Department of Health and Human Services February 10, 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Request for Information on Promising Practices for Advancing Health Equity for Intersex Individuals
Through this Request for Information (RFI), the Office of the Assistant Secretary for Health (OASH), Department of Health & Human Services, invites feedback from stakeholders throughout the scientific research community, clinical practice communities, patient and family advocates, scientific or professional organizations, federal partners, internal HHS stakeholders, and other interested constituents on the development of a report on promising practices for advancing health equity for intersex individuals. The overarching purpose of the report on the promising practices for advancing health equity for intersex individuals is to ensure access to affirming, high-quality care for intersex people who live in America.
Emergent Biosolutions Inc.; Withdrawal of Approval of a Supplemental New Drug Application for NARCAN (Naloxone Hydrochloride) Nasal Spray, 2 Milligrams/0.1 Milliliter
The Food and Drug Administration (FDA or Agency) is withdrawing the approval of a supplemental new drug application (sNDA) for NARCAN (naloxone hydrochloride) nasal spray, 2 milligrams (mg)/0.1 milliliter (mL), held by Emergent Biosolutions Inc., 400 Professional Dr., Suite 400, Gaithersburg, MD 20879. Emergent Biosolutions, Inc., has notified the Agency in writing that NARCAN (naloxone hydrochloride) nasal spray, 2 mg/0.1 mL, is not marketed and has requested that approval of the sNDA be withdrawn. This action has no impact on the continued approval and marketing of NARCAN (naloxone hydrochloride) nasal spray, 4 mg/0.1 mL.
Termination of Declaration Authorizing Emergency Use of New In Vitro Diagnostics for Detection of Enterovirus D68
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 February 6, 2015, pursuant to section 564 of the FD&C Act, Sylvia M. Burwell, former Secretary of HHS, determined that there was a significant potential for a public health emergency that had a significant potential to affect national security or the health and security of United States citizens living abroad and that involved enterovirus D68 (EV-D68). Also on February 6, 2015, based on that determination, former Secretary Burwell declared that circumstances existed justifying the authorization of emergency use of new in vitro diagnostics for detection of EV-D68 pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section. As of September 2022, the Centers for Disease Control and Prevention's (CDC's) EV-D68 2014 rRT-PCR for which an EUA was issued is no longer produced and all test kits were destroyed. CDC's EV-D68 2014 rRT-PCR was never distributed. On February 6, 2023, pursuant to section 564 of the FD&C Act, the Secretary of HHS determined that there is no longer a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves EV-D68. The Secretary of HHS also determined that circumstances justifying the authorization of emergency use of new in vitro diagnostics for detection of EV-D68 no longer exist. Based on these determinations, the Secretary of HHS terminated the declaration, effective February 20, 2023, that circumstances justifying the authorization of emergency use of new in vitro diagnostics for detection of EV-D68 exist.
Medicaid and Children's Health Insurance Program (CHIP) Generic Information Collection Activities: Proposed Collection; Comment Request
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.
Meetings of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). The meeting will be held in-person at the Hubert H. Humphrey building in Washington, DC, and will be open to the public; the meeting will be streamed live on hhs.gov/live. A pre-registered public comment session will be held during the meeting. Pre-registration is required for members of the public who wish to present their comments in-person at the meeting. Individuals who wish to send in their written public comment should send an email to CARB@hhs.gov. Registration information is available on the website https://www.hhs.gov/paccarb and must be completed by March 17, 2023 for the March 23-24, 2023 Public Meeting. Additional information about registering for the meeting and providing public comment can be obtained at https://www.hhs.gov/paccarb on the Upcoming Meetings page.
Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency; Withdrawal of Guidance
The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of the guidance for industry entitled ``Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency,'' which was issued in April 2020 to communicate a temporary policy regarding the repackaging or combining of propofol drug products. FDA is withdrawing this guidance document because the conditions that created the need for this policy described in the document have evolved and the policy is no longer needed.
Protein Efficiency Ratio Rat Bioassay Studies To Demonstrate That a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance entitled ``Protein Efficiency Ratio (PER) Rat Bioassay Studies To Demonstrate That a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein.'' The draft guidance, when finalized, will provide information for manufacturers and contract laboratories that perform PER studies to assist in designing, conducting, evaluating, and reporting PER studies. The draft guidance, when finalized, will explain ``appropriate modifications'' of AOAC Official Method 960.48 (the AOAC Method) with the aim of supporting industry in successfully conducting PER studies that demonstrate that a new infant formula meets the quality factor of sufficient biological quality of protein when fed as the sole source of nutrition.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
