Department of Health and Human Services August 15, 2022 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
National Institute on Disability, Independent Living, and Rehabilitation Research
The Administration for Community Living (ACL) within the Department of Health and Human Services (HHS or the Department) is amending its regulations for the National Institute on Disability, Independent Living and Rehabilitation Research (NIDILRR). These minor amendments to NIDILRR's peer review criteria allow NIDILRR to better evaluate the extent to which our grant applicants conduct outreach to people with disabilities and people from other groups that traditionally have been underserved and underrepresented, as described in Executive Order 13985, and emphasize the need for research and development activities that apply appropriate engineering knowledge and techniques within NIDILRR's Rehabilitation Engineering Research Centers (RERC) program.
Office of the Secretary; Emergency Use Authorization; Monkeypox Virus Vaccine
The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act. On August 9, 2022, the Secretary determined pursuant to his authority under section 564 of the FD&C Act that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad that involves monkeypox virus. On the basis of this determination, he also declared that circumstances exist justifying the authorization of emergency use of vaccines for use against monkeypox virus pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.
Soliciting Public Comment on Appendix A of the Food and Drug Administration's July 2018 Guidance Entitled “Abbreviated New Drug Application Submissions-Amendments To Abbreviated New Drug Applications Under Generic Drug User Fee Amendments;” Notice; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket to solicit comments on the content of Appendix A in the July 2018 guidance for industry entitled ``ANDA SubmissionsAmendments to Abbreviated New Drug Applications Under GDUFA'' (ANDA Amendments Guidance). We are soliciting comments on the content of Appendix A. The Agency is taking this action to fulfill the Agency's commitment described in section IX.B. of the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 Commitment Letter (GDUFA III Commitment Letter).
Meeting of the Advisory Committee on Infant and Maternal Mortality (Formerly the Advisory Committee on Infant Mortality)
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Infant and Maternal Mortality (ACIMM) has scheduled a public meeting. Information about ACIMM and the agenda for this meeting can be found on the ACIMM website at https://www.hrsa.gov/advisory-committees/infant-mortality/ index.html.
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, National Institute for Occupational Safety and Health (BSC, NIOSH), National Firefighter Registry Subcommittee. This meeting is open to the public via virtual meeting, limited only by the number of web conference seats (500 web conference seats are available). Time will be available for public comment.
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