Medical Devices; Immunology and Microbiology Devices; Classification of Clostridium Difficile Toxin Gene Amplification Assay
The Food and Drug Administration (FDA) is classifying Clostridium difficile (C. difficile) toxin gene amplification assay into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Determination That BIAXIN XL Oral Tablets Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products; Guidance for Industry.'' The guidance document provides sponsors of virus or bacteria-based gene therapy products (VBGT products) and oncolytic viruses or bacteria (oncolytic products) with recommendations on how to conduct shedding studies during preclinical and clinical development. The guidance announced in this notice finalizes the draft guidance of the same title dated July 2014.
Best Pharmaceuticals for Children Act (BPCA) Priority List of Needs in Pediatric Therapeutics
The National Institutes of Health (NIH) hereby announces the Best Pharmaceuticals for Children Act (BPCA) Priority List of Needs in Pediatric Therapeutics for 2015. The Best Pharmaceuticals for Children Act (BPCA) seeks to improve the level of information on the safe and effective use of pharmaceuticals used to treat children. The BPCA requires that the NIH identify the drugs of highest priority for study in pediatric populations, and publish a list of drugs/needs in pediatric therapeutics. This notice fulfills the requirement to publish that list.
Request for Quality Metrics; Notice of Draft Guidance Availability and Public Meeting; Request for Comments; Extension of Comment Period
The Food and Drug Administration (FDA) is extending the comment period for the notice of draft guidance availability and public meeting that appeared in the Federal Register of July 28, 2015, and August 7, 2015. In the notice of draft guidance availability and public meeting, FDA requested comments on a number of specific questions identified in the document. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Reporting of Pregnancy Success Rates From Assisted Reproductive Technology (ART) Programs
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the requirements for reporting of pregnancy success rates from assisted reproductive technology (ART) programs as required by the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA). This notice describes who shall report to HHS/CDC, the reporting system (National ART Surveillance System (NASS); the process for reporting by each ART program; the data to be reported; and the contents of the published reports. The proposed changes to reporting requirements were published in the Federal Register on July 21, 2014 (79 FR. 42328) and February 18, 2015 (80 FR. 8659) in accordance with requirements under the Paperwork Reduction Act; public comments and recommendations were requested. This notice incorporates the comments received from those notices and supersedes the previous notice published in the Federal Register, September 1, 2000 (65 FR. 53310).
Fees for Sanitation Inspections of Cruise Ships
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces fees for vessel sanitation inspections for Fiscal Year (FY) 2016. These inspections are conducted by HHS/CDC's Vessel Sanitation Program (VSP). VSP helps the cruise line industry fulfill its responsibility for developing and implementing comprehensive sanitation programs to minimize the risk for acute gastroenteritis. Every vessel that has a foreign itinerary and carries 13 or more passengers is subject to twice-yearly unannounced inspections and, when necessary, reinspection.
Meeting on American Indian/Alaska Native Lesbian, Gay, Bisexual, and Transgender Health Issues
The Indian Health Service (IHS) is continuing to seek broad public input as it continues efforts to advance and promote the health needs of the American Indian/Alaska Native (AI/AN) Lesbian, Gay, Bisexual, and Transgender (LGBT) community.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor Reporting
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.
Meeting of the Community Preventive Services Task Force (Task Force)
The Centers for Disease Control and Prevention (CDC) announces the next meeting of the Community Preventive Services Task Force (Task Force). The Task Force is an independent, nonpartisan, nonfederal, and unpaid panel. Its members represent a broad range of research, practice, and policy expertise in prevention, wellness, health promotion, and public health, and are appointed by the CDC Director. The Task Force was convened in 1996 by the Department of Health and Human Services (HHS) to identify community preventive programs, services, and policies that increase healthy longevity, save lives and dollars and improve Americans' quality of life. CDC is mandated to provide ongoing administrative, research, and technical support for the operations of the Task Force. During its meetings, the Task Force considers the findings of systematic reviews on existing research, and issues recommendations. Task Force recommendations are not mandates for compliance or spending. Instead, they provide information about evidence-based options that decision makers and stakeholders can consider when determining what best meets the specific needs, preferences, available resources, and constraints of their jurisdictions and constituents. The Task Force's recommendations, along with the systematic reviews of the scientific evidence on which they are based, are compiled in the Guide to Community Preventive Services (Community Guide).
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (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.
Submission for OMB Review; 30-Day Comment Request; Surveys To Support an Evaluation of the National Human Genome Research Institute (NHGRI) Summer Workshop in Genomics (Short Course)
Under the provisions of Section 3507(a)(l)(D) 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. This proposed information collection was previously published in the Federal Register on March 17, 2015, Vol. 80, Page 13845 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Human Genome Research Institute (NHGRI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395- 6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
Medicare Program; Comprehensive Care for Joint Replacement Payment Model for Acute Care Hospitals Furnishing Lower Extremity Joint Replacement Services; Corrections
This document corrects technical and typographical errors that appeared in the proposed rule published in the July 14, 2015 Federal Register entitled ``Medicare Program; Comprehensive Care for Joint Replacement Payment Model for Acute Care Hospitals Furnishing Lower Extremity Joint Replacement Services.''
Medical Device Epidemiology Network Registry Task Force Report; Availability, Web Site Location and Request for Comments
The Food and Drug Administration (FDA) is announcing the availability of the report and Web site location where the Agency has posted the report entitled ``Recommendations for a National Medical Device Evaluation System: Strategically Coordinated Registry Networks to Bridge the Clinical Care and Research,'' developed by the Medical Device Epidemiology Network's Medical Device Registry Task Force. In addition, FDA has established a docket where stakeholders may provide comments.
National Vaccine Injury Compensation Program; List of Petitions Received
The 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 Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services 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 National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting September 9-10, 2015. The meeting is open to the public. However, pre- registration is required for both public attendance and public comment. Individuals who wish to attend the meeting and/or participate in the public comment session should register at http://www.hhs.gov/nvpo/nvac/ meetings/upcomingmeetings/. Participants may also register by emailing email@example.com or by calling 202-690-5566 and providing their name, organization, and email address.
Use of Rare Pediatric Disease Priority Review Voucher; Approval of a Drug Product
The Food and Drug Administration (FDA) is announcing the recent approval of a drug product under an application for which the sponsor redeemed a rare pediatric disease priority review voucher. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to redeem priority review vouchers submitted by sponsors of product applications that might otherwise not qualify for priority review. These vouchers entitle the holder of such a voucher to priority review of a single human drug application submitted under the FD&C Act or the Public Health Service Act. FDA has approved PRALUENT (alirocumab), manufactured by Sanofi-Aventis U.S. Inc., under a priority review.
Surrogate Endpoints for Clinical Trials in Kidney Transplantation; Notice of Public Workshop; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in theFederal Register of Monday, August 3, 2015 (80 FR 45999). The document announced a public workshop entitled ``Surrogate Endpoints for Clinical Trials in Kidney Transplantation.'' The document was published without the email address and fax number in the Contact Person section and without the option for email or phone registration in the Registration section. This document corrects those errors.