81388 Federal Register / Vol. 85, No. 242 / Wednesday, December 16, 2020 / Rules and Regulations

[email protected]. Before using any DEPARTMENT OF JUSTICE Mailing Address: 8701 Morrissette approved AMOC, notify your appropriate Drive, Springfield, Virginia 22152; principal inspector, or lacking a principal Drug Enforcement Administration Telephone: (571) 362–3249. inspector, the manager of the responsible SUPPLEMENTARY INFORMATION: Flight Standards Office. 21 CFR Part 1308 (2) Contacting the Manufacturer: For any Posting of Public Comments [Docket No. DEA–671] requirement in this AD to obtain instructions Please note that all comments from a manufacturer, the instructions must Schedules of Controlled Substances: received are considered part of the be accomplished using a method approved public record. They will, unless by the Manager, Large Aircraft Section, Exempt Anabolic Steroid Products reasonable cause is given, be made International Validation Branch, FAA; or AGENCY: Drug Enforcement available by DEA for public inspection ANAC; or ANAC’s authorized Designee. If Administration, Department of Justice. approved by the ANAC Designee, the online at http://www.regulations.gov. approval must include the Designee’s ACTION: Order with opportunity for Such information includes personal authorized signature. comment. identifying information (such as your name, address, etc.) voluntarily (j) Related Information SUMMARY: The Drug Enforcement submitted by the commenter. The For more information about this AD, Administration is denying applications Freedom of Information Act applies to contact Kathleen Arrigotti, Aerospace to designate four in-process all comments received. If you want to Engineer, Large Aircraft Section, preparations containing trenbolone submit personal identifying information International Validation Branch, FAA, 2200 acetate as exempt anabolic steroid (such as your name, address, etc.) as South 216th St., Des Moines, WA 98198; products under the Controlled part of your comment, but do not want telephone and fax 206–231–3218; Substances Act. it to be made publicly available, you [email protected]. DATES: This order is effective December must include the phrase ‘‘PERSONAL (k) Material Incorporated by Reference 16, 2020. Written comments must be IDENTIFYING INFORMATION’’ in the (1) The Director of the Federal Register postmarked, and electronic comments first paragraph of your comment. You approved the incorporation by reference must be sent, on or before February 16, must also place all the personal (IBR) of the service information listed in this 2021. identifying information you do not want paragraph under 5 U.S.C. 552(a) and 1 CFR ADDRESSES: To ensure proper handling publicly available in the first paragraph part 51. of comments, please reference ‘‘Docket of your comment and identify what (2) You must use this service information No. DEA–671’’ on all electronic and information you want redacted. as applicable to do the actions required by written correspondence, including any If you want to submit confidential this AD, unless this AD specifies otherwise. attachments. business information as part of your (i) Ageˆncia Nacional de Aviac¸a˜o Civil Electronic comments: The Drug comment, but do not want it to be made (ANAC) AD 2020–04–01R01, effective May Enforcement Administration (DEA) publicly available, you must include the 22, 2020. encourages all comments be submitted phrase ‘‘CONFIDENTIAL BUSINESS (ii) [Reserved] electronically through the Federal INFORMATION’’ in the first paragraph (3) For ANAC AD 2020–04–01R01, contact of your comment. You must also ANAC, Aeronautical Products Certification eRulemaking Portal which provides the ability to type short comments directly prominently identify confidential Branch (GGCP), Rua Dr. Orlando Feirabend business information to be redacted Filho, 230—Centro Empresarial Aquarius— into the comment field on the web page or attach a file for lengthier comments. within the comment. Torre B—Andares 14 a 18, Parque Comments containing personal ˜ Please go to http://www.regulations.gov/ Residencial Aquarius, CEP 12.246–190—Sao identifying information and confidential Jose´ dos Campos—SP, BRAZIL, Tel: 55 (12) and follow the online instructions at 3203–6600; Email: [email protected]; internet that site for submitting comments. Upon business information identified as www.anac.gov.br/en/. You may find this IBR completion of your submission, you will directed above will generally be made material on the ANAC website at https:// receive a Comment Tracking Number for publicly available in redacted form. If a sistemas.anac.gov.br/certificacao/DA/ your comment. Please be aware that comment has so much confidential DAE.asp. submitted comments are not business information or personal (4) You may view this material at the FAA, instantaneously available for public identifying information that it cannot be Airworthiness Products Section, Operational view on Regulations.gov. If you have effectively redacted, all or part of that Safety Branch, 2200 South 216th St., Des received a Comment Tracking Number, comment may not be made publicly Moines, WA. For information on the available. Comments posted to http:// availability of this material at the FAA, call your comment has been successfully submitted and there is no need to www.regulations.gov may include any 206–231–3195. This material may be found personal identifying information (such in the AD docket on the internet at https:// resubmit the same comment. Paper comments: Paper comments as name, address, and phone number) www.regulations.gov by searching for and included in the text of your electronic locating Docket No. FAA–2020–0584. that duplicate electronic submissions submission that is not identified as (5) You may view this material that is are not necessary and are discouraged. incorporated by reference at the National Should you wish to mail a paper directed above as confidential. Archives and Records Administration comment in lieu of an electronic An electronic copy of this document (NARA). For information on the availability comment, it should be sent via regular is available at http:// of this material at NARA, email fedreg.legal@ or express mail to: Drug Enforcement www.regulations.gov for easy reference. nara.gov, or go to: https://www.archives.gov/ Administration, Attn: DEA Federal Legal Authority federal-register/cfr/ibr-locations.html. Register Representative/DPW, 8701 Anabolic steroids are listed in Issued on December 1, 2020. Morrissette Drive, Springfield, Virginia schedule III of the Controlled Lance T. Gant, 22152. Substances Act (CSA). 21 U.S.C. 802(41) Director, Compliance & Airworthiness FOR FURTHER INFORMATION CONTACT: and 812(c), Schedule III(e). The CSA Division, Aircraft Certification Service. Terrence L. Boos, Drug and Chemical further provides that the Attorney [FR Doc. 2020–27619 Filed 12–15–20; 8:45 am] Evaluation, Diversion Control Division, General may, by regulation, exempt BILLING CODE 4910–13–P Drug Enforcement Administration; from any or all CSA provisions any

VerDate Sep<11>2014 16:21 Dec 15, 2020 Jkt 253001 PO 00000 Frm 00050 Fmt 4700 Sfmt 4700 E:\FR\FM\16DER1.SGM 16DER1 khammond on DSKJM1Z7X2PROD with RULES Federal Register / Vol. 85, No. 242 / Wednesday, December 16, 2020 / Rules and Regulations 81389

‘‘compound, mixture, or preparation the product preparations were longer be concluded that the addition of which contains any anabolic steroid, Component T–H in-process granulation estradiol to a substance containing which is intended for administration to and Component T–H in-process pellets trenbolone acetate deters the abuse of a human being or an animal, and which, in bulk containers. Id. trenbolone acetate.’’ Id. because of its concentration, Ivy based its application on the HHS thus concluded ‘‘that the preparation, formulation or delivery grounds that DEA had ‘‘previously products Component T–H in-process system, does not present any significant identified Component TE–S in process granulation and Component T–H in- potential for abuse.’’ 21 U.S.C. granulation and in process pellets as process pellets, and Component TE–H 811(g)(3)(C). The authority to exempt exempt from the CSA as the formulation in-process granulation and Component these products has been delegated from prevented significant potential for TE–H in-process pellets do not fit into the Attorney General to the abuse.’’ Id. The application noted that the category of having no significant Administrator of the Drug Enforcement the ‘‘combination of [trenbolone acetate] potential for abuse based on Administration (DEA) (28 CFR 0.100(b)), with the excipient materials under the concentration, preparation, formulation, who in turn, re-delegated this authority manufacturing process conditions or delivery system.’’ Id. The ASH thus to the Assistant Administrator of removes significant potential for abuse recommended that Ivy’s ‘‘products be Diversion Control (DC) (28 CFR part 0, of the anabolic steroid in the denied exemption from scheduling Appendix to Subpart R, section 7(g)). granulation mixture and resultant in under the CSA.’’ Id. The procedures for implementing this process pellets.’’ Id. Ivy further noted Further, after a review of the available section are found at 21 CFR 1308.33. that this formulation ‘‘is identical to that kits and protocols, DEA finds this of the Component® T–H packaged information credible, easy to Findings of Fact product pellets and presents no more understand, and requires no specialized DEA received an application from Ivy potential for abuse than that of the skill or experience to carry out the Animal Health, Inc. (Ivy), dated March excluded packaged implant product.’’ required steps. Thus, DEA concludes 27, 2015, seeking to exempt two Id. at 4. Ivy claimed that for Component that trenbolone acetate can be easily anabolic steroid-containing product T–H in-process granulation and separated from estradiol and other preparations containing trenbolone Component T–H in-process pellets, excipient materials used to make acetate from control under the CSA. ‘‘[c]omplicated manipulation of the Component TE–H in-process Letter from Ivy Animal Health, Inc. to material, including dissolution, granulation, Component TE–H in- DEA (Mar. 27, 2015), at 1. Specifically, separation, and reconstituting, would be process pellets, Component T–H in- the product preparations were required to convert the in process process granulation, and Component T– Component TE–H in-process material to Trenbolone acetate and H in-process pellets. The composition of granulation and Component TE–H in- prepare it for injection or some other these in-process materials containing process pellets in bulk containers. Id. delivery method.’’ Id. at 5. significant quantities of trenbolone Ivy based its application on the Upon review of the application, DEA acetate does not prevent significant grounds that DEA had previously accepted it for filing. On June 4, 2015, potential for abuse. exempted other in-process granulations DEA provided a copy of Ivy’s Conclusions of Law and pellets containing trenbolone application to the Secretary of HHS and acetate, and the Component TE–H requested an evaluation and a Based on the evaluation and ‘‘product formulations contain the same recommendation. recommendation of the ASH, as well as active ingredients Trenbolone acetate On October 8, 2019, the Assistant DEA’s review of available evidence of and Estradiol’’ as the other in-process Secretary for Health (ASH) provided diversion of these types of products, the materials that are currently exempt. Id. HHS’s evaluation and recommendation Assistant Administrator does not find Ivy’s application further stated that to DEA for both applications. Letter that ‘‘because of [their] concentration, ‘‘[t]he presence of Estradiol in the from Assistant Secretary for Health, preparation, formulation, or delivery formulation with Trenbolone acetate HHS, to Acting Administrator, DEA, at system,’’ Ivy’s Component TE–H in- renders the Component TE–H in process 1 (Oct. 8, 2019) (ASH Letter). HHS process granulation, Component TE–H granulation and pellets unusable for found that ‘‘[a]lthough there is no in-process pellets, Component T–H in- anabolic steroid abuse.’’ Id. at 4–5. Ivy evidence that trenbolone is being process granulation, and Component T– noted that DEA has ‘‘previously obtained from in-process materials there H in-process pellets ‘‘ha[ve] no identified Component TE–S in process is evidence that it is being abused.’’ Id. significant potential for abuse.’’ 21 CFR granulation and in process pellets as HHS noted the availability of ‘‘protocols 1308.33(a). exempt from the CSA as the presence of or kits to purify trenbolone from Therefore, the Assistant Estradiol in the formulation prevented marketed cattle pellets’’ and concluded Administrator, Diversion Control significant potential for abuse.’’ Id. at 5. that these ‘‘do-it-yourself kits’’ makes Division, hereby orders that the above Upon review of the application, DEA the ‘‘in-process materials easy to abuse.’’ products containing anabolic steroids accepted it for filing. On April 29, 2015, Id. not be exempted from application of any DEA provided a copy of Ivy’s With respect to the inclusion of section of the CSA, and they are not to application to the Secretary of Health estradiol in Component TE–H in- be included in the list of products and Human Services (HHS) and process granulation and Component described in 21 CFR 1308.34. These in- requested an evaluation and a TE–H in-process pellets, HHS found process materials remain controlled as recommendation. that ‘‘protocols and kits have been an anabolic steroid in schedule III. DEA also received an application developed to purify trenbolone from Unless specifically excepted, to the from Ivy Animal Health, Inc., dated estradiol.’’ Id. Although HHS had extent Ivy handles trenbolone acetate in April 30, 2015, seeking to exempt two previously ‘‘recommended that DEA the manufacturing process, Ivy must anabolic steroid-containing product exempt in-process substances comply with all applicable registration, preparations containing trenbolone containing trenbolone and estradiol’’ on security and recordkeeping acetate from control under the CSA. the basis that ‘‘inclusion of estradiol requirements set forth in the CSA and Letter from Ivy Animal Health, Inc. to deterred abuse,’’ because these kits and DEA regulations. Exemptions granted or DEA (Apr. 30, 2015), at 1. Specifically, protocols are now available, ‘‘it can no denied under 21 CFR 1308.33 are

VerDate Sep<11>2014 16:21 Dec 15, 2020 Jkt 253001 PO 00000 Frm 00051 Fmt 4700 Sfmt 4700 E:\FR\FM\16DER1.SGM 16DER1 khammond on DSKJM1Z7X2PROD with RULES 81390 Federal Register / Vol. 85, No. 242 / Wednesday, December 16, 2020 / Rules and Regulations

product- and manufacturer-specific, and provide for increased flexibility, the World Bank as upper middle income the present order does not address any targeting, and speed of procurement of countries according to their gross other product currently listed in 21 CFR Emergency Medical Supplies (EMS) national income per capita, except for 1308.34. required to address the COVID–19 those countries in which USAID This order does not apply to the final, pandemic worldwide. That TFR provides assistance. USAID will packaged, and labeled products inadvertently resulted in the deletion of maintain a list of advanced developing ‘‘containing an anabolic steroid, that are defined terms. This document corrects countries primarily based on the most expressly intended for administration the TFR by restoring those definitions. recent World Bank determinations, and through implants to cattle or other DATES: The rule is effective on will make the list available in USAID’s nonhuman species’’ where the products December 16, 2020, through April 30, Automated Directives System, ADS 310. ‘‘have been approved by the Secretary of 2021, and is applicable beginning This list will include determinations Health and Human Services for such October 23, 2020. made under § 228.17 of this part. Available for purchase means for administration.’’ 21 CFR 1308.26(a). FOR FURTHER INFORMATION CONTACT: commodities, that the commodity is Under 21 U.S.C. 802(41)(B)(i), such Natalie J. Freeman (or designee), offered for sale in a country in the products are excepted from the Attorney Advisor, Office of the General authorized principal geographic code at definition of an anabolic steroid without Counsel, USAID, 1300 Pennsylvania undergoing the exemption process the time of purchase from the supplier, Ave. NW, Washington, DC 20523, irrespective of the place of manufacture described in 21 CFR 1308.33, and [email protected]. without any evaluation or determination or production, unless it is a prohibited SUPPLEMENTARY INFORMATION: This of their abuse potential. source country. If applicable, the document corrects 22 CFR 228.01, commodity must also be able to be Opportunity for Comment which was amended by the TFR serviced, and, if warrantied, have a Pursuant to 21 CFR 1308.33, any published in the Federal Register on valid warranty. For services, available interested person may submit written October 23, 2020 (85 FR 67443). The for purchase means the service is comments on, or objections to, the TFR revised the definitions in § 228.01 offered from a vendor which has denial of an exemption for any product by adding a new definition for complied with nationality and foreign listed in this order, within 60 days of ‘‘Essential medical supplies.’’ This new government-owned organization the date of publication of this order, as definition was intended to be added to requirements of this regulation, and is specified above. If any comments or the existing list in alphabetical order, otherwise organized in a country in the objections raise significant issues but it inadvertently resulted in the authorized principal geographic code regarding any finding of fact or deletion of the terms previously defined designated in an implementing conclusion of law upon which this in § 228.01. After publication, instrument. This definition does not order is based, the Assistant stakeholders notified USAID of the apply to procurements under the Administrator, Diversion Control missing definitions, which are used geographic Code 935, see § 228.03 of Division, may reconsider the throughout 22 CFR part 228. This this part, because that geographic code application in light of the comments document effectuates the intent of the is for any country or area except for and objections filed. 21 CFR 1308.33. TFR by restoring the definitions in prohibited source countries. Thereafter, the Assistant Administrator § 228.01 and adding the definition of Commission means any payment or shall amend his original order as he ‘‘Essential medical supplies’’ to the allowance by a supplier to any person determines appropriate. Id. alphabetical list. This correction does for the contribution which that person not otherwise affect the changes made has made to secure the sale or contract William T. McDermott, by the TFR to 22 CFR part 228, or its for the supplier or which that person Assistant Administrator. effective dates of October 23, 2020, makes to securing on a continuing basis [FR Doc. 2020–25288 Filed 12–15–20; 8:45 am] through April 30, 2021. similar sales or contracts for the BILLING CODE 4410–09–P List of Subjects in 22 CFR Part 228 supplier. Commodities or goods means any Government procurement. material, article, supply, good, or AGENCY FOR INTERNATIONAL For the reasons discussed above, 22 equipment. DEVELOPMENT CFR part 228 is corrected by making the Commodity-related services means following correcting amendments: delivery services and/or incidental 22 CFR Part 228 services. PART 228—RULES FOR Cooperating country or recipient [AID–2020–0004] PROCUREMENT OF COMMODITIES country means the country receiving the AND SERVICES FINANCED BY USAID USAID assistance subject to this part RIN 0412–AB02 228, and includes all the countries ■ 1. The authority citation for 22 CFR Procurement of Certain Essential receiving assistance under a regional part 228 continues to read as follows: Medical Supplies To Address the program or project. COVID–19 Pandemic; Correction Authority: Sec. 621, Pub. L. 87–195, 75 Delivery means the transfer to, or for Stat. 445 (22 U.S.C. 2381), as amended, E.O. the account of, an importer of the right AGENCY: Agency for International 12163, Sept. 29, 1979, 44 FR 56673: 3 CFR to possession of a commodity, or, with Development. 1979 Comp., p. 435. respect to a commodity-related service, ACTION: Correcting amendments. ■ 2. Revise § 228.01 to read as follows: the rendering to, or for the account of, an importer of any such service. SUMMARY: On October 23, 2020, the § 228.01 Definitions. Delivery service means any service United States Agency for International As used in this part, the following customarily performed in a commercial Development (USAID) issued a terms shall have the following export or import transaction which is Temporary Final Rule (TFR) amending meanings: necessary to affect a physical transfer of our regulations to allow USAID to waive Advanced developing countries mean commodities to the cooperating/ ‘‘Source and Nationality’’ rules to those countries that are categorized by recipient country. Examples of such

VerDate Sep<11>2014 16:21 Dec 15, 2020 Jkt 253001 PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 E:\FR\FM\16DER1.SGM 16DER1 khammond on DSKJM1Z7X2PROD with RULES