Department of Health and Human Services September 5, 2019 – Federal Register Recent Federal Regulation Documents
Results 1 - 11 of 11
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Applications for Food and Drug Administration Approval To Market a New Drug-Patent Submission and Listing Requirements
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on E6(R2) Good Clinical Practice; International Council for Harmonisation; Integrated Addendum to International Council for Harmonisation E6(R1)
The Food and Drug Administration (FDA, Agency, or we) 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 information collection recommendations found in Agency guidance pertaining to the development of a system to manage quality as well as information to include in a clinical study report about the quality management approach.
Determination of Regulatory Review Period for Purposes of Patent Extension; GIAPREZA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for GIAPREZA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Agency Information Collection Activities; Proposed Collection; Comment Request; Accreditation Scheme for Conformity Assessment Pilot Program
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, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program.
The National Institutes of Health (NIH) Sexual & Gender Minority Research Listening Session
The National Institutes of Health (NIH) Sexual & Gender Minority Research Office (SGMRO) will be holding a listening session with the Sexual & Gender Minority (SGM) community. The primary objectives of the NIH's listening session are: (1) To hear from community stakeholders about what issues are on their minds with regard to SGM-related research and related activities at the NIH, and (2) to use these individual viewpoints to help inform the development of the NIH SGM Research FY 2021-2025 strategic plan. The goal is to hold a listening session every year, to provide different SGM focused organizations an opportunity to join a session in person.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on Performance Monitoring of Working with Publicly Funded Health Centers to Reduce Teen Pregnancy among Youth from Vulnerable Populations (OMB Control No. 0920-1156, Exp. 01/ 30/2020). A Revision is requested to continue collecting data through the end of the funding period and to develop systematic approaches to referring youth at risk for a teen pregnancy to reproductive health care.
Amendments to the List of Bulk Drug Substances That Can Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration (FDA or Agency) has issued a regulation creating a list of bulk drug substances (active pharmaceutical ingredients) that can be used to compound drug products in accordance with certain compounding provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), although they are neither the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drugs. This proposed rule would amend that list by placing five additional bulk drug substances on the list. This proposed rule also identifies 26 bulk drug substances that FDA has considered and proposes not to include on the list. Additional substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of a future rulemaking.
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