Department of Health and Human Services December 22, 2022 – Federal Register Recent Federal Regulation Documents
Results 1 - 16 of 16
Notice To Announce the Updated Significant Changes to the Revised NIH Grants Policy Statement for Fiscal Year 2023
The National Institutes of Health (NIH) announces publication of the updated Significant Changes that have already been made to the NIH Grants Policy Statement (NIHGPS) in fiscal year 2022 that will be reflected in the GPS for fiscal year 2023. The NIHGPS provides both up- to-date policy guidance that serves as NIH standard terms and conditions of award for all NIH grants and cooperative agreements, and extensive guidance to those who are interested in pursuing NIH grants. This update incorporates significant changes for FY 2023, such as new and modified requirements, clarifies certain policies, and implements changes in statutes, regulations, and policies that have been implemented through appropriate legal and/or policy processes since the previous version of the NIHGPS dated December 2021.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Q-Submission Program for Medical Devices
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Submission for Office of Management and Budget Review; Case Studies of Child Care and Development Fund Lead Agencies' Consumer Education Strategies (New Collection)
The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) is proposing to collect qualitative data to examine innovative and promising consumer education strategies that Child Care and Development Fund (CCDF) Lead Agencies are using to help families search for and select child care and early education (CCEE). This information collection aims to present an internally valid description of the experiences of up to six, purposively selected case study sites, not to promote statistical generalization to different sites or service populations.
Submission for OMB Review; 30-Day Comment Request Special Volunteer and Guest Researcher Assignment (Office of Intramural Research, Office of the Director)
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health. Nominations will be accepted for current and upcoming vacancies effective February 1, 2023, with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
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 (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.
Controlled Correspondence Related to Generic Drug Development; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Controlled Correspondence Related to Generic Drug Development.'' This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA requesting information related to generic drug development and the Agency's process for providing communications related to such correspondence. This guidance also describes the process by which generic drug manufacturers and related industry can submit requests to clarify ambiguities in FDA's controlled correspondence response and the Agency's process for responding to those requests. This draft guidance revises the guidance for industry entitled ``Controlled Correspondence Related to Generic Drug Development'' issued in December 2020.
Agency Information Collection Activities; Proposed Collection; Comment Request; Tracking Network for PETNet, LivestockNet, and SampleNet
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on our use of a tracking network to collect and share safety information about animal food from Federal, State, and Territorial Agencies.
Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning Experiences With Approved New Animal Drugs: Adverse Event Reports
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on adverse event reporting by FDA on new animal drugs and product manufacturing defects.
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
M11 Clinical Electronic Structured Harmonised Protocol; International Council for Harmonisation; Draft Guidance for Industry; Draft Template; and Technical Specification; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP),'' and two supplemental documents entitled ``M11 Template,'' and ``M11 Technical Specification.'' The draft guidance, template, and technical specification were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation. The draft guidance provides recommendations for a harmonized clinical trial protocol including the organization of standardized content and formatting. The draft template identifies headers, common text, and a set of data fields and terminologies that will be the basis for efficiencies in data exchange. The technical specification recommends the use of an open, non-proprietary standard to enable electronic exchange of clinical protocol information. The intent of the draft guidance and supporting documents is to create an international standard for the content and exchange of clinical trial protocol information facilitating review and assessment by regulators, sponsors, ethical oversight bodies, investigators, and other stakeholders.
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