79456 Federal Register / Vol. 85, No. 238 / Thursday, December 10, 2020 / Proposed Rules could influence the distribution and under the Paperwork Reduction Act, 44 Federal Motor Vehicle Safety Standards dispensing rates, if any, of samidorphan, U.S.C. 3501–3521. This action would (FMVSS) may be a candidate for DEA is unable to determine the number not impose recordkeeping or reporting replacement, repeal, or modification, for of entities and small entities which requirements on State or local reasons other than for considerations might handle samidorphan. In some governments, individuals, businesses, or relevant only to automated driving instances where a controlled organizations. systems (ADS). This document is a pharmaceutical drug is removed from continuation of the Agency’s efforts to List of Subjects in 21 CFR Part 1308 the schedules of the CSA, DEA is able improve the FMVSS and minimize to quantify the estimated number of Administrative practice and burdens. The Agency takes this action affected entities and small entities procedure, Drug traffic control, in response to its review of the FMVSS because the handling of the drug is Reporting and recordkeeping and to public comments solicited by expected to be limited to DEA requirements. DOT in a 2017 notice on its regulatory registrants even after removal from the For the reasons set out above, 21 CFR reform efforts. The commenters schedules. In such instances, DEA’s part 1308 is proposed to be amended to requested that NHTSA amend test knowledge of its registrant population read as follows: procedures for air brakes and occupant forms the basis for estimating the crash protection. NHTSA has also number of affected entities and small PART 1308—SCHEDULES OF identified some possible additional test entities. However, DEA does not have a CONTROLLED SUBSTANCES procedure issues and discusses them in basis to estimate whether samidorphan this Notice. In addition, this ANPRM is expected to be handled by persons ■ 1. The authority citation for 21 CFR also seeks comments and supporting who hold DEA registrations, by persons part 1308 continues to read as follows: information relating to any other test who are not currently registered with Authority: 21 U.S.C. 811, 812, 871(b), procedures which may be a candidate DEA to handle controlled substances, or 956(b), unless otherwise noted. for replacement, repeal or modification, both. Therefore, DEA is unable to ■ 2. In § 1308.12, revise the introductory not just those specifically discussed in estimate the number of entities and text of paragraph (b)(1) to read as this Notice. small entities who plan to handle follows: DATES: Comments must be received no samidorphan. later than February 8, 2021. See the Although DEA does not have a § 1308.12 Schedule II. Public Participation heading of the reliable basis to estimate the number of * * * * * SUPPLEMENTARY INFORMATION section of affected entities and quantify the (b) * * * this document for more information economic impact of this final rule, a (1) Opium and opiate, and any salt, about written comments. qualitative analysis indicates that this compound, derivative, or preparation of rule is likely to result in some cost ADDRESSES: You may submit comments opium or opiate excluding to the docket number identified in the savings. As noted above, DEA is apomorphine, thebaine-derived specifically soliciting comments on the heading of this document by any of the butorphanol, dextrorphan, nalbuphine, following methods: economic impact of this proposed rule. naldemedine, nalmefene, naloxegol, • DEA will revise this section if warranted Federal eRulemaking Portal: Go to naloxone, 6b-naltrexol, naltrexone, and http://www.regulations.gov. Follow the after consideration of any comments samidorphan, and their respective salts, received. Any person planning to online instructions for submitting but including the following: comments. handle samidorphan will realize cost • savings in the form of saved DEA * * * * * Mail: Docket Management Facility: U.S. Department of Transportation, 1200 registration fees, and the elimination of Timothy J. Shea, physical security, recordkeeping, and New Jersey Avenue SE, West Building Acting Administrator. Ground Floor, Room W12–140, reporting requirements. [FR Doc. 2020–26812 Filed 12–9–20; 8:45 am] Because of these factors, DEA projects Washington, DC 20590–0001 BILLING CODE 4410–09–P • that this rule will not result in a Hand Delivery or Courier: 1200 significant economic impact on a New Jersey Avenue SE, West Building substantial number of small entities. Ground Floor, Room W12–140, between DEPARTMENT OF TRANSPORTATION 9 a.m. and 5 p.m. ET, Monday through Unfunded Mandates Reform Act of 1995 Friday, except Federal holidays. On the basis of information contained National Highway Traffic Safety • Fax: 202–493–2251. in the ‘‘RFA’’ section above, DEA has Administration Instructions: For detailed instructions determined and certifies pursuant to the on submitting comments and additional Unfunded Mandates Reform Act of 1995 49 CFR Part 571 information on the rulemaking process, (UMRA), 2 U.S.C. 1501 et seq., that this [Docket No. NHTSA–2020–0109] see the Public Participation heading of action would not result in any federal the SUPPLEMENTARY INFORMATION section RIN 2127–AM04 mandate that may result ‘‘in the of this document. Note that all expenditure by State, local, and tribal Federal Motor Vehicle Safety comments received will be posted governments, in the aggregate, or by the Standards: Test Procedures without change to http:// private sector, of $100,000,000 or more www.regulations.gov, including any (adjusted for inflation) in any one year AGENCY: National Highway Traffic personal information provided. Please * * *.’’ Therefore, neither a Small Safety Administration (NHTSA), see the ‘‘Privacy Act’’ heading below. Government Agency Plan nor any other Department of Transportation (DOT). Privacy Act: Anyone is able to search action is required under provisions of ACTION: Advance notice of proposed the electronic form of all comments UMRA. rulemaking (ANPRM). received into any docket by the name of the individual submitting the comment Paperwork Reduction Act SUMMARY: NHTSA is issuing this (or signing the comment, if submitted This action does not impose a new ANPRM to seek public comment on on behalf of an association, business, collection of information requirement whether any test procedures for any labor union, etc.). You may review VerDate Sep<11>2014 16:26 Dec 09, 2020 Jkt 253001 PO 00000 Frm 00023 Fmt 4702 Sfmt 4702 E:\FR\FM\10DEP1.SGM 10DEP1 jbell on DSKJLSW7X2PROD with PROPOSALS Federal Register / Vol. 85, No. 238 / Thursday, December 10, 2020 / Proposed Rules 79457 DOT’s complete Privacy Act Statement advance notices of proposed rulemaking Because these comments require in the Federal Register published on (ANPRMs) on various regulatory reform consideration of both performance April 11, 2000 (65 FR 19477–78). topics. requirements and test procedures, the Confidential Information: If you wish This ANPRM specifically discusses comments are discussed in the ANPRM to submit any information under a claim test procedures 2 that may be candidates for RIN 2127–AM05, which deals with of confidentiality, you should submit for replacement, repeal, or modification. regulatory barriers in the performance three copies of your complete This Notice does not address the requirements for non-ADS vehicles. submission, including the information performance requirements within the A. FMVSS No. 103 you claim to be confidential business standards, but only the test procedures information, to the Chief Counsel of specified in the standards for NHTSA to Compliance with the performance NHTSA, at the address given under FOR use to verify compliance. Additionally, requirements of FMVSS No. 103, FURTHER INFORMATION CONTACT. In this Notice does not address issues Windshield defrosting and defogging addition, you should submit two copies, related to test procedures relevant only systems (49 CFR 571.103), is determined from which you have deleted the to technologies for automated driving by the Agency using a test procedure claimed confidential business systems (ADS), commonly referred to as incorporated from SAE Recommended information, to Docket Management at automated or self-driving vehicles. Practice J902 (August 1964 or March the address given above under Comments on test procedures that may 1967), which is predicated on a ADDRESSES. When you send a comment be candidates for repeal, replacement, or vehicle’s having a conventional internal containing information claimed to be modification to permit the introduction combustion engine (ICE). The Agency is confidential business information, you and certification of ADS would be more considering whether these procedures should include a cover letter setting appropriate for the ANPRM for RIN should be revised or modified for forth the information specified in the 2127–AM00 3 or one of the topic- vehicles with other types of propulsion confidential business information specific ANPRMs. NHTSA also notes and requests comment on this issue. regulation. (49 CFR part 512.) that the specific test procedures B. FMVSS 104 Docket: For access to the docket to discussed in the remainder of this read background documents or Notice are not meant to be an exclusive Determination of compliance with the comments received, go to http:// listing of the test procedures that may be performance requirements of FMVSS www.regulations.gov or the street suitable