Solicitation of Written Comments on Draft National Vaccine Advisory Committee Vaccine Safety Working Group, etc.
Federal Register: April 13, 2009 (Volume 74, Number 69)
Notices
Page 16872-16873
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr13ap09-62
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.
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:
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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).
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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.
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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
