Department of Health and Human Services February 28, 2022 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Advisory Commission on Childhood Vaccines Meeting Cancellation
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``AHRQ's National Nursing Home COVID-19 Coordinating Center.'' This proposed information collection was previously published in the Federal Register on December 8th, 2021 and allowed 60 days for public comment. AHRQ did not receive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Conduct of Persons and Traffic on the National Institutes of Health Federal Enclave
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.
Submission for OMB Review; Annual Report on Households Assisted by the Low Income Home Energy Assistance Program (LIHEAP)
The Office of Community Services (OCS), Division of Energy Assistance, is requesting a 3-year extension of the Household Report Form (OMB #0970-0060, expiration 02/28/2022). Submission of the completed report is one requirement for LIHEAP grant recipients applying for federal LIHEAP block grant funds. OCS proposes minor changes related to reporting of supplemental funding and to update reporting dates and number of respondents.
Fresenius Kabi USA, LLC, et al.; Withdrawal of Approval of Five Abbreviated New Drug Applications
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.
Patient-Focused Drug Development: Methods To Identify What Is Important to Patients; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry, FDA staff, and other stakeholders entitled ``Patient-Focused Drug Development: Methods To Identify What Is Important to Patients.'' This guidance (Guidance 2) is the second in a series of four methodological guidance documents that FDA committed to develop to describe how to collect and submit information from patients and caregivers to be used for medical product development and regulatory decision making. This guidance finalizes the draft guidance of the same title issued on October 1, 2019.
New Animal Drugs; Withdrawal of Approval of New Animal Drug Application
The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) at the sponsor's request because the product is no longer manufactured or marketed.
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor
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.
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