Department of Health and Human Services October 17, 2012 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: 2012-25587
Type: Notice
Date: 2012-10-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
Announcement of the Award of Two Single-Source Program Expansion Supplements to Grantees Under the Pathways to Responsible Fatherhood Grants
Document Number: 2012-25561
Type: Notice
Date: 2012-10-17
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Office of Family Assistance (OFA), Division of State and Territory TANF Management (DSTTM) announces the award of single-source program expansion supplement grants of $131,666 each to Kanawha Institute for Social Research & Action (KISRA) in Dunbar, WV, and Connections to Success in Kansas City, MO. Connections to Success and KISRA offer community-centered, comprehensive approaches to promoting responsible fatherhood, and activities designed to promote economic stability, subsidized employment, and supportive services. The primary purpose of the projects is to eliminate barriers for fathers to achieve social and economic self-sufficiency through subsidized employment, including individuals preparing to reenter their communities or those who have recently returned to their communities following incarceration. Both projects implement three legislatively specified activities: healthy marriage, responsible parenting, and economic stability.
Oncologic Drugs Advisory Committee; Cancellation
Document Number: 2012-25503
Type: Notice
Date: 2012-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The meeting of the Oncologic Drugs Advisory Committee Meeting scheduled for November 8, 2012, is canceled. This cancellation applies to both the morning session and afternoon session of the meeting. This meeting was announced in the Federal Register of September 20, 2012 (77 FR 58399). The issues for which the FDA was seeking the scientific input of the committee have been resolved.
Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability
Document Number: 2012-25494
Type: Notice
Date: 2012-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``eCopy Program for Medical Device Submissions.'' The purpose of the draft guidance is to explain the new electronic copy (eCopy) program for medical device submissions. The draft guidance describes how FDA plans to implement the eCopy Program under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The inclusion of an eCopy is expected to improve the efficiency of the review process by allowing for the immediate availability of an electronic version for review rather than relying solely on the paper version. This draft guidance is not final nor is it in effect at this time.
Announcement of the Award of a Single-Source Program Expansion Supplement to One Grantee Under the Community-Centered Responsible Fatherhood Ex-Prisoner Reentry Pilot Project Grants
Document Number: 2012-25486
Type: Notice
Date: 2012-10-17
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Office of Family Assistance (OFA), Division of State and Territory TANF Management (DSTTM) announces the award of a single-source program expansion award of $131,666 to The RIDGE Project in Defiancé, OH. The RIDGE Project is a 501(c)(3), faith-based organization founded in 2000 and provides a broad range of services in Ohio to over 30,000 individuals a year with over 100,000 units of service each year. Their mission is to strengthen families through youth development, marriage and fatherhood programs, workforce development, and reentry programs designed to equip people to achieve social and economic self- sufficiency. Activities include the provision of economic stability, subsidized employment, and supportive services. Upon release from prison, participants continue in the program and are served by The RIDGE Project or one of its regional partners. The primary purpose is to eliminate barriers for fathers to achieve social and economic self-sufficiency through subsidized employment for individuals preparing to reenter their communities or those who have recently returned to their communities following incarceration. The RIDGE Project also implements three legislatively specified activities: Healthy marriage, responsible parenting, and economic stability. The program expansion supplement will support the project's culinary arts training and employment, designed to prepare program participants for careers in the culinary field. According to recent data from the People Report Workforce Index, which surveys restaurant human resources departments and recruiters on trends in employment, continued job growth is anticipated in the food service industry, with high levels of recruiting difficulty, and a rise in vacancies/turnovers expected. Employers are reporting that though they have hundreds of applicants, they are finding it increasingly difficult to find employees with the right skill set. The RIDGE Project will begin offering an 8-week Culinary Arts training to formerly incarcerated fathers who have successfully completed their flagship responsible fatherhood and economic stability program and have evidenced their commitment to responsible fatherhood and show an aptitude and interest in the food service industry. The program will provide students with the basic skills necessary to function in an entry-level capacity in a restaurant or commercial kitchen. Successful students will complete the program having achieved the ServSafeTM Certification, and will have demonstrated the core skills necessary to begin work in food preparation or as a line cook entrance chef. Finally, upon satisfactory completion, The RIDGE Project's Workforce Development Department will function to assist the fathers with job placement, including subsidized wages in local restaurants.
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
Document Number: 2012-25484
Type: Notice
Date: 2012-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting
Document Number: 2012-25483
Type: Notice
Date: 2012-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
Document Number: 2012-25482
Type: Notice
Date: 2012-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
Report on Carcinogens Evaluation of Pentachlorophenol; Request for Nominations of Scientific Experts
Document Number: 2012-25472
Type: Notice
Date: 2012-10-17
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS), is initiating development of the Report on Carcinogens (RoC) monograph on pentachlorophenol. To inform development of that monograph, the Office of the RoC (ORoC) will hold a web-based meeting to obtain information related to evaluating human epidemiologic studies on exposure to pentachlorophenol and cancer risk and invites the nomination of speakers. Nominees should have expertise in cancer epidemiology and knowledge of studies related to exposure to pentachlorophenol. Self-nomination is permitted.
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2013 Rates; Hospitals' Resident Caps for Graduate Medical Education Payment Purposes; Quality Reporting Requirements for Specific Providers and for Ambulatory Surgical Centers; Correcting Amendment
Document Number: 2012-25464
Type: Rule
Date: 2012-10-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors in the regulations text of the final rule that appeared in the August 31, 2012 Federal Register entitled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2013 Rates; Hospitals' Resident Caps for Graduate Medical Education Payment Purposes; Quality Reporting Requirements for Specific Providers and for Ambulatory Surgical Centers'' (hereinafter referred to as the FY 2013 IPPS/LTCH PPS final rule).
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2012-25449
Type: Notice
Date: 2012-10-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2012-25448
Type: Notice
Date: 2012-10-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2012-25447
Type: Notice
Date: 2012-10-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Amended Notice of Meeting
Document Number: 2012-25446
Type: Notice
Date: 2012-10-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2012-25445
Type: Notice
Date: 2012-10-17
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2012-25442
Type: Notice
Date: 2012-10-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 2012-25441
Type: Notice
Date: 2012-10-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2012-25440
Type: Notice
Date: 2012-10-17
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meetings
Document Number: 2012-25439
Type: Notice
Date: 2012-10-17
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2012-25438
Type: Notice
Date: 2012-10-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2012-25437
Type: Notice
Date: 2012-10-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2012-25436
Type: Notice
Date: 2012-10-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2012-25435
Type: Notice
Date: 2012-10-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2012-25434
Type: Notice
Date: 2012-10-17
Agency: Department of Health and Human Services, National Institutes of Health
Influenza Viruses Containing the Hemagglutinin from the Goose/Guangdong/1/96 Lineage
Document Number: 2012-25377
Type: Proposed Rule
Date: 2012-10-17
Agency: Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) announces the opening of a docket to obtain information and comments from the public to questions concerning highly pathogenic avian influenza (HPAI) H5N1 viruses that contain a hemagglutinin (HA) from the Goose/Guangdong/1/96 lineage, and their potential to pose a severe threat to public health and safety. This information will be considered in a determination of whether such viruses should be listed as HHS select agents, by revising the HHS Select Agent Regulations (42 CFR Part 73).
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