Department of Health and Human Services November 18, 2009 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Nutrition Facts Label Formats
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
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
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
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.
Anti-Infective Drugs Advisory Committee; Amendment of Notice
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
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
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
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.
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
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
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.
Government-Owned Inventions; Availability for Licensing
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
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
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.
Request for Public Comment: 60-Day Proposed Information Collection: Office of Urban Indian Health Programs Uniform Data System
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.
Total Inward Leakage Requirements for Respirators
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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