Department of Health and Human Services April 2008 – Federal Register Recent Federal Regulation Documents

Results 251 - 300 of 337
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: E8-7533
Type: Notice
Date: 2008-04-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Meeting
Document Number: E8-7532
Type: Notice
Date: 2008-04-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meetings
Document Number: E8-7528
Type: Notice
Date: 2008-04-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: E8-7527
Type: Notice
Date: 2008-04-10
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: E8-7500-2
Type: Notice
Date: 2008-04-10
Agency: Department of Health and Human Services, Health Resources and Services Administration
Guidance for Industry on Blue Bird Medicated Feed Labels; Availability
Document Number: E8-7500
Type: Notice
Date: 2008-04-10
Agency: Food and Drug Administration, Department of Health and Human Services, Health Resources and Services Administration
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (181) entitled ``Blue Bird Medicated Feed Labels.'' This guidance provides new animal drug application (NADA) sponsors with the Center for Veterinary Medicine's current thinking on what constitutes recommended content and format of representative labels for new animal drugs intended for use in the manufacture of medicated feeds.
Developmental Disabilities Program
Document Number: E8-7412
Type: Proposed Rule
Date: 2008-04-10
Agency: Department of Health and Human Services
This rule proposes clarifications and new requirements to implement the Developmental Disabilities Assistance and Bill of Rights Act of 2000 (DD Act of 2000). Of particular note, the proposed rule covers responsibilities of the Secretary in the area of program accountability and the indicators of progress. Under the proposal, one or more measures of progress must be used to measure the goal(s) developed for each area of emphasis. The areas of emphasis include: (1) Quality assurance activities; (2) education activities and early intervention activities; (3) child care-related activities; (4) health- related activities; (5) employment-related activities; (6) housing- related activities; (7) transportation-related activities; (8) recreation-related activities; and (9) other services available or offered to individuals in a community, including formal and informal community supports that affect their qualify of life.
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: E8-7429
Type: Notice
Date: 2008-04-09
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at http:// www.workplace.samhsa.gov and http://www.drugfreeworkplace.gov.
Submission for OMB Review; Comment Request
Document Number: E8-7408
Type: Notice
Date: 2008-04-09
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-7390
Type: Notice
Date: 2008-04-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: E8-7257
Type: Notice
Date: 2008-04-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-7256
Type: Notice
Date: 2008-04-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting
Document Number: E8-7254
Type: Notice
Date: 2008-04-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: E8-7253
Type: Notice
Date: 2008-04-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: E8-7251
Type: Notice
Date: 2008-04-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Meeting
Document Number: E8-7250
Type: Notice
Date: 2008-04-09
Agency: Department of Health and Human Services, National Institutes of Health
Issuance of Final Policy Directive
Document Number: E8-7238
Type: Notice
Date: 2008-04-09
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
The Administration for Native Americans (ANA) herein describes its issuance of final interpretive rules, general statements of policy and rules of agency procedure or practice relating to the Social and Economic Development Strategies (hereinafter referred to as SEDS), Native Language Preservation and Maintenance (hereinafter referred to as Native Language), Environmental Regulatory Enhancement (hereinafter referred to as Environmental) programs, Environmental Mitigation (hereinafter referred to as Mitigation), and Native American Healthy Marriage Initiative (hereinafter referred to as NAHMI).
New Animal Drugs for Use in Animal Feed; Zilpaterol; Technical Amendment
Document Number: E8-7307
Type: Rule
Date: 2008-04-08
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 of a new animal drug application (NADA) filed by Intervet Inc. The NADA provides for use of approved, single-ingredient Type A medicated articles containing zilpaterol hydrochloride, monensin USP, tylosin phosphate, and melengestrol acetate in four-way combination Type B and Type C medicated feeds for heifers fed in confinement for slaughter.
Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS)
Document Number: E8-7301
Type: Notice
Date: 2008-04-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Center for Injury Prevention and Control Initial Review Group, (NCIPC/IRG)
Document Number: E8-7300
Type: Notice
Date: 2008-04-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Center for Injury Prevention and Control/ Initial Review Group, (NCIPC/IRG)
Document Number: E8-7298
Type: Notice
Date: 2008-04-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Availability of Final Toxicological Profiles
Document Number: E8-7295
Type: Notice
Date: 2008-04-08
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
This notice announces the availability of seven updated final toxicological profiles of priority hazardous substances. This is the 19th set of toxicological profiles that ATSDR has compiled.
Prospective Grant of Exclusive License: Codon Optimized IL-15 and IL-15R-Alpha Genes for Expression in Mammalian Cells
Document Number: E8-7260
Type: Notice
Date: 2008-04-08
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license worldwide to practice the invention embodied in U.S. Serial Numbers 60/758,819, filed January 13, 2006 and 60/812,566, filed June 9, 2006; PCT filed (PCT/US2007/000774) on January 12, 2007, entitled ``Codon Optimized IL-15 and IL-15RAlpha Genes for Expression in Mammalian Cells'' (HHS Ref. E-254-2005/2) to Marine Polymer Technologies, Inc., having a place of business in Danvers, Massachusetts. The patent rights in these inventions have been assigned to the United States of America.
Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Investigational Use
Document Number: E8-7255
Type: Notice
Date: 2008-04-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the 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 reporting and recordkeeping requirements for ``New Animal Drugs for Investigational Use.''
Agency Information Collection Request; 30-Day Public Comment Request
Document Number: E8-7252
Type: Notice
Date: 2008-04-08
Agency: Department of Health and Human Services
Agency Information Collection Request; 30-Day Public Comment Request
Document Number: E8-7249
Type: Notice
Date: 2008-04-08
Agency: Department of Health and Human Services
International Conference on Harmonisation; Guidance on E15 Pharmacogenomics Definitions and Sample Coding; Availability
Document Number: E8-7237
Type: Notice
Date: 2008-04-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics, and genomic data and sample coding categories. In the effort to develop harmonized approaches to drug regulation, it is important to ensure that consistent definitions of terminology are being applied across all constituents of the ICH. The guidance is intended to facilitate the integration of the discipline of pharmacogenomics and pharmacogenetics into global drug development and approval processes.
Proposed Information Collection Activity; Comment Request
Document Number: E8-7139
Type: Notice
Date: 2008-04-08
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Proposed Information Collection Activity; Comment Request
Document Number: E8-7137
Type: Notice
Date: 2008-04-08
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Agency Information Collection Request: 60-Day Public Comment Request
Document Number: E8-7242
Type: Notice
Date: 2008-04-07
Agency: Department of Health and Human Services
Organ Procurement and Transplantation Network
Document Number: E8-7174
Type: Notice
Date: 2008-04-07
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources Services Administration (HRSA) published a notice in the Federal Register of March 3, 2008 (FR Doc. E8-3994), pages 11420-11421, requesting comments to assist in determining whether it should engage in rulemaking with respect to vascularized composite allografts, and also to announce a meeting for discussion and recommendations regarding that issue. The notice is to extend HRSA's deadline for receiving written comments to July 2, 2008, and to change the zip code of the address where the meeting will be held. Correction: In the Federal Register of March 3, 2008, in FR Doc. E8-3994, on page 11421, 1st column under the heading DATES: 1st line, change to read: Written comments must be received at HRSA by July 2, 2008. 10th line, change to read: The meeting will be held on Friday, April 4, 2008, from 10 a.m. to 4 p.m., at the Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857.
Proposed Information Collection Activity; Comment Request
Document Number: E8-7138
Type: Notice
Date: 2008-04-07
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-7133
Type: Notice
Date: 2008-04-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meetings
Document Number: E8-7132
Type: Notice
Date: 2008-04-07
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: E8-7131
Type: Notice
Date: 2008-04-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Closed Meeting
Document Number: E8-7130
Type: Notice
Date: 2008-04-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: E8-7129
Type: Notice
Date: 2008-04-07
Agency: Department of Health and Human Services, National Institutes of Health
Fiscal Year (FY) 2008 Funding Opportunity
Document Number: E8-6997
Type: Notice
Date: 2008-04-07
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award approximately $996,000 (total costs) per year for up to two years to the Education Development Resource Center, Inc. Newton, Massachusetts. This is not a formal request for applications. Assistance will be provided only to the Education Development Resource Center, Inc. based on the receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: SM-08-014 Catalog of Federal Domestic Assistance (CFDA) Number: 93.243
Medicare Program; Standards for E-Prescribing Under Medicare Part D and Identification of Backward Compatible Version of Adopted Standard for E-Prescribing and the Medicare Prescription Drug Program (Version 8.1)
Document Number: 08-1094
Type: Rule
Date: 2008-04-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Children and Families Administration
This final rule adopts uniform standards for medication history, formulary and benefits, and fill status notification (RxFill) for the Medicare Part D electronic prescribing (e-prescribing) drug program as required by section 1860D-4(e)(4)(D) of the Social Security Act (the Act). In addition, we are adopting the National Provider Identifier (NPI) as a standard for identifying health care providers in e-prescribing transactions. It also finalizes the June 23, 2006 interim final rule with comment period that identified the National Council for Prescription Drug Programs (NCPDP) Prescriber/Pharmacist Interface SCRIPT standard, Implementation Guide, Version 8.1 (``NCPDP SCRIPT 8.1'') as a backward compatible update of the NCPDP SCRIPT 5.0 (``NCPDP SCRIPT 5.0''), until April 1, 2009. This final rule also retires NCPDP SCRIPT 5.0 and adopts the newer version, NCPDP SCRIPT 8.1, as the adopted standard. Finally, except as otherwise set forth herein, we are implementing our compliance date of 1 year after the publication of these final uniform standards. This is the second set in a continuing process of issuing e-prescribing final standards for the Medicare Part D program,
Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Withdrawal
Document Number: E8-7107
Type: Rule
Date: 2008-04-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing a direct final rule that published in the Federal Register of December 4, 2007 (72 FR 68064), to amend certain regulations as the first phase of an incremental approach to modernize or clarify some of the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations. The comment period closed February 19, 2008. FDA is withdrawing the direct final rule because the agency received significant adverse comments. FDA will consider the comments received under our usual procedures for notice and comment in connection with the notice of proposed rulemaking that was published in the Federal Register of December 4, 2007, as a companion to the direct final rule (72 FR 68113).
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of NADAs; Technical Amendment
Document Number: E8-7103
Type: Rule
Date: 2008-04-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of seven new animal drug applications (NADAs) because FDA is withdrawing approval of the NADAs.
President's Committee for People With Intellectual Disabilities; Notice of Meeting
Document Number: E8-7072
Type: Notice
Date: 2008-04-04
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Privacy Act of 1974, New OIG Privacy Act System of Records: Administrative Files
Document Number: E8-7034
Type: Notice
Date: 2008-04-04
Agency: Office of Inspector General, Department of Health and Human Services
The Office of Inspector General (OIG) is proposing a new system of records, entitled ``Administrative Files'' (09-90-0076). This proposed notice is in accordance with the Privacy Act requirement that agencies publish their systems of records in the Federal Register when there is a revision, change, or addition. This system of records contains certain administrative files for the purpose of maintaining, archiving, and filing records.
National Center for Injury Prevention and Control Initial Review Group (NCIPC/IRG)
Document Number: E8-7031
Type: Notice
Date: 2008-04-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-6979
Type: Notice
Date: 2008-04-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: E8-6978
Type: Notice
Date: 2008-04-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: E8-6977
Type: Notice
Date: 2008-04-04
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meetings
Document Number: E8-6976
Type: Notice
Date: 2008-04-04
Agency: Department of Health and Human Services, National Institutes of Health