Department of Health and Human Services September 24, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 17 of 17
Submission for OMB Review; 30-Day Comment Request; Post-Award Reporting Requirements Including Research Performance Progress Report Collection (Office of the Director)
In compliance with the requirement of 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.
Submission for OMB Review; 30-Day Comment Request; Public Health Service (PHS) Applications and Pre-Award Reporting Requirements (Office of the Director)
In compliance with the requirement of 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.
Building Interdisciplinary Research Careers in Women's Health (BIRCWH)
The Building Interdisciplinary Research Careers in Women's Health (BIRCWH) is an institutional mentored career-development program designed to connect junior faculty, known as BIRCWH Scholars, to senior faculty mentors with shared interest in women's health and sex differences research. The BIRCWH Annual Meeting is a gathering of senior and junior faculty that provides an opportunity to network and share scientific advances.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government 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; 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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; OJJAARA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OJJAARA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; BRAVECTO; Correction
The Food and Drug Administration (FDA or the Agency) published a notice in the Federal Register of February 12, 2018, for the determination of the regulatory review period for the animal drug BRAVECTO. In accordance with the Court's order in Nissan Chemical Corp., et al. v. FDA, et al., No. 22-01598 (D.D.C), this document revises the SUPPLEMENTARY INFORMATION section of that notice by adjusting the start date of the testing phase for BRAVECTO. This notice supersedes the June 11, 2021, Federal Register document revising the February 12, 2018, notice.
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the FDA Regulation: Small Entity Compliance Guide." We are updating the small entity compliance guide (SECG) to help small entities comply with revised requirements related to agricultural water in the "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption" regulation.
Determination of Regulatory Review Period for Purposes of Patent Extension; QUVIVIQ
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for QUVIVIQ 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.
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