Department of Health and Human Services July 25, 2018 – Federal Register Recent Federal Regulation Documents
Results 1 - 10 of 10
Scholarly and Journalistic Activities Deemed Not To Be Research: 2018 Requirements; Draft Guidance; When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018 Through January 20, 2019: 2018 Requirements; Draft Guidance Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements; Draft Guidance
The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health is announcing the availability of three draft guidance documents titled, ``Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements,'' ``When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018 through January 20, 2019: 2018 Requirements,'' and ``Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements,'' respectively.
Government-Owned Inventions; Availability for Licensing
The invention listed below is jointly owned by an agency of the U.S. Government with Vanderbilt University, University of Alabama and University of Pennsylvania and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; New Data Collection; National Center on Law and Elder Rights (NCLER)
The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to ACL's National Center on Law and Elder Rights.
Administration for Community Living; Notice of Federal Review of the Puerto Rico State Council on Developmental Disabilities (SCDD) and the Protection and Advocacy System (P&A)
Representatives of the Administration on Intellectual and Developmental Disabilities (AIDD), Administration for Community Living (ACL), will be conducting a federal review of the Puerto Rico State Council on Developmental Disabilities (SCDD) and the Protection and Advocacy System (P&A) on September 17-21, 2018. AIDD is soliciting comments from interested parties on your experiences with the work, program, and strategies employed by P&A and SDCC in meeting the needs of individuals with developmental disabilities and their families in Puerto Rico. You are encouraged to share your experiences by way of any of the following methods: Email: Clare.huerta@acl.hhs.gov. Telephone: 202-795-7301. Mail Comments To: Clare Huerta, Program Specialist, Administration on Intellectual and Developmental Disabilities, Administration for Community Living, 330 C Street SW, 1st Floor, Washington, DC 20201. Comments should be received by September 10, 2018 in order to be included in the final report.
Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments.'' This draft guidance applies to orally administered drug products and provides recommendations to sponsors who will use or recommend use of liquids and/or soft foods as vehicles for drug administration in investigational new drug applications (INDs), new drug applications (NDAs), Biologics License Applications (BLAs), as applicable, and in supplements to these applications.
Facilitating Competition and Innovation in the Biological Products Marketplace; Public Hearing; Request for Comments
The Food and Drug Administration (FDA or the Agency) is announcing a public hearing on FDA's approach to enhancing competition and innovation in the biological products marketplace, including by facilitating greater availability of biosimilar and interchangeable products.
Secretarial Review and Publication of the National Quality Forum 2017 Annual Report to Congress and the Secretary of the Department of Health and Human Services Submitted by the Consensus-Based Entity Regarding Performance Measurement
This notice acknowledges the Secretary of the Department of Health and Human Services' (the Secretary) receipt and review of the National Quality Forum 2017 Annual Report to Congress and the Secretary submitted by the consensus-based entity under contract with the Secretary in accordance with the Social Security Act. The Secretary has reviewed and is publishing the report in the Federal Register together with the Secretary's comments on the report not later than 6 months after receiving the report in accordance with the Act.
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