[Federal Register Volume 74, Number 69 (Monday, April 13, 2009)]
[Notices]
[Pages 16872-16873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-8399]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Solicitation of Written Comments on Draft National Vaccine 
Advisory Committee Vaccine Safety Working Group Recommendations to the 
Immunization Safety Office

AGENCY: Department of Health and Human Services, Office of the 
Secretary.

ACTION: Notice.

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SUMMARY: The National Vaccine Program Office (NVPO) is soliciting 
public comment on the National Vaccine Advisory Committee (NVAC) 
Vaccine Safety Working Group draft Recommendations to the Centers for 
Disease Control and Prevention's Immunization Safety Office (ISO).

DATES: Comments on the NVAC Vaccine Safety Working Group draft report 
should be received no later than 5 p.m. on May 13, 2009.

ADDRESSES: Electronic responses are preferred and may be addressed to 
vaccinesafetyRFI@hhs.gov. Written responses should be addressed to 
National Vaccine Program Office, U.S. Department of Health and Human 
Services, 200 Independence Avenue, SW., Room 715-H, Washington, DC 
20201, Attention: Vaccine Safety RFI.

FOR FURTHER INFORMATION CONTACT: Ms. Kirsten Vannice, National Vaccine 
Program Office, Department of Health and Human Services, Hubert H. 
Humphrey Building, 200 Independence Avenue, SW., Room 443-H, 
Washington, DC 20201; telephone (202) 690-5566; fax 202-260-1165; e-
mail vaccinesafetyRFI@hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Ensuring the optimal safety of vaccines and immunizations is 
important to everyone. The National Vaccine Program Office (NVPO) is 
located within the Office of Public Health and Science, Office of the 
Secretary, Department of Health and Human Services (HHS), and has 
responsibility for coordinating and ensuring collaboration among the 
many Federal agencies involved in vaccine and immunization activities. 
NVPO also has responsibility for managing and providing support 
services for the National Vaccine Advisory Committee (NVAC). NVAC is a 
statutory Federal advisory committee that was established to provide 
advice and make recommendations to the Director of the National Vaccine 
Program on matters related to the Program's responsibilities. The 
Assistant Secretary for Health serves as Director of the National 
Vaccine Program.
    The Centers for Disease Control and Prevention's (CDC) Immunization 
Safety Office (ISO) has significant responsibility for monitoring and 
studying the safety of vaccines after they are licensed and used in the 
United States (http://www.cdc.gov/vaccinesafety). ISO has drafted a 
five-year scientific agenda that identifies vaccine safety issues to 
consider for scientific study, in addition to any new questions that 
may arise. The draft ISO Scientific Agenda can be found at: http://www.cdc.gov/vaccinesafety/00_pdf/draft_agenda_recommendations_080404.pdf and the addendum at http://www.cdc.gov/vaccinesafety/00_pdf/draft_recommendations_add_080410.pdf.
    Since not all questions and issues can be addressed at once, 
setting priorities is also important, and ISO has requested a review of 
the draft Scientific Agenda by the National Vaccine Advisory Committee 
(NVAC) for the purpose of identifying gaps and setting priorities. The 
NVAC Vaccine Safety Working Group has written a draft report of 
recommendations on the content and priorities of the draft ISO 
Scientific Agenda. The draft report may be found at http://www.hhs.gov/nvpo/nvac/reports.html.
    Through this request for information (RFI) HHS is seeking comments 
from everyone, including stakeholders and the broad public, on the NVAC 
Vaccine Safety Working Group draft report. Comments received will be 
available for public viewing on the NVAC Vaccine Safety Working Group 
Web site (http://www.hhs.gov/nvpo/nvac/vaccinesafety.html).

II. Information Request

    NVPO, on behalf of the NVAC Vaccine Safety Working Group, requests 
input on the draft Working Group report (http://www.hhs.gov/nvpo/nvac/reports.html). In addition to general comments, NVPO is seeking input 
on any additional gaps not addressed in the ISO Scientific Agenda nor 
the NVAC Vaccine Safety Working Group draft report, and/or 
prioritization criteria and its application to the ISO Scientific 
Agenda.
    Please limit comments to 6 pages.

III. Potential Responders

    HHS invites input from a broad range of individuals and 
organizations that have interests in vaccines and vaccine safety. Some 
examples of these organizations include but are not limited to the 
following:
--General public;
--Advocacy groups and public interest organizations;
--State and local governments;
--State and local public health departments;
--Vaccine manufacturing industry, distributors and other businesses;
--Health care professional societies and organizations.
    When responding, please self-identify with any of the above or 
other categories (include all that apply) and your name. All comments 
submitted will be made publicly available. Anonymous submissions will 
not have their comments posted and will not be considered.
    The submission of written materials in response to the RFI should 
not exceed six pages, not including appendices and supplemental 
documents. Responders may submit other forms of electronic materials to 
demonstrate or exhibit concepts of their written responses. Any 
information you submit will be made public. Consequently, do not send 
proprietary, commercial, financial, business confidential, trade 
secret, or personal information that you do not wish to be made public.
    Public Access: Responses to this RFI will be available to the 
public on the NVAC Web site at http://www.hhs.gov/nvpo/nvac/vaccinesafety.html. You may access public comments received from this 
RFI by going to the above Web site.


[[Page 16873]]


    Dated: March 31, 2009.
Bruce G. Gellin,
Deputy Assistant Secretary for Health, Director, National Vaccine 
Program Office, U.S. Department of Health and Human Services.
[FR Doc. E9-8399 Filed 4-10-09; 8:45 am]
BILLING CODE 4150-44-P