[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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