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Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Proposed Rules
59 FR 7629, February 16, 1994. The SIP is not approved to apply on any Indian reservation land or any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the SIP-related rules do not have tribal implications as specified by Executive Order 13175 65 FR 67249, November 9, 2000, nor will it impose substantial direct costs on tribal governments or preempt tribal law.
Furthermore, the proposed rules regarding Title V Operating Permit programs do not have tribal implications because they are not approved to apply to any source of air pollution over which an Indian Tribe has jurisdiction, nor will these proposed rules impose substantial direct costs on tribal governments or preempt tribal law.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid Services 42 CFR Parts 433, 438, 447, and 456
CMS2482P2
RIN 0938AT82

List of Subjects
Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review DUR and Supporting Value-Based Purchasing VBP for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability TPL
Requirements: Delay of Effective Date for Provision Relating to Manufacturer Reporting of Multiple Best Prices Connected to a Value Based Purchasing Arrangement; Delay of Inclusion of Territories in Definition of States and United States
40 CFR Part 52

AGENCY:

Environmental protection, Administrative practice and procedure, Air pollution control, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements.
40 CFR Part 70
Environmental protection, Administrative practice and procedure, Air pollution control, Incorporation by reference, Intergovernmental relations, Operating Permits, Reporting and recordkeeping requirements.
Authority: 42 U.S.C. 7401 et seq.
Dated: May 20, 2021.
John Blevins, Acting Regional Administrator, Region 4.
FR Doc. 202111149 Filed 52721; 8:45 am BILLING CODE 656050P

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Centers for Medicare &
Medicaid Services CMS, Department of Health and Human Services HHS.
ACTION: Proposed rule.
This proposed rule proposes to delay for 6 months the January 1, 2022 effective date for amendatory instruction 10.a., which addresses the reporting by manufacturers of multiple best prices connected to a value based purchasing arrangement, of the final rule entitled, Medicaid Program;
Establishing Minimum Standards in Medicaid State Drug Utilization Review DUR and Supporting Value-Based Purchasing VBP for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability TPL
Requirements, published in the December 31, 2020 Federal Register.
This proposed rule also proposes to delay for 2 years the April 1, 2022
effective date of inclusion inclusion date for U.S. territories American Samoa, Northern Mariana Islands, Guam, Puerto Rico, and the Virgin Islands in the amended regulatory definitions of States and United States for purposes of the Medicaid Drug Rebate Program MDRP, adopted in the interim final rule with comment period entitled, Medicaid Program;
Covered Outpatient Drug; Further Delay of Inclusion of Territories in Definitions of States and United States, published in the November 25, 2019 Federal Register to April 1, 2024. In the alternative, we are proposing to finalize an inclusion date that may be earlier than April 1, 2024, but not before January 1, 2023, based on public comments received. We are requesting
SUMMARY:

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public comment on the proposed delays of applicable effective date and inclusion date discussed in greater detail below.
DATES: To be assured consideration, comments on the proposals must be received at one of the addresses provided below by June 28, 2021.
ADDRESSES: In commenting, please refer to file code CMS2482P2.
Comments, including mass comment submissions, must be submitted in one of the following three ways please choose only one of the ways listed:
1. Electronically. You may submit electronic comments on this regulation to http www.regulations.gov. Follow the Submit a comment instructions.
2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare &
Medicaid Services, Department of Health and Human Services, Attention:
CMS2482P2, P.O. Box 8016, Baltimore, MD 212448016.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS2482P2, Mail Stop C42605, 7500 Security Boulevard, Baltimore, MD 212441850.
For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Christine Hinds, 410 7864578;
Wendy Tuttle, 410 7868690.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the close of the applicable comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the applicable comment period on the following website as soon as possible after they have been received: http
www.regulations.gov. Follow the search instructions on that website to view public comments. CMS will not post on Regulations.gov public comments that make threats to individuals or institutions or suggest that the individual will take actions to harm the individual. CMS continues to encourage individuals not to submit duplicative comments. We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments.

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