Department of Health and Human Services April 29, 2010 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Part D Comprehensive Services and Access to Research for Women, Infants, Children and Youth Grant Under the Ryan White HIV/AIDS Program
HRSA will be awarding non-competitive Part D funds to the Mecklenburg County Health Department in order to ensure continuity of critical HIV medical care and treatment services, and to avoid a disruption of HIV clinical care and support services to women, infants, children, and youth in the Charlotte, North Carolina and surrounding counties. HRSA will also be awarding non-competitive Part D Funds to Duke University in order to ensure continuity of critical HIV medical care and treatment services, and to avoid a disruption of HIV clinical care and support services to women, infants, children, and youth in the central North Carolina area.
Front-of-Pack and Shelf Tag Nutrition Symbols; Establishment of Docket; Request for Comments and Information
The Food and Drug Administration (FDA) is announcing the establishment of a docket to obtain data and other information that will inform the agency's deliberations about ways to enhance the usefulness to consumers of point-of-purchase nutrition information, such as information on the principal display panel of food products (``front-of-pack'' labeling) or on shelf tags in retail stores. In particular, FDA is interested in the following: Data and information on the extent to which consumers notice, use, and understand nutrition symbols on front-of-pack labeling of food packages or on shelf tags in retail stores; research assessing and comparing the effectiveness of particular possible approaches to front- of-pack labeling; graphic design, marketing, and advertising data and information that can inform and guide the development of better point- of-purchase nutrition information; and the extent to which point-of- purchase nutrition information may affect decisions by food manufacturers to reformulate products. The goal of this front-of-pack nutrition labeling effort is to maximize the number of consumers who readily notice, understand, and use point-of-purchase information to make more nutritious choices for themselves and their families. FDA is establishing this docket in order to provide an opportunity for interested parties to provide data and information and share views that will inform future agency actions with respect to these matters.
Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g); Requests for Information; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Draft Guidance for Industry and FDA Staff; User Fees for 513(g) Requests for Information.'' This draft guidance describes the user fees associated with 513(g) requests for information.
Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Draft Guidance for Industry and FDA Staff; FDA and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic Act.'' This draft guidance is not final nor is it in effect at this time. Elsewhere in this issue of the Federal Register, FDA is also publishing a notice of availability for a draft guidance entitled ``Draft Guidance for Industry and FDA Staff; User Fees for 513(g) Requests for Information.''
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products
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 Office and Management and Budget Review; Comment Request; Guidance for Industry on How to Submit a Notice of Final Disposition of Investigational Animals Not Intended for Immediate Slaughter in Electronic Format to the Center for Veterinary Medicine
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.
Implantation or Injectable Dosage Form New Animal Drugs; Butorphanol
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Modern Veterinary Therapeutics, LLC. The ANADA provides for use of an injectable solution of butorphanol tartrate in cats for the relief of pain.
Agency Information Collection Activities; Submission for Office and Management and Budget Review; Comment Request; Guidance for Industry on How to Submit a Protocol Without Data in Electronic Format to the Center for Veterinary Medicine
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.
Proposed Collection; Comment Request; NIH Toolbox for Assessment of Neurological and Behavioral Function
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute on Aging (NIA), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
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