Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Proposed Rules 31521

I. Background document to http://www.regulations.gov DATES: Interested persons may file FDA is announcing the availability of or written comments to the Division of written comments on this proposal in a draft revised GFI #120 entitled Dockets Management (see ADDRESSES). It accordance with 21 CFR 1308.43(g). ‘‘Veterinary Feed Directive Regulation is only necessary to send one set of Electronic comments must be Questions and Answers.’’ The audience comments. Identify comments with the submitted, and written comments must for this draft guidance is comprised of docket number found in brackets in the be postmarked, on or before July 6, veterinarians issuing VFD orders, feed heading of this document. Received 2015. Commenters should be aware that mills manufacturing VFD feeds and comments may be seen in the Division the electronic Federal Docket other distributors, animal producers of Dockets Management between 9 a.m. Management System will not accept who obtain VFD feeds for use in treating and 4 p.m., Monday through Friday, and comments after 11:59 p.m. Eastern Time their animals, and others. This draft will be posted to the docket at http:// on the last day of the comment period. revised guidance reflects changes to the www.regulations.gov. Interested persons, defined at 21 CFR 1300.01 as those ‘‘adversely affected or VFD requirements under the VFD final V. Electronic Access rule published elsewhere in this edition aggrieved by any rule or proposed rule of the Federal Register. Persons with access to the Internet issuable pursuant to section 201 of the In 1996, Congress enacted the Animal may obtain the draft guidance at either Act (21 U.S.C. 811)’’, may file a request Drug Availability Act (ADAA) to http://www.fda.gov/AnimalVeterinary/ for hearing or waiver of participation facilitate the approval and marketing of GuidanceComplianceEnforcement/ pursuant to 21 CFR 1308.44 and in new animal drugs and medicated feeds. GuidanceforIndustry/default.htm or accordance with 21 CFR 1316.45, In passing the ADAA, Congress created http://www.regulations.gov. 1316.47, 1316.48, or 1316.49, as a new regulatory category for certain Dated: May 28, 2015. applicable. Requests for hearing, notices animal drugs used in animal feed called Leslie Kux, of appearance, and waivers of an opportunity for a hearing or to veterinary feed directive (VFD) drugs. Associate Commissioner for Policy. VFD drugs are new animal drugs participate in a hearing must be [FR Doc. 2015–13394 Filed 6–2–15; 8:45 am] intended for use in or on animal feed received on or before July 6, 2015. BILLING CODE 4164–01–P which are limited to use under the ADDRESSES: To ensure proper handling professional supervision of a licensed of comments, please reference ‘‘Docket veterinarian. FDA published final No. DEA–415’’ on all correspondence, regulations implementing the VFD- DEPARTMENT OF JUSTICE including any attachments. related provisions of the ADAA in 2000. • Electronic comments: The DEA Elsewhere in this edition of the Drug Enforcement Administration encourages that all comments be Federal Register, FDA is publishing a submitted through the Federal VFD final rule that revises those VFD 21 CFR Part 1308 eRulemaking Portal, which provides the regulations and introduces clarifying ability to type short comments directly changes to specified definitions. This [Docket No. DEA–415] into the comment field on the Web page draft revised guidance includes or to attach a file for lengthier revisions that are consistent with the Schedules of Controlled Substances: comments. Please go to http:// 123 requirements in that final rule. Removal of [ I]Ioflupane From www.regulations.gov and follow the Schedule II of the Controlled II. Significance of Guidance online instructions at that site for Substances Act submitting comments. Upon completion This level 1 draft guidance is being of your submission you will receive a issued consistent with FDA’s good AGENCY: Drug Enforcement Administration, Department of Justice. Comment Tracking Number for your guidance practices regulation (21 CFR comment. Please be aware that ACTION: Notice of proposed rulemaking. 10.115). The draft guidance, when submitted comments are not finalized, will represent the Agency’s SUMMARY: The Drug Enforcement instantaneously available for public current thinking on this topic. It does view on Regulations.gov. If you have not establish any rights for or on any Administration proposes to remove 123 received a Comment Tracking Number, person and does is not binding on FDA [ I]ioflupane from the schedules of the Controlled Substances Act. This action your comment has been successfully or the public. An alternative approach submitted and there is no need to may be used if such approach satisfies is pursuant to the Controlled Substances Act which requires that such actions be resubmit the same comment. the requirements of the applicable • Paper comments: Paper comments statutes and regulations. made on the record after an opportunity for a hearing through formal that duplicate an electronic submission III. Paperwork Reduction Act of 1995 rulemaking. [123I]Ioflupane is, by are not necessary and are discouraged. Should you wish to mail a comment in This draft guidance refers to definition, a schedule II controlled lieu of submitting a comment online, it previously approved collections of substance because it is derived from should be sent via regular or express information found in FDA regulations. cocaine via ecgonine, both of which are mail to: Drug Enforcement These collections of information are schedule II controlled substances. This Administration, Attention: DEA Federal subject to review by the Office of action would remove the regulatory Register Representative/ODXL, 8701 Management and Budget (OMB) under controls and administrative, civil, and Morrissette Drive, Springfield, Virginia the Paperwork Reduction Act of 1995 criminal sanctions applicable to 22152. (44 U.S.C. 3501–3520). The collections controlled substances, including those • Hearing requests: All requests for of information in 21 CFR 558.6 have specific to schedule II controlled hearing must be sent to: DEA Federal been approved under OMB control substances, on persons who handle Register Representative/ODL, 8701 number 0910–0363. (manufacture, distribute, reverse distribute, dispense, conduct research, Morrissette Drive, Springfield, Virginia IV. Comments import, export, or conduct chemical 22152. Interested persons may submit either analysis) or propose to handle FOR FURTHER INFORMATION CONTACT: John electronic comments regarding this [123I]ioflupane. R. Scherbenske, Office of Diversion

VerDate Sep<11>2014 17:19 Jun 02, 2015 Jkt 235001 PO 00000 Frm 00035 Fmt 4702 Sfmt 4702 E:\FR\FM\03JNP1.SGM 03JNP1 asabaliauskas on DSK5VPTVN1PROD with PROPOSALS 31522 Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Proposed Rules

Control, Drug Enforcement record after opportunity for a hearing.’’ found at 21 U.S.C. 812(c) and the Administration; Mailing Address: 8701 Such proceedings are conducted current list of scheduled substances is Morrissette Drive, Springfield, Virginia pursuant to the provisions of the published at 21 CFR part 1308. 22152; Telephone: (202) 598–6812. Administrative Procedure Act (APA) (5 Pursuant to 21 U.S.C. 811(a)(2), the SUPPLEMENTARY INFORMATION: U.S.C. 551–559). 21 CFR 1308.41– Attorney General may, by rule, ‘‘remove 1308.45, and 21 CFR part 1316 subpart any drug or other substance from the Posting of Public Comments D. In accordance with 21 CFR 1308.44 schedules if he [or she] finds that the Please note that all comments (a)–(c), requests for hearing, notices of drug or other substance does not meet received in response to this docket are appearance, and waivers of an the requirements for inclusion in any considered part of the public record. opportunity for a hearing or to schedule.’’ The Attorney General has They will, unless reasonable cause is participate in a hearing may be delegated scheduling authority under 21 given, be made available by the DEA for submitted only by interested persons, U.S.C. 811 to the Administrator of the public inspection online at http:// defined as those ‘‘adversely affected or DEA, 28 CFR 0.100. www.regulations.gov. Such information aggrieved by any rule or proposed rule The CSA provides that proceedings includes personal identifying issuable pursuant to section 201 of the for the issuance, amendment, or repeal information (such as your name, Act (21 U.S.C. 811).’’ 21 CFR 1300.01. of the scheduling of any drug or other address, etc.) voluntarily submitted by Such requests or notices must conform substance may be initiated by the the commenter. The Freedom of to the requirements of 21 CFR 1308.44 Attorney General (1) on his or her own Information Act (FOIA) applies to all (a) or (b), and 1316.47 or 1316.48, as motion, (2) at the request of the comments received. If you want to applicable, and include a statement of Secretary of the Department of Health submit personal identifying information the interest of the person in the and Human Services,1 or (3) on the (such as your name, address, etc.) as proceeding and the objections or issues, petition of any interested party. 21 part of your comment, but do not want if any, concerning which the person U.S.C. 811(a). This action was initiated it to be made publicly available, you desires to be heard. Any waiver must at the request of the Assistant Secretary must include the phrase ‘‘PERSONAL conform to the requirements of 21 CFR for Health of the HHS, and is supported IDENTIFYING INFORMATION’’ in the 1308.44(c) and 1316.49, including a by an evaluation of all relevant data by first paragraph of your comment. You written statement regarding the the HHS and the DEA. This action must also place the personal identifying interested person’s position on the would remove the regulatory controls information you do not want made matters of fact and law involved in any and administrative, civil, and criminal publicly available in the first paragraph hearing. sanctions applicable to controlled of your comment and identify what substances, including those specific to Legal Authority information you want redacted. schedule II controlled substances, on If you want to submit confidential The Drug Enforcement persons who handle or propose to business information as part of your Administration (DEA) implements and handle [123I]ioflupane. enforces titles II and III of the comment, but do not want it to be made Background publicly available, you must include the Comprehensive Drug Abuse Prevention phrase ‘‘CONFIDENTIAL BUSINESS and Control Act of 1970, as amended. 21 DaTscan is a single-dose, injectable INFORMATION’’ in the first paragraph U.S.C. 801–971. Titles II and III are diagnostic radiopharmaceutical for use of your comment. You must also referred to as the ‘‘Controlled in hospital settings with specialized prominently identify confidential Substances Act’’ and the ‘‘Controlled gamma cameras. It was developed as a business information to be redacted Substances Import and Export Act,’’ diagnostic tool for visualization of within the comment. respectively, but they are collectively dopamine transporters (DAT) by using Comments containing personal referred to as the ‘‘Controlled single photon emission computed identifying information and confidential Substances Act’’ or the ‘‘CSA’’ for the tomography (SPECT) brain imaging. The business information identified as purposes of this action. The DEA Food and Drug Administration (FDA) directed above will generally be made publishes the implementing regulations approved the New Drug Application publicly available in redacted form. If a for these statutes in title 21 of the Code (NDA) for DaTscan on January 14, 2011, comment has so much confidential of Federal Regulations (CFR), chapter II. for the indication of visualizing striatal business information or personal The CSA and its implementing DATs in the brains of adult patients identifying information that it cannot be regulations are designed to prevent, with suspected Parkinsonian syndromes effectively redacted, all or part of that detect, and eliminate the diversion of (PS). [123I]Ioflupane is the active comment may not be made publicly controlled substances and listed pharmaceutical ingredient (API) in available. Comments posted to http:// chemicals into the illicit market while DaTscan and it is a new molecular www.regulations.gov may include any ensuring an adequate supply is available entity. However, [123I]Ioflupane is, by personal identifying information (such for the legitimate medical, scientific, definition, a schedule II controlled as name, address, and phone number) research, and industrial needs of the substance because it is derived from included in the text of your online United States. Controlled substances cocaine, a schedule II substance, via submission that is not identified as have the potential for abuse and ecgonine (a schedule II substance). See directed above as confidential. dependence and are controlled to 21 U.S.C. 812(c), Schedule II, (a)(4). An electronic copy of this document protect the public health and safety. and supplemental information to this Under the CSA, each controlled 1 As discussed in a memorandum of substance is classified into one of five understanding entered into by the Food and Drug proposed rule are available at http:// Administration (FDA) and the National Institute on www.regulations.gov for easy reference. schedules based upon its potential for Drug Abuse (NIDA), the FDA acts as the lead agency abuse, its currently accepted medical within the HHS in carrying out the Secretary’s Request for Hearing, Notice of use in treatment in the United States, scheduling responsibilities under the CSA, with the Appearance at or Waiver of and the degree of dependence the drug concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. Participation in Hearing The Secretary of the HHS has delegated to the or other substance may cause. 21 U.S.C. Assistant Secretary for Health of the HHS the Pursuant to 21 U.S.C. 811(a), this 812. The initial schedules of controlled authority to make domestic drug scheduling action is a formal rulemaking ‘‘on the substances established by Congress are recommendations. 58 FR 35460, July 1, 1993.

VerDate Sep<11>2014 17:19 Jun 02, 2015 Jkt 235001 PO 00000 Frm 00036 Fmt 4702 Sfmt 4702 E:\FR\FM\03JNP1.SGM 03JNP1 asabaliauskas on DSK5VPTVN1PROD with PROPOSALS Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Proposed Rules 31523

Each vial of DaTscan contains 0.325 under ‘‘Supporting and Related pharmacological effects resulting from micrograms (mg) of [123I]ioflupane per Material’’ of the public docket for this DaTscan administration. The maximum 2.5 milliliters (ml). The average and rule at http://www.regulations.gov dose of [123I]ioflupane in DaTscan that maximum amounts of non-radioactive under docket number DEA–415. is administered to the patient prior to ioflupane in each DaTscan vial are undergoing an imaging procedure is 1. The Drug’s Actual or Relative estimated to be between 0.21 mg and 0.325 mg (0.13 mg/ml). HHS extrapolated Potential for Abuse 0.31 mg. Although ioflupane, the non- from the locomotor study and drug radiolabeled API of the drug product According to HHS and the DEA, there discrimination study on non- DaTscan, binds to DAT and elicits are no data demonstrating that radiolabeled ioflupane and estimated behavioral effects similar to that of individuals are administering quantities that the lowest active dose of DaTscan cocaine, based upon the available of DaTscan sufficient to create a hazard for a 60 kg (132.2 lb) human to achieve information and DaTscan’s unique to their health or to the safety of other a pharmacologic effect would be 288 mg formulation-specific properties, individuals or to the community. In or 886 vials of DaTscan. In addition, the DaTscan itself presents no practical clinical studies, DaTscan, due to its low recreational dose of DaTscan is possibility of abuse, misuse, diversion concentrations of [123I]ioflupane lacked, estimated as 1921 mg or 5,910 vials. or clandestine production. central nervous activity (CNS) in Although [123I]ioflupane would be humans. expected to have a pharmacological Proposed Determination To Decontrol According to HHS review of 123 profile nearly identical to its non- [ I]Ioflupane Sponsor’s calculation regarding radioactive form, its unique properties Pursuant to 21 U.S.C. 811(b), (c), and psychoactive doses of DaTscan, (i.e., manufacturing limits and (f), the HHS recommended to the DEA approximately 6,000 vials of DaTscan radioactive properties) pose practical on November 2, 2010, that FDA- would be required to produce a barriers to its abuse. Furthermore, approved products containing subjective ‘‘high’’ in humans from according to HHS, the amount of [123I]ioflupane be removed from exposure to [123I]ioflupane in this [123I]ioflupane in DaTscan is schedule II of the CSA. HHS provided product. The volume of 6,000 vials is significantly less than the amounts of to DEA a scientific and medical about 15 liters (L) of fluid, an amount ioflupane used to elicit the evaluation document entitled ‘‘Basis for that would be lethal if administered pharmacological response in preclinical the Recommendation to Remove FDA intravenously (i.v.). The short half-life studies with this compound. Approved Products Containing of DaTscan (due to its radioactive decay) [123I]Ioflupane from Schedule II of the will prevent its extended storage for 3. The State of Current Scientific Controlled Substances Act (CSA).’’ future use at the manufacturing, Knowledge Regarding the Drug or Other Pursuant to 21 U.S.C. 811(b), this distributing, or radiopharmacy site; Substance document contained an eight-factor thereby limiting the amount available The international non-proprietary analysis of FDA-approved products for diversion. It is highly unlikely that name of [123I]ioflupane is methyl(1R, containing [123I]ioflupane, along with individuals will administer DaTscan on 2S, 3S, 5S)-8-(3-fluoropropyl)-3-(4- the HHS’s recommendation to remove their own initiative since DaTscan has [123I]iodophenyl)-8-azabicyclo[3,2,1] FDA-approved products containing a very dilute and small dose of octane-2-carboxylate. The molecular [123I]ioflupane from the schedules of the [123I]ioflupane, and possesses formula of [123I]ioflupane is 123 CSA. radioactivity. As a result, DaTscan will C18H23F[ I]NO2 and the molecular In response, the DEA reviewed the not have significant capability of weight is 427.28 g/mol. [123I]Ioflupane scientific and medical evaluation and creating hazards to the health of the user is a clear, colorless solution and is only scheduling recommendation provided or to the safety of the community. present in a solution of ethanol and by the HHS, and all other relevant data. sodium acetate buffer. Non-radioactive The DEA and HHS collaborated further 2. Scientific Evidence of the Drug’s ioflupane is a white solid with a melting regarding the available information. By Pharmacological Effects, If Known point of 83 °C to 87 °C and soluble in letter dated February 2, 2015, the HHS DaTscan blocks monoamine water (less than 0.1 mg/ml), sodium provided detailed responses to specific transporters, such as DAT and other acetate buffer (pH 7.4; 16 mg/ml), and inquiries from the DEA (submitted by monoamine transporters such as ethanol (27 mg/ml). letter dated September 16, 2014). Upon serotonin transporters. Ioflupane, the HHS states that meaningful extraction further review of all of the available active pharmaceutical ingredient in of [123I]ioflupane from DaTscan would information, the DEA completed its own DaTscan, was demonstrated to have an be impossible due to its limited eight-factor review document on FDA- affinity to DAT that was approximately production and availability and because approved diagnostic products 10- and 100-fold greater than cocaine in extraction is technically complex and containing [123I]ioflupane (currently, rodent brain homogenates or in cells would require advanced equipment not only DaTscan) pursuant to 21 U.S.C. transfected with rat DAT (Neumeyer et available to the general public. 811(c). The FDA-approved diagnostic al., 1996; Okada et al., 1998; Scheffel et Importantly, if extraction of ioflupane product, DaTscan, was used as the basis al., 1997). As reported by HHS, non- from [123I]ioflupane is accomplished, for the scientific and medical evaluation radiolabeled ioflupane at doses >0.1 mg/ the ioflupane would be subject to of FDA-approved diagnostic products kg, i.v. was able to substitute for cocaine schedule II controls under the CSA. containing [123I]ioflupane for both the in cocaine-trained rats (10 mg/kg, According to HHS, the retrosynthesis of HHS and DEA eight-factor analysis. intraperitoneal administration) using a DaTscan to cocaine and ecgonine would Included below is a brief summary of drug discrimination protocol which is be difficult. Production of DaTscan is each factor as analyzed by the HHS and predictive of subjective behavioral technically complex as it requires the DEA, and as considered by the DEA effects in humans. specialized equipment, facilities, in this proposed rule to remove HHS reviewed data from eight human scientific training and expertise, making [123I]ioflupane from the schedules of the clinical trials involving 942 subjects and clandestine manufacturing particularly CSA. Please note that both the DEA and nine years of post-approval use in difficult. HHS indicated that the non- HHS analyses and other relevant Europe and found that there was not radiolabeled precursors needed for the documents are available in their entirety any clinical evidence of synthesis of [123I]ioflupane (and

VerDate Sep<11>2014 17:19 Jun 02, 2015 Jkt 235001 PO 00000 Frm 00037 Fmt 4702 Sfmt 4702 E:\FR\FM\03JNP1.SGM 03JNP1 asabaliauskas on DSK5VPTVN1PROD with PROPOSALS 31524 Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Proposed Rules

DaTscan) are abusable. In addition, the part 35 and/or by states) 4 on the [123I]ioflupane from schedule II of the’’ non-radiolabeled precursors derived manufacturing and handling of CSA. However, because the DEA finds from cocaine or ecgonine are also DaTscan, abuse of DaTscan is not no basis to remove only FDA approved schedule II controlled substances. possible as a practical matter. Thus, products containing [123I]ioflupane from However, even if an individual obtained there is little to no practical risk to the schedules, this action proposes to the precursors, it is impractical and public health from DaTscan abuse. remove the substance [123I]ioflupane highly unlikely that they would 7. Its Psychic or Physiological from the CSA schedules. Historically, synthesize the abusable compound into Dependence Liability when new molecular entities are a radiolabeled formulation with a removed from control, the substance limited storage life that is not desired by As reviewed by HHS, non- itself is removed from control rather drug users. radiolabeled ioflupane has cocaine-like than the specific FDA-approved drug On January 14, 2011, FDA approved properties. In a drug discrimination product (e.g., naloxegol, 80 FR 3468; the NDA for DaTscan with the study in cocaine-trained rats, non- naloxone, 39 FR 44392). As summarized indication of visualizing striatal radiolabeled ioflupane produced above, the data currently support dopamine transporters in the brains of cocaine-appropriate responding, which removal of substances that contain adult patients with suspected suggests that non-radiolabeled ioflupane [123I]ioflupane, primarily because Parkinsonian syndromes using SPECT may produce cocaine-like subjective [123I]ioflupane itself has a lethal imaging. As such, any FDA-approved effects in humans (HHS, 2010). radioactive barrier, and its diagnostic product containing However, the available evidence manufacturing process is highly [123I]ioflupane has a currently accepted suggests that there is no psychic or regulated and technically complex, thus medical use in the United States. physiological dependence potential of making abuse highly unlikely. FDA-approved diagnostic products After consideration of the analyses 4. Its History and Current Pattern of 123 containing [ I]ioflupane. The psychic and recommendation of the Assistant Abuse or physiological dependence potential Secretary for Health of the HHS and of FDA-approved diagnostic products is According to HHS, there have been no review of all relevant and available data, 123 currently expected to be very limited reports of abuse of [ I]ioflupane. Over the Administrator of the DEA, pursuant due to the low exposure concentration 168,000 doses of DaTscan have been to 21 U.S.C. 812(b)(5), finds that: of [123I]ioflupane, the aforementioned administered to patients worldwide, (1) [123I]Ioflupane has no comparable low potential for abuse (see Factor 1) and no pharmacological effects have potential for abuse relative to substances and the extremely high and lethal been noted. Further, according to HHS, in Schedule V. quantities needed to achieve a no single user has received more than (2) [123I]Ioflupane has a currently subjective ‘‘high.’’ 10 vials of DaTscan in a single day. accepted medical use in treatment in the 5. The Scope, Duration, and 8. Whether the Substance Is an United States. FDA approved the New Significance of Abuse Immediate Precursor of a Substance Drug Application for DaTscan on Already Controlled Under the CSA January 14, 2011, with the indication of There have been no reports of abuse [123I]Ioflupane is not an immediate visualizing striatal dopamine of [123I]ioflupane. According to the transporters in the brains of adult National Forensic Laboratory precursor of a substance already controlled under the CSA. patients with suspected Parkinsonian Information System (NFLIS) 2 and the syndromes using SPECT imaging. System to Retrieve Information from Conclusion (3) [123I]Ioflupane is not abusable, 3 Drug Evidence (STRIDE) , there have Based on consideration of the therefore, its use is not likely to lead to 123 been no reports of [ I]ioflupane scientific and medical evaluation and physical or psychological dependence. seizures during the time period January accompanying recommendation of the Based on these findings, the 2010 to February 2015. HHS and based on the DEA’s Administrator of the DEA concludes 6. What, If Any, Risk There Is to the consideration of its own eight-factor that [123I]ioflupane does not warrant Public Health analysis, the DEA finds that the facts control under the CSA. and all available and relevant data According to the HHS, because of the Effect on Other Rulemakings demonstrate that [123I]ioflupane does limited amounts of manufactured not possess abuse or dependence On November 25, 2014, DEA DaTscan, the low concentration of potential. Accordingly, the DEA finds published an interim final rule waiving [123I]ioflupane per vial, and the that [123I]ioflupane does not meet the the requirement of DEA registration for existence of stringent regulatory requirements for inclusion in any certain entities that are authorized controls (controls other than those schedule and should be removed from under other federal or state authorities imposed by the CSA and its control under the CSA. to administer DaTscan. 79 FR 70085. If implementing regulations, including finalized, this proposal to remove regulation by the United States Nuclear Findings for Schedule Placement [123I]ioflupane from the schedules of Regulatory Commission under 10 CFR Pursuant to 21 U.S.C. 812(b) controlled substances would make such The CSA outlines the findings waivers unnecessary. Therefore, if this 2 NFLIS is a program of the DEA that collects drug required to place a drug or other action is finalized, DEA intends to identification results from drug cases analyzed by other Federal, State, and local forensic laboratories. substance in any particular schedule (I, withdraw the regulations established NFLIS was queried on April 16, 2015. II, III, IV, or V). 21 U.S.C. 812(b). The through that interim final rule. 3 STRIDE collected the results of drug evidence Assistant Secretary for Health of the Regulatory Analyses analyzed at DEA laboratories and reflects evidence HHS recommended removal of ‘‘FDA submitted by the DEA, other Federal law enforcement agencies, and some local law approved products containing Executive Orders 12866 and 15363 enforcement agencies. STRIDE data was queried by In accordance with 21 U.S.C. 811(a), date submitted to Federal forensic laboratories. On 4 There are Federal and state laws and regulations October 1, 2014, STARLiMS replaced STRIDE as which limit the public’s exposure to radioactivity this scheduling action is subject to the DEA laboratory drug evidence data system of in radiopharmaceuticals, thus limiting the potential formal rulemaking procedures done ‘‘on record. for toxicity imposed on the public. the record after opportunity for a

VerDate Sep<11>2014 17:19 Jun 02, 2015 Jkt 235001 PO 00000 Frm 00038 Fmt 4702 Sfmt 4702 E:\FR\FM\03JNP1.SGM 03JNP1 asabaliauskas on DSK5VPTVN1PROD with PROPOSALS Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Proposed Rules 31525

hearing,’’ which are conducted pursuant unquantifiable variables that potentially List of Subjects in 21 CFR part 1308 to the provisions of 5 U.S.C. 556 and could influence the distribution and Administrative practice and 557. The CSA sets forth the criteria for administration rates of new molecular procedure, Drug traffic control, scheduling a drug or other substance entities, the DEA is unable to determine Reporting and recordkeeping and for removing a drug or substance the number of entities and small entities requirements. from the schedules of controlled 123 which might handle [ I]ioflupane. For the reasons set out above, 21 CFR substances. Such actions are exempt Although the DEA does not have a part 1308 is proposed to be amended to from review by the Office of reliable basis to estimate the number of read as follows: Management and Budget (OMB) affected entities and quantify the pursuant to section 3(d)(1) of Executive economic impact of this proposed rule, PART 1308—SCHEDULES OF Order 12866 and the principles a qualitative analysis indicates that, if CONTROLLED SUBSTANCES reaffirmed in Executive Order 13563. finalized, this rule is likely to result in ■ 1. The authority citation for 21 CFR Executive Order 12988 some cost savings for the healthcare part 1308 continues to read as follows: This regulation meets the applicable industry. The affected entities will standards set forth in sections 3(a) and continue to meet existing Federal and/ Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted. 3(b)(2) of Executive Order 12988 Civil or state requirements applicable to those Justice Reform to eliminate drafting who handle radiopharmaceutical ■ 2. In § 1308.12, revise paragraph (b)(4) errors and ambiguity, minimize substances, including licensure, to read as follows: security, recordkeeping, and reporting litigation, provide a clear legal standard § 1308.12 Schedule II. for affected conduct, and promote requirements, which in many cases are simplification and burden reduction. more stringent than the DEA’s * * * * * requirements. However, the DEA (b) * * * Executive Order 13132 estimates cost savings will be realized (4) Coca leaves (9040) and any salt, This rulemaking does not have from the removal of the administrative, compound, derivative or preparation of federalism implications warranting the civil, and criminal sanctions for those coca leaves (including cocaine (9041) application of Executive Order 13132. entities handling or proposing to handle and ecgonine (9180) and their salts, isomers, derivatives and salts of isomers The rule does not have substantial [123I]ioflupane, in the form of saved and derivatives), and any salt, direct effects on the States, on the registration fees, and the elimination of compound, derivative, or preparation relationship between the Federal additional physical security, thereof which is chemically equivalent Government and the States, or the recordkeeping, and reporting or identical with any of these distribution of power and requirements. responsibilities among the various substances, except that the substances levels of government. Because of these facts, this rule will shall not include: not result in a significant economic (i) Decocainized coca leaves or Executive Order 13175 impact on a substantial number of small extraction of coca leaves, which This rule does not have tribal entities. extractions do not contain cocaine or ecgonine; or implications warranting the application Unfunded Mandates Reform Act of 1995 of Executive Order 13175. This rule (ii) [123I]ioflupane. does not have substantial direct effects On the basis of information contained * * * * * on one or more Indian tribes, on the in the ‘‘Regulatory Flexibility Act’’ Dated: May 6, 2015. relationship between the Federal section above, the DEA has determined Michele M. Leonhart, Government and Indian tribes, or on the and certifies pursuant to the Unfunded Administrator. distribution of power and Mandates Reform Act of 1995 (UMRA), [FR Doc. 2015–13455 Filed 6–2–15; 8:45 am] responsibilities between the Federal 2 U.S.C. 1501 et seq., that this action BILLING CODE 4410–09–P Government and Indian tribes. would not result in any federal mandate Regulatory Flexibility Act that may result ‘‘in the expenditure by State, local, and tribal governments, in The Administrator, in accordance DEPARTMENT OF STATE the aggregate, or by the private sector, of with the Regulatory Flexibility Act (5 $100,000,000 or more (adjusted for U.S.C. 601–612) (RFA), has reviewed 22 CFR Parts 120, 123, 125, and 127 inflation) in any one year * * * .’’ this proposed rule and by approving it Therefore, neither a Small Government [Public Notice 9149] certifies that it will not have a Agency Plan nor any other action is significant economic impact on a RIN 1400–AD70 required under provisions of UMRA. substantial number of small entities. International Traffic in Arms: Revisions The purpose of this rule is to remove Paperwork Reduction Act 123 to Definitions of Defense Services, [ I]ioflupane from the list of schedules Technical Data, and Public Domain; of the CSA. This action will remove This action does not impose a new collection of information requirement Definition of Product of Fundamental regulatory controls and administrative, Research; Electronic Transmission civil, and criminal sanctions applicable under the Paperwork Reduction Act, 44 U.S.C. 3501–3521. This action would and Storage of Technical Data; and to controlled substances for handlers Related Definitions and proposed handlers of not impose recordkeeping or reporting [123I]ioflupane. Accordingly, it has the requirements on State or local AGENCY: Department of State. potential for some economic impact in governments, individuals, businesses, or ACTION: Proposed rule. the form of cost savings. organizations. An agency may not If finalized, the proposed rule will conduct or sponsor, and a person is not SUMMARY: As part of the President’s affect all persons who would handle, or required to respond to, a collection of Export Control Reform (ECR) initiative, propose to handle, [123I]ioflupane. Due information unless it displays a the Department of State proposes to to the wide variety of unidentifiable and currently valid OMB control number. amend the International Traffic in Arms

VerDate Sep<11>2014 17:19 Jun 02, 2015 Jkt 235001 PO 00000 Frm 00039 Fmt 4702 Sfmt 4702 E:\FR\FM\03JNP1.SGM 03JNP1 asabaliauskas on DSK5VPTVN1PROD with PROPOSALS