Implementation of Executive Order on Access to Affordable Life-Saving Medications

AGENCY:

Health Resources and Services Administration (HRSA), Health and Human Services (HHS).

ACTION:

Final rule; delay of effective date.

SUMMARY:

In accordance with the memorandum of January 20, 2021, from the Assistant to the President and Chief of Staff, entitled “Regulatory Freeze Pending Review,” this action temporarily delays for 60 days from the date of the memorandum the effective date of the final rule titled “Implementation of Executive Order on Access to Affordable Life-saving Medications,” published in the December 23, 2020, Federal Register. This document announces that the effective date is delayed until March 22, 2021, the first business day after 60 days from the date of the memorandum.

DATES:

The effective date of the final rule published in the December 23, 2020, Federal Register (85 FR 83822), is delayed from January 22, 2021, to March 22, 2021.

FOR FURTHER INFORMATION CONTACT:

Jennifer Joseph, Director, Office of Policy and Program Development, Bureau of Primary Health Care, HRSA, 5600 Fishers Lane, Rockville, MD 20857; by email at jjoseph@hrsa.gov; telephone: 301-594-4300; fax: 301-594-4997.

SUPPLEMENTARY INFORMATION:

The January 20, 2021 memorandum from the Assistant to the President and Chief of Staff, entitled “Regulatory Freeze Pending Review,” instructed Federal agencies to delay the effective date of rules published in the Federal Register, but which have not yet taken effect, for a period of 60 days from the date of the memorandum. This final rule will apply to all health centers receiving section 330(e) grant funds that participate in the 340B Drug Pricing Program (340B Program), (42 U.S.C. 254b and 256b), and requires such entities to make insulin and injectable epinephrine available to health center patients identified as low-income or below the same price the health center paid through the 340B Program. The effective date of that rule, which would have been January 22, 2021, is now March 22, 2021. The temporary delay in the effective date of this final rule is necessary to give Department officials the opportunity for further review and consideration of new regulations, consistent with the memorandum of January 20, 2021, from the Assistant to the President and Chief of Staff, entitled “Regulatory Freeze Pending Review.”