Department of Health and Human Services February 2022 – Federal Register Recent Federal Regulation Documents

This is to notify the public that the March 3, 2022, meeting of the Advisory Commission on Childhood Vaccines (ACCV) is canceled and will be rescheduled. This meeting was announced in the Federal Register, Vol. 87, No. 20 on Monday, January 31, 2022 (FR Doc. 2022- 01848 Filed 1-28-22). Future meetings will occur in June, September, and December of calendar year 2022 and were announced through the same Federal Register notice.

The Department of Health and Human Services (HHS or Department), through the National Institutes of Health (NIH), proposes to amend the existing regulation for the conduct of persons and traffic on the NIH enclave in Bethesda, Maryland, in order to update certain provisions of the regulation.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of five abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and a conditionally approved new animal drug application (cNADA) during July, August, and September 2021. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy of the regulations.

The Office of Child Care (OCC), Administration for Children and Families (ACF) is requesting a 3-year extension of the form ACF- 801: CCDF Quarterly Case-Level Report (OMB #0970-0167, expiration 2/28/ 2022). OCC proposes minor changes to the response categories under the following three data elements: Child's gender, ethnicity, and race.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on exemptions from substantial equivalence requirements for tobacco products.

This document corrects technical errors that appeared in the proposed rule published in the Federal Register on January 12, 2022 entitled ``Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs.''

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements associated with the sanitary transportation of human and animal food.

On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the ``generic'' clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low- burden, and uncontroversial collections,'' do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938-1148 (CMS- 10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit comments regarding our burden estimates or any other aspect of this collection of information, including: the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Lead Exposure and Prevention Advisory Committee (LEPAC), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through January 17, 2024.

In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection titled, ``Addendum to Declaration for Federal Employment, Child Care and Indian Child Care Worker Positions,'' Office of Management and Budget (OMB) Control Number 0917-0028. The IHS is requesting OMB to approve an extension for this collection, which expires on February 28, 2022. Notice regarding the information collection was last published in the Federal Register on December 13, 2021, and allowed 60 days for public comment. The purpose of this notice is to announce the IHS' intent to submit this collection to OMB and to allow 30 days for public comment to be submitted directly to OMB. A copy of the supporting statement is available at www.regulations.gov (see Docket ID: IHS_FRDOC_0001).

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $200,000, with an expected total funding of approximately $1,000,000 over a five-year period to the International Agency for Research on Cancer (IARC). The award will support the IARC Handbooks on Cancer Prevention program which provide comprehensive reviews and consensus evaluations evidence on the effectiveness of preventive interventions that may reduce cancer incidence or mortality in the United States and other countries.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $2,000,000 for Year 1 of funding to the Ho Chi Minh City Department of Health (HCMC DOH). The award will strengthen the capacity of the HCMC DOH to provide sustainable evidence-based effective HIV prevention, care and treatment services. As Ho Chi Minh City contributes to 22.6% of the HIV burden, HCMC DOH remains critical to the success of HIV program in Vietnam. This NOFO will contribute directly to the national HIV prevention, care and treatment goals by supporting direct services and will support long-term sustainability of the HIV response through capacity building and technical assistance (TA). Funding amounts for years 2-5 will be set at continuation.