[Federal Register: January 2, 2009 (Volume 74, Number 1)]
[Notices]               
[Page 107-108]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02ja09-30]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

 
Solicitation of Written Comments on Draft Centers for Disease 
Control and Prevention's Immunization Safety Office Scientific Agenda

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 Centers for Disease Control and Prevention's 
Immunization Safety Office (ISO) draft Scientific Agenda related to 
scientific research questions in vaccine safety.

DATES: Comments on the draft ISO Scientific Agenda should be received 
no later than 5 p.m. on February 2, 2009.

ADDRESSES: Electronic responses are preferred and may be addressed to 
vaccinsafetyRFI@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 443-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. NVPO is located within the Office of Public 
Health and Science within the 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. NVAC is a statutory 
Federal advisory committee that provides advice and makes 
recommendations to the Director of the National Vaccine Program on 
matters related to the program.

[[Page 108]]

    Vaccine safety research is done from the time vaccine development 
begins through when it is licensed and used routinely. Within HHS, 
vaccine and vaccine safety research during the development process is 
supported primarily by the National Institutes of Health. The Food and 
Drug Administration then carefully reviews safety and effectiveness 
information in deciding whether a vaccine should be licensed. After 
licensure, when a vaccine is used in children, adolescents or adults, 
its safety is monitored and further scientific studies are done to 
assure that the vaccine is safe, to evaluate potential safety problems, 
or to identify ways that the vaccine can be used more safely.
    The Center 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 
scientific agenda that identifies vaccine safety issues to consider for 
scientific study over the next five years, in addition to any new 
questions that may arise. Since not all questions and issues can be 
addressed at once, setting priorities is important. 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.
    ISO has requested a review of the draft Scientific Agenda by the 
National Vaccine Advisory Committee (NVAC).
    The NVAC review of the draft ISO Scientific Agenda will include 
providing recommendations on the agenda contents and on priorities for 
scientific research either done or funded by ISO. Public and 
stakeholder input will be important to the development of the NVAC 
recommendations, along with the expertise of the NVAC and NVAC Vaccine 
Safety Working Group members. Public and stakeholder input is being 
requested by written comment in response to this RFI; at community 
meetings taking place in Ashland, OR, Birmingham, AL, and Indianapolis, 
IN; at a meeting of stakeholders; and at a meeting of the NVAC Vaccine 
Safety Working Group (for more information, see http://www.hhs.gov/
nvpo/nvac/PublicEngagement.html).
    Through this RFI, HHS is seeking comments from everyone, including 
stakeholders and the broad public. Comments received will be available 
for public viewing and will be presented in an open meeting on February 
4, 2009, to the NVAC Vaccine Safety Working Group.

II. Information Request

    NVPO, on behalf of the NVAC Vaccine Safety Working Group requests 
input in three broad areas: (1) Concerns about vaccines and 
immunization safety, (2) comments on what values, considerations, or 
factors are most important to consider in prioritizing scientific 
research, and (3) specific comments on the draft ISO Scientific Agenda. 
Responders may address one or all of the topics below.
    (1) Concerns about vaccines and immunization safety: What are your 
primary concerns about the safety of vaccines and immunization? Why are 
those concerns most important to you? If interested, please share any 
personal experience that may further explain your concerns and their 
importance. [Provide up to 3 pages for an answer to this question]
    (2) Comments on what values or factors are most important to 
consider in prioritizing scientific research: What values, 
considerations, or factors are most important to you in deciding what 
vaccine and immunization safety research should be conducted first? Why 
are these values, considerations, and factors most important to you? 
Examples of values or factors that you may consider include, but are 
not limited to, the frequency, severity, or duration of an event; the 
age, number of people, or vulnerability of persons exposed to a 
vaccine; the amount of scientific or public concern; and whether or not 
a vaccine is required for child-care or school entry or as a condition 
for employment. [Provide up to 3 pages for an answer to this question]
    (3) Specific comments on the ISO draft scientific agenda: The draft 
CDC ISO Scientific Agenda can be viewed and downloaded from the CDC Web 
site (internet address is provided in the Background section, above).
    a. Please provide any general comments on the draft ISO Scientific 
Agenda.
    b. The following questions relate to the 30 items identified as 
potential 5-year research needs (see page 27 of draft ISO Scientific 
Agenda for a condensed list):
    i. What scientific issues should be included in the draft ISO 
Scientific Agenda that are not there now, or what issues that are 
currently included should be removed? Why should these issues be added 
or deleted?
    ii. What issues in the draft ISO Scientific Agenda are most 
important to you and should be made a priority to study and what issues 
are least important to you? Why are they the highest or lowest 
priorities?

[Provide up to 3 pages for an answer to this question]

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. Anonymous 
submissions will not have their comments posted.
    The submission of written materials in response to the RFI should 
not exceed 9 pages (3 pages for each of the three broad topics), 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/
PublicEngagement/RFIresponses.html. You may access public comments 
received from this RFI by going to the above Web site.

    Dated: December 22, 2008.
Raymond A. Strikas,
Acting Director, National Vaccine Program Office, U.S. Department of 
Health and Human Services.
 [FR Doc. E8-31196 Filed 12-31-08; 8:45 am]

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