Department of Health and Human Services June 4, 2021 – Federal Register Recent Federal Regulation Documents
Results 1 - 17 of 17
Intent To Award 54 Single-Source Supplements for Current Senior Medicare Patrol (SMP) State Grantee
The Administration for Community Living (ACL) announces the intent to award 54 administrative supplements in the form of cooperative agreements to existing SMP project grantees to further support SMP activities in each state, the District of Columbia, Guam, Puerto Rico, and the U.S. Virgin Islands. The purpose of existing grantees' work is to empower and assist Medicare beneficiaries, their families, and caregivers to prevent, detect, and report health care fraud, errors, and abuse through outreach, counseling, and education with an emphasis on reaching Medicare beneficiaries with limited income and those residing in rural areas. The administrative supplements for FY 2021 will be distributed via formula to the existing 54 SMP state grantees, bringing the total for the supplement awards to $2,002,468. These current SMP grantees will use this funding to further enhance or expand existing and prior established plans to empower and assist Medicare beneficiaries, their families, and caregivers to prevent, detect, and report health care fraud, errors, and abuse through outreach, counseling, and education. This additional funding will be targeted to reach Medicare beneficiaries with limited income, and/or those residing in rural areas.
Proposed Information Collection Activity; Head Start REACH: Strengthening Outreach, Recruitment, and Engagement Approaches With Families (New Collection)
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send 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.
Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH), National Firefighter Registry Subcommittee
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.
Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC). This is a virtual meeting open to the public, limited by the capacity of the conference webinar which is 2,000 participants. Pre-registration is required by accessing the link at: https://dceproductions.zoom.us/ webinar/register/WN_vCTciAdyQIeDK5g3NfFPow. There will be a public comment period from 2:15 p.m. to 4:15 p.m., EDT. The public is encouraged to register to provide public comment using the registration form available at the link provided in the meeting information section below.
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act.'' The draft guidance is intended to help industry better understand the definitions of ``suspect'' and ``illegitimate'' product as defined in the Drug Supply Chain Security Act (DSCSA). The draft guidance lays out FDA's current understanding of the following key terms used to define ``suspect'' and ``illegitimate'' product: ``Counterfeit,'' ``diverted,'' ``stolen,'' ``fraudulent transaction,'' and ``unfit for distribution.'' This revised draft guidance clarifies certain points of the draft guidance for industry ``Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act'' issued in March 2018 (March 2018 draft guidance), including FDA's current understanding of the term ``stolen.''
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability
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.
Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers.'' The guidance is intended to address questions regarding product identifiers that, under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Drug Supply Chain Security Act (DSCSA), are required to be affixed to, or imprinted on, packages and homogenous cases of certain drug products intended to be introduced in a transaction into commerce. This guidance is intended to clarify FDA's interpretation of these requirements, including as they relate to the linear barcode requirements under the Code of Federal Regulations. This guidance finalizes the draft guidance issued on September 20, 2018.
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Guidance for Industry; Availability
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.
Notice of Diabetes Mellitus Interagency Coordinating Committee Meeting
The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a joint meeting with the National Institutes of Arthritis and Musculoskeletal and Skin Diseases on June 4, 2021. The topic for this meeting will be ``Diabetes and Bone.'' The meeting is open to the public.
Agency Information Collection Request; 30-Day Public Comment Request
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.
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