Department of Health and Human Services November 5, 2013 – Federal Register Recent Federal Regulation Documents

New Animal Drugs; Afoxolaner; Carprofen; Ceftiofur Hydrochloride; Monensin
Document Number: 2013-26473
Type: Rule
Date: 2013-11-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September 2013. FDA is also informing the public of the availability of summaries on the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for an ANADA.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-26469
Type: Notice
Date: 2013-11-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute on Aging; Amended Notice of Meeting
Document Number: 2013-26441
Type: Notice
Date: 2013-11-05
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-26436
Type: Notice
Date: 2013-11-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2013-26435
Type: Notice
Date: 2013-11-05
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Amended Notice of Meeting
Document Number: 2013-26434
Type: Notice
Date: 2013-11-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Amended Notice of Meeting
Document Number: 2013-26433
Type: Notice
Date: 2013-11-05
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Amended Notice of Meeting
Document Number: 2013-26432
Type: Notice
Date: 2013-11-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Amended Notice of Meeting
Document Number: 2013-26431
Type: Notice
Date: 2013-11-05
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2013-26430
Type: Notice
Date: 2013-11-05
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2013-26429
Type: Notice
Date: 2013-11-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Amended Notice of Meeting
Document Number: 2013-26428
Type: Notice
Date: 2013-11-05
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2013-26427
Type: Notice
Date: 2013-11-05
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2013-26426
Type: Notice
Date: 2013-11-05
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2013-26425
Type: Notice
Date: 2013-11-05
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2013-26424
Type: Notice
Date: 2013-11-05
Agency: Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-26423
Type: Notice
Date: 2013-11-05
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2013-26422
Type: Notice
Date: 2013-11-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2013-26421
Type: Notice
Date: 2013-11-05
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2013-26420
Type: Notice
Date: 2013-11-05
Agency: Department of Health and Human Services
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2013-26419
Type: Notice
Date: 2013-11-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Workshop
Document Number: 2013-26418
Type: Notice
Date: 2013-11-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2013-26417
Type: Notice
Date: 2013-11-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2013-26416
Type: Notice
Date: 2013-11-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2013-26415
Type: Notice
Date: 2013-11-05
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Amended Notice of Meeting
Document Number: 2013-26414
Type: Notice
Date: 2013-11-05
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-26401
Type: Notice
Date: 2013-11-05
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Draft Guidance for Industry: Use of Donor Screening Tests To Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products for Infection With Treponema pallidum (Syphilis); Availability
Document Number: 2013-26397
Type: Notice
Date: 2013-11-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (Syphilis),'' dated October 2013. The draft guidance document provides establishments that make donor eligibility determinations for donors of HCT/Ps (HCT/P Establishments), with updated recommendations concerning donor testing for evidence of Treponema pallidum (T. pallidum) infection, the etiologic agent of syphilis. HCT/P Establishments must, as required under Federal regulations, test a donor specimen for evidence of T. pallidum infection using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, unless an exception to this requirement applies. The draft guidance clarifies that FDA does not consider diagnostic tests or pre-amendment devices (which have not been licensed, approved, or cleared) to be adequate for use in donor testing for T. pallidum infection under the criteria specified in Federal regulations. The recommendations in this guidance, when finalized, will supersede those recommendations for testing HCT/P donors for evidence of T. pallidum infection contained in the document entitled ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),'' dated August 2007.
Proposed Information Collection Activity; Comment Request
Document Number: 2013-26383
Type: Notice
Date: 2013-11-05
Agency: Department of Health and Human Services, Administration for Children and Families
Medicare & Medicaid Programs: Application From the Accreditation Commission for Health Care for Continued CMS-Approval of Its Hospice Accreditation Program
Document Number: 2013-26374
Type: Notice
Date: 2013-11-05
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve the Accreditation Commission for Health Care (ACHC) for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs.