Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

# 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:

## 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.                

      ( print 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