[Federal Register Volume 76, Number 90 (Tuesday, May 10, 2011)]
[Notices]
[Pages 27059-27060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-11401]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Solicitation of Written Comments on the Draft Report and Draft 
Recommendations of the Vaccine Safety Working Group for Consideration 
by the National Vaccine Advisory Committee on the Federal Vaccine 
Safety System

AGENCY: National Vaccine Program Office, Office of the Assistant 
Secretary for Health, Office of the Secretary, Department of Health and 
Human Services.

ACTION: Notice.

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SUMMARY: The National Vaccine Advisory Committee (NVAC) was established 
in 1987 to comply with Title XXI of the Public Health Service Act (Pub. 
L. 99-660) (Section 2105) (42 U.S. Code 300aa-5 (PDF--78 KB)). Its 
purpose is to advise and make recommendations to the Director of the 
National Vaccine Program on matters related to program 
responsibilities. The Assistant Secretary for Health (ASH) has been 
designated by the Secretary of Health and Human Services as the 
Director of the National Vaccine Program. The ASH has charged the NVAC 
``To review the current federal vaccine safety system and develop a 
White Paper describing the infrastructure needs for a federal vaccine 
safety system to fully characterize the safety profile of vaccines in a 
timely manner, reduce adverse events whenever possible, and maintain 
and improve public confidence in vaccine safety.'' On behalf of the 
NVAC, the Vaccine Safety Working Group (VSWG) has developed a draft 
report and draft recommendations for the consideration by the NVAC in 
developing the NVAC's final recommendations to the ASH. The National 
Vaccine Program Office (NVPO) is soliciting public comment on the 
National Vaccine Advisory Committee (NVAC) Vaccine Safety Working Group 
draft report and draft recommendations for the federal vaccine safety 
system to be considered by the NVAC. Individuals and organizations are 
encouraged to submit their comments on the draft report and draft 
recommendations. It is anticipated that the draft report and draft 
recommendations, as revised with consideration given to public comment 
and stakeholder input, will be presented in mid to late 2011 to the 
NVAC for deliberation and decision on their final recommendations.

DATES: To receive consideration comments should be received no later 
than 5 p.m. EST on June 6, 2011.

ADDRESSES: 1. The draft report and draft recommendations are available 
on the Web at http://www.hhs.gov/nvpo/nvac/subgroups/vaccinesafety.html.
    2. Electronic responses are preferred and may be addressed to 
[email protected].
    3. Written responses should be addressed to: National Vaccine 
Program Office, U.S. Department of Health and Human Services, 200 
Independence Avenue, SW., Room 739G.5, Washington, DC 20201, Attention: 
Vaccine Safety c/o Kristin Goddard.

FOR FURTHER INFORMATION CONTACT: Kristin Goddard, National Vaccine 
Program Office, Department of Health and Human Services, Hubert H. 
Humphrey Building, 200 Independence Avenue, SW., Room 439G.5, 
Washington, DC 20201, Attn: NVAC Vaccine Safety Working Group, 
telephone (202) 205-5317; fax 202-260-1165; e-mail 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The National Vaccine Program Office (NVPO) is located within the 
Office of the Assistant Secretary for Health (OASH), Office of the 
Secretary, Department of Health and Human Services and has the 
responsibility for coordinating and fostering collaborations among the 
many Federal agencies involved in vaccine and immunization activities. 
NVPO also has responsibility for the management of the National Vaccine 
Advisory Committee, a chartered federal advisory committee that reports 
to the Assistant Secretary for Health in his role as the Director of 
the National Vaccine Program (NVP).
    Recognizing the importance of vaccine safety in the NVP, the ASH 
charged NVAC to ``review the current federal vaccine safety system and 
develop a White Paper describing the infrastructure needs for a federal 
vaccine safety system to fully characterize the safety profile of 
vaccines in a timely manner, reduce adverse events whenever possible, 
and maintain and improve public confidence in vaccine safety.'' On 
behalf of the NVAC the Vaccine Safety Working Group (VSWG) has 
developed a draft report and draft recommendations for the 
consideration by the NVAC in developing the NVAC's final 
recommendations to the ASH. The VSWG membership represents a broad 
range of expertise including pediatric and adult infectious diseases, 
genomics, immunology, epidemiology, public health, maternal and child 
health, pharmacoepidemiology, and biostatistics. Through review of 
previous recommendations on improvement to the vaccine safety system, 
input from an array of experts and stakeholders, and identification of 
gaps in the current federal vaccine safety system the VSWG developed 
draft recommendations for the consideration of the NVAC to achieve the 
charge as noted above.
    The draft report describes relative benefits and risks of vaccines, 
current vaccine coverage levels, successes and challenges of the 
current system, methodology for VSWG recommendation development, and 
the conclusions of the VSWG from these findings. From these conclusions 
the VSWG has developed draft recommendations in eight categories: 
Leadership, Coordination, Research, Post Licensure Surveillance, 
Clinical Practice, Communications, Stakeholder and Public Engagement, 
and Assurance and Accountability.
    Through this request for comment HHS is seeking comments from 
everyone, including stakeholders and the broad public, on the NVAC 
Vaccine Safety Working Group draft report and draft recommendations to 
be submitted to the NVAC for consideration in their final 
recommendations to the ASH. Comments received will be available for 
public viewing on the NVAC Vaccine Safety Working Group section of the 
NVPO Web site (http://www.hhs.gov/nvpo/nvac/subgroups/vaccinesafety.html).

II. Request for Comment

    NVPO, on behalf of the NVAC Vaccine Safety Working Group, requests 
input on the draft report and draft recommendations. (http://www.hhs.gov/nvpo/nvac/subgroups/vaccinesafety.html). In addition to 
general comments, NVPO is seeking input on any additional gaps not 
addressed in the NVAC Vaccine Safety Working Group draft report, and/or 
prioritization criteria and its application

[[Page 27060]]

to the draft recommendations. Please limit comments to six 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 be considered and will not have their comments posted.
    Written comment submission should not exceed six pages. 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: Comments on the draft report and draft 
recommendations will be available to the public on the NVAC Web site at 
http://www.hhs.gov/nvpo/nvac/subgroups/vaccinesafety.html. You may 
access public comments received by going to the above Web site.

    Dated: May 4, 2011.
Wanda K. Jones,
Principal Deputy Assistant Secretary for Health.
[FR Doc. 2011-11401 Filed 5-9-11; 8:45 am]
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