Department of Health and Human Services June 1, 2009 – Federal Register Recent Federal Regulation Documents
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Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatDrug Establishment Registration and Drug Listing.'' This guidance document is designed to assist industry (e.g., manufacturers, repackers, and relabelers) with the electronic submission of drug establishment registration and drug listing information. Specifically, the document provides guidance to industry on the types of information to include for purposes of drug establishment registration and drug listing and on how to prepare and submit the information in an electronic format that FDA can process, review, and archive.
Privacy Act of 1974, as Amended; Computer Matching Program
In compliance with the Privacy Act of 1974, as amended by Public Law 100-503, the Computer Matching and Privacy Protection Act of 1988, ACF is publishing a notice of a computer matching program. The purpose of this computer match is to identify specific individuals who are receiving benefits from the Department of Veterans Affairs (VA) and also receiving payments pursuant to various benefit programs administered by both the Department of Health and Human Services (HHS) and the Department of Agriculture. ACF will facilitate this program on behalf of the State Public Assistance Agencies (SPAAs) that participate in the Public Assistance Reporting Information System (PARIS) for verification of continued eligibility for public assistance. The match will utilize VA and SPAA records.
Small Entity Compliance Guide: Bottled Water: Residual Disinfectants and Disinfection Byproducts; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Bottled Water: Residual Disinfectants and Disinfection ByproductsSmall Entity Compliance Guide'' for a direct final rule published in the Federal Register of March 28, 2001. This small entity compliance guide (SECG) is intended to set forth in plain language the requirements of the regulation and to help small businesses understand the regulation.
Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Nutrition Symbols on Food Packages
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 the Experimental Study of Nutrition Symbols on Food Packages.
Submission for OMB Review; Comment Request; Survey of NHLBI Constituents' Health Information Needs and Preferred Formats
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 (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on March 19, 2009, pages 11736-11737 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. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Independent Scientific Peer Review Panel Report: Updated Validation Status of New Versions and Applications of the Murine Local Lymph Node Assay: A Test Method for Assessing the Allergic Contact Dermatitis Potential of Chemicals and Products: Notice of Availability and Request for Public Comments
NICEATM, in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), convened an independent, international, scientific peer review panel (hereafter, Panel) on April 28-29, 2009, to evaluate three non-radioactive modified versions and new applications for the Murine Local Lymph Node Assay (LLNA). The LLNA is an alternative test method that can be used to determine the allergic contact dermatitis potential of chemicals and products. The Panel report from this meeting is now available. The report contains (1) the Panel's evaluation of the updated validation status of the methods and (2) the Panel's comments on the updated draft ICCVAM test method recommendations. NICEATM invites public comment on the Panel's report. The report is available on the NICEATM-ICCVAM Web site at https://iccvam.niehs.nih.gov/docs/immunotoxdocs/
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