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

Results 201 - 231 of 231
Proposed Information Collection Activity; Comment Request
Document Number: E8-28656
Type: Notice
Date: 2008-12-04
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Proposed Information Collection Activity; Comment Request
Document Number: E8-28655
Type: Notice
Date: 2008-12-04
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Submission for OMB Review; Comment Request
Document Number: E8-28625
Type: Notice
Date: 2008-12-04
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Center for Scientific Review; Notice of Closed Meeting
Document Number: E8-28622
Type: Notice
Date: 2008-12-04
Agency: Department of Health and Human Services, National Institutes of Health
Draft Guidance for Industry on the Submission of Patent Information for Certain Old Antibiotics; Availability
Document Number: E8-28657
Type: Notice
Date: 2008-12-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Submission of Patent Information for Certain Old Antibiotics.'' The draft guidance describes the agency's current thinking on the implementation of certain provisions of the Q1 Program Supplemental Funding Act (the Q1 Act) that concern old antibiotics and addresses which sponsors of new drug applications (NDAs) must submit patent information under the Q1 Act by December 5, 2008.
Medicare Program; Hospital Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates: Fiscal Year 2009 Wage Index Changes Following Implementation of Section 124 of the Medicare Improvement for Patients and Providers Act of 2008
Document Number: E8-28619
Type: Notice
Date: 2008-12-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice contains fiscal year (FY) 2009 revised final wage indices and hospital reclassifications for 27 hospitals. These revised final wage indices and hospital reclassifications were made according to special procedural rules set forth in the FY 2009 hospital inpatient prospective payment systems final rule (73 FR 48588-9).
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: E8-28509
Type: Notice
Date: 2008-12-03
Agency: Department of Health and Human Services, National Institutes of Health
Medicaid Program; State Flexibility for Medicaid Benefit Packages
Document Number: E8-28330
Type: Rule
Date: 2008-12-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule will implement provisions of section 6044 of the Deficit Reduction Act of 2005, which amends the Social Security Act by adding a new section 1937 related to the coverage of medical assistance under approved State plans. It also provides States increased flexibility under an approved State plan to define the scope of covered medical assistance by offering coverage of benchmark or benchmark-equivalent benefit packages to certain Medicaid recipients. In addition, this final rule responds to public comments on the February 22, 2008, proposed rule that pertain to the State Medicaid benefit package provisions.
Government-Owned Inventions; Availability for Licensing
Document Number: E8-28614
Type: Notice
Date: 2008-12-02
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
Document Number: E8-28611
Type: Notice
Date: 2008-12-02
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: E8-28554
Type: Notice
Date: 2008-12-02
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 https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-28553
Type: Notice
Date: 2008-12-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-28552
Type: Notice
Date: 2008-12-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Substances To Be Evaluated for Set 23 Toxicological Profiles
Document Number: E8-28551
Type: Notice
Date: 2008-12-02
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
This notice announces the list of proposed substances that will be evaluated for CERCLA Set 23 toxicological profile development. ATSDR's Division of Toxicology and Environmental Medicine is soliciting public nominations from the list of proposed substances to be evaluated for toxicological profile development. ATSDR also will consider the evaluation of any additional substances that may have public health implications.
Proposed Information Collection Activity; Comment Request
Document Number: E8-28543
Type: Notice
Date: 2008-12-02
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-28541
Type: Notice
Date: 2008-12-02
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-28540
Type: Notice
Date: 2008-12-02
Agency: Department of Health and Human Services, Health Resources and Services Administration
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: E8-28493
Type: Notice
Date: 2008-12-02
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Comment Request
Document Number: E8-28481
Type: Notice
Date: 2008-12-02
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-28431
Type: Notice
Date: 2008-12-01
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Amended Notice of Meeting
Document Number: E8-28395
Type: Notice
Date: 2008-12-01
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request. 60-Day Public Comment Request
Document Number: E8-28389
Type: Notice
Date: 2008-12-01
Agency: Department of Health and Human Services
Guidance for Sponsors, Clinical Investigators, and IRBs; Data Retention When Subjects Withdraw From FDA-Regulated Clinical Trials; Availability
Document Number: E8-28387
Type: Notice
Date: 2008-12-01
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 ``Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials.'' This guidance clarifies FDA's position that it is critical that data be retained from trial participants who decide to discontinue participation in a clinical study of an investigational product, who are withdrawn by their legally authorized representative, as applicable, or who were discontinued from participation by the clinical investigator. The guidance will be of interest especially to sponsors, clinical investigators, and members of investigational review boards (IRBs).
New Animal Drugs; Ractopamine
Document Number: E8-28384
Type: Rule
Date: 2008-12-01
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 Elanco Animal Health. The NADA provides for use of ractopamine hydrochloride Type A medicated articles to make Type B and Type C medicated feeds used for increased rate of weight gain and improved feed efficiency in finishing turkeys.
Draft Guidance on Important Considerations for When Participation of Human Subjects in Research Is Discontinued
Document Number: E8-28369
Type: Notice
Date: 2008-12-01
Agency: Department of Health and Human Services
The Office for Human Research Protections (OHRP), Office of Public Health and Science, is announcing the availability of a draft guidance document entitled, ``Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued,'' and is seeking comment on the draft guidance. The draft guidance document, when finalized, would provide OHRP's first formal guidance on this topic. The draft document, which is available on the OHRP Web site at https://www.hhs.gov/ohrp/requests/, is intended primarily for institutional review boards (IRBs), investigators, and funding agencies that may be responsible for the review or oversight of human subject research conducted or supported by the Department of Health and Human Services (HHS). OHRP will consider comments received before issuing the final guidance document.
Center for Substance Abuse Prevention; Notice of Meeting
Document Number: E8-28310
Type: Notice
Date: 2008-12-01
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Center for Substance Abuse Treatment; Notice of Meeting
Document Number: E8-28309
Type: Notice
Date: 2008-12-01
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Submission for OMB Review; Comment Request
Document Number: E8-28249
Type: Notice
Date: 2008-12-01
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Library of Medicine; Notice of Meeting
Document Number: E8-28204
Type: Notice
Date: 2008-12-01
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-28033
Type: Notice
Date: 2008-12-01
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Colorado Regional Health Information Exchange (CORHIO) Point of Care Exchange System Evaluation: Point of Care Questionnaires and Focus Groups.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-28031
Type: Notice
Date: 2008-12-01
Agency: Department of Health and Human Services, National Institutes of Health
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