Department of Health and Human Services November 18, 2009 – Federal Register Recent Federal Regulation Documents

Indian Health Service
Document Number: E9-27721
Type: Notice
Date: 2009-11-18
Agency: Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Nutrition Facts Label Formats
Document Number: E9-27720
Type: Notice
Date: 2009-11-18
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, and to allow 60 days for public comment in response to the notice. This notice solicits comments on an experimental study of Nutrition Facts label formats.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; User Fee Cover Sheet; Form FDA 3397
Document Number: E9-27719
Type: Notice
Date: 2009-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting
Document Number: E9-27718
Type: Notice
Date: 2009-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a meeting with sponsors of certain opioid drug products regarding the development of Risk Evaluation and Mitigation Strategies (REMS) for these products. Other members of the public are invited to attend and observe. The REMS is intended to ensure that the benefits of these drugs continue to outweigh certain risks. FDA has encouraged affected sponsors to work collectively to develop a proposed REMS. The purpose of this meeting is to hear from sponsors about the status of the development of a proposed REMS and their views regarding the specific features of the REMS for these products. To promote transparency of the REMS development process, other members of the public are invited to attend the meeting as observers. Additional opportunities for public input will be provided before FDA finalizes the elements of the REMS.
Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing; Form FDA 3486 and Addendum 3486A
Document Number: E9-27716
Type: Notice
Date: 2009-11-18
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 information collection requirements relating to the reporting of biological product deviations (BPDs) and human cells, tissues, and cellular and tissue-based product (HCT/P) deviations, and Form FDA 3486 and Addendum 3486A.
National Cancer Institute; Notice of Closed Meeting
Document Number: E9-27715
Type: Notice
Date: 2009-11-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting
Document Number: E9-27713
Type: Notice
Date: 2009-11-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: E9-27712
Type: Notice
Date: 2009-11-18
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: E9-27711
Type: Notice
Date: 2009-11-18
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Research Resources; Notice of Closed Meetings
Document Number: E9-27710
Type: Notice
Date: 2009-11-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: E9-27709
Type: Notice
Date: 2009-11-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: E9-27708
Type: Notice
Date: 2009-11-18
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Alternative Medicine; Notice of Closed Meeting
Document Number: E9-27707
Type: Notice
Date: 2009-11-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Meeting
Document Number: E9-27706
Type: Notice
Date: 2009-11-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: E9-27705
Type: Notice
Date: 2009-11-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: E9-27704
Type: Notice
Date: 2009-11-18
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: E9-27703
Type: Notice
Date: 2009-11-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: E9-27696
Type: Notice
Date: 2009-11-18
Agency: Department of Health and Human Services, National Institutes of Health
Anti-Infective Drugs Advisory Committee; Amendment of Notice
Document Number: E9-27693
Type: Notice
Date: 2009-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Anti-Infective Drugs Advisory Committee. This meeting was announced in the Federal Register of October 26, 2009 (74 FR 55057). The amendment is being made to reflect a change in the Location portion of the document. There are no other changes.
Acrylamide in Food; Request for Comments and for Scientific Data and Information; Extension of Comment Period
Document Number: E9-27692
Type: Notice
Date: 2009-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending to January 25, 2010, the comment period for the notice entitled ``Acrylamide in Food; Request for Comments and for Scientific Data and Information,'' that appeared in the Federal Register of August 26, 2009 (74 FR 43134). In the notice, FDA requested comments and scientific data and information on acrylamide in food. The agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Submission for OMB review; Comment Request; Parental Knowledge, Attitudes, and Behaviors Related to Pediatric Cardiovascular Health
Document Number: E9-27688
Type: Notice
Date: 2009-11-18
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on Wednesday, July 29, 2009, Volume 74, Number 144 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.
Administration on Children, Youth and Families; Notice To Award One Expansion Supplement Grant
Document Number: E9-27667
Type: Notice
Date: 2009-11-18
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
This notice announces the award of an expansion supplement grant to one grantee under the Family and Youth Services Bureau (FYSB)/ Family Violence Prevention and Services Program. The expansion supplement award is made to the Pennsylvania Coalition Against Domestic Violence, Harrisburg, PA, a technical assistance provider, to support their capacity to provide technical support and training to State and local domestic violence advocates and social service agencies. These efforts will allow FYSB to support collaborative work to enhance the capacity of Temporary Assistance to Needy Families (TANF) and other Federal programs to provide assistance to eligible victims of domestic violence.
Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting
Document Number: E9-27660
Type: Notice
Date: 2009-11-18
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities; Proposed Collection; Comment Request; “Real Time” Surveys of Consumers' Knowledge, Perceptions, and Reported Behavior Concerning Foodborne Illness Outbreaks or Food Recalls
Document Number: E9-27659
Type: Notice
Date: 2009-11-18
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on ``Real Time'' surveys of consumers' knowledge, perceptions, and beliefs concerning foodborne illness outbreaks or food recalls.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infectious Disease Issues in Xenotransplantation
Document Number: E9-27658
Type: Notice
Date: 2009-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E9-27641
Type: Notice
Date: 2009-11-18
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Government-Owned Inventions; Availability for Licensing
Document Number: E9-27633
Type: Notice
Date: 2009-11-18
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.
Memorandum of Understanding Between the Food and Drug Administration and Waterfront Media
Document Number: E9-27630
Type: Notice
Date: 2009-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and Waterfront Media. The purpose of the MOU is to extend the reach of FDA Consumer Health Information and to provide consumers with better information and timely content concerning public health and safety topics, including alerts of emerging safety issues and product recalls.
Sauflon Pharmaceuticals Ltd.; Filing of Color Additive Petition
Document Number: E9-27629
Type: Notice
Date: 2009-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that Sauflon Pharmaceuticals Ltd. has filed a petition proposing that the color additive regulations be amended to provide for the safe use of disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2- sulfonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-su lfonate (CAS Reg. No. 70209-99-3) as a color additive in contact lenses.
Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH)
Document Number: E9-27623
Type: Notice
Date: 2009-11-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Request for Public Comment: 60-Day Proposed Information Collection: Office of Urban Indian Health Programs Uniform Data System
Document Number: E9-27540
Type: Notice
Date: 2009-11-18
Agency: Department of Health and Human Services, Indian Health Service
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 60 day advance opportunity for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review.
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: E9-27411
Type: Notice
Date: 2009-11-18
Agency: Department of Health and Human Services, National Institutes of Health
Total Inward Leakage Requirements for Respirators
Document Number: E9-27388
Type: Proposed Rule
Date: 2009-11-18
Agency: Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), will hold a public meeting concerning the proposed rule that was published in the Federal Register on Friday, October 30, 2009. The proposed rule proposes to establish total inward leakage (TIL) requirements for half- mask air-purifying particulate respirators approved by NIOSH. The proposed new requirements specify TIL minimum performance requirements and testing to be conducted by NIOSH and respirator manufacturers to demonstrate that these respirators, when selected and used correctly, provide effective respiratory protection to intended users against toxic dusts, mists, fumes, fibers, and biological and infectious aerosols (e.g. influenza A(H5N1), severe acute respiratory syndrome (SARS) coronavirus, and Mycobacterium tuberculosis).
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