Department of Health and Human Services June 2021 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) has determined that ATROVENT (ipratropium bromide) metered spray, 0.021 micrograms (mcg)/spray and 0.042 mcg/spray, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) is proposing to collect data on different approaches that Head Start programs use for the recruitment, selection, enrollment, and retention (RSER) of families facing adversities and the community organizations with which it partners to support these activities. This study aims to present an internally valid description of RSER approaches used by six purposively selected programs, not to promote statistical generalization to different sites or service populations.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Board of Scientific Counselors (BSC), National Institute for Occupational Safety and Health (NIOSH), National Firefighter Registry Subcommittee. This is a virtual meeting. It is open to the public, limited only by web conference seats (500 web conference seats are available). If you wish to attend, please register at the NIOSH website https://www.cdc.gov/niosh/bsc/nfrs/ registration.html or call (404-498-2581) no later than August 6, 2021. Time will be available for public comment.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act.'' The Drug Supply Chain Security Act (DSCSA) outlines critical enhanced drug distribution security requirements for building an electronic, interoperable system by November 27, 2023, that will identify and trace certain prescription drugs at the package level as they are distributed within the United States. This draft guidance clarifies these requirements and provides recommendations on the system attributes necessary to enable the secure tracing of product at the package level, including allowing for the use of verification, inference, and aggregation, as necessary.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.'' The guidance addresses provisions in the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). The guidance is intended to aid certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product and specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain. The guidance also describes how trading partners should notify FDA of illegitimate product and sets forth a process for terminating notifications of illegitimate product in consultation with FDA. In addition, this guidance describes when manufacturers should notify FDA of a high risk that a product is illegitimate. This guidance responds to comments from stakeholders in order to clarify certain points and finalizes the remaining draft portion of the final guidance for industry entitled ``Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification,'' issued in December 2016.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Administration for Children and Families (ACF) Office of Refugee Resettlement (ORR) seeks approval for a revision to an existing information collection, requesting Refugee Support Services (RSS) grantees and RSS Set Aside grantees to provide the agency name, city, state, website, and funding amount for each contracted sub-grantee. Additionally, ORR seeks approval to have the option to make this information public. This would enhance the accessibility of refugee service provider information to eligible clients in support of the service referral responsibilities of the State Refugee Coordinators. Similar information for ORR's discretionary grants is currently made public.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations.'' This draft guidance provides recommendations for consistent in vitro testing of oral drug products to demonstrate their suitability to be administered via enteral tube. In addition, it supports the development of clear product-specific enteral tube administration instructions in labeling for administration to patients unable to ingest oral drug products.

The Food and Drug Administration (FDA, Agency, or we) has determined that SANDOSTATIN (octreotide acetate) injection, equal to (EQ) 0.2 milligrams (mg) base/milliliter (mL) and 1 mg base/mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

This document corrects technical and typographical errors in the final rule that appeared in the January 19, 2021 Federal Register titled ``Medicare and Medicaid Programs; Contract Year 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All Inclusive Care for the Elderly.'' The effective date of the final rule was March 22, 2021.