Department of Health and Human Services, Office of the Secretary.
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.
Comments on the draft ISO Scientific Agenda should be received no later than 5 p.m. on February 2, 2009.
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.Start Further Info
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.End Further Info End Preamble Start Supplemental Information
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. Start Printed 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:
—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.Start Signature
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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