Department of Health and Human Services October 22, 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 16 of 16
National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments
This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. This meeting is by webcast only and is open to the public. Written comments will be accepted and registration is required to present oral comments. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/165.
21st Century Cures Act: Annual Compilation of Notices of Updates From the Susceptibility Test Interpretive Criteria Web Page; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of the Agency's annual compilation of notices of updates to the Agency's Susceptibility Test Interpretive Criteria web page. The Agency established the Susceptibility Test Interpretive Criteria web page on December 13, 2017, and since establishment has provided updates to both the format of the web pages and to the susceptibility test interpretive criteria identified and recognized by FDA on the web pages. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act (Cures Act).
Meeting of the Presidential Advisory Council on HIV/AIDS
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA or the Council) will be holding the 69th full Council meeting utilizing virtual technology. PACHA members will be discussing HIV, the Ending the HIV Epidemic: A Plan for America (EHE) initiative, and the novel coronavirus (COVID- 19). The meeting will be open to the public; a public comment session will be held during the meeting. Pre-registration is required to provide public comment. To pre-register to attend or to provide public comment, please send an email to PACHA@hhs.gov and include your name, organization, and title by close of business Friday November 20, 2020. If you decide you would like to provide public comment but do not pre- register, you may submit your written statement by emailing PACHA@hhs.gov by close of business Thursday, December 10, 2020. The meeting agenda will be posted on the PACHA page on HIV.gov at https:// www.hiv.gov/ federal-response/pacha/about-pacha prior to the meeting.
Fit for Use Pilot Program Invitation for the Clinical Data Interchange Standards Consortium for Standard for Exchange of Nonclinical Data Implementation Guide Developmental and Reproductive Toxicology: Version 1.1
The Food and Drug Administration (FDA or Agency) is announcing that it intends to conduct a Fit for Use (FFU) pilot program to test the processing and analysis of nonclinical study data provided electronically for the Clinical Data Interchange Standards Consortium (CDISC) for Standard for Exchange of Nonclinical Data (SEND) Implementation Guide (IG): Developmental and Reproductive Toxicology v1.1 (SEND-DART). The Agency's Center for Drug Evaluation and Research (CDER) will test the processing and analysis of nonclinical study data provided electronically in SEND-DART format. FDA is inviting individual firms that wish to participate in this pilot program to submit participation requests via email or in writing.
Prospective Grant of an Exclusive Patent License: Development of a Direct Ocular Administered Formulation of Metformin for Use in Therapeutic Treatment of Retinal Degenerative Diseases in Humans
The National Eye Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice certain of the inventions embodied in the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this notice to Connectyx Technologies Holdings Group located in Boca Raton, Florida.
Prospective Grant of an Exclusive Patent License: Development of a Topical Ointment Containing Immunostimulatory CpG Oligodeoxynucleotides (ODN) for Dermatological Wound Healing
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Six Therapeutics Technologies Holdings Group. (``Six Therapeutics'') located in New Jersey.
Proposed Establishment of the Advisory Committee on Heritable Disorders in Newborns and Children
In accordance with the Federal Advisory Committee Act (FACA) and section 1111 of the Public Health Service (PHS) Act, HHS announces the establishment of the ACHDNC as a discretionary advisory committee.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded-Time and Extent Applications for Nonprescription Drug Products
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.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
