Department of Health and Human Services March 2, 2023 – Federal Register Recent Federal Regulation Documents

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA or the Council) will convene the 76th full council meeting on Wednesday, March 29 and Thursday March 30, 2023. The meeting will convene in Washington, DC and it will also utilize virtual technologies. The meeting will be open to the public. Due to limited space, pre-registration is encouraged for members of the public who wish to attend the meeting in-person. Please email your name to PACHA@hhs.gov by close of business Wednesday, March 22, 2023 to pre-reigster. There will be a public comment session during the meeting; pre-registration is required to provide public comment. To pre-register to provide public comment, please send an email to PACHA@hhs.gov and include your name, organization, and title by close of business March 22, 2023. If you decide you would like to provide public comment but do not pre-register, you may submit your written statement by emailing PACHA@hhs.gov by close of business April 5, 2023. The meeting agenda will be posted on the PACHA page on HIV.gov at https://www.hiv.gov/federal-response/pacha/about-pacha prior to the meeting.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

Before using an electronic signature in an electronic record required by the Food and Drug Administration (FDA or Agency), a person must submit a letter of non-repudiation to FDA. Letters of non- repudiation are required to certify that a person's electronic signatures are intended to be the legally binding equivalent of traditional handwritten signatures. FDA is amending its regulations to update the address for submission of a certification in paper form and to provide an option for electronic submission. This amendment is to ensure accuracy and clarity in the Agency's regulations. This technical amendment is nonsubstantive.

The Office of the Assistant Secretary for Health published a document in the Federal Register of February 23, 2023, announcing the solicitation of rritten comments on the Physical Activity Guidelines Midcourse Report on Older Adults. The document announces the availability of the draft Physical Activity Guidelines Midcourse Report on Older Adults (Midcourse Report) and solicits written public comment on the draft report by March 10, 2023. The published Notice did not include the comment deadline.

The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the analysis of Senior Medicare Patrol Grantees' Program Implementation.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The meeting of the Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee scheduled for March 20, 2023, is cancelled. This meeting was announced in the Federal Register of January 30, 2023. The meeting is no longer needed.