Federal Register / Vol. 86, No. 20 / Tuesday, February 2, 2021 / Rules and Regulations 7815

DEPARTMENT OF HEALTH AND Assistant to the President and Chief of ■ 2. Section 1001.952 is amended by HUMAN SERVICES Staff, entitled ‘‘Regulatory Freeze adding paragraphs (h)(6) through (9), Pending Review,’’ instructed Federal (cc), and (dd) to read as follows: Office of Inspector General agencies to consider delaying the effective date of rules published in the § 1001.952 [Corrected] 42 CFR Part 1001 Federal Register, but which have not ■ 2. On page 76731, first column, § 1001.952 is corrected by removing ‘‘(5) RIN 0936–AA08 yet taken effect, for a period of 60 days from the date of the memorandum to * * * ’’, and the text of paragraphs (vi) Fraud and Abuse; Removal of Safe permit review of the rule. This action is through (viii). consistent with that memorandum Harbor Protection for Rebates § 1001.952 [Corrected] Involving Prescription insofar as the Department has decided ■ Pharmaceuticals and Creation of New to review the rule at issue, and needs 3. On page 76731, third column, add Safe Harbor Protection for Certain time to determine what additional amendatory instruction 3 to read as Point-of-Sale Reductions in Price on action, if any, is appropriate. follows: Prescription Pharmaceuticals and The Department also has good cause 3. Effective January 1, 2022, Certain Pharmacy Benefit Manager to delay this rule’s effective date § 1001.952 is amended by revising Service Fees without advance notice and comment paragraphs (h)(5)(vi) and (vii) and under 5 U.S.C. 553(b)(B) because of the adding paragraph (h)(5)(viii) to read as AGENCY: Office of Inspector General pendency of litigation challenging the follows: (OIG), Health and Human Services final rule, and the Department’s interest § 1001.952 Exceptions. (HHS). in evaluating its position in that ACTION: Final rule; delay of effective litigation. The litigation includes both * * * * * date; correction. procedural and substantive challenges (h) * * * to the rule and its effective date. Though (5) * * * SUMMARY: In accordance with the the provisions of the rule being delayed (vi) Services provided in accordance memorandum of January 20, 2021, from by this notice do not fully overlap with with a personal or management services the Assistant to the President and Chief the provisions at issue in the pending contract; of Staff, entitled ‘‘Regulatory Freeze litigation, the intersections between the (vii) Other remuneration, in cash or in Pending Review,’’ and given the rule’s various provisions and the overall kind, not explicitly described in this pendency of litigation, Pharmaceutical regulatory framework are complex. HHS paragraph (h)(5); or Care Management Association v. U.S. intends to evaluate those interactions as (viii) A reduction in price or other Department of Health and Human part of its regulatory review process, but remuneration in connection with the Services, et al., Civil Action No. 21–95 needs additional time to do so beyond sale or purchase of a prescription (JDB) (D.D.C.), challenging the final rule, the current effective date of January 29, pharmaceutical product from a this action temporarily delays for 60 2021. manufacturer to a plan sponsor under days from the date of the memorandum Accordingly, this final rule delays the Medicare Part D either directly to the the effective date of certain amendments effective date of certain portions of the plan sponsor under Medicare Part D, or as promulgated by the final rule titled safe harbor regulation concerning indirectly through a pharmacy benefit ‘‘Fraud and Abuse; Removal of Safe discounts for prescription manager acting under contract with a Harbor Protection for Rebates Involving pharmaceutical products at 42 CFR plan sponsor under Medicare Part D, Prescription Pharmaceuticals and 1001.952. The effective date of new unless it is a price reduction or rebate Creation of New Safe Harbor Protection paragraphs (h)(6) through (9), (cc), and that is required by law. for Certain Point-of-Sale Reductions in (dd) of that rule, which would have * * * * * Price on Prescription Pharmaceuticals been January 29, 2021, is now March 22, and Certain Pharmacy Benefit Manager 2021. The temporary delay in the Norris Cochran, Service Fees,’’ published in the effective date of this final rule is Acting Secretary. November 30, 2020, Federal Register. necessary to give Department officials [FR Doc. 2021–02132 Filed 1–29–21; 8:45 am] This document announces that the the opportunity for further review and BILLING CODE 4152–01–P effective date for the certain provisions consideration of the revisions to of the final rule is delayed until March paragraphs (h)(5)(vi) and (viii), as well 22, 2021, the first business day after 60 as the addition of new paragraphs days from the date of the memorandum. DEPARTMENT OF COMMERCE (h)(5)(iii), (6) through (9), (cc), and (dd) This document also corrects a technical of 42 CFR 1001.952, consistent with the National Oceanic and Atmospheric error in the amendatory instructions. memorandum of January 20, 2021. Administration DATES: As of January 29, 2021, the Separately, November 2020 final rule effective date of the amendments to 42 contained a technical error in the 50 CFR Part 622 CFR 1001.952 (h)(6) through (9), (cc), amendatory instructions that would and (dd) published at 85 FR 76666, [Docket No. 160426363–7275–02; RTID have prevented the Office of the Federal 0648–XA837] November 30, 2020, is delayed until Register from properly incorporating the March 22, 2021. amendments to § 1001.952 into the CFR. Coastal Migratory Pelagic Resources This correction is effective as of This document also corrects that error. March 22, 2021. The amendatory of the Gulf of Mexico and Atlantic ■ In FR 2020–25841 (85 FR 76666), instructions in FR 2020–25841 (85 FR Region; 2020–2021 Closure of published on November 30, 2020, the 76666), published on November 30, Commercial Run-Around Gillnet for following corrections are made: 2020 is corrected. King Mackerel FOR FURTHER INFORMATION CONTACT: § 1001.952 [Corrected] AGENCY: National Marine Fisheries Aaron Zajic, (202) 619–0335. ■ 1. On page 76730, third column, Service (NMFS), National Oceanic and SUPPLEMENTARY INFORMATION: The instruction 2 (including a. and b.) is Atmospheric Administration (NOAA), January 20, 2021 memorandum from the corrected to read as follows: Commerce.

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