Department of Health and Human Services August 7, 2017 – Federal Register Recent Federal Regulation Documents

Announcement of Meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030
Document Number: 2017-16608
Type: Notice
Date: 2017-08-07
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services (HHS) announces the next meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 (Committee). The meeting is open to the public and will be held in the Washington, DC metropolitan area. The Committee is working to accomplish its mission to provide independent advice based on current scientific evidence for use by the Secretary of the U.S. Department of Health and Human Services or a designated representative in the development of Healthy People 2030.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Advertisements
Document Number: 2017-16607
Type: Notice
Date: 2017-08-07
Agency: Food and Drug Administration, Department of Health and Human Services
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.
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2017-16584
Type: Notice
Date: 2017-08-07
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Meeting of the Advisory Commission on Childhood Vaccines
Document Number: 2017-16582
Type: Notice
Date: 2017-08-07
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with section 10(a)(2) of the Federal Advisory Committee Act, notice is hereby given that a meeting is scheduled for the Advisory Commission on Childhood Vaccines (ACCV). This meeting will be open to the public. Information about the ACCV and the agenda for this meeting can be obtained by accessing the following Web site: http://www.hrsa.gov/advisorycommittees/childhoodvaccines/inde x.html.
Product-Specific Guidances; Final Guidances for Industry; Availability
Document Number: 2017-16581
Type: Notice
Date: 2017-08-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of final product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The product- specific guidances identified in this notice were developed using the process described in that guidance.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry-User Fee Waivers, Reductions, and Refunds for Drug and Biological Products
Document Number: 2017-16580
Type: Notice
Date: 2017-08-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency or we) 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: Cooperative Manufacturing Arrangements for Licensed Biologics
Document Number: 2017-16564
Type: Notice
Date: 2017-08-07
Agency: Food and Drug Administration, Department of Health and Human Services
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 the proposed extension of the collection of information concerning cooperative manufacturing arrangements for licensed biologics.
Agency Information Collection Activities; Proposed Collection; Comment Request; Safety Assurance Case; Withdrawal of Notice
Document Number: 2017-16561
Type: Notice
Date: 2017-08-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the withdrawal of a notice that was published in the Federal Register of March 15, 2017.
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2017-16533
Type: Notice
Date: 2017-08-07
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of Exclusive Patent License: The Development of a Bispecific, Biparatopic Antibody-Drug Conjugate to GPC3 for the Treatment of Human Liver Cancers
Document Number: 2017-16525
Type: Notice
Date: 2017-08-07
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to Salubris Biotherapeutics, Inc. (Salubris), located in Gaithersburg, Maryland, to practice the inventions embodied in the patent applications listed in the SUPPLEMENTARY INFORMATION section of this notice.
Prospective Grant of Exclusive Patent License: MicroRNA Therapeutics for Treating Squamous Cell Carcinomas
Document Number: 2017-16524
Type: Notice
Date: 2017-08-07
Agency: Department of Health and Human Services, National Institutes of Health
The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to MiRecule, Inc., located in Rockville, Maryland, to practice the inventions embodied in the patent applications listed in the SUPPLEMENTARY INFORMATION section of this notice.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-16523
Type: Notice
Date: 2017-08-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-16522
Type: Notice
Date: 2017-08-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2017-16521
Type: Notice
Date: 2017-08-07
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Notice of Meeting
Document Number: 2017-16520
Type: Notice
Date: 2017-08-07
Agency: Department of Health and Human Services, National Institutes of Health
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
Document Number: 2017-16519
Type: Notice
Date: 2017-08-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2017-16518
Type: Notice
Date: 2017-08-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) 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 the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Determination of Regulatory Review Period for Purposes of Patent Extension; CINQAIR
Document Number: 2017-16516
Type: Notice
Date: 2017-08-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CINQAIR 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 biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; VONVENDI
Document Number: 2017-16515
Type: Notice
Date: 2017-08-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VONVENDI 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 biological product.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: AIDS Drug Assistance Program Data Report, OMB No. 0915-0345-Extension
Document Number: 2017-16495
Type: Notice
Date: 2017-08-07
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Medicare Program; FY 2018 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update
Document Number: 2017-16430
Type: Notice
Date: 2017-08-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice with comment period updates the prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs), which include freestanding IPFs and psychiatric units of an acute care hospital or critical access hospital. These changes are applicable to IPF discharges occurring during the fiscal year (FY) beginning October 1, 2017 through September 30, 2018 (FY 2018).