1991; 57 FR 43615, Sept. 22, Administration unless the transaction 1992; 59 FR 51367, Oct. 11, 1994; 60 FR 19510, is approved by the Administration. Apr. 19, 1995; 60 FR 32460, June 22, 1995; 60 FR (c) Each regulated person who im- 42436, Aug. 16, 1995; 62 FR 5917, Feb. 10, 1997] ports or exports a tableting machine, or encapsulation machine, shall file a § 1310.05 Reports. report (not a 486) of such importation (a) Each regulated person shall re- or exportation with the Administration port to the Special Agent in Charge of at the following address on or before the DEA Divisional Office for the area the date of importation or exportation: in which the regulated person making Drug Enforcement Administration, the report is located, as follows: P.O. Box 28346, Washington, DC 20038. (1) Any regulated transaction involv- In order to facilitate the importation ing an extraordinary quantity of a list- or exportation of any tableting ma- ed chemical, an uncommon method of chine or encapsulating machine and payment or delivery, or any other cir- implement the purpose of the Act, reg- cumstance that the regulated person ulated persons may wish to report to believes may indicate that the listed the Administration as far in advance as

110 Drug Enforcement Administration, Justice § 1310.06 possible. A copy of the report may be from the report, that report may be transmitted directly to the Drug En- submitted in satisfaction of this re- forcement Administration through quirement. Each report shall be sub- electronic facsimile media. Any mitted to the DEA under company let- tableting machine or encapsulating terhead and signed by an appropriate, machine may be imported or exported responsible official. For purposes of if that machine is needed for medical, this paragraph only, the term regu- commercial, scientific, or other legiti- lated bulk manufacturer of a listed mate uses. However, an importation or chemical means a person who manufac- exportation of a tableting machine or tures a listed chemical by means of encapsulating machine may not be chemical synthesis or by extraction completed with a person whose descrip- from other substances. The term bulk tion or identifying characteristic has manufacturer does not include persons previously been furnished to the regu- whose sole activity consists of the related person by the Administration un- packaging or relabeling of listed chem- less the transaction is approved by the ical products or the manufacture of Administration. drug dosage form products which con- (d) Each regulated bulk manufac- tain a listed chemical. turer of a listed chemical shall submit [54 FR 31665, Aug. 1, 1989, as amended at 57 manufacturing, inventory and use data FR 2461, Jan. 22, 1992; 61 FR 14024, Mar. 29, on an annual basis as set forth in 1996; 61 FR 17958, Apr. 23, 1996; 62 FR 13968, § 1310.06(h). This data shall be sub- Mar. 24, 1997] mitted annually to the Drug and Chem- ical Evaluation Section, Drug Enforce- § 1310.06 Content of records and re- ment Administration (DEA), Wash- ports. ington, D.C. 20537, on or before the 15th (a) Each record required by § 1310.03 day of March of the year immediately shall include the following: following the calendar year for which (1) The name, address, and, if resubmitted. A business entity which quired, DEA registration number of manufactures a listed chemical may each party to the regulated trans- elect to report separately by individual action. location or report as an aggregate (2) The date of the regulated trans- amount for the entire business entity action. provided that they inform the DEA of (3) The name, quantity and form of which method they will use. This repackaging of the listed chemical or a porting requirement does not apply to description of the tableting machine or drug or other products which are ex- encapsulating machine (including empted under §§ 1310.01(f)(1)(iv) or make, model and serial number). 1310.01(f)(1)(v) except as set forth in (4) The method of transfer (company § 1310.06(h)(5). Bulk manufacturers that truck, picked up by customer, etc.). produce a listed chemical solely for in- (5) The type of identification used by ternal consumption shall not be re- the purchaser and any unique number quired to report for that listed chem- on that identification. ical. For purposes of these reporting re- (b) For purposes of this section, nor- quirements, internal consumption shall mal business records shall be consid- consist of any quantity of a listed ered adequate if they contain the infor- chemical otherwise not available for mation listed in paragraph (a) of this further resale or distribution. Internal section and are readily retrievable consumption shall include (but not be from other business records of the reg- limited to) quantities used for quality ulated person. For prescription drug control testing, quantities consumed products, prescription and hospital in-house or production losses. Internal records kept in the normal course of consumption does not include the medical treatment shall be considered quantities of a listed chemical con- adequate for satisfying the require- sumed in the production of exempted ments of paragraph (a) of this section products. If an existing standard indus- with respect to dispensing to patients, try report contains the information re- and records required to be maintained quired in § 1310.06(h) and such informa- pursuant to the Federal Food and Drug tion is separate or readily retrievable Administration regulations relating to

111 § 1310.06 21 CFR Ch. II (4–1–99 Edition) the distribution of prescription drugs, Description of Circumstances llllllll as set forth in 21 CFR part 205, shall be considered adequate for satisfying the Public reporting burden for this collec- requirements of paragraph (a) of this tion of information is estimated to av- section with respect to distributions. erage ten minutes per response, includ- (c) Each report required by Section ing the time for reviewing instructions, 1310.05(a) shall include the information searching existing data sources, gath- as specified by Section 1310.06(a) and, ering and maintaining the data needed, where obtainable, the registration and completing and reviewing the col- number of the other party, if such lection of information. Send comments party is registered. A report submitted regarding this burden estimate or any pursuant to § 1310.05(a)(1) or (a)(4) must other aspect of this collection of infor- also include a description of the cir- mation, including suggestions for re- cumstances leading the regulated per- ducing this burden to the Drug En- son to make the report, such as the forcement Administration, Records reason that the method of payment Management Section, Washington, D.C. was uncommon or the loss unusual. If 20537; and to the Office of Management the report is for a loss or disappearance and Budget, Paperwork Reduction under § 1310.05(a)(4), the circumstances Project No. 1117–0024, Washington, D.C. of such loss must be provided (in-tran- 20503. sit, theft from premises, etc.) (e) Each report of an importation of a (d) A suggested format for the re- tableting machine or an encapsulating ports is provided below: machine required by § 1310.05(c) shall include the following information: Supplier: (1) The name, address, telephone Registration Number llllllllllll number, tdlex number, and, where Name llllllllllllllllllll available, the facsimile number of the Business Address llllllllllllll regulated person; the name, address, City lllllllllllllllllllll telephone number, telex number, and, llllllllllllllllllll State where available, the facsimile number Zip lllllllllllllllllllll Business Phone lllllllllllllll of the import broker or forwarding agent, if any: Purchaser: (2) The description of each machine Registration Number llllllllllll (including make, model, and serial Name llllllllllllllllllll number) and the number of machines Business Address llllllllllllll being received; lllllllllllllllllllll City (3) The proposed import date, and the State llllllllllllllllllll Zip lllllllllllllllllllll first U.S. Customs Port of Entry; and Business Phone lllllllllllllll (4) The name, address, telephone Identification llllllllllllllll number, telex number, and, where available, the facsimile number of the Shipping Address (if different than purchaser consignor in the foreign country of ex- Address): portation. Street llllllllllllllllllll (f) Each report of an exportation of a lllllllllllllllllllll City tableting machine or an encapsulating State llllllllllllllllllll Zip lllllllllllllllllllll machine required by § 1310.05(c) shall Date of Shipment llllllllllllll include the following information: Name of Listed Chemical(s) lllllllll (1) The name, address, telephone Quantity and Form of Packaging llllll number, telex number, and, where Description of Machine: available, the facsimile number of the regulated person; the name, address, Make llllllllllllllllllll telephone number, telex number, and, llllllllllllllllllll Model where available, the facsimile number Serial # lllllllllllllllllll Method of Transfer lllllllllllll of the export broker, if any; (2) The description of each machine If Loss or Disappearance: (including make, model, and serial Date of Loss lllllllllllllllll number) and the number of machines Type of Loss llllllllllllllll being shipped;

112 Drug Enforcement Administration, Justice § 1310.07

(3) The proposed export date, the U.S. becomes a component of a product ex- Customs Port of exportation, and the empted from Section 1310.01(f)(1)(iv) or foreign Port of Entry; and 1310.01(f)(1)(v) during the preceding cal- (4) The name, address, telephone, endar year. telex, and, where available, the fac- (6) Data shall identify the specific simile number of the consignee in the isomer, salt or ester when applicable country where the shipment is des- but quantitative data shall be reported tined; the name(s) and address(es) of as anhydrous base or acid in kilogram any intermediate consignee(s). units of measure. (g) Declared exports of machines which are refused, rejected, or other- [54 FR 31665, Aug. 1, 1989, as amended at 57 wise deemed undeliverable may be re- FR 2462, Jan. 22, 1992; 59 FR 51364, Oct. 11, 1994; 60 FR 32461, June 22, 1995; 61 FR 14024, turned to the U.S. exporter of record. A Mar. 29, 1996; 61 FR 32926, June 26, 1996] brief written report outlining the circumstances must be sent to the Drug § 1310.07 Proof of identity. Enforcement Administration, P.O. Box 28346, Washington, DC 20038, following (a) Each regulated person who en- the return within a reasonable time. gages in a regulated transaction must This provision does not apply to ship- identify the other party to the trans- ments that have cleared foreign cus- action. For domestic transaction, this toms, been delivered, and accepted by shall be accomplished by having the the foreign consignee. Returns to third other party present documents which parties in the United States will be re- would verify the identity, or registra- garded as imports. tion status if a registrant, of the other (h) Each annual report required by party to the regulated person at the Section 1310.05(d) shall provide the fol- time the order is placed. For export lowing information for each listed transactions, this shall be accom- chemical manufactured: plished by good faith inquiry through (1) The name, address and chemical reasonably available research docu- registration number (if any) of the ments or publicly available informa- manufacturer and person to contact for tion which would indicate the exist- information. ence of the foreign customer. No proof (2) The aggregate quantity of each of identity is required for foreign sup- listed chemical that the company man- pliers. ufactured during the preceding cal- (b) The regulated person must verify endar year. the existence and apparent validity of (3) The year-end inventory of each a business entity ordering a listed listed chemical as of the close of busi- chemical, tableting machine or encap- ness on the 31st day of December of sulating machine. For domestic trans- each year. (For each listed chemical, if actions, this may be accomplished by the prior period’s ending inventory has such methods as checking the tele- not previously been reported to DEA, phone directory, the local credit bu- this report should also detail the begin- reau, the local Chamber of Commerce ning inventory for the period.) For pur- or the local Better Business Bureau, or, poses of this requirement, inventory if the business entity is a registrant, shall reflect the quantity of listed by verification of the registration. For chemicals, whether in bulk or non-ex- export transactions, a good faith in- empt product form, held in storage for quiry to verify the existence and appar- later distribution. Inventory does not ent validity of a foreign business entity include waste material for destruction, may be accomplished by such methods material stored as an in-process inter- as verifying the business telephone mediate or other in-process material. listing through international telephone (4) The aggregate quantity of each information, the firm’s listing in inter- listed chemical used for internal con- national or foreign national chemical sumption during the preceding cal- directories or other commerce direc- endar year, unless the chemical is pro- tories or trade publications, confirma- duced solely for internal consumption. tion through foreign subsidiaries of the (5) The aggregate quantity of each U.S. regulated person, verification listed chemical manufactured which through the country of destination’s

113 § 1310.08 21 CFR Ch. II (4–1–99 Edition) embassy Commercial Attache, or offi- Chemical Diversion and Trafficking cial documents provided by the pur- Act and, therefore, they have been ex- chaser which confirm the existence and cluded from the definitions of regu- apparent validity of the business enti- lated transactions: ty. (a) Domestic and import transactions (c) When transacting business with a of hydrochloric and sulfuric acids. new representative of a firm, the regu- (b) Exports, transshipments, and lated person must verify the claimed international transactions of hydro- agency status of the representative. chloric and sulfuric acids, except for (d) For sales to individuals or cash exports, transshipments and inter- purchasers, the type of documents and national transactions to the following other evidence of proof must consist of countries: at least a signature of the purchaser, a (1) Argentina driver’s license and one other form of (2) Bolivia identification. Any exports to individ- (3) Brazil uals or exports paid in cash are suspect (4) Chile and should be handled as such. For (5) Colombia such exports, the regulated person (6) Ecuador shall diligently obtain from the pur- (7) French Guiana chaser or independently seek to con- (8) Guyana firm clear documentation which proves (9) Panama the person is properly identified such (10) Paraguay as through foreign identity documents, (11) Peru driver’s license, passport information (12) Suriname and photograph, etc. Any regulated (13) Uruguay person who fails to adequately prove (14) Venezuela the identity of the other party to the (c) Domestic transactions of Methyl transaction may be subject to the spe- Isobutyl Ketone (MIBK). cific penalties provided for violations (d) Import transactions of Methyl of law related to regulated trans- Isobutyl Ketone (MIBK) destined for actions in listed chemicals. the United States. (e) For a new customer who is not an (e) Export transactions, inter- individual or cash customer, the regu- national transactions, and import lated person shall establish the iden- transactions for transshipment or tity of the authorized purchasing agent transfer of Methyl Isobutyl Ketone or agents and have on file that person’s (MIBK) destined for Canada or any signature, electronic password, or country outside of the Western Hemi- other identification. Once the author- sphere. ized purchasing agent has been established, the agent list may be updated [57 FR 43615, Sept. 22, 1992, as amended at 60 FR 19510, Apr. 19, 1995; 60 FR 32461, June 22, annually rather than on each order. 1995; 62 FR 13968, Mar. 24, 1997] The regulated person must ensure that shipments are not made unless the § 1310.09 Temporary exemption from order is placed by an authorized agent registration. of record. (a) Each person required by section (f) With respect to electronic orders, 302 of the act (21 U.S.C. 822) to obtain a the identity of the purchaser shall con- registration to distribute, import, or sist of a computer password, identifica- export a combination ephedrine prod- tion number or some other means of uct is temporarily exempted from the identification consistent with elec- registration requirement, provided tronic orders and with § 1310.07(e). that the person submits a proper appli- [54 FR 31665, Aug. 1, 1989, as amended at 60 cation for registration on or before FR 32461, June 22, 1995] July 12, 1997. The exemption will remain in effect for each person who has § 1310.08 Excluded transactions. made such application until the Ad- Pursuant to 21 U.S.C. 802(39)(A)(iii), ministration has approved or denied regulation of the following trans- that application. This exemption ap- actions has been determined to be un- plies only to registration; all other necessary for the enforcement of the chemical control requirements set

114 Drug Enforcement Administration, Justice § 1310.10 forth in parts 1309, 1310, and 1313 of this written comments on or objections to chapter remain in full force and effect. the proposal. After considering any (b) Each person required by section comments or objections filed, the Ad- 302 of the act (21 U.S.C. 822) to obtain a ministrator shall publish in the FED- registration to distribute, import, or ERAL REGISTER his final order. export a drug product that contains (c) The Administrator shall limit the pseudoephedrine or phenylpropanola- removal of a drug or group of drugs mine that is regulated pursuant to from exemption under paragraph (a) of § 1300.02(b)(28)(1)(D) of this chapter is this section to the most identifiable temporarily exempted from the reg- type of the drug or group of drugs for istration requirement, provided that which evidence of diversion exists un- the person submits a proper applica- less there is evidence, based on the pat- tion for registration on or before De- tern of diversion and other relevant cember 3, 1997. The exemption will re- factors, that the diversion will not be main in effect for each person who has limited to that particular drug or made such application until the Ad- group of drugs. ministration has approved or denied (d) Any manufacturer seeking rein- that application. This exemption ap- statement of a particular drug product plies only to registration; all other that has been removed from an exemp- chemical control requirements set tion under paragraph (a) of this sec- forth in parts 1309, 1310, and 1313 of this tion, may apply to the Administrator chapter remain in full force and effect. for reinstatement of the exemption for [62 FR 27693, May 21, 1997, as amended at 62 that particular drug product on the FR 53960, Oct. 17, 1997] grounds that the particular drug product is manufactured and distributed in § 1310.10 Removal of the exemption of a manner that prevents diversion. In drugs distributed under the Food, determining whether the exemption Drug and Cosmetic Act. should be reinstated the Administrator (a) The Administrator may remove shall consider: from exemption under (1) The package sizes and manner of § 1310.01(b)(28)(i)(D) any drug or group packaging of the drug product; of drugs that the Administrator finds (2) The manner of distribution and is being diverted to obtain a listed advertising of the drug product; chemical for use in the illicit produc- (3) Evidence of diversion of the drug tion of a controlled substance. In re- product; moving a drug or group of drugs from (4) Any actions taken by the manu- the exemption the Administrator shall facturer to prevent diversion of the consider: drug product; and (1) The scope, duration, and signifi- (5) Such other factors as are relevant cance of the diversion; to and consistent with the public (2) Whether the drug or group of health and safety, including the factors drugs is formulated in such a way that described in paragraph (a) of this sec- it cannot be easily used in the illicit tion as applied to the drug product. production of a controlled substance; (e) Within a reasonable period of and time after receipt of the application for (3) Whether the listed chemical can reinstatement of the exemption, the be readily recovered from the drug or Administrator shall notify the appli- group of drugs. cant of his acceptance or non-accept- (b) Upon determining that a drug or ance of his application, and if not ac- group of drugs should be removed from cepted, the reason therefor. If the ap- the exemption under paragraph (a) of plication is accepted for filing, the Ad- this section, the Administrator shall ministrator shall issue and publish in issue and publish in the FEDERAL REG- the FEDERAL REGISTER his order on the ISTER his proposal to remove the drug reinstatement of the exemption for the or group of drugs from the exemption, particular drug product, which shall in- which shall include a reference to the clude a reference to the legal authority legal authority under which the pro- under which the order is based. This posal is based. The Administrator shall order shall specify the date on which it permit any interested person to file shall take effect. The Administrator

115 § 1310.11 21 CFR Ch. II (4–1–99 Edition) shall permit any interested person to described in paragraphs (b), (c), and (d) file written comments on or objections of this section. to the order. If any such comments (b) No reinstated exemption granted raise significant issues regarding any pursuant to 1310.10 affects the criminal finding of fact or conclusion of law liability for illegal possession or dis- upon which the order is based, the Ad- tribution of listed chemicals contained ministrator shall immediately suspend in the exempt drug product. the effectiveness of the order until he (c) Changes in exempt drug product may reconsider the application in light compositions: Any change in the quan- of the comments and objections filed. titative or qualitative composition, Thereafter, the Administrator shall re- trade name or other designation of an instate, revoke, or amend his original exempt drug product listed in para- order as he determines appropriate. graph (d) requires a new application for (f) Unless the Administrator has evi- reinstatement of the exemption. dence that the drug product is being di- (d) The following drug products, in verted, as determined by applying the the form and quantity listed in the ap- factors set forth in paragraph (a) of plication submitted (indicated as the this section, and the Administrator so ‘‘date’’) are designated as reinstated notifies the applicant, transactions in- exempt drug products for the purposes volving a specific drug product will not set forth in this section: be considered regulated transactions during the following periods: EXEMPT DRUG PRODUCTS (1) While a bonafide application for reinstatement of exemption under Supplier Product name Form Date paragraph (d) of this section for the [Reserved] ...... specific drug product is pending resolution, provided that the application for reinstatement is filed not later than 60 [60 FR 32462, June 22, 1995] days after the publication of the final order removing the exemption; and § 1310.14 Exemption of drug products (2) For a period of 60 days following containing ephedrine and therapeutically significant quantities of the Administrator’s denial of an appli- another active medicinal ingre- cation for reinstatement. dient. (g) An order published by the Admin- istrator in the FEDERAL REGISTER, pur- (a) Any manufacturer of a drug prod- suant to paragraph (e) of this section, uct containing ephedrine in combina- to reinstate an exemption may be tion with another active medicinal in- modified or revoked with respect to a gredient, the product formulation of particular drug product upon a finding which is not listed in the compendiums that: set forth in § 1310.01(b)(28)(i)(D)(1), may (1) Applying the factors set forth in request that the Administrator exempt paragraph (a) of this section to the par- the product as one which contains ticular drug product, the drug product ephedrine together with a therapeuti- is being diverted; or cally significant quantity of another (2) There is a significant change in active medicinal ingredient. the data that led to the issuance of the (b) An application for an exemption final rule. under this section shall contain the following information: [60 FR 32461, June 22, 1995, as amended at 62 (1) The name and address of the ap- FR 13968, Mar. 24, 1997] plicant; § 1310.11 Reinstatement of exemption (2) The exact trade name of the drug for drug products distributed under product for which exemption is sought; the Food, Drug and Cosmetic Act. (3) The complete quantitative and (a) The Administrator has reinstated qualitative composition of the drug the exemption for the drug products product; listed in paragraph (e) of this section (4) A brief statement of the facts from application of sections 302, 303, which the applicant believes justify the 310, 1007, and 1008 of the Act (21 U.S.C. granting of an exemption under this 822–823, 830, and 957–958), to the extent section; and

116 Drug Enforcement Administration, Justice Pt. 1312

(5) Certification by the applicant § 1310.15 Exempt drug products con- that the product may be lawfully mar- taining ephedrine and therapeuti- keted or distributed under the Food, cally significant quantities of an- Drug, and Cosmetic Act. other active medicinal ingredient. (6) The identification of any informa- (a) The drug products containing tion on the application which is consid- ephedrine and therapeutically signifi- ered by the applicant to be a trade se- cant quantities of another active me- cret or confidential and entitled to pro- dicinal ingredient listed in paragraph tection under U.S. laws restricting the (e) of this section have been exempted public disclosure of such information by the Administrator from application by government employees. of sections 302, 303, 310, 1007, and 1008 of (c) The Administrator may require the Act (21 U.S.C. 822–3, 830, and 957–8) the applicant to submit such additional to the extent described in paragraphs (b), (c), and (d) of this section. documents or written statements of (b) No exemption granted pursuant to fact relevant to the application which 1310.14 affects the criminal liability for he deems necessary for determining if illegal possession or distribution of the application should be granted. listed chemicals contained in the ex- (d) Within a reasonable period of empt drug product. time after the receipt of a completed (c) Changes in drug product composi- application for an exemption under tions: Any change in the quantitative this section, the Administrator shall or qualitative composition of an ex- notify the applicant of acceptance or empt drug product listed in paragraph non-acceptance of the application. If (d) requires a new application for ex- the application is not accepted, an exemption. planation will be provided. The Admin- (d) In addition to the drug products istrator is not required to accept an ap- listed in the compendium set forth in plication if any of the information re- § 1310.01(b)(28)(i)(D)(1), the following quired in paragraph (b) of this section drug products, in the form and quan- or requested pursuant to paragraph (c) tity listed in the application submitted of this section is lacking or not readily (indicated as the ‘‘date’’) are des- understood. The applicant may, how- ignated as exempt drug products for ever, amend the application to meet the purposes set forth in this section: the requirements of paragraphs (b) and (c) of this section. If the application is EXEMPT DRUG PRODUCTS CONTAINING EPHED- accepted for filing, the Administrator RINE AND THERAPEUTICALLY SIGNIFICANT shall issue and publish in the FEDERAL QUANTITIES OF ANOTHER ACTIVE MEDICINAL REGISTER an order on the application, INGREDIENT which shall include a reference to the Supplier Product name Form Date legal authority under which the order is based. This order shall specify the [Reserved] ...... date on which it shall take effect. The Administrator shall permit any inter- [60 FR 32463, June 22, 1995, as amended at 62 ested person to file written comments FR 13968, Mar. 24, 1997] on or objections to the order. If any comments or objections raise signifi- PARTS 1311 [RESERVED] cant issues regarding any findings of fact or law upon which the order is PART 1312—IMPORTATION AND based, the Administrator shall imme- EXPORTATION OF CONTROLLED diately suspend the effectiveness of the SUBSTANCES order until he may reconsider the application in light of the comments and Sec. objections filed. Thereafter, the Ad- 1312.01 Scope of part 1312. ministrator shall reinstate, revoke, or 1312.02 Definitions. amend the original order as deemed ap- IMPORTATION OF CONTROLLED SUBSTANCES propriate. 1312.11 Requirement of authorization to im- [60 FR 32462, June 22, 1995, as amended at 62 port. FR 13968, Mar. 24, 1997] 1312.12 Application for import permit.

117 § 1312.01 21 CFR Ch. II (4–1–99 Edition)

1312.13 Issuance of import permit. 102 of the Act (21 U.S.C. 802) or part 1312.14 Distribution of copies of import per- 1300 of this chapter. mit. 1312.15 Shipments in greater or less amount [62 FR 13969, Mar. 24, 1997] than authorized. 1312.16 Cancellation of permit; expiration IMPORTATION OF CONTROLLED date. SUBSTANCES 1312.17 Special report from importers. 1312.18 Contents of import declaration. § 1312.11 Requirement of authoriza- 1312.19 Distribution of import declaration. tion to import. (a) No person shall import or cause to EXPORTATION OF CONTROLLED SUBSTANCES be imported any controlled substance 1312.21 Requirement of authorization to ex- listed in Schedule I or II or any nar- port. cotic controlled substance listed in 1312.22 Application for export permit. Schedule III, IV or V or any non-nar- 1312.23 Issuance of export permit. cotic controlled substance in Schedule 1312.24 Distribution of copies of export per- III which the Administrator has spe- mit. 1312.25 Expiration date. cifically designated by regulation in 1312.26 Records required of exporter. § 1312.30 of this part or any non-nar- 1312.27 Contents of special controlled sub- cotic controlled substance in Schedule stances invoice. IV or V which is also listed in Schedule 1312.28 Distribution of special controlled I or II of the Convention on Psycho- substances invoice. tropic Substances unless and until such 1312.29 Domestic release prohibited. person is properly registered under the 1312.30 Schedule III, IV, and V non-narcotic Act (or exempt from registration) and controlled substances requiring an im- the Administrator has issued him a port and export permit. permit to do so pursuant to § 1312.13 of TRANSSHIPMENT AND IN-TRANSIT SHIPMENT OF this part. CONTROLLED SUBSTANCES (b) No person shall import or cause to 1312.31 Schedule I: Application for prior be imported any non-narcotic con- written approval. trolled substance listed in Schedule III, 1312.32 Schedules II, III, IV: Advance notice. IV or V, excluding those described in paragraph (a) of this section, unless HEARINGS and until such person is properly reg- 1312.41 Hearings generally. istered under the Act (or exempt from 1312.42 Purpose of hearing. registration) and has filed an import 1312.43 Waiver or modification of rules. declaration to do so with the Adminis- 1312.44 Request for hearing or appearance; trator, pursuant to § 1312.18 of this part. waiver. (c) When an import permit or dec- 1312.45 Burden of proof. laration is required, a separate permit 1312.46 Time and place of hearing. 1312.47 Final order. or declaration must be obtained for each consignment of controlled sub- AUTHORITY: 21 U.S.C. 952, 953, 954, 957, 958. stances to be imported. SOURCE: 36 FR 7815, Apr. 24, 1971, unless [36 FR 7815, Apr. 24, 1971, as amended at 37 otherwise noted. Redesignated at 38 FR 26609, FR 15923, Aug. 8, 1972. Redesignated at 38 FR Sept. 24, 1973. 26609, Sept. 24, 1973, and amended at 52 FR 17289, May 7, 1987] § 1312.01 Scope of part 1312. Procedures governing the importa- § 1312.12 Application for import per- tion, exportation, transshipment and mit. intransit shipment of controlled sub- (a) An application for a permit to im- stances pursuant to section 1002, 1003, port controlled substances shall be and 1004 of the Act (21 U.S.C. 952, 953, made on DEA Form 357. DEA Form 357 and 954) are governed generally by may be obtained from, and shall be those sections and specifically by the filed with, the Drug Enforcement Ad- sections of this part. ministration, Drug Operations Section, Washington, DC 20537. Each application § 1312.02 Definitions. shall show the date of execution; the Any term contained in this part shall registration number of the importer; a have the definition set forth in section detailed description of each controlled

118 Drug Enforcement Administration, Justice § 1312.13 substance to be imported including the ternate ports in different countries will drug name, dosage form, National Drug not be authorized in the same permit. Code (NDC) number, the Administra- tion Controlled Substance Code Num- [36 FR 7815, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. Redesignated at 38 FR ber as set forth in part 1308 of this 26609, Sept. 24, 1973, and amended at 39 FR chapter, the number and size of pack- 43218, Dec. 11, 1974; 45 FR 74715, Nov. 12, 1980; ages or containers, the name and quan- 51 FR 5319 and 5320, Feb. 13, 1986; 52 FR 17289, tity of the controlled substance con- May 7, 1987; 62 FR 13969, Mar. 24, 1997] tained in any finished dosage units, and the net quantity of any controlled § 1312.13 Issuance of import permit. substance (expressed in anhydrous (a) The Administrator may authorize acid, base or alkaloid) given in kilograms or parts thereof. The application importation of any controlled sub- shall also include the following: stance listed in Schedule I or II or any (1) The name, address, and business narcotic drug listed in Schedule III, IV, of the consignor, if known at the time or V if he finds: application is submitted, but if un- (1) That the substance is crude known at that time, the fact should be opium, poppy straw, concentrate of indicated and the name and address poppy straw, or coca leaves, in such afterwards furnished to the Adminis- quantity as the Administrator finds trator as soon as ascertained by the necessary to provide for medical, sci- importer; entific, or other legitimate purposes; (2) The foreign port of exportation (2) That the substance is necessary to (i.e., the place where the article will provide for medical and scientific needs begin its journey of exportation to the or other legitimate needs of the United United States); States during an emergency where do- (3) The port of entry into the United mestic supplies of such substance or States; drug are found to be inadequate, or in (4) The latest date said shipment will any case in which the Administrator leave said foreign port; finds that competition among domestic (5) The stock on hand of the con- manufacturers of the controlled sub- trolled substance desired to be im- stance is inadequate and will not be ported; rendered adequate by the registration (6) The name of the importing carrier or vessel (if known, or if unknown it of additional manufacturers under sec- should be stated whether shipment will tion 303 of the Controlled Substances be made by express, freight, or other- Act (21 U.S.C. 823); or wise, imports of controlled substances (3) That the domestic supply of any in Schedules I or II and narcotic drugs controlled substance is inadequate for in Schedules III, IV, or V by mail being scientific studies, and that the impor- prohibited); tation of that substance for scientific (7) The total tentative allotment to purposes is only for delivery to offi- the importer of such controlled sub- cials of the United Nations, of the stance for the current calendar year; United States, or of any State, or to (8) The total number of kilograms of any person registered or exempted said allotment for which permits have from registration under sections 1007 previously been issued and the total and 1008 of the Act (21 U.S.C. 957 and quantity of controlled substance actu- 958). ally imported during the current year (4) That the importation of the con- to date. trolled substance is for ballistics or (b) If desired, alternative foreign other analytical or scientific purposes, ports of exportation within the same and that the importation of that sub- country may be indicated upon the ap- stance is only for delivery to officials plication (e.g., (1) Calcutta, (2) Bom- of the United Nations, of the United bay). If a formal permit is issued pursuant to such application, it will bear the States, or of any State, or to any per- names of the two ports in the order son registered or exempted from reg- given in the application and will au- istration under sections 1007 and 1008 of thorize shipment from either port. Al- the Act (21 U.S.C. 957 and 958).

119 § 1312.14 21 CFR Ch. II (4–1–99 Edition)

(b) The Administrator may require under the Act, to import, throtgh the that such non-narcotic controlled sub- port named, one shipment of not to ex- stances in Schedule III as he shall des- ceed the specified quantity of the ignate by regulation in § 1312.30 of this named controlled substances, shipment part be imported only pursuant to the to be made before a specified date. Not issuance of an import permit. The Ad- more than one shipment shall be made ministrator may authorize the impor- on a single import permit. The permit tation of such substances if he finds shall state that the Administrator is that the substance is being imported satisfied that the consignment pro- for medical, scientific or other legiti- posed to be imported is required for le- mate uses. gitimate purposes. (c) If a non-narcotic substance listed (f) Notwithstanding paragraphs (a)(1) in Schedule IV or V is also listed in and (a)(2) of this section, the Adminis- Schedule I or II of the Convention on trator shall permit, pursuant to 21 Psychotropic Substances, 1971, it shall U.S.C. 952(a)(1) or (a)(2)(A), the impor- be imported only pursuant to the tation of approved narcotic raw mate- issuance of an import permit. The Ad- rial (opium, poppy straw and con- ministrator may authorize the impor- centrate of poppy straw) having as its tation of such substances if it is found source: that the substance is being imported (1) Turkey, for medical, scientific or other legitimate uses. (2) India, (d) The Administrator may require (3) Yugoslavia, an applicant to submit such documents (4) France, or written statements of fact relevant (5) Poland, to the application as he deems nec- (6) Hungary, and essary to determine whether the appli- (7) Australia. cation should be granted. The failure of (g) At least eighty (80) percent of the the applicant to provide such docu- narcotic raw material imported into ments or statements within a reason- the United States shall have as its able time after being requested to do so original source Turkey and India. Ex- shall be deemed to be a waiver by the cept under conditions of insufficient applicant of an opportunity to present supplies of narcotic raw materials, not such documents or facts for consider- more than twenty (20) percent of the ation by the Administrator in granting narcotic raw material imported into or denying the application. the United States annually shall have (e) Each import permit shall be as its source Yugoslavia, France, Po- issued in sextuplet and serially num- land, Hungary and Australia. bered, with all six copies bearing the same serial number and being des- [36 FR 23624, Dec. 11, 1971, as amended at 37 ignated ‘‘original’’ (Copy 1), ‘‘dupli- FR 15923, Aug. 8, 1972. Redesignated at 38 FR cate’’ (Copy 2), etc., respectively. All 26609, Sept. 24, 1973, and amended at 46 FR copies of import permits shall bear the 41776, Aug. 18, 1981; 52 FR 17289, May 7, 1987] signature of the Director or his dele- § 1312.14 Distribution of copies of im- gate, and facsimiles of signatures shall port permit. not be used. No permit shall be altered or changed by any person after being Copies of the import permit shall be signed by the Administrator or his del- distributed and serve purposes as fol- egate and any change or alteration lows: upon the face of any permit after it (a) The original and quintuplet copies shall have been signed by the Adminis- (Copy 1 and Copy 5) shall be trans- trator or his delegate shall render it mitted by the Administration to the void and of no effect. Permits are not importer, who shall retain the quin- transferable. Each copy of the permit tuplet copy (Copy 5) on file as his shall have printed or stamped thereon record of authority for the importa- the disposition to be made thereof. tion, and shall transmit the original Each permit shall be dated and shall copy (Copy 1) to the foreign exporter. certify that the importer named there- The foreign exporter will submit the in is thereby permitted as a registrant original copy (Copy 1) to the proper

120 Drug Enforcement Administration, Justice § 1312.16 governmental authority in the export- feiture, pending an explanation; except ing country, if required, as a pre- that shipments of substances exceeding requisite to the issuance of an export the maximum authorized amount by authorization. This copy of the permit less than 1 percent may be released to will accompany the shipment. Upon ar- the importer upon the filing by him of rival of the imported merchandise, the an amended import permit. If the sub- District Director of the U.S. Customs stance is included in Schedule I, it will Service at the port of entry will, after be summarily forfeited to the Govern- appraising the merchandise, forward ment. the original copy (Copy 1) to the Drug (b) If the shipment made under the Operations Section with a report on permit is less than the maximum the reverse side of such copy, showing amount authorized to be imported the name of the port of importation, under the permit as determined at the date prepared, name and net quantity weighing by the District Director of of each substance, and report of anal- the U.S. Customs Service, such dif- ysis of the merchandise entered. ference, when ascertained by the Ad- (b) The duplicate copy (Copy 2) shall ministration, shall be recredited to the be forwarded by the Administration to tentative allotment against which the the proper governmental authorities of quantity covered by the permit was the exporting country. charged, and the balance of any such (c) The quadruplet copy (Copy 4) tentative allotment with any such re- shall be forwarded by the Administra- credits will remain available to the im- tion to the District Director of the U.S. porter to whom made (unless pre- Customs Service at the U.S. port of viously revoked in whole or in part), entry, which shall be the customs port for importations pursuant to any per- of destination in the case of shipments mit or permits as are requested and transported under immediate transpor- issued during the remainder of the cal- tation entries, in order that the Dis- endar year to which the allotment is trict Director may compare it with the applicable. No permit shall be issued original copy (Copy 1) and the bill of for importation of a quantity of con- lading upon arrival of the merchandise. trolled substances as a charge against If a discrepancy is noted between cor- the tentative allotment for a given cal- responding items upon different copies endar year, after the close of such cal- of a permit bearing the same serial endar year, unless the Director of the number when compared by the District Administration decides to make an ex- Director, he shall refuse to permit ception for good cause shown. entry of the merchandise until the [36 FR 7815, Apr. 24, 1971. Redesignated at 38 facts are communicated to the Admin- FR 26609, Sept. 24, 1973, and amended at 46 istration and further instructions are FR 28841, May 29, 1981] received. (d) The triplicate copy (Copy 3) and § 1312.16 Cancellation of permit; expi- sextuplet copy (Copy 6) shall be re- ration date. tained by the Administration. (a) A permit may be canceled after being issued, at the request of the im- [36 FR 7815, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. Redesignated at 38 FR porter, provided no shipment has been 26609, Sept. 24, 1973, and further amended at made thereunder. In the event that a 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, permit is lost, the Administrator may, 1986; 53 FR 48244, Nov. 30, 1988; 62 FR 13969, upon the production by the importer of Mar. 24, 1997] satisfactory proof, by affidavit or otherwise, issue a duplicate permit. Noth- § 1312.15 Shipments in greater or less ing in this part shall affect the right, amount than authorized. hereby reserved by the Administrator, (a) If the shipment made under an to cancel a permit at any time for import permit is greater than the max- proper cause. imum amount authorized to be im- (b) An import permit shall not be ported under the permit, as determined valid after the date specified therein, at the weighing by the District Direc- and in no event shall the date be subse- tor of the U.S. Customs Service, such quent to 6 months after the date the difference shall be seized subject to for- permit is issued. Any unused import

121 § 1312.17 21 CFR Ch. II (4–1–99 Edition) permit shall be returned for cancella- tribute four copies of same as herein- tion by the registrant to the Drug En- after directed in § 1312.19. forcement Administration, Drug Oper- (c) DEA Form 236 must be executed ations Section, Washington, DC 20537. in quintuplicate and will include the [36 FR 7815, Apr. 24, 1971. Redesignated at 38 following information: FR 26609, Sept. 24, 1973, and amended at 45 (1) The name, address, and registra- FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, tion number of the importer; and the 1986; 53 FR 48244, Nov. 30, 1988; 62 FR 13969, name and address and registration Mar. 24, 1997] number of the import broker, if any; and § 1312.17 Special report from import- (2) A complete description of the con- ers. trolled substances to be imported, in- Whenever requested by the Adminis- cluding drug name, dosage form, Na- trator, importers shall render to him tional Drug Code (NDC) number, the not later than 30 days after receipt of Administration Controlled Substances the request therefor a statement under Code Number as set forth in part 1308 oath of the stocks of controlled sub- of this chapter, the number and size of stances on hand as of the date specified packages or containers, the name and by the Administrator in his request, quantity of the controlled substance and, if desired by the Administrator, contained in any finished dosage units, an estimate of the probable require- and the net quantity of any controlled ments for legitimate uses of the im- substance (expressed in anhydrous porter for any subsequent period that acid, base, or alkaloid) given in kilo- may be designated by the Adminis- grams or parts thereof; and trator. In lieu of any special statement (3) The proposed import date, the for- that may be considered necessary, the eign port of exportation to the United Administrator may accept the figures States, the port of entry, and the given upon the reports subsequent by name, address, and registration num- said importer under part 1304 of this ber of the recipient in the United chapter. States; and [36 FR 7815, Apr. 24, 1971. Redesignated at 38 (4) The name and address of the con- FR 26609, Sept. 24, 1973, as amended at 62 FR signor in the foreign country of expor- 13969, Mar. 24, 1997] tation, and any registration or license numbers if the consignor is required to § 1312.18 Contents of import declara- have such numbers either by the coun- tion. try of exportation or under U.S. law. (a) Any non-narcotic controlled sub- (d) Notwithstanding the time limita- stance listed in Schedule III, IV, or V, tions included in paragraph (a) of this not subject to the requirement of an section, an applicant may obtain a spe- import permit pursuant to § 1312.13 (b) cial waiver of these time limitations in or (c) of this chapter, may be imported emergency or unusual instances, pro- if that substance is needed for medical, vided that a specific confirmation is re- scientific or other legitimate uses in ceived from the Administrator or his the United States, and will be imported delegate advising the registrant to pro- pursuant to a controlled substances ceed pursuant to the special waiver. import declaration. (b) Any person registered or author- [36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR ized to import and desiring to import 26609, Sept. 24, 1973, and amended at 45 FR any non-narcotic controlled substance 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; in Schedules III, IV, or V which is not 52 FR 17290, May 7, 1987; 62 FR 13969, Mar. 24, subject to the requirement of an im- 1997] port permit as described in paragraph (a) of this section, must furnish a con- § 1312.19 Distribution of import dec- trolled substances import declaration laration. on DEA Form 236 to the Drug Enforce- The required five copies of the con- ment Administration, Drug Operations trolled substances import declaration Section, Washington, DC 20537, not will be distributed as follows: later than 15 calendar days prior to the (a) Copy 1, Copy 2, and Copy 3 shall proposed date of importation and dis- be transmitted to the foreign shipper.

122 Drug Enforcement Administration, Justice § 1312.22

The foreign shipper will submit Copy 1 paragraph (a) of this section, or any to the proper governmental authority narcotic controlled substance listed in in the foreign country, if required as a Schedule V, unless and until such per- prerequisite to export authorization. son is properly registered under the Copy 1 will then accompany the ship- Act (or exempted from registration) ment to its destination, and shall be and has furnished a special controlled retained on file by the importer. Copy substance export invoice as provided by 2 shall be detached and retained by the section 1003 of the Act (21 U.S.C. 953(e)) appropriate customs official of the for- to the Administrator pursuant to eign country. Copy 3 shall be removed § 1312.28 of this part. by the District Director of the U.S. (c) A separate authorization repuest Customs Service at the port of entry, is obtained for each consignment of who shall sign and date the certifi- such controlled substances to be ex- cation of customs on Copy 3, noting ported. any changes from the entries made by the importer, and shall then forward [36 FR 7815, Apr. 24, 1971, as amended at 37 that copy to the Drug Operations Sec- FR 15923, Aug. 8, 1972. Redesignated at 38 FR tion of the Administration. 26609, Sept. 24, 1973, and amended at 52 FR (b) Copy 4 shall be forwarded, within 17290, May 7, 1987] the time limit required in § 1312.18, directly to the Drug Enforcement Ad- § 1312.22 Application for export permit. ministration, Drug Operations Section, Washington, DC 20537. (a) An application for a permit to ex- (c) Copy 5 shall be retained by the port controlled substances shall be importer on file as his record of au- made on DEA Form 161 which may be thority for the importation. obtained from, and shall be filed with, the Drug Enforcement Administration, [36 FR 7815, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971; 37 FR 15923, Aug. 8, Drug Operations Section, Washington, 1972. Redesignated at 38 FR 26609, Sept. 24, DC 20537. Each application shall show 1973, and further amended at 45 FR 74715, the exporter’s name, address, and reg- Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 FR istration number; a detailed descrip- 48244, Nov. 30, 1988; 62 FR 13969, Mar. 24, 1997] tion of each controlled substance desired to be exported including the drug EXPORTATION OF CONTROLLED name, dosage form, National Drug Code SUBSTANCES (NDC) number, the Administration § 1312.21 Requirement of authoriza- Controlled Substance Code Number as tion to export. set forth in part 1308 of this chapter, (a) No person shall in any manner ex- the number and size of packages or port or cause to be exported from the containers, the name and quantity of United States any controlled substance the controlled substance contained in listed in Schedule I or II, or any nar- any finished dosage units, and the cotic substance listed in Schedule III quantity of any controlled substance or IV, or any non-narcotic substance in (expressed in anhydrous acid, base, or Schedule III which the Administrator alkaloid) given in kilograms or parts has specifically designated by regula- thereof. The application shall include tion in § 1312.30 of this part or any non- the name, address, and business of the narcotic substance in Schedule IV or V consignee, foreign port of entry, the which is also listed in Schedule I or II port of exportation, the approximate of the Convention on Psychotropic date of exportation, the name of the Substances unless and until such per- exporting carrier or vessel (if known, son is properly registered under the or if unknown it should be stated Act (or exempted from registration) whether shipment will be made by ex- and the Administrator has issued a per- press, freight, or otherwise, exports of mit pursuant to § 1312.23 of this part. controlled substances by mail being (b) No person shall in any manner ex- prohibited), the date and number, if port or cause to be exported from the any, of the supporting foreign import United States any non-narcotic con- license or permit accompanying the ap- trolled substance listed in Schedule III, plication, and the authority by whom IV, or V, excluding those described in such foreign license or permit was

123 § 1312.23 21 CFR Ch. II (4–1–99 Edition) issued. The application shall also con- stance listed in Schedule I or II or any tain an affidavit that the packages are narcotic controlled substance listed in labeled in conformance with obliga- Schedule III or IV if he finds that such tions of the United States under inter- exportation is permitted by sub- national treaties, conventions, or pro- sections 1003(a), (b), (c), or (d) of the tocols in effect on May 1, 1971, and Act (21 U.S.C. 953 (a), (b), (c), or (d). that, to the best of affiant’s knowledge (b) The Administrator may require and belief, the controlled substances that such non-narcotic controlled sub- therein are to be applied exclusively to stances in Schedule III as shall be des- medical or scientific uses within the ignated by regulation in § 1312.30 of this country to which exported, will not be part be exported only pursuant to the reexported therefrom and that there is issuance of an export permit. The Ad- an actual need for the controlled sub- ministrator may authorize the expor- stance for medical or scientific uses tation of such substances if he finds within such country. In the case of ex- that such exportation is permitted by portation of crude cocaine, the affi- section 1003(e) of the Act (21 U.S.C. davit may state that to the best of 953(e)). knowledge and belief, the controlled (c) If a non-narcotic substance listed substances will be processed within the in Schedule IV or V is also listed in country to which exported, either for Schedule I or II of the Convention on medical or scientific use within that Psychotropic Substances, it shall be country or for reexportation in accord- exported only pursuant to the issuance ance with the laws of that country to of an export permit. The Administrator another for medical or scientific use may authorize the exportation of such within that country. The application substances if he finds that such expor- shall be signed and dated by the ex- tation is permitted by section 1003(e) of porter and shall contain the address the Act (21 U.S.C. 953(e)). from which the substances will be (d) The Administrator may require shipped for exportation. an applicant to submit such documents (b) There shall also be submitted or written statements of fact relevant with the application any import license to the application as he deems nec- or permit (and a translation thereof if essary to determine whether the appli- in a foreign language) or a certified cation should be granted. The failure of copy of any such license or permit the applicant to provide such docu- issued by competent authorities in the ments or statements within a reason- country of destination, or other docu- able time after being requested to do so mentary evidence deemed adequate by shall be deemed to be a waiver by the the Administrator, showing that the applicant of an opportunity to present merchandise is consigned to an author- such documents or facts for consider- ized permittee, that it is to be applied ation by the Administrator in granting exclusively to medical or scientific use or denying the application. within the country of destination, that (e) Each export permit shall be issued it will not be reexported from such in septuplet and serially numbered, country, and that there is an actual with all seven copies bearing the same need for the controlled substance for serial number and being designated medical or scientific use within such ‘‘original’’ (Copy 1), ‘‘duplicate’’ (Copy country. (In the case of exportation of 2), etc., respectively. Each export per- bulk coca leaf alkaloid, the submitted mit shall be predicated upon an import evidence need only show the material certificate or other documentary evi- outlined in paragraph (a) of this sec- dence. Export permits are not transfer- tion for such exportations.) able. [36 FR 7815, Apr. 24, 1971. Redesignated at 38 (f) No export permit shall be issued FR 26609, Sept. 24, 1973, and amended at 52 for the exportation of any narcotic FR 17290, May 7, 1987; 62 FR 13969, Mar. 24, drug to any country when the Adminis- 1997] trator has information to show that the estimates submitted with respect § 1312.23 Issuance of export permit. to that country for the current period, (a) The Administrator may authorize under the Narcotic Limitation Conven- exportation of any controlled sub- tion of 1931, or the Single Convention

124 Drug Enforcement Administration, Justice § 1312.27 on Narcotic Drugs of 1961, have been, (d) The sextuplet and septuplet cop- or, considering the quantity proposed ies (Copy 6 and Copy 7) shall be re- to be imported, will be exceeded. If it tained by the Administration. shall appear through subsequent advice [36 FR 7815, Apr. 24, 1971, as amended at 36 received from the International Nar- FR 13387, July 21, 1971. Redesignated at 38 FR cotic Control Board of the United Na- 26609, Sept. 24, 1973, and amended at 45 FR tions that the estimates of the country 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; of destination have been adjusted to 53 FR 48244, Nov. 30, 1988; 62 FR 13969, Mar. 24, 1997] permit further importation of the narcotic drug, an export permit may then § 1312.25 Expiration date. be issued if otherwise permissible. An export permit shall not be valid [36 FR 23625, Dec. 11, 1971, as amended at 37 after the date specified therein, which FR 15923, Aug. 8, 1972. Redesignated at 38 FR date shall conform to the expiration 26609, Sept. 24, 1973, and amended at 52 FR date specified in the supporting import 17290, May 7, 1987] certificate or other documentary evidence upon which the export permit is § 1312.24 Distribution of copies of ex- founded, but in no event shall the date port permit. be subsequent to 6 months after the Copies of the export permit shall be date the permit is issued. Any unused distributed and serve purposes as fol- export permit shall be returned by the lows: permittee to the Drug Operations Sec- tion for cancellation. (a) The original, duplicate, and triplicate copies (Copy 1, Copy 2, and Copy [36 FR 7815, Apr. 24, 1971. Redesignated at 38 3) shall be transmitted by the Adminis- FR 26609, Sept. 24, 1973, and amended at 45 tration to the exporter who will retain FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 FR 48244, Nov. 30, 1988; 62 FR 13969, the triplicate copy (Copy 3) as his Mar. 24, 1997] record of authority for the exportation. The exporter shall present to the Dis- § 1312.26 Records required of exporter. trict Director of the U.S. Customs The exporter shall keep a record of Service at the port of export and at the any serial numbers that might appear time of shipment, the original and du- on packages of narcotic drugs in quan- plicate copies (Copy 1 and Copy 2). tities of one ounce or more in such a After endorsing the port of export on manner as will identify the foreign the reverse side of the original and du- consignee, along with Copy 3 of the ex- plicate copies (Copy 1 and Copy 2) the port permit. District Director shall forward the endorsed original copy (Copy 1) with the § 1312.27 Contents of special controlled substances invoice. shipment, and return the endorsed duplicate copy (Copy 2) to the Drug En- (a) A person registered or authorized forcement Administration, Drug Oper- to export any non-narcotic controlled ations Section, Washington, DC 20537. substance listed in Schedule III, IV, or (b) The quadruplet copy (Copy 4) V, which is not subject to the requirement of an export permit pursuant to shall be forwarded by the Adminis- § 1312.23 (b) or (c), or any person reg- trator to the District Director of the istered or authorized to export any U.S. Customs Service at the port of ex- controlled substance in Schedule V, port for comparison with the original must furnish a special controlled sub- copy (Copy 1) and for retention for the stances export invoice on DEA Form customs record. 236 to the Drug Enforcement Adminis- (c) The quintuplet copy (Copy 5) shall tration, Drug Operations Section, be forwarded by the Administration to Washington, DC 20537, not less than 15 the officer in the country of destina- calendar days prior to the proposed tion who issued the import certificate, date of exportation, and distribute four or other documentary evidence upon copies of same as hereinafter directed which the export permit is founded. in § 1312.28 of this part.

125 § 1312.27 21 CFR Ch. II (4–1–99 Edition)

(b) This invoice must be executed by (ii) Finished dosage units, if reex- the exporter in quintuplicate and in- ported, will be in a commercial pack- clude the following information. age, properly sealed and labeled for le- (1) The name, address, and registra- gitimate medical use in the country of tion number, if any, of the exporter; destination. and the name, address and registration (iii) Any reexportation be made number of the exporter broker, if any; known to DEA at the time the initial and DEA Form 236, Controlled Substances (2) A complete description of the con- Import/Export Declaration is com- trolled substances to be exported in- pleted, by checking the box marked cluding the drug name, dosage form, ‘‘other’’ on the certification. The fol- National Drug Code (NDC) number, the lowing information will be furnished in Administration Controlled Substances the remarks section: Code Number as set forth in part 1308 (A) Indicate ‘‘for reexport’’. of this chapter, the number and size of (B) Indicate if reexport is bulk or fin- packages or containers, the name and ished dosage units. quantity of the controlled substance (C) Indicate product name, dosage contained in finished dosage units, and strength, commercial package size, and the net quantity of any controlled sub- quantity. stance (expressed in anhydrous acid, (D) Indicate name of consignee, com- base, or alkaloid) given in kilograms or plete address, and expected shipment parts thereof; and date, as well as, the name and address (3) The proposed export date, the port of the ultimate consignee in the coun- of exportation, the foreign port of try to where the substances will be re- entry, the carriers and shippers in- exported. volved, method of shipment, the name (E) A statement that the consignee of the vessel if applicable, and the in the country of ultimate destination name, address, and reghstration num- is authorized under the laws and regu- ber, if any, of any forwarding agent lations of the country of ultimate des- utilized; and tination to receive the controlled sub- (4) The name and address of the con- stances. signee in the country of destination, (iv) Shipments which have been ex- and any registration or license number ported from the United States and are if the consignee is required to have refused by the consignee in the country such numbers either by the country of of destination, or are otherwise unac- destination or under United States law. ceptable or undeliverable, may be re- In addition, documentation must be turned to the registered exporter in the provided to show that: United States upon authorization of (i) The consignee is authorized under the Drug Enforcement Administration. the laws and regulations of the country In this circumstance, the exporter in of destination to receive the controlled the United States shall file a written substances, and that request for reexport, along with a com- (ii) The substance is being imported pleted DEA Form 236, Import Declara- for consumption within the importing tion with the Drug Enforcement Ad- country to satisfy medical, scientific ministration, Drug Operations Section, or other legitimate purposes, and that Washington, DC 20537. A brief summary (5) The reexport of non-narcotic con- of the facts that warrant the return of trolled substances in Schedules III and the substance to the United States IV, and controlled substances in Sched- along with an authorization from the ule V is not permitted under the au- country of export will be included with thority of 21 U.S.C. 953(e), except as the request. DEA will evaluate the re- provided below: quest after considering all the facts as (i) Bulk substances will not be reex- well as the exporter’s registration sta- ported in the same form as exported tus with DEA. The substance may be from the United States, i.e, the mate- returned to the United States only rial must undergo further manufac- after affirmative authorization is turing process. This further manufac- issued in writing by DEA. tured material may only be reexported (c) Notwithstanding the time limita- to a country of ultimate consumption. tions included in paragraph (a) of this

126 Drug Enforcement Administration, Justice § 1312.31 section, a registrant may obtain a spe- port or border, or deliver the controlled cial waiver of these time limitations in substances to a bonded carrier ap- emergency or unusual instances; pro- proved by the consignor for delivery to vided that a specific confirmation is re- the port or border, and may not, under ceived from the Administrator or his any other circumstances, release a delegate advising the registrant to pro- shipment of controlled substances to ceed pursuant to the special waiver. anyone, including the foreign consignee or his agent, within the United [36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR States. 26609, Sept. 24, 1973, and amended at 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; § 1312.30 Schedule III, IV, and V non- 52 FR 17290, May 7, 1987; 62 FR 13969, Mar. 24, narcotic controlled substances re- 1997] quiring an import and export permit. § 1312.28 Distribution of special con- The following Schedule III, IV, and V trolled substances invoice. non-narcotic controlled substances The required five copies of the spe- have been specifically designated by cial controlled substances export in- the Administrator of the Drug Enforce- voice, DEA (or BND) Form 236, will be ment Administration as requiring im- distributed as follows: port and export permits pursuant to (a) Copy 1 shall accompany the ship- sections 1002(b)(2) and 1003(e)(3) of the ment and remain with the shipment to Act (21 U.S.C. 952(b)(2) and 953(e)(3)): its destination. (a) [Reserved] (b) Copy 2 shall accompany the ship- [52 FR 17291, May 7, 1987] ment and will be detached and retained by appropriate customs officials at the TRANSSHIPMENT AND IN-TRANSIT foreign country of destination. SHIPMENT OF CONTROLLED SUBSTANCES (c) Copy 3 shall accompany the shipment and will be detached by the Dis- § 1312.31 Schedule I: Application for trict Director of the U.S. Customs prior written approval. Service at the port of exportation, who (a) A controlled substance listed in shall sign and date the certification of schedule I may be imported into the customs on such Copy 3, noting any United States for transshipment, or changes from the entries made by the may be transferred or transshipped exporter, and shall then promptly for- within the United States for immediate ward Copy 3 to the Drug Control Sec- exportation, provided that: tion of the Administration. (1) The controlled substance is nec- (d) Copy 4 shall be forwarded, within essary for scientific, medical, or other the time limit required in § 1312.27 of legitimate purposes in the country of this part, directly to the Drug Enforce- destination, and ment Administration, Drug Operations (2) A transshipment permit has been Section, Washington, DC 20537. The issued by the Administrator. documentation required by (b) An application for a trans- § 1312.27(b)(4) of this part must be at- shipment permit must be submitted to tached to this copy. the Drug Enforcement Administration, (e) Copy 5 shall be retained by the ex- Drug Operations Section, Washington, porter on file as his record of authority DC 20537, at least 30 days, or in the case for the exportation. of an emergency as soon as practicable, prior to the expected date of importa- [36 FR 7815, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. Redesignated at 38 FR tion, transfer or transshipment. Each 26609, Sept. 24, 1973, and amended at 45 FR application shall contain the following: 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; (1) The date of execution; 52 FR 17291, May 7, 1987; 53 FR 48244, Nov. 30, (2) The identification and description 1988; 62 FR 13969, Mar. 24, 1997] of the controlled substance; (3) The net quantity thereof; § 1312.29 Domestic release prohibited. (4) The number and size of the con- An exporter or a forwarding agent trolled substance containers; acting for an exporter must either de- (5) The name, address, and business liver the controlled substances to the of the foreign exporter;

127 § 1312.32 21 CFR Ch. II (4–1–99 Edition)

(6) The foreign port of exportation; written statements of fact relevant to (7) The approximate date of expor- the application as he deems necessary tation; to determine whether the application (8) The identification of the export- should be granted. The failure of the ing carrier; applicant to provide such documents or (9) The name, address and business of statements within a reasonable time the importer, transferor, or after being requested to do so shall be transshipper; deemed to be a waiver by the applicant (10) The registration number, if any, of an opportunity to present such docu- of the importer, transferor or ments or facts for consideration by the transshipper; Administrator in granting or denying (11) The U.S. port of entry; the application. (12) The approximate date of entry; (13) The name, address and business (g) The Administrator shall, within of the consignee at the foreign port of 21 days from the date of receipt of the entry; application, either grant or deny the (14) The shipping route from the U.S. application. The applicant shall be ac- port of exportation to the foreign port corded an opportunity to amend the of entry; application, with the Administrator ei- (15) The approximate date of receipt ther granting or denying the amended by the consignee at the foreign port of application within 7 days of its receipt. entry; and If the Administrator does not grant or (16) The signature of the importer, deny the application within 21 days of transferor or transshipper, or his agent its receipt, or in the case of an amend- accompanied by the agent’s title. ed application, within 7 days of its re- (c) An application shall be accom- ceipt, the application shall be deemed panied by an export license, permit, or approved and the applicant may pro- a certified copy of the export license, ceed. permit, or other authorization, issued by a competent authority of the coun- [36 FR 7815, Apr. 24, 1971, as amended at 37 try of origin (or other documentary FR 15923, Aug. 8, 1972. Redesignated at 38 FR evidence deemed adequate by the Ad- 26609, Sept. 24, 1973, and further amended at ministrator). 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 FR 48244, Nov. 30, 1988; 62 FR 13969, (d) An application shall be accom- Mar. 24, 1997] panied by an import license or permit or a certified copy of such license or § 1312.32 Schedules II, III, IV: Advance permit issued by a competent author- notice. ity of the country of destination (or other documentary evidence deemed (a) A controlled substance listed in adequate by the Administrator), indi- Schedules II, III, or IV may be im- cating that the controlled substance: ported into the United States for trans- (1) Is to be applied exclusively to sci- shipment, or may be transferred or entific, medical or other legitimate transshipped within the United States uses within the country of destination; for immediate exportation, provided (2) Will not be exported from such that written notice is submitted to the country; and Drug Enforcement Administration, (3) Is needed therein because there is Drug Operations Section, Washington, an actual shortage thereof and a de- DC 20537, at least 15 days prior to the mand therefor for scientific, medical or expected date of importation, transfer other legitimate uses within such or transshipment. country. (b) Each advance notice shall contain (e) Verification by an American con- those items required by § 1312.31 (b) and sular officer of the signatures on a for- (c). eign import license or permit shall be required, if such license or permit does [36 FR 7815, Apr. 24, 1971. Redesignated at 38 not bear the seal of the authority sign- FR 26609, Sept. 24, 1973, and amended at 45 ing them. FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, (f) The Administrator may require an 1986; 53 FR 48244, Nov. 30, 1988; 62 FR 13969, applicant to submit such documents or Mar. 24, 1997]

128 Drug Enforcement Administration, Justice § 1312.46

HEARINGS § 1312.44 Request for hearing or appearance; waiver. § 1312.41 Hearings generally. (a) Any applicant entitled to a hear- (a) In any case where the Adminis- ing pursuant to § 1312.42 and who de- trator shall hold a hearing regarding sires a hearing on the denial of his ap- the denial of an application for an im- plication for an import, export, or port, export or transshipment permit, transshipment permit shall, within 30 the procedures for such hearing shall days after the date of receipt of the de- be governed generally by the adjudica- nial of his application, file with the Ad- tion procedures set forth in the Admin- ministrator a written request for a istrative Procedure Act (5 U.S.C. 551– hearing in the form prescribed in § 1316.47 of this chapter. 559) and specifically by sections 1002 (b) Any applicant entitled to a hear- and 1003 of the Act (21 U.S.C. 952 and ing pursuant to § 1312.42 may, within 953), by §§ 1312.42–1312.47, and by the the period permitted for filing a re- procedures for administrative hearings quest for a hearing, file with the Ad- under the Act set forth in §§ 1316.41– ministrator a waiver of an opportunity 1316.67 of this chapter. for a hearing, together with a written (b) [Reserved] statement regarding his position on [36 FR 23625, Dec. 11, 1971, as amended at 37 the matters of fact and law involved in FR 15923, Aug. 8, 1972. Redesignated at 38 FR such hearing. Such statement, if ad- 26609, Sept. 24, 1973] missible, shall be made a part of the record and shall be considered in light § 1312.42 Purpose of hearing. of the lack of opportunity for cross-examination in determining the weight (a) If requested by a person applying to be attached to matters of fact as- for an import, export, or transshipment serted therein. permit, the Administrator shall hold a (c) If any applicant entitled to a hearing for the purpose of receiving hearing pursuant to § 1312.42 fails to ap- factual evidence regarding the issues pear at the hearing, he shall be deemed involved in the issuance or denial of to have waived his opportunity for the such permit to such person. hearing unless he shows good cause for (b) Extensive argument should not be such failure. offered into evidence but rather pre- (d) If the applicant waives or is sented in opening or closing state- deemed to have waived this oppor- ments of counsel or in memoranda or tunity for the hearing, the Adminis- proposed findings of fact and conclu- trator may cancel the hearing, if sions of law. scheduled, and issue his final order pursuant to § 1312.47 without a hearing. [36 FR 23625, Dec. 11, 1971, as amended at 37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR [37 FR 15923, Aug. 8, 1972. Redesignated at 38 26609, Sept. 24, 1973] FR 26609, Sept. 24, 1973] § 1312.45 Burden of proof. § 1312.43 Waiver or modification of rules. At any hearing on the denial of an application for an import, export, or The Administrator of the presiding transshipment permit, the Adminis- officer (with respect to matters pend- trator shall have the burden of proving ing before him) may modify or waive that the requirements for such permit any rule in this part by notice in ad- pursuant to sections 1002, 1003, and 1004 vance of the hearing, if he determines of the Act (21 U.S.C. 952, 953, and 954) that no party in the hearing will be un- are not satisfied. duly prejudiced and the ends of justice will thereby be served. Such notice of [37 FR 15924, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973] modification or waiver shall be made a part of the record of the hearing. § 1312.46 Time and place of hearing. [36 FR 23625, Dec. 11, 1971. Redesignated at 38 (a) If any applicant for an import, ex- FR 26609, Sept. 24, 1973] port, or transshipment permit requests

129 § 1312.47 21 CFR Ch. II (4–1–99 Edition) a hearing on the issuance or denial of 1313.23 Distribution of export declaration. his application, the Administrator 1313.24 Waiver of 15-day advance notice for shall hold such hearing. Notice of the chemical exporters. hearing shall be given to the applicant 1313.25 Foreign import restrictions. of the time and place at least 30 days TRANSSHIPMENTS, IN-TRANSIT SHIPMENTS AND prior to the hearing, unless the appli- INTERNATIONAL TRANSACTIONS INVOLVING cant waives such notice and requests LISTED CHEMICALS the hearing be held at an earlier time, 1313.31 Advance notice of importation for in which case the Administrator shall transshipment or transfer. fix a date for such hearing as early as 1313.32 Requirement of authorization for reasonably possible. international transactions. (b) The hearing will commence at the 1313.33 Contents of an international trans- place and time designated in the notice action declaration. given pursuant to paragraph (a) of this 1313.34 Distribution of the international section but thereafter it may be moved transaction declaration. 1313.41 Suspension of shipments. to a different place and may be continued from day to day or recessed to a HEARINGS later day without notice other than an- 1313.51 Hearings generally. nouncement thereof by the presiding 1313.52 Purpose of hearing. officer at the hearing. 1313.53 Waiver of modification of rules. 1313.54 Request for hearing. [37 FR 15924, Aug. 8, 1972. Redesignated at 38 1313.55 Burden of proof. FR 26609, Sept. 24, 1973] 1313.56 Time and place of hearing. 1313.57 Final order. § 1312.47 Final order. As soon as practicable after the pre- AUTHORITY: 21 U.S.C. 802, 830, 871(b), 971. siding officer has certified the record SOURCE: 54 FR 31665, Aug. 1, 1989, unless to the Administrator, the Adminis- otherwise noted. trator shall issue his order on the issuance or denial of the application § 1313.01 Scope. for and import, export, or trans- Procedures governing the importa- shipment permit. The order shall in- tion, exportation, transshipment and clude the findings of fact and conclu- in-transit shipment of listed chemicals sions of law upon which the order is pursuant to section 1018 of the Act (21 based. The Administrator shall serve U.S.C. 971) are governed generally by one copy of his order upon the appli- that section and specifically by the cant. sections of this part. [37 FR 15924, Aug. 8, 1972. Redesignated at 38 [54 FR 31665, Aug. 1, 1989, as amended at 60 FR 26609, Sept. 24, 1973] FR 32465, June 22, 1995]

PART 1313—IMPORTATION AND § 1313.02 Definitions. EXPORTATION OF PRECURSORS Any term used in this part shall have AND ESSENTIAL CHEMICALS the definition set forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter. Sec. 1313.01 Scope. [62 FR 13969, Mar. 24, 1997] 1313.02 Definitions. IMPORTATION OF LISTED CHEMICALS IMPORTATION OF LISTED CHEMICALS 1313.12 Requirement of authorization to im- § 1313.12 Requirement of authoriza- port. tion to import. 1313.13 Contents of import declaration. (a) Each regulated person who im- 1313.14 Distribution of import declaration. ports a listed chemical that meets or 1313.15 Waiver of 15-day advance notice for regular importers. exceeds the threshold quantities identified in § 1310.04(f) or is a listed chemical EXPORTATION OF LISTED CHEMICALS for which no threshold has been estab- 1313.21 Requirement of authorization to ex- lished as identified in § 1310.04(g) of this port. chapter, shall notify the Administrator 1313.22 Contents of export declaration. of the importation not later than 15

130 Drug Enforcement Administration, Justice § 1313.13 days before the transaction is to take has been waived for imports of the fol- place. lowing listed chemicals: (b) A completed DEA Form 486 must (1) [Reserved] be received at the following address not later than 15 days prior to the importa- [54 FR 31665, Aug. 1, 1989, as amended at 59 FR 51367, Oct. 11, 1994; 60 FR 32464, June 22, tion: 1995] Drug Enforcement Administration, P.O. Box 28346, Washington, DC 20038. § 1313.13 Contents of import declaration. A copy of the completed DEA Form 486 may be transmitted directly to the (a) Any List I or List II chemical list- Drug Enforcement Administration, ed in § 1310.02 of this chapter may be Drug Control Section, through elec- imported if that chemical is necessary tronic facsimile media not later than for medical, commercial, scientific, or 15 days prior to the importation. other legitimate uses within the (c) The 15-day advance notification United States. Chemical importations requirement for listed chemical im- into the United States for immediate ports may be waived for: transfer/transshipment outside the (1) Any regulated person who has sat- United States must comply with the isfied the requirements for reporting to procedures set forth in § 1313.31. the Administration as a regular im- (b) Any regulated person who desires porter of such listed chemicals; or to import a threshold or greater quan- (2) A specific listed chemical, as set tity of a listed chemical shall notify forth in paragraph (f) of this section, the Administration through procedures for which the Administrator deter- set forth in § 1313.12 and distribute mines that advance notification is not three copies of DEA Form 486 as di- necessary for effective chemical diver- rected in § 1313.14. sion control. (c) The DEA Form 486 must be exe- (d) For imports where advance notifi- cuted in triplicate and must include cation is waived pursuant to paragraph the following information: (c)(1) of this section, the DEA Form 486 (1) The name, address, telephone must be received by the Drug Enforce- number, telex number, and, where ment Administration, Chemical Oper- available, the facsimile number of the ations Section, on or before the date of chemical importer; the name, address, importation through use of the mailing telephone, telex, and where available, address listed in § 1313.12(b) or through the facsmile number of the broker or use of electronic facsimile media. forwarding agent (if any); and (e) For importations where advance (2) The name and description of each notification is waived pursuant to listed chemical as it appears on the paragraph (c)(2) of this section no DEA label or container, the name of each Form 486 is required, however, the reg- chemical as it is designated in 1310.02 ulated person shall submit quarterly of this chapter, the size or weight of reports to the Drug Enforcement Ad- container, the number of containers, ministration, Chemical Operations the net weight of each listed chemical Section, P.O. Box 28346, Washington, given in kilograms or parts thereof; DC 20038, by no later than the 15th day and the gross weight of the shipment of the month following the end of each given in kilograms or parts thereof; quarter. The report shall contain the and following information regarding each (3) The proposed import date, the for- individual importation: eign port of exportation and the first (1) The name of the listed chemical; U.S. Customs Port of Entry; and (2) The quantity and date imported; (3) The name and full business ad- (4) The name, address, telephone dress of the supplier; number, telex number, and, where (4) The foreign port of embarkation; available, the facsmile number of the and consignor in the foreign country of ex- (5) The port of entry. portation. (f) The 15 day advance notification [54 FR 31665, Aug. 1, 1989, as amended at 60 requirement set forth in paragraph (a) FR 32465, June 22, 1995]

131 § 1313.14 21 CFR Ch. II (4–1–99 Edition)

§ 1313.14 Distribution of import dec- (d) Unless the Administration noti- laration. fies the chemical importer to the con- The required three copies of the list- trary, the qualification of a regular im- ed chemical import declaration (DEA porter of any one of these three chemi- Form 486) will be distributed as fol- cals, acetone, 2-Butanone (MEK), or lows: toluene, qualifies that importer as a (a) Copy 1 shall be retained on file by regular importer of all three of these the regulated person as the official chemicals. record of import. Import declaration (e) All chemical importers shall be forms involving a List I chemical must required to file a DEA Form 486 as re- be retained for four years; declaration quired by Section 1313.12. forms for List II chemical must be re- [60 FR 32464, June 22, 1995, as amended at 62 tained for two years. FR 13969, Mar. 24, 1997] (b) Copy 2 is the Drug Enforcement Administration copy used to fulfill the EXPORTATION OF LISTED CHEMICALS notification requirements of Section 6053 of the Chemical Diversion and § 1313.21 Requirement of authoriza- Trafficking Act of 1988, as specified in tion to export. § 1313.12. (a) No person shall export or cause to (c) Copy 3 shall be presented to the be exported from the United States any U.S. Customs Sevice along with the chemical listed in § 1310.02 of this chap- customs entry. If the import is a regu- ter, which meets or exceeds the thresh- lated transaction for which the 15-day old quantities identified in § 1310.04(f) advance notice requirement has been or is a listed chemical for which no waived, the regulated person shall de- threshold has been established as iden- clare this information to the U.S. Cus- tified in § 1310.04(g) of this chapter, toms Service Official by checking the until such time as the Administrator block on the DEA Form 486 designated has been notified. Notification must be for this purpose. made not later than 15 days before the [54 FR 31665, Aug. 1, 1989, as amended at 60 transaction is to take place. In order to FR 32465, June 22, 1995] facilitate the export of listed chemicals and implement the purpose of the Act, § 1313.15 Waiver of 15-day advance no- regulated persons may wish to provide tice for regular importers. notification to the Administration as (a) Each regulated person seeking far in advance of the 15 days as pos- designation as a ‘‘regular importer’’ sible. shall provide, by certified mail return (b) A completed DEA Form 486 must receipt requested, to the Administra- be received at the following address not tion such information as is required later than 15 days prior to the expor- under § 1300.02(b)(13), documenting their tation: status as a regular importer. Drug Enforcement Administration, P.O. (b) Each regulated person making ap- Box 28346, Washington, DC 20038. plication under paragraph (a) of this section shall be considered a ‘‘regular A copy of the completed DEA Form importer’’ for purposes of waiving the 486 may be transmitted directly to the 15-day advance notice, 30 days after re- Drug Enforcement Administration, ceipt of the application by the Admin- Drug Control Section, through elec- istration, as indicated on the return re- tronic facsimile media not later than ceipt, unless the regulated person is 15 days prior to the exportation. otherwise notified in writing by the (c) The 15-day advance notification Administration. requirement for listed chemical ex- (c) The Administrator, may, at any ports may be waived for: time, disqualify a regulated person’s (1) Any regulated person who has sat- status as a regular importer on the isfied the requirements of Section grounds that the chemical being im- 1313.24 for reporting to the Administra- ported may be diverted to the clandes- tion an established business relation- tine manufacture of a controlled sub- ship with a foreign customer as defined stance. in § 1300.02(b)(12).

132 Drug Enforcement Administration, Justice § 1313.22

(2) A specific listed chemical to a which DEA has knowledge as provided specified country, as set forth in para- in § 1313.25. graph (f) of this section, for which the [54 FR 31665, Aug. 1, 1989, as amended at 59 Administrator determines that ad- FR 51367, Oct. 11, 1994; 60 FR 32464, June 22, vance notification is not necessary for 1995; 62 FR 13969, Mar. 24, 1997] effective chemical diversion control. (d) For exports where advance notifi- § 1313.22 Contents of export declara- cation is waived pursuant to paragraph tion. (c)(1) of this section, the DEA Form 486 (a) Any List I or List II chemical list- must be received by the Drug Enforce- ed in § 1310.02 of this chapter which ment Administration, Chemical Oper- meets or exceeds the quantitative ations Section, on or before the date of threshold criteria established in exportation through use of the mailing § 1310.04(f) of this chapter may be ex- address listed in Section 1313.12(b) or ported if that chemical is needed for through use of electronic facsimile medical, commercial, scientific, or media. other legitimate uses. (e) For exportations where advance (b) Any regulated person who desires notification is waived pursuant to to export a threshold or greater quan- paragraph (c)(2) of this section, the reg- tity of a listed chemical shall notify ulated person shall file quarterly re- the Administration through procedures ports to the Drug Enforcement Admin- outlined in § 1313.21 and distribute istration, Chemical Operations Sec- three copies of DEA Form 486 as dition, P.O. Box 28346, Washington, DC rected in § 1313.23. 20038, by no later than the 15th day of (c) The DEA Form 486 must be exe- the month following the end of each cuted in triplicate and must include all quarter. The report shall contain the the following information: following information regarding each (1) The name, address, telephone individual importation: number, telex number, and, where (1) The name of the listed chemical; available, the facsimile number of the (2) The quantity and date exported; chemical exporter; the name, address, (3) The name and full business ad- telephone number, telex number, and, dress of the foreign customer; where available, the facsimile number of the export broker, if any; (4) The port of embarkation; and (2) The name and description of each (5) The foreign port of entry. listed chemical as it appears on the (f) The 15 day advance notification label or container, the name of each requirement set forth in paragraph (a) listed chemical as it is designated in of this section has been waived for ex- § 1310.02 of this chapter, the size or ports of the following listed chemicals weight of container, the number of con- to the following countries: tainers, the net weight of each listed Name of Chemical Country chemical given in kilograms or parts thereof, and the gross weight of the [Reserved] ...... shipment given in kilograms or parts thereof; (g) No person shall export or cause to (3) The proposed export date, the U.S. be exported any listed chemical, know- Customs port of exportation, and the ing or having reasonable cause to be- foreign port of entry; and lieve the export is in violation of the (4) The name, address, telephone, laws of the country to which the chem- telex, and where available, the fac- ical is exported or the chemical will be simile number of the consignee in the used to manufacture a controlled sub- country where the chemical shipment stance in violation of the Act or the is destined; the name(s) and address(es) laws of the country to which the chem- of any intermediate consignee(s). ical is exported. The Administration (d) Notwithstanding the time limita- will publish a notice of foreign import tions included in paragraph (b) of this restrictions for listed chemicals of section, a regulated person may receive

133 § 1313.23 21 CFR Ch. II (4–1–99 Edition) a waiver of the 15-day advance notifica- with a foreign customer not later than tion requirement following the proce- August 31, 1989. dures outlined in § 1313.24. (b) Not later than October 31, 1989, (e) Declared exports of listed chemi- each regular customer so identified in cals which are refused, rejected, or oth- notifications made under § 1313.24(a) erwise deemed undeliverable may be shall be a regular customer for pur- returned to the U.S. chemical exporter poses of waiving the 15-day advance no- of record. A brief written notification tice requirement, unless the regulated (this does not require a DEA Form 486) person is otherwise notified in writing outlining the circumstances must be by the Administration. sent to the Drug Enforcement Adminis- (c) Each foreign customer identified tration, P.O. Box 28346, Washington, DC on an initial DEA Form 486 submitted 20038, following the return within a after the effective date of the imple- reasonable time. This provision does mentation of part 1313 shall, after the not apply to shipments that have expiration of the 15-day period, qualify cleared foreign customs, been deliv- as a regular customer, unless the Ad- ered, and accepted by the foreign con- ministration otherwise notifies the signee. Returns to third parties in the regulated person in writing. United States will be regarded as imports. (d) Unless the Administration notifies the chemical exporter to the con- [54 FR 31665, Aug. 1, 1989, as amended at 60 trary, the qualification of a regular FR 32465, June 22, 1995] customer for any one of these three chemicals, acetone, 2-Butanone (MEK), § 1313.23 Distribution of export declaration. or toluene, qualifies that customer as a regular customer for all three of these The required three copies of the list- chemicals. ed chemical export declaration (DEA (e) The Administrator may notify Form 486) will be distributed as fol- any chemical exporter that a regular lows: customer has been disqualified or that (a) Copy 1 shall be retained on file by a new customer for whom a notifica- the chemical exporters as the official tion has been submitted is not to be ac- record of export. Export declaration forms involving a List I chemical must corded the status of a regular cus- be retained for four years; declaration tomer. In the event of a disqualifica- forms for list II chemical must be re- tion of an established regular cus- tained for two years. tomer, the chemical exporter will be (b) Copy 2 is the Drug Enforcement notified in writing of the reasons for Administration copy used to fulfill the such action. notification requirements of Section Public reporting (one-time) burden for 6053 of the Chemical Diversion and this collection of information is esti- Trafficking Act of 1988, as specified in mated to average four hours per re- § 1313.21 sponse, including the time for review- (c) Copy 3 shall be presented to the ing instructions, searching existing U.S. Customs Service at the port of data sources, gathering and maintain- exit for each export of a listed chem- ing the data needed, and completing ical or chemicals on or before the day and reviewing and collection of infor- of exportation, and when possible, mation. Send comments regarding this along with the Shippers Export Dec- burden estimate or any other aspect of laration. this collection of information, including suggestions for reducing this bur- [54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32465, June 22, 1995; 61 FR 51004, Sept. 30, den to the Drug Enforcement Adminis- 1996] tration, Records Management Section, Washington, DC 20537; and to the Office § 1313.24 Waiver of 15-day advance no- of Management and Budget, Paperwork tice for chemical exporters. Reduction Project No. 1117–0025, Wash- (a) Each regulated person shall pro- ington, DC 20503. vide to the Administration the identity [54 FR 31665, Aug. 1, 1989, as amended at 56 and information listed in § 1300.02(b)(12) FR 55077, Oct. 24, 1991; 62 FR 13969, Mar. 24, for an established business relationship 1997]

134 Drug Enforcement Administration, Justice § 1313.32

§ 1313.25 Foreign import restrictions. of the importer, transferor, or Any export from the United States in transshipper; violation of the law of the country to (12) The U.S. port of entry; which the chemical is exported is sub- (13) The approximate date of entry; ject to the penalties of Title 21 United (14) The name, address, telephone States Code 960(d). number, telex number, business of the consignee and, where available, fac- TRANSSHIPMENTS, IN-TRANSIT SHIP- simile number of the consignee at the MENTS AND INTERNATIONAL TRANS- foreign port of entry; ACTIONS INVOLVING LISTED CHEMICALS (15) The shipping route from the U.S. port of exportation to the foreign port § 1313.31 Advance notice of importa- of entry at final destination; tion for transshipment or transfer. (16) The approximate date of receipt (a) A quantity of a chemical listed in by the consignee at the foreign port of § 1310.02 of this chapter that meets or entry; and exceeds the threshold reporting re- (17) The signature of the importer, quirements found in § 1310.04(f) of this transferor or transshipper, or his chapter may be imported into the agent, accompanied by the agent’s United States for transshipment, or title. may be transferred or transshipped (c) Unless notified to the contrary within the United States for immediate prior to the expected date of delivery, exportation, provided that advance no- the importation for transshipment or tice is given to the Administration. transfer is considered approved. (b) Advance notification must be pro- (d) No waiver of the 15-day advance vided to the Drug Enforcement Admin- notice will be given for imports of list- istration, P.O. Box 28346, Washington, ed chemicals in quantities meeting or DC 20038, not later than 15 days prior to exceeding threshold quantities for the proposed date the listed chemical transshipment or transfer outside the will transship or transfer through the United States. United States. The written notification (not a DEA Form 486) shall contain the § 1313.32 Requirement of authoriza- following information: tion for international transactions. (1) The date the notice was executed; (a) A broker or trader shall notify (2) The complete name and descrip- the Administrator prior to an inter- tion of the listed chemical as it ap- national transaction involving a listed pears on the label or container. chemical which meets or exceeds the (3) The name of the listed chemical threshold amount identified in Section as designated by § 1310.02 of this chap- 1310.04 of this chapter, in which the ter. broker or trader participates. Notifica- (4) The number of containers and the tion must be made no later than 15 size or weight of the container for each days before the transaction is to take listed item; place. In order to facilitate an inter- (5) The new weight of each listed national transaction involving listed chemical given in kilograms or parts chemicals and implement the purpose thereof; of the Act, regulated persons may wish (6) The gross weight of the shipment to provide advance notification to the given in kilograms or parts thereof; Administration as far in advance of the (7) The name, address, telephone 15 days as possible. number, telex number, business of the (b)(1) A completed DEA Form 486 foreign exporter and, where available, must be received at the following ad- the facsimile number; dress not later than 15 days prior to the (8) The foreign port of exportation; international transaction: (9) The approxhmate date of exportation; Drug Enforcement Administration, P.O. (10) The complete identification of Box 28346, Washington, D.C. 20038 the exporting carrier; (2) A copy of the DEA Form 486 may (11) The name, address, business, be transmitted directly to the Drug telephone number, telex number, and, Enforcement Administration, Chemical where available, the facsimile number Operations Section, through electronic

135 § 1313.33 21 CFR Ch. II (4–1–99 Edition) facsimile media not later than 15 days (3) The proposed export date, the port prior to the exportation. of exportation, and the port of impor- (c) No person shall serve as a broker tation; and or trader for an international trans- (4) The name, address, telephone, action involving a listed chemical telex, and where available, the fac- knowing or having reasonable cause to simile number, of the consignee in the believe that the transaction is in viola- country where the chemical shipment tion of the laws of the country to is destined; the name(s) and address(es) which the chemical is exported or the of any intermediate consignee(s). chemical will be used to manufacture a [60 FR 32465, June 22, 1995] controlled substance in violation of the laws of the country to which the chem- § 1313.34 Distribution of the inter- ical is exported. The Administration national transaction declaration. will publish a notice of foreign import The required three copies of the DEA restrictions for listed chemicals of Form 486 will be distributed as follows: which DEA has knowledge as provided (a) Copies 1 and 3 shall be retained on in Section 1313.25. file by the broker or trader as the offi- [60 FR 32465, June 22, 1995; 61 FR 17566, Apr. cial record of the international trans- 22, 1996] action. Declaration forms involving List I chemicals shall be retained for § 1313.33 Contents of an international List II chemicals shall be retained for transaction declaration. four years; declaration forms for two (a) An international transaction in- years. volving a chemical listed in § 1310.02 of (b) Copy 2 is the Drug Enforcement this chapter which meets the threshold Administration copy used to fulfill the criteria established in § 1310.04 of this notification requirements of Section chapter may be arranged by a broker 1313.32. or trader if the chemical is needed for [60 FR 32465, June 22, 1995; 60 FR 35264, July medical, commercial, scientific, or 6, 1995] other legitimate uses. (b) Any broker or trader who desires § 1313.41 Suspension of shipments. to arrange an international trans- (a) The Administrator may suspend action involving a listed chemical any importation or exportation of a which meets the criteria set forth in chemical listed in § 1310.02 of this chap- Section 1310.04 shall notify the Admin- ter based on evidence that the chem- istration through the procedures out- ical proposed to be imported or ex- lined in Section 1313.32(b). ported may be diverted to the clandes- (c) The DEA Form 486 must be exe- tine manufacture of a controlled sub- cuted in triplicate and must include all stance. If the Administrator so sus- the following information: pends, he shall provide written notice (1) The name, address, telephone of such suspension to the regulated number, telex number, and, where person. Such notice shall contain a available, the facsimile number of the statement of the legal and factual basis chemical exporter; the name, address, for the order. telephone number, telex number, and, (b) Upon service of the order of sus- where available, the facsimile number pension, the regulated person to whom of the chemical importer; the order applies under paragraph (a) of (2) The name and description of each this section must, if he desires a hear- listed chemical as it appears on the ing, file a written request for a hearing label or container, the name of each pursuant to §§ 1313.51–1313.57. listed chemical as it is designated in Section 1310.02 of this chapter, the size HEARINGS or weight of container, the number of containers, the net weight of each list- § 1313.51 Hearings generally. ed chemical given in kilograms or In any case where a regulated person parts thereof, and the gross weight of requests a hearing regarding the sus- the shipment given in kilograms or pension of a shipment of a listed chem- parts thereof; ical, the procedures for such hearing

136 Drug Enforcement Administration, Justice Pt. 1316 shall be governed generally by the pro- § 1313.55 Burden of proof. cedures set forth in the Administrative At any hearing regarding the suspen- Procedure Act (5 U.S.C. 551–559) and sion of shipments, the Agency shall specifically by section 6053 of the have the burden of proving that the re- Chemical Diversion and Trafficking quirements of this part for such sus- Act (Pub. L. 100–690), by 21 CFR 1313.52– pension are satisfied. 1313.57, and by the procedures for administrative hearings under the Con- § 1313.56 Time and place of hearing. trolled Substances Act set forth in §§ 1316.41–1316.67 of this chapter. (a) If any regulated person requests a hearing on the suspension of ship- § 1313.52 Purpose of hearing. ments, a hearing will be scheduled no later than 45 days after the request is If requested by a person entitled to a made, unless the regulated person re- hearing, the Administrator shall cause quests an extension to this date. a hearing to be held for the purpose of (b) The hearing will commence at the receiving factual evidence regarding place and time designated in the notice the issues involved in the suspension of given pursuant to paragraph (a) of this shipments within 45 days of the date of section but thereafter it may be moved the request, unless the requesting to a different place and may be contin- party requests an extension of time. ued from day to day or recessed to a § 1313.53 Waiver of modification of later day without notice other than an- rules. nouncement thereof by the presiding officer at the hearing. The Administrator or the presiding officer (with respect to matters pend- § 1313.57 Final order. ing before him) may modify or waive any rule in this part by notice in ad- As soon as practicable after the pre- vance of the hearing, if he determines siding officer has certified the record that no party in the hearing will be un- to the Administrator, the Adminis- duly prejudiced and the ends of justice trator shall issue his order regarding will thereby be served. Such notice of the suspension of shipment. The order modification or waiver shall be made a shall include the findings of fact and part of the record of the hearing. conclusions of law upon which the order is based. The Administrator shall § 1313.54 Request for hearing. serve one copy of his order upon each party in the hearing. (a) Any person entitled to a hearing pursuant to § 1313.52 and desiring a hearing shall, within 30 days after re- PARTS 1314–1315 [RESERVED] ceipt of the notice to suspend the shipment, file with the Administrator a PART 1316—ADMINISTRATIVE written request for a hearing in the FUNCTIONS, PRACTICES, AND form prescribed in § 1316.47 of this chap- PROCEDURES ter. (b) If any person entitled to a hearing Subpart A—Administrative Inspections or to participate in a hearing pursuant to § 1313.41 fails to file a request for a Sec. hearing or a notice of appearance, or if 1316.01 Scope of subpart A. 1316.02 Definitions. he so files and fails to appear at the 1316.03 Authority to make inspections. hearing, he shall be deemed to have 1316.04 Exclusion from inspection. waived his opportunity for the hearing 1316.05 Entry. or to participate in the hearing, unless 1316.06 Notice of inspection. he shows good cause for such failure. 1316.07 Requirement for administrative in- (c) If all persons entitled to a hearing spection warrant; exceptions. or to participate in a hearing waive or 1316.08 Consent to inspection. are deemed to waive their opportunity 1316.09 Application for administrative inspection warrant. for the hearing or to participate in the 1316.10 Administrative probable cause. hearing, the Administrator may cancel 1316.11 Execution of warrants. the hearing, if scheduled, and issue his 1316.12 Refusal to allow inspection with an final order pursuant to § 1313.57. administrative warrant.

137 § 1316.01 21 CFR Ch. II (4–1–99 Edition)

1316.13 Frequency of administrative inspec- 1316.75 Advertisement. tions. 1316.76 Requirements as to claim and bond. 1316.77 Administrative forfeiture. Subpart B—Protection of Researchers and 1316.78 Judicial forfeiture. Research Subjects 1316.79 Petitions for remission or mitigation of forfeiture. 1316.21 Definitions. 1316.80 Time for filing petitions. 1316.22 Exemption. 1316.81 Handling of petitions. 1316.23 Confidentiality of identity of research subjects. Subpart F—Expedited Forfeiture 1316.24 Exemption from prosecution for researchers. Proceedings for Certain Property 1316.90 Purpose and scope. Subpart C—Enforcement Proceedings 1316.91 Definitions. 1316.31 Authority for enforcement pro- 1316.92 Petition for expedited release in an ceeding. administrative forfeiture action. 1316.32 Notice of proceeding; time and place. 1316.93 Ruling on petition for expedited re- 1316.33 Conduct of proceeding. lease in an administrative forfeiture ac- 1316.34 Records of proceeding. tion. 1316.94 Posting of substitute res in an ad- Subpart D—Administrative Hearings ministrative forfeiture action. 1316.95 Petition for expedited release of a 1316.41 Scope of subpart D. conveyance in a judicial forfeiture ac- 1316.42 Definitions. tion. 1316.43 Information; special instructions. 1316.96 Ruling on a petition for expedited 1316.44 Waiver or modification of rules. release of a conveyance in a judicial for- 1316.45 Filings; address; hours. feiture action. 1316.46 Inspection of record. 1316.97 Initiating judicial forfeiture pro- 1316.47 Request for hearing. ceeding against a conveyance within 60 1316.48 Notice of appearance. days of the filing of a claim and cost 1316.49 Waiver of hearing. bond. 1316.50 Appearance; representation; author- 1316.98 Substitute res bond in a judicial for- ization. feiture action against a conveyance. 1316.51 Conduct of hearing and parties; ex 1316.99 Notice provisions. parte communications. 1316.52 Presiding officer. SOURCE: 36 FR 7820, Apr. 24, 1971, unless 1316.53 Time and place of hearing. otherwise noted. Redesignated at 38 FR 26609, 1316.54 Prehearing conference. Sept. 24, 1973. 1316.55 Prehearing ruling. 1316.56 Burden of proof. 1316.57 Submission of documentary evidence Subpart A—Administrative and affidavits and identification of wit- Inspections nesses subsequent to prehearing conference. AUTHORITY: 21 U.S.C. 822(f), 830(a), 871(b), 1316.58 Summary of testimony; affidavits. 880, 958(f), 965. 1316.59 Submission and receipt of evidence. 1316.60 Objections; offer of proof. § 1316.01 Scope of subpart A. 1316.61 Exceptions to rulings. Procedures regarding administrative 1316.62 Appeal from ruling of presiding officer. inspections and warrants pursuant to 1316.63 Official transcript; index; correc- sections 302(f), 510, 1008(d), and 1015 of tions. the Act (21 U.S.C. 822(f), 880, 958(d), and 1316.64 Proposed findings of fact and conclu- 965) are governed generally by those sions of law. sections and specifically by the sec- 1316.65 Report and record. tions of this subpart. 1316.66 Exceptions. 1316.67 Final order. § 1316.02 Definitions. 1316.68 Copies of petitions for judicial review. As used in this subpart, the following terms shall have the meanings speci- Subpart E—Seizure, Forfeiture, and fied: Disposition of Property (a) The term Act means the Con- 1316.71 Definitions. trolled Substances Act (84 Stat. 1242; 21 1316.72 Officers who will make seizures. U.S.C. 801) and/or the Controlled Sub- 1316.73 Custody and other duties. stances Import and Export Act (84 1316.74 Appraisement. Stat. 1285; 21 U.S.C. 951).

138 Drug Enforcement Administration, Justice § 1316.03

(b) The term Administration means part 1304 of this chapter, order form the Drug Enforcement Administration. records required to be kept pursuant to (c) The term controlled premises part 1305 of this chapter, prescription means— and distribution records required to be (1) Places where original or other kept pursuant to part 1306 of this chap- records or documents required under ter, records of listed chemicals, the Act are kept or required to be kept, tableting machines, and encapsulating and machines required to be kept pursuant (2) Places, including factories, ware- to part 1310 of this chapter, import/ex- houses, or other establishments and port records of listed chemicals re- conveyances, where persons registered quired to be kept pursuant to part 1313 under the Act or exempted from registration under the Act, or regulated of this chapter, shipping records identi- persons may lawfully hold, manufac- fying the name of each carrier used and ture, or distribute, dispense, admin- the date and quantity of each ship- ister, or otherwise dispose of controlled ment, and storage records identifying substances or listed chemicals or where the name of each warehouse used and records relating to those activities are the date and quantity of each storage. maintained. (b) Inspecting within reasonable lim- (d) The term Administrator means the its and to a reasonable manner all per- Administrator of the Administration. tinent equipment, finished and unfin- The Administrator has been delegated ished controlled substances, listed authority under the Act by the Attor- chemicals, and other substances or ma- ney General (28 CFR 0.100). terials, containers, and labeling found (e) The term inspector means an offi- at the controlled premises relating to cer or employee of the Administration this Act; authorized by the Administrator to (c) Making a physical inventory of make inspections under the Act. all controlled substances and listed (f) The term register and registration chemicals on-hand at the premises; refer to registration required and per- (d) Collecting samples of controlled mitted by sections 303 and 1008 of the Act (21 U.S.C. 823 and 958). substances or listed chemicals (in the (g) Any term not defined in this part event any samples are collected during shall have the definition set forth in an inspection, the inspector shall issue section 102 of the Act (21 U.S.C. 802) or a receipt for such samples on DEA part 1300 of this chapter. Form 84 to the owner, operator, or agent in charge of the premises); [36 FR 7820, Apr. 24, 1971. Redesignated at 38 (e) Checking of records and informa- FR 26609, Sept. 24, 1973, as amended at 60 FR 32465, June 22, 1995; 60 FR 36334, July 14, 1995; tion on distribution of controlled sub- 62 FR 13969, Mar. 24, 1997] stances or listed chemicals by the registrant or regulated person (i.e., has § 1316.03 Authority to make inspec- the distribution of controlled sub- tions. stances or listed chemicals increased In carrying out his functions under markedly within the past year, and if the Act, the Administrator, through so why); his inspectors, is authorized in accord- (f) Except as provided in § 1316.04, all ance with sections 510 and 1015 of the other things therein (including records, Act (21 U.S.C. 880 and 965) to enter con- files, papers, processes, controls and fa- trolled premises and conduct adminis- cilities) appropriate for verification of trative inspections thereof, for the pur- the records, reports, documents re- pose of: ferred to above or otherwise bearing on (a) Inspecting, copying, and verifying the provisions of the Act and the regu- the correctness of records, reports, or other documents reqtired to be kept or lations thereunder. made under the Act and regulations [36 FR 7820, Apr. 24, 1971. Redesignated at 38 promulgated under the Act, including, FR 26609, Sept. 24, 1973, and amended at 51 but not limited to, inventory and other FR 5319, Feb. 13, 1986; 55 FR 50827, Dec. 11, records required to be kept pursuant to 1990; 60 FR 32465, June 22, 1995]

139 § 1316.04 21 CFR Ch. II (4–1–99 Edition)

§ 1316.04 Exclusion from inspection. for initial registration under the Act, (a) Unless the owner, operator or for the inspection of books and records agent in charge of the controlled prem- pursuant to an administrative sub- ises so consents in writing, no inspec- poena issued in accordance with section authorized by these regulations tion 506 of the Act (21 U.S.C. 876) nor shall extend to: for entries in administrative inspec- (1) Financial data: tions (including seizures of property): (2) Sales data other than shipping (a) With the consent of the owner, op- data; or erator, or agent in charge of the con- (3) Pricing data. trolled premises as set forth in § 1316.08; (b) [Reserved] (b) In situations presenting imminent danger to health or safety; § 1316.05 Entry. (c) In situations involving inspection An inspection shall be carried out by of conveyances where there is reason- an inspector. Any such inspector, upon able cause to obtain a warrant; (a) stating his purpose and (b) pre- (d) In any other exceptional or emer- senting to the owner, operator or agent gency circumstance or time or oppor- in charge of the premises to be in- tunity to apply for a warrant is lack- spected (1) appropriate credentials, and ing; or (2) written notice of his inspection au- (e) In any other situations where a thority under § 1316.06 of this chapter, warrant is not constitutionally re- and (c) receiving informed consent quired. under § 1316.08 or through the use of administrative warrant issued under § 1316.08 Consent to inspection. §§ 1316.09–1316.13, shall have the right to (a) An administrative inspection war- enter such premises and conduct in- rant shall not be required if informed spections at reasonable times and in a consent is obtained from the owner, op- reasonable manner. erator, or agent in charge of the con- [36 FR 7820, Apr. 24, 1971, as amended at 36 trolled premises to be inspected. FR 13387, July 21, 1971. Redesignated at 38 FR (b) Wherever possible, informed con- 26609, Sept. 24, l973; 62 FR 13970, Mar. 24, 1997] sent shall consist of a written statement signed by the owner, operator, or § 1316.06 Notice of inspection. agent in charge of the premises to be The notice of inspection (DEA (or inspected and witnessed by two per- DNB) Form 82) shall contain: sons. The written consent shall contain (a) The name and title of the owner, the following information: operator, or agent in charge of the con- (1) That he (the owner, operator, or trolled premises; agent in charge of the premises) has (b) The controlled premises name; been informed of his constitutional (c) The address of the controlled right not to have an administrative in- premises to be inspected; spection made without an administra- (d) The date and time of the inspec- tive inspection warrant; tion; (2) That he has right to refuse to con- (e) A statement that a notice of in- sent to such an inspection; spection is given pursuant to section 510 of the Act (21 U.S.C. 880); (3) That anything of an incriminating (f) A reproduction of the pertinent nature which may be found may be parts of section 510 of the Act; and seized and used against him in a crimi- (g) The signature of the inspector. nal prosecution; (4) That he has been presented with a § 1316.07 Requirement for administra- notice of inspection as set forth in tive inspection warrant; exceptions. § 1316.06; In all cases where an inspection is (5) That the consent is given by him contemplated, an administrative in- is voluntary and without threats of any spection warrant is required pursuant kind; and to section 510 of the Act (21 U.S.C. 880), (6) That he may withdraw his consent except that such warrant shall not be at any time during the course of in- required for establishments applying spection.

140 Drug Enforcement Administration, Justice § 1316.13

(c) The written consent shall be pro- mean criminal probable cause as de- duced in duplicate and be distributed fined by Federal statute or case law. as follows: (1) The original will be retained by § 1316.11 Execution of warrants. the inspector; and An administrative inspection war- (2) The duplicate will be given to the rant shall be executed and returned as person inspected. required by, and any inventory or sei- [36 FR 7820, Apr. 24, 1971, as amended at 37 zure made shall comply with the re- FR 15924, Aug. 8, 1972. Redesignated at 38 FR quirements of, section 510(d)(3) of the 26609, Sept. 24, 1973] Act (21 U.S.C. 880(d)(3)). The inspection shall begin as soon as is practicable § 1316.09 Application for administra- after the issuance of the administrative inspection warrant. tive inspection warrant and shall be (a) An administrative inspection war- completed with reasonable promptness. rant application shall be submitted to The inspection shall be conducted dur- any judge of the United States or of a ing regular business hours and shall be State court of record, or any United completed in a reasonable manner. States magistrate and shall contain the following information: § 1316.12 Refusal to allow inspection with an administrative warrant. (1) The name and address of the controlled premises to be inspected; If a registrant or any person subject (2) A statement of statutory author- to the Act refuses to permit execution ity for the administrative inspection of an administrative warrant or im- warrant, and that the fact that the par- pedes the inspector in the execution of ticular inspection in question is de- that warrant, he shall be advised that signed to insure compliance with the such refusal or action constitutes a Act and the regulations promulgated violation of section 402(a)(6) of the Act thereunder; (21 U.S.C. 842(a)(6)). If he persists and (3) A statement relating to the na- the circumstances warrant, he shall be ture and extent of the administrative arrested and the inspection shall com- inspection, including, where necessary, mence or continue. a request to seize specified items and/or [36 FR 7820, Apr. 24, 1971. Redesignated at 38 to collect samples of finished or unfin- FR 26609, Sept. 24, 1973, as amended at 62 FR ished controlled substances or listed 13970, Mar. 24, 1997] chemicals; (4) A statement that the establish- § 1316.13 Frequency of administrative ment either: inspections. (i) Has not been previously inspected, Except where circumstances other- or wise dictate, it is the intent of the Ad- (ii) Was last inspected on a particular ministration to inspect all manufactur- date. ers of controlled substances listed in (b) The application shall be sub- Schedules I and II and distributors of mitted under oath to an appropriate controlled substances listed in Sched- judge or magistrate. ule I once each year. Distributors of controlled substances listed in Sched- [36 FR 7820, Apr. 24, 1971, as amended at 36 ules II through V and manufacturers of FR 13387, July 21, 1971. Redesignated at 38 FR controlled substances listed in Sched- 26609, Sept. 24, 1973; 60 FR 32466, June 22, 1995] ules III through V shall be inspected as § 1316.10 Administrative probable circumstances may require, based in cause. part on the registrant’s history of compliance with the requirements of this If the judge or magistrate is satisfied chapter and maintenance of effective that ‘‘administrative probable cause,’’ controls and procedures to guard as defined in section 510(d)(1) of the Act against the diversion of controlled sub- (21 U.S.C. 880(d)(1)) exists, he shall stances. issue an administrative warrant. Ad- ministrative probable cause shall not [62 FR 13969, Mar. 24, 1997]

141 § 1316.21 21 CFR Ch. II (4–1–99 Edition)

Subpart B—Protection of Re- subjects of such research may petition searchers and Research Sub- the Administrator of the Drug Enforce- jects ment Administration for a grant of confidentiality: Providing, That: AUTHORITY: 21 U.S.C. 830, 871(b). (1) The Attorney General is authorized to carry out such research under § 1316.21 Definitions. the provisions of Section 502(a) (2–6) of As used in this part, the following the Controlled Substances Act of 1970 terms shall have the meanings speci- (21 U.S.C. 872(a) (2–6)); and the research fied: is being conducted with funds provided (a) The term investigative personnel in whole or part by the Department of includes managers, Diversion Inves- Justice; or tigators, attorneys, analysts and sup- (2) The research is of a nature that port personnel employed by the Drug the Attorney General would be author- Enforcement Administration who are ized to carry out under the provisions involved in the processing, reviewing of Section 502(a) (2–6) of the Controlled and analyzing of declarations and other Substances Act (21 U.S.C. 872(a) (2–6), relevant documents or data relative to and is being conducted with funds pro- regulated transactions or are involved vided from sources outside the Depart- in conducting investigations initiated ment of Justice. pursuant to the receipt of such declara- (b) All petitions for Grants of Con- tions, documents or data. fidentiality shall be addressed to the (b) The term law enforcement per- Administrator, Drug Enforcement Ad- sonnel means Special Agents employed ministration, Washington, DC 20537, by the Drug Enforcement Administra- and shall contain the following: tion who, in the course of their official (1) A statement as to whether the re- duties, gain knowledge of information search protocol requires the manufac- which is confidential under such sec- ture, production, import, export, dis- tion. tribution, dispensing, administration, or possession of controlled substances, [54 FR 31670, Aug. 1, 1989] and if so the researcher’s registration § 1316.22 Exemption. number or a statement that an application for such registration has been sub- (a) Any person who is aggrieved by a mitted to DEA; disclosure of information in violation (2) The location of the research of subsection (c)(1) of Section 310 of the project; Controlled Substances Act (21 U.S.C. (3) The qualifications of the principal 830) may bring a civil action against investigator; the violator for appropriate relief. (4) A general description of the re- (b) Notwithstanding the provision of search or a copy of the research pro- paragraph (a), a civil action may not be tocol; brought under such paragraph against (5) The source of funding for the re- investigative or law enforcement per- search project; sonnel of the Drug Enforcement Ad- (6) A statement as to the risks posed ministration. to the research subjects by the re- [54 FR 31670, Aug. 1, 1989] search procedures and what protection will be afforded to the research sub- § 1316.23 Confidentiality of identity of jects; research subjects. (7) A statement as to the risks posed (a) Any person conducting a bona fide to society in general by the research research project directly related to the procedures and what measures will be enforcement of the laws under the ju- taken to protect the interests of soci- risdiction of the Attorney General con- ety; cerning drugs or other substances (8) A specific request to withhold the which are or may be subject to control names and/or any other identifying under the Controlled Substances Act characteristics of the research sub- (84 Stat. 1242; 21 U.S.C. 801) who intends jects; and to maintain the confidentiality of the (9) Statements establishing that a identity of those persons who are the grant of confidentiality is necessary to

142 Drug Enforcement Administration, Justice § 1316.24 the successful completion of the re- motion or upon request in writing from search project. the Secretary or from the researcher or (c) The grant of confidentiality of researching practitioner, may exempt identity of research subjects shall con- the registrant when acting within the sist of a letter issued by the Adminis- scope of his registration, from prosecu- trator, which shall include: tion under Federal, State, or local laws (1) The researcher’s name and ad- for offenses relating to possession, dis- dress. tribution or dispensing of those con- (2) The researcher’s registration trolled substances within the scope of number, if applicable. his exemption. However, this exemp- (3) The title and purpose of the re- tion does not diminish any require- search. ment of compliance with the Federal (4) The location of the research Food, Drug and Cosmetic Act (21 U.S.C. project. 301). (5) An authorization for all persons (b) All petitions for Grants of Exemp- engaged in the research to withhold tion from Prosecution for the Re- the names and identifying characteris- searcher shall be addressed to the Ad- tics of persons who are the subjects of ministrator, Drug Enforcement Admin- such research, stating that persons who istration, 1405 I Street NW., Wash- obtain this authorization may not be ington, DC 20537 and shall contain the compelled in any Federal, State, or following: local civil, criminal, administrative, (1) The researcher’s registration legislative, or other proceeding to iden- number if any, for the project; tify the subjects of such research for (2) The location of the research which this authorization was obtained. project; (6) The limits of this authorization, if (3) The qualifications of the principal any. investigator; (7) A statement to the effect that the grant of confidentiality of identity of (4) A general description of the re- research subjects shall be perpetual but search or a copy of the research pro- shall pertain only to the subjects of the tocol; research described in the research pro- (5) The source of funding for the re- tocol, the description of the research search project; submitted to DEA, or as otherwise es- (6) A statement as to the risks posed tablished by DEA. to the research subjects by the re- (d) Within 30 days of the date of com- search procedures and what protection pletion of the research project, the re- will be afforded to the research sub- searcher shall so notify the Adminis- jects; trator. The Administrator shall issue (7) A statement as to the risks posed another letter including the informa- to society in general by the research tion required in paragraph (c) of this procedures and what measures will be section and stating the starting and taken to protect the interests of soci- finishing dates of the research for ety; which the confidentiality of identity of (8) A specific request for exemption research subjects was granted; upon re- from prosecution by Federal, State, or ceipt of this letter, the research shall local authorities for offenses related to return the original letter of exemption. the possession, distribution, and dispensing of controlled substances in ac- [42 FR 54946, Oct. 12, 1977. Redesignated at 54 FR 31670, Aug. 1, 1989, as amended at 62 FR cord with the procedures described in 13970, Mar. 24, 1997] the research protocol; (9) A statement establishing that a § 1316.24 Exemption from prosecution grant of exemption from prosecution is for researchers. necessary to the successful completinn (a) Upon registration of an individual of the research project. to engage in research in controlled sub- (c) Any researcher or practitioner stances under the Controlled Sub- proposing to engage in research re- stances Act (84 Stat. 1242; 21 U.S.C. questing both exemption from prosecu- 801), the Administrator of the Drug En- tion and confidentiality of identity of forcement Administration, on his own research subjects may submit a single

143 § 1316.31 21 CFR Ch. II (4–1–99 Edition) petition incorporating the information for bringing his alleged violations into required in § § 1316.23(b) and 1316.24(b). compliance with the law. Such hearing (d) The exemption shall consist of a will also permit him to show cause why letter issued by the Administrator, prosecution should not be instituted, which shall include: or to present his views on the con- (1) The researcher’s name and ad- templated proceeding. dress; (2) The researcher’s registration [36 FR 7820, Apr. 24, 1971. Redesignated at 38 number for the research project; FR 26609, Sept. 24, 1973, and amended at 47 (3) The location of the research FR 41735, Sept. 22, 1982] project; § 1316.32 Notice of proceeding; time (4) A concise statement of the scope and place. of the researcher’s registration; (5) Any limits of the exemption; and Appropriate notice designating the (6) A statement that the exemption time and place for the hearing shall be shall apply to all acts done in the scope given to the person. Upon request, of the exemption while the exemption timely and properly made, by the per- is in effect. The exemption shall re- son to whom notice has been given, the main in effect until completion of the time or place of the hearing, or both, research project or until the registra- may be changed if the request states tion of the researcher is either revoked reasonable grounds for such change. or suspended or his renewal of registra- Such request shall be addressed to the tion is denied. However, the protection Special Agent in Charge who issued the afforded by the grant of exemption notice. from prosecution during the research [36 FR 7820, Apr. 24, 1971. Redesignated at 38 period shall be perpetual. FR 26609, Sept. 24, 1973, and amended at 47 (e) Within 30 days of the date of com- FR 41735, Sept. 22, 1982] pletion of the research project, the researcher shall so notify the Adminis- § 1316.33 Conduct of proceeding. trator. The Administrator shall issue Presentation of views at a hearing another letter including the informa- under this subpart shall be private and tion required in paragraph (d) of this informal. The views presented shall be section and stating the date of which confined to matters relevant to bring- the period of exemption concluded; ing violations into compliance with the upon receipt of this letter the re- Act or to other contemplated pro- searcher shall return the original let- ceedings under the Act. These views ter of exemption. may be presented orally or in writing [42 FR 54946, Oct. 12, 1977. Redesignated at 54 by the person to whom the notice was FR 31670, Aug. 1, 1989, as amended at 62 FR given, or by his authorized representa- 13970, Mar. 24, 1997] tive.

Subpart C—Enforcement § 1316.34 Records of proceeding. Proceedings A formal record, either verbatim or summarized, of the hearing may be AUTHORITY: 21 U.S.C. 871(b), 883. made at the discretion of the Special § 1316.31 Authority for enforcement Agent in Charge. If a verbatim record proceeding. is to be made, the person attending the hearing will be so advised prior to the A hearing may be ordered or granted start of the hearing. by any Special Agent in Charge of the Drug Enforcement Administration, at [37 FR 15924, Aug. 8, 1972. Redesignated at 38 his discretion, to permit any person FR 26609, Sept. 24, 1973, and amended at 47 against whom criminal and/or civil ac- FR 41735, Sept. 22, 1982] tion is contemplated under the Con- trolled Substances Act (84 Stat. 1242; 21 Subpart D—Administrative U.S.C. 801) or the Controlled Sub- Hearings stances Import and Export Act (84 Stat. 1285; 21 U.S.C. 951) an opportunity AUTHORITY: 21 U.S.C. 811, 812, 871(b), 875, to present his views and his proposals 958(d), 965.

144 Drug Enforcement Administration, Justice § 1316.46

§ 1316.41 Scope of subpart D. section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter. Procedures in any administrative hearing held under the Act are gov- [36 FR 7820, Apr. 24, 1971, as amended at 38 erned generally by the rule making FR 757, Jan. 4, 1973. Redesignated at 38 FR and/or adjudication procedures set 26609, Sept. 24, 1973, as amended at 62 FR 13969, Mar. 24, 1997] forth in the Administrative Procedure Act (5 U.S.C. 551–559) and specifically § 1316.43 Information; special instruc- by the procedures set forth in this sub- tions. part, except where more specific regu- Information regarding procedure lations (set forth in §§ 1301.51–1301.57, under these rules and instructions §§ 1303.31–1303.37, §§ 1308.41–1308.51, supplementing these rules in special §§ 1311.51–1311.53, §§ 1312.41–1312.47, or instances will be furnished by the §§ 1313.51–1313.57) apply. Hearing Clerk upon request.

[36 FR 7820, Apr. 24, 1971, as amended at 37 § 1316.44 Waiver or modification of FR 15924, Aug. 8, 1972. Redesignated at 38 FR rules. 26609, Sept. 24, 1973, as amended at 62 FR 13970, Mar. 24, 1997] The Administrator or the presiding officer (with respect to matters pend- § 1316.42 Definitions. ing before him) may modify or waive any rule in this subpart by notice in As used in this subpart, the following advance of the hearing, if he deter- terms shall have the meanings speci- mines that no party in the hearing will fied: be unduly prejudiced and the ends of (a) The term Act means the Con- justice will thereby be served. Such no- trolled Substances Act (84 Stat. 1242; 21 tice of modification or waiver shall be U.S.C. 801) and/or the Controlled Sub- made a part of the record of the hear- stances Import and Export Act (84 ing. Stat. 1285; 21 U.S.C. 951). (b) The term Administrator means the § 1316.45 Filings; address; hours. Administrator of the Administration. Documents required or permitted to The Administrator has been delegated be filed in, and correspondence relating authority under the Act by the Attor- to, hearings governed by the regula- ney General (28 CFR 0.100). tions in this chapter shall be filed with (c) The term hearing means any hear- the Hearing Clerk, Drug Enforcement ing held pursuant to the Act. Administration, Department of Jus- (d) The term Hearing Clerk means the tice, Washington, DC 20537. This office hearing clerk of the Administration. is open Monday through Friday from 8:30 a.m. to 5 p.m. eastern standard or (e) The term person includes an indi- daylight saving time, whichever is ef- vidual, corporation, government or fective in the District of Columbia at governmental subdivision or agency, the time, except on national legal holi- business trust, partnership, association days. Documents shall be dated and or other legal entitx. deemed filed upon receipt by the Hear- (f) The term presiding officer means ing Clerk. an administrative law judge qualified and appointed as provided in the Ad- [36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 55 ministrative Procedure Act (5 U.S.C. FR 27464, July 3, 1990] 556). (g) The term proceeding means all ac- § 1316.46 Inspection of record. tions involving a hearing, colmencing (a) The record bearing on any pro- with the publication by the Adminis- ceeding, except for material described trator of the notice of proposed rule in subsection (b) of this section, shall making or the issuance of an order to be available for inspection and copying show cause. by any person entitled to participate in (h) Any term not defined in this part such proceeding, during office hours in shall have the definition set forth in the office of the Hearing Clerk, Drug

145 § 1316.47 21 CFR Ch. II (4–1–99 Edition)

Enforcement Administration, Depart- All notices to be sent pursuant to the pro- ment of Justice, Washington, DC 20537. ceeding should be addressed to: (b) The following material shall not llllllllllllllllllllllll be available for inspection as part of (Name) the record: (1) A research protocol filed with an llllllllllllllllllllllll application for registration to conduct (Street address) research with controlled substances listed in Schedule I, pursuant to llllllllllllllllllllllll § 1301.32 (a)(6) of this chapter, if the ap- (City and State) plicant requests that the protocol be kept confidential; Respectfully yours, (2) An outline of a production or llllllllllllllllllllllll manufacturing process filed with an (Signature of person) application for registration to manufacture a new narcotic controlled sub- (b) The Administrative Law Judge, stance, pursuant to § 1301.33 of this upon request and showing of good chapter, if the applicant requests that cause, may grant a reasonable exten- the outline be kept confidential; sion of the time allowed for response to (3) Any confidential or trade secret an Order to Show Cause. information disclosed in conjunction with an application for registration, or [36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. Redesignated at 38 FR in reports filed while registered, or ac- 26609, Sept. 24, 1973] quired in the course of an investigation, entitled to protection under sub- EDITORIAL NOTE: For FEDERAL REGISTER ci- section 402(a) (8) of the Act (21 U.S.C. tations affecting § 1316.47, see the List of CFR 842(a) (8)) or any other law restricting Sections Affected in the Finding Aids section of this volume. public disclosure of information; and (4) Any material contained in any in- § 1316.48 Notice of appearance. vestigatory report, memorandum, or file, or case report compiled by the Ad- Any person entitled to a hearing and ministration. desiring to appear in any hearing, shall, if he has not filed a request for [36 FR 7820, Apr. 24, 1971. Redesignated at 38 hearing, file within the time specified FR 26609, Sept. 24, 1973, as amended at 62 FR in the notice of proposed rule making, 13970, Mar. 24, 1997] a written notice of appearance in the § 1316.47 Request for hearing. following form: (a) Any person entitled to a hearing —————— (Date) and desiring a hearing shall, within the Administrator, Drug Enforcement Adminis- period permitted for filing, file a re- tration, United States Department of Jus- quest for a hearing in the following tice, Washington, DC 20537, Attention: DEA form: Federal Register Representative. DEAR SIR: Please take notice that —————— (Date) —————————— (Name of person) will ap- Administrator, Drug Enforcement Adminis- pear in the matter of: ———————————— tration, United States Department of Jus- (Identification of the proceeding). tice, Washington, DC 20537, Attention: DEA (A) (State with particularity the interest Federal Register Representative. of the person in the proceeding.) DEAR SIR: The undersigned (B) (State with particularity the objections —————————— (Name of person) hereby or issues, if any, concerning which the per- requests a hearing in the matter of: son desires to be heard.) ———————————— (Identification of the (C) (State briefly the position of the person proceeding). with regard to the particular objections or (A) (State with particularity the interest issues.) of the person in the proceeding.) All notices to be sent pursuant to this ap- (B) (State with particularity the objections pearance should be addressed to: or issues, if any, concerning which the per- llllllllllllllllllllllll son desires to be heard.) (C) (State briefly the position of the person (Name) with regard to the particular objections or issues.) llllllllllllllllllllllll

146 Drug Enforcement Administration, Justice § 1316.52

(Street address) ance with law and the directions of the llllllllllllllllllllllll presiding officer. (b) Participants in any hearing and (City and State) their representatives, whether or not members of the bar, shall conduct Respectfully yours, themselves in accordance with judicial llllllllllllllllllllllll standards of practice and ethics and (Signature of person) the directions of the presiding officer. Refusal to comply with this section [36 FR 7820, Apr. 24, 1971, as amended at 36 shall constitute grounds for immediate FR 13387, July 21, 1971. Redesignated at 38 FR exclusion from any hearing. 26609, Sept. 24, 1973, and amended at 40 FR (c) If any official of the Administra- 57210, Dec. 8, 1975] tion is contacted by any individual in private or public life concerning any § 1316.49 Waiver of hearing. substantive matter which is the sub- Any person entitled to a hearing ject of any hearing, at any time after may, within the period permitted for the date on which the proceedings com- filing a request for hearing or notice of mence, the official who is contacted appearance, waiver of an opportunity shall prepare a memorandum setting for a hearing, together with a written forth the substance of the conversation statement regarding his position on and shall file this memorandum in the the matters of fact and law involved in appropriate public docket file. The pre- such hearing. Such statement, if ad- siding officer and employees of the Ad- missible, shall be made a part of the ministration shall comply with the re- record and shall be considered in light quirements of 5 U.S.C. 554(d) regarding of the lack of opportunity for crors-ex- ex parte communications and partici- amination in determining the weight pation in any hearing. to be attached to matters of fact asserted therein. § 1316.52 Presiding officer. A presiding officer, designated by the § 1316.50 Appearance; representation; Administrator, shall preside over all authorization. hearings. The functions of the pre- Any person entitled to appear in a siding officer shall commence upon his hearing may appear in person or by a designation and terminate upon the representative in any proceeding or certification of the record to the Ad- hearing and may be heard with respect ministrator. The presiding officer shall to matters relevant to the issues under have the duty to conduct a fair hear- consideration. A representative must ing, to take all necessary action to either be an employee of the person or avoid delay, and to maintain order. He an attorney at law who is a member of shall have all powers necessary to the bar, in good standing, of any State, these ends, including (but not limited territory, or the District of Columbia, to) the power to: and admitted to practice before the (a) Arrange and change the date, highest court of that jurisdiction. Any time, and place of hearings (other than representative may be required by the the time and place prescribed in Administrator or the presiding officer § 1301.56) and prehearing conferences to present a notarized power of attor- and issue notice thereof. ney showing his authority to act in (b) Hold conferences to settle, sim- such representative capacity and/or an plify, or determine the issues in a hear- affidavit or certificate of admission to ing, or to consider other matters that practice. may aid in the expeditious disposition [36 FR 7820, Apr. 24, 1971, as amended at 36 of the hearing. FR 13387, July 21, 1971. Redesignated at 38 FR (c) Require parties to state their po- 26609, Sept. 24, 1973] sition in writing with respect to the various issues in the hearing and to ex- § 1316.51 Conduct of hearing and par- change such statements with all other ties; ex parte communications. parties. (a) Hearings shall be conducted in an (d) Sign and issue subpoenas to com- informal but orderly manner in accord- pel the attendance of witnesses and the

147 § 1316.53 21 CFR Ch. II (4–1–99 Edition) production of documents and materials agreements made by the partier, the to the extent necessary to conduct ad- schedule of witnesses, and a statement ministrative hearings pending before of the issues for hearing. Such ruling him. shall control the subsequent course of (e) Examine witnesses and direct wit- the hearing unless modified by a subse- nesses to testify. quent ruling. (f) Receive, rule on, exclude, or limit evidence. § 1316.56 Burden of proof. (g) Rule on procedural items pending At any hearing, the proponent for the before him. issuance, amendment, or repeal of any (h) Take any action permitted to the rule shall have the burden of proof. presiding officer as authorized by this part or by the provisions of the Admin- § 1316.57 Submission of documentary istrative Procedure Act (5 U.S.C. 551– evidence and affidavits and identi- 559). fication of witnesses subsequent to prehearing conference. [36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 42 All documentary evidence and affida- FR 57457, Nov. 3, 1977; 62 FR 13970, Mar. 24, vits not submitted and all witnesses 1997] not identified at the prehearing conference shall be submitted or identified § 1316.53 Time and place of hearing. to the presiding officer as soon as pos- The hearing will commence at the sible, with a showing that the offering place and time designated in the notice party had good cause for failing to so of hearing published in the FEDERAL submit or identify at the prehearing REGISTER but thereafter it may be conference. If the presiding officer de- moved to a different place and may be termines that good cause does exist, continued from day to day or recessed the documents or affidavits shall be to a later day without notice other submitted or witnesses identified to all than announcement thereof by the pre- parties sufficiently in advance of the siding officer at the hearing. offer of such documents or affidavits or witnesses at the hearing to avoid preju- § 1316.54 Prehearing conference. dice or surprise to the other parties. If The presiding officer on his own mo- the presiding officer determines that tion, or on the motion of any party for good cause does not exist, he may good cause shown, may direct all par- refuse to admit as evidence such docu- ties to appear at a specified time and ments or affidavits or the testimony of place for a conference for: such witnesses. (a) The simplification of the issues. (b) The possibility of obtaining stipu- § 1316.58 Summary of testimony; affi- lations, admission of facts, and docu- davits. ments. (a) The presiding officer may direct (c) The possibility of limiting the that summaries of the direct testimony number of expert witnesses. of witnesses be prepared in writing and (d) The identification and, if prac- served on all parties in advance of the ticable, the scheduling of all witnesses hearing. Witnesses will not be per- to be called. mitted to read summaries of their tes- (e) The advance submission at the timony into the record and all wit- prehearing conference of all documen- nesses shall be available for cross-ex- tary evidence and affidavits to be amination. Each witness shall, before marked for identification. proceeding to testify, be sworn or make (f) Such other matters as may aid in affirmation. the expeditious disposition of the hear- (b) Affidavits submitted at the pre- ing. hearing conference or pursuant to § 1316.57 with good cause may be exam- § 1316.55 Prehearing ruling. ined by all parties and opposing affida- The presiding officer may have the vits may be submitted to the presiding prehearing conference reported ver- officer within a perhod of time fixed by batim and shall make a ruling reciting him. Affidavits admitted into evidence the action taken at the conference, the shall be considered in light of the lack

148 Drug Enforcement Administration, Justice § 1316.63 of opportunity for cross-examination in grounds for such objection without ex- determining the weight to be attached tended argument or debate thereon ex- to statements made therein. cept as permitted by the presiding officer. A ruling of the presiding officer on [36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. Redesignated at 38 FR any such objection shall be a part of 26609, Sept. 24, 1973] the transcript together with such offer of proof as has been made if a proper § 1316.59 Submission and receipt of foundation has been laid for its admis- evidence. sion. An offer of proof made in connec- (a) The presiding officer shall admit tion with an objection taken to any only evidence that is competent, rel- ruling of the presiding officer rejecting evant, material and not unduly repeti- or excluding proffered oral testimony tious. shall consist of a statement of the sub- (b) Opinion testimony shall be admit- stance of the evidence which the party ted when the presiding officer is satis- contends would be adduced by such tes- fied that the witness is properly quali- timony; and, if the excluded evidence fied. consists of evidence in documentary or (c) The authenticity of all documents written form a copy of such evidence submitted in advance shall be deemed shall be marked for identification and admitted unless written objection shall accompany the records as the thereto is filed with the presiding offi- offer of proof. cer, except that a party will be permitted to challenge such authenticity § 1316.61 Exceptions to rulings. at a later time upon a showing of good Exceptions to rulings of the presiding cause for failure to have filed such officer are unnecessary. It is sufficient written objection. that a party, at the time the ruling of (d) Samples, if otherwise admissible the presiding officer is sought, makes into evidence, may be displayed at the known the action that he desires the hearing and may be described for pur- presiding officer to take, or his objec- poses of the record, or may be admitted tion to an action taken, and his in evidence as exhibits. grounds therefor. (e) Where official notice is taken or is to be taken of a material fact not ap- § 1316.62 Appeal from ruling of pre- pearing in the evidence of record, any siding officer. party, on timely request, shall be af- Rulings of the presiding officer may forded opportunity to controvert such not be appealed to the Administrator fact. prior to his consideration of the entire (f) The presiding officer shall file as hearing, except with the consent of the exhibits copies of the folloving docu- presiding officer and where he certifies ments: on the record or in writing that the al- (1) The order to show cause or notice lowance of an interlocutory appeal is of hearing; clearly necessary to prevent excep- (2) Any notice of waiver or modifica- tional delay, expense, or prejudice to tion of rules made pursuant to § 1316.44 any party or substantial detriment to or otherwise; the public interest. If an appeal is al- (3) Any waiver of hearing (together lowed, any party in the hearing may with any statement filed therewith) file a brief in quintuplicate with the filed pursuant to § 1316.49 or otherwise; Administrator within such period that (4) The prehearing ruling, if any, the presiding officer directs. No oral made pursuant to § 1316.55; argument will be heard unless the Ad- (5) Any other document necessary to ministrator directs otherwise. show the basis for the hearing. § 1316.63 Official transcript; index; § 1316.60 Objections; offer of proof. corrections. If any party in the hearing objects to (a) Testimony given at a hearing the admission or rejection of any evi- shall be reported verbatim. The Admin- dence or to other limitation of the istration will make provision for a scope of any examination or cross-ex- stenographic record of the testimony amination, he shall state briefly the and for such copies of the transcript

149 § 1316.64 21 CFR Ch. II (4–1–99 Edition) thereof as it requires for its own pur- parties, the presiding officer shall cer- pose. tify to the Administrator the record, (b) At the close of the hearing, the which shall contain the transcript of presiding officer shall afford the par- testimony, exhibits, the findings of ties and witnesses time (not longer fact and conclusions of law proposed by than 30 days, except in unusual cases) the parties, the presiding officer’s rein which to submit written proposed port, and any exceptions thereto which corrections of the transcript, pointing may have been filed by the parties. out errors that may have been made in [36 FR 7778, Apr. 24, 1971. Redesignated at 38 transcribing the testimony. The pre- FR 26609, Sept. 24, 1973 and amended at 44 FR siding officer shall promptly thereafter 55332, Sept. 26, 1979] order such corrections made as in his judgment are required to make the § 1316.66 Exceptions. transcript conform to the testimony. (a) Within twenty days after the date [36 FR 7820, Apr. 24, 1971, as amended at 36 upon which a party is served a copy of FR 13387, July 21, 1971. Redesignated at 38 FR the report of the presiding officer, such 26609, Sept. 24, 1973, and amended at 50 FR party may file with the Hearing Clerk, 2046, Jan. 15, 1985] Office of the Administrative Law Judge, exceptions to the recommended § 1316.64 Proposed findings of fact and conclusions of law. decision, findings of fact and conclusions of law contained in the report. Any party in the hearing may file in The party shall include a statement of quintuplicate proposed findings of fact supporting reasons for such exceptions, and conclusions of law within the time together with evidence of record (in- fixed by the presiding officer. Any cluding specific and complete citations party so filing shall also serve one copy of the pages of the transcript and ex- of his proposed findings and conclusion hibits) and citations of the authorities upon each other party in the hearing. relied upon. The party shall include a statement of (b) The Hearing Clerk shall cause supporting reasons for the proposed such filings to become part of the findings and conclusions, together with record of the proceeding. evidence of record (including specific (c) The Administrative Law Judge and complete citations of the pages of may, upon the request of any party to the transcript and exhibits) and cita- a proceeding, grant time beyond the tions of authorities relied upon. twenty days provided in paragraph (a) § 1316.65 Report and record. of this section for the filing of a response to the exceptions filed by an- (a) As soon as practicable after the other party if he determines that no time for the parties to file proposed party in the hearing will be unduly findings of fact and conclusions of law prejudiced and that the ends of justice has expired, the presiding officer shall will be served thereby. Provided how- prepare a report containing the fol- ever, that each party shall be entitled lowing: to only one filing under this section; (1) His recommended rulings on the that is, either a set of exceptions or a proposed findings of fact and conclu- response thereto. sions of law; (2) His recommended findings of fact [44 FR 55332, Sept. 26, 1979] and conclusions of law, with the reasons therefore; and § 1316.67 Final order. (3) His recommended decision. As soon as practicable after the pre- (b) The presiding officer shall serve a siding officer has certified the record copy of his report upon each party in to the Administrator, the Adminis- the hearing. The report shall be consid- trator shall cause to be published in ered to have been served when it is the FEDERAL REGISTER his final order mailed to such party or its attorney of in the proceeding, which shall set forth record. the final rule and the findings of fact (c) Not less than twenty-five days and conclusions of law upon which the after the date on which he caused cop- rule is based. This order shall specify ies of his report to be served upon the the date on which it shall take effect,

150 Drug Enforcement Administration, Justice § 1316.74 which date shall not be less than 30 zure initially made by any other officer days from the date of publication in or by a private person. the FEDERAL REGISTER unless the Ad- (e) The term Special Agents-in-Charge ministrator finds that the public inter- means Drug Enforcement Administra- est in the matter necessitates an ear- tion Special Agents-in-Charge or Resi- lier effective date, in which event the dent Agents in Charge and Federal Bu- Administrator shall specify in the reau of Investigation Special Agents- order his findings as to the conditions in-Charge. which led him to conclude that an ear- (f) Any term not defined in this sec- lier effective date was required. tion shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) [44 FR 42179, July 19, 1979, as amended at 44 or part 1300 of this chapter. FR 55332, Sept. 26, 1979] [36 FR 7820, Apr. 24, 1971. Redesignated at 38 § 1316.68 Copies of petitions for judi- FR 26609, Sept. 24, 1973, and amended at 45 cial review. FR 20096, Mar. 27, 1980; 47 FR 43370, Oct. 1, 1982; 49 FR 28701, July 16, 1984; 62 FR 13969, Copies of petitions for judicial re- Mar. 24, 1997] view, filed pursuant to section 507 of the Act (21 U.S.C. 877) shall be deliv- § 1316.72 Officers who will make sei- ered to and served upon the Adminis- zures. trator in quintuplicate. The Adminis- For the purpose of carrying out the trator shall certify the record of the provisions of the Act, all special agents hearing and shall file the certified of the Drug Enforcement Administra- record in the appropriate U.S. Court of tion and the Federal Bureau of Inves- Appeals. tigation are authorized and designated [36 FR 7820, Apr. 24, 1971. Redesignated at 44 to seize such property as may be sub- FR 42179, July 19, 1979] ject to seizure. [47 FR 43370, Oct. 1, 1982] Subpart E—Seizure, Forfeiture, and Disposition of Property § 1316.73 Custody and other duties. An officer seizing property under the AUTHORITY: 21 U.S.C 871(b), 881, 965, 19 Act shall store the property in a loca- U.S.C. 1606, 1607, 1608, 1610, 1613, 1618, 28 tion designated by the custodian, gen- U.S.C. 509, 510. erally in the judicial district of seizure. The Special Agents-in-Charge are des- § 1316.71 Definitions. ignated as custodians to receive and As used in this subpart, the following maintain in storage all property seized terms shall have the meanings speci- pursuant to the Act, are authorized to fied: dispose of any property pursuant to the (a) The term Act means the Con- Act and any other applicable statutes trolled Substances Act (84 Stat. 1242; 21 or regulations relative to disposal, and U.S.C. 801) and/or the Controlled Sub- to perform such other duties regarding stances Import and Export Act (84 such seized property as are appro- Stat. 1285; 21 U.S.C. 951). priate, including the impound release (b) The term custodian means the of- of property pursuant to 28 CFR 0.101(c). ficer required under § 1316.72 to take [47 FR 43370, Oct. 1, 1982] custody of particular property which has been seized pursuant to the Act. § 1316.74 Appraisement. (c) The term property means a con- The custodian shall appraise the trolled substance, raw material, prod- property to determine the domestic uct, container, equipment, money or value at the time and place of seizure. other asset, vessel, vehicle, or aircraft The domestic value shall be considered within the scope of the Act. the price at which such or similar prop- (d) The terms seizing officer, officer erty is freely offered for sale. If there is seizing, etc., mean any officer, author- no market for the property at the place ized and designated by § 1316.72 to carry of seizure, the domestic value shall be out the provisions of the Act, who ini- considered the value in the principal tially seizes property or adopts a sei- market nearest the place of seizure.

151 § 1316.75 21 CFR Ch. II (4–1–99 Edition)

(Sec. 606, 46 Stat. 754 (19 U.S.C. 1606)) shall, after finding the documents in [36 FR 7820, Apr. 24, 1971. Redesignated at 38 proper form and the sureties satisfac- FR 26609, Sept. 24, 1973, and amended at 52 tory, transmit the documents, together FR 41418, Oct. 28, 1987] with a description of the property and a complete statement of the facts and § 1316.75 Advertisement. circumstances surrounding the seizure, (a) If the appraised value does not ex- to the United States Attorney for the ceed the monetary amount set forth in judicial district in which the pro- title 19, United States Code, Section ceeding for forfeiture is brought. If the 1607; the seized merchandise is any documents are not in satisfactory con- monetary instrument within the mean- dition when first received, a reasonable ing of section 5312(a)(3) of title 31 of the time for correction may be alloved. If United States Code; or if a conveyance correction is not made within a reason- used to import, export or otherwise able time the documents may be treat- transport or store any controlled sub- ed as nugatory, and the case shall pro- stance is involved, the custodian or ceed as though they had not been ten- DEA Asset Forfeiture Section shall dered. cause a notice of the seizure and of the (b) The filing of the claim and the intention to forfeit and sell or other- posting of the bond does not entitle the wise dispose of the property to be pub- claimant to possession of the property, lished once a week for at least 3 succes- however, it does stop the administra- sive weeks in a newspaper of general tive forfeiture proceedings. The bond circulation in the judicial district in posted to cover corts may be in cash, which the processing for forfeiture is certified check, or satisfactory sure- brought. ties. The costs and expenses secured by (b) The notice shall: (1) Describe the the bond are such as are incurred after property seized and show the motor the filing of the bond including storage and serial numbers, if any; (2) state the cost, safeguarding, court fees, mar- time, cause, and place of seizure; and shal’s costs, etc. (3) state that any person desiring to (Sec. 608, 46 Stat. 755 (19 U.S.C. 1608); Pub. L. claim the property may, within 20 days 98–473, Pub. L. 98–573) from the date of first publication of the [36 FR 7820, Apr. 24, 1971. Redesignated at 38 notice, file with the custodian or DEA FR 26609, Sept. 24, 1973 and amended at 49 FR Asset Forfeiture Section a claim to the 1178, Jan. 10, 1984; 49 FR 50643, Dec. 31, 1984; property and a bond with satisfactory 56 FR 8686, Mar. 1, 1991] sureties in the sum of $5,000 or ten percent of the value of the claimed prop- § 1316.77 Administrative forfeiture. erty whichever is lower, but not less (a) For property seized by officers of than $250. the Drug Enforcement Administration, (Sec. 607, 46 Stat. 754, as amended (19 U.S.C. if the appraised value does not exceed 1607); Pub. L. 98–473, Pub. L. 98–573) the jurisdictional limits in § 1316.75(a), and a claim and bond are not filed [36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973 and amended at 44 FR within the 20 days hereinbefore men- 56324, Oct. 1, 1979; 49 FR 1178, Jan. 10, 1984; 49 tioned, the DEA Special Agent-in- FR 50643, Dec. 31, 1984; 52 FR 24446, July 1, Charge or DEA Asset Forfeiture Sec- 1987; 56 FR 8686, Mar. 1, 1991] tion shall declare the property forfeited. The DEA Special Agent-in- § 1316.76 Requirements as to claim and Charge or DEA Asset Forfeiture Sec- bond. tion shall prepare the Declaration of (a) The bond shall be rendered to the Forfeiture and forward it to the Ad- United States, with sureties to be ap- ministrator of the Administration as proved by the custodian or DEA Asset notification of the action he has taken. Forfeiture Section, conditioned that in Thereafter, the property shall be re- the case of condemnation of the prop- tained in the district of the DEA Spe- erty the obligor shall pay all costs and cial Agent-in-Charge or DEA Asset expenses of the proceedings to obtain Forfeiture Section or delivered else- such condemnation. When the claim where for official use, or otherwise dis- and bond are received by the custodian posed of, in accordance with official in- or DEA Asset Forfeiture Section, he structions received by the DEA Special

152 Drug Enforcement Administration, Justice § 1316.80

Agent-in-Charge or DEA Asset For- for remission or mitigation of the forfeiture Section. feiture. Such petition shall be filed in (b) For property seized by officers of triplicate with the DEA Asset For- the Federal Bureau of Investigation, if feiture Section or Special Agent-in- the appraised value does not exceed the Charge of the DEA or FBI, depending jurisdictional limits in § 1316.75(a), and upon which agency seized the property, a claim and bond are not filed within for the judicial district in which the the 20 days hereinbefore mentioned, proceeding for forfeiture is brought. It the FBI Property Management Officer shall be addressed to the Director of shall declare the property forfeited. the FBI or the Administrator of the The FBI Property Management Officer DEA, depending upon which agency shall prepare the Declaration of For- seized the property, if the property is feiture. Thereafter, the property shall subject to administrative forfeiture be retained in the field office or deliv- pursuant to § 1316.77, and addressed to ered elsewhere for official use, or oth- the Attorney General if the property is erwise disposed of, in accordance with subject to judicial forfeiture pursuant the official instructions of the FBI to § 1316.78. The petition must be exe- Property Management Officer. cuted and sworn to by the person alleg- (28 U.S.C. 509 and 510; 21 U.S.C. 871 and 881(d); ing interest in the property. Pub. L. 98–473, Pub. L. 98–573) (b) The petition shall include the following: (1) A complete description of [48 FR 35087, Aug. 3, 1983, as amended at 49 FR 1178, Jan. 10, 1984; 49 FR 50643, Dec. 31, the property, including motor and se- 1984; 56 FR 8686, Mar. 1, 1991; 62 FR 13970, rial numbers, if any, and the date and Mar. 24, 1997] place of seizure; (2) the petitioner’s interest in the property, which shall be § 1316.78 Judicial forfeiture. supported by bills of sale, contracts, If the appraised value is greater than mortgages, or other satisfactory docu- the jurisdictional limits in § 1316.75(a) mentary evidence; and, (3) the facts or a claim and satisfactory bond have and circumstances, to be established by been received for property the jurisdic- satisfactory proof, relied upon by the tional limits in § 1316.76, the custodian petitioner to justify remission or miti- or DEA Asset Forfeiture Section shall gation. transmit a description of the property (c) Where the petition is for restora- and a complete statement of the facts tion of the proceeds of sale, or for value and circumstances surrounding the sei- of the property placed in official use, it zure to the U.S. Attorney for the judi- must be supported by satisfactory cial district in which the proceeding proof that the petitioner did not know for forfeiture is sought for the purpose of the seizure prior to the declaration of instituting condemnation proof condemnation of forfeiture and was ceedings. The U.S. Attorney shall also in such circumstances as prevented be furnished the newspaper advertise- him from knowing of the same. ments required by § 1316.75. The For- (Secs. 613, 618, 46 Stat. 756, 757, as amended feiture Counsel of DEA shall make ap- (19 U.S.C. 1613, 1618; 28 U.S.C. 509 and 510; 21 plications to the U.S. District Courts U.S.C. 871 and 881(d)); Pub. L. 98–473, Pub. L. to place property in official DEA use. 98–573) (Sec. 610, 46 Stat. 755 (19 U.S.C. 1610); Pub. L. [36 FR 7820, Apr. 24, 1971. Redesignated at 38 98–473, Pub. L. 98–573) FR 26609, Sept. 24, 1973, and amended at 48 [36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 35088, Aug. 3, 1983; 49 FR 1178, Jan. 10, FR 26609, Sept. 24, 1973 and amended at 44 FR 1984; 49 FR 50643, Dec. 31, 1984; 56 FR 8686, 56324, Oct. 1, 1979; 49 FR 1178, Jan. 10, 1984; 49 Mar. 1, 1991] FR 32174, Aug. 13, 1984; 49 FR 50643, Dec. 31, 1984; 56 FR 8686, Mar. 1, 1991] § 1316.80 Time for filing petitions. (a) In order to be considered as sea- § 1316.79 Petitions for remission or sonably filed, a petition for remission mitigation of forfeiture. or mitigation of forfeiture should be (a) Any person interested in any filed within 30 days of the receipt of property which has been seized, or for- the notice of seizure. If a petition for feited either administratively or by remission or mitigation of forfeiture court proceedings, may file a petition has not been received within 30 days of

153 § 1316.81 21 CFR Ch. II (4–1–99 Edition) the notice of seizure, the property will tablish and implement procedures re- either be placed in official service or quired by sections 6079 and 6080 of the sold as soon as it is forfeited. Once Anti-Drug Abuse Act of 1988, Public property is placed in official use, or is Law No. 100–690 (102 Stat. 4181). They sold, a petition for remission or mitiga- are intended to supplement existing tion of forfeiture can no longer be ac- law and procedures relative to the for- cepted. feiture of property under the identified (b) A petition for restoration of pro- statutory authority. The provisions of ceeds of sale, or for the value of prop- these regulations do not affect the ex- erty placed in official use, must be isting legal and equitable rights and filed within 90 days of the sale of the remedies of those with an interest in property, or within 90 days of the date property seized for forfeiture, nor do the property is placed in official use. these provisions relieve interested par- (Secs. 613, 618, 46 Stat. 756, 757, as amended ties from their existing obligations and (19 U.S.C. 1613, 1618); Pub. L. 98–473, Pub. L. responsibilities in pursuing their inter- 98–573) ests through such courses of action. These regulations are intended to re- [36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 49 flect the intent of Congress to mini- FR 50643, Dec. 31, 1984] mize the adverse impact on those entitled to legal or equitable relief occa- § 1316.81 Handling of petitions. sioned by the prolonged detention of Upon receipt of a petition, the custo- property subject to forfeiture due to dian or DEA Asset Forfeiture System violations of law involving personal use shall request an appropriate investiga- quantities of controlled substances, tion. The petition and the report of in- and conveyances seized for drug-related vestigation shall be forwarded to the offenses. The definition of personal use Director of the FBI or to the Adminis- quantities of a controlled substance as trator of the DEA, depending upon contained herein is intended to distin- which agency seized the property. If guish between those quantities small the petition involves a case which has in amount which are generally consid- been referred to the U.S. Attorney for ered to be possessed for personal con- the institution of court proceedings, sumption and not for further distribu- the custodian or DEA Asset Forfeiture tion, and those larger quantities gen- System shall transmit the petition to erally considered to be subject to fur- the U.S. Attorney for the judicial dis- ther distribution. trict in which the proceeding for for- (b) In this regard, for violations in- feiture is brought. He shall notify the volving the porsession of personal use petitioner of this action. quantities of a controlled substance, section 6079(b)(2) requires either that (28 U.S.C. 509 and 510; 21 U.S.C. 871 and 881(d); administrative forfditure be completed Pub. L. 98–473, Pub. L. 98–573) within 21 days of the seizure of the [48 FR 35088, Aug. 3, 1983, as amended at 49 property, or alternatively, that proce- FR 1178, Jan. 10, 1984; 49 FR 50643, Dec. 31, dures are established that provide a 1984; 56 FR 8686, Mar. 1, 1991; 62 FR 13970, means by which an individual entitled Mar. 24, 1997] to relief may initiate an expedited administrative review of the legal and Subpart F—Expedited Forfeiture factual basis of the seizure for for- Proceedings for Certain Property feiture. Should an individual request relief pursuant to these regulations AUTHORITY: 21 U.S.C. 822, 871, 872, 880, 881, and be entitled to the return of the 881–1, 883, 958, 965; 19 U.S.C. 1606, 1607, 1608, seized property, such property shall be 1610, 1613, 1618; 28 U.S.C. 509, 510; Pub. L. No. returned immediately following that 100–690, sec. 6079, 6080. determination, and the administrative SOURCE: 54 FR 37610, Sept. 11, 1989, unless forfeiture process shall cease. Should otherwise noted. the individual not be entitled to the return of the seized property, however, § 1316.90 Purpose and scope. the administrative forfeiture of that (a) The following definitions, regula- property shall proceed. The owner may, tions, and criteria are designed to es- in any event, obtain release of property

154 Drug Enforcement Administration, Justice § 1316.91 pending the administrative forfeiture dited release. This includes a by submitting to the agency making lienholder (to the extent of his interest the determination, property sufficient in the property) whose claim is in writ- to preserve the government’s vested ining (except for a maritime lien which terest for purposes of the administra- need not be in writing), unless the col- tive forfeiture. lateral is in the porsession of the se- (c) Section 6080 requires a similar ex- cured party. The agreement securing pedited review by the Attorney General such lien must create or provide for a or his representative in those instances security interest in the collateral, de- where a conveyance is being forfeited scribe the collateral, and be signed by in a civil judicial proceeding following the debtor. its seizure for a drug-related offense. (g) The term Legal and Factual Basis of the Seizure means a statement of the § 1316.91 Definitions. applicable law under which the prop- As used in this subpart, the following erty is seized, and a statement of the terms shall have the meanings speci- circumstances of the seizure suffi- fied: ciently precise to enable an owner or (a) The term Appraised Value means other interested party to identify the the estimated domestic price at the date, place, and use or acquisition time of seizure at which such or simi- which makes the property subject to lar property is freely offered for sale. forfeiture. (b) The term Commercial Fishing In- (h) The term Normal and Customary dustry Vessel means a vessel that: Manner means that inquiry suggested (1) Commercially engages in the by particular facts and circumstances catching, taking, or harvesting of fish which would customarily be under- or an activity that can reasonably be taken by a reasonably prudent indi- expected to result in the catching, tak- vidual in a like or similar situation. ing, or harvesting of fish; Actual knowledge of such facts and cir- (2) Commercially prepares fish or fish cumstances is unnecessary, and im- products other than by gutting, decapi- plied, imputed, or constructive knowl- tating, gilling, skinning, shucking, edge is sufficient. An established norm, icing, freezing, or brine chilling; or standard, or custom is persuasive but (3) Commercially supplies, stores, re- not conclusive or controlling in deter- frigerates, or transports fish, fish prod- mining whether an owner acted in a ucts, or materials directly related to normal and customary manner to as- fishing or the preparation of fish to or certain how property would be used by from a fishing, fish processing, or fish another legally in possession of the tender vessel or fish processing facil- property. The failure to act in a nority. mal and customary manner as defined (c) The term Controlled Substance has herein will result in the denial of a pe- the meaning given in section 802 of tition for expedited release of the prop- title 21, United States Code (U.S.C.). erty and is intended to have the desir- (d) The term Drug-Related Offense able effect of inducing owners of the means any proscribed offense which in- property to exercise greater care in volves the possession, distribution, transferring possession of their prop- manufacture, cultivation, sale, trans- erty. fer, or the attempt or conspiracy to (i) The term Owner means one having possess, distribute, manufacture, cul- a legal and possessory interest in the tivate, sell or transfer any substance property seized for forfeiture. Even the possession of which is prohibited by though one may hold primary and di- Title 21, U.S.C. rect title to the property seized, such (e) The term Immediately means with- person may not have sufficient actual in 20 days of the filing of a petition for beneficial interest in the property to expedited release by an owner. support a petition as owner if the facts (f) The term Interested Party means indicate that another person had do- one who was in legal possession of the minion and control over the property. property at the time of seizure and is (j) The term Personal Use Quantities entitled to legal possdssion at the time means possession of controlled sub- of the granting of the petition for expe- stances in circumstances where there

155 § 1316.91 21 CFR Ch. II (4–1–99 Edition) is no other evidence of an intent to dis- ecgonine or their salts have been re- tribute, of to facilitate the manufac- moved; turing, compounding, processing, deliv- (B) Cocaine, its salts, optical and ering, importing or exporting of any geometric isomers, and salts of iso- controlled substance. Evidence of per- mers; sonal use quantities shall not include (C) Ecgonine, its derivatives, their sweepings or other evidence of posses- salts, isomers, and salts of isomers; or sion of quantities of a controlled sub- (D) Any compound, mixture or prepa- stance for other than personal use. ration which contains any quantity of (1) Such other evidence shall include: any of the substances referred to in (i) Evidence, such as drug scales, paragraphs (j)(2)(ii)(A) through drug distribution paraphernalia, drug (j)(2)(ii)(C) of this section; records, drug packaging material, (iii) 1⁄10th gram of a mixture or sub- method of drug packaging, drug ‘‘cut- stance described in paragraph (j)(2)(ii) ting’’ agents and other equipment, that of this section which contains cocaine indicates an intent to process, package base; or distribute a controlled substance; (iv) 1⁄10th gram of a mixture or sub- (ii) Information from reliable sources stance containing a detectable amount indicating possession of a controlled of phencyclidine (PCP); substance with intent to distribute; (v) 500 micrograms of a mixture or (iii) The arrest and/or conviction substance containing a detectable record of the person or persons in ac- amount of lysergic acid diethylamide tual or constructive possession of the (LSD); controlled substance for offenses under (vi) One ounce of a mixture of sub- Federal, State or local law that indi- stance containing a detectable amount cates an intent to distribute a con- of marihuana; trolled substance; (iv) The controlled substance is re- (vii) One gram of methamphetamine, lated to large amounts of cash or any its salts, isomers, and salts of its iso- amount of prerecorded government mers, or one gram of a mixture or sub- funds; stance containing a detectable amount (v) The controlled substance is pos- of methamphetamine, its salts, iso- sessed under circumstances that indi- mers, or salts of its isomers. cate such a controlled substance is a (3) The possession of a narcotic, a de- sample intended for distribution in an- pressant, a stimulant, a hallucinogen ticipation of a transaction involving or cannabis-controlled substance will large quantities, or is part of a larger be considered in excess of personal use delivery; or quantities if the dosage unit amount (vi) Statements by the possessor, or possessed provides the same or greater otherwise attributable to the pos- equivalent efficacy as described in sessor, including statements of con- paragraph (j)(2) of this section. spirators, that indicate possession with (k) The term Property means property intent to distribute. subject to forfeiture under title 21, (2) Possession of a controlled sub- U.S.C., sections 881(a) (4), (6), and (7); stance shall be presumed to be for per- title 19, U.S.C., section 1595a, and; title sonal use when there are no indicia of 49, U.S.C. App., section 782. illicit drug trafficking or distribution (l) The term Seizing Agency means the such as, but not limited to, the factors Federal agency which has seized the listed above and the amounts do not property or adopted the seizure of an- exceed the following quantities: other agency, and has the responsi- (i) One gram of a mixture of sub- bility for administratively forfeiting stance containing a detectable amount the property; of heroin; (m) The term Statutory Rights or De- (ii) One gram of a mixture or sub- fenses to the Forfeiture means all legal stance containing a detectable amount and equitable rights and remedies of— available to a claimant of property (A) Coca leaves, except coba leaves seized for forfeiture. and extracts of coca leaves frol which (n) The term Sworn to as used in cocaine, ecgonine, and derivations of §§1316.92(e) and 1316.95(c) refers to the

156 Drug Enforcement Administration, Justice § 1316.93 oath as provided by Title 28, U.S.C., on the issue of forfeiture, such factors section 1746. shall also be considered in ruling on the petition for expedited release. § 1316.92 Petition for expedited release (e) A petition for expedited release in an administrative forfeiture ac- must be filed in a timely manner to be tion. considered by the seizing agency. In (a) Where property is seized for ad- order to be filed in a timely manner, ministrative forfeiture involving con- the petition must be received by the trolled substances in personal use appropriate seizing agency within 20 quantities the owner may petition the days from the date of the first publica- seizing agency for expedited release of tion of the notice of seizure. The peti- the property. tion must be executed and sworn to by (b) Where property described in para- the owner and both the envelope and graph (a) of this section is a commer- the request must be clearly marked cial fishing industry vessel proceeding ‘‘PETITION FOR EXPEDITED RE- to or from a fishing area or inter- LEASE.’’ Such petition shall be filed in mediate port of call or actually en- triplicate with the Special Agent in gaged in fishing operations, which Charge of the Drug Enforcement Ad- would be subject to seizure for adminis- ministration (DEA) or Federal Bureau trative forfeiture for a violation of law of Investigation (FBI) field office in the involving controlled substances in per- judicial district in which the property sonal use quantities, a summons to ap- was seized, depending upon which agen- pear shall be isrued in lieu of a phys- cy seized the property. The petition ical seizure. The vessel shall report to shall be addressed to the Director of the port designated in the summons. the FBI or to the Administrator of the The seizing agency shall be authorized DEA, depending upon which agency to effect administrative forfeiture as if seized the property. the vessel had been physically seized. (f) The petition shall include the fol- Upon answering the summons to ap- lowing: pear on or prior to the last reporting date specified in the summons, the (1) A complete description of the owner of the vessel may file a petition property, including identification num- for expedited release pursuant to para- bers, if any, and the date and place of graph (a) of this section and the provi- seizure; sions of paragraph (a) of this section (2) The petitioner’s interest in the and other provishons in this subpart property, which shall be supported by pertaining to a petition for expedited title documentation, bills of sale, con- release shall apply as if the vessel had tracts, mortgages, or other satisfac- been physically seized. tory documentary evidence; and (c) The owner filing the petition for (3) A statement of the facts and cir- expedited release shall establish the cumstances, to be established by satis- following: factory proof, relied upon by the peti- (1) The owner has a valid, good faith tioner to justify expedited release of interest in the seized property as owner the seized property. or otherwise; (2) The owner reasonably attempted § 1316.93 Ruling on petition for expe- to ascertain the use of the property in dited release in an administrative a normal and customary manner; and forfeiture action. (3) The owner did not know or con- (a) Upon receipt of a petition for ex- sent to the illegal use of the property, pedited release filed pursuant to or in the event that the owner knew or § 1316.92(a), the seizing agency shall de- should have known of the illegal use, termine first whether a final adminis- the owner did what reasonably could be trative determination of the case, expected to prevent the violation. without regard to the provisions of this (d) In addition to those factors listed subpart, can be made within 21 days of in paragraph (c) of this section, if an the seizure. If such a final administra- owner can demonstrate that the owner tive determination is made within 21 has other statutnry rights or defenses days, no further action need be taken that would cause the owner to prevail under this subpart.

157 § 1316.94 21 CFR Ch. II (4–1–99 Edition)

(b) If no such final administrative defense, the owner may petition the termination is made within 21 days of United States Attorney for an expe- the seizure, the following procedure dited release of the conveyance. shall apply. The seizing agency shall, (b) The owner filing the petition for within 20 days after the receipt of the expedited release shall establish the petition for expedited release, deter- following: mine whether the petition filed by the (1) The owner has a valid, good faith owner has established the factors listed interest in the seized conveyance as in § 1316.92(c) and: owner or otherwise; (1) If the seizing agency determines (2) The owner has statutory rights or that those factors have been estab- defenses that would show to a substan- lished, it shall terminate the adminis- tial probability that the owner would trative proceedings and return the prevail on the issue of forfeiture; property to the owner (or in the case of (3) The owner reasonably attempted a commercial fishing industry vessel to ascertain the use of the conveyance for which a summons has been issued in a normal and customary manner; shall dismiss the summons), except and where it is evidence of a violation of (4) The owner did not know or con- law; or sent to the illegal use of the convey- (2) If the seizing agency determines ance; or in the event that the owner that those factors have not been estab- knew or should have known of the ille- lished, the agency shall proceed with gal use, the owner did what reasonably the administrative forfeiture. could be expected to prevent the viola- § 1316.94 Posting of substitute res in tion. an administrative forfeiture action. (c) A petition for expedited release (a) Where property is seized for ad- must be filed in a timely manner in ministrative forfeiture involving con- order to be considered by the United trolled substances in personal use States Attorney. To be considered as quantities, the owner may obtain re- filed in a timely manner, the petition lease of the property by posting a sub- must be received by the appropriate stitute res with the seizing agency. The United States Attorney within 20 days property will be released to the owner from the date of the first publication of upon the payment of an amount equal the notice of the action and arrest of to the appraised value of the property the property, or within 30 days after if it is not evidence of a violation of filing of the claim, whichever occurs law or has design or other characteris- later. The petition must be executed tics that particularly suit it for use in and sworn to by the owner, and both illegal activities. This payment must the envelope and the request must be be in the form of a traveler’s check, a clearly marked ‘‘PETITION FOR EX- money order, a cashier’s check or an ir- PEDITED RELEASE.’’ Such petition revocable letter of credit made payable shall be filed in triplicate and ad- to the seizing agency. A bond in the dressed to and filed with the United form of a cashier’s check will be con- States Attorney prosecuting the considered as paid once the check has been veyance for forfeiture with a copy to accepted for payment by the financial the seizing agency. institution which issued the check. (d) The petition shall include the fol- (b) If a substitute res is posted and lowing: the property is administratively for- (1) A complete description of the con- feited, the seizing agency will forfeit veyance, including the identification the substitute res in lieu of the prop- number, and the date and place of sei- erty. zure; (2) The petitioner’s interest in the § 1316.95 Petition for expedited release conveyance, which shall be supported of a conveyance in a judicial for- by bills of sale, contracts, mortgages, feiture action. or other satisfactory documentary evi- (a) Where a conveyance has been dence; and, seized and is being forfeited in a judi- (3) The facts and circumstances, to be cial proceeding for a drug-related of- established by satisfactory proof, relied

158 Drug Enforcement Administration, Justice § 1316.99 upon by the petitioner to justify expe- § 1316.98 Substitute res bond in a judi- dited release of the seized conveyance. cial forfeiture action against a conveyance. § 1316.96 Ruling on a petition for expedited release of a conveyance in a (a) Where a conveyance is being for- judicial forfeiture action. feited in a judicial proceeding for a drug-related offense, the owner may (a) Upon receipt of a petition for ex- obtain release of the property by filing pedited release filed pursuant to a substitute res bond with the seizing § 1316.95, the United States Attorney agency. The conveyance will be re- shall rule on the petition within 20 leased to the owner upon the payment days of receipt. A petition shall be of a bond in the amount of the ap- deemed filed on the date it is received praised value of the conveyance if it is by the United States Attorney. not evidence of a violation of law or (b) If the United States Attorney has design or other characteristics that does not rule on the petition for expe- particularly suit it for use in illegal ac- dited release within 20 days after the tivities. This bond must be in the form date on which it is filed, the convey- of a traveler’s check, a money order, a ance shall be returned to the owner or cashier’s check or an irrevocable letter interested party pending further for- of credit made payable to the Depart- feiture proceedings, except where it is ment of Justice or to the United States evidence of a violation of law. Release Customs Service depending on which of conveyance under provisions of this agency seized the conveyance. A bond paragraph shall not affect the for- in the form of a cashier’s check will be feiture action with respect to that con- considered as paid once the check has veyance. been accepted for payment by the fi- (c) Upon a favorable ruling on the pe- nancial institution which issued the tition for expedited release, the United check. States Attorney shall, where necessary, move to terminate the judicial (b) If a substitute res bond is filed proceedings against the conveyance and the conveyance is judicially for- and immediately direct the return of feited, the court will forfeit the bond in the conveyance except where it is evi- lieu of the property. dence of a violation of law. § 1316.99 Notice provisions. (d) If, within 20 days, the United States Attorney denies the petition for (a) Special notice provision. At the expedited release, the government time of seizure of property defined in shall retain possession of the convey- § 1316.91 for violations involving the ance until the owner provides a sub- possession of personal use quantities of stitute res bond pursuant to § 1316.98 or a controlled substance and convey- the forfeiture is finalized. ances seized pursuant to § 1316.95, written notice must be provided to the pos- § 1316.97 Initiating judicial forfeiture sessor of the property regarding appli- proceeding against a conveyance cable statutes and Federal regulations within 60 days of the filing of a including the procedures established claim and cost bond. for the filing of a petition for expedited (a) The United States Attorney shall release and for the posting of a sub- file a complaint for forfeiture of the stitute res bond as set forth in sections conveyance within 60 days of the filing 6079 and 6080 of the Anti-Drug Abuse of the claim and cost bond. Act of 1988 and implementing regula- (b) Upon the failure of the United tions. States Attorney to file a complaint for (b) Standard notice provision. The forfeiture of a conveyance within 60 standard notice to the owner as re- days unless the court extends the 60- quired by title 19, U.S.C., section 1607 day period following a showing of good and applicable regulations, shall be cause, or unless the owner and the made at the earliest practicable oppor- United States Attorney agree to such tunity after determining ownership of an extension, the court shall order the the seized property or conveyance and return of the conveyance and the re- shall include the legal and factual turn of any bond. basis of the seizure.

159

CHAPTER III—OFFICE OF NATIONAL DRUG CONTROL POLICY

Part Page 1400 [Reserved] 1401 Public availability of information ...... 163 1402 Mandatory declassification review ...... 169 1403 Uniform administrative requirements for grants and cooperative agreements to State and local governments ...... 170 1404 Governmentwide debarment and suspension (nonprocurement) and governmentwide requirements for drug-free workplace (grants) ...... 202 1405–1499 [Reserved]

161

PART 1400 [RESERVED] ONDCP that can be answered by telephone, they may call the Office of Pub- PART 1401—PUBLIC AVAILABILITY lic Affairs at (202) 467–9890. This number should not be used to make FOIA OF INFORMATION requests. All oral requests for information under FOIA will be rejected. Sec. 1401.1 Purpose. § 1401.3 Definitions. 1401.2 The Office of National Drug Control Policy—Organization and functions. As used in this part, the following 1401.3 Definitions. definitions shall apply: 1401.4 Records of other agencies. (a) Commercial-use request means a re- 1401.5 How to request records—form and quest from or on behalf of one who content. seeks information for a cause or pur- 1401.6 Initial determination. pose that furthers the commercial, 1401.7 Prompt response. 1401.8 Responses—form and content. trade or profit interests of the re- 1401.9 Appeal procedures. quester or the person or institution on 1401.10 Fee schedule. whose behalf the request is made. In 1401.11 Payment of fees. determining whether a requester prop- 1401.12 Waiver of fees. erly belongs in this category, ONDCP 1401.13 Aggregation of requests. will consider how the requester intends 1401.14 Records that are exempt from disclo- to use the documents. sure. (b) Direct costs means those expendi- 1401.15 Deletion of exempted information. tures that ONDCP actually incurs in AUTHORITY: 5 U.S.C. 552, as amended. searching for and duplicating (and in SOURCE: 57 FR 59803, Dec. 16. 1992, unless the case of commercial requesters, re- otherwise noted. viewing) documents to respond to a FOIA request. Direct costs include, for § 1401.1 Purpose. example, the salary of the employee The purpose of this part is to pre- performing work (the basic rate of pay scribe rules, guidelines and procedures for the employee plus 16 percent of that to implement the Freedom of Informa- rate to cover benefits) and the cost of tion Act (FOIA), 5 U.S.C. 552, as amend- operating duplicating machinery. Not ed. included in direct costs are overhead expenses such as costs of space, and § 1401.2 The Office of National Drug heating or lighting the facility in Control Policy—Organization and which the records are stored. functions. (c) Duplication means the process of (a) The Office of National Drug Con- making a copy of a document in re- trol Policy (ONDCP) was created by sponse to a FOIA request. Such copies the Anti-Drug Abuse Act of 1988, 21 can take the form of paper copy, U.S.C. 1501 et seq. The mission of microform, audio-visual materials, or ONDCP is to coordinate the anti-drug machine readable documentation. efforts of the various agencies and de- ONDCP will provide a copy of the ma- partments of the Federal government, terial in a form that is usable by the to consult with States and localities requester unless it is administratively and assist their anti-drug efforts, and burdensome to do so. to annually promulgate the National (d) Educational institution means pre- Drug Control Strategy. ONDCP is school, a public or private elementary headed by the Director of National or secondary school, an institution of Drug Control Policy. The Director is graduate higher education, an institu- assisted by a Deputy Director for Sup- tion of undergraduate higher edu- ply Reduction, a Deputy Director for cation, an institution of professional Demand Reduction, and an Associate education, or an institution of voca- Director for State and Local Affairs. tional education, which operates a pro- (b) ONDCP has an Office of Public Af- gram or programs of scholarly re- fairs that is responsible for providing search. information to the press and to the (e) Noncommercial scientific institution general public. If members of the pub- means an institution that is not oper- lic have general questions about ated on a ‘‘commercial’’ basis as that

163 § 1401.4 21 CFR Ch. III (4–1–99 Edition) term is referenced above, and that is the document not subject to disclosure operated solely for the purpose of con- under FOIA and otherwise preparing ducting scientific research the results them for release). Review does not in- of which are not intended to promote clude time spent resolving general any particular product or industry. legal or policy issues regarding the ap- (f) Records and/or information means plication of exemptions. all books, papers, manuals, maps, pho- (j) Search means all time spent look- tographs, or other documentary mate- ing for material that is responsive to a rials, regardless of physical form or request, including page-by-page or line- characteristics, made or received by by-line identification of material with- ONDCP and preserved or appropriate in documents. Searches should be per- for preservation by ONDCP as evidence formed in the most efficient and least of the organization, functions, policies, expensive manner so as to minimize decisions, procedures, operations, or costs for both ONDCP and the re- other activities of the Government or quester; for example, line-by-line because of the information value of the searches should not be undertaken data in them, but does not include when it would be more efficient to du- books, magazines or other material ac- plicate the entire document. Searches quired solely for library purposes and should be distinguished from ‘‘review’’ through other sources, and does not in- of material in order to determine clude analyses, computations, or com- whether the material is exempt from pilations of information not extant at disclosure. Searches may be done the time of the request. The term manually or by computer using exist- ‘‘records’’ does not include objects or ing programming. articles such as structures, furniture, paintings, sculptures, three-dimen- § 1401.4 Records of other agencies. sional models, vehicles, and equipment. Requests for records that originated (g) Representative of the news media in another agency and are in the cus- means any person actively gathering tody of ONDCP shall be referred to the news for an entity that is organized originating agency for processing, and and operated to publish or broadcast the person submitting the request shall news to the public. The term ‘‘news’’ be so notified. Any decision made by means information that is about cur- the originating agency with respect to rent events or that would be of current such records will be honored by interest to the public. Examples of ONDCP. news media include television or radio stations broadcasting to the public at § 1401.5 How to request records—form large, and publishers of periodicals (but and content. only in those instances when they can (a) Requests for records under FOIA qualify as disseminators of ‘‘news’’) must be submitted in writing, ad- that make their products available for dressed to: Office of the General Coun- purchase or subscription by the general sel, Office of National Drug Control public. Freelance journalists may be Policy, Executive Office of the Presi- regarded as working for a news organi- dent, Washington, DC 20500. The words zation if they can demonstrate a rea- ‘‘FOIA REQUEST’’ or ‘‘REQUEST FOR sonable basis for expecting publication RECORDS’’ must be clearly marked on through that organization, even though both the letter and the envelope. If the not actually employed by it. request is not so marked and ad- (h) Request means a letter or other dressed, the 10-day time limit imposed written communication seeking by § 1401.7 of this part shall not begin to records or information under FOIA. run until the request has been received (i) Review means the process of exam- by the Office of the General Counsel ining documents located in response to and identified as a FOIA request. Due a commercial-use request to determine to security requirements, FOIA re- if that document or any portion of that quests may not be delivered in person. document is permitted to be withheld. (b) Any ONDCP employee who re- It also includes processing any docu- ceives a request shall promptly forward ment for disclosure (i.e., doing all that it to the Office of the General Counsel. is necessary to excise those portions of Any ONDCP employee who receives an

164 Office of National Drug Control Policy § 1401.8 oral request made under the FOIA shall tinct records that are demanded in a inform the person making the request single request; or of the provisions of this part requiring (2) It is necessary to consult with an- a written request. other agency having a substantial in- (c) Each request must reasonably de- terest in the determination of the re- scribe the record(s) sought, including quest or among two or more compo- when known: The specific event or ac- nents of ONDCP that have a substan- tion to which the request refers, if any; tial interest in the subject matter of the name of the agency, office, organi- the request. zation or person that originated the (b) When additional time is required record; the date or time period to for one of the reasons stated in para- which the request refers; the subject graph (a) of this section, the General matter of the records requested; the Counsel or his or her designee shall ac- type of document requested; the loca- knowledge receipt of the request with- tion of the record(s) requested; and any in the 10 working day period and in- other pertinent information that would clude a brief explanation of the reason assist in promptly locating the for delay, indicating the date by which record(s). a determination will be forthcoming. (d) When a request is not considered An extended deadline adopted for one reasonably descriptive, or requires the of the reasons set forth above may not production of voluminous records, or exceed 10 additional working days. places an extraordinary burden on § 1401.8 Responses—form and content. ONDCP, seriously interfering with its normal functioning to the detriment of (a) When a requested record has been the business of the Government, identified and is available, the General ONDCP may require the person or Counsel or his or her designee shall no- agent making the FOIA request to con- tify the person making the request as fer with an ONDCP representative in to where and when the record will be order to attempt to verify, and, if pos- available for inspection or the copies sible, narrow the scope of the request. will be available. The notification shall (e) Upon initial receipt of a request, also advise the person making the re- the Office of the General Counsel shall quest of any fees assessed under determine which official or officials § 1401.10 of this part. within ONDCP shall have the primary (b) A denial or partial denial of a re- responsibility for collecting and request for a record shall be in writing viewing the requested information and signed by the General Counsel or his or drafting a proposed response. her designee and shall include: (1) The name and title of the person § 1401.6 Initial determination. making the determination; (2) Either a reference to the specific The General Counsel or his or her exemption under FOIA authorizing the designee shall have the authority to withholding of the record and a brief approve or deny requests received pur- explanation of how the exemption ap- suant to these regulations. The deci- plies to the record withheld, or a state- sion of the General Counsel shall be ment that, after diligent effort, the re- final, subject only to administrative quested records have not been found or review as provided in § 1401.9. have not been adequately examined during the time allowed by § 1401.7, and § 1401.7 Prompt response. that the denial will be reconsidered as (a) The General Counsel or his or her soon as the search or examination is designee shall either approve or deny a complete; and request for records within 10 working (3) A statement that the denial may days (excluding Saturday, Sunday and be appealed to the Director within 30 Federal holidays) after receipt of the days of its receipt by the requester. request unless additional time is re- (c) If a requested record cannot be lo- quired for one of the following reasons: cated from the information supplied, or (1) It is necessary to search for, col- is known to have been destroyed or lect, and appropriately examine a volu- otherwise disposed of, the person mak- minous amount of separate and dis- ing the request shall be so notified and

165 § 1401.9 21 CFR Ch. III (4–1–99 Edition) the legal authority for disposition shall (2) Educational and non-commercial sci- be cited. entific institutions. When a request for records is made by an educational or a § 1401.9 Appeal procedures. non-commercial scientific institution (a) When the General Counsel or his in furtherance of scholarly or scientific or her designee denies a request for research, charges will be assessed to records in whole or in part, the person cover the cost of duplication alone, ex- making the request may, within 30 cluding charges for duplication of the days of receipt of the notice of denial, first 100 pages. appeal the denial to the Director of (3) Requests by representatives of the ONDCP. The appeal must be in writing, news media. When a request for records addressed to the Director, Office of Na- is made by a representative of the news tional Drug Control Policy, Executive media for the purpose of news dissemi- Office of the President, Washington, nation, charges will be assessed to DC 20500. The envelope should be clear- cover the cost of duplication alone, ex- ly labeled as a ‘‘Freedom of Informa- cluding charges for duplication of the tion Act Appeal.’’ first 100 pages. (b) The Director will act upon the ap- (4) All other requests. When a request peal within 20 working days of its re- for records is made by a requester who ceipt. The Director may extend the 20- does not fit into any of the preceding day period of time by any number of categories, charges will be assessed to working days which could have been cover the costs of searching for and du- used by the General Counsel or his or plicating the records sought, excluding her designee under § 1401.7 but which charges for the first two hours of were not used in making the initial de- search time and the duplication of the termination. The Director’s action on an appeal shall be in writing and first 100 pages. Moreover, requests from signed. individuals for records about themselves will be treated under the Pri- (c) If the decision is in favor of the requester, the Director shall order vacy Act of 1974, 5 U.S.C. 552a, which records promptly made available to the permits the assessment of fees for du- requester. plication costs only, regardless of the (d) A denial in whole or in part of a requester’s characterization of the request on appeal shall set forth a brief search. explanation of the reasons for the deci- (b) Fees for searches, review of sion, and shall inform the requester of records and duplication of records are his or her right to seek judicial review charged as follows: of the denial and ruling on appeal as (1) Search for records. The charge for a provided in 5 U.S.C. 552(a)(4). manual search is calculated by deter- (e) No personal appearance, oral ar- mining the search time to the nearest gument or hearing will ordinarily be quarter hour and multiplying that fig- permitted in connection with an appeal ure by the sum of the basic rate of pay to the Director. per hour of the employee conducting the search plus 16 percent of that rate. § 1401.10 Fee schedule. The charge for a computer search is (a) There are four categories of re- calculated by determining the search questers: Commercial use requesters; time to the nearest quarter hour and educational and non-commercial sci- multiplying that figure by the sum of entific institutions; representatives of the basic rate of pay per hour of the the news media; and all other request- employee conducting the search, plus ers. FOIA prescribes different levels of 16 percent of that rate, plus the direct fees for each of these categories. cost of the operation of the computer (1) Commercial use requesters. When a for that portion of time attributable to request for records is made for com- the search. mercial use, charges will be assessed to (2) Review of records. Only requesters cover all the costs of searching for, re- who are seeking documents for com- viewing for release, and duplicating the mercial use will be charged for time records sought. spent reviewing records to determine

166 Office of National Drug Control Policy § 1401.12 whether they are exempt from manda- his willingness to pay such fees, the re- tory disclosure. Charges will be as- quester shall be promptly notified of sessed only for the initial review; i.e., the amount of the anticipated fee or the review undertaken the first time such portion thereof as can readily be ONDCP analyzes the applicability of a estimated. In instances where the esti- specific exemption to a particular mated fees will exceed $250.00, an ad- record or portion of a record. Charges vance deposit may be required. The no- will not be assessed for review at the tice or request for an advance deposit administrative appeal level of the ex- shall extend to the requester an offer emption(s) already applied. The cost to consult with ONDCP personnel in for review will be calculated based on order to reformulate the request in a the salary of the category of the em- manner which will reduce the fees. A ployee who actually performed the re- reformulated request shall be consid- view plus 16 percent of that rate. ered a new request, thus beginning a (3) Duplication of records. Copies made new 10 workday period for responding by routine photostatic copying shall be to the request. charged at the rate of $0.15 per page. If (d) When a requester has previously copies need to be made by other meth- failed to pay a fee in a timely fashion ods, the direct costs of such copies will (i.e., within 30 days of the date of the be charged to the requester, as deter- billing), ONDCP may require the re- mined by the General Counsel. quester to demonstrate that he or she (4) Unsuccessful searches. Requesters has, in fact, paid any outstanding fees may be charged for unsuccessful or un- from past requests, and to make an ad- productive searches or for searches vance payment of the full amount of when records located are determined to the estimated fee for the present re- be exempt from disclosure. quest before ONDCP responds to that (5) Other charges. ONDCP will recover request. the direct costs of providing special (e) Interest charges on an unpaid bill services such as certifying that records may be assessed starting on the 31st are true copies, and sending records by day following the day on which the special methods such as express mail. billing was sent. Interest shall be as- (c) No fee will be charged by ONDCP sessed at the rate prescribed in 31 when the routine costs of collecting U.S.C. 3717, and shall accrue from the and processing the fee equal to or ex- date of the billing. The fact that a fee ceed the amount of the fee. For pur- has been received by ONDCP, even if poses of this section, the routine costs not processed, will suffice to stay the of collecting and processing a fee accrual of interest. chargeable under FOIA are estimated (f) To encourage the repayment of de- to be $15.00 for each FOIA request. linquent fees, ONDCP shall use the procedures described in the Debt Collec- § 1401.11 Payment of fees. tion Act of 1982, 31 U.S.C. 3716–3719, in- (a) The requester must agree to pay cluding the use of collection agencies all fees that are chargeable under this and disclosure to consumer reporting section prior to issuance of the re- agencies. quested copies. (b) Payment of fees shall be in the § 1401.12 Waiver of fees. form either of a personal check or bank (a) Records shall be furnished with- draft drawn on a bank in the United out charge, or at a reduced charge, States, or a postal money order. Re- upon a determination by the General mittances shall be made payable to the Counsel of ONDCP that: order of the Treasurer of the United (1) Waiver or reduction of the fees is States and mailed to the General Coun- in the public interest because release sel, Office of National Drug Control of the requested information is likely Policy, Executive Office of the Presi- to contribute significantly to public dent, Washington, DC 20500. understanding of the operations or ac- (c) If it is anticipated that the fees tivities of ONDCP and is not primarily chargeable under this section will in the commercial interest of the re- amount to more than $25.00, and the requester; or quester has not indicated in advance (2) Assessment of fees is not feasible.

167 § 1401.13 21 CFR Ch. III (4–1–99 Edition)

(b) Upon written request, a written (4) Records of trade secrets and com- explanation will be provided as to why mercial or financial information ob- a request for waiver or reduction of tained from a person and privileged or FOIA fees was not granted. confidential; (c) There is no right to an adminis- (5) Inter-agency or intra-agency trative appeal from a decision not to memoranda or letters which would not waive or reduce fees. be available by law to a party other than in litigation with the agency; § 1401.13 Aggregation of requests. (6) Personnel and medical files and (a) When the General Counsel reason- similar files the disclosure of which ably believes that a requester, or a would constitute a clearly unwarranted group of requesters acting in concert, invasion of personal privacy; and is attempting to break down a request (7) Records or information compiled into a series of requests for the purpose for law enforcement purposes, but only of evading the assessment of fees, such to the extent that the production of requests may be aggregated and fees such law enforcement records or infor- may be charged accordingly. mation: (i) Could reasonably be expected to (b) In determining whether a series of interfere with enforcement pro- requests shall be aggregated, the Gen- ceedings, eral Counsel will consider two factors: (ii) Would deprive a person of a right whether the requests concern a single to a fair trial or an impartial adjudica- subject or two or more closely related tion, subjects; and whether the requests (iii) Could reasonably be expected to were all made within a 30-day period. If constitute an unwarranted invasion of a series of requests is made by multiple personal privacy, requesters, the General Counsel will (iv) Could reasonably be expected to also consider whether there is substan- disclose the identity of a confidential tial evidence to support the conclusion source including a state, local, or for- that the requesters are acting in con- eign agency or authority or any pri- cert. vate institution which furnished infor- § 1401.14 Records that are exempt mation on a confidential basis, and, in from disclosure. the case of a record compiled by a criminal law enforcement authority in (a) Records described in 5 U.S.C. the course of a criminal investigation, 552(b) are exempt from disclosure under or by an agency conducting a lawful FOIA. These include the following cat- national security intelligence inves- egories of records: tigation, information furnished by a (1) Records that are specifically au- confidential source, thorized under criteria established by (v) Would disclose techniques and an Executive order to be kept secret in procedures for law enforcement inves- the interest of national defense or for- tigations or prosecutions, or would dis- eign policy and are in fact properly close guidelines for law enforcement classified pursuant to such Executive investigations or prosecutions if such order; disclosure could reasonably be ex- (2) Records related solely to the in- pected to risk circumvention of the ternal personnel rules and practices of law, or an agency; (vi) Could reasonably be expected to (3) Records specifically exempted endanger the life or physical safety of from disclosure by statute (other than any individual. 5 U.S.C. 552b), provided that such statute: § 1401.15 Deletion of exempted infor- (i) requires that the matters be with- mation. held from the public in such a manner When requested records contain mat- as to leave no discretion on the issue, ters that are exempted under 5 U.S.C. or 552(b), but such exempted matters are (ii) establishes particular criteria for reasonably segregable from the re- withholding or refers to particular mainder of the records, the records types of matters to be withheld; shall be disclosed by ONDCP with the

168 Office of National Drug Control Policy § 1402.7 necessary deletions. ONDCP shall at- fice of Planning, Budget, and Adminis- tach to each such record a written jus- tration of ONDCP and/or the office of tification for making the deletion or primary interest to determine whether, deletions. A single such justification under the declassification provisions of shall suffice for deletions made in a section 3.1 of Executive Order 12356 (3 group of similar or related records. CFR, 1982 Comp., p. 166), the requested information may be declassified. If the PART 1402—MANDATORY information may not be released, in DECLASSIFICATION REVIEW whole or in part, the requester shall be given a brief statement as to the rea- Sec. sons for denial, a notice of the right to 1402.1 Purpose. appeal the determination to the Direc- 1402.2 Responsibility. tor of ONDCP, and a notice that such 1402.3 Information in the custody of an appeal must be filed within 60 days ONDCP. in order to be considered. 1402.4 Information classified by another agency. 1402.5 Appeal procedure. § 1402.4 Information classified by an- 1402.6 Fees. other agency. 1402.7 Suggestions and complaints. When a request is received for infor- AUTHORITY: Section 3.4, E.O. 12356 (3 CFR, mation that was classified by another 1982 Comp., p. 166), and Information Security agency, the Director of the Office of Oversight Office Directive No. 1 (32 CFR Planning, Budget, and Administration 2001.32). of ONDCP will forward the request and SOURCE: 57 FR 55089, Nov. 24, 1992, unless a copy of the document(s) along with otherwise noted. any other related materials, to the appropriate agency for review and deter- § 1402.1 Purpose. mination as to release. Recommenda- Other government agencies, U.S. citi- tions as to release or denial may be zens or permanent resident aliens may made if appropriate. The requester will request that classified information in be notified of the referral, unless the files of the Office of National Drug receiving agency objects on the Control Policy (ONDCP) be reviewed grounds that its association with the for possible declassification and re- information requires protection. lease. This part prescribes the procedures for such review and subsequent § 1402.5 Appeal procedure. release or denial. Appeals reviewed as a result of a denial will be routed to the Director of § 1402.2 Responsibility. ONDCP, who will take action as nec- All requests for the mandatory de- essary to determine whether any part classification review of classified infor- of the information may be declassified. mation in ONDCP files should be ad- If so, the Director shall notify the re- dressed to the Security Officer, Office quester of this determination and shall of National Drug Control Policy, Exec- make any information available that is utive Office of the President, Wash- declassified and is otherwise releas- ington, DC 20500, who will acknowledge able. If continued classification is re- receipt of the request. When a request quired, the requester shall be notified does not reasonably describe the infor- by the Director of ONDCP of the rea- mation sought, the requester shall be sons therefore. notified that unless additional information is provided, or the scope of the § 1402.6 Fees. request is narrowed, no further action will be taken. There will normally be no fees charged for the mandatory review of § 1402.3 Information in the custody of classified material for declassification ONDCP. under this part. Information contained in ONDCP files and under the exclusive declas- § 1402.7 Suggestions and complaints. sification jurisdiction of ONDCP will Suggestions and complaints regard- be reviewed by the Director of the Of- ing the information security program

169 Pt. 1403 21 CFR Ch. III (4–1–99 Edition) of ONDCP should be submitted, in writ- 1403.51 Later disallowances and adjusting, to the Security Officer, Office of ments. National Drug Control Policy, Wash- 1403.52 Collection of amounts due. ington, DC 20500. Subpart E—Entitlement [Reserved]

PART 1403—UNIFORM ADMINIS- APPENDIX A TO PART 1403—OMB CIRCULAR A– TRATIVE REQUIREMENTS FOR 128,‘‘AUDITS OF STATE AND LOCAL GOVERN- GRANTS AND COOPERATIVE MENTS’’ AGREEMENTS TO STATE AND LOCAL GOVERNMENTS AUTHORITY: 5 U.S.C. 301. SOURCE: 57 FR 55092, Nov. 24, 1992, unless Subpart A—General otherwise noted. Sec. 1403.1 Purpose and scope of this part. Subpart A—General 1403.2 Scope of subpart. 1403.3 Definitions. § 1403.1 Purpose and scope of this 1403.4 Applicability. part. 1403.5 Effect on other issuances. This part establishes uniform admin- 1403.6 Additions and exceptions. istrative rules for Federal grants and cooperative agreements and subawards Subpart B—Pre-Award Requirements to State, local and Indian tribal gov- 1403.10 Forms for applying for grants. ernments. 1403.11 State plans. 1403.12 Special grant or subgrant conditions § 1403.2 Scope of subpart. for ‘‘high-risk’’ grantees. This subpart contains general rules Subpart C—Post-Award Requirements pertaining to this part and procedures for control of exceptions from this FINANCIAL ADMINISTRATION part. 1403.20 Standards for financial management systems. § 1403.3 Definitions. 1403.21 Payment. 1403.22 Allowable costs. As used in this part: 1403.23 Period of availability of funds. Accrued expenditures mean the 1403.24 Matching or cost sharing. charges incurred by the grantee during 1403.25 Program income. a given period requiring the provision 1403.26 Non-Federal audit. of funds for: CHANGES, PROPERTY, AND SUBAWARDS (1) Goods and other tangible property 1403.30 Changes. received; 1403.31 Real property. (2) Services performed by employees, 1403.32 Equipment. contractors, subgrantees, subcontrac- 1403.33 Supplies. tors, and other payees; and 1403.34 Copyrights. (3) Other amounts becoming owed 1403.35 Subawards to debarred and suspended parties. under programs for which no current 1403.36 Procurement. services or performance is required, 1403.37 Subgrants. such as annuities, insurance claims, and other benefit payments. REPORTS, RECORDS, RETENTION, AND ENFORCEMENT Accrued income means the sum of: (1) Earnings during a given period 1403.40 Monitoring and reporting program performance. from services performed by the grantee 1403.41 Financial reporting. and goods and other tangible property 1403.42 Retention and access requirements delivered to purchasers, and for records. (2) Amounts becoming owed to the 1403.43 Enforcement. grantee for which no current services 1403.44 Termination for convenience. or performance is required by the Subpart D—After-The-Grant Requirements grantee. 1403.50 Closeout.

170 Office of National Drug Control Policy § 1403.3

Acquisition cost of an item of pur- Equipment means tangible, non- chased equipment means the net in- expendable, personal property having a voice unit price of the property includ- useful life of more than one year and ing the cost of modifications, attach- an acquisition cost of $5,000 or more ments, accessories, or auxiliary appa- per unit. A grantee may use its own ratus necessary to make the property definition of equipment provided that usable for the purpose for which it was such definition would at least include acquired. Other charges such as the all equipment defined above. cost of installation, transportation, Expenditure report means: taxes, duty or protective in-transit in- (1) For nonconstruction grants, the surance, shall be included or excluded SF–269 ‘‘Financial Status Report’’ (or from the unit acquisition cost in ac- other equivalent report); cordance with the grantee’s regular ac- (2) For construction grants, the SF– counting practices. 271 ‘‘Outlay Report and Request for Re- Administrative requirements mean imbursement’’ (or other equivalent re- those matters common to grants in port). general, such as financial management, Federally recognized Indian tribal gov- kinds and frequency of reports, and re- ernment means the governing body or a tention of records. These are distin- governmental agency of any Indian guished from ‘‘programmatic’’ require- tribe, band, nation, or other organized ments, which concern matters that can group or community (including any be treated only on a program-by-pro- Native village as defined in section 3 of gram or grant-by-grant basis, such as the Alaska Native Claims Settlement kinds of activities that can be sup- Act, 85 Stat. 688) certified by the Sec- ported by grants under a particular retary of the Interior as eligible for the program. special programs and services provided Awarding agency means: by him through the Bureau of Indian (1) With respect to a grant, the Fed- Affairs. eral agency, and Government means a State or local (2) With respect to a subgrant, the government or a federally recognized party that awarded the subgrant. Indian tribal government. Cash contributions means the grant- Grant means an award of financial as- ee’s cash outlay, including the outlay sistance, including cooperative agree- of money contributed to the grantee or ments, in the form of money, or prop- subgrantee by other public agencies erty in lieu of money, by the Federal and institutions, and private organiza- Government to an eligible grantee. The tions and individuals. When authorized term does not include technical assist- by Federal legislation, Federal funds ance which provides services instead of received from other assistance agree- money, or other assistance in the form ments may be considered as grantee or of revenue sharing, loans, loan guaran- subgrantee cash contributions. tees, interest subsidies, insurance, or Contract means (except as used in the direct appropriations. Also, the term definitions for ‘‘grant’’ and ‘‘subgrant’’ does not include assistance, such as a in this section and except where quali- fellowship or other lump sum award, fied by ‘‘Federal’’) a procurement con- which the grantee is not required to ac- tract under a grant or subgrant, and count for. means a procurement subcontract Grantee means the government to under a contract. which a grant is awarded and which is Cost sharing or matching means the accountable for the use of the funds value of the third party in-kind con- provided. The grantee is the entire tributions and the portion of the costs legal entity even if only a particular of a federally assisted project or pro- component of the entity is designated gram not borne by the Federal Govern- in the grant award document. ment. Local government means a county, Cost-type contract means a contract or municipality, city, town, township, subcontract under a grant in which the local public authority (including any contractor or subcontractor is paid on public and Indian housing agency the basis of the costs it incurs, with or under the United States Housing Act of without a fee. 1937) school district, special district,

171 § 1403.3 21 CFR Ch. III (4–1–99 Edition) intrastate district, council of govern- costs under the grant to which the ac- ments (whether or not incorporated as quisition costs under the grant to a nonprofit corporation under state which the acquisition cost of the prop- law), any other regional or interstate erty was charged. Only costs are to be government entity, or any agency or counted—not the value of third-party instrumentality of a local government. in-kind contributions. Obligations means the amounts of or- State means any of the several States ders placed, contracts and subgrants of the United States, the District of awarded, goods and services received, Columbia, the Commonwealth of Puer- and similar transactions during a given to Rico, any territory or possession of period that will require payment by the United States, or any agency or in- the grantee during the same or a future strumentality of a State exclusive of period. local governments. The term does not OMB means the United States Office include any public and Indian housing of Management and Budget. agency under United States Housing Outlays (expenditures) means charges Act of 1937. made to the project or program. They Subgrant means an award of financial may be reported on a cash or accrual assistance in the form of money, or basis. For reports prepared on a cash property in lieu of money, made under basis, outlays are the sum of actual a grant by a grantee to an eligible sub- cash disbursement for direct charges grantee. The term includes financial for goods and service, the amount of in- assistance when provided by contrac- direct expense incurred, the value of tual legal agreement, but does not in- in-kind contributions applied, and the clude procurement purchases, nor does amount of cash advances and payments it include any form of assistance which made to contractors and subgrantees. is excluded from the definition of For reports prepared on an accrued ex- ‘‘grant’’ in this part. penditure basis, outlays are the sum of Subgrantee means the government or actual cash disbursements, the amount other legal entity to which a subgrant of indirect expense incurred, the value of in-kind contributions applied, and is awarded and which is accountable to the new increase (or decrease) in the the grantee for the use of the funds amounts owed by the grantee for goods provided. and other property received, for serv- Supplies means all tangible personal ices performed by employees, contrac- property other than ‘‘equipment’’ as tors, subgrantees, subcontractors, and defined in this part. other payees, and other amounts be- Suspension means depending on the coming owed under programs for which context, either no current services or performance are (1) Temporary withdrawal of the au- required, such as annuities, insurance thority to obligate grant funds pending claims, and other benefit payments. corrective action by the grantee or Percentage of completion method refers subgrantee or a decision to terminate to a system under which payments are the grant, or made for construction work according (2) In action taken by a suspending to the percentage of completion of the official in accordance with agency reg- work, rather than to the grantee’s cost ulations implementing E.O. 12549 to incurred. immediately exclude a person from Prior approval means documentation participating in grant transactions for evidencing consent prior to incurring a period, pending completion of an in- specific cost. vestigation and such legal or debar- Real property means land, including ment proceedings as may ensue. land improvements, structures and ap- Termination means permanent with- purtenances thereto, excluding mov- drawal of the authority to obligate pre- able machinery and equipment. viously-awarded grant funds before Share, when referring to the awarding that authority would otherwise expire. agency’s portion of real property, It also means the voluntary relinquish- equipment or supplies, means the same ment of that authority by the grantee percentage as the awarding agency’s or subgrantee. ‘‘Termination’’ does not portion of the acquiring party’s total include:

172 Office of National Drug Control Policy § 1403.4

(1) Withdrawal of funds awarded on Services; Maternal and Child Health the basis of the grantee’s underesti- Services; Social Services; Low-Income mate of the unobligated balance in a Home Energy Assistance; States’ Pro- prior period; gram of Community Development (2) Withdrawal of the unobligated Block Grants for Small Cities; and Ele- balance as of the expiration of a grant; mentary and Secondary Education (3) Refusal to extend a grant or other than programs administered by award additional funds, to make a com- the Secretary of Education under title peting or noncompeting continuation, V, subtitle D, chapter 2, section 583— renewal, extension, or supplemental the Secretary’s discretionary grant award; or program) and titles I–III of the Job (4) Voiding of a grant upon deter- Training Partnership Act of 1982 and mination that the award was obtained under the Public Health Services Act fraudulently, or was otherwise illegal (Section 1921), Alcohol and Drug Abuse or invalid from inception. Treatment and Rehabilitation Block Terms of a grant or subgrant mean all Grant and part C of title V, Mental requirements of the grant or subgrant, Health Service for the Homeless Block whether in statute, regulations, or the Grant); award document. (3) Entitlement grants to carry out Third party in-kind contributions mean the following programs of the Social property or services which benefit a Security Act: federally assisted project or program (i) Aid to Needy Families with De- and which are contributed by non-Fed- pendent Children (title IV–A of the eral third parties without charge to the Act, not including the Work Incentive grantee, or a cost-type contractor Program (WIN) authorized by section under the grant agreement. 402(a)19(G); HHS grants for WIN are Unliquidated obligations for reports subject to this part); prepared on a cash basis mean the (ii) Child Support Enforcement and amount of obligations incurred by the Establishment of Paternity (title IV–D grantee that has not been paid. For re- of the Act); ports prepared on an accrued expendi- (iii) Foster Care and Adoption Assist- ture basis, they represent the amount ance (title IV–E of the Act); of obligations incurred by the grantee (iv) Aid to the Aged, Blind, and Dis- for which an outlay has not been re- abled (titles I, X, XIV, and XVI–AABD corded. of the Act); and Unobligated balance means the por- (v) Medical Assistance (Medicaid) tion of the funds authorized by the (title XIX of the Act) not including the Federal agency that has not been obli- State Medicaid Fraud Control program gated by the grantee and is determined authorized by section 1903(a)(6)(B); by deducting the cumulative obliga- (4) Entitlement grants under the fol- tions from the cumulative funds au- lowing programs of The National thorized. School Lunch Act: (i) School Lunch (section 4 of the § 1403.4 Applicability. Act), (a) General. Subparts A–D of this part (ii) Commodity Assistance (section 6 apply to all grants and subgrants to of the Act), governments, except where incon- (iii) Special Meal Assistance (section sistent with Federal statutes or with 11 of the Act), regulations authorized in accordance (iv) Summer Food Service for Chil- with the exception provision of § 1403.6, dren (section 13 of the Act), and or: (v) Child Care Food Program (section (1) Grants and subgrants to State and 17 of the Act); local institutions of higher education (5) Entitlement grants under the fol- or State and local hospitals; lowing programs of The Child Nutri- (2) The block grants authorized by tion Act of 1966: the Omnibus Budget Reconciliation (i) Special Milk (section 3 of the Act), Act of 1981 (Community Services; Pre- and ventive Health and Health Services; Al- (ii) School Breakfast (section 4 of the cohol, Drug Abuse, and Mental Health Act);

173 § 1403.5 21 CFR Ch. III (4–1–99 Edition)

(6) Entitlement grants for State Ad- Subpart B—Pre-Award ministrative expenses under The Food Requirements Stamp Act of 1977 (section 16 of the Act); § 1403.10 Forms for applying for (7) A grant for an experimental, pilot, grants. or demonstration project that is also (a) Scope. (1) This section prescribes supported by a grant listed in para- forms and instructions to be used by graph (a)(3) of this section; governmental organizations (except (8) Grant funds awarded under sub- hospitals and institutions of higher section 412(e) of the Immigration and education operated by a government) Nationality Act (8 U.S.C. 1522(e)) and in applying for grants. This section is subsection 501(a) of the Refugee Edu- not applicable, however, to formula cation Assistance Act of 1980 (Pub. L. grant programs which do not require 96–422, 94 Stat. 1809), for cash assist- applicants to apply for funds on a ance, medical assistance, and supple- project basis. mental security income benefits to ref- (2) This section applies only to appli- ugees and entrants and the administra- cations to Federal agencies for grants, tive costs of providing the assistance and is not required to be applied by and benefits; grantees in dealing with applicants for (9) Grants to local education agencies subgrants. However, grantees are en- under 20 U.S.C. 236 through 241–1(a), couraged to avoid more detailed or bur- and 242 through 244 (portions of the Im- densome application requirements for pact Aid program), except for 20 U.S.C. subgrants. 238(d)(2)(c) and 240(f) (Entitlement In- (b) Authorized forms and instructions crease for Handicapped Children); and for governmental organizations. (1) In ap- (10) Payments under the Veterans plying for grants, applicants shall only Administration’s State Home Per Diem use standard application forms or those Program (38 U.S.C. 641(a)). prescribed by the granting agency with (b) Entitlement programs. Entitlement the approval of OMB under the Paper- programs enumerated above in work Reduction Act of 1980. § 1403.4(a) (3) through (8) are subject to (2) Applicants are not required to subpart E. submit more than the original and two copies of preapplications or applica- § 1403.5 Effect on other issuances. tions. All other grants administration pro- (3) Applicants must follow all appli- visions of codified program regula- cable instructions that bear OMB tions, program manuals, handbooks clearance numbers. Federal agencies and other nonregulatory materials may specify and describe the programs, which are inconsistent with this part functions, or activities that will be are superseded, except to the extent used to plan, budget, and evaluate the they are required by statute, or au- work under a grant. Other supple- thorized in accordance with the excep- mentary instructions may be issued tion provision in § 1403.6. only with the approval of OMB to the extent required under the Paperwork § 1403.6 Additions and exceptions. Reduction Act of 1980. For any stand- (a) For classes of grants and grantees ard form, except the SF–424 facesheet, subject to this part, Federal agencies Federal agencies may shade out or in- may not impose additional administra- struct the applicant to disregard any tive requirements except in codified line item that is not needed. regulations published in the FEDERAL (4) When a grantee applies for addi- REGISTER. tional funding (such as a continuation (b) Exceptions for classes of grants or or supplemental award) or amends a grantees may be authorized only by previously submitted application, only OMB. the affected pages need be submitted. (c) Exceptions on a case-by-case basis Previously submitted pages with infor- and for subgrantees may be authorized mation that is still current need not be by the affected Federal agencies. resubmitted.

174 Office of National Drug Control Policy § 1403.20

§ 1403.11 State plans. (5) Is otherwise not responsible; and (a) Scope. The statutes for some pro- if the awarding agency determines that grams require States to submit plans an award will be made, special condi- before receiving grants. Under regulations and/or restrictions shall cor- tions implementing Executive Order respond to the high risk condition and 12372, ‘‘Intergovernmental Review of shall be included in the award. Federal Programs,’’ States are allowed (b) Special conditions or restrictions to simplify, consolidate and substitute may include: plans. This section contains additional (1) Payment on a reimbursement provisions for plans that are subject to basis; regulations implementing the Execu- (2) Withholding authority to proceed tive Order. to the next phase until receipt of evi- (b) Requirements. A State need meet dence of acceptable performance within only Federal administrative or pro- a given funding period; grammatic requirements for a plan (3) Requiring additional, more de- that are in statutes or codified regula- tailed financial reports; tions. (4) Additional project monitoring; (c) Assurances. In each plan the (5) Requiring the grantee or sub- States will include an assurance that grantee to obtain technical or manage- the State shall comply with all appli- ment assistance; or cable Federal statutes and regulations (6) Establishing additional prior ap- in effect with respect to the periods for provals; which it receives grant funding. For (c) If an awarding agency decides to this assurance and other assurances re- impose such conditions, the awarding quired in the plan, the State may: official will notify the grantee or sub- (1) Cite by number the statutory or grantee as early as possible, in writing, regulatory provisions requiring the as- of: surances and affirm that it gives the (1) The nature of the special condi- assurances required by those provi- tions/restrictions; sions, (2) The reason(s) for imposing them; (2) Repeat the assurance language in (3) The corrective actions which must the statutes or regulations, or be taken before they will be removed (3) Develop its own language to the and the time allowed for completing extent permitted by law. the corrective actions; and (d) Amendments. A State will amend a (4) The method of requesting recon- plan whenever necessary to reflect: (1) sideration of the conditions/restric- New or revised Federal statutes or reg- tions imposed. ulations or (2) a material change in any State law, organization, policy, or Subpart C—Post-Award State agency operation. The State will Requirements obtain approval for the amendment and its effective date but need submit for FINANCIAL ADMINISTRATION approval only the amended portions of the plan. § 1403.20 Standards for financial management systems. § 1403.12 Special grant or subgrant (a) A State must expend and account conditions for ‘‘high-risk’’ grantees. for grant funds in accordance with (a) A grantee or subgrantee may be State laws and procedures for expend- considered ‘‘high risk’’ if an awarding ing and accounting for its own funds. agency determines that a grantee or Fiscal control and accounting proce- subgrantee: dures of the State, as well as its sub- (1) Has a history of unsatisfactory grantees and cost-type contractors, performance, or must be sufficient to— (2) Is not financially stable, or (1) Permit preparation of reports re- (3) Has a management system which quired by this part and the statutes au- does not meet the management stand- thorizing the grant, and ards set forth in this part, or (2) Permit the tracing of funds to a (4) Has not conformed to terms and level of expenditures adequate to es- conditions of previous awards, or tablish that such funds have not been

175 § 1403.21 21 CFR Ch. III (4–1–99 Edition) used in violation of the restrictions whenever advance payment procedures and prohibitions of applicable statutes. are used. Grantees must establish rea- (b) The financial management sys- sonable procedures to ensure the re- tems of other grantees and subgrantees ceipt of reports on subgrantees’ cash must meet the following standards: balances and cash disbursements in (1) Financial reporting. Accurate, cur- sufficient time to enable them to pre- rent, and complete disclosure of the fi- pare complete and accurate cash trans- nancial results of financially assisted actions reports to the awarding agen- activities must be made in accordance cy. When advances are made by letter- with the financial reporting require- of-credit or electronic transfer of funds ments of the grant or subgrant. methods, the grantee must make (2) Accounting records. Grantees and drawdowns as close as possible to the subgrantees must maintain records time of making disbursements. Grant- which adequately identify the source ees must monitor cash drawdowns by and application of funds provided for fi- their subgrantees to assure that they nancially-assisted activities. These conform substantially to the same records must contain information per- standards of timing and amount as taining to grant or subgrant awards apply to advances to the grantees. and authorizations, obligations, unobli- (c) An awarding agency may review gated balances, assets, liabilities, out- the adequacy of the financial manage- lays or expenditures, and income. ment system of any applicant for fi- (3) Internal control. Effective control nancial assistance as part of a and accountability must be maintained preaward review or at any time subse- for all grant and subgrant cash, real quent to award. and personal property, and other assets. Grantees and subgrantees must § 1403.21 Payment. adequately safeguard all such property (a) Scope. This section prescribes the and must assure that it is used solely basic standard and the methods under for authorized purposes. which a Federal agency will make pay- (4) Budget control. Actual expendi- ments to grantees, and grantees will tures or outlays must be compared make payments to subgrantees and with budgeted amounts for each grant contractors. or subgrant. Financial information (b) Basic standard. Methods and pro- must be related to performance or procedures for payment shall minimize ductivity data, including the develop- the time elapsing between the transfer ment of unit cost information when- of funds and disbursement by the ever appropriate or specifically re- grantee or subgrantee, in accordance quired in the grant or subgrant agree- with Treasury regulations at 31 CFR ment. If unit cost data are required, es- part 205. timates based on available documenta- (c) Advances. Grantees and sub- tion will be accepted whenever pos- grantees shall be paid in advance, pro- sible. vided they maintain or demonstrate (5) Allowable cost. Applicable OMB the willingness and ability to maintain cost principles, agency program regula- procedures to minimize the time elaps- tions, and the terms of grant and ing between the transfer of the funds subgrant agreements will be followed and their disbursement by the grantee in determining the reasonableness, al- or subgrantee. lowability, and allocability of costs. (d) Reimbursement. Reimbursement (6) Source documentation. Accounting shall be the preferred method when the records must be supported by such requirements in paragraph (c) of this source documentation as canceled section are not met. Grantees and sub- checks, paid bills, payrolls, time and grantees may also be paid by reim- attendance records, contract and bursement for any construction grant. subgrant award documents, etc. Except as otherwise specified in regula- (7) Cash management. Procedures for tion, Federal agencies shall not use the minimizing the time elapsing between percentage of completion method to the transfer of funds from the U.S. pay construction grants. The grantee Treasury and disbursement by grantees or subgrantee may use that method to and subgrantees must be followed pay its construction contractor, and if

176 Office of National Drug Control Policy § 1403.22 it does, the awarding agency’s pay- (3) A Federal agency shall not make ments to the grantee or subgrantee payment to grantees for amounts that will be based on the grantee’s or sub- are withheld by grantees or subgrantee’s actual rate of disbursement. grantees from payment to contractors (e) Working capital advances. If a to assure satisfactory completion of grantee cannot meet the criteria for work. Payments shall be made by the advance payments described in para- Federal agency when the grantees or graph (c) of this section, and the Fed- subgrantees actually disburse the with- eral agency has determined that reim- held funds to the contractors or to es- bursement is not feasible the grantee crow accounts established to assure lacks sufficient working capital, the satisfactory completion of work. awarding agency may provide cash or a (h) Cash depositories. (1) Consistent working capital advance basis. Under with the national goal of expanding the this procedure the awarding agency opportunities for minority business en- shall advance cash to the grantee to terprises, grantees and subgrantees are cover its estimated disbursement needs encouraged to use minority banks (a for an initial period generally geared bank which is owned at least 50 percent to the grantee’s disbursing cycle. by minority group members). A list of Thereafter, the awarding agency shall minority owned banks can be obtained reimburse the grantee for its actual from the Minority Business Develop- cash disbursements. The working cap- ment Agency, Department of Com- ital advance method of payment shall merce, Washington, DC 20230. not be used by grantees or subgrantees (2) A grantee or subgrantee shall if the reason for using such method is maintain a separate bank account only the unwillingness or inability of the when required by Federal-State agree- grantee to provide timely advances to ment. the subgrantee to meet the sub- (i) Interest earned on advances. Except grantee’s actual cash disbursements. for interest earned on advances of (f) Effect of program income, refunds, funds exempt under the Intergovern- and audit recoveries on payment. (1) mental Cooperation Act (31 U.S.C. 6501 Grantees and subgrantees shall dis- et seq.) and the Indian Self-Determina- burse repayments to and interest tion Act (23 U.S.C. 450), grantees and earned on a revolving fund before re- subgrantees shall promptly, but at questing additional cash payments for least quarterly, remit interest earned the same activity. on advances to the Federal agency. The (2) Except as provided in paragraph grantee or subgrantee may keep inter- (f)(1) of this section, grantees and sub- est amounts up to $100 per year for ad- grantees shall disburse program in- ministrative expenses. come, rebates, refunds, contract settle- ments, audit recoveries and interest § 1403.22 Allowable costs. earned on such funds before requesting (a) Limitation on use of funds. Grant additional cash payments. funds may be used only for: (g) Withholding payments. (1) Unless (1) The allowable costs of the grant- otherwise required by Federal statute, ees, subgrantees and cost-type contrac- awarding agencies shall not withhold tors, including allowable costs in the payments for proper charges incurred form of payments to fixed-price con- by grantees or subgrantees unless—— tractors; and (i) The grantee or subgrantee has (2) Reasonable fees or profit to cost- failed to comply with grant award con- type contractors but not any fee or ditions or profit (or other increment above allow- (ii) The grantee or subgrantee is in- able costs) to the grantee or sub- debted to the United States. grantee. (2) Cash withheld for failure to com- (b) Applicable cost principles. For each ply with grant award condition, but kind of organization, there is a set of without suspension of the grant, shall Federal principles for determining al- be released to the grantee upon subse- lowable costs. Allowable costs will be quent compliance. When a grant is sus- determined in accordance with the cost pended, payment adjustments will be principles applicable to the organiza- made in accordance with § 1403.43(c). tion incurring the costs. The following

177 § 1403.23 21 CFR Ch. III (4–1–99 Edition) chart lists the kinds of organizations (b) Qualifications and exceptions—(1) and the applicable cost principles. Costs borne by other Federal grant agreements. Except as provided by Federal For the costs of aÐ Use the principles inÐ statute, a cost sharing or matching re- State, local or Indian tribal OMB Circular A±87. quirement may not be met by costs government. borne by another Federal grant. This Private nonprofit organization OMB Circular A±122. prohibition does not apply to income other than (1) institution of higher education, (2) hos- earned by a grantee or subgrantee from pital, or (3) organization a contract awarded under another Fed- named in OMB Circular A± eral grant. 122 as not subject to that circular. (2) General revenue sharing. For the Educational institutions ...... OMB Circular A±21. purpose of this section, general revenue For-profit organizations other 48 CFR part 31. Contract sharing funds distributed under 31 than a hospital and an or- Cost Principles and Proce- ganization named in OMB dures, or uniform cost ac- U.S.C. 6702 are not considered Federal Circular A±122 as not sub- counting standards that grant funds. ject to that circular. comply with cost principles (3) Cost or contributions counted to- acceptable to the Federal wards other Federal cost-sharing require- agency. ments. Neither costs nor the values of third party in-kind contributions may § 1403.23 Period of availability of count towards satisfying a cost sharing funds. or matching requirement of a grant (a) General. Where a funding period is agreement if they have been or will be specified, a grantee may charge to the counted towards satisfying a cost shar- award only costs resulting from obliga- ing or matching requirement of an- tions of the funding period unless car- other Federal grant agreement, a Fed- ryover of unobligated balances is per- eral procurement contract, or any mitted, in which case the carryover other award of Federal funds. balances may be charged for costs re- (4) Costs financed by program income. sulting from obligations of the subse- Costs financed by program income, as quent funding period. defined in § 1403.25, shall not count to- (b) Liquidation of obligations. A grant- wards satisfying a cost sharing or ee must liquidate all obligations in- matching requirement unless they are curred under the award not later than expressly permitted in the terms of the 90 days after the end of the funding pe- assistant agreement. (This use of gen- riod (or as specified in a program regu- eral program income is described in lation) to coincide with the submission § 1403.25(g).) of the annual Financial Status Report (5) Services or property financed by in- (SF–269). The Federal agency may ex- come earned by contractors. Contractors tend this deadline at the request of the under a grant may earn income from grantee. the activities carried out under the contract in addition to the amounts § 1403.24 Matching or cost sharing. earned from the party awarding the (a) Basic rule: Costs and contributions contract. No costs of services or prop- acceptable. With the qualifications and erty supported by this income may exceptions listed in paragraph (b) of count toward satisfying cost sharing or this section, a matching or cost shar- matching requirement unless other ing requirement may be satisfied by ei- provisions of the grant agreement ex- ther or both of the following: pressly permit this kind of income to (1) Allowable costs incurred by the be used to meet the requirement. grantee, subgrantee or a cost-type con- (6) Records. Costs and third party in- tractor under the assistance agree- kind contributions counting towards ment. This includes allowable costs satisfying a cost sharing or matching borne by non-Federal grants or by oth- requirement must be verifiable from ers cash donations from non-Federal the records of grantees and subgrantee third parties. or cost-type contractors. These records (2) The value of third party in-kind must show how the value placed on contributions applicable to the period third party in-kind contributions was to which the cost sharing or matching derived. To the extent feasible, volun- requirements applies. teer services will be supported by the

178 Office of National Drug Control Policy § 1403.24 same methods that the organization (2) Employees of other organizations. uses to support the allocability of reg- When an employer other than a grant- ular personnel costs. ee, subgrantee, or cost-type contractor (7) Special standards for third party in- furnishes free of charge the services of kind contributions. (i) Third party in- an employee in the employee’s normal kind contributions count towards sat- line of work, the services will be valued isfying a cost sharing or matching re- at the employee’s regular rate of pay quirement only where, if the party re- exclusive of the employee’s fringe ben- ceiving the contributions were to pay efits and overhead costs. If the services for them, the payments would be allow- are in a different line of work, para- able costs. graph (c)(1) of this section applies. (ii) Some third party in-kind con- (d) Valuation of third party donated tributions are goods and services that, supplies and loaned equipment or space. if the grantee, subgrantee, or con- (1) If a third party donates supplies, tractor receiving the contribution had the contribution will be valued at the to pay for them, the payments would market value of the supplies at the have been an indirect costs. Costs shar- time of donation. ing or matching credit for such con- (2) If a third party donates the use of tributions shall be given only if the equipment or space in a building but grantee, subgrantee, or contractor has retains title, the contribution will be established, along with its regular indi- valued at the fair rental rate of the rect cost rate, a special rate for allo- equipment or space. cating to individual projects or pro- (e) Valuation of third party donated grams the value of the contributions. equipment, buildings, and land. If a third (iii) A third party in-kind contribu- party donates equipment, buildings, or tion to a fixed-price contract may land, and title passes to a grantee or count towards satisfying a cost sharing subgrantee, the treatment of the do- or matching requirement only if it re- nated property will depend upon the sults in: purpose of the grant or subgrant, as (A) An increase in the services or follows: property provided under the contract (without additional cost to the grantee (1) Awards for capital expenditures. If or subgrantee) or the purpose of the grant or subgrant is to assist the grantee or subgrantee in (B) A cost savings to the grantee or subgrantee. the acquisition of property, the market value of that property at the time of (iv) The values placed on third party donation may be counted as cost shar- in-kind contributions for cost sharing ing or matching. or matching purposes will conform to the rules in the succeeding sections of (2) Other awards. If assisting in the this part. If a third party in-kind con- acquisition of property is not the pur- tribution is a type not treated in those pose of the grant or subgrant, para- sections, the value placed upon it shall graphs (e)(2) (i) and (ii) of this section be fair and reasonable. apply: (c) Valuation of donated services—(1) (i) If approval is obtained from the Volunteer services. Unpaid services pro- awarding agency, the market value at vided to a grantee or subgrantee by in- the time of donation of the donated dividuals will be valued at rates con- equipment or buildings and the fair sistent with those ordinarily paid for rental rate of the donated land may be similar work in the grantee’s or sub- counted as cost sharing or matching. grantee’s organization. If the grantee In the case of a subgrant, the terms of or subgrantee does not have employees the grant agreement may require that performing similar work, the rates will the approval be obtained from the Fed- be consistent with those ordinarily eral agency as well as the grantee. In paid by other employers for similar all cases, the approval may be given work in the same labor market. In ei- only if a purchase of the equipment or ther case, a reasonable amount for rental of the land would be approved as fringe benefits may be included in the an allowable direct cost. If any part of valuation. the donated property was acquired

179 § 1403.25 21 CFR Ch. III (4–1–99 Edition) with Federal funds, only the non-fed- Except as otherwise provided in regula- eral share of the property may be tions of the Federal agency, program counted as cost-sharing or matching. income does not include interest on (ii) If approval is not obtained under grant funds, rebates, credits, discounts, paragraph (e)(2)(i) of this section, no refunds, etc., and interest earned on amount may be counted for donated any of them. land, and only depreciation or use al- (b) Definition of program income. Pro- lowances may be counted for donated gram income means gross income re- equipment and buildings. The deprecia- ceived by the grantee or subgrantee dition or use allowances for this property rectly generated by a grant supported are not treated as third party in-kind activity, or earned only as a result of contributions. Instead, they are treat- the grant agreement during the grant ed as costs incurred by the grantee or period. ‘‘During the grant period’’ is subgrantee. They are computed and al- the time between the effective date of located (usually as indirect costs) in the award and the ending date of the accordance with the cost principles award reflected in the final financial specified in § 1403.22, in the same way as report. depreciation or use allowances for pur- (c) Cost of generating program income. chased equipment and buildings. The If authorized by Federal regulations or amount of depreciation or use allow- the grant agreement, costs incident to ances for donated equipment and build- the generation of program income may ings is based on the property’s market be deducted from gross income to de- value at the time it was donated. termine program income. (f) Valuation of grantee or subgrantee (d) Governmental revenues. Taxes, spe- donates real property for construction/ac- cial assessments levies, fines, and other quisition. If a grantee or subgrantee donates real property for a construction such revenues raised by a grantee or or facilities acquisition project, the subgrantee are not program income un- current market value of that property less the revenues are specifically iden- may be counted as cost sharing or tified in the grant agreement or Fed- matching. If any part of the donated eral agency regulations as program in- property was acquired with Federal come. funds, only the non-federal share of the (e) Royalties. Income from royalties property may be counted as cost shar- and license fees for copyrighted mate- ing or matching. rial, patents, and inventions developed (g) Appraisal of real property. In some by a grantee or subgrantee is program cases under paragraphs (d), (e) and (f) income only if the revenues are specifi- of this section, it will be necessary to cally identified in the grant agreement establish the market value of land or a or Federal agency regulations as pro- building or the fair rental rate of land gram income. (See § 1403.34.) or of space in a building. In these cases, (f) Property. Proceeds from the sale of the Federal agency may require the real property or equipment will be han- market value or fair rental value be set dled in accordance with the require- by an independent appraiser, and that ments of § 1403.31 and § 1403.32. the value or rate be certified by the (g) Use of program income. Program grantee. This requirement will also be income shall be deducted from outlays imposed by the grantee on subgrantees. which may be both Federal and non- Federal as described below, unless the § 1403.25 Program income. Federal agency regulations or the (a) General. Grantees are encouraged grant agreement specify another alter- to earn income to defray program native (or a combination of the alter- costs. Program income includes income natives). In specifying alternatives, the from fees for services performed, from Federal agency may distinguish be- the use of rental of real or personal tween income earned by the grantee property acquired with grant funds, and income earned by subgrantees and from the sale of commodities or items between the sources, kinds, or amounts fabricated under a grant agreement, of income. When Federal agencies au- and from payments of principal and in- thorize the alternatives in paragraphs terest on loans made with grant funds. (g) (2) and (3) of this section, program

180 Office of National Drug Control Policy § 1403.30 income in excess of any limits stipu- (1) Determine whether State or local lated shall also be deducted from out- subgrantees have met the audit re- lays. quirements of the Act and whether sub- (1) Deduction. Ordinarily program in- grantees covered by OMB Circular A– come shall be deducted from total al- 110, ‘‘Uniform Administrative Require- lowable costs to determine the net al- ments for Grants and Agreements with lowable costs. Program income shall be Institutions of Higher Education, Hos- used for current costs unless the Fed- pitals, and Other Non-Profit Organiza- eral agency authorizes otherwise. Pro- tions,’’ have met the audit require- gram income which the grantee did not ments of the Act. Commercial contrac- anticipate at the time of the award tors (private for-profit and private and shall be used to reduce the Federal governmental organizations) providing agency and grantee contributions rath- goods and services to State and local er than to increase the funds com- governments are not required to have a mitted to the project. single audit performed. State and local (2) Addition. When authorized, pro- governments should use their own program income may be added to the cedures to ensure that the contractor funds committed to the grant agree- has complied with laws and regulations ment by the Federal agency and the affecting the expenditure of Federal grantee. The program income shall be funds; used for the purposes and under the (2) Determine whether the sub- conditions of the grant agreement. grantee spent Federal assistance funds (3) Cost sharing or matching. When au- provided in accordance with applicable thorized, program income may be used laws and regulations. This may be ac- to meet the cost sharing or matching complished by reviewing an audit of requirement of the grant agreement. the subgrantee made in accordance The amount of the Federal grant award with the Act, Circular A–110, or remains the same. through other means (e.g., program re- (h) Income after the award period. views) if the subgrantee has not had There are no Federal requirements gov- such an audit; erning the disposition of program in- (3) Ensure that appropriate correc- come earned after the end of the award tive action is taken within six months period (i.e., until the ending date of the after receipt of the audit report in in- final financial report, see paragraph (a) stance of noncompliance with Federal of this section), unless the terms of the laws and regulations; agreement or the Federal agency regu- (4) Consider whether subgrantee au- lations provide otherwise. dits necessitate adjustment of the grantee’s own records; and § 1403.26 Non-Federal audit. (5) Require each subgrantee to permit (a) Basic rule. Grantees and sub- independent auditors to have access to grantees are responsible for obtaining the records and financial statements. audits in accordance with the Single (c) Auditor selection. In arranging for Audit Act Amendments of 1996 (31 audit services, § 1403.36 shall be fol- U.S.C. 7501–7507) and revised OMB Cir- lowed. cular A–133, ‘‘Audits of States, Local [57 FR 55092, Nov. 24, 1992, as amended at 62 Governments, and Non-Profit Organi- FR 45939, 45941, Aug. 29, 1997] zations.’’ The audits shall be made by an independent auditor in accordance CHANGES, PROPERTY, AND SUBAWARDS with generally accepted government auditing standards covering financial § 1403.30 Changes. audits. (a) General. Grantees and subgrantees (b) Subgrantees. State or local govern- are permitted to rebudget within the ments, as those terms are defined for approved direct cost budget to meet purposes of the Single Audit Act unanticipated requirements and may Amendments of 1996, that provide Fed- make limited program changes to the eral awards to a subgrantee, which ex- approved project. However, unless pends $300,000 or more (or other waived by the awarding agency, certain amount as specified by OMB) in Fed- types of post-award changes in budgets eral awards in a fiscal year, shall: and projects shall require the prior

181 § 1403.31 21 CFR Ch. III (4–1–99 Edition) written approval of the awarding agen- (3) Changes in key persons in cases cy. where specified in an application or a (b) Relation to cost principles. The ap- grant award. In research projects, a plicable cost principles (see § 1403.22) change in the project director or prin- contain requirements for prior ap- cipal investigator shall always require proval of certain types of costs. Except approval unless waived by the award- where waived, those requirements ing agency. apply to all grants and subgrants even (4) Under nonconstruction projects, if paragraphs (c) through (f) of this sec- contracting out, subgranting (if au- tion do not. thorized by law) or otherwise obtaining (c) Budget changes—(1) Nonconstruc- the services of a third party to perform tion projects. Except as stated in other activities which are central to the pur- regulations or an award document, poses of the award. This approval re- grantees or subgrantees shall obtain quirement is in addition to the ap- the prior approval of the awarding proval requirements of § 1403.36 but agency whenever any of the following does not apply to the procurement of changes is anticipated under a non- equipment, supplies, and general sup- construction award: port services. (i) Any revision which would result (e) Additional prior approval require- in the need for additional funding. ments. The awarding agency may not (ii) Unless waived by the awarding require prior approval for any budget agency, cumulative transfers among di- revision which is not described in para- rect cost categories, or, if applicable, graph (c) of this section. among separately budgeted programs, (f) Requesting prior approval. (1) A re- projects, functions, or activities which quest for prior approval of any budget exceed or are expected to exceed ten revision will be in the same budget for- percent of the current total approved mat the grantee used in its application budget, whenever the awarding agen- and shall be accompanied by a nar- cy’s share exceeds $100,000. rative justification for the proposed re- (iii) Transfer of funds allotted for vision. training allowances (i.e., from direct payments to trainees to other expense (2) A request for a prior approval categories). under the applicable Federal cost prin- (2) Construction projects. Grantees and ciples (see § 1403.22) may be made by subgrantees shall obtain prior written letter. approval for any budget revision which (3) A request by a subgrantee for would result in the need for additional prior approval will be addressed in funds. writing to the grantee. The grantee (3) Combined construction and non- will promptly review such request and construction projects. When a grant or shall approve or disapprove the request subgrant provides funding for both con- in writing. A grantee will not approve struction and nonconstruction activi- any budget or project revision which is ties, the grantee or subgrantee must inconsistent with the purpose or terms obtain prior written approval from the and conditions of the Federal grant to awarding agency before making any the grantee. If the revision requested fund or budget transfer from non- by the subgrantee would result in a construction to construction or vice change to the grantee’s approved versa. project which requires Federal prior (d) Programmatic changes. Grantees or approval, the grantee will obtain the subgrantees must obtain the prior ap- Federal agency’s approval before approval of the awarding agency when- proving the subgrantee’s request. ever any of the following actions is anticipated: § 1403.31 Real property. (1) Any revision of the scope or objec- (a) Title. Subject to the obligations tives of the project (regardless of and conditions set forth in this section, whether there is an associated budget title to real property acquired under a revision requiring prior approval). grant or subgrant will vest upon acqui- (2) Need to extend the period of avail- sition in the grantee or subgrantee re- ability of funds. spectively.

182 Office of National Drug Control Policy § 1403.32

(b) Use. Except as otherwise provided § 1403.32 Equipment. by Federal statutes, real property will (a) Title. Subject to the obligations be used for the originally authorized and conditions set forth in this section, purposes as long as needed for those title to equipment acquired under a purposes, and the grantee or subgrant or subgrant will vest upon acqui- grantee shall not dispose of or encum- sition in the grantee or subgrantee re- ber its title or other interests. spectively. (c) Disposition. When real property is (b) States. A State will use, manage, no longer needed for the originally au- and dispose of equipment acquired thorized purpose, the grantee or sub- under a grant by the State in accord- grantee will request disposition in- ance with State laws and procedures. structions from the awarding agency. Other grantees and subgrantees will The instructions will provide for one of follow paragraphs (c) through (e) of the following alternatives: this section. (1) Retention of title. Retain title after (c) Use. (1) Equipment shall be used compensating the awarding agency. by the grantee or subgrantee in the The amount paid to the awarding agen- program or project for which it was ac- cy will be computed by applying the quired as long as needed, whether or awarding agency’s percentage of par- not the project or program continues ticipation in the cost of the original to be supported by Federal funds. When purchase to the fair market value of no longer needed for the original pro- the property. However, in those situa- gram or project, the equipment may be tions were a grantee or subgrantee is used in other activities currently or disposing of real property acquired previously supported by a Federal agency. with grant funds and acquiring replacement real property under the same pro- (2) The grantee or subgrantee shall also make equipment available for use gram, the net proceeds from the dis- on other projects or programs cur- position may be used as an offset to the rently or previously supported by the cost of the replacement property. Federal Government, providing such (2) Sale of property. Sell the property use will not interfere with the work on and compensate the awarding agency. the projects or program for which it The amount due to the awarding agen- was originally acquired. First pref- cy will be calculated by applying the erence for other use shall be given to awarding agency’s percentage of par- other programs or projects supported ticipation in the cost of the original by the awarding agency. User fees purchase to the proceeds of the sale should be considered if appropriate. after deduction of any actual and rea- (3) Notwithstanding the encourage- sonable selling and fixing-up expenses. ment in § 1403.25(a) to earn program in- If the grant is still active, the net pro- come, the grantee or subgrantee must ceeds from sale may be offset against not use equipment acquired with grant the original cost of the property. When funds to provide services for a fee to a grantee or subgrantee is directed to compete unfairly with private compa- sell property, sales procedures shall be nies that provide equivalent services, followed that provide for competition unless specifically permitted or con- to the extent practicable and result in templated by Federal statute. the highest possible return. (4) When acquiring replacement (3) Transfer of title. Transfer title to equipment, the grantee or subgrantee the awarding agency or to a third- may use the equipment to be replaced party designated/approved by the as a trade-in or sell the property and awarding agency. The grantee or sub- use the proceeds to offset the cost of the replacement property, subject to grantee shall be paid an amount cal- the approval of the awarding agency. culated by applying the grantee or sub- (d) Management requirements. Proce- grantee’s percentage of participation dures for managing equipment (includ- in the purchase of the real property to ing replacement equipment), whether the current fair market value of the acquired in whole or in part with grant property. funds, until disposition takes place

183 § 1403.33 21 CFR Ch. III (4–1–99 Edition) will, as a minimum, meet the following (f) Federal equipment. In the event a requirements: grantee or subgrantee is provided fed- (1) Property records must be main- erally-owned equipment: tained that include a description of the (1) Title will remain vested in the property, a serial number or other Federal Government. identification number, the source of (2) Grantees or subgrantees will man- property, who holds title, the acquisi- age the equipment in accordance with tion date, and cost of the property, per- Federal agency rules and procedures, centage of Federal participation in the and submit an annual inventory list- cost of the property, the location, use ing. and condition of the property, and any (3) When the equipment is no longer ultimate disposition data including the needed, the grantee or subgrantee will date of disposal and sale price of the request disposition instructions from property. the Federal agency. (2) A physical inventory of the prop- (g) Right to transfer title. The Federal erty must be taken and the results rec- awarding agency may reserve the right onciled with the property records at to transfer title to the Federal Govern- least once every two years. ment or a third party named by the (3) A control system must be devel- awarding agency when such a third oped to ensure adequate safeguards to party is otherwise eligible under exist- prevent loss, damage, or theft of the ing statutes. Such transfers shall be property. Any loss, damage, or theft subject to the following standards: shall be investigated. (1) The property shall be identified in (4) Adequate maintenance procedures the grant or otherwise made known to must be developed to keep the property the grantee in writing. in good condition. (2) The Federal awarding agency (5) If the grantee or subgrantee is au- shall issue disposition instruction thorized or required to sell the prop- within 120 calendar days after the end erty, proper sales procedures must be of the Federal support of the project established to ensure the highest pos- for which it was acquired. If the federal sible return. awarding agency fails to issue disposi- (e) Disposition. When original or re- tion instructions within the 120 cal- placement equipment acquired under a endar-day period the grantee shall fol- grant or subgrant is no longer needed low § 1403.32(e). for the original project or program or (3) When title to equipment is trans- for other activities currently or preferred, the grantee shall be paid an viously supported by a Federal agency, amount calculated by applying the per- disposition of the equipment will be centage of participation in the pur- made as follows: chase to the current fair market value (1) Items of equipment with a current of the property. per-unit fair market value of less than $5,000 may be retained, sold or other- § 1403.33 Supplies. wise disposed of with no further obligation to the awarding agency. (a) Title. Title to supplies acquired (2) Items of equipment with a current under a grant or subgrant will vest, per unit fair market value in excess of upon acquisition, in the grantee or sub- $5,000 may be retained or sold and the grantee respectively. awarding agency shall have a right to (b) Disposition. If there is a residual an amount calculated by multiplying inventory of unused supplies exceeding the current market value or proceeds $5,000 in total aggregate fair market from sale by the awarding agency’s value upon termination or completion share of the equipment. of the award, and if the supplies are (3) In cases where a grantee or sub- not needed for any other federally grantee fails to take appropriate dis- sponsored programs or projects, the position actions, the awarding agency grantee or subgrantee shall com- may direct the grantee or subgrantee pensate the awarding agency for its to take excess and disposition actions. share.

184 Office of National Drug Control Policy § 1403.36

§ 1403.34 Copyrights. employee, officer or agent of the grant- The Federal awarding agency re- ee or subgrantee shall participate in se- serves a royalty-free, nonexclusive, and lection, or in the award or administra- irrevocable license to reproduce, pub- tion of a contract supported by Federal lish or otherwise use, and to authorize funds if a conflict of interest, real or others to use, for Federal Government apparent, would be involved. Such a purposes: conflict would arise when: (a) The copyright in any work devel- (i) The employee, officer or agent, oped under a grant, subgrant, or con- (ii) Any member of his immediate tract under a grant or subgrant; and family, (b) Any rights of copyright to which (iii) His or her partner, or a grantee, subgrantee or a contractor (iv) An organization which employs, purchases ownership with grant sup- or is about to employ, any of the port. above, has a financial or other interest in the firm selected for award. The § 1403.35 Subawards to debarred and grantee’s or subgrantee’s officers, em- suspended parties. ployees or agents will neither solicit Grantees and subgrantees must not nor accept gratuities, favors or any- make any award or permit any award thing of monetary value from contrac- (subgrant or contract) at any tier to tors, potential contractors, or parties any party which is debarred or sus- to subagreements. Grantee and sub- pended or is otherwise excluded from or grantees may set minimum rules where ineligible for participation in Federal the financial interest is not substantial assistance programs under Executive or the gift is an unsolicited item of Order 12549, ‘‘Debarment and Suspen- nominal intrinsic value. To the extent sion.’’ permitted by State or local law or reg- § 1403.36 Procurement. ulations, such standards or conduct will provide for penalties, sanctions, or (a) States. When procuring property other disciplinary actions for viola- and services under a grant, a State will tions of such standards by the grant- follow the same policies and procedures ee’s and subgrantee’s officers, employ- it uses for procurements from its non- ees, or agents, or by contractors or Federal funds. The State will ensure their agents. The awarding agency may that every purchase order or other contract includes any clauses required by in regulation provide additional prohi- Federal statutes and executive orders bitions relative to real, apparent, or and their implementing regulations. potential conflicts of interest. Other grantees and subgrantees will (4) Grantee and subgrantee proce- follow paragraphs (b) through (i) of this dures will provide for a review of pro- section. posed procurements to avoid purchase (b) Procurement standards. (1) Grant- of unnecessary or duplicative items. ees and subgrantees will use their own Consideration should be given to con- procurement procedures which reflect solidating or breaking out procure- applicable State and local laws and ments to obtain a more economical regulations, provided that the procure- purchase. Where appropriate, an anal- ments conform to applicable Federal ysis will be made of lease versus pur- law and the standards identified in this chase alternatives, and any other ap- section. propriate analysis to determine the (2) Grantees and subgrantees will most economical approach. maintain a contract administration (5) To foster greater economy and ef- system which ensures that contractors ficiency, grantees and subgrantees are perform in accordance with the terms, encouraged to enter into State and conditions, and specifications of their local intergovernmental agreements contracts or purchase orders. for procurement or use of common (3) Grantees and subgrantees will goods and services. maintain a written code of standards of (6) Grantees and subgrantees are en- conduct governing the performance of couraged to use Federal excess and sur- their employees engaged in the award plus property in lieu of purchasing new and administration of contracts. No equipment and property whenever such

185 § 1403.36 21 CFR Ch. III (4–1–99 Edition) use is feasible and reduces project resolve disputes relating to their pro- costs. curements and shall in all instances (7) Grantees and subgrantees are en- disclose information regarding the pro- couraged to use value engineering test to the awarding agency. A clauses in contracts for construction protestor must exhaust all administra- projects of sufficient size to offer rea- tive remedies with the grantee and sub- sonable opportunities for cost reduc- grantee before pursuing a protest with tions. Value engineering is a system- the Federal agency. Reviews of pro- atic and creative analysis of each con- tests by the Federal agency will be lim- tract item or task to ensure that its es- ited to: sential function is provided at the (i) Violations of Federal law or regu- overall lower cost. lations and the standards of this sec- (8) Grantees and subgrantees will tion (violations of State or local law make awards only to responsible con- will be under the jurisdiction of State tractors possessing the ability to per- or local authorities) and form successfully under the terms and (ii) Violations of the grantee’s or sub- conditions of a proposed procurement. grantee’s protest procedures for failure Consideration will be given to such to review a complaint or protest. Pro- matters as contractor integrity, com- tests received by the Federal agency pliance with public policy, record of other than those specified above will be past performance, and financial and referred to the grantee or subgrantee. technical resources. (c) Competition. (1) All procurement (9) Grantees and subgrantees will transactions will be conducted in a maintain records sufficient to detail manner providing full and open com- the significant history of a procure- petition consistent with the standards ment. These records will include, but of § 1403.36. Some of the situations con- are not necessarily limited to the fol- sidered to be restrictive of competition lowing: rationale for the method of include but are not limited to: procurement, selection of contract (i) Placing unreasonable require- type, contractor selection or rejection, ments on firms in order for them to and the basis for the contract price. qualify to do business, (10) Grantees and subgrantees will (ii) Requiring unnecessary experience use time and material type contracts and excessive bonding, only— (iii) Noncompetitive pricing practices (i) After a determination that no between firms or between affiliated other contract is suitable, and companies, (ii) If the contract includes a ceiling (iv) Noncompetitive awards to con- price that the contractor exceeds at its sultants that are on retainer contracts, own risk. (v) Organizational conflicts of inter- (11) Grantees and subgrantees alone est, will be responsible, in accordance with (vi) Specifying only a ‘‘brand name’’ good administrative practice and sound product instead of allowing ‘‘an equal’’ business judgment, for the settlement product to be offered and describing of all contractual and administrative the performance of other relevant re- issues arising out of procurements. quirements of the procurement, and These issues include, but are not lim- (vii) Any arbitrary action in the pro- ited to source evaluation, protests, dis- curement process. putes, and claims. These standards do (2) Grantees and subgrantees will not relieve the grantee or subgrantee conduct procurements in a manner of any contractual responsibilities that prohibits the use of statutorily or under its contracts. Federal agencies administratively imposed in-State or will not substitute their judgment for local geographical preferences in the that of the grantee or subgrantee un- evaluation of bids or proposals, except less the matter is primarily a Federal in those cases where applicable Federal concern. Violations of law will be re- statutes expressly mandate or encour- ferred to the local, State, or Federal age geographic preference. Nothing in authority having proper jurisdiction. this section preempts State licensing (12) Grantees and subgrantees will laws. When contracting for architec- have protest procedures to handle and tural and engineering (A/E) services,

186 Office of National Drug Control Policy § 1403.36 geographic location may be a selection be obtained from an adequate number criteria provided its application leaves of qualified sources. an appropriate number of qualified (2) Procurement by sealed bids (for- firms, given the nature and size of the mal advertising). Bids are publicly so- project, to compete for the contract. licited and a firm-fixed-price contract (3) Grantees will have written selec- (lump sum or unit price) is awarded to tion procedures for procurement trans- the responsible bidder whose bid, con- actions. These procedures will ensure forming with all the material terms that all solicitations: and conditions of the invitation for (i) Incorporate a clear and accurate bids, is the lowest in price. The sealed description of the technical require- bid method is the preferred method for ments for the material, product, or procuring construction, if the condi- service to be procured. Such descrip- tions in § 1403.36(d)(2)(i) apply. tion shall not, in competitive procure- (i) In order for sealed bidding to be ments, contain features which unduly feasible, the following conditions restrict competition. The description should be present: may include a statement of the quali- (A) A complete, adequate, and real- tative nature of the material, product istic specification or purchase descrip- or service to be procured, and when tion is available; necessary, shall set forth those min- (B) Two or more responsible bidders imum essential characteristics and are willing and able to compete effec- standards to which it must conform if tively and for the business; and it is to satisfy its intended use. De- (C) The procurement lends itself to a tailed product specifications should be firm fixed price contract and the selec- avoided if at all possible. When it is tion of the successful bidder can be impractical or uneconomical to make a made principally on the basis of price. clear and accurate description of the (ii) If sealed bids are used, the fol- technical requirements, a ‘‘brand name lowing requirements apply: or equal’’ description may be used as a (A) The invitation for bids will be means to define the performance or publicly advertised and bids shall be other salient requirements of a pro- solicited from an adequate number of curement. The specific features of the known suppliers, providing them suffi- named brand which must be met by cient time prior to the date set for offerors shall be clearly stated; and opening the bids; (ii) Identify all requirements which (B) The invitation for bids, which the offerors must fulfill and all other will include any specifications and per- factors to be used in evaluating bids or tinent attachments, shall define the proposals. items or services in order for the bidder (4) Grantees and subgrantees will en- to properly respond; sure that all prequalified lists of per- (C) All bids will be publicly opened at sons, firms, or products which are used the time and place prescribed in the in- in acquiring goods and services are cur- vitation for bids; rent and include enough qualified (D) A firm fixed-price contract award sources to ensure maximum open and will be made in writing to the lowest free competition. Also, grantees and responsive and responsible bidder. subgrantees will not preclude potential Where specified in bidding documents, bidders from qualifying during the so- factors such as discounts, transpor- licitation period. tation cost, and life cycle costs shall be (d) Methods of procurement to be fol- considered in determining which bid is lowed. (1) Procurement by small pur- lowest. Payment discounts will only be chase procedures. Small purchase proce- used to determine the low bid when dures are those relatively simple and prior experience indicates that such informal procurement methods for se- discounts are usually taken advantage curing services, supplies, or other prop- of; and erty that do not cost more than the (E) Any or all bids may be rejected if simplified acquisition threshold fixed there is a sound documented reason. at 41 U.S.C. 403(11) (currently set at (3) Procurement by competitive pro- $100,000). If small purchase procedures posals. The technique of competitive are used, price or rate quotations shall proposals is normally conducted with

187 § 1403.36 21 CFR Ch. III (4–1–99 Edition) more than one source submitting an (C) The awarding agency authorizes offer, and either a fixed-price or cost- noncompetitive proposals; or reimbursement type contract is award- (D) After solicitation of a number of ed. It is generally used when conditions sources, competition is determined in- are not appropriate for the use of adequate. sealed bids. If this method is used, the (ii) Cost analysis, i.e., verifying the following requirements apply: proposed cost data, the projections of (i) Requests for proposals will be pub- the data, and the evaluation of the spe- licized and identify all evaluation fac- cific elements of costs and profits, is tors and their relative importance. Any required. response to publicized requests for pro- (iii) Grantees and subgrantees may posals shall be honored to the max- be required to submit the proposed pro- imum extent practical; curement to the awarding agency for (ii) Proposals will be solicited from pre-award review in accordance with an adequate number of qualified paragraph (g) of this section. sources; (e) Contracting with small and minority (iii) Grantees and subgrantees will firms, women’s business enterprise and have a method for conducting tech- labor surplus area firms. (1) The grantee nical evaluations of the proposals re- and subgrantee will take all necessary ceived and for selecting awardees; affirmative steps to assure that minority firms, women’s business enter- (iv) Awards will be made to the re- prises, and labor surplus area firms are sponsible firm whose proposal is most used when possible. advantageous to the program, with (2) Affirmative steps shall include: price and other factors considered; and (i) Placing qualified small and minor- (v) Grantees and subgrantees may ity businesses and women’s business use competitive proposal procedures enterprises on solicitation lists; for qualifications-based procurement of (ii) Assuring that small and minority architectural/engineering (A/E) profes- businesses, and women’s business en- sional services whereby competitors’ terprises are solicited whenever they qualifications are evaluated and the are potential sources; most qualified competitor is selected, (iii) Dividing total requirements, subject to negotiation of fair and rea- when economically feasible, into small- sonable compensation. The method, er tasks or quantities to permit max- where price is not used as a selection imum participation by small and mi- factor, can only be used in procure- nority business, and women’s business ment of A/E professional services. It enterprises; cannot be used to purchase other types (iv) Establishing delivery schedules, of services though A/E firms are a po- where the requirement permits, which tential source to perform the proposed encourage participation by small and effort. minority business, and women’s busi- (4) Procurement by noncompetitive ness enterprises; proposals is procurement through solic- (v) Using the services and assistance itation of a proposal from only one of the Small Business Administration, source, or after solicitation of a num- and the Minority Business Develop- ber of sources, competition is deter- ment Agency of the Department of mined inadequate. Commerce; and (i) Procurement by noncompetitive (vi) Requiring the prime contractor, proposals may be used only when the if subcontracts are to be let, to take award of a contract is infeasible under the affirmative steps listed in para- small purchase procedures, sealed bids graphs (e)(2) (i) through (v) of this sec- or competitive proposals and one of the tion. following circumstances applies: (f) Contract cost and price. (1) Grant- (A) The item is available only from a ees and subgrantees must perform a single source; cost or price analysis in connection (B) The public exigency or emergency with every procurement action includ- for the requirement will not permit a ing contract modifications. The meth- delay resulting from competitive solic- od and degree of analysis is dependent itation; on the facts surrounding the particular

188 Office of National Drug Control Policy § 1403.36 procurement situation, but as a start- erally will take place prior to the time ing point, grantees must make inde- the specification is incorporated into a pendent estimates before receiving bids solicitation document. However, if the or proposals. A cost analysis must be grantee or subgrantee desires to have performed when the offeror is required the review accomplished after a solici- to submit the elements of his esti- tation has been developed, the award- mated cost, e.g., under professional, ing agency may still review the speci- consulting, and architectural engineer- fications, with such review usually lim- ing services contracts. A cost analysis ited to the technical aspects of the pro- will be necessary when adequate price posed purchase. competition is lacking, and for sole (2) Grantees and subgrantees must on source procurements, including con- request make available for awarding tract modifications or change orders, agency pre-award review procurement unless price reasonableness can be es- documents, such as requests for pro- tablished on the basis of a catalog or posals or invitations for bids, inde- market price of a commercial product pendent cost estimates, etc. when: sold in substantial quantities to the (i) A grantee’s or subgrantee’s pro- general public or based on prices set by curement procedures or operation fails law or regulation. A price analysis will to comply with the procurement stand- be used in all other instances to deter- ards in this section; or mine the reasonableness of the pro- (ii) The procurement is expected to posed contract price. exceed the simplified acquisition (2) Grantees and subgrantees will ne- threshold and is to be awarded without gotiate profit as a separate element of competition or only one bid or offer is the price for each contract in which received in response to a solicitation; there is no price competition and in all or cases where cost analysis is performed. (iii) The procurement, which is ex- To establish a fair and reasonable prof- pected to exceed the simplified acquisi- it, consideration will be given to the tion threshold, specifies a ‘‘brand complexity of the work to be per- name’’ product; or formed, the risk borne by the con- (iv) The proposed award is more than tractor, the contractor’s investment, the simplified acquisition threshold the amount of subcontracting, the and is to be awarded to other than the quality of its record of past perform- apparent low bidder under a sealed bid ance, and industry profit rates in the procurement; or surrounding geographical area for (v) A proposed contract modification similar work. changes the scope of a contract or in- (3) Costs or prices based on estimated creases the contract amount by more costs for contracts under grants will be than the simplified acquisition thresh- allowable only to the extent that costs old. incurred or cost estimates included in (3) A grantee or subgrantee will be negotiated prices are consistent with exempt from the pre-award review in Federal cost principles (see § 1403.22). paragraph (g)(2) of this section if the Grantees may reference their own cost awarding agency determines that its principles that comply with the appli- procurement systems comply with the cable Federal cost principles. standards of this section. (4) The cost plus a percentage of cost (i) A grantee or subgrantee may re- and percentage of constructing cost quest that its procurement system be methods of contracting shall not be reviewed by the awarding agency to de- used. termine whether its system meets (g) Awarding agency review. (1) Grant- these standards in order for its system ees and subgrantees must make avail- to be certified. Generally, these re- able, upon request of the awarding views shall occur where there is a con- agency, technical specifications on pro- tinuous high-dollar funding, and third- posed procurements where the award- party contracts are awarded on a reg- ing agency believes such review is ular basis. needed to ensure that the item and/or (ii) A grantee or subgrantee may self- service specified is the one being pro- certify its procurement system. Such posed for purchase. This review gen- self-certification shall not limit the

189 § 1403.36 21 CFR Ch. III (4–1–99 Edition) awarding agency’s right to survey the (1) Administrative, contractual, or system. Under a self-certification pro- legal remedies in instances where con- cedure, awarding agencies may wish to tractors violate or breach contract rely on written assurances from the terms, and provide for such sanctions grantee or subgrantee that it is com- and penalties as may be appropriate. plying with these standards. A grantee (Contracts more than the simplified ac- or subgrantee will cite specific proce- quisition threshold) dures, regulations, standards, etc., as (2) Termination for cause and for being in compliance with these require- convenience by the grantee or sub- ments and have its system available grantee including the manner by which for review. it will be effected and the basis for set- (h) Bonding requirements. For con- tlement. (All contracts in excess of struction or facility improvement con- $10,000) tracts or subcontracts exceeding the (3) Compliance with Executive Order simplified acquisition threshold, the 11246 of September 24, 1965, entitled awarding agency may accept the bond- ‘‘Equal Employment Opportunity,’’ as ing policy and requirements of the amended by Executive Order 11375 of grantee or subgrantee provided the October 13, 1967, and as supplemented awarding agency has made a deter- in Department of Labor regulations (41 mination that the awarding agency’s CFR chapter 60). (All construction con- interest is adequately protected. If tracts awarded in excess of $10,000 by such a determination has not been grantees and their contractors or sub- made, the minimum requirements shall grantees) be as follows: (4) Compliance with the Copeland (1) A bid guarantee from each bidder ‘‘Anti-Kickback’’ Act (18 U.S.C. 874) as equivalent to five percent of the bid price. supplemented in Department of Labor The ‘‘bid guarantee’’ shall consist of a regulations (29 CFR Part 3). (All contracts and subgrants for construction firm commitment such as a bid bond, or repair) certified check, or other negotiable in- (5) Compliance with the Davis-Bacon strument accompanying a bid as assur- Act (40 U.S.C. 276a to 276a–7) as supple- ance that the bidder will, upon accept- mented by Department of Labor regu- ance of his bid, execute such contrac- lations (29 CFR Part 5). (Construction tual documents as may be required contracts in excess of $2000 awarded by within the time specified. grantees and subgrantees when re- (2) A performance bond on the part of quired by Federal grant program legis- the contractor for 100 percent of the con- lation) tract price. A ‘‘performance bond’’ is (6) Compliance with Sections 103 and one executed in connection with a con- 107 of the Contract Work Hours and tract to secure fulfillment of all the Safety Standards Act (40 U.S.C. 327–330) contractor’s obligations under such as supplemented by Department of contract. Labor regulations (29 CFR Part 5). (3) A payment bond on the part of the (Construction contracts awarded by contractor for 100 percent of the contract grantees and subgrantees in excess of price. A ‘‘payment bond’’ is one exe- $2000, and in excess of $2500 for other cuted in connection with a contract to contracts which involve the employ- assure payment as required by law of ment of mechanics or laborers) all persons supplying labor and mate- (7) Notice of awarding agency re- rial in the execution of the work pro- quirements and regulations pertaining vided for in the contract. to reporting. (i) Contract provisions. A grantee’s (8) Notice of awarding agency re- and subgrantee’s contracts must con- quirements and regulations pertaining tain provisions in paragraph (i) of this to patent rights with respect to any section. Federal agencies are permitted discovery or invention which arises or to require changes, remedies, changed is developed in the course of or under conditions, access and records reten- such contract. tion, suspension of work, and other (9) Awarding agency requirements clauses approved by the Office of Fed- and regulations pertaining to copy- eral Procurement Policy. rights and rights in data.

190 Office of National Drug Control Policy § 1403.40

(10) Access by the grantee, the subpart which are applicable to awarding grantee, the Federal grantor agency, agencies when awarding and admin- the Comptroller General of the United istering subgrants (whether on a cost States, or any of their duly authorized reimbursement or fixed amount basis) representatives to any books, docu- of financial assistance to local and In- ments, papers, and records of the con- dian tribal governments. Grantees tractor which are directly pertinent to shall: that specific contract for the purpose (1) Ensure that every subgrant in- of making audit, examination, ex- cludes a provision for compliance with cerpts, and transcriptions. this part; (11) Retention of all required records (2) Ensure that every subgrant infor three years after grantees or sub- cludes any clauses required by Federal grantees make final payments and all statute and executive orders and their other pending matters are closed. implementing regulations; and (12) Compliance with all applicable (3) Ensure that subgrantees are standards, orders, or requirements aware of requirements imposed upon issued under section 306 of the Clean them by Federal statutes and regula- Air Act (42 U.S.C. 1857(h)), section 508 tions. of the Clean Water Act (33 U.S.C. 1368), (c) Exceptions. By their own terms, Executive Order 11738, and Environ- certain provisions of this part do not mental Protection Agency regulations apply to the award and administration (40 CFR part 15). (Contracts, sub- of subgrants: contracts, and subgrants of amounts in (1) Section 1403.10; excess of $100,000). (2) Section 1403.11; (13) Mandatory standards and policies (3) The letter-of-credit procedures relating to energy efficiency which are specified in Treasury Regulations at 31 contained in the state energy conserva- CFR part 205, cited in § 1403.21; and tion plan issued in compliance with the (4) Section 1403.50. Energy Policy and Conservation Act (Pub. L. 94–163, 89 Stat. 871). REPORTS, RECORDS, RETENTION, AND [57 FR 55092, Nov. 24, 1992, as amended at 60 ENFORCEMENT FR 19639, 19642, Apr. 19, 1995] § 1403.40 Monitoring and reporting § 1403.37 Subgrants. program performance. (a) States. States shall follow state (a) Monitoring by grantees. Grantees law and procedures when awarding and are responsible for managing the day- administering subgrants (whether on a to-day operations of grant and cost reimbursement or fixed amount subgrant supported activities. Grantees basis) of financial assistance to local must monitor grant and subgrant sup- and Indian tribal governments. States ported activities to assure compliance shall: with applicable Federal requirements (1) Ensure that every subgrant in- and that performance goals are being cludes any clauses required by Federal achieved. Grantee monitoring must statute and executive orders and their cover each program, function or activ- implementing regulations; ity. (2) Ensure that subgrantees are (b) Nonconstruction performance re- aware of requirements imposed upon ports. The Federal agency may, if it de- them by Federal statute and regula- cides that performance information tion; available from subsequent applications (3) Ensure that a provision for com- contains sufficient information to pliance with § 1403.42 is placed in every meet its programmatic needs, require cost reimbursement subgrant; and the grantee to submit a performance (4) Conform any advances of grant report only upon expiration or termi- funds to subgrantees substantially to nation of grant support. Unless waived the same standards of timing and by the Federal agency this report will amount that apply to cash advances by be due on the same date as the final Fi- Federal agencies. nancial Status Report. (b) All other grantees. All other grant- (1) Grantees shall submit annual per- ees shall follow the provisions of this formance reports unless the awarding

191 § 1403.41 21 CFR Ch. III (4–1–99 Edition) agency requires quarterly or semi-an- (1) Problems, delays, or adverse con- nual reports. However, performance re- ditions which will materially impair ports will not be required more fre- the ability to meet the objective of the quently than quarterly. Annual reports award. This disclosure must include a shall be due 90 days after the grant statement of the action taken, or con- year, quarterly or semi-annual reports templated, and any assistance needed shall be due 30 days after the reporting to resolve the situation. period. The final performance report (2) Favorable developments which en- will be due 90 days after the expiration able meeting time schedules and objec- or termination of grant support. If a tives sooner or at less cost than antici- justified request is submitted by a pated or producing more beneficial re- grantee, the Federal agency may ex- sults than originally planned. tend the due date for any performance (e) Federal agencies may make site report. Additionally, requirements for visits as warranted by program needs. unnecessary performance reports may (f) Waivers, extensions. (1) Federal be waived by the Federal agency. agencies may waive any performance (2) Performance reports will contain, report required by this part if not need- for each grant, brief information on the ed. following: (2) The grantee may waive any per- (i) A comparison of actual accom- formance report from a subgrantee plishments to the objectives estab- when not needed. The grantee may ex- lished for the period. Where the output tend the due date for any performance of the project can be quantified, a com- report from a subgrantee if the grantee putation of the cost per unit of output will still be able to meet its perform- may be required if that information ance reporting obligations to the Fed- will be useful. eral agency. (ii) The reasons for slippage if established objectives were not met. § 1403.41 Financial reporting. (iii) Additional pertinent information (a) General. (1) Except as provided in including, when appropriate, analysis paragraphs (a) (2) and (5) of this sec- and explanation of cost overruns or tion, grantees will use only the forms high unit costs. specified in paragraphs (a) through (e) (3) Grantees will not be required to of this section, and such supple- submit more than the original and two mentary or other forms as may from copies of performance reports. time to time be authorized by OMB, (4) Grantees will adhere to the stand- for: ards in this section in prescribing per- (i) Submitting financial reports to formance reporting requirements for Federal agencies, or subgrantees. (ii) Requesting advances or reim- (c) Construction performance reports. bursements when letters of credit are For the most part, on-site technical in- not used. spections and certified percentage-of- (2) Grantees need not apply the forms completion data are relied on heavily prescribed in this section in dealing by Federal agencies to monitor with their subgrantees. However, progress under construction grants and grantees shall not impose more burden- subgrants. The Federal agency will re- some requirements on subgrantees. quire additional formal performance (3) Grantees shall follow all applica- reports only when considered nec- ble standard and supplemental Federal essary, and never more frequently than agency instructions approved by OMB quarterly. to the extent required under the Paper- (d) Significant developments. Events work Reduction Act of 1980 for use in may occur between the scheduled per- connection with forms specified in formance reporting dates which have paragraphs (b) through (e) of this sec- significant impact upon the grant or tion. Federal agencies may issue sub- subgrant supported activity. In such stantive supplementary instructions cases, the grantee must inform the only with the approval of OMB. Federal Federal agency as soon as the following agencies may shade out or instruct the types of conditions become known: grantee to disregard any line item that

192 Office of National Drug Control Policy § 1403.41 the Federal agency finds unnecessary (c) Federal Cash Transactions Report— for its decision making purposes. (1) Form. (i) For grants paid by letter of (4) Grantees will not be required to credit, Treasury check advances or submit more than the original and two electronic transfer of funds, the grant- copies of forms required under this ee will submit the Standard Form 272, part. Federal Cash Transactions Report, and (5) Federal agencies may provide when necessary, its continuation sheet, computer outputs to grantees to expe- Standard Form 272a, unless the terms dite or contribute to the accuracy of of the award exempt the grantee from reporting. Federal agencies may accept this requirement. the required information from grantees (ii) These reports will be used by the in machine usable format or computer Federal agency to monitor cash ad- printouts instead of prescribed forms. vanced to grantees and to obtain dis- (6) Federal agencies may waive any bursement or outlay information for report required by this section if not each grant from grantees. The format needed. of the report may be adapted as appropriate when reporting is to be accom- (7) Federal agencies may extend the plished with the assistance of auto- due date of any financial report upon matic data processing equipment pro- receiving a justified request from a vided that the information to be subgrantee. mitted is not changed in substance. (b) Financial Status Report—(1) Form. (2) Forecasts of Federal cash require- Grantees will use Standard Form 269 or ments. Forecasts of Federal cash re- 269A, Financial Status Report, to requirements may be required in the port the status of funds for all non- ‘‘Remarks’’ section of the report. construction grants and for construc- (3) Cash in hands of subgrantees. When tion grants when required in accord- considered necessary and feasible by ance with paragraph § 1403.41(e)(2)(iii) the Federal agency, grantees may be of this section. required to report the amount of cash (2) Accounting basis. Each grantee will advances in excess of three days’ needs report program outlays and program in the hands of their subgrantees or income on a cash or accrual basis as contractors and to provide short nar- prescribed by the awarding agency. If rative explanations of actions taken by the Federal agency requires accrual in- the grantee to reduce the excess formation and the grantee’s accounting balances. records are not normally kept on the (4) Frequency and due date. Grantees accrual basis, the grantee shall not be must submit the report no later than 15 required to convert its accounting sys- working days following the end of each tem but shall develop such accrual in- quarter. However, where an advance ei- formation through an analysis of the ther by letter of credit or electronic documentation on hand. transfer of funds is authorized at an (3) Frequency. The Federal agency annualized rate of one million dollars may prescribe the frequency of the re- or more, the Federal agency may report for each project or program. How- quire the report to be submitted within ever, the report will not be required 15 working days following the end of more frequently than quarterly. If the each month. Federal agency does not specify the (d) Request for advance or reimburse- frequency of the report, it will be sub- ment—(1) Advance payments. Requests mitted annually. A final report will be for Treasury check advance payments required upon expiration or termi- will be submitted on Standard Form nation of grant support. 270, Request for Advance or Reimburse- (4) Due date. When reports are re- ment. (This form will not be used for quired on a quarterly or semiannual drawdowns under a letter of credit, basis, they will be due 30 days after the electronic funds transfer or when reporting period. When required on an Treasury check advance payments are annual basis, they will be due 90 days made to the grantee automatically on after the grant year. Final reports will a predetermined basis.) be due 90 days after the expiration or (2) Reimbursements. Requests for reim- termination of grant support. bursement under nonconstruction

193 § 1403.42 21 CFR Ch. III (4–1–99 Edition) grants will also be submitted on Stand- tical records, and other records of ard Form 270. (For reimbursement re- grantees or subgrantees which are: quests under construction grants, see (i) Required to be maintained by the paragraph (e)(1) of this section.) terms of this Part, program regula- (3) The frequency for submitting pay- tions or the grant agreement, or ment requests is treated in (ii) Otherwise reasonably considered § 1403.41(b)(3). as pertinent to program regulations or (e) Outlay report and request for reim- the grant agreement. bursement for construction programs—(1) (2) This section does not apply to Grants that support construction activi- records maintained by contractors or ties paid by reimbursement method. (i) subcontractors. For a requirement to Requests for reimbursement under con- place a provision concerning records in struction grants will be submitted on Standard Form 271, Outlay Report and certain kinds of contracts, see Request for Reimbursement for Con- § 1403.36(i)(10). struction Programs. Federal agencies (b) Length of retention period. (1) Ex- may, however, prescribe the Request cept as otherwise provided, records for Advance or Reimbursement form, must be retained for three years from specified in § 1403.41(d), instead of this the starting date specified in paragraph form. (c) of this section. (ii) The frequency for submitting re- (2) If any litigation, claim, negotia- imbursement requests is treated in tion, audit or other action involving § 1403.41(b)(3). the records has been started before the (2) Grants that support construction ac- expiration of the 3-year period, the tivities paid by letter of credit, electronic records must be retained until comple- funds transfer or Treasury check ad- tion of the action and resolution of all vance. (i) When a construction grant is issues which arise from it, or until the paid by letter of credit, electronic end of the regular 3-year period, which- funds transfer or Treasury check ad- ever is later. vances, the grantee will report its out- (3) To avoid duplicate recordkeeping, lays to the Federal agency using awarding agencies may make special Standard Form 271, Outlay Report and arrangements with grantees and sub- Request for Reimbursement for Con- grantees to retain any records which struction Programs. The Federal agen- are continuously needed for joint use. cy will provide any necessary special The awarding agency will request instruction. However, frequency and transfer of records to its custody when due date shall be governed by it determines that the records possess § 1403.41(b) (3) and (4). long-term retention value. When the (ii) When a construction grant is paid records are transferred to or main- by Treasury check advances based on tained by the Federal agency, the 3- periodic requests from the grantee, the advances will be requested on the form year retention requirement is not ap- specified in § 1403.41(d). plicable to the grantee or subgrantees. (iii) The Federal agency may sub- (c) Starting date of retention period—(1) stitute the Financial Status Report General. When grant support is contin- specified in § 1403.41(b) for the Outlay ued or renewed at annual or other in- Report and Request for Reimbursement tervals, the retention period for the for Construction Programs. records of each funding period starts on (3) Accounting basis. The accounting the day the grantee or subgrantee sub- basis for the Outlay Report and Re- mits to the awarding agency its single quest for Reimbursement for Construc- or last expenditure report for that pe- tion Programs shall be governed by riod. However, if grant support is con- § 1403.41(b)(2). tinued or renewed quarterly, the retention period for each year’s records § 1403.42 Retention and access re- starts on the day the grantee submits quirements for records. its expenditure report for the last quar- (a) Applicability. (1) This section ap- ter of the Federal fiscal year. In all plies to all financial and programmatic other cases, the retention period starts records, supporting documents, statis- on the day the grantee submits its

194 Office of National Drug Control Policy § 1403.43 final expenditure report. If an expendi- documents, papers, or other records of ture report has been waived, the reten- grantees and subgrantees which are tion period starts on the day the report pertinent to the grant, in order to would have been due. make audits, examinations, excerpts, (2) Real property and equipment and transcripts. records. The retention period for real (2) Expiration of right of access. The property and equipment records starts rights of access in this section must from the date of the disposition or re- not be limited to the required reten- placement or transfer at the direction tion period but shall last as long as the of the awarding agency. records are retained. (3) Records for income transactions (f) Restrictions on public access. The after grant or subgrant support. In some Federal Freedom of Information Act (5 cases grantees must report income U.S.C. 552) does not apply to records. after the period of grant support. Unless required by Federal, State, or Where there is such a requirement, the local law, grantees and subgrantees are retention period for the records per- not required to permit public access to taining to the earning of the income their records. starts from the end of the grantee’s fiscal year in which the income is earned. § 1403.43 Enforcement. (4) Indirect cost rate proposals, cost al- (a) Remedies for noncompliance. If a locations plans, etc. This paragraph ap- grantee or subgrantee materially fails plies to the following types of docu- to comply with any term of an award, ments, and their supporting records: whether stated in a Federal statute or indirect cost rate computations or pro- regulation, an assurance, in a State posals, cost allocation plans, and any plan or application, a notice of award, similar accounting computations of or elsewhere, the awarding agency may the rate at which a particular group of take one or more of the following ac- costs is chargeable (such as computer tions, as appropriate in the cir- usage chargeback rates or composite cumstances: fringe benefit rates). (1) Temporarily withhold cash pay- (i) If submitted for negotiation. If the ments pending correction of the defi- proposal, plan, or other computation is ciency by the grantee or subgrantee or required to be submitted to the Federal more severe enforcement action by the Government (or to the grantee) to form awarding agency, the basis for negotiation of the rate, (2) Disallow (that is, deny both use of then the 3-year retention period for its funds and matching credit for) all or supporting records starts from the date part of the cost of the activity or ac- of such submission. tion not in compliance, (ii) If not submitted for negotiation. If (3) Wholly or partly suspend or ter- the proposal, plan, or other computa- minate the current award for the tion is not required to be submitted to grantee’s or subgrantee’s program, the Federal Government (or to the (4) Withhold further awards for the grantee) for negotiation purposes, then program, or the 3-year retention period for the pro- (5) Take other remedies that may be posal plan, or computation and its sup- legally available. porting records starts from end of the (b) Hearings, appeals. In taking an en- fiscal year (or other accounting period) forcement action, the awarding agency covered by the proposal, plan, or other will provide the grantee or subgrantee computation. an opportunity for such hearing, ap- (d) Substitution of microfilm. Copies peal, or other administrative pro- made by microfilming, photocopying, ceeding to which the grantee or sub- or similar methods may be substituted grantee is entitled under any statute for the original records. or regulation applicable to the action (e) Access to records—(1) Records of involved. grantees and subgrantees. The awarding (c) Effects of suspension and termi- agency and the Comptroller General of nation. Costs of grantee or subgrantee the United States, or any of their au- resulting from obligations incurred by thorized representatives, shall have the the grantee or subgrantee during a sus- right of access to any pertinent books, pension or after termination of an

195 § 1403.44 21 CFR Ch. III (4–1–99 Edition) award are not allowable unless the Subpart D—After-The-Grant awarding agency expressly authorizes Requirements them in the notice of suspension or termination or subsequently. Other grant- § 1403.50 Closeout. ee or subgrantee costs during suspen- (a) General. The Federal agency will sion or after termination which are close out the award when it determines necessary and not reasonably avoidable that all applicable administrative ac- are allowable if: tions and all required work of the (1) The costs result from obligations grant has been completed. which were properly incurred by the (b) Reports. Within 90 days after the grantee or subgrantee before the effec- expiration or termination of the grant, tive date of suspension or termination, the grantee must submit all financial, are not in anticipation of it, and, in the performance, and other reports re- case of a termination, are quired as a condition of the grant. noncancellable, and, Upon request by the grantee, Federal (2) The costs would be allowable if agencies may extend this time frame. the award were not suspended or ex- These may include but are not limited pired normally at the end of the fund- to: ing period in which the termination (1) Final performance or progress re- takes effect. port. (d) Relationship to Debarment and Sus- (2) Financial Status Report (SF 269) pension. The enforcement remedies or Outlay Report and Request for Re- identified in this section, including imbursement for Construction Pro- suspension and termination, do not grams (SF–271) (as applicable). preclude grantee or subgrantee from (3) Final request for payment (SF– being subject to ‘‘Debarment and Sus- 270) (if applicable). pension’’ under E.O. 12549 (see § 1403.35). (4) Invention disclosure (if applicable). § 1403.44 Termination for convenience. (5) Federally-owned property report: Except as provided in § 1403.43 awards In accordance with § 1403.32(f), a grant- may be terminated in whole or in part ee must submit an inventory of all fed- only as follows: erally owned property (as distinct from property acquired with grant funds) for (a) By the awarding agency with the which it is accountable and request dis- consent of the grantee or subgrantee in position instructions from the Federal which case the two parties shall agree agency of property no longer needed. upon the termination conditions, in- (c) Cost adjustment. The Federal agen- cluding the effective date and in the cy will, within 90 days after receipt of case of partial termination, the portion reports in paragraph (b) of this section, to be terminated, or make upward or downward adjust- (b) By the grantee or subgrantee ments to the allowable costs. upon written notification to the award- (d) Cash adjustments. (1) The Federal ing agency, setting forth the reasons agency will make prompt payment to for such termination, the effective the grantee for allowable reimbursable date, and in the case of partial termi- costs. nation, the portion to be terminated. (2) The grantee must immediately re- However, if, in the case of a partial ter- fund to the Federal agency any balance mination, the awarding agency deter- of unobligated (unencumbered) cash mines that the remaining portion of advanced that is not authorized to be the award will not accomplish the pur- retained for use on other grants. poses for which the award was made, the awarding agency may terminate § 1403.51 Later disallowances and ad- the award in its entirety under either justments. § 1403.43 or paragraph (a) of this sec- The closeout of a grant does not af- tion. fect:

196 Office of National Drug Control Policy Pt. 1403, App. A

(a) The Federal agency’s right to dis- Circular A–102, ‘‘Uniform requirements for allow costs and recover funds on the grants to State and local governments.’’ basis of a later audit or other review; 3. Background. The Single Audit Act builds upon earlier efforts to improve audits of Fed- (b) The grantee’s obligation to return eral aid programs. The Act requires State or any funds due as a result of later re- local governments that receive $100,000 or funds, corrections, or other trans- more a year in Federal funds to have an actions; audit made for that year. Section 7505 of the (c) Records retention as required in Act requires the Director of the Office of § 1403.42; Management and Budget to prescribe policies, procedures and guidelines to implement (d) Property management require- the Act. It specifies that the Director shall ments in § 1403.31 and § 1403.32; and designate ‘‘cognizant’’ Federal agencies, de- (e) Audit requirements in § 1403.26. termine criteria for making appropriate charges to federal programs for the cost of § 1403.52 Collection of amounts due. audits, and provide procedures to assure that (a) Any funds paid to a grantee in ex- small firms or firms owned and controlled by disadvantaged individuals have the oppor- cess of the amount to which the grant- tunity to participate in contracts for single ee is finally determined to be entitled audits. under the terms of the award con- 4. Policy. The Single Audit Act requires stitute a debt to the Federal Govern- the following: ment. If not paid within a reasonable a. State or local governments that receive period after demand, the Federal agen- $100,000 or more a year in Federal financial cy may reduce the debt by: assistance shall have an audit made in accordance with this Circular. (1) Making an administrative offset b. State or local governments that receive against other requests for reimburse- between $25,000 and $100,000 a year shall have ment, an audit made in accordance with this Cir- (2) Withholding advance payments cular, or in accordance with Federal laws otherwise due to the grantee, or and regulations governing the programs they (3) Other action permitted by law. participate in. c. State or local governments that receive (b) Except where otherwise provided less than $25,000 a year shall be exempt from by statutes or regulations, the Federal compliance with the Act and other Federal agency will charge interest on an over- audit requirements. These State and local due debt in accordance with the Fed- governments shall be governed by audit re- eral Claims Collection Standards (4 quirements prescribed by State or local law CFR ch. II). The date from which inter- or regulation. est is computed is not extended by liti- d. Nothing in this paragraph exempts State or local governments from maintaining gation or the filing of any form of ap- records of Federal financial assistance or peal. from providing access to such records to Fed- eral agencies, as provided for in Federal law Subpart E—Entitlement or in Circular A–102, ‘‘Uniform requirements for grants to state or local governments.’’ [Reserved] 5. Definitions. For the purposes of this Cir- cular the following definitions from the Sin- APPENDIX A TO PART 1403—OMB CIR- gle Audit Act apply: CULAR A–128, ‘‘AUDITS OF STATE AND a. Cognizant agency means the Federal LOCAL GOVERNMENTS’’ agency assigned by the Office of Manage- ment and Budget to carry out the respon- Circular No. A–128 sibilities described in paragraph 11 of this April 12, 1985. Circular. To the Heads of Executive Departments and b. Federal financial assistance means assist- Establishments ance provided by a Federal agency in the Subject: Audits of State and Local Govern- form of grants, contracts, cooperative agreements. ments, loans, loan guarantees, property, in- 1. Purpose. This Circular is issued pursuant terest subsidies, insurance, or direct appro- to the Single Audit Act of 1984, Pub. L. 98– priations, but does not include direct Federal 502. It establishes audit requirements for cash assistance to individuals. It includes State and local governments that receive awards received directly from Federal agen- Federal aid, and defines Federal responsibil- cies, or indirectly through other units of ities for implementing and monitoring those States and local governments. requirements. c. Federal agency has the same meaning as 2. Supersession. The Circular supersedes the term ‘‘agency’’ in section 551(1) of Title Attachment P, ‘‘Audit Requirements,’’ of 5, United States Code.

197 Pt. 1403, App. A 21 CFR Ch. III (4–1–99 Edition)

d. Generally accepted accounting principles gram. A subrecipient may also be a direct re- has the meaning specified in the generally cipient of Federal financial assistance. accepted government auditing standards. 6. Scope of audit. The Single Act provides e. Generally accepted government auditing that: standards means the Standards For Audit of a. The audit shall be made by an inde- Government Organizations, Programs, Ac- pendent auditor in accordance with gen- tivities, and Functions, developed by the erally accepted government auditing stand- Comptroller General, dated February 27, ards covering financial and compliance au- 1981. dits. f. Independent auditor means: b. The audit shall cover the entire oper- (1) A State or local government auditor ations of a State or local government or, at who meets the independence standards speci- the option of that government, it may cover fied in generally accepted government audit- departments, agencies or establishments ing standards; or that received, expended, or otherwise admin- (2) A public accountant who meets such istered Federal financial assistance during independence standards. the year. However, if a State or local govern- g. Internal controls means the plan of orga- ment receives $25,000 or more in General nization and methods and procedures adopt- Revenue Sharing Funds in a fiscal year, it ed by management to ensure that: shall have an audit of its entire operations. (1) Resource use is consistent with laws, A series of audits of individual departments, regulations, and policies; agencies, and establishments for the same (2) Resources are safeguarded against fiscal year may be considered a single audit. waste, loss, and misuse; and c. Public hospitals and public colleges and (3) Reliable data are obtained, maintained, universities may be excluded from State and and fairly disclosed in reports. local audits and the requirements of this Cir- h. Indian tribe means any Indian tribe, cular. However, if such entities are excluded, band, nations, or other organized group or audits of these entities shall be made in ac- community, including any Alaskan Native cordance with statutory requirements and village or regional or village corporations (as the provisions of Circular A–110, ‘‘Uniform defined in, or established under, the Alaskan requirements for grants to universities, hos- Native Claims Settlement Act) that is recog- pitals, and other nonprofit organizations.’’ nized by the United States as eligible for the special programs and services provided by d. The auditor shall determine whether: the United States to Indians because of their (1) The financial statements of the govern- status as Indians. ment, department, agency or establishment i. Local government means any unit of local present fairly its financial position and the government within a State, including a results of its financial operations in accord- county, a borough, municipality, city, town, ance with generally accepted accounting township, parish, local public authority, spe- principles; cial district, school district, intrastate dis- (2) The organization has internal account- trict, council of government, and any other ing and other control systems to provide rea- instrumentality of local government. sonable assurance that it is managing Fed- j. Major Federal Assistance Program, as de- eral financial assistance programs in compli- fined by Pub. L. 98–502, is described in the ance with applicable laws and regulations; Attachment to this Circular. and k. Public accountants means those individ- (3) The organization has complied with uals who meet the qualification standards laws and regulations that may have material included in generally accepted government effect on its financial statements and on auditing standards for personnel performing each major Federal assistance program. government audits. 7. Frequency of audit. Audits shall be made l. State means any State of the United annually unless the State or local govern- States, the District of Columbia, the Com- ment has, by January 1, 1987, a constitu- monwealth of Puerto Rico, the Virgin Is- tional or statutory requirement for less fre- lands, Guam, American Samoa, the Com- quent audits. For those governments, the monwealth of the Northern Mariana Islands, cognizant agency shall permit biennial au- and the Trust Territory of the Pacific Is- dits, covering both years, if the government lands, any instrumentality thereof, and any so requests. It shall also honor requests for multi-State, regional, or interstate entity biennial audits by governments that have an that has governmental functions and any In- administrative policy calling for audits less dian tribe. frequent than annual, but only for fiscal m. Subrecipient means any person or gov- years beginning before January 1, 1987. ernment department, agency, or establish- 8. Internal control and compliance reviews. ment that receives Federal financial assist- The Single Audit Act requires that the inde- ance to carry out a program through a State pendent auditor determine and report on or local government, but does not include an whether the organization has internal con- individual that is a beneficiary of such a pro- trol systems to provide reasonable assurance

198 Office of National Drug Control Policy Pt. 1403, App. A that it is managing Federal assistance pro- and records from which the basic financial grams in compliance with applicable laws statements have been prepared, and and regulations. —Amounts claimed or used for matching a. Internal control review. In order to pro- were determined in accordance with OMB vide this assurance the auditor must make a Circular A–87, ‘‘Cost principles for State study and evaluation of internal control sys- and local governments,’’ and Attachment tems used in administering Federal assist- F of Circular A–102, ‘‘Uniform require- ance programs. The study and evaluation ments for grants to State and local govern- must be made whether or not the auditor in- ments.’’ tends to place reliance on such systems. As (c) The principal compliance requirements part of this review, the auditor shall: of the largest Federal aid programs may be (1) Test whether these internal control sys- ascertained by referring to the Compliance tems are functioning in accordance with pre- Supplement for Single Audits of State and scribed procedures. Local Governments, issued by OMB and (2) Examine the recipient’s system for available from the Government Printing Of- monitoring subrecipients and obtaining and fice. For those programs not covered in the acting on subrecipient audit reports. Compliance Supplement, the auditor may as- b. Compliance review. The law also re- certain compliance requirements by requires the auditor to determine whether the searching the statutes, regulations, and organization has complied with laws and reg- agreements governing individual programs. ulations that may have a material effect on (3) Transactions related to other Federal assistance programs that are selected in con- each major Federal assistance program. nection with examinations of financial state- (1) In order to determine which major pro- ments and evaluations of internal controls grams are to be tested for compliance, State shall be tested for compliance with Federal and local governments shall identify in their laws and regulations that apply to such accounts all Federal funds received and ex- transactions. pended and the programs under which they 9. Subrecipients. State or local govern- were received. This shall include funds re- ments that receive Federal financial assist- ceived directly from Federal agencies and ance and provide $25,000 or more of it in a fis- through other State and local governments. cal year to a subrecipient shall: (2) The review must include the selection a. Determine whether State or local sub- and testing of a representative number of recipients have met the audit requirements charges from each major Federal assistance of this Circular and whether subrecipients program. The selection and testing of trans- covered by Circular A–110, ‘‘Uniform require- actions shall be based on the auditor’s pro- ments for grants to universities, hospitals, fessional judgment considering such factors and other nonprofit organizations,’’ have as the amount of expenditures for the pro- met that requirement; gram and the individual awards; the newness b. Determine whether the subrecipient of the program or changes in its conditions; spent Federal assistance funds provided in prior experience with the program, particu- accordance with applicable laws and regula- larly as revealed in audits and other evaluations. This may be accomplished by review- tions (e.g., inspections program reviews); the ing an audit of the subrecipient made in ac- extent to which the program is carried out cordance with this Circular, Circular A–110, through subrecipients; the extent to which or through other means (e.g., program re- the program contracts for goods or services; views) if the subrecipient has not yet had the level to which the program is already such an audit; subject to program reviews or other forms of c. Ensure that appropriate corrective ac- independent oversight; the adequacy of the tion is taken within six months after receipt controls for ensuring compliance; the excep- of the audit report in instances of non- tion of adherence or lack of adherence to the compliance with Federal laws and regula- applicable laws and regulations; and the po- tions; tential impact of adverse findings. d. Consider whether subrecipient audits ne- (a) In making the test of transactions, the cessitate adjustment of the recipient’s own auditor shall determine whether: records; and —The amounts reported as expenditures e. Require each subrecipient to permit were for allowable services, and independent auditors to have access to the —The records show that those who received records and financial statements as nec- services or benefits were eligible to receive essary to comply with this Circular. them. 10. Relation to other audit requirements. (b) In addition to transaction testing, the The Single Audit Act provides that an audit auditor shall determine whether: made in accordance with this Circular shall —Matching requirements, levels of effort and be in lieu of any financial or financial com- earmarking limitations were met, pliance audit required under individual Fed- —Federal financial reports and claims for eral assistance programs. To the extent that advances and reimbursements contain in- a single audit provides Federal agencies with formation that is supported by the books information and assurances they need to

199 Pt. 1403, App. A 21 CFR Ch. III (4–1–99 Edition) carry out their overall responsibilities, they (5) Advise the recipient of audits that have shall rely upon and use such information. been found not to have met the requirements However, a Federal agency shall make any set forth in this Circular. In such instances, additional audits which are necessary to the recipient will be expected to work with carry out its responsibilities under Federal the auditor to take corrective action. If cor- law and regulation. Any additional Federal rective action is not taken, the cognizant audit effort shall be planned and carried out agency shall notify the recipient and Federal in such a way as to avoid duplication. awarding agencies of the facts and make rec- a. The provisions of this Circular do not ommendations for followup action. Major in- limit the authority of Federal agencies to adequacies or repetitive substandard per- make, or contract for audits and evaluations formance of independent auditors shall be re- of Federal financial assistance programs, nor ferred to appropriate professional bodies for do they limit the authority of any Federal disciplinary action. agency Inspector General or other Federal (6) Coordinate, to the extent practicable, audit official. audits made by or for Federal agencies that b. The provisions of this Circular do not are in addition to the audits made pursuant authorize any State or local government or to this Circular; so that the additional au- subrecipient thereof to constrain Federal dits build upon such audits. agencies, in any manner, from carrying out (7) Oversee the resolution of audit findings additional audits. that affect the programs of more than one c. A Federal agency that makes or con- agency. tracts for audits in addition to the audits 12. Illegal acts or irregularities. If the made by recipients pursuant to this Circular auditor becomes aware of illegal acts or shall, consistent with other applicable laws other irregularities, prompt notice shall be given to recipient management officials and regulations, arrange for funding the cost above the level of involvement. (See also of such additional audits. Such additional paragraph 13(a)(3) below for the auditor’s re- audits include economy and efficiency au- porting responsibilities.) The recipient, in dits, program results audits, and program turn, shall promptly notify the cognizant evaluations. agency of the illegal acts or irregularities 11. Cognizant agency responsibilities. The and of proposed and actual actions, if any. Il- Single Audit Act provides for cognizant Fed- legal acts and irregularities include such eral agencies to oversee the implementation matters as conflicts of interest, falsification of this Circular. of records or reports, and misappropriations a. The Office of Management and Budget of funds or other assets. will assign cognizant agencies for States and 13. Audit reports. Audit reports must be their subdivisions and larger local govern- prepared at the completion of the audit. Re- ments and their subdivisions. Other Federal ports serve many needs of State and local agencies may participate with an assigned governments as well as meeting the require- cognizant agency, in order to fulfill the cog- ments of the Single Audit Act. nizance responsibilities. Smaller govern- a. The audit report shall state that the ments not assigned a cognizant agency will audit was made in accordance with the pro- be under the general oversight of the Federal visions of this Circular. The report shall be agency that provides them the most funds made up of at least: whether directly or indirectly. (1) The auditor’s report on financial state- b. A cognizant agency shall have the fol- ments and on a schedule of Federal assist- lowing responsibilities: ance; the financial statements; and a sched- (1) Ensure that audits are made and re- ule of Federal assistance, showing the total ports are received in a timely manner and in expenditures for each Federal assistance pro- accordance with the requirements of this gram as identified in the Catalog of Federal Circular. Domestic Assistance. Federal programs or (2) Provide technical advice and liaison to grants that have not been assigned a catalog State and local governments and inde- number shall be identified under the caption pendent auditors. ‘‘other Federal assistance.’’ (3) Obtain or make quality control reviews (2) The auditor’s report on the study and of selected audits made by non-Federal audit evaluation of internal control systems must organizations, and provide the results, when identify the organization’s significant inter- appropriate, to other interested organiza- nal accounting controls, and those controls tions. designed to provide reasonable assurance (4) Promptly inform other affected Federal that Federal programs are being managed in agencies and appropriate Federal law en- compliance with laws and regulations. It forcement officials of any reported illegal must also identify the controls that were acts or irregularities. They should also in- evaluated, the controls that were not evalu- form State or local law enforcement and ated, and the material weaknesses identified prosecuting authorities, if not advised by the as a result of the evaluation. recipient, of any violation of law within (3) The auditor’s report on compliance con- their jurisdiction. taining:

200 Office of National Drug Control Policy Pt. 1403, App. A

—A statement of positive assurance with re- of the recipient and that agency. Alternate spect to those items tested for compliance, arrangements may be made on a case-by- including compliance with law and regula- case basis by agreement among the agencies tions pertaining to financial reports and concerned. claims for advances and reimbursements; Resolution shall be made within six —Negative assurance on those items not months after receipt of the report by the tested; Federal departments and agencies. Correc- —A summary of all instances of noncompli- tive action should proceed as rapidly as pos- ance; and sible. —An identification of total amounts ques- 15. Audit workpapers and reports. tioned, if any, for each Federal assistance Workpapers and reports shall be retained for award, as a result of noncompliance. a minimum of three years from the date of b. The three parts of the audit report may the audit report, unless the auditor is noti- be bound into a single report, or presented at fied in writing by the cognizant agency to the same time as separate documents. extend the retention period. Audit c. All fraud abuse, or illegal acts or indica- workpapers shall be made available upon re- tions of such acts, including all questioned quest to the cognizant agency or its designee costs found as the result of these acts that or the General Accounting Office, at the auditors become aware of, should normally completion of the audit. be covered in a separate written report sub- 16. Audit Costs. The cost of audits made in mitted in accordance with paragraph 13f. accordance with the provisions of this Cir- d. In addition to the audit report, the re- cular are allowable charges to Federal as- cipient shall provide comments on the find- sistance programs. ings and recommendations in the report, in- a. The charges may be considered a direct cluding a plan for corrective action taken or cost or an allocated indirect cost, deter- planned and comments on the status of cor- mined in accordance with the provision of rective action taken on prior findings. If corrective action is not necessary, a statement Circular A–87, ‘‘Cost principles for State and describing the reason it is not should accom- local governments.’’ pany the audit report. b. Generally, the percentage of costs e. The reports shall be made available by charged to Federal assistance programs for a the State or local government for public in- single audit shall not exceed the percentage spection within 30 days after the completion that Federal funds expended represent of of the audit. total funds expended by the recipient during f. In accordance with generally accepted the fiscal year. The percentage may be ex- government audit standards, reports shall be ceeded, however, if appropriate documenta- submitted by the auditor to the organization tion demonstrates higher actual cost. audited and to those requiring or arranging 17. Sanctions. The Single Audit Act pro- for the audit. In addition, the recipient shall vides that no cost may be charged to Federal submit copies of the reports to each Federal assistance programs for audits required by department or agency that provided Federal the Act that are not made in accordance assistance funds to the recipient. Subrecipi- with this Circular. In cases of continued in- ents shall submit copies to recipients that ability or unwillingness to have a proper provided them Federal assistance funds. The audit, Federal agencies must consider other reports shall be sent within 30 days after the appropriate sanctions including: completion of the audit, but no later than —Withhodling a percentage of assistance one year after the end of the audit period un- payments until the audit is completed sat- less a longer period is agreed to with the cog- isfactorily, nizant agency. —Withholding or disallowing overhead costs, g. Recipients of more than $100,000 in Fed- and eral funds shall submit one copy of the audit —Suspending the Federal assistance agree- report within 30 days after issuance to a cen- ment until the audit is made. tral clearinghouse to be designated by the 18. Auditor Selection. In arranging for Office of Management and Budget. The clear- audit services State and local governments inghouse will keep completed audits on file shall follow the procurement standards pre- and follow up with State and local govern- scribed by Attachment O of Circular A–102, ments that have not submitted required ‘‘Uniform requirements for grants to State audit reports. and local governments.’’ The standards pro- h. Recipients shall keep audit reports on vide that while recipients are encouraged to file for three years from their issuance. enter into intergovernmental agreements for 14. Audit Resolution. As provided in para- audit and other services, analysis should be graph 11, the cognizant agency shall be re- made to determine whether it would be more sponsible for monitoring the resolution of economical to purchase the services from audit findings that affect the programs of private firms. In instances where use of such more than one Federal agency. Resolution of intergovernmental agreements are required findings that relate to the programs of a sin- by State statutes (e.g., audit services) these gle Federal agency will be the responsibility statutes will take precedence.

201 Pt. 1404 21 CFR Ch. III (4–1–99 Edition)

19. Small and Minority Audit Firms. Small 23. Inquiries. All questions or inquiries audit firms and audit firms owned and con- should be addressed to Financial Manage- trolled by socially and economically dis- ment Division, Office of Management and advantaged individuals shall have the max- Budget, telephone number (202) 395–3993. imum practicable opportunity to participate 24. Sunset review date. This Circular shall in contracts awarded to fulfill the require- have an independent policy review to ascer- ments of this Circular. Recipients of Federal tain its effectiveness three years from the assistance shall take the following steps to date of issuance. further this goal: David A. Stockman, a. Assure that small audit firms and audit Director. firms owned and controlled by socially and economically disadvantaged individuals are CIRCULAR A–128 ATTACHMENT used to the fullest extent practicable. b. Make information on forthcoming op- DEFINITION OF MAJOR PROGRAM AS PROVIDED portunities available and arrange time IN PUB. L. 98–502 frames for the audit so as to encourage and ‘‘Major Federal Assistance Program,’’ for facilitate participation by small audit firms State and local governments having Federal and audit firms owned and controlled by so- assistance expenditures between $100,000 and cially and economically disadvantaged indi- $100,000,000. means any program for which viduals. Federal expenditures during the applicable c. Consider in the contract process whether year exceed the larger of $300,000, or 3 per- firms competing for larger audits intend to cent of such total expenditures. subcontract with small audit firms and audit Where total expenditures of Federal assist- firms owned and controlled by socially and ance exceed $100,000,000, the following cri- economically disadvantaged individuals. teria apply: d. Encourage contracting with small audit firms or audit firms owned and controlled by Total expenditures of Federal financial Major Federal as- socially and economically disadvantaged in- assistance for all programs sistance program means any program dividuals which have traditionally audited More than But less than that exceeds government programs and, in such cases where this is not possible, assure that these $100 million 1 billion $3 million firms are given consideration for audit sub- 1 billion 2 billion 4 million contracting opportunities. 2 billion 3 billion 7 million e. Encourage contracting with consortiums 3 billion 4 billion 10 million 4 billion 5 billion 13 million of small audit firms as described in para- 5 billion 6 billion 16 million graph (a) above when a contract is too large 6 billion 7 billion 19 million for an individual small audit firm or audit Over 7 billion 20 million firm owned and controlled by socially and economically disadvantaged individuals. f. Use the services and assistance, as appro- [57 FR 55092, Nov. 24, 1992; 58 FR 26185, Apr. priate, of such organizations as the Small 30, 1993] Business Administration in the solicitation and utilization of small audit firms or audit PART 1404—GOVERNMENTWIDE firms owned and controlled by socially and DEBARMENT AND SUSPENSION economically disadvantaged individuals. 20. Reporting. Each Federal agency will re- (NONPROCUREMENT) AND GOV- port to the Director of OMB on or before ERNMENTWIDE REQUIREMENTS March 1, 1987, and annually thereafter on the FOR DRUG-FREE WORKPLACE effectiveness of State and local governments (GRANTS) in carrying out the provisions of this Cir- cular. The report must identify each State or local government or Indian tribe that, in the Subpart A—General opinion of the agency, is failing to comply Sec. with Circular. 1404.100 Purpose. 21. Regulations. Each Federal agency shall 1404.105 Definitions. include the provisions of this Circular in its 1404.110 Coverage. regulations implementing the Single Audit 1404.115 Policy. Act. 22. Effective date. This Circular is effective Subpart B—Effect of Action upon publication and shall apply to fiscal years of State and local governments that 1404.200 Debarment or suspension. begin after December 31, 1984. Earlier imple- 1404.205 Ineligible persons. mentation is encouraged. However, until it is 1404.210 Voluntary exclusion. implemented, the audit provisions of Attach- 1404.215 Exception provision. ment P to Circular A–102 shall continue to be 1404.220 Continuation of covered trans- observed. actions.

202 Office of National Drug Control Policy § 1404.100

1404.225 Failure to adhere to restrictions. SOURCE: 57 FR 56263, Nov. 27, 1992, unless otherwise noted. Subpart C—Debarment 1404.300 General. Subpart A—General 1404.305 Causes for debarment. 1404.310 Procedures. § 1404.100 Purpose. 1404.311 Investigation and referral. (a) Executive Order (E.O.) 12549 pro- 1404.312 Notice of proposed debarment. vides that, to the extent permitted by 1404.313 Opportunity to contest proposed debarment. law, Executive departments and agen- 1404.314 Debarring official’s decision. cies shall participate in a government- 1404.315 Settlement and voluntary exclu- wide system for nonprocurement debar- sion. ment and suspension. A person who is 1404.320 Period of debarment. debarred or suspended shall be excluded 1404.325 Scope of debarment. from Federal financial and non- financial assistance and benefits under Subpart D—Suspension Federal programs and activities. De- 1404.400 General. barment or suspension of a participant 1404.405 Causes for suspension. in a program by one agency shall have 1404.410 Procedures. governmentwide effect. 1404.411 Notice of suspension. (b) These regulations implement sec- 1404.412 Opportunity to contest suspension. 1404.413 Suspending official’s decision. tion 3 of E.O. 12549 and the guidelines 1404.415 Period of suspension. promulgated by the Office of Manage- 1404.420 Scope of suspension. ment and Budget under section 6 of the E.O. by: Subpart E—Responsibilities of GSA, Agency (1) Prescribing the programs and ac- and Participants tivities that are covered by the governmentwide system; 1404.500 GSA responsibilities. 1404.505 ONDCP responsibilities. (2) Prescribing the governmentwide 1404.510 Participants’ responsibilities. criteria and governmentwide minimum due process procedures that each agen- Subpart F—Drug-Free Workplace cy shall use; Requirements (Grants) (3) Providing for the listing of debarred and suspended participants, 1404.600 Purpose. participants declared ineligible (see 1404.605 Definitions. 1404.610 Coverage. definition of ‘‘ineligible’’ in § 1404.105), 1404.615 Grounds for suspension of pay- and participants who have voluntarily ments, suspension or termination of excluded themselves from participation grants, or suspension or debarment. in covered transactions; 1404.620 Effect of violation. (4) Setting forth the consequences of 1404.625 Exception provision. a debarment, suspension, determina- 1404.630 Certification requirements and pro- tion of ineligibility, or voluntary ex- cedures. 1404.635 Reporting of and employee sanc- clusion; and tions for convictions of criminal drug of- (5) Offering such other guidance as fenses. necessary for the effective implementa- APPENDIX A TO PART 1404—CERTIFICATION RE- tion and administration of the govern- GARDING DEBARMENT, SUSPENSION, AND mentwide system. OTHER RESPONSIBILITY MATTERS—PRI- (c) These regulations also implement MARY COVERED TRANSACTIONS Executive Order 12689 (3 CFR, 1989 APPENDIX B TO PART 1404—CERTIFICATION RE- Comp., p. 235) and 31 U.S.C. 6101 note GARDING DEBARMENT, SUSPENSION, INELI- (Public Law 103–355, sec. 2455, 108 Stat. GIBILITY AND VOLUNTARY EXCLUSION— 3327) by— LOWER TIER COVERED TRANSACTIONS APPENDIX C TO PART 1404—CERTIFICATION RE- (1) Providing for the inclusion in the GARDING DRUG-FREE WORKPLACE RE- List of Parties Excluded from Federal Pro- QUIREMENTS curement and Nonprocurement Programs all persons proposed for debarment, AUTHORITY: Executive Order 12549, 3 CFR, 1986 Comp., p. 189; 5 U.S.C. 301; Sec. 5151–5160 debarred or suspended under the Fed- of the Drug-Free Workplace Act of 1988 (Pub. eral Acquisition Regulation, 48 CFR L. 100–690, Title V, Subtitle D, 102 stat. 4304; Part 9, subpart 9.4; persons against 41 U.S.C. 701 et seq.). which governmentwide exclusions have

203 § 1404.105 21 CFR Ch. III (4–1–99 Edition) been entered under this part; and per- from participating in covered trans- sons determined to be ineligible; and actions. A person so excluded is (2) Setting forth the consequences of ‘‘debarred.’’ a debarment, suspension, determina- Debarring official. An official author- tion of ineligibility, or voluntary ex- ized to impose debarment. The debar- clusion. ring official is either: (d) Although these regulations cover (1) The agency head, or the listing of ineligible participants (2) An official designated by the and the effect of such listing, they do agency head. not prescribe policies and procedures Indictment. Indictment for a criminal governing declarations of ineligibility. offense. An information or other filing [60 FR 33040, 33045, June 26, 1995] by competent authority charging a criminal offense shall be given the § 1404.105 Definitions. same effect as an indictment. The following definitions apply to Ineligible. Excluded from participa- this part: tion in Federal nonprocurement pro- Adequate evidence. Information suffi- grams pursuant to a determination of cient to support the reasonable belief ineligibility under statutory, executive that a particular act or omission has order, or regulatory authority, other occurred. than Executive Order 12549 and its Affiliate. Persons are affiliates of agency implementing regulations; for each other if, directly or indirectly, ei- example, excluded pursuant to the ther one controls or has the power to Davis-Bacon Act and its implementing control the other, or, a third person regulations, the equal employment op- controls or has the power to control portunity acts and executive orders, or both. Indicia of control include, but are the environmental protection acts and not limited to: interlocking manage- executive orders. A person is ineligible ment or ownership, identity of inter- where the determination of ineligi- ests among family members, shared fa- bility affects such person’s eligibility cilities and equipment, common use of to participate in more than one cov- employees, or a business entity orga- ered transaction. nized following the suspension or de- Legal proceedings. Any criminal pro- barment of a person which has the ceeding or any civil judicial proceeding same or similar management, owner- to which the Federal Government or a ship, or principal employees as the sus- State or local government or quasi- pended, debarred, ineligible, or volun- governmental authority is a party. The tarily excluded person. term includes appeals from such pro- Agency. Any executive department, ceedings. military department or defense agency List of Parties Excluded from Federal or other agency of the executive Procurement and Nonprocurement Pro- branch, excluding the independent reg- grams. A list compiled, maintained and ulatory agencies. distributed by the General Services Ad- Civil judgment. The disposition of a ministration (GSA) containing the civil action by any court of competent names and other information about jurisdiction, whether entered by ver- persons who have been debarred, sus- dict, decision, settlement, stipulation, pended, or voluntarily excluded under or otherwise creating a civil liability Executive Orders 12549 and 12689 and for the wrongful acts complained of; or these regulations or 48 CFR part 9, sub- a final determination of liability under part 9.4, persons who have been pro- the Program Fraud Civil Remedies Act posed for debarment under 48 CFR part of 1988 (31 U.S.C. 3801–12). 9, subpart 9.4, and those persons who Conviction. A judgment or conviction have been determined to be ineligible. of a criminal offense by any court of Notice. A written communication competent jurisdiction, whether en- served in person or sent by certified tered upon a verdict or a plea, includ- mail, return receipt requested, or its ing a plea of nolo contendere. equivalent, to the last known address Debarment. An action taken by a de- of a party, its identified counsel, its barring official in accordance with agent for service of process, or any these regulations to exclude a person partner, officer, director, owner, or

204 Office of National Drug Control Policy § 1404.110 joint venturer of the party. Notice, if ment. A State instrumentality will be undeliverable, shall be considered to considered part of the State govern- have been received by the addressee ment if it has a written determination five days after being properly sent to from a State government that such the last address known by the agency. State considers that instrumentality Participant. Any person who submits to be an agency of the State govern- a proposal for, enters into, or reason- ment. ably may be expected to enter into a Suspending official. An official au- covered transaction. This term also in- thorized to impose suspension. The sus- cludes any person who acts on behalf of pending official is either: or is authorized to commit a partici- (1) The agency head, or pant in a covered transaction as an (2) An official designated by the agent or representative of another par- agency head. ticipant. Suspension. An action taken by a sus- Person. Any individual, corporation, pending official in accordance with partnership, association, unit of gov- these regulations that immediately ex- ernment or legal entity, however orga- cludes a person from participating in nized, except: Foreign governments or covered transactions for a temporary foreign governmental entities, public period, pending completion of an inves- international organizations, foreign tigation and such legal, debarment, or government owned (in whole or in part) Program Fraud Civil Remedies Act or controlled entities, and entities con- proceedings as may ensue. A person so sisting wholly or partially of foreign excluded is ‘‘suspended.’’ governments or foreign governmental Voluntary exclusion or voluntarily ex- entities. cluded. A status of nonparticipation or Preponderance of the evidence. Proof limited participation in covered trans- by information that, compared with actions assumed by a person pursuant that opposing it, leads to the conclu- to the terms of a settlement. sion that the fact at issue is more prob- [57 FR 56263, Nov. 27, 1992, as amended at 60 ably true than not. FR 33041, 33045, June 26, 1995] Principal. Officer, director, owner, partner, key employee, or other person § 1404.110 Coverage. within a participant with primary (a) These regulations apply to all per- management or supervisory respon- sons who have participated, are cur- sibilities; or a person who has a critical rently participating or may reasonably influence on or substantive control be expected to participate in trans- over a covered transaction, whether or actions under Federal nonprocurement not employed by the participant. Per- programs. For purposes of these regula- sons who have a critical influence on or tions such transactions will be referred substantive control over a covered to as ‘‘covered transactions.’’ transaction are: (1) Covered transaction. For purposes (1) Principal investigators. of these regulations, a covered trans- Proposal. A solicited or unsolicited action is a primary covered transaction bid, application, request, invitation to or a lower tier covered transaction. consider or similar communication by Covered transactions at any tier need or on behalf of a person seeking to par- not involve the transfer of Federal ticipate or to receive a benefit, directly funds. or indirectly, in or under a covered (i) Primary covered transaction. Except transaction. as noted in paragraph (a)(2) of this sec- Respondent. A person against whom a tion, a primary covered transaction is debarment or suspension action has any nonprocurement transaction be- been initiated. tween an agency and a person, regard- State. Any of the States of the United less of type, including: Grants, cooper- States, the District of Columbia, the ative agreements, scholarships, fellow- Commonwealth of Puerto Rico, any ships, contracts of assistance, loans, territory or possession of the United loan guarantees, subsidies, insurance, States, or any agency of a State, exclu- payments for specified use, donation sive of institutions of higher education, agreements and any other nonprocure- hospitals, and units of local government transactions between a Federal

205 § 1404.115 21 CFR Ch. III (4–1–99 Edition) agency and a person. Primary covered (vi) Incidental benefits derived from transactions also include those trans- ordinary governmental operations; and actions specially designated by the (vii) Other transactions where the ap- U.S. Department of Housing and Urban plication of these regulations would be Development in such agency’s regula- prohibited by law. tions governing debarment and suspen- (b) Relationship to other sections. This sion. section describes the types of trans- (ii) Lower tier covered transaction. A actions to which a debarment or sus- lower tier covered transaction is: pension under the regulations will (A) Any transaction between a par- apply. Subpart B, ‘‘Effect of Action,’’ ticipant and a person other than a pro- § 1404.200, ‘‘Debarment or suspension,’’ curement contract for goods or serv- sets forth the consequences of a debar- ices, regardless of type, under a pri- ment or suspension. Those con- mary covered transaction. sequences would obtain only with re- (B) Any procurement contract for spect to participants and principals in goods or services between a participant the covered transactions and activities and a person, regardless of type, ex- described in § 1404.110(a). Sections pected to equal or exceed the Federal § 1404.325, ‘‘Scope of debarment,’’ and procurement small purchase threshold § 1404.420, ‘‘Scope of suspension,’’ gov- fixed at 10 U.S.C. 2304(g) and 41 U.S.C. ern the extent to which a specific par- 253(g) (currently $25,000) under a pri- ticipant or organizational elements of mary covered transaction. a participant would be automatically (C) Any procurement contract for included within a debarment or suspen- goods or services between a participant sion action, and the conditions under and a person under a covered trans- which affiliates or persons associated action, regardless of amount, under with a participant may also be brought which that person will have a critical within the scope of the action. influence on or substantive control (c) Relationship to Federal procurement over that covered transaction. Such activities. In accordance with E.O. 12689 persons are: and section 2455 of Public Law 103–355, (1) Principal investigators. any debarment, suspension, proposed (2) Providers of federally-required debarment or other governmentwide audit services. exclusion initiated under the Federal (2) Exceptions. The following trans- Acquisition Regulation (FAR) on or actions are not covered: after August 25, 1995 shall be recog- (i) Statutory entitlements or manda- nized by and effective for Executive tory awards (but not subtier awards Branch agencies and participants as an thereunder which are not themselves exclusion under this regulation. Simi- mandatory), including deposited funds larly, any debarment, suspension or insured by the Federal Government; other governmentwide exclusion initi- (ii) Direct awards to foreign govern- ated under this regulation on or after ments or public international organiza- August 25, 1995 shall be recognized by tions, or transactions with foreign gov- and effective for those agencies as a de- ernments or foreign governmental en- barment or suspension under the FAR. tities, public international organiza- [57 FR 56263, Nov. 27, 1992, as amended at 60 tions, foreign government owned (in FR 33041, 33045, June 26, 1995] whole or in part) or controlled entities, entities consisting wholly or partially § 1404.115 Policy. of foreign governments or foreign gov- (a) In order to protect the public in- ernmental entities; terest, it is the policy of the Federal (iii) Benefits to an individual as a Government to conduct business only personal entitlement without regard to with responsible persons. Debarment the individual’s present responsibility and suspension are discretionary ac- (but benefits received in an individual’s tions that, taken in accordance with business capacity are not excepted); Executive Order 12549 and these regula- (iv) Federal employment; tions, are appropriate means to imple- (v) Transactions pursuant to national ment this policy. or agency-recognized emergencies or (b) Debarment and suspension are se- disasters; rious actions which shall be used only

206 Office of National Drug Control Policy § 1404.215 in the public interest and for the Fed- whole or in part) or controlled entities, eral Government’s protection and not and entities consisting wholly or par- for purposes of punishment. Agencies tially of foreign governments or for- may impose debarment or suspension eign governmental entities; for the causes and in accordance with (3) Benefits to an individual as a per- the procedures set forth in these regu- sonal entitlement without regard to lations. the individual’s present responsibility (c) When more than one agency has (but benefits received in an individual’s an interest in the proposed debarment business capacity are not excepted); or suspension of a person, consideration shall be given to designating one (4) Federal employment; agency as the lead agency for making (5) Transactions pursuant to national the decision. Agencies are encouraged or agency-recognized emergencies or to establish methods and procedures disasters; for coordinating their debarment or (6) Incidental benefits derived from suspension actions. ordinary governmental operations; and (7) Other transactions where the ap- Subpart B—Effect of Action plication of these regulations would be prohibited by law. § 1404.200 Debarment or suspension. [60 FR 33041, 33045, June 26, 1995] (a) Primary covered transactions. Ex- cept to the extent prohibited by law, § 1404.205 Ineligible persons. persons who are debarred or suspended shall be excluded from primary covered Persons who are ineligible, as defined transactions as either participants or in § 1404.105(i), are excluded in accord- principals throughout the Executive ance with the applicable statutory, ex- Branch of the Federal Government for ecutive order, or regulatory authority. the period of their debarment, suspension, or the period they are proposed § 1404.210 Voluntary exclusion. for debarment under 48 CFR part 9, Persons who accept voluntary exclu- subpart 9.4. Accordingly, no agency sions under § 1404.315 are excluded in shall enter into primary covered trans- accordance with the terms of their set- actions with such excluded persons tlements. The Office of National Drug during such period, except as permitted Control Policy (ONDCP) shall, and par- pursuant to § 1404.215. ticipants may, contact the original ac- (b) Lower tier covered transactions. Ex- tion agency to ascertain the extent of cept to the extent prohibited by law, the exclusion. persons who have been proposed for debarment under 48 CFR part 9, subpart § 1404.215 Exception provision. 9.4, debarred or suspended shall be excluded from participating as either [Agency] may grant an exception per- participants or principals in all lower mitting a debarred, suspended, or vol- tier covered transactions (see untarily excluded person, or a person § 1404.110(a)(1)(ii)) for the period of their proposed for debarment under 48 CFR exclusion. part 9, subpart 9.4, to participate in a (c) Exceptions. Debarment or suspen- particular covered transaction upon a sion does not affect a person’s eligi- written determination by the agency bility for— head or an authorized designee stating (1) Statutory entitlements or manda- the reason(s) for deviating from the tory awards (but not subtier awards Presidential policy established by Ex- thereunder which are not themselves ecutive Order 12549 and § 1404.200. How- mandatory), including deposited funds ever, in accordance with the Presi- insured by the Federal Government; dent’s stated intention in the Execu- (2) Direct awards to foreign govern- tive Order, exceptions shall be granted ments or public international organiza- only infrequently. Exceptions shall be tions, or transactions with foreign gov- reported in accordance with ernments or foreign governmental en- § 1404.505(a). tities, public international organizations, foreign government owned (in [60 FR 33041, 33045, June 26, 1995]

207 § 1404.220 21 CFR Ch. III (4–1–99 Edition)

§ 1404.220 Continuation of covered proof that a participant did knowingly transactions. do business with a person that filed an (a) Notwithstanding the debarment, erroneous certification. suspension, proposed debarment under [60 FR 33041, 33045, June 26, 1995] 48 CFR part 9, subpart 9.4, determination of ineligibility, or voluntary ex- Subpart C—Debarment clusion of any person by an agency, agencies and participants may con- § 1404.300 General. tinue covered transactions in existence The debarring official may debar a at the time the person was debarred, person for any of the causes in suspended, proposed for debarment § 1404.305, using procedures established under 48 CFR part 9, subpart 9.4, de- in §§ 1404.310 through 1404.314. The exist- clared ineligible, or voluntarily ex- ence of a cause for debarment, how- cluded. A decision as to the type of ter- ever, does not necessarily require that mination action, if any, to be taken the person be debarred; the seriousness should be made only after thorough re- of the person’s acts or omissions and view to ensure the propriety of the pro- any mitigating factors shall be consid- posed action. ered in making any debarment deci- (b) Agencies and participants shall sion. not renew or extend covered transactions (other than no-cost time exten- § 1404.305 Causes for debarment. sions) with any person who is debarred, suspended, proposed for debarment Debarment may be imposed in ac- under 48 CFR part 9, subpart 9.4, ineli- cordance with the provisions of gible or voluntary excluded, except as § 1404.300 through § 1404.314 for: provided in § 1404.215. (a) Conviction of or civil judgment for: [60 FR 33041, 33045, June 26, 1995] (1) Commission of fraud or a criminal offense in connection with obtaining, § 1404.225 Failure to adhere to restric- attempting to obtain, or performing a tions. public or private agreement or trans- (a) Except as permitted under action; § 1404.215 or § 1404.220, a participant (2) Violation of Federal or State anti- shall not knowingly do business under trust statutes, including those pro- a covered transaction with a person scribing price fixing between competi- who is— tors, allocation of customers between (1) Debarred or suspended; competitors, and bid rigging; (2) Proposed for debarment under 48 (3) Commission of embezzlement, CFR part 9, subpart 9.4; or theft, forgery, bribery, falsification or (3) Ineligible for or voluntarily ex- destruction of records, making false cluded from the covered transaction. statements, receiving stolen property, (b) Violation of the restriction under making false claims, or obstruction of paragraph (a) of this section may re- justice; or sult in disallowance of costs, annul- (4) Commission of any other offense ment or termination of award, issuance indicating a lack of business integrity of a stop work order, debarment or sus- or business honesty that seriously and pension, or other remedies as appro- directly affects the present responsi- priate. bility of a person. (c) A participant may rely upon the (b) Violation of the terms of a public certification of a prospective partici- agreement or transaction so serious as pant in a lower tier covered trans- to affect the integrity of an agency action that it and its principals are not program, such as: debarred, suspended, proposed for de- (1) A willful failure to perform in ac- barment under 48 CFR part 9, subpart cordance with the terms of one or more 9.4, ineligible, or voluntarily excluded public agreements or transactions; from the covered transaction (See ap- (2) A history of failure to perform or pendix B of these regulations), unless it of unsatisfactory performance of one or knows that the certification is erro- more public agreements or trans- neous. An agency has the burden of actions; or

208 Office of National Drug Control Policy § 1404.314

(3) A willful violation of a statutory § 1404.312 Notice of proposed debar- or regulatory provision or requirement ment. applicable to a public agreement or A debarment proceeding shall be ini- transaction. tiated by notice to the respondent ad- (c) Any of the following causes: vising: (1) A nonprocurement debarment by (a) That debarment is being consid- any Federal agency taken before Octo- ered; ber 1, 1988, or a procurement debarment (b) Of the reasons for the proposed by any Federal agency taken pursuant debarment in terms sufficient to put to 48 CFR subpart 9.4; the respondent on notice of the con- (2) Knowingly doing business with a duct or transaction(s) upon which it is based; debarred, suspended, ineligible, or vol- (c) Of the cause(s) relied upon under untarily excluded person, in connection § 1404.305 for proposing debarment; with a covered transaction, except as (d) Of the provisions of §§ 1404.311 permitted in § 1404.215 or § 1404.220; through 1404.314, and any other ONDCP (3) Failure to pay a single substantial procedures, if applicable, governing de- debt, or a number of outstanding debts barment decision making; and (including disallowed costs and over- (e) Of the potential effect of a debar- payments, but not including sums owed ment. the Federal Government under the In- ternal Revenue Code) owed to any Fed- § 1404.313 Opportunity to contest pro- eral agency or instrumentality, proposed debarment. vided the debt is uncontested by the (a) Submission in opposition. Within 30 debtor or, if contested, provided that days after receipt of the notice of pro- the debtor’s legal and administrative posed debarment, the respondent may remedies have been exhausted; submit, in person, in writing, or (4) Violation of a material provision through a representative, information and argument in opposition to the proof a voluntary exclusion agreement en- posed debarment. tered into under § 1404.315 or of any set- (b) Additional proceedings as to dis- tlement of a debarment or suspension puted material facts. (1) In actions not action; or based upon a conviction or civil judg- (5) Violation of any requirement of ment, if the debarring official finds Subpart F of this part relating to pro- that the respondent’s submission in op- viding a drug-free workplace, as set position raises a genuine dispute over forth in § 1404.615 of this part. facts material to the proposed debar- (d) Any other cause of so serious or ment, respondent(s) shall be afforded compelling a nature that it affects the an opportunity to appear with a rep- present responsibility of a person. resentative, submit documentary evidence, present witnesses, and confront § 1404.310 Procedures. any witness the agency presents. ONDCP shall process debarment ac- (2) A transcribed record of any additions as informally as practicable, con- tional proceedings shall be made avail- sistent with the principles of funda- able at cost to the respondent, upon request, unless the respondent and the mental fairness, using the procedures agency, by mutual agreement, waive in § 1404.311 through § 1404.314. the requirement for a transcript.

§ 1404.311 Investigation and referral. § 1404.314 Debarring official’s decision. Information concerning the existence (a) No additional proceedings necessary. of a cause for debarment from any In actions based upon a conviction or source shall be promptly reported, in- civil judgment, or in which there is no vestigated, and referred, when appro- genuine dispute over material facts, priate, to the debarring official for con- the debarring official shall make a de- sideration. After consideration, the decision on the basis of all the informa- barring official may issue a notice of tion in the administrative record, in- proposed debarment. cluding any submission made by the respondent. The decision shall be made

209 § 1404.315 21 CFR Ch. III (4–1–99 Edition) within 45 days after receipt of any in- to a subsequent imposition of debar- formation and argument submitted by ment by any other agency. the respondent, unless the debarring official extends this period for good § 1404.315 Settlement and voluntary cause. exclusion. (b) Additional proceedings necessary. (a) When in the best interest of the (1) In actions in which additional pro- Government, ONDCP may, at any time, ceedings are necessary to determine settle a debarment or suspension ac- disputed material facts, written find- tion. ings of fact shall be prepared. The de- (b) If a participant and the agency barring official shall base the decision agree to a voluntary exclusion of the on the facts as found, together with participant, such voluntary exclusion any information and argument sub- shall be entered on the Nonprocure- mitted by the respondent and any ment List (see Subpart E of this part). other information in the administrative record. § 1404.320 Period of debarment. (2) The debarring official may refer disputed material facts to another offi- (a) Debarment shall be for a period cial for findings of fact. The debarring commensurate with the seriousness of official may reject any such findings, the causes(s). If a suspension precedes a in whole or in part, only after specifi- debarment, the suspension period shall cally determining them to be arbitrary be considered in determining the de- and capricious or clearly erroneous. barment period. (3) The debarring official’s decision (1) Debarment for causes other than shall be made after the conclusion of those related to a violation of the re- the proceedings with respect to dis- quirements of Subpart F of this part puted facts. generally should not exceed three (c)(1) Standard of proof. In any debar- years. When circumstances warrant, a ment action, the cause for debarment longer period of debarment may be im- must be established by a preponderance posed. of the evidence. Where the proposed de- (2) In the case of a debarment for a barment is based upon a conviction or violation of the requirement of Subpart civil judgment, the standard shall be F of this part (see § 1404.305.(c)(5)), the deemed to have been met. period of debarment shall not exceed (2) Burden of proof. The burden of five years. proof is on the agency proposing debar- (b) The debarring official may extend ment. an existing debarment for an addi- (d) Notice of debarring official’s deci- tional period, if that official deter- sion. (1) If the debarring official decides mines that an extension is necessary to to impose debarment, the respondent protect the public interest. However, a shall be given prompt notice: debarment may not be extended solely (i) Referring to the notice of proposed on the basis of the facts and cir- debarment; cumstances upon which the initial de- (ii) Specifying the reasons for debar- barment action was based. If debarment; (iii) Stating the period of debarment, ment for an additional period is deter- including effective dates; and mined to be necessary, the procedures (iv) Advising that the debarment is of § 1404.311 through § 1404.314 shall be effective for covered transactions followed to extend the debarment. throughout the executive branch of the (c) The respondent may request the Federal Government unless an agency debarring official to reverse the debar- head or an authorized designee makes ment decision or to reduce the period the determination referred to in or scope of debarment. Such a request § 1404.215. shall be in writing and supported by (2) If the debarring official decides documentation. The debarring official not to impose debarment, the respond- may grant such a request for reasons ent shall be given prompt notice of including, but not limited to: that decision. A decision not to impose (1) Newly discovered material evi- debarment shall be without prejudice dence;

210 Office of National Drug Control Policy § 1404.405

(2) Reversal of the conviction or civil pant in a joint venture, grant pursuant judgment upon which the debarment to a joint application, or similar ar- was based; rangement may be imputed to other (3) Bona fide change in ownership or participants if the conduct occurred for management; or on behalf of the joint venture, grant (4) Elimination of other causes for pursuant to a joint application, or which the debarment was imposed; or similar arrangement may be imputed (5) Other reasons the debarring offi- to other participants if the conduct oc- cial deems appropriate. curred for or on behalf of the joint ven- § 1404.325 Scope of debarment. ture, grant pursuant to a joint application, or similar arrangement or with (a) Scope in general. (1) Debarment of the knowledge, approval, or acquies- a person under these regulations con- cence of these participants. Acceptance stitutes debarment of all its divisions of the benefits derived from the con- and other organizational elements from all covered transactions, unless duct shall be evidence of such knowl- the debarment decision is limited by edge, approval, or acquiescence. its terms to one or more specifically identified individuals, divisions or Subpart D—Suspension other organizational elements or to specific types of transactions. § 1404.400 General. (2) The debarment action may in- (a) The suspending official may sus- clude any affiliate of the participant pend a person for any of the causes in that is specifically named and given § 1404.405 using procedures established notice of the proposed debarment and in § 1404.410 through § 1404.413. an opportunity to respond (see § 1404.311 (b) Suspension is a serious action to through § 1404.314). be imposed only when: (b) Imputing conduct. For purposes of (1) There exists adequate evidence of determining the scope of debarment, conduct may be imputed as follows: one or more of the causes set out in (1) Conduct imputed to participant. The § 1404.405, and fraudulent, criminal or other seriously (2) Immediate action is necessary to improper conduct of any officer, direc- protect the public interest. tor, shareholder, partner, employee, or (c) In assessing the adequacy of the other individual associated with a par- evidence, the agency should consider ticipant may be imputed to the partici- how much information is available, pant when the conduct occurred in con- how credible it is given the cir- nection with the individual’s perform- cumstances, whether or not important ance of duties for or on behalf of the allegations are corroborated, and what participant, or with the participant’s inferences can reasonably be drawn as knowledge, approval, or acquiescence. a result. This assessment should in- The participant’s acceptance of the clude an examination of basic docu- benefits derived from the conduct shall ments such as grants, cooperative be evidence of such knowledge, ap- agreements, loan authorizations, and proval, or acquiescence. contracts. (2) Conduct imputed to individuals associated with participant. The fraudulent, § 1404.405 Causes for suspension. criminal, or other seriously improper (a) Suspension may be imposed in ac- conduct of a participant may be im- cordance with the provisions of puted to any officer, director, shareholder, partner, employee, or other in- § 1404.400 through § 1404.413 upon ade- dividual associated with the partici- quate evidence: pant who participated in, knew of, or (1) To suspect the commission of an had reason to know of the participant’s offense listed in § 1404.305(a); or conduct. (2) That a cause for debarment under (3) Conduct of one participant imputed § 1404.305 may exist. to other participants in a joint venture. (b) Indictment shall constitute ade- The fraudulent, criminal, or other seri- quate evidence for purposes of suspen- ously improper conduct of one partici- sion actions.

211 § 1404.410 21 CFR Ch. III (4–1–99 Edition)

§ 1404.410 Procedures. the suspension, respondent(s) shall be (a) Investigation and referral. Informa- afforded an opportunity to appear with tion concerning the existence of a a representative, submit documentary cause for suspension from any source evidence, present witnesses, and con- shall be promptly reported, inves- front any witness the agency presents, tigated, and referred, when appro- unless: priate, to the suspending official for (i) The action is based on an indict- consideration. After consideration, the ment, conviction or civil judgment, or suspending official may issue a notice (ii) A determination is made, on the of suspension. basis of Department of Justice advice, (b) Decision making process. ONDCP that the substantial interests of the shall process suspension actions as in- Federal Government in pending or con- formally as practicable, consistent templated legal proceedings based on with principles of fundamental fair- the same facts as the suspension would ness, using the procedures in § 1404.411 be prejudiced. through § 1404.413. (2) A transcribed record of any addi- § 1404.411 Notice of suspension. tional proceedings shall be prepared and made available at cost to the re- When a respondent is suspended, no- spondent, upon request, unless the re- tice shall immediately be given: spondent and the agency, by mutual (a) That suspension has been imposed; agreement, waive the requirement for a (b) That the suspension is based on transcript. an indictment, conviction, or other § 1404.413 Suspending official’s deci- adequate evidence that the respondent sion. has committed irregularities seriously reflecting on the propriety of further The suspending official may modify Federal Government dealings with the or terminate the suspension (for exam- respondent; ple, see § 1404.320(c) for reasons for re- (c) Describing any such irregularities ducing the period or scope of debar- in terms sufficient to put the respond- ment) or may leave it in force. How- ent on notice without disclosing the ever, a decision to modify or terminate Federal Government’s evidence; the suspension shall be without preju- (d) Of the cause(s) relied upon under dice to the subsequent imposition of § 1404.405 for imposing suspension; suspension by any other agency or de- (e) That the suspension is for a tem- barment by any agency. The decision porary period pending the completion shall be rendered in accordance with of an investigation or ensuing legal, de- the following provisions: barment, or Program Fraud Civil Rem- (a) No additional proceedings necessary. edies Act proceedings; In actions: based on an indictment, (f) Of the provisions of § 1404.411 conviction, or civil judgment; in which through § 1404.413 and any other ONDCP there is no genuine dispute over mate- procedures, if applicable, governing rial facts; or in which additional pro- suspension decision making; and (g) Of the effect of the suspension. ceedings to determine disputed material facts have been denied on the basis § 1404.412 Opportunity to contest sus- of Department of Justice advice, the pension. suspending official shall make a deci- (a) Submission in opposition. Within 30 sion on the basis of all the information days after receipt of the notice of sus- in the administrative record, including pension, the respondent may submit, in any submission made by the respond- person, in writing, or through a rep- ent. The decision shall be made within resentative, information and argument 45 days after receipt of any information in opposition to the suspension. and argument submitted by the re- (b) Additional proceedings as to dis- spondent, unless the suspending official puted material facts. (1) If the sus- extends this period for good cause. pending official finds that the respond- (b) Additoinal proceedings necessary. ent’s submission in opposition raises a (1) In actions in which additional pro- genuine dispute over facts material to ceedings are necessary to determine

212 Office of National Drug Control Policy § 1404.505 disputed material facts, written find- Subpart E—Responsibilities of GSA, ings of fact shall be prepared. The sus- Agency and Participants pending official shall base the decision on the facts as found, together with § 1404.500 GSA responsibilities. any information and argument sub- (a) In accordance with the OMB mitted by the respondent and any guidelines, GSA shall compile, main- other information in the administra- tain, and distribute a list of all persons tive record. who have been debarred, suspended, or (2) The suspending official may refer voluntarily excluded by agencies under matters involving disputed material Executive Order 12549 and these regula- facts to another official for findings of tions, and those who have been deter- fact. The suspending official may re- mined to be ineligible. ject any such findings, in whole or in (b) At a minimum, this list shall in- part, only after specifically deter- dicate: mining them to be arbitrary or capri- (1) The names and addresses of all debarred, suspended, ineligible, and cious or clearly erroneous. voluntarily excluded persons, in alpha- (c) Notice of suspending official’s deci- betical order, with cross-references sion. Prompt written notice of the sus- when more than one name is involved pending official’s decision shall be sent in a single action; to the respondent. (2) The type of action; (3) The cause for the action; § 1404.415 Period of suspension. (4) The scope of the action; (a) Suspension shall be for a tem- (5) Any termination date for each porary period pending the completion listing; and of an investigation or ensuing legal, de- (6) The agency and name and tele- barment, or Program Fraud Civil Rem- phone number of the agency point of edies Act proceedings, unless termi- contact for the action. nated sooner by the suspending official § 1404.505 ONDCP responsibilities. or as provided in paragraph (b) of this section. (a) The agency shall provide GSA with current information concerning (b) If legal or administrative pro- debarments, suspension, determina- ceedings are not initiated within 12 tions of ineligibility, and voluntary ex- months after the date of the suspension clusions it has taken. notice, the suspension shall be termi- (b) Unless an alternative schedule is nated unless an Assistant Attorney agreed to by GSA, the agency shall ad- General or United States Attorney re- vise GSA of the information set forth quests its extension in writing, in in § 1404.500(b) and of the exceptions which case it may be extended for an granted under § 1404.215 within five additional six months. In no event may working days after taking such ac- a suspension extend beyond 18 months, tions. unless such proceedings have been ini- (c) The agency shall direct inquiries tiated within that period. concerning listed persons to the agency (c) The suspending official shall no- that took the action. tify the Department of Justice of an (d) Agency officials shall check the impending termination of a suspension, Nonprocurement List before entering at least 30 days before the 12-month pe- covered transactions to determine riod expires, to give that Department whether a participant in a primary an opportunity to request an exten- transaction is debarred, suspended, in- sion. eligible, or voluntarily excluded (Tel. #1B). § 1404.420 Scope of suspension. (e) Agency officials shall check the Nonprocurement List before approving The scope of a suspension is the same principals or lower tier participants as the scope of a debarment (see where agency approval of the principal § 1404.325), except that the procedures of or lower tier participant is required § 1404.410 through § 1404.413 shall be used under the terms of the transaction, to in imposing a suspension. determine whether such principals or

213 § 1404.510 21 CFR Ch. III (4–1–99 Edition) participants are debarred, suspended, ticipants in lower tier covered trans- ineligible, or voluntarily excluded. actions shall provide the same updated notice to the participant to which it § 1404.510 Participants’ responsibil- submitted its proposals. ities. (a) Certification by participants in pri- Subpart F—Drug-Free Workplace mary covered transactions. Each partici- Requirements (Grants) pant shall submit the certification in appendix A to this part for it and its § 1404.600 Purpose. principals at the time the participant (a) The purpose of this subpart is to submits its proposal in connection with carry out the Drug-Free Workplace Act a primary covered transaction, except of 1988 by requiring that— that States need only complete such (1) A grantee, other than an indi- certification as to their principals. vidual, shall certify to the agency that Participants may decide the method it will provide a drug-free workplace; and frequency by which they determine (2) A grantee who is an individual the eligibility of their principals. In shall certify to the agency that, as a addition, each participant may, but is condition of the grant, he or she will not required to, check the Nonprocure- not engage in the unlawful manufac- ment List for its principals. Adverse ture, distribution, dispensing, posses- information on the certification will sion or use of a controlled substance in not necessarily result in denial of par- conducting any activity with the ticipation. However, the certification, grant. and any additional information per- (b) Requirements implementing the taining to the certification submitted Drug-Free Workplace Act of 1988 for by the participant, shall be considered contractors with the agency are found in the administration of covered trans- at 48 CFR subparts 9.4, 23.5, and 52.2. actions. (b) Certification by participants in § 1404.605 Definitions. lower tier covered transactions. (1) Each (a) Except as amended in this sec- participant shall require participants tion, the definitions of § 1404.105 apply in lower tier covered transactions to to this subpart. include the certification in Appendix B (b) For purposes of this subpart— to this Part for it and its principals in (1) Controlled substance means a con- any proposal submitted in connection trolled substance in schedules I with such lower tier covered trans- through V of the Controlled Substances actions. Act (21 U.S.C. 812), and as further de- (2) A participant may rely upon the fined by regulation at 21 CFR 1308.11 certification of a prospective partici- through 1308.15; pant in a lower tier covered trans- (2) Conviction means a finding of guilt action that it and its principals are not (including a plea of nolo contendere) or debarred, suspended, ineligible, or vol- imposition of sentence, or both, by any untarily excluded from the covered judicial body charged with the respon- transaction by any Federal agency, un- sibility to determine violations of the less it knows that the certification is Federal or State criminal drug stat- erroneous. Participants may decide the utes; method and frequency by which they (3) Criminal drug statute means a Fed- determine the eligibility of their prin- eral or non-Federal criminal statute cipals. In addition, a participant may, involving the manufacture, distribu- but is not required to, check the Non- tion, dispensing, use, or possession of procurement List for its principals and any controlled substance; for participants. (4) Drug-free workplace means a site (c) Changed circumstances regarding for the performance of work done in certification. A participant shall provide connection with a specific grant at immediate written notice to ONDCP if which employees of the grantee are at any time the participant learns that prohibited from engaging in the unlaw- its certification was erroneous when ful manufacture, distribution, dis- submitted or has become erroneous by pensing, possession, or use of a con- reason of changed circumstances. Par- trolled substance;

214 Office of National Drug Control Policy § 1404.615

(5) Employee means the employee of a lumbia, the Commonwealth of Puerto grantee directly engaged in the per- Rico, any territory or possession of the formance of work under the grant, in- United States, or any agency of a cluding: State, exclusive of institutions of high- (i) All direct charge employees; er education, hospitals, and units of (ii) All indirect charge employees, un- local government. A State instrumen- less their impact or involvement is in- tality will be considered part of the significant to the performance of the State government if it has a written grant; and, determination from a State govern- (iii) Temporary personnel and con- ment that such State considers the in- sultants who are directly engaged in strumentality to be an agency of the the performance of work under the State government. grant and who are on the grantee’s payroll. This definition does not in- § 1404.610 Coverage. clude workers not on the payroll of the (a) This subpart applies to any grant- grantee (e.g., volunteers, even if used ee of the agency. to meet a matching requirement; con- (b) This subpart applies to any grant, sultants or independent contractors except where application of this sub- not on the payroll; or employees of part would be inconsistent with the subrecipients or subcontractors in cov- international obligations of the United ered workplaces); States or the laws or regulations of a (6) Federal agency or agency means foreign government. A determination any United States executive depart- of such inconsistency may be made ment, military department, govern- only by the agency head or his/her des- ment corporation, government con- ignee. trolled corporation, any other estab- (c) The provisions of subparts A, B, C, lishment in the executive branch (in- D and E of this part apply to matters cluding the Executive Office of the covered by this subpart, except where President), or any independent regu- specifically modified by this subpart. latory agency; In the event of any conflict between (7) Grant means an award of financial provisions of this subpart and other assistance, including a cooperative provisions of this part, the provisions agreement, in the form of money, or of this subpart are deemed to control property in lieu of money, by a Federal with respect to the implementation of agency directly to a grantee. The term drug-free workplace requirements con- grant includes block grant and entitle- cerning grants. ment grant programs, whether or not exempted from coverage under the § 1404.615 Grounds for suspension of grants management government gov- payments, suspension or termi- ernment-wide common rule on uniform nation of grants, or suspension or administrative requirements for grants debarment. and cooperative agreements. The term A grantee shall be deemed in viola- does not include technical assistance tion of the requirements of this sub- that provides services instead of part if the agency head or his or her of- money, or other assistance in the form ficial designee determines, in writing, of loans, loan guarantees, interest sub- that— sidies, insurance, or direct appropria- (a) The grantee has made a false cer- tions; or any veterans’ benefits to indi- tification under § 1404.630; viduals, i.e., any benefit to veterans, (b) With respect to a grantee other their families, or survivors by virtue of than an individual— the service of a veteran in the Armed (1) The grantee has violated the cer- Forces of the United States; tification by failing to carry out the (8) Grantee means a person who ap- requirements of subparagraphs (A)(a)– plies for or receives a grant directly (g) and/or (B) of the certification (Al- from a Federal agency (except another ternate I to Appendix C); or Federal agency); (2) Such a member of employees of (9) Individual means a natural person; the grantee have been convicted of vio- (10) State means any of the States of lations of criminal drug statutes for the United States, the District of Co- violations occurring in the workplace

215 § 1404.620 21 CFR Ch. III (4–1–99 Edition) as to indicate that the grantee has before March 18, 1989, or under a no- failed to make a good faith effort to cost time extension of such a grant. provide a drug-free workplace. However, the grantee shall make a one- (c) With respect to a grantee who is time drug-free workplace certification an individual— for a non-automatic continuation of (1) The grantee has violated the cer- such a grant made on or after March tification by failing to carry out its re- 18, 1989. quirements (Alternate II to Appendix (b) Except as provided in this section, C); or all grantees shall make the required (2) The grantee is convicted of a certification for each grant. For man- criminal drug offense resulting from a datory formula grants and entitle- violation occurring during the conduct ments that have no application proc- of any grant activity. ess, grantees shall submit a one-time certification in order to continue re- § 1404.620 Effect of violation. ceiving awards. (a) In the event of a violation of this (c) A grantee that is a State may subpart as provided in § 1404.615, and in elect to make one certification in each accordance with applicable law, the Federal fiscal year. States that pre- grantee shall be subject to one or more viously submitted an annual certifi- of the following actions: cation are not required to make a cer- (1) Suspension of payments under the tification for Fiscal Year 1990 until grant; June 30, 1990. Except as provided in (2) Suspension or termination of the paragraph (d) of this section, this cer- grant; and tification shall cover all grants to all (3) Suspension or debarment of the State agencies from any Federal agen- grantee under the provisions of this cy. The State shall retain the original part. of this statewide certification in its (b) Upon issuance of any final deci- Governor’s office and, prior to grant sion under this part requiring debar- award, shall ensure that a copy is sub- ment of a grantee, the debarred grant- mitted individually with respect to ee shall be ineligible for award of any each grant, unless the Federal agency grant from any Federal agency for a had designated a central location for period specified in the decision, not to submission. exceed five years (see § 1404.320(a)(2) of (d)(1) The Governor of a State may this part). exclude certain State agencies from the statewide certification and author- § 1404.625 Exception provision. ize these agencies to submit their own The agency head may waive with re- certifications to Federal agencies. The spect to a particular grant, in writing, statewide certification shall name any a suspension of payments under a State agencies so excluded. grant, suspension or termination of a (2) A State agency to which the grant, or suspension or debarment of a statewide certification does not apply, grantee if the agency head determines or a State agency in a State that does that such a waiver would be in the pub- not have a statewide certification, may lic interest. This exception authority elect to make one certification in each cannot be delegated to any other offi- Federal fiscal year. State agencies that cial. previously submitted a State agency certification are not required to make § 1404.630 Certification requirements a certification for Fiscal Year 1990 and procedures. until June 30, 1990. The State agency (a)(1) As a prior condition of being shall retain the original of this State awarded a grant, each grantee shall agency-wide certification in its central make the appropriate certification to office and, prior to grant award, shall the Federal agency providing the ensure that a copy is submitted indi- grant, as provided in Appendix C to vidually with respect to each grant, this part. unless the Federal agency designates a (2) Grantees are not required to make central location for submission. a certification in order to continue re- (3) When the work of a grant is done ceiving funds under a grant awarded by more than one State agency, the

216 Office of National Drug Control Policy Pt. 1404, App. A certification of the State agency di- (b) A grantee who is an individual rectly receiving the grant shall be who is convicted for a violation of a deemed to certify compliance for all criminal drug statute occurring during workplaces, including those located in the conduct of any grant activity shall other State agencies. report the conviction, in writing, with- (e)(1) For a grant of less than 30 days in 10 calendar days, to his or her Fed- performance duration, grantees shall eral agency grant officer, or other des- have this policy statement and pro- ignee, unless the Federal agency has gram in place as soon as possible, but designated a central point for the rein any case by a date prior to the date ceipt of such notices. Notification shall on which performance is expected to be include the identification number(s) completed. for each of the Federal agency’s af- (2) For a grant of 30 days or more per- fected grants. formance duration, grantees shall have this policy statement and program in APPENDIX A TO PART 1404—CERTIFI- place within 30 days after award. CATION REGARDING DEBARMENT, (3) Where extraordinary cir- SUSPENSION, AND OTHER RESPONSI- cumstances warrant for a specific BILITY MATTERS—PRIMARY COVERED grant, the grant officer may determine TRANSACTIONS a different date on which the policy Instructions for Certification statement and program shall be in place. 1. By signing and submitting this proposal, the prospective primary participant is pro- § 1404.635 Reporting of and employee viding the certification set out below. sanctions for convictions of crimi- 2. The inability of a person to provide the nal drug offenses. certification required below will not necessarily result in denial of participation in (a) When a grantee other than an in- this covered transaction. The prospective dividual is notified that an employee participant shall submit an explanation of has been convicted for a violation of a why it cannot provide the certification set criminal drug statute occurring in the out below. The certification or explanation workplace, it shall take the following will be considered in connection with the department or agency’s determination whether actions: to enter into this transaction. However, fail- (1) Within 10 calendar days of receiv- ure of the prospective primary participant to ing notice of the conviction, the grant- furnish a certification or an explanation ee shall provide written notice, includ- shall disqualify such person from participa- ing the convicted employee’s position tion in this transaction. title, to every grant officer, or other 3. The certification in this clause is a ma- designee on whose grant activity the terial representation of fact upon which reli- convicted employee was working, un- ance was placed when the department or agency determined to enter into this trans- less a Federal agency has designated a action. If it is later determined that the pro- central point for the receipt of such no- spective primary participant knowingly ren- tifications. Notification shall include dered an erroneous certification, in addition the identification number(s) for each of to other remedies available to the Federal the Federal agency’s affected grants. Government, the department or agency may (2) Within 30 calendar days of receiv- terminate this transaction for cause or de- ing notice of the conviction, the grant- fault. ee shall do the following with respect 4. The prospective primary participant shall provide immediate written notice to to the employee who was convicted: the department or agency to which this pro- (i) Take appropriate personnel action posal is submitted if at any time the pro- against the employee, up to and includ- spective primary participant learns that its ing termination, consistent with re- certification was erroneous when submitted quirements of the Rehabilitation Act or has become erroneous by reason of of 1973, as amended; or changed circumstances. (ii) Require the employee to partici- 5. The terms covered transaction, debarred, pate satisfactorily in a drug abuse as- suspended, ineligible, lower tier covered transaction, participant, person, primary covered sistance or rehabilitation program ap- transaction, principal, proposal, and volun- proved for such purposes by a Federal, tarily excluded, as used in this clause, have State, or local health, law enforce- the meanings set out in the Definitions and ment, or other appropriate agency. Coverage sections of the rules implementing

217 Pt. 1404, App. B 21 CFR Ch. III (4–1–99 Edition)

Executive Order 12549. You may contact the Certification Regarding Debarment, Suspension, department or agency to which this proposal and Other Responsibility Matters—Primary is being submitted for assistance in obtain- Covered Transactions ing a copy of those regulations. (1) The prospective primary participant 6. The prospective primary participant certifies to the best of its knowledge and be- agrees by submitting this proposal that, lief, that it and its principals: should the proposed covered transaction be (a) Are not presently debarred, suspended, entered into, it shall not knowingly enter proposed for debarment, declared ineligible, into any lower tier covered transaction with or voluntarily excluded by any Federal de- a person who is proposed for debarment partment or agency; under 48 CFR part 9, subpart 9.4, debarred, (b) Have not within a three-year period suspended, declared ineligible, or voluntarily preceding this proposal been convicted of or excluded from participation in this covered had a civil judgment rendered against them transaction, unless authorized by the depart- for commission of fraud or a criminal offense ment or agency entering into this trans- in connection with obtaining, attempting to obtain, or performing a public (Federal, action. State or local) transaction or contract under 7. The prospective primary participant fur- a public transaction; violation of Federal or ther agrees by submitting this proposal that State antitrust statutes or commission of it will include the clause titled ‘‘Certifi- embezzlement, theft, forgery, bribery, fal- cation Regarding Debarment, Suspension, sification or destruction of records, making Ineligibility and Voluntary Exclusion-Lower false statements, or receiving stolen prop- Tier Covered Transaction,’’ provided by the erty; department or agency entering into this cov- (c) Are not presently indicted for or other- ered transaction, without modification, in wise criminally or civilly charged by a gov- all lower tier covered transactions and in all ernmental entity (Federal, State or local) solicitations for lower tier covered trans- with commission of any of the offenses enu- actions. merated in paragraph (1)(b) of this certifi- 8. A participant in a covered transaction cation; and may rely upon a certification of a prospec- (d) Have not within a three-year period tive participant in a lower tier covered preceding this application/proposal had one transaction that it is not proposed for debar- or more public transactions (Federal, State ment under 48 CFR part 9, subpart 9.4, or local) terminated for cause or default. (2) Where the prospective primary partici- debarred, suspended, ineligible, or volun- pant is unable to certify to any of the state- tarily excluded from the covered trans- ments in this certification, such prospective action, unless it knows that the certification participant shall attach an explanation to is erroneous. A participant may decide the this proposal. method and frequency by which it determines the eligibility of its principals. Each [60 FR 33042, 33045, June 26, 1995] participant may, but is not required to, check the List of Parties Excluded from Fed- APPENDIX B TO PART 1404—CERTIFI- eral Procurement and Nonprocurement Pro- CATION REGARDING DEBARMENT, grams. SUSPENSION, INELIGIBILITY AND VOL- 9. Nothing contained in the foregoing shall UNTARY EXCLUSION—LOWER TIER be construed to require establishment of a COVERED TRANSACTIONS system of records in order to render in good Instructions for Certification faith the certification required by this clause. The knowledge and information of a 1. By signing and submitting this proposal, participant is not required to exceed that the prospective lower tier participant is pro- which is normally possessed by a prudent viding the certification set out below. person in the ordinary course of business 2. The certification in this clause is a ma- dealings. terial representation of fact upon which reli- 10. Except for transactions authorized ance was placed when this transaction was entered into. If it is later determined that under paragraph 6 of these instructions, if a the prospective lower tier participant know- participant in a covered transaction knowingly rendered an erroneous certification, in ingly enters into a lower tier covered trans- addition to other remedies available to the action with a person who is proposed for de- Federal Government the department or barment under 48 CFR part 9, subpart 9.4, agency with which this transaction origi- suspended, debarred, ineligible, or volun- nated may pursue available remedies, includ- tarily excluded from participation in this ing suspension and/or debarment. transaction, in addition to other remedies 3. The prospective lower tier participant available to the Federal Government, the de- shall provide immediate written notice to partment or agency may terminate this the person to which this proposal is sub- transaction for cause or default. mitted if at any time the prospective lower

218 Office of National Drug Control Policy Pt. 1404, App. C tier participant learns that its certification dition to other remedies available to the was erroneous when submitted or had be- Federal Government, the department or come erroneous by reason of changed cir- agency with which this transaction origi- cumstances. nated may pursue available remedies, includ- 4. The terms covered transaction, debarred, ing suspension and/or debarment. suspended, ineligible, lower tier covered transaction, participant, person, primary covered Certification Regarding Debarment, Suspension, transaction, principal, proposal, and volun- Ineligibility an Voluntary Exclusion—Lower tarily excluded, as used in this clause, have Tier Covered Transactions the meaning set out in the Definitions and (1) The prospective lower tier participant Coverage sections of rules implementing Ex- certifies, by submission of this proposal, that ecutive Order 12549. You may contact the neither it nor its principals is presently person to which this proposal is submitted debarred, suspended, proposed for debarment, for assistance in obtaining a copy of those declared ineligible, or voluntarily excluded regulations. from participation in this transaction by any 5. The prospective lower tier participant Federal department or agency. agrees by submitting this proposal that, (2) Where the prospective lower tier partic- should the proposed covered transaction be ipant is unable to certify to any of the state- entered into, it shall not knowingly enter ments in this certification, such prospective into any lower tier covered transaction with participant shall attach an explanation to a person who is proposed for debarment this proposal. under 48 CFR part 9, subpart 9.4, debarred, suspended, declared ineligible, or voluntarily [60 FR 33042, 33045, June 26, 1995] excluded from participation in this covered transaction, unless authorized by the depart- APPENDIX C TO PART 1404—CERTIFI- ment or agency with which this transaction CATION REGARDING DRUG-FREE originated. WORKPLACE REQUIREMENTS 6. The prospective lower tier participant further agrees by submitting this proposal Instructions for Certification that it will include this clause titled ‘‘Cer- 1. By signing and/or submitting this appli- tification Regarding Debarment, Suspension, cation or grant agreement, the grantee is Ineligibility and Voluntary Exclusion-Lower providing the certification set out below. Tier Covered Transaction,’’ without modi- 2. The certification set out below is a ma- fication, in all lower tier covered trans- terial representation of fact upon which reli- actions and in all solicitations for lower tier ance is placed when the agency awards the covered transactions. grant. If it is later determined that the 7. A participant in a covered transaction grantee knowingly rendered a false certifi- may rely upon a certification of a prospec- cation, or otherwise violates the require- tive participant in a lower tier covered ments of the Drug-Free Workplace Act, the transaction that it is not proposed for debar- agency, in addition to any other remedies ment under 48 CFR part 9, subpart 9.4, available to the Federal Government, may debarred, suspended, ineligible, or volun- take action authorized under the Drug-Free tarily excluded from covered transactions, Workplace Act. unless it knows that the certification is erro- 3. For grantees other than individuals, Al- neous. A participant may decide the method ternate I applies. and frequency by which it determines the 4. For grantees who are individuals, Alter- eligibility of its principals. Each participant nate II applies. may, but is not required to, check the List of 5. Workplaces under grants, for grantees Parties Excluded from Federal Procurement other than individuals, need not be identified and Nonprocurement Programs. on the certification. If known, they may be 8. Nothing contained in the foregoing shall identified in the grant application. If the be construed to require establishment of a grantee does not identify the workplaces at system of records in order to render in good the time of application, or upon award, if faith the certification required by this there is no application, the grantee must clause. The knowledge and information of a keep the identity of the workplace(s) on file participant is not required to exceed that in its office and make the information avail- which is normally possessed by a prudent able for Federal inspection. Failure to iden- person in the ordinary course of business tify all known workplaces constitutes a vio- dealings. lation of the grantee’s drug-free workplace 9. Except for transactions authorized under requirements. paragraph 5 of these instructions, if a partic- 6. Workplace identifications must include ipant in a covered transaction knowingly en- the actual address of buildings (or parts of ters into a lower tier covered transaction buildings) or other sites where work under with a person who is proposed for debarment the grant takes place. Categorical descrip- under 48 CFR part 9, subpart 9.4, suspended, tions may be used (e.g., all vehicles of a mass debarred, ineligible, or voluntarily excluded transit authority or State highway depart- from participation in this transaction, in ad- ment while in operation, State employees in

219 Pt. 1404, App. C 21 CFR Ch. III (4–1–99 Edition)

each local unemployment office, performers (3) Any available drug counseling, rehabili- in concert halls or radio studios). tation, and employee assistance programs; 7. If the workplace identified to the agency and changes during the performance of the grant, (4) The penalties that may be imposed the grantee shall inform the agency of the upon employees for drug abuse violations oc- change(s), if it previously identified the curring in the workplace; workplaces in question (see paragraph five). (c) Making it a requirement that each em- 8. Definitions of terms in the Nonprocure- ployee to be engaged in the performance of ment Suspension and Debarment common the grant be given a copy of the statement rule and Drug-Free Workplace common rule required by paragraph (a); apply to this certification. Grantees’ atten- (d) Notifying the employee in the state- tion is called, in particular, to the following ment required by paragraph (a) that, as a definitions from these rules: condition of employment under the grant, Controlled substance means a controlled the employee will— substance in Schedules I through V of the (1) Abide by the terms of the statement; Controlled Substances Act (21 U.S.C. 812) and and as further defined by regulation (21 CFR (2) Notify the employer in writing of his or 1308.11 through 1308.15); her conviction for a violation of a criminal Conviction means a finding of guilt (including a plea of nolo contendere) or imposition drug statute occurring in the workplace no of sentence, or both, by any judicial body later than five calendar days after such con- charged with the responsibility to determine viction; violations of the Federal or State criminal (e) Notifying the agency in writing, within drug statutes; ten calendar days after receiving notice Criminal drug statute means a Federal or under subparagraph (d)(2) from an employee non-Federal criminal statute involving the or otherwise receiving actual notice of such manufacture, distribution, dispensing, use, conviction. Employers of convicted employ- or possession of any controlled substance; ees must provide notice, including position Employee means the employee of a grantee title, to every grant officer or other designee directly engaged in the performance of work on whose grant activity the convicted em- under a grant, including: (i) All ‘‘direct ployee was working, unless the Federal agen- charge’’ employees; (ii) all ‘‘indirect charge’’ cy has designated a central point for the re- employees unless their impact or involve- ceipt of such notices. Notice shall include ment is insignificant to the performance of the identification number(s) of each affected the grant; and, (iii) temporary personnel and grant; consultants who are directly engaged in the (f) Taking one of the following actions, performance of work under the grant and within 30 calendar days of receiving notice who are on the grantee’s payroll. This defini- under subparagraph (d)(2), with respect to tion does not include workers not on the any employee who is so convicted— payroll of the grantee (e.g., volunteers, even (1) Taking appropriate personnel action if used to meet a matching requirement; con- against such an employee, up to and includ- sultants or independent contractors not on ing termination, consistent with the require- the grantee’s payroll; or employees of sub- ments of the Rehabilitation Act of 1973, as recipients or subcontractors in covered amended; or workplaces). (2) Requiring such employee to participate satisfactorily in a drug abuse assistance or Certification Regarding Drug-Free Workplace rehabilitation program approved for such Requirements purposes by a Federal, State, or local health, Alternate I. (Grantees Other Than Individ- law enforcement, or other appropriate agen- uals) cy; A. The grantee certifies that it will or will (g) Making a good faith effort to continue continue to provide a drug-free workplace to maintain a drug-free workplace through by: implementation of paragraphs (a), (b), (c), (a) Publishing a statement notifying em- (d), (e) and (f). ployees that the unlawful manufacture, dis- B. The grantee may insert in the space pro- tribution, dispensing, possession, or use of a vided below the site(s) for the performance of controlled substance is prohibited in the work done in connection with the specific grantee’s workplace and specifying the ac- grant: tions that will be taken against employees for violation of such prohibition; Place of Performance (Street address, city, (b) Establishing an ongoing drug-free county, state, zip code) awareness program to inform employees llllllllllllllllllllllll about— llllllllllllllllllllllll (1) The dangers of drug abuse in the work- llllllllllllllllllllllll place; Check b if there are workplaces on file that (2) The grantee’s policy of maintaining a are not identified here. drug-free workplace; Alternate II. (Grantees Who Are Individuals)

220 Office of National Drug Control Policy Pt. 1404, App. C

(a) The grantee certifies that, as a condi- 10 calendar days of the conviction, to every tion of the grant, he or she will not engage grant officer or other designee, unless the in the unlawful manufacture, distribution, Federal agency designates a central point for dispensing, possession, or use of a controlled the receipt of such notices. When notice is substance in conducting any activity with made to such a central point, it shall include the grant; the identification number(s) of each affected (b) If convicted of a criminal drug offense grant. resulting from a violation occurring during the conduct of any grant activity, he or she will report the conviction, in writing, within PARTS 1405–1499 [RESERVED]

221 FINDING AIDS

A list of CFR titles, subtitles, chapters, subchapters and parts and an alphabetical list of agencies publishing in the CFR are included in the CFR Index and Finding Aids volume to the Code of Federal Regulations which is published separately and revised annually. Table of CFR Titles and Chapters Alphabetical List of Agencies Appearing in the CFR List of CFR Sections Affected

223

Table of CFR Titles and Chapters (Revised as of March 31, 1999)

Title 1—General Provisions

I Administrative Committee of the Federal Register (Parts 1—49) II Office of the Federal Register (Parts 50—299) IV Miscellaneous Agencies (Parts 400—500)

Title 2—[Reserved]

Title 3—The President

I Executive Office of the President (Parts 100—199)

Title 4—Accounts

I General Accounting Office (Parts 1—99) II Federal Claims Collection Standards (General Accounting Of- fice—Department of Justice) (Parts 100—299)

Title 5—Administrative Personnel

I Office of Personnel Management (Parts 1—1199) II Merit Systems Protection Board (Parts 1200—1299) III Office of Management and Budget (Parts 1300—1399) IV Advisory Committee on Federal Pay (Parts 1400—1499) V The International Organizations Employees Loyalty Board (Parts 1500—1599) VI Federal Retirement Thrift Investment Board (Parts 1600—1699) VII Advisory Commission on Intergovernmental Relations (Parts 1700—1799) VIII Office of Special Counsel (Parts 1800—1899) IX Appalachian Regional Commission (Parts 1900—1999) XI Armed Forces Retirement Home (Part 2100) XIV Federal Labor Relations Authority, General Counsel of the Fed- eral Labor Relations Authority and Federal Service Impasses Panel (Parts 2400—2499) XV Office of Administration, Executive Office of the President (Parts 2500—2599) XVI Office of Government Ethics (Parts 2600—2699) XXI Department of the Treasury (Parts 3100—3199)

225 Title 5—Administrative Personnel—Continued Chap.

XXII Federal Deposit Insurance Corporation (Part 3201) XXIII Department of Energy (Part 3301) XXIV Federal Energy Regulatory Commission (Part 3401) XXV Department of the Interior (Part 3501) XXVI Department of Defense (Part 3601) XXVIII Department of Justice (Part 3801) XXIX Federal Communications Commission (Parts 3900—3999) XXX Farm Credit System Insurance Corporation (Parts 4000—4099) XXXI Farm Credit Administration (Parts 4100—4199) XXXIII Overseas Private Investment Corporation (Part 4301) XXXV Office of Personnel Management (Part 4501) XL Interstate Commerce Commission (Part 5001) XLI Commodity Futures Trading Commission (Part 5101) XLII Department of Labor (Part 5201) XLIII National Science Foundation (Part 5301) XLV Department of Health and Human Services (Part 5501) XLVI Postal Rate Commission (Part 5601) XLVII Federal Trade Commission (Part 5701) XLVIII Nuclear Regulatory Commission (Part 5801) L Department of Transportation (Part 6001) LII Export-Import Bank of the United States (Part 6201) LIII Department of Education (Parts 6300—6399) LIV Environmental Protection Agency (Part 6401) LVII General Services Administration (Part 6701) LVIII Board of Governors of the Federal Reserve System (Part 6801) LIX National Aeronautics and Space Administration (Part 6901) LX United States Postal Service (Part 7001) LXI National Labor Relations Board (Part 7101) LXII Equal Employment Opportunity Commission (Part 7201) LXIII Inter-American Foundation (Part 7301) LXV Department of Housing and Urban Development (Part 7501) LXVI National Archives and Records Administration (Part 7601) LXIX Tennessee Valley Authority (Part 7901) LXXI Consumer Product Safety Commission (Part 8101) LXXIV Federal Mine Safety and Health Review Commission (Part 8401) LXXVI Federal Retirement Thrift Investment Board (Part 8601) LXXVII Office of Management and Budget (Part 8701)

Title 6—[Reserved]

Title 7—Agriculture

SUBTITLE A—OFFICE OF THE SECRETARY OF AGRICULTURE (PARTS 0—26) SUBTITLE B—REGULATIONS OF THE DEPARTMENT OF AGRICULTURE

226 Title 7—Agriculture—Continued Chap.

I Agricultural Marketing Service (Standards, Inspections, Mar- keting Practices), Department of Agriculture (Parts 27—209) II Food and Nutrition Service, Department of Agriculture (Parts 210—299) III Animal and Plant Health Inspection Service, Department of Ag- riculture (Parts 300—399) IV Federal Crop Insurance Corporation, Department of Agriculture (Parts 400—499) V Agricultural Research Service, Department of Agriculture (Parts 500—599) VI Natural Resources Conservation Service, Department of Agri- culture (Parts 600—699) VII Farm Service Agency, Department of Agriculture (Parts 700— 799) VIII Grain Inspection, Packers and Stockyards Administration (Fed- eral Grain Inspection Service), Department of Agriculture (Parts 800—899) IX Agricultural Marketing Service (Marketing Agreements and Or- ders; Fruits, Vegetables, Nuts), Department of Agriculture (Parts 900—999) X Agricultural Marketing Service (Marketing Agreements and Or- ders; Milk), Department of Agriculture (Parts 1000—1199) XI Agricultural Marketing Service (Marketing Agreements and Or- ders; Miscellaneous Commodities), Department of Agriculture (Parts 1200—1299) XIII Northeast Dairy Compact Commission (Parts 1300—1399) XIV Commodity Credit Corporation, Department of Agriculture (Parts 1400—1499) XV Foreign Agricultural Service, Department of Agriculture (Parts 1500—1599) XVI Rural Telephone Bank, Department of Agriculture (Parts 1600— 1699) XVII Rural Utilities Service, Department of Agriculture (Parts 1700— 1799) XVIII Rural Housing Service, Rural Business-Cooperative Service, Rural Utilities Service, and Farm Service Agency, Depart- ment of Agriculture (Parts 1800—2099) XXVI Office of Inspector General, Department of Agriculture (Parts 2600—2699) XXVII Office of Information Resources Management, Department of Agriculture (Parts 2700—2799) XXVIII Office of Operations, Department of Agriculture (Parts 2800— 2899) XXIX Office of Energy, Department of Agriculture (Parts 2900—2999) XXX Office of the Chief Financial Officer, Department of Agriculture (Parts 3000—3099) XXXI Office of Environmental Quality, Department of Agriculture (Parts 3100—3199) XXXII Office of Procurement and Property Management, Department of Agriculture (Parts 3200—3299)

227 Title 7—Agriculture—Continued Chap.

XXXIII Office of Transportation, Department of Agriculture (Parts 3300—3399) XXXIV Cooperative State Research, Education, and Extension Service, Department of Agriculture (Parts 3400—3499) XXXV Rural Housing Service, Department of Agriculture (Parts 3500— 3599) XXXVI National Agricultural Statistics Service, Department of Agri- culture (Parts 3600—3699) XXXVII Economic Research Service, Department of Agriculture (Parts 3700—3799) XXXVIII World Agricultural Outlook Board, Department of Agriculture (Parts 3800—3899) XLI [Reserved] XLII Rural Business-Cooperative Service and Rural Utilities Service, Department of Agriculture (Parts 4200—4299)

Title 8—Aliens and Nationality

I Immigration and Naturalization Service, Department of Justice (Parts 1—499)

Title 9—Animals and Animal Products

I Animal and Plant Health Inspection Service, Department of Ag- riculture (Parts 1—199) II Grain Inspection, Packers and Stockyards Administration (Packers and Stockyards Programs), Department of Agri- culture (Parts 200—299) III Food Safety and Inspection Service, Department of Agriculture (Parts 300—599)

Title 10—Energy

I Nuclear Regulatory Commission (Parts 0—199) II Department of Energy (Parts 200—699) III Department of Energy (Parts 700—999) X Department of Energy (General Provisions) (Parts 1000—1099) XVII Defense Nuclear Facilities Safety Board (Parts 1700—1799)

Title 11—Federal Elections

I Federal Election Commission (Parts 1—9099)

Title 12—Banks and Banking

I Comptroller of the Currency, Department of the Treasury (Parts 1—199) II Federal Reserve System (Parts 200—299) III Federal Deposit Insurance Corporation (Parts 300—399)

228 Title 12—Banks and Banking—Continued Chap.

IV Export-Import Bank of the United States (Parts 400—499) V Office of Thrift Supervision, Department of the Treasury (Parts 500—599) VI Farm Credit Administration (Parts 600—699) VII National Credit Union Administration (Parts 700—799) VIII Federal Financing Bank (Parts 800—899) IX Federal Housing Finance Board (Parts 900—999) XI Federal Financial Institutions Examination Council (Parts 1100—1199) XIV Farm Credit System Insurance Corporation (Parts 1400—1499) XV Department of the Treasury (Parts 1500—1599) XVII Office of Federal Housing Enterprise Oversight, Department of Housing and Urban Development (Parts 1700-1799) XVIII Community Development Financial Institutions Fund, Depart- ment of the Treasury (Parts 1800—1899)

Title 13—Business Credit and Assistance

I Small Business Administration (Parts 1—199) III Department of Commerce, Economic Development Administra- tion, (Parts 300—399)

Title 14—Aeronautics and Space

I Federal Aviation Administration, Department of Transportation (Parts 1—199) II Office of the Secretary, Department of Transportation (Aviation Proceedings) (Parts 200—399) III Commercial Space Transportation, Federal Aviation Adminis- tration, Department of Transportation (Parts 400—499) V National Aeronautics and Space Administration (Parts 1200— 1299)

Title 15—Commerce and Foreign Trade

SUBTITLE A—OFFICE OF THE SECRETARY OF COMMERCE (PARTS 0— 29) SUBTITLE B—REGULATIONS RELATING TO COMMERCE AND FOREIGN TRADE I Bureau of the Census, Department of Commerce (Parts 30—199) II National Institute of Standards and Technology, Department of Commerce (Parts 200—299) III International Trade Administration, Department of Commerce (Parts 300—399) IV Foreign-Trade Zones Board, Department of Commerce (Parts 400—499) VII Bureau of Export Administration, Department of Commerce (Parts 700—799)

229 Title 15—Commerce and Foreign Trade—Continued Chap.

VIII Bureau of Economic Analysis, Department of Commerce (Parts 800—899) IX National Oceanic and Atmospheric Administration, Department of Commerce (Parts 900—999) XI Technology Administration, Department of Commerce (Parts 1100—1199) XIII East-West Foreign Trade Board (Parts 1300—1399) XIV Minority Business Development Agency (Parts 1400—1499) SUBTITLE C—REGULATIONS RELATING TO FOREIGN TRADE AGREE- MENTS XX Office of the United States Trade Representative (Parts 2000— 2099) SUBTITLE D—REGULATIONS RELATING TO TELECOMMUNICATIONS AND INFORMATION XXIII National Telecommunications and Information Administration, Department of Commerce (Parts 2300—2399)

Title 16—Commercial Practices

I Federal Trade Commission (Parts 0—999) II Consumer Product Safety Commission (Parts 1000—1799)

Title 17—Commodity and Securities Exchanges

I Commodity Futures Trading Commission (Parts 1—199) II Securities and Exchange Commission (Parts 200—399) IV Department of the Treasury (Parts 400—499)

Title 18—Conservation of Power and Water Resources

I Federal Energy Regulatory Commission, Department of Energy (Parts 1—399) III Delaware River Basin Commission (Parts 400—499) VI Water Resources Council (Parts 700—799) VIII Susquehanna River Basin Commission (Parts 800—899) XIII Tennessee Valley Authority (Parts 1300—1399)

Title 19—Customs Duties

I United States Customs Service, Department of the Treasury (Parts 1—199) II United States International Trade Commission (Parts 200—299) III International Trade Administration, Department of Commerce (Parts 300—399)

230 Title 20—Employees’ Benefits Chap.

I Office of Workers’ Compensation Programs, Department of Labor (Parts 1—199) II Railroad Retirement Board (Parts 200—399) III Social Security Administration (Parts 400—499) IV Employees’ Compensation Appeals Board, Department of Labor (Parts 500—599) V Employment and Training Administration, Department of Labor (Parts 600—699) VI Employment Standards Administration, Department of Labor (Parts 700—799) VII Benefits Review Board, Department of Labor (Parts 800—899) VIII Joint Board for the Enrollment of Actuaries (Parts 900—999) IX Office of the Assistant Secretary for Veterans’ Employment and Training, Department of Labor (Parts 1000—1099)

Title 21—Food and Drugs

I Food and Drug Administration, Department of Health and Human Services (Parts 1—1299) II Drug Enforcement Administration, Department of Justice (Parts 1300—1399) III Office of National Drug Control Policy (Parts 1400—1499)

Title 22—Foreign Relations

I Department of State (Parts 1—199) II Agency for International Development (Parts 200—299) III Peace Corps (Parts 300—399) IV International Joint Commission, United States and Canada (Parts 400—499) V United States Information Agency (Parts 500—599) VII Overseas Private Investment Corporation, International Devel- opment Cooperation Agency (Parts 700—799) IX Foreign Service Grievance Board Regulations (Parts 900—999) X Inter-American Foundation (Parts 1000—1099) XI International Boundary and Water Commission, United States and Mexico, United States Section (Parts 1100—1199) XII United States International Development Cooperation Agency (Parts 1200—1299) XIII Board for International Broadcasting (Parts 1300—1399) XIV Foreign Service Labor Relations Board; Federal Labor Relations Authority; General Counsel of the Federal Labor Relations Authority; and the Foreign Service Impasse Disputes Panel (Parts 1400—1499) XV African Development Foundation (Parts 1500—1599) XVI Japan-United States Friendship Commission (Parts 1600—1699) XVII United States Institute of Peace (Parts 1700—1799)

231 Title 23—Highways Chap.

I Federal Highway Administration, Department of Transportation (Parts 1—999) II National Highway Traffic Safety Administration and Federal Highway Administration, Department of Transportation (Parts 1200—1299) III National Highway Traffic Safety Administration, Department of Transportation (Parts 1300—1399)

Title 24—Housing and Urban Development

SUBTITLE A—OFFICE OF THE SECRETARY, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT (PARTS 0—99) SUBTITLE B—REGULATIONS RELATING TO HOUSING AND URBAN DE- VELOPMENT I Office of Assistant Secretary for Equal Opportunity, Department of Housing and Urban Development (Parts 100—199) II Office of Assistant Secretary for Housing-Federal Housing Com- missioner, Department of Housing and Urban Development (Parts 200—299) III Government National Mortgage Association, Department of Housing and Urban Development (Parts 300—399) IV Office of Multifamily Housing Assistance Restructuring, Depart- ment of Housing and Urban Development (Parts 400—499) V Office of Assistant Secretary for Community Planning and De- velopment, Department of Housing and Urban Development (Parts 500—599) VI Office of Assistant Secretary for Community Planning and De- velopment, Department of Housing and Urban Development (Parts 600—699) [Reserved] VII Office of the Secretary, Department of Housing and Urban Devel- opment (Housing Assistance Programs and Public and Indian Housing Programs) (Parts 700—799) VIII Office of the Assistant Secretary for Housing—Federal Housing Commissioner, Department of Housing and Urban Develop- ment (Section 8 Housing Assistance Programs, Section 202 Di- rect Loan Program, Section 202 Supportive Housing for the El- derly Program and Section 811 Supportive Housing for Persons With Disabilities Program) (Parts 800—899) IX Office of Assistant Secretary for Public and Indian Housing, De- partment of Housing and Urban Development (Parts 900—999) X Office of Assistant Secretary for Housing—Federal Housing Commissioner, Department of Housing and Urban Develop- ment (Interstate Land Sales Registration Program) (Parts 1700—1799) XII Office of Inspector General, Department of Housing and Urban Development (Parts 2000—2099) XX Office of Assistant Secretary for Housing—Federal Housing Commissioner, Department of Housing and Urban Develop- ment (Parts 3200—3899) XXV Neighborhood Reinvestment Corporation (Parts 4100—4199)

232 Title 25—Indians Chap.

I Bureau of Indian Affairs, Department of the Interior (Parts 1— 299) II Indian Arts and Crafts Board, Department of the Interior (Parts 300—399) III National Indian Gaming Commission, Department of the Inte- rior (Parts 500—599) IV Office of Navajo and Hopi Indian Relocation (Parts 700—799) V Bureau of Indian Affairs, Department of the Interior, and Indian Health Service, Department of Health and Human Services (Part 900) VI Office of the Assistant Secretary-Indian Affairs, Department of the Interior (Part 1001) VII Office of the Special Trustee for American Indians, Department of the Interior (Part 1200)

Title 26—Internal Revenue

I Internal Revenue Service, Department of the Treasury (Parts 1— 799)

Title 27—Alcohol, Tobacco Products and Firearms

I Bureau of Alcohol, Tobacco and Firearms, Department of the Treasury (Parts 1—299)

Title 28—Judicial Administration

I Department of Justice (Parts 0—199) III Federal Prison Industries, Inc., Department of Justice (Parts 300—399) V Bureau of Prisons, Department of Justice (Parts 500—599) VI Offices of Independent Counsel, Department of Justice (Parts 600—699) VII Office of Independent Counsel (Parts 700—799)

Title 29—Labor

SUBTITLE A—OFFICE OF THE SECRETARY OF LABOR (PARTS 0—99) SUBTITLE B—REGULATIONS RELATING TO LABOR I National Labor Relations Board (Parts 100—199) II Office of Labor-Management Standards, Department of Labor (Parts 200—299) III National Railroad Adjustment Board (Parts 300—399) IV Office of Labor-Management Standards, Department of Labor (Parts 400—499) V Wage and Hour Division, Department of Labor (Parts 500—899) IX Construction Industry Collective Bargaining Commission (Parts 900—999) X National Mediation Board (Parts 1200—1299)

233 Title 29—Labor—Continued Chap.

XII Federal Mediation and Conciliation Service (Parts 1400—1499) XIV Equal Employment Opportunity Commission (Parts 1600—1699) XVII Occupational Safety and Health Administration, Department of Labor (Parts 1900—1999) XX Occupational Safety and Health Review Commission (Parts 2200—2499) XXV Pension and Welfare Benefits Administration, Department of Labor (Parts 2500—2599) XXVII Federal Mine Safety and Health Review Commission (Parts 2700—2799) XL Pension Benefit Guaranty Corporation (Parts 4000—4999)

Title 30—Mineral Resources

I Mine Safety and Health Administration, Department of Labor (Parts 1—199) II Minerals Management Service, Department of the Interior (Parts 200—299) III Board of Surface Mining and Reclamation Appeals, Department of the Interior (Parts 300—399) IV Geological Survey, Department of the Interior (Parts 400—499) VI Bureau of Mines, Department of the Interior (Parts 600—699) VII Office of Surface Mining Reclamation and Enforcement, Depart- ment of the Interior (Parts 700—999)

Title 31—Money and Finance: Treasury

SUBTITLE A—OFFICE OF THE SECRETARY OF THE TREASURY (PARTS 0—50) SUBTITLE B—REGULATIONS RELATING TO MONEY AND FINANCE I Monetary Offices, Department of the Treasury (Parts 51—199) II Fiscal Service, Department of the Treasury (Parts 200—399) IV Secret Service, Department of the Treasury (Parts 400—499) V Office of Foreign Assets Control, Department of the Treasury (Parts 500—599) VI Bureau of Engraving and Printing, Department of the Treasury (Parts 600—699) VII Federal Law Enforcement Training Center, Department of the Treasury (Parts 700—799) VIII Office of International Investment, Department of the Treasury (Parts 800—899)

Title 32—National Defense

SUBTITLE A—DEPARTMENT OF DEFENSE I Office of the Secretary of Defense (Parts 1—399) V Department of the Army (Parts 400—699) VI Department of the Navy (Parts 700—799)

234 Title 32—National Defense—Continued Chap.

VII Department of the Air Force (Parts 800—1099) SUBTITLE B—OTHER REGULATIONS RELATING TO NATIONAL DE- FENSE XII Defense Logistics Agency (Parts 1200—1299) XVI Selective Service System (Parts 1600—1699) XIX Central Intelligence Agency (Parts 1900—1999) XX Information Security Oversight Office, National Archives and Records Administration (Parts 2000—2099) XXI National Security Council (Parts 2100—2199) XXIV Office of Science and Technology Policy (Parts 2400—2499) XXVII Office for Micronesian Status Negotiations (Parts 2700—2799) XXVIII Office of the Vice President of the United States (Parts 2800— 2899) XXIX Presidential Commission on the Assignment of Women in the Armed Forces (Part 2900)

Title 33—Navigation and Navigable Waters

I Coast Guard, Department of Transportation (Parts 1—199) II Corps of Engineers, Department of the Army (Parts 200—399) IV Saint Lawrence Seaway Development Corporation, Department of Transportation (Parts 400—499)

Title 34—Education

SUBTITLE A—OFFICE OF THE SECRETARY, DEPARTMENT OF EDU- CATION (PARTS 1—99) SUBTITLE B—REGULATIONS OF THE OFFICES OF THE DEPARTMENT OF EDUCATION I Office for Civil Rights, Department of Education (Parts 100—199) II Office of Elementary and Secondary Education, Department of Education (Parts 200—299) III Office of Special Education and Rehabilitative Services, Depart- ment of Education (Parts 300—399) IV Office of Vocational and Adult Education, Department of Edu- cation (Parts 400—499) V Office of Bilingual Education and Minority Languages Affairs, Department of Education (Parts 500—599) VI Office of Postsecondary Education, Department of Education (Parts 600—699) VII Office of Educational Research and Improvement, Department of Education (Parts 700—799) XI National Institute for Literacy (Parts 1100-1199) SUBTITLE C—REGULATIONS RELATING TO EDUCATION XII National Council on Disability (Parts 1200—1299)

235 Title 35—Panama Canal Chap.

I Panama Canal Regulations (Parts 1—299)

Title 36—Parks, Forests, and Public Property

I National Park Service, Department of the Interior (Parts 1—199) II Forest Service, Department of Agriculture (Parts 200—299) III Corps of Engineers, Department of the Army (Parts 300—399) IV American Battle Monuments Commission (Parts 400—499) V Smithsonian Institution (Parts 500—599) VII Library of Congress (Parts 700—799) VIII Advisory Council on Historic Preservation (Parts 800—899) IX Pennsylvania Avenue Development Corporation (Parts 900—999) X Presidio Trust (Parts 1000—1099) XI Architectural and Transportation Barriers Compliance Board (Parts 1100—1199) XII National Archives and Records Administration (Parts 1200—1299) XIV Assassination Records Review Board (Parts 1400-1499)

Title 37—Patents, Trademarks, and Copyrights

I Patent and Trademark Office, Department of Commerce (Parts 1—199) II Copyright Office, Library of Congress (Parts 200—299) IV Assistant Secretary for Technology Policy, Department of Com- merce (Parts 400—499) V Under Secretary for Technology, Department of Commerce (Parts 500—599)

Title 38—Pensions, Bonuses, and Veterans’ Relief

I Department of Veterans Affairs (Parts 0—99)

Title 39—Postal Service

I United States Postal Service (Parts 1—999) III Postal Rate Commission (Parts 3000—3099)

Title 40—Protection of Environment

I Environmental Protection Agency (Parts 1—799) V Council on Environmental Quality (Parts 1500—1599)

Title 41—Public Contracts and Property Management

SUBTITLE B—OTHER PROVISIONS RELATING TO PUBLIC CONTRACTS 50 Public Contracts, Department of Labor (Parts 50–1—50–999)

236 Title 41—Public Contracts and Property Management—Continued Chap.

51 Committee for Purchase From People Who Are Blind or Severely Disabled (Parts 51–1—51–99) 60 Office of Federal Contract Compliance Programs, Equal Employ- ment Opportunity, Department of Labor (Parts 60–1—60–999) 61 Office of the Assistant Secretary for Veterans Employment and Training, Department of Labor (Parts 61–1—61–999) SUBTITLE C—FEDERAL PROPERTY MANAGEMENT REGULATIONS SYSTEM 101 Federal Property Management Regulations (Parts 101–1—101–99) 105 General Services Administration (Parts 105–1—105–999) 109 Department of Energy Property Management Regulations (Parts 109–1—109–99) 114 Department of the Interior (Parts 114–1—114–99) 115 Environmental Protection Agency (Parts 115–1—115–99) 128 Department of Justice (Parts 128–1—128–99) SUBTITLE D—OTHER PROVISIONS RELATING TO PROPERTY MANAGE- MENT [RESERVED] SUBTITLE E—FEDERAL INFORMATION RESOURCES MANAGEMENT REGULATIONS SYSTEM 201 Federal Information Resources Management Regulation (Parts 201–1—201–99) [Reserved] SUBTITLE F—FEDERAL TRAVEL REGULATION SYSTEM 300 General (Parts 300–1—300.99) 301 Temporary Duty (TDY) Travel Allowances (Parts 301–1—301–99) 302 Relocation Allowances (Parts 302–1—302–99) 303 Payment of Expenses Connected with the Death of Certain Em- ployees (Parts 303–1—303–2) 304 Payment from a Non-Federal Source for Travel Expenses (Parts 304–1—304–99)

Title 42—Public Health

I Public Health Service, Department of Health and Human Serv- ices (Parts 1—199) IV Health Care Financing Administration, Department of Health and Human Services (Parts 400—499) V Office of Inspector General-Health Care, Department of Health and Human Services (Parts 1000—1999)

Title 43—Public Lands: Interior

SUBTITLE A—OFFICE OF THE SECRETARY OF THE INTERIOR (PARTS 1—199) SUBTITLE B—REGULATIONS RELATING TO PUBLIC LANDS I Bureau of Reclamation, Department of the Interior (Parts 200— 499) II Bureau of Land Management, Department of the Interior (Parts 1000—9999)

237 Title 43—Public Lands: Interior—Continued Chap.

III Utah Reclamation Mitigation and Conservation Commission (Parts 10000—10005)

Title 44—Emergency Management and Assistance

I Federal Emergency Management Agency (Parts 0—399) IV Department of Commerce and Department of Transportation (Parts 400—499)

Title 45—Public Welfare

SUBTITLE A—DEPARTMENT OF HEALTH AND HUMAN SERVICES (PARTS 1—199) SUBTITLE B—REGULATIONS RELATING TO PUBLIC WELFARE II Office of Family Assistance (Assistance Programs), Administra- tion for Children and Families, Department of Health and Human Services (Parts 200—299) III Office of Child Support Enforcement (Child Support Enforce- ment Program), Administration for Children and Families, Department of Health and Human Services (Parts 300—399) IV Office of Refugee Resettlement, Administration for Children and Families Department of Health and Human Services (Parts 400—499) V Foreign Claims Settlement Commission of the United States, Department of Justice (Parts 500—599) VI National Science Foundation (Parts 600—699) VII Commission on Civil Rights (Parts 700—799) VIII Office of Personnel Management (Parts 800—899) X Office of Community Services, Administration for Children and Families, Department of Health and Human Services (Parts 1000—1099) XI National Foundation on the Arts and the Humanities (Parts 1100—1199) XII Corporation for National and Community Service (Parts 1200— 1299) XIII Office of Human Development Services, Department of Health and Human Services (Parts 1300—1399) XVI Legal Services Corporation (Parts 1600—1699) XVII National Commission on Libraries and Information Science (Parts 1700—1799) XVIII Harry S. Truman Scholarship Foundation (Parts 1800—1899) XXI Commission on Fine Arts (Parts 2100—2199) XXII Christopher Columbus Quincentenary Jubilee Commission (Parts 2200—2299) XXIII Arctic Research Commission (Part 2301) XXIV James Madison Memorial Fellowship Foundation (Parts 2400— 2499) XXV Corporation for National and Community Service (Parts 2500— 2599)

238 Title 46—Shipping Chap.

I Coast Guard, Department of Transportation (Parts 1—199) II Maritime Administration, Department of Transportation (Parts 200—399) III Coast Guard (Great Lakes Pilotage), Department of Transpor- tation (Parts 400—499) IV Federal Maritime Commission (Parts 500—599)

Title 47—Telecommunication

I Federal Communications Commission (Parts 0—199) II Office of Science and Technology Policy and National Security Council (Parts 200—299) III National Telecommunications and Information Administration, Department of Commerce (Parts 300—399)

Title 48—Federal Acquisition Regulations System

1 Federal Acquisition Regulation (Parts 1—99) 2 Department of Defense (Parts 200—299) 3 Department of Health and Human Services (Parts 300—399) 4 Department of Agriculture (Parts 400—499) 5 General Services Administration (Parts 500—599) 6 Department of State (Parts 600—699) 7 United States Agency for International Development (Parts 700—799) 8 Department of Veterans Affairs (Parts 800—899) 9 Department of Energy (Parts 900—999) 10 Department of the Treasury (Parts 1000—1099) 12 Department of Transportation (Parts 1200—1299) 13 Department of Commerce (Parts 1300—1399) 14 Department of the Interior (Parts 1400—1499) 15 Environmental Protection Agency (Parts 1500—1599) 16 Office of Personnel Management Federal Employees Health Ben- efits Acquisition Regulation (Parts 1600—1699) 17 Office of Personnel Management (Parts 1700—1799) 18 National Aeronautics and Space Administration (Parts 1800— 1899) 19 United States Information Agency (Parts 1900—1999) 20 Nuclear Regulatory Commission (Parts 2000—2099) 21 Office of Personnel Management, Federal Employees Group Life Insurance Federal Acquisition Regulation (Parts 2100—2199) 23 Social Security Administration (Parts 2300—2399) 24 Department of Housing and Urban Development (Parts 2400— 2499) 25 National Science Foundation (Parts 2500—2599) 28 Department of Justice (Parts 2800—2899) 29 Department of Labor (Parts 2900—2999)

239 Title 48—Federal Acquisition Regulations System—Continued Chap.

34 Department of Education Acquisition Regulation (Parts 3400— 3499) 35 Panama Canal Commission (Parts 3500—3599) 44 Federal Emergency Management Agency (Parts 4400—4499) 51 Department of the Army Acquisition Regulations (Parts 5100— 5199) 52 Department of the Navy Acquisition Regulations (Parts 5200— 5299) 53 Department of the Air Force Federal Acquisition Regulation Supplement (Parts 5300—5399) 54 Defense Logistics Agency, Department of Defense (Part 5452) 57 African Development Foundation (Parts 5700—5799) 61 General Services Administration Board of Contract Appeals (Parts 6100—6199) 63 Department of Transportation Board of Contract Appeals (Parts 6300—6399) 99 Cost Accounting Standards Board, Office of Federal Procure- ment Policy, Office of Management and Budget (Parts 9900— 9999)

Title 49—Transportation

SUBTITLE A—OFFICE OF THE SECRETARY OF TRANSPORTATION (PARTS 1—99) SUBTITLE B—OTHER REGULATIONS RELATING TO TRANSPORTATION I Research and Special Programs Administration, Department of Transportation (Parts 100—199) II Federal Railroad Administration, Department of Transportation (Parts 200—299) III Federal Highway Administration, Department of Transportation (Parts 300—399) IV Coast Guard, Department of Transportation (Parts 400—499) V National Highway Traffic Safety Administration, Department of Transportation (Parts 500—599) VI Federal Transit Administration, Department of Transportation (Parts 600—699) VII National Railroad Passenger Corporation (AMTRAK) (Parts 700—799) VIII National Transportation Safety Board (Parts 800—999) X Surface Transportation Board, Department of Transportation (Parts 1000—1399) XI Bureau of Transportation Statistics, Department of Transpor- tation (Parts 1400—1499)

Title 50—Wildlife and Fisheries

I United States Fish and Wildlife Service, Department of the Inte- rior (Parts 1—199)

240 Title 50—Wildlife and Fisheries—Continued Chap.

II National Marine Fisheries Service, National Oceanic and Atmos- pheric Administration, Department of Commerce (Parts 200— 299) III International Fishing and Related Activities (Parts 300—399) IV Joint Regulations (United States Fish and Wildlife Service, De- partment of the Interior and National Marine Fisheries Serv- ice, National Oceanic and Atmospheric Administration, De- partment of Commerce); Endangered Species Committee Reg- ulations (Parts 400—499) V Marine Mammal Commission (Parts 500—599) VI Fishery Conservation and Management, National Oceanic and Atmospheric Administration, Department of Commerce (Parts 600—699)

CFR Index and Finding Aids

Subject/Agency Index List of Agency Prepared Indexes Parallel Tables of Statutory Authorities and Rules List of CFR Titles, Chapters, Subchapters, and Parts Alphabetical List of Agencies Appearing in the CFR

241

Alphabetical List of Agencies Appearing in the CFR (Revised as of March 31, 1999)

CFR Title, Subtitle or Agency Chapter Administrative Committee of the Federal Register 1, I Advanced Research Projects Agency 32, I Advisory Commission on Intergovernmental Relations 5, VII Advisory Committee on Federal Pay 5, IV Advisory Council on Historic Preservation 36, VIII African Development Foundation 22, XV Federal Acquisition Regulation 48, 57 Agency for International Development 22, II Federal Acquisition Regulation 48, 7 Agricultural Marketing Service 7, I, IX, X, XI Agricultural Research Service 7, V Agriculture Department Agricultural Marketing Service 7, I, IX, X, XI Agricultural Research Service 7, V Animal and Plant Health Inspection Service 7, III; 9, I Chief Financial Officer, Office of 7, XXX Commodity Credit Corporation 7, XIV Cooperative State Research, Education, and Extension 7, XXXIV Service Economic Research Service 7, XXXVII Energy, Office of 7, XXIX Environmental Quality, Office of 7, XXXI Farm Service Agency 7, VII, XVIII Federal Acquisition Regulation 48, 4 Federal Crop Insurance Corporation 7, IV Food and Nutrition Service 7, II Food Safety and Inspection Service 9, III Foreign Agricultural Service 7, XV Forest Service 36, II Grain Inspection, Packers and Stockyards Administration 7, VIII; 9, II Information Resources Management, Office of 7, XXVII Inspector General, Office of 7, XXVI National Agricultural Library 7, XLI National Agricultural Statistics Service 7, XXXVI Natural Resources Conservation Service 7, VI Operations, Office of 7, XXVIII Procurement and Property Management, Office of 7, XXXII Rural Business-Cooperative Service 7, XVIII, XLII Rural Development Administration 7, XLII Rural Housing Service 7, XVIII, XXXV Rural Telephone Bank 7, XVI Rural Utilities Service 7, XVII, XVIII, XLII Secretary of Agriculture, Office of 7, Subtitle A Transportation, Office of 7, XXXIII World Agricultural Outlook Board 7, XXXVIII Air Force Department 32, VII Federal Acquisition Regulation Supplement 48, 53 Alcohol, Tobacco and Firearms, Bureau of 27, I AMTRAK 49, VII American Battle Monuments Commission 36, IV American Indians, Office of the Special Trustee 25, VII Animal and Plant Health Inspection Service 7, III; 9, I Appalachian Regional Commission 5, IX

243 CFR Title, Subtitle or Agency Chapter Architectural and Transportation Barriers Compliance Board 36, XI Arctic Research Commission 45, XXIII Armed Forces Retirement Home 5, XI Army Department 32, V Engineers, Corps of 33, II; 36, III Federal Acquisition Regulation 48, 51 Assassination Records Review Board 36, XIV Benefits Review Board 20, VII Bilingual Education and Minority Languages Affairs, Office of 34, V Blind or Severely Disabled, Committee for Purchase From 41, 51 People Who Are Board for International Broadcasting 22, XIII Census Bureau 15, I Central Intelligence Agency 32, XIX Chief Financial Officer, Office of 7, XXX Child Support Enforcement, Office of 45, III Children and Families, Administration for 45, II, III, IV, X Christopher Columbus Quincentenary Jubilee Commission 45, XXII Civil Rights, Commission on 45, VII Civil Rights, Office for 34, I Coast Guard 33, I; 46, I; 49, IV Coast Guard (Great Lakes Pilotage) 46, III Commerce Department 44, IV Census Bureau 15, I‘ Economic Affairs, Under Secretary 37, V Economic Analysis, Bureau of 15, VIII Economic Development Administration 13, III Emergency Management and Assistance 44, IV Export Administration, Bureau of 15, VII Federal Acquisition Regulation 48, 13 Fishery Conservation and Management 50, VI Foreign-Trade Zones Board 15, IV International Trade Administration 15, III; 19, III National Institute of Standards and Technology 15, II National Marine Fisheries Service 50, II, IV, VI National Oceanic and Atmospheric Administration 15, IX; 50, II, III, IV, VI National Telecommunications and Information 15, XXIII; 47, III Administration National Weather Service 15, IX Patent and Trademark Office 37, I Productivity, Technology and Innovation, Assistant 37, IV Secretary for Secretary of Commerce, Office of 15, Subtitle A Technology, Under Secretary for 37, V Technology Administration 15, XI Technology Policy, Assistant Secretary for 37, IV Commercial Space Transportation 14, III Commodity Credit Corporation 7, XIV Commodity Futures Trading Commission 5, XLI; 17, I Community Planning and Development, Office of Assistant 24, V, VI Secretary for Community Services, Office of 45, X Comptroller of the Currency 12, I Construction Industry Collective Bargaining Commission 29, IX Consumer Product Safety Commission 5, LXXI; 16, II Cooperative State Research, Education, and Extension 7, XXXIV Service Copyright Office 37, II Corporation for National and Community Service 45, XII, XXV Cost Accounting Standards Board 48, 99 Council on Environmental Quality 40, V Customs Service, United States 19, I Defense Contract Audit Agency 32, I Defense Department 5, XXVI; 32, Subtitle A Advanced Research Projects Agency 32, I Air Force Department 32, VII

244 CFR Title, Subtitle or Agency Chapter Army Department 32, V; 33, II; 36, III, 48, 51 Defense Intelligence Agency 32, I Defense Logistics Agency 32, I, XII; 48, 54 Engineers, Corps of 33, II; 36, III Federal Acquisition Regulation 48, 2 National Imagery and Mapping Agency 32, I Navy Department 32, VI; 48, 52 Secretary of Defense, Office of 32, I Defense Contract Audit Agency 32, I Defense Intelligence Agency 32, I Defense Logistics Agency 32, XII; 48, 54 Defense Nuclear Facilities Safety Board 10, XVII Delaware River Basin Commission 18, III Drug Enforcement Administration 21, II East-West Foreign Trade Board 15, XIII Economic Affairs, Under Secretary 37, V Economic Analysis, Bureau of 15, VIII Economic Development Administration 13, III Economic Research Service 7, XXXVII Education, Department of 5, LIII Bilingual Education and Minority Languages Affairs, Office 34, V of Civil Rights, Office for 34, I Educational Research and Improvement, Office of 34, VII Elementary and Secondary Education, Office of 34, II Federal Acquisition Regulation 48, 34 Postsecondary Education, Office of 34, VI Secretary of Education, Office of 34, Subtitle A Special Education and Rehabilitative Services, Office of 34, III Vocational and Adult Education, Office of 34, IV Educational Research and Improvement, Office of 34, VII Elementary and Secondary Education, Office of 34, II Employees’ Compensation Appeals Board 20, IV Employees Loyalty Board 5, V Employment and Training Administration 20, V Employment Standards Administration 20, VI Endangered Species Committee 50, IV Energy, Department of 5, XXIII; 10, II, III, X Federal Acquisition Regulation 48, 9 Federal Energy Regulatory Commission 5, XXIV; 18, I Property Management Regulations 41, 109 Energy, Office of 7, XXIX Engineers, Corps of 33, II; 36, III Engraving and Printing, Bureau of 31, VI Environmental Protection Agency 5, LIV; 40, I Federal Acquisition Regulation 48, 15 Property Management Regulations 41, 115 Environmental Quality, Office of 7, XXXI Equal Employment Opportunity Commission 5, LXII; 29, XIV Equal Opportunity, Office of Assistant Secretary for 24, I Executive Office of the President 3, I Administration, Office of 5, XV Environmental Quality, Council on 40, V Management and Budget, Office of 25, III, LXXVII; 48, 99 National Drug Control Policy, Office of 21, III National Security Council 32, XXI; 47, 2 Presidential Documents 3 Science and Technology Policy, Office of 32, XXIV; 47, II Trade Representative, Office of the United States 15, XX Export Administration, Bureau of 15, VII Export-Import Bank of the United States 5, LII; 12, IV Family Assistance, Office of 45, II Farm Credit Administration 5, XXXI; 12, VI Farm Credit System Insurance Corporation 5, XXX; 12, XIV Farm Service Agency 7, VII, XVIII Federal Acquisition Regulation 48, 1

245 CFR Title, Subtitle or Agency Chapter Federal Aviation Administration 14, I Commercial Space Transportation 14, III Federal Claims Collection Standards 4, II Federal Communications Commission 5, XXIX; 47, I Federal Contract Compliance Programs, Office of 41, 60 Federal Crop Insurance Corporation 7, IV Federal Deposit Insurance Corporation 5, XXII; 12, III Federal Election Commission 11, I Federal Emergency Management Agency 44, I Federal Acquisition Regulation 48, 44 Federal Employees Group Life Insurance Federal Acquisition 48, 21 Regulation Federal Employees Health Benefits Acquisition Regulation 48, 16 Federal Energy Regulatory Commission 5, XXIV; 18, I Federal Financial Institutions Examination Council 12, XI Federal Financing Bank 12, VIII Federal Highway Administration 23, I, II; 49, III Federal Home Loan Mortgage Corporation 1, IV Federal Housing Enterprise Oversight Office 12, XVII Federal Housing Finance Board 12, IX Federal Labor Relations Authority, and General Counsel of 5, XIV; 22, XIV the Federal Labor Relations Authority Federal Law Enforcement Training Center 31, VII Federal Maritime Commission 46, IV Federal Mediation and Conciliation Service 29, XII Federal Mine Safety and Health Review Commission 5, LXXIV; 29, XXVII Federal Pay, Advisory Committee on 5, IV Federal Prison Industries, Inc. 28, III Federal Procurement Policy Office 48, 99 Federal Property Management Regulations 41, 101 Federal Property Management Regulations System 41, Subtitle C Federal Railroad Administration 49, II Federal Register, Administrative Committee of 1, I Federal Register, Office of 1, II Federal Reserve System 12, II Board of Governors 5, LVIII Federal Retirement Thrift Investment Board 5, VI, LXXVI Federal Service Impasses Panel 5, XIV Federal Trade Commission 5, XLVII; 16, I Federal Transit Administration 49, VI Federal Travel Regulation System 41, Subtitle F Fine Arts, Commission on 45, XXI Fiscal Service 31, II Fish and Wildlife Service, United States 50, I, IV Fishery Conservation and Management 50, VI Food and Drug Administration 21, I Food and Nutrition Service 7, II Food Safety and Inspection Service 9, III Foreign Agricultural Service 7, XV Foreign Assets Control, Office of 31, V Foreign Claims Settlement Commission of the United States 45, V Foreign Service Grievance Board 22, IX Foreign Service Impasse Disputes Panel 22, XIV Foreign Service Labor Relations Board 22, XIV Foreign-Trade Zones Board 15, IV Forest Service 36, II General Accounting Office 4, I, II General Services Administration 5, LVII Contract Appeals, Board of 48, 61 Federal Acquisition Regulation 48, 5 Federal Property Management Regulations System 41, 101, 105 Federal Travel Regulation System 41, Subtitle F General 41, 300 Payment From a Non-Federal Source for Travel Expenses 41, 304 Payment of Expenses Connected With the Death of Certain 41, 303 Employees Relocation Allowances 41, 302

246 CFR Title, Subtitle or Agency Chapter Temporary Duty (TDY) Travel Allowances 41, 301 Geological Survey 30, IV Government Ethics, Office of 5, XVI Government National Mortgage Association 24, III Grain Inspection, Packers and Stockyards Administration 7, VIII; 9, II Harry S. Truman Scholarship Foundation 45, XVIII Health and Human Services, Department of 5, XLV; 45, Subtitle A Child Support Enforcement, Office of 45, III Children and Families, Administration for 45, II, III, IV, X Community Services, Office of 45, X Family Assistance, Office of 45, II Federal Acquisition Regulation 48, 3 Food and Drug Administration 21, I Health Care Financing Administration 42, IV Human Development Services, Office of 45, XIII Indian Health Service 25, V Inspector General (Health Care), Office of 42, V Public Health Service 42, I Refugee Resettlement, Office of 45, IV Health Care Financing Administration 42, IV Housing and Urban Development, Department of 5, LXV; 24, Subtitle B Community Planning and Development, Office of Assistant 24, V, VI Secretary for Equal Opportunity, Office of Assistant Secretary for 24, I Federal Acquisition Regulation 48, 24 Federal Housing Enterprise Oversight, Office of 12, XVII Government National Mortgage Association 24, III Housing—Federal Housing Commissioner, Office of 24, II, VIII, X, XX Assistant Secretary for Inspector General, Office of 24, XII Multifamily Housing Assistance Restructuring, Office of 24, IV Public and Indian Housing, Office of Assistant Secretary for 24, IX Secretary, Office of 24, Subtitle A, VII Housing—Federal Housing Commissioner, Office of Assistant 24, II, VIII, X, XX Secretary for Human Development Services, Office of 45, XIII Immigration and Naturalization Service 8, I Independent Counsel, Office of 28, VII Indian Affairs, Bureau of 25, I, V Indian Affairs, Office of the Assistant Secretary 25, VI Indian Arts and Crafts Board 25, II Indian Health Service 25, V Information Agency, United States 22, V Federal Acquisition Regulation 48, 19 Information Resources Management, Office of 7, XXVII Information Security Oversight Office, National Archives and 32, XX Records Administration Inspector General Agriculture Department 7, XXVI Health and Human Services Department 42, V Housing and Urban Development Department 24, XII Institute of Peace, United States 22, XVII Inter-American Foundation 5, LXIII; 22, X Intergovernmental Relations, Advisory Commission on 5, VII Interior Department American Indians, Office of the Special Trustee 25, VII Endangered Species Committee 50, IV Federal Acquisition Regulation 48, 14 Federal Property Management Regulations System 41, 114 Fish and Wildlife Service, United States 50, I, IV Geological Survey 30, IV Indian Affairs, Bureau of 25, I, V Indian Affairs, Office of the Assistant Secretary 25, VI Indian Arts and Crafts Board 25, II Land Management, Bureau of 43, II Minerals Management Service 30, II Mines, Bureau of 30, VI

247 CFR Title, Subtitle or Agency Chapter National Indian Gaming Commission 25, III National Park Service 36, I Reclamation, Bureau of 43, I Secretary of the Interior, Office of 43, Subtitle A Surface Mining and Reclamation Appeals, Board of 30, III Surface Mining Reclamation and Enforcement, Office of 30, VII Internal Revenue Service 26, I International Boundary and Water Commission, United States 22, XI and Mexico, United States Section International Development, Agency for 22, II Federal Acquisition Regulation 48, 7 International Development Cooperation Agency, United 22, XII States International Development, Agency for 22, II; 48, 7 Overseas Private Investment Corporation 5, XXXIII; 22, VII International Fishing and Related Activities 50, III International Investment, Office of 31, VIII International Joint Commission, United States and Canada 22, IV International Organizations Employees Loyalty Board 5, V International Trade Administration 15, III; 19, III International Trade Commission, United States 19, II Interstate Commerce Commission 5, XL James Madison Memorial Fellowship Foundation 45, XXIV Japan–United States Friendship Commission 22, XVI Joint Board for the Enrollment of Actuaries 20, VIII Justice Department 5, XXVIII; 28, I Drug Enforcement Administration 21, II Federal Acquisition Regulation 48, 28 Federal Claims Collection Standards 4, II Federal Prison Industries, Inc. 28, III Foreign Claims Settlement Commission of the United 45, V States Immigration and Naturalization Service 8, I Offices of Independent Counsel 28, VI Prisons, Bureau of 28, V Property Management Regulations 41, 128 Labor Department 5, XLII Benefits Review Board 20, VII Employees’ Compensation Appeals Board 20, IV Employment and Training Administration 20, V Employment Standards Administration 20, VI Federal Acquisition Regulation 48, 29 Federal Contract Compliance Programs, Office of 41, 60 Federal Procurement Regulations System 41, 50 Labor-Management Standards, Office of 29, II, IV Mine Safety and Health Administration 30, I Occupational Safety and Health Administration 29, XVII Pension and Welfare Benefits Administration 29, XXV Public Contracts 41, 50 Secretary of Labor, Office of 29, Subtitle A Veterans’ Employment and Training, Office of the Assistant 41, 61; 20, IX Secretary for Wage and Hour Division 29, V Workers’ Compensation Programs, Office of 20, I Labor-Management Standards, Office of 29, II, IV Land Management, Bureau of 43, II Legal Services Corporation 45, XVI Library of Congress 36, VII Copyright Office 37, II Management and Budget, Office of 5, III, LXXVII; 48, 99 Marine Mammal Commission 50, V Maritime Administration 46, II Merit Systems Protection Board 5, II Micronesian Status Negotiations, Office for 32, XXVII Mine Safety and Health Administration 30, I Minerals Management Service 30, II Mines, Bureau of 30, VI

248 CFR Title, Subtitle or Agency Chapter Minority Business Development Agency 15, XIV Miscellaneous Agencies 1, IV Monetary Offices 31, I Multifamily Housing Assistance Restructuring, Office of 24, IV National Aeronautics and Space Administration 5, LIX; 14, V Federal Acquisition Regulation 48, 18 National Agricultural Library 7, XLI National Agricultural Statistics Service 7, XXXVI National Archives and Records Administration 5, LXVI; 36, XII Information Security Oversight Office 32, XX National Bureau of Standards 15, II National Capital Planning Commission 1, IV National Commission for Employment Policy 1, IV National Commission on Libraries and Information Science 45, XVII National and Community Service, Corporation for 45, XII, XXV National Council on Disability 34, XII National Credit Union Administration 12, VII National Drug Control Policy, Office of 21, III National Foundation on the Arts and the Humanities 45, XI National Highway Traffic Safety Administration 23, II, III; 49, V National Imagery and Mapping Agency 32, I National Indian Gaming Commission 25, III National Institute for Literacy 34, XI National Institute of Standards and Technology 15, II National Labor Relations Board 5, LXI; 29, I National Marine Fisheries Service 50, II, IV, VI National Mediation Board 29, X National Oceanic and Atmospheric Administration 15, IX; 50, II, III, IV, VI National Park Service 36, I National Railroad Adjustment Board 29, III National Railroad Passenger Corporation (AMTRAK) 49, VII National Science Foundation 5, XLIII; 45, VI Federal Acquisition Regulation 48, 25 National Security Council 32, XXI National Security Council and Office of Science and 47, II Technology Policy National Telecommunications and Information 15, XXIII; 47, III Administration National Transportation Safety Board 49, VIII National Weather Service 15, IX Natural Resources Conservation Service 7, VI Navajo and Hopi Indian Relocation, Office of 25, IV Navy Department 32, VI Federal Acquisition Regulation 48, 52 Neighborhood Reinvestment Corporation 24, XXV Northeast Dairy Compact Commission 7, XIII Nuclear Regulatory Commission 5, XLVIII; 10, I Federal Acquisition Regulation 48, 20 Occupational Safety and Health Administration 29, XVII Occupational Safety and Health Review Commission 29, XX Offices of Independent Counsel 28, VI Operations Office 7, XXVIII Overseas Private Investment Corporation 5, XXXIII; 22, VII Panama Canal Commission 48, 35 Panama Canal Regulations 35, I Patent and Trademark Office 37, I Payment From a Non-Federal Source for Travel Expenses 41, 304 Payment of Expenses Connected With the Death of Certain 41, 303 Employees Peace Corps 22, III Pennsylvania Avenue Development Corporation 36, IX Pension and Welfare Benefits Administration 29, XXV Pension Benefit Guaranty Corporation 29, XL Personnel Management, Office of 5, I, XXXV; 45, VIII Federal Acquisition Regulation 48, 17 Federal Employees Group Life Insurance Federal 48, 21 Acquisition Regulation

249 CFR Title, Subtitle or Agency Chapter Federal Employees Health Benefits Acquisition Regulation 48, 16 Postal Rate Commission 5, XLVI; 39, III Postal Service, United States 5, LX; 39, I Postsecondary Education, Office of 34, VI President’s Commission on White House Fellowships 1, IV Presidential Commission on the Assignment of Women in the 32, XXIX Armed Forces Presidential Documents 3 Presidio Trust 36, X Prisons, Bureau of 28, V Procurement and Property Management, Office of 7, XXXII Productivity, Technology and Innovation, Assistant 37, IV Secretary Public Contracts, Department of Labor 41, 50 Public and Indian Housing, Office of Assistant Secretary for 24, IX Public Health Service 42, I Railroad Retirement Board 20, II Reclamation, Bureau of 43, I Refugee Resettlement, Office of 45, IV Regional Action Planning Commissions 13, V Relocation Allowances 41, 302 Research and Special Programs Administration 49, I Rural Business-Cooperative Service 7, XVIII, XLII Rural Development Administration 7, XLII Rural Housing Service 7, XVIII, XXXV Rural Telephone Bank 7, XVI Rural Utilities Service 7, XVII, XVIII, XLII Saint Lawrence Seaway Development Corporation 33, IV Science and Technology Policy, Office of 32, XXIV Science and Technology Policy, Office of, and National 47, II Security Council Secret Service 31, IV Securities and Exchange Commission 17, II Selective Service System 32, XVI Small Business Administration 13, I Smithsonian Institution 36, V Social Security Administration 20, III; 48, 23 Soldiers’ and Airmen’s Home, United States 5, XI Special Counsel, Office of 5, VIII Special Education and Rehabilitative Services, Office of 34, III State Department 22, I Federal Acquisition Regulation 48, 6 Surface Mining and Reclamation Appeals, Board of 30, III Surface Mining Reclamation and Enforcement, Office of 30, VII Surface Transportation Board 49, X Susquehanna River Basin Commission 18, VIII Technology Administration 15, XI Technology Policy, Assistant Secretary for 37, IV Technology, Under Secretary for 37, V Tennessee Valley Authority 5, LXIX; 18, XIII Thrift Supervision Office, Department of the Treasury 12, V Trade Representative, United States, Office of 15, XX Transportation, Department of 5, L Coast Guard 33, I; 46, I; 49, IV Coast Guard (Great Lakes Pilotage) 46, III Commercial Space Transportation 14, III Contract Appeals, Board of 48, 63 Emergency Management and Assistance 44, IV Federal Acquisition Regulation 48, 12 Federal Aviation Administration 14, I Federal Highway Administration 23, I, II; 49, III Federal Railroad Administration 49, II Federal Transit Administration 49, VI Maritime Administration 46, II National Highway Traffic Safety Administration 23, II, III; 49, V Research and Special Programs Administration 49, I Saint Lawrence Seaway Development Corporation 33, IV

250 CFR Title, Subtitle or Agency Chapter Secretary of Transportation, Office of 14, II; 49, Subtitle A Surface Transportation Board 49, X Transportation Statistics Bureau 49, XI Transportation, Office of 7, XXXIII Transportation Statistics Brureau 49, XI Travel Allowances, Temporary Duty (TDY) 41, 301 Treasury Department 5, XXI; 12, XV; 17, IV Alcohol, Tobacco and Firearms, Bureau of 27, I Community Development Financial Institutions Fund 12, XVIII Comptroller of the Currency 12, I Customs Service, United States 19, I Engraving and Printing, Bureau of 31, VI Federal Acquisition Regulation 48, 10 Federal Law Enforcement Training Center 31, VII Fiscal Service 31, II Foreign Assets Control, Office of 31, V Internal Revenue Service 26, I International Investment, Office of 31, VIII Monetary Offices 31, I Secret Service 31, IV Secretary of the Treasury, Office of 31, Subtitle A Thrift Supervision, Office of 12, V Truman, Harry S. Scholarship Foundation 45, XVIII United States and Canada, International Joint Commission 22, IV United States and Mexico, International Boundary and Water 22, XI Commission, United States Section Utah Reclamation Mitigation and Conservation Commission 43, III Veterans Affairs Department 38, I Federal Acquisition Regulation 48, 8 Veterans’ Employment and Training, Office of the Assistant 41, 61; 20, IX Secretary for Vice President of the United States, Office of 32, XXVIII Vocational and Adult Education, Office of 34, IV Wage and Hour Division 29, V Water Resources Council 18, VI Workers’ Compensation Programs, Office of 20, I World Agricultural Outlook Board 7, XXXVIII

251

List of CFR Sections Affected All changes in this volume of the Code of Federal Regulations which were made by documents published in the FEDERAL REGISTER since Jan- uary 1, 1986, are enumerated in the following list. Entries indicate the nature of the changes effected. Page numbers refer to Federal Register pages. The user should consult the entries for chapters and parts as well as sections for revisions. For the period before January 1, 1986, see the ‘‘List of CFR Sections Affected, 1949–1963, 1964–1972, and 1973–1985’’ published in seven separate volumes.

1986 21 CFR—Continued 51 FR Page 21 CFR 51 FR Chapter II—Continued Page 1304.35 Redesignated as 1304.33 Chapter II and (a) amended ...... 5319 1301.03 Amended...... 5319 Redesignated from 1304.38 ...... 5320 1301.24 (b) amended ...... 5319 1304.36 (a) and (b) removed ...... 5319 1301.26 (e) amended...... 5319 (c) redesignated as 1304.34(c) ...... 5320 1301.32 (a)(7), (c) and (f) amend- Redesignated from 1304.39 ...... 5320 ed...... 5319 1304.37 Redesignated as 1304.34 1301.33 (c) amended...... 5319 and amended; new 1304.37 re- 1301.34 (a) amended ...... 5319 designated from 1304.40...... 5320 1301.61 Amended...... 5319 1304.38 Redesignated as 1304.35; 1301.64 Removed...... 5319 new 1304.38 redesignated from 1301.71 (d) amended ...... 5319 1304.41 ...... 5320 1302 Authtority citation re- 1304.39 Redesignated as 1304.36...... 5320 1304.40 Redesignated as 1304.37...... 5320 vised ...... 5319 1304.41 (a) amended ...... 5319 1303 Authority citation re- Redesignated as 1304.38 ...... 5320 vised ...... 5319 1305.03 (c) amended...... 5320 1303.12 (b) and (d) amended...... 5319 1305.05 (b) and (d) amended...... 5319 1303.22 Amended...... 5319 1305.12 (b) amended ...... 5319 1303.27 Amended...... 5319 1306 Authority citation re- 1304.03 (d) amended ...... 5319 vised ...... 5319 (b) corrected ...... 26154 1306.15 Amended...... 5320 1304.04 (f) and (g) amended ...... 5320 1306.23 Amended...... 5320 1304.31 Removed; new 1304.31 re- 1306.25 Amended...... 5320 designated from 1304.33...... 5319 1306.31 (a) amended...... 5320 (a) amended...... 5320 1307.14 (a) amended ...... 5319 1304.32 Removed; new 1304.32 re- 1308.02 (c) revised; (e) and (f) redesignated from 1304.34...... 5319 designated as (f) and (g); new (e) (a) amended...... 5320 added...... 15317 1304.33 Redesignated as 1304.31; 1308.03 (a) revised...... 15318 new 1304.33 redesignated from 1308.04 (a) amended ...... 5320 1304.35 ...... 5319 1308.11 (g)(13) added ...... 4723 1304.34 Redesignated as 1304.32...... 5319 (b)(17) amended ...... 5320 Redesignated from 1304.37 and (b)(17) correctly designated...... 9440 amended...... 5320 1308.11 (g)(1) effective date ex- (c) redesignated from 1304.36(c) tended ...... 15474 ...... 5320 (g)(2) effective date extended...... 21912

253 21 CFR (4–1–99 Edition)

21 CFR—Continued 51 FR 21 CFR—Continued 52 FR Page Page Chapter II—Continued Chapter II—Continued (g)(3) and (4) effective date ex- 1306.22 (a) revised...... 1904, 3605 tended ...... 28695 Technical correction ...... 13430 (g)(1) removed; (b)(31) through 1308.11 (g) (1) and (2) removed; (b) (46) and (g)(2) through (13) re- (33) through (47) and (g) (3) designated as (b)(32) through through (11) redesignated as (b) (47) and (g)(1) through (12); (34) through (37) and (b) (39) new (b)(31) added...... 33593 through (49) and (g) (1) through (d)(7) through (24) redesignated (9); (b) (33) and (38) added ...... 2516 as (d)(8) through (25); new (b)(2) removed; (b) (3) through (d)(7) added; (g)(1) removed; (49) redesignated as (b) (2) (g)(2) through (12) redesig- through (48)...... 2517 nated as (g)(1) through (11) ...... 36560 (g)(5) through (12) addition at 50 (g) designations corrected...... 6546 FR 43700 effective date ex- (g) temporary placement extended ...... 42834 tended ...... 7270 1308.12 (b)(4) revised...... 15318 (b) introductory text revised; (b) (f) redesignated as (g); new (f) (1) through (48) redesignated added ...... 17478 as (b) (2) through (7), (9) and 1308.13 (e)(3) and (4) amended ...... 5320 (10), (12) through (33), (35) 1308.14 (c)(3) table revised ...... 10191 through (40), (42) through (51), 1308.24 Amended...... 5319 (53) and (54); new (b) (1), (8), 1308.52 Added ...... 15318 (11), (34), (41), and (52) added; 1311 Authority citation re- (g) (1), (2), (4), (6), (8), and (9) vised ...... 5319 removed; (g) (3), (5), and (7) re- 1311.03 Amended...... 5319 designated as (g) (1), (2), and 1311.32 (c) and (f) amended ...... 5319 (3) ...... 20072 (b) and (c) amended ...... 5320 Technical correction ...... 27198 1311.61 Amended...... 5319 (g) (4) through (6) added ...... 38226 1311.64 Removed...... 5320 1308.12 (c) (1) through (23) redesig- 1312 Authority citation re- nated as (c) (2) through (24); vised ...... 5319 new (c)(1) added ...... 2517 1312.02 (a) amended ...... 5320 (f)(2) added...... 11043 1312.12 (a) amended ...... 5319, 5320 (f)(2) corrected...... 12285 1312.14 (a) amended ...... 5319 1312.16 (b) amended...... 5319 1308.13 (c)(12) added ...... 2222 1312.18 (b) amended ...... 5319 (c)(1)(i), (ii), and (iii) and (2)(i), 1312.19 (a) and (b) amended...... 5319 (ii), and (iii) revised ...... 5952 1312.22 (a) amended ...... 5319 1308.14 (b)(1) and (2) revised...... 5952 1312.24 (a) amended ...... 5319 1308.15 (c)(6) revised ...... 5952 1312.25 Amended...... 5319 1308.24 (i) table revised; in- 1312.27 (a) amended ...... 5319 terim ...... 9807 1312.28 (c) and (d) amended...... 5319 1308.31—1308.32 Undesignated 1312.31 (b) amended ...... 5319 center heading revised; in- 1312.32 (a) amended ...... 5319 terim ...... 9803 1316 Authority citation re- 1308.31 Heading, (a), (b) introduc- vised ...... 5319 tory text, and (d) revised; (c) 1316.03 (d) amended...... 5319 amended; interim...... 9803 1308.32 Revised; interim ...... 9803 1987 1311.02 (d) revised...... 17288 21 CFR 52 FR 1311.21 Revised ...... 17288 Page 1311.26 Revised ...... 17288 Chapter II 1311.32 (d) revised; (e) and (f) re- 1301.11 (c) and (d) revised ...... 20598 designated as (f) and (g); new (e) 1301.12 Revised ...... 20599 added...... 17288 1301.22 (a)(10) revised ...... 17287 1311.42 (a), (b)(6) (i) and (iv) re- 1301.31 (c) revised; (d) added...... 20599 vised...... 17288

254 List of CFR Sections Affected

21 CFR—Continued 52 FR 21 CFR—Continued 53 FR Page Page Chapter II—Continued Chapter II—Continued 1311.44 (a) and (b) revised; (c) 1306.11 (d) introductory text through (e) redesignated as (e) amended ...... 4964 through (g); new (c) and (d) 1308.11 (g)(2) removed; (b) (12) added; new (f) (1) and (2) and (g) through (54) and (g) (3) through (1) and (2) revised ...... 17288 (6) redesignated as (b) (13) 1311.47 Revised ...... 17289 through (55) and (g) (2) through 1311.53 Revised ...... 17289 (5); new (b)(12) added ...... 501 1311.61 Revised ...... 17289 (d)(7) rdmoved; (d)(8) through 1312 Authority citation re- (25) redesignated as (d)(7) vised...... 17289 through (24)...... 2226 1312.11 (a) and (b) revised...... 17289 (b)(12) correctly revised ...... 3744 1312.12 (a) introductory text re- (d) (7) through (24) redesignated vised...... 17289 as (d) (8) through (25); new 1312.13 (a)(1) revised; (b) through (d)(7) added...... 5158 (e) redesignated as (d) through 1308.11 (g)(6) added ...... 29233 (g); new (b) and (c) added...... 17289 (g) temporary scheduling ex- 1312.18 (a), (b), and (c)(2) re- tended ...... 40061 vised...... 17290 1308.12 (f)(2) corrected; CFR cor- 1312.21 (a) and (b) revised...... 17290 rection ...... 31837 1312.22 (a) revised...... 17290 (c) (6) through (24) redesignated 1312.23 (b) through (d) redesig- as (c) (7) through (25); new nated as (d) through (f); new (b) (c)(6) added ...... 43685 1308.14 (e) (1) through (6) redesig- and (c) added ...... 17290 nated as (e) (2), (5), and (7) 1312.27 (a), (b) (2) and (4) revised; through (10); new (e) (1), (3), (4), (b)(5) added ...... 17290 and (6) added ...... 17460 1312.28 (d) revised...... 17291 1308.15 (d) added ...... 10870 1312.30 Added ...... 17291 1308.24 (i) table revised...... 10835, 36152 1316.71-1316.81 (Subpart E) Au- 1308.32 Table revised ...... 10861 thority citation revised ...... 24446 1311.11 (a) and (b) amended...... 4963 1316.74 Amended ...... 41418 1311.12 Revised ...... 4963 1316.75 (b)(3) amended ...... 24446 1311.32 (a), (b) and (c) amended ...... 4963 1311.43 (a) and (b) amended...... 4963 1988 1312.14 (a) amended ...... 48244 1312.16 (b) amended ...... 48244 21 CFR 53 FR Page 1312.19 (a) and (b) amended ...... 48244 Chapter II 1312.24 (a) amended ...... 48244 1312.25 Amended ...... 48244 1301.11 (a) through (f) amended ...... 4963 1312.28 (c) amended ...... 48244 1301.12 Amended...... 4963 1312.31 (b) amended ...... 48244 1301.13 (a) through (c) amend- 1312.32 (a) amended ...... 48244 ed...... 4963 1301.22 (a)(4) and (b) (5) and (6) amended ...... 4963 1989 1301.32 (a) (1) through (6) and (8), 21 CFR 54 FR (b) (1) through (9) and (c) Page amended ...... 4963 Chapter II 1301.32 (d) revised; (e) and (f) re- 1301.74 (g) amended ...... 33674 designated as (f) and (g); new (e) 1301.75 (d) amended ...... 33674 added...... 21813 1306.06 (b) amended ...... 33674 1301.44 (a) and (b) amended...... 4963 1306.13 (d) amended ...... 33674 1301.61 Amended...... 4963 1305.16 (a) and (b)(1) amended ...... 33674 1303.12 (f) amended ...... 4963 1308.11 (g) (3) and (4) removed; (d) 1305.03 Introductory text amend- (8) through (25) and (g) (5) and ed...... 4963 (6) redesignated as (d) (10) 1305.05 (a) revised; (b) amended ...... 4963 through (27) and (g) (3) and (4); 1305.06 (a) and (b) amended...... 4963 (d) (8) and (9) added ...... 14798

255 21 CFR (4–1–99 Edition)

21 CFR—Continued 54 FR 21 CFR—Continued 56 FR Page Page Chapter II—Continued Chapter II—Continued (g)(3) removed; (f)(2) and (g)(4) 1308.02 (b) through (g) redesig- redesignated as (f)(3) and nated as (c) through (h); new (b) (g)(3); new (f)(2) added...... 14800 added ...... 5754 (d)(28) added...... 28415 1308.12 (e)(2) through (4) redesig- (g) temporary scheduling ex- nated as (e)(3) through (5); new tended ...... 31815 (e)(2) added ...... 11932 1308.22 Table amended...... 2100 1308.13 (f) added ...... 5754 Table revised ...... 12162 (c)(5) removed; (c)(6) through 1308.24 (i) table revised; in- (12) redesignated as (c)(5) terim...... 10633 through (11) ...... 11932 1308.32 Table revised; interim ...... 11520 1308.15 (d)(1) removed; (d)(2) re- 1310 Revised ...... 31662 designated as (d)(1) ...... 61372 1313 Added ...... 31665 1308.24 (i) table revised; in- Policy statement...... 49750 terim ...... 9133 1316 Authority citation re- 1308.25—1308.26 Undesignated vised...... 37610 center heading added ...... 42936 1316.21—1316.22 (Subpart B) Au- 1308.25 Added ...... 42936 thority citation revised ...... 31670 1308.26 Added ...... 42936 1316.21 Redesignated as 1316.23; 1308.33—1308.34 Undesignated new 1316.21 added ...... 31670 center heading added ...... 42936 1316.22 Redesignated as 1316.24; 1308.33 Added ...... 42936 new 1316.22 added ...... 31670 1308.34 Added ...... 42937 1316.23 Redesignated from 1310.02 (a)(13) through (24) added; 1316.21...... 31670 (b)(5) removed; (b)(6), (7) and (8) 1316.24 Redesignated from redesignated as (b)(5), (6) and 1316.22...... 31670 (7)...... 48733 1316.90—1316.99 (Subpart F) 1310.03 Amended...... 8277 Added ...... 37610 1310.04 (f)(1)(xii) revised; (f)(1)(xiii) through (xxiv) 1990 added; (f)(2)(i)(E), and (ii)(E) removed; (f)(2)(i)(F), (G), (H), 21 CFR 55 FR (ii)(F), (G) and (H) redesig- Page nated as (f)(2)(i)(E), (F), (G), Chapter II (ii)(E), (F) and (G) ...... 48733 1308.11 (f)(3) added; (g)(3) re- 1313 Policy statement...... 19269 moved ...... 3588 1313.15 (d) redesignated as (e); new (f)(4) correctly added...... 9117 (d) added ...... 55076 1308.22 table revised...... 12162 1313.24 (d) redesignated as (e); new 1308.24 (i) table revised; interim; (d) added ...... 55077 eff. 4–9–90...... 8915 1316.75 (a) and (b) amended...... 8686 1308.32 Table revised; interim ...... 9114 1316.76 (a) amended...... 8686 1316.03 (a) revised...... 50827 1316.77 (a) amended...... 8686 1316.45 Amended ...... 27464 1316.78 Amended...... 8686 1316.79 (a) amended...... 8686 1991 1316.81 Amended...... 8686 21 CFR 56 FR Page 1992 Chapter II 21 CFR 57 FR 1301.02 (e) revised...... 36726 Page 1301.76 (a) revised...... 36728 Chapter II 1302 Labeling deadlines exten- 1302 Labeling deadlines extension ...... 42231 sion...... 5817 1306.05 (a) revised...... 25026 1308.11 (g)(3) added ...... 18825 1306.13 (b), (c) introductory text (g)(4) added ...... 43401 and (1) revised...... 25027 1308.12 (b)(1) introductory text re- 1308 Technical correction ...... 13854 vised...... 31126

256 List of CFR Sections Affected

21 CFR—Continued 57 FR 21 CFR—Continued 58 FR Page Page Chapter II—Continued Chapter II—Continued 1308.24 (i) table revised; in- (b)(4) revised...... 43796 terim ...... 5818 Regulation at 57 FR 43401 eff. Regulation at 57 FR 5818 con- date extended to 3-21-94 ...... 44611 firmed...... 36371 (g)(3) removed; (f)(3), (4), (5), 1308.26 (a) table revised; in- (g)(4) and (5) redesignated as terim...... 19534 (f)(4), (5), (6), (g)(3) and (4); new Regulation at 57 FR 19534 con- (f)(3) added...... 53406 firmed...... 36372 1308.12 (c)(11) through (25) redes- 1308.32 Introductory text re- ignated as (c)(12) through (26); vised...... 23301 new (c)(11) added ...... 43796 1308.33 (c)(10)(a) and (b) correctly 1308.14 (c)(48) added ...... 7187 designated as (c)(10)(i) and 1308.24 (i) table revised...... 17107 (ii) ...... 10815 1308.26 (a) table amended ...... 15088 1308.34 Table revised ...... 32423, 55091 1308.34 Table amended; in- 1310.02 (b)(8) and (9) added ...... 43615 terim...... 16773 1310.04 (f)(2)(iv) added ...... 43615 Table amended; interim ...... 34708 1310.05 (c) added...... 2461 Regulation at 58 FR 16773 con- 1310.06 (c) revised; (e), (f) and (g) firmed...... 34709 added ...... 2462 Regulation at 58 FR 34708 con- 1310.08 Added ...... 43615 firmed...... 49924 Chapter III 1311.11 Revised ...... 15274 Chapter III Chapter estab- Chapter III lished ...... 55089 1403 appendix A corrected ...... 26185 1401 Added ...... 59803 1402 Added ...... 55089 1994 1403 Added ...... 55092 1404 Added ...... 56263 21 CFR 59 FR Page Chapter II 1993 1301.13 (a) and (b) revised ...... 8859 21 CFR 58 FR 1306.02 (h) redesignated as (i); new Page (h) added...... 26111 Chapter II 1306.11 (a) revised; (e) and (f) 1301 Effective date paragraph at added...... 26111 58 FR 31172 corrected ...... 31907 (a) and (f) corrected ...... 30832 1301.11 Revised ...... 15274 1306.21 (a) and (c) revised ...... 26112 1301.22 (b)(6) revised...... 31175 1306.31 (c) revised...... 26112 1301.24 (b) and (c) introductory (c) corrected ...... 30832 text revised ...... 31175 1308.11 (g)(5) added ...... 673 1304 Effective date paragraph at Regulation at 58 FR 13534 eff. 58 FR 31172 corrected ...... 31907 date extended to 9-12-94 ...... 10720 1304.02 (f) through (i) redesig- (f)(1) through (6) redesignated as nated as (g) through (j); new (f) (f)(2) through (7); new (f)(1) added...... 31175 added ...... 12829 1304.03 (e) through (g) redesig- (g)(3) removed; (g)(4) and (5) re- nated as (f) through (h); new (e) designated as (g)(3) and (4)...... 12830 added; new (h) revised ...... 31175 (g)(3) removed; (d)(1) through 1308.11 (d)(3) through (28) redesig- (29) and (g)(4) redesignated as nated as (d)(4) through (29); (d)(2) through (30) and (g)(3); new (d)(3) added...... 4317 new (d)(1) added ...... 46759 (f)(1) through (4) redesignated as Regulation at 59 FR 673 eff. date (f)(2) through (5); new (f)(1) extended ...... 65710 added ...... 4318 1308.24 (i) table revised ...... 15053 (g)(5) added ...... 13534 Regulation at 59 FR 15053 con- Regulation at 57 FR 18824 eff. firmed...... 52905 date extended to 11-1-93 ...... 25934 1310 Technical correction ...... 52588

257 21 CFR (4–1–99 Edition)

21 CFR—Continued 59 FR 21 CFR—Continued 60 FR Page Page Chapter II—Continued Chapter II—Continued 1310.04 (f) introductory text re- 1310.06 Regulation at 59 FR 51364 vised; (f)(1)(iii) removed; confirmed...... 17628 (f)(1)(iv) through (xxiv) redes- (a) introductory text, (1), (c) and ignated as (f)(1)(iii) through (d) revised...... 32461 (xxiii); (g) added...... 51367 1310.07 (a) and (b) revised...... 32461 1310.06 (b) revised; interim ...... 51364 1310.08 (c), (d) and (e) added...... 19510 1310.09 Added; interim ...... 13882 (b) introductory text revised ...... 32461 1313 Technical correction ...... 52588 1310.09 Revised; interim...... 53122 1313.12 (a) introductory text re- 1310.10 Added ...... 32461 vised...... 51367 1310.11 Added ...... 32462 1313.21 (a) introductory text re- 1310.14 Added ...... 32462 vised...... 51367 1310.15 Added ...... 32463 1313.01 Amended ...... 32465 1995 1313.02 (c), (d) introductory text, 21 CFR 60 FR (1), (h) and (i) revised; (m) re- Page designated as (o); new (m) and Chapter II (n) added...... 32463 1301 Policy statement...... 55310 1313.12—1313.15 Undesignated 1301.24 (b), (c) introductory text center heading amended ...... 32465 and (5) revised...... 36641 1313.12 (c) revised; (d), (e) and (f) 1308.24 (i) table amendeded...... 15956 added...... 32464 1301.37 (a) revised...... 32101 1313.13 (a) amended ...... 32465 1301.43 (a) revised...... 32101 1313.14 Introductory text and (a) 1301.44 (b) redesignated as (c); new amended...... 32465 (b) added ...... 32101 1313.15 Revised ...... 32464 1301.54 (a) through (d) revised...... 32101 1313.21—1313.25 Undesignated 1301.55 (a) revised...... 32102 center heading amended ...... 32465 1306.05 (b) revised...... 36641 1313.21 (d) redesignated as (g); (c) 1307.03 Revised ...... 32454 and new (g) revised; new (d), (e) 1308.11 (d)(3) through (30) redesig- and (f) added ...... 32464 nated as (d)(4) through (31); 1313.22 (a) amended ...... 32465 new (d)(3) added; (g)(3) re- 1313.23 Introductory text and (a) moved ...... 28719 amended...... 32465 1309 Added ...... 32454 1313.31 Undesignated center 1309.02 (f), (g) and (h) correctly re- heading added...... 32465 designated as (e), (f) and (g) ...... 42436 1313.32 Added ...... 32465 1309.12 (b) corrected ...... 35264 1313.33 Added ...... 32465 1310 Technical correction ...... 54409 1313.34 Added ...... 32465 1310.01 (b) through (e), (f)(1) and (a) corrected ...... 35264 (g) revised; (k) redesignated as 1316 Authority citation re- (m); new (k) and (l) added...... 32459 vised...... 32465 1310.02 (b)(10) added ...... 19510 1316.02 (c)(2) revised ...... 32465 Introductory text, (a) and (b) re- (c)(2) corrected ...... 35264 vised ...... 32460 1316.03 (b) through (e) revised ...... 32465 1310.04 (f)(2)(v) added ...... 19510 1316.09 (a)(3) revised...... 32466 (a), (b), (f)(1) and (2) introductory text revised; (f)(1)(xiv), Chapter III (xx) and (xxii) removed; 1403.36 (d), (g), (h) and (i) re- (f)(1)(xv) through (xix), (xxi), vised...... 19639, 19642 and (xxiii) redesignated as 1404.100 Revised ...... 33040, 33045 (f)(1)(xiv) through (xviii), (xix) 1404.105 Amended...... 33041, 33045 and (xx); new (f)(1)(xxi) and 1404.110 (c) revised ...... 33041, 33045 (xxii) added...... 32460 1404.200 Revised ...... 33041, 33045 1310.04 (f)(1)(xxii) and (xxiii) 1404.215 Revised ...... 33041, 33045 correctly redesignated as 1404.220 Revised ...... 33041, 33045 (f)(1)(xxi) and (xxii)...... 42436 1404.225 Revised ...... 33041, 33045

258 List of CFR Sections Affected

21 CFR—Continued 60 FR 21 CFR—Continued 61 FR Page Page Chapter III—Continued Chapter II—Continued 1404 Appendixes A and B re- 1313.32 Heading correctly revised...... 33042, 33045 vised...... 17566 1316.01—1316.13 (Subpart A) Au- 1996 thority citation correctly revised...... 17566 21 CFR 61 FR Page Chapter II 1997 1301 Comment request ...... 68624 21 CFR 62 FR 1308.12 (c)(26) redesignated as Page (c)(27); new (c)(26) added ...... 56894 Chapter II 1308.24 (i) table revised...... 13690 1300 Added ...... 13941 1309.02 (f) revised ...... 40989 1300.02 (b)(28)(i)(D)(1), (2) and (29) Corrected...... 41836 correctly revised ...... 15392 (f) corrected...... 48830 1301.01 Revised ...... 13945 Regulation at 61 FR 40989 with- 1301.02 Revised ...... 13945 drawn ...... 52287 1301.11—1301.18 Undesignated 1309.21 Revised ...... 32926 center heading revised ...... 13945 1309.22 (b) revised...... 32926 1301.11 Revised ...... 13945 1309.28 Added ...... 32926 1301.12 Revised ...... 13945 1309.29 Added ...... 40989 1301.13 Revised ...... 13946 Correctly designated ...... 48830 1301.14 Added ...... 13948 Regulation at 61 FR 40989 with- 1301.15 Added ...... 13948 drawn ...... 52287 1301.16 Added ...... 13949 1309.71 (a)(2) revised...... 40989 1301.17 Added ...... 13949 Regulation at 61 FR 40989 with- 1301.18 Added ...... 13949 drawn ...... 52287 1301.21—1301.26 Undesignated 1310.01 (f)(1)(iv)(A) revised ...... 40990 center heading revised ...... 13950 Regulation at 61 FR 40990 with- 1301.21 Revised ...... 13950 drawn ...... 52287 1301.22 Revised ...... 13950 1310.03 Existing text designated 1301.23 Revised ...... 13951 as (a); (b) added; eff. 4–29–96...... 14023 1301.24 Revised ...... 13951 1310.04 (f) introductory text and 1301.25 Revised ...... 13951 (1)(x) revised...... 40990 1301.26 Revised ...... 13952 Corrected...... 48830 1301.31—1301.37 Undesignated Regulation at 61 FR 40990 with- center heading revised ...... 13953 drawn ...... 52287 1301.31 Revised ...... 13953 1310.05 (d) added; eff. 4–29–96 ...... 14024 1301.32 Revised ...... 13953 Corrected...... 17958 1301.33 Revised ...... 13953 1310.06 (h) added; eff. 4–29–96 ...... 14024 1301.34 Revised ...... 13953 (b) revised...... 32926 1301.35 Revised ...... 13954 1310.09 Revised ...... 40990 1301.36 Revised ...... 13955 Regulation at 61 FR 40990 with- 1301.37 Revised ...... 13955 drawn ...... 52287 1301.41—1301.46 Undesignated 1310.14 Heading and (a) revised ...... 40990 center heading revised ...... 13956 Regulation at 61 FR 40990 with- 1301.41 Revised ...... 13956 drawn ...... 52287 1301.42 Revised ...... 13956 1310.15 Heading, (a) and (d) re- 1301.43 Revised ...... 13956 vised...... 40990 1301.44 Revised ...... 13956 Regulation at 61 FR 40990 with- 1301.45 Revised ...... 13956 drawn ...... 52287 1301.46 Revised ...... 13956 1311 Comment request ...... 68624 1301.51—1301.52 Undesignated 1313 Policy statement...... 13759 center heading revised ...... 13956 1313.02 (d)(1)(iv)(A) revised...... 40991 1301.51 Revised ...... 13956 Regulation at 61 FR 40991 with- 1301.52 Revised ...... 13957 drawn ...... 52287 1301.53 Removed ...... 13945 1313.23 (c) revised...... 51004 1301.54 Removed ...... 13945

259 21 CFR (4–1–99 Edition)

21 CFR—Continued 62 FR 21 CFR—Continued 62 FR Page Page Chapter II—Continued Chapter II—Continued 1301.55 Removed ...... 13945 1304.25 Removed; new 1304.25 re- 1301.56 Removed ...... 13945 designated from 1304.29 ...... 13961 1301.57 Removed ...... 13945 1304.26 Removed ...... 13961 1301.61—1301.63 Undesignated 1304.27 Redesignated as 1304.23 ...... 13961 center heading removed...... 13945 1304.28 Redesignated as 1304.24 ...... 13961 1301.61 Removed ...... 13945 1304.29 Redesignated as 1304.25 ...... 13961 1301.62 Removed ...... 13945 1304.31 Revised ...... 13961 1301.63 Removed ...... 13945 1304.32 Revised ...... 13962 1301.72 (b)(4)(i)(b) amended ...... 13957 1304.33 Removed; new 1304.33 re- 1301.75 (b) revised...... 13957 designated from 1304.34 and re- 1301.76 (c) revised...... 13957 vised (OMB number) ...... 13962 1302.02 Revised ...... 13958 1304.34 Redesignated as 1304.33 ...... 13962 1302.04 Revised ...... 13958 1304.35 Removed ...... 13963 1302.05 Removed; new 1302.05 re- 1304.36 Removed ...... 13963 designated from 1302.06 and re- 1304.37 Removed ...... 13963 vised...... 13958 1304.38 Removed ...... 13963 1302.06 Redesignated as 1302.05; 1305.02 Revised ...... 13963 new 1302.06 redesignated from 1305.03 Revised ...... 13963 1302.07 and revised...... 13958 1305.04 (b) amended ...... 13964 1302.07 Redesignated as 1302.06; 1305.05 (b) amended ...... 13964 new 1302.07 redesignated from 1305.06 Revised ...... 13963 1302.08 and revised...... 13958 1305.07 Revised ...... 13963 1302.08 Redesignated as 1302.07 ...... 13958 1305.08 (a) amended ...... 13964 1303.02 Revised ...... 13958 1305.09 (b) and (d) amended ...... 13964 1303.12 (b), (d), (e)(1) and (3) 1305.10 (a) amended ...... 13964 amended...... 13958 1305.12 (b) revised...... 13964 1303.21 (a) amended ...... 13958 1305.13 (a), (b), and (c) amend- 1303.22 Introductory text amended ...... 13964 ed ...... 13958 1305.14 Amended ...... 13964 1303.26 Amended ...... 13958 1305.16 (b) amended ...... 13964 1303.27 Amended ...... 13958 1306.02 Revised ...... 13964 1303.32 (b) amended ...... 13958 1306.03 (a)(2) amended ...... 13966 1303.35 (a) amended ...... 13958 1306.05 (b) and (c) amended ...... 13966 1304 Authority citation re- 1306.11 (a), (d)(4) and (e) revised; vised...... 13958 (g) added ...... 13964 1304.02 Revised ...... 13958 1306.13 (b) revised...... 13965 1304.03 (f) revised; (g) and (h) re- 1306.14 Heading revised; (c) moved ...... 13958 added...... 13965 1304.04 (a) introductory text 1306.15 Removed ...... 13965 amended; (e) and (h) revised ...... 13959 1306.21—1306.26 Undesignated 1304.11 Revised ...... 13959 center heading revised ...... 13965 1304.12 Removed ...... 13960 1306.21 Revised ...... 13965 1304.13 Removed ...... 13960 1306.22 (a)(2), (b) introductory 1304.14 Removed ...... 13960 text, (2) and (4) amended...... 13966 1304.15 Removed ...... 13960 1306.23 Introductory text re- 1304.16 Removed ...... 13960 vised...... 13965 1304.17 Removed ...... 13960 1306.24 Revised ...... 13965 1304.18 Removed ...... 13960 1306.25 Removed ...... 13965 1304.19 Removed ...... 13960 Redesignated from 1306.26; (a) 1304.21 (a) and (c) revised ...... 13960 and (b) revised ...... 13966 1304.22 Revised ...... 13960 1306.26 Redesignated as 1306.25; 1304.23 Removed; new 1304.23 renew 1306.26 redesignated from designated from 1304.27 ...... 13961 1306.32; introductory text and 1304.24 Removed; new 1304.24 re- (a) revised...... 13966 designated from 1304.28; (b) and 1306.31—1306.32 Undesignated (d) amended ...... 13961 center heading removed...... 13966

260 List of CFR Sections Affected

21 CFR—Continued 62 FR 21 CFR—Continued 62 FR Page Page Chapter II—Continued Chapter II—Continued 1306.31 Removed ...... 13966 1309 Waiver...... 53958 1306.32 Redesignated as 1306.26 ...... 13966 1309.02 Revised ...... 13968 1307.01 Revised ...... 13966 1309.21 (a) and (b) amended ...... 13968 1307.02 Revised ...... 13966 1309.25 (a) and (b) amended ...... 13968 1307.03 Revised ...... 13966 1309.29 Added; interim...... 5916 1307.11 (a)(2), (4) and (b) amend- Regulation at 62 FR 5916 con- ed ...... 13967 firmed...... 52256 1307.12 Removed ...... 13966 Revised...... 53960 Redesignated from 1307.13...... 13967 1309.43 (d) revised; (e) added; in- 1307.13 Redesignated as 1307.12; terim ...... 5916 new 1307.13 redesignated from Regulation at 62 FR 5916 con- 1307.15...... 13967 firmed...... 52256 1307.14 Removed ...... 13967 1309.44 (b) revised; interim...... 5916 1307.15 Redesignated as 1307.13 ...... 13967 Regulation at 62 FR 5916 con- 1307.21 (a) revised...... 13967 firmed...... 52256 1307.22 Amended ...... 13967 1309.53 Removed; new 1309.53 re- 1308 Controlled substance sched- designated from 1309.54 ...... 13968 ules ...... 29288, 29289, 51774, 51776 1308.02 Revised ...... 13967 1309.54 Redesignated as 1309.53; 1308.03 (a) amended ...... 13968 new 1309.54 redesignated from 1308.04 Removed ...... 13967 1309.55...... 13968 1308.12 (g) amended ...... 13968 1309.55 Redesignated as 1309.54; 1308.13 (b)(1) amended ...... 13968 new 1309.55 redesignated from 1308.14 (f)(2) added...... 51371 1309.56...... 13968 1308.22 Table amended ...... 13968 1309.56 Redesignated as 1309.55 ...... 13968 1308.23 (c)(7) and (f) amended ...... 13968 1309.57 Removed ...... 13968 1308.24 Table removed; (a) and (i) 1309.62 Existing text designated revised ...... 13967 as (a); new (a) revised; (b) (d) amended ...... 13968 added; interim...... 5916 1308.26 Table removed; (a) re- Regulation at 62 FR 5916 con- vised...... 13967 firmed...... 52256 1308.32 Table removed...... 13967 1309.71 (a)(2) amended ...... 13968 1308.33 (a) and (b) amended ...... 13968 1310.01 (f)(1)(iv)(A) and (B) re- 1308.34 Table removed...... 13967 vised; (g) through (k) and (l) re- 1308.42 Revised ...... 13968 designated as (h) through (l) 1308.43 Removed; new 1308.43 re- and (o); new (g) and (n) added; designated from 1308.44; (f) interim ...... 5916 amended...... 13968 Revised...... 13968 1308.44 Redesignated as 1308.43; Regulation at 62 FR 5917 con- new 1308.44 redesignated from firmed...... 52256 1308.45; (e) amended...... 13968 1310.02 (a)(16) and (21) revised; in- 1308.45 Redesignated as 1308.44; terim ...... 5917 new 1308.45 redesignated from Regulation at 62 FR 5917 con- 1308.48...... 13968 firmed...... 52256 1308.46 Removed; new 1308.46 re- 1310.04 (a) revised; interim...... 5917 designated from 1308.49; cor- Regulation at 62 FR 5917 con- rected...... 13968 firmed...... 52256 1308.47 Removed; new 1308.47 re- 1310.05 (c) amended ...... 13968 designated from 1308.50 ...... 13968 1310.08 Introductory text amend- 1308.48 Redesignated as 1308.45 ...... 13968 ed ...... 13968 1308.49 Redesignated as 1308.45; 1310.09 Revised; interim ...... 5917 new 1308.49 redesignated from Removed...... 13968 1308.52; amended ...... 13968 Reinstated...... 15392 1308.50 Redesignated as 1308.45 ...... 13968 Revised; interim...... 27693 1308.51 Removed ...... 13968 Regulation at 62 FR 27693 con- 1308.52 Redesignated as 1309.49 ...... 13968 firmed...... 52256

261 21 CFR (4–1–99 Edition)

21 CFR—Continued 62 FR 21 CFR—Continued 62 FR Page Page Chapter II—Continued Chapter II—Continued Existing text designated as (a); 1316.13 Revised ...... 13969 (b) added ...... 53960 1316.23 (b) amended ...... 13970 1310.10 (a) amended ...... 13968 1316.24 (c) amended ...... 13970 1310.14 (a) amended ...... 13968 1316.41 Amended ...... 13970 1310.15 (d) amended ...... 13968 1316.42 (h) revised...... 13969 1311 Removed ...... 13969 1316.46 (b)(1) amended ...... 13970 1311.27 (b)(2) revised; (c) added ...... 4645 1316.52 (a) amended ...... 13970 1312.02 Revised ...... 13969 1316.71 (f) revised ...... 13969 1312.12 (a) amended ...... 13969 1316.77 (a) amended ...... 13970 1312.14 (a) amended ...... 13969 1316.81 Amended ...... 13970 1312.16 (b) amended ...... 13969 1312.17 Amended ...... 13969 Chapter III 1312.18 (b) and (c) amended ...... 13969 1403.26 (a), (b) introductory text 1312.19 (a) and (b) amended ...... 13969 and (1) revised...... 45939, 45941 1312.22 (a) amended ...... 13969 1312.24 (a) amended ...... 13969 1998 1312.25 Amended ...... 13969 21 CFR 63 FR 1312.27 (a), (b)(5)(iii) and (iv) Page amended...... 13969 Chapter II 1312.28 (d) amended ...... 13969 1312.31 (b) amended ...... 13969 1308.14 (e)(10) redesignated as 1312.32 (a) amended ...... 13969 (e)(11); new (e)(10) added...... 6864 1313.02 (d)(1)(iv)(A) and (B) revised; interim...... 5917 1999 Revised...... 13969 (Regulations published from January 1, Regulation at 62 FR 5917 con- 1999, through April 1, 1999) firmed...... 52256 1313.15 (a) amended ...... 13969 21 CFR 64 FR 1313.21 (c)(1) amended ...... 13969 Page 1313.24 (a) amended ...... 13969 Chapter II 1316.02 (g) revised...... 13969 1308.4 (e)(7) through (11) redesig- 1316.05 Amended ...... 13970 nated as (e)(8) through (12); new 1316.12 Amended ...... 13970 (e)(7) added...... 4052 Æ

262