Department of Health and Human Services December 26, 2007 – Federal Register Recent Federal Regulation Documents
Results 1 - 32 of 32
New Animal Drugs; Change of Sponsor's Name
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Altana, Inc., to Nycomed US, Inc.
Maximizing the Public Health Benefit of Adverse Event Collection Throughout a Product's Marketed Life Cycle; Public Workshop; Request for Comments
The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) are announcing a public workshop entitled ``Maximizing the Public Health Benefit of Adverse Event Collection Throughout a Product's Marketed Life Cycle.'' The purpose of the public workshop is to solicit information and views from interested persons on research approaches and methods associated with the best ways to assess the public health benefit of collecting and reporting all adverse events (AEs). The input from this workshop will be used to publish a request for information to determine the types of outside organizations that would be interested in, and have the capability to conduct, the research described in this paragraph, followed by a request for proposal (RFP).
Clinical Trial Design for Community-Acquired Pneumonia; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop, cosponsored with the Infectious Diseases Society of America (IDSA), regarding scientific issues in clinical trial design for community-acquired pneumonia. This public workshop is intended to provide information for and to gain perspective from health care providers, academia, and industry on various aspects of antimicrobial drug development for community-acquired pneumonia, including diagnosis of community-acquired pneumonia, effect of antimicrobial treatment for community-acquired pneumonia, endpoints for trials of community- acquired pneumonia, and statistical issues in analysis of results of trials in community-acquired pneumonia. The input from this public workshop will help in developing topics for further discussion. Date and Time: The public workshop will be held on January 17, 2008, from 8 a.m. to 6 p.m. and on January 18, 2008, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Crowne Plaza Hotel, Kennedy Room, 8777 Georgia Ave., Silver Spring, MD 20910, 301- 589-0800. Seating is limited and available only on a first-come, first- served basis. Contact Person: Chris Moser or Lori Benner, Center for Drug Evaluation and Research, Office of Antimicrobial Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6413, Silver Spring, MD 20993-0002, 301-796-0767, or 301-796-0849. Registration: There is no registration fee for the public workshop. Space is limited; therefore, interested parties are encouraged to register early. Seating will be available on a first-come, first-served basis. To register electronically, e-mail registration information (including name, title, firm name, address, telephone, and fax number) to CAPwkshp@fda.hhs.gov by January 9, 2008. Persons without access to the Internet can call 301-796-1300 to register. Persons needing a sign language interpreter or other special accommodations should notify Chris Moser or Lori Benner (see Contact Person) at least 7 days in advance.
Agency Emergency Processing Under the Office of Management and Budget Review; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of December 12, 2007 (72 FR 70599). The document announced that a proposed collection of information had been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995. The document was published with an error. This document corrects that error.
DSM Nutritional Products, Inc.; Filing of Color Additive Petition; Correction
The Food and Drug Administration is correcting a notice that appeared in the Federal Register of December 4, 2007 (72 FR 68166). The document announced that DSM Nutritional Products, Inc., has filed a petition proposing that the color additive regulations be amended to provide for the safe use of astaxanthin dimethyldisuccinate as a color additive in the feed of salmonid fish to enhance the color of their flesh.
Division of Loan Repayment; Proposed Collection; Comment Request; National Institutes of Health Loan Repayment Programs
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 Division of Loan Repayment, 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. Proposed Collection: Title: National Institutes of Health Loan Repayment Programs. Type of Information Collection Request: Revision of currently approved collection (OMB No. 0925-0361, expiration date 6/30/ 08). Form Numbers: NIH 2674-1, NIH 2674-2, NIH 2674-3, NIH 2674-4, NIH 2674-5, NIH 2674-6, NIH 2674-7, NIH 2674-8, NIH 2674-9, NIH 2674-10, NIH 2674-11, NIH 2674-12, NIH 2674-13, NIH 2674-14, NIH 2674-15, NIH 2674-16, NIH 2674-17, NIH 2674-18, and NIH 2674-19. Need and Use of Information Collection: The NIH makes available financial assistance, in the form of educational loan repayment, to M.D., Ph.D., Pharm.D., D.D.S., D.M.D., D.P.M., D.C., and N.D. degree holders, or the equivalent, who perform biomedical or behavioral research in NIH intramural laboratories or as extramural grantees for a minimum of 2 years (3 years for the General Research Loan Repayment Program (LRP)) in research areas supporting the mission and priorities of the NIH. The AIDS Research Loan Repayment Program (AIDS-LRP) is authorized by Section 487A of the Public Health Service Act (42 U.S.C. 288-1); the Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds (CR-LRP) is authorized by Section 487E (42 U.S.C. 288-5); the General Research Loan Repayment Program (GR-LRP) is authorized by Section 487C (42 U.S.C. 288-3); the Loan Repayment Program Regarding Clinical Researchers (LRP-CR) is authorized by Section 487F (42 U.S.C. 288-5a); the Pediatric Research Loan Repayment Program (PR-LRP) is authorized by Section 487F (42 U.S.C. 288-6); the Extramural Clinical Research LRP for Individuals from Disadvantaged Backgrounds (ECR-LRP) is authorized by an amendment to Section 487E (42 U.S.C. 288-5); the Contraception and Infertility Research LRP (CIR-LRP) is authorized by Section 487B (42 U.S.C. 288-2); and the Health Disparities Research Loan Repayment Program (HD-LRP) is authorized by Section 485G (42 U.S.C. 287c-33). The Loan Repayment Programs provide for the repayment of up to $35,000 a year of the principal and interest of the educational loan debt of qualified health professionals who agree to conduct qualifying research for each year of obligated service. The information proposed for collection will be used to determine an applicant's eligibility for participation in the program. Frequency of Response: Initial application and annual or biennial renewal application. Affected Public: Applicants, financial institutions, research institutions, recommenders. Type of Respondents: Physicians, other scientific or medical personnel, and organizational officials. The annual reporting burden is as follows:
Office of the National Coordinator for Health Information Technology; American Health Information Community Population Health and Clinical Care Connections Workgroup Meeting
This notice announces the 22nd meeting of the American Health Information Community Population Health and Clinical Care Connections Workgroup in accordance with the Federal Advisory Committee act (Pub. L. 92-463, 5 U.S.C., App.)
Office of the National Coordinator for Health Information Technology; American Health Information Community Electronic Health Records Workgroup Meeting
This notice announces the 21st meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)
Office of the National Coordinator for Health Information Technology; American Health Information Community Electronic Health Records Workgroup Meeting
This notice announces the 21st meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Confidentiality, Privacy, and Security Workgroup Meeting
This notice announces the 16th meeting of the American Health Information Community Confidentiality, Privacy, and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Consumer Empowerment Workgroup Meeting
This notice announces the 22nd meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)
Office of the National Coordinator for Health Information Technology; American Health Information Community Personalized Healthcare Workgroup Meeting
This notice announces the 11th meeting of the American Health Information Community Personalized Healthcare Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
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