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, 27059-27060 [2011-11401]
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Federal Register / Vol. 76, No. 90 / Tuesday, May 10, 2011 / Notices
2820, or e-mail your request, including
your address, to: [darwinw@od.nih.gov].
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
Dated: May 4, 2011.
Wanda R. Darwin,
Human Resources Specialist, Office of
Human Resources, National Institutes of
Health.
[FR Doc. 2011–11406 Filed 5–9–11; 8:45 am]
BILLING CODE 4140–01–P
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
National Vaccine Program
Office, Office of the Assistant Secretary
for Health, Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
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
jlentini on DSKJ8SOYB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:02 May 09, 2011
Jkt 223001
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 https://www.hhs.gov/nvpo/nvac/
subgroups/vaccinesafety.html.
2. Electronic responses are preferred
and may be addressed to
vaccinesafetyRFI@hhs.gov.
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 vaccinesafetyRFI@hhs.gov.
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
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
27059
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 (https://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. (https://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
E:\FR\FM\10MYN1.SGM
10MYN1
27060
Federal Register / Vol. 76, No. 90 / Tuesday, May 10, 2011 / Notices
to the draft recommendations. Please
limit comments to six pages.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 https://www.hhs.gov/nvpo/
nvac/subgroups/vaccinesafety.html.
You may access public comments
received by going to the above Web site.
Administration for Children and
Families
Dated: May 4, 2011.
Wanda K. Jones,
Principal Deputy Assistant Secretary for
Health.
[FR Doc. 2011–11401 Filed 5–9–11; 8:45 am]
BILLING CODE 4150–44–P
Proposed Information Collection
Activity; Comment Request
Title: Request for Assistance for Child
Victims of Human Trafficking.
OMB No.: 0970–0362.
Description: The William Wilberforce
Trafficking Victims Protection
Reauthorization Act (TVPRA) of 2008,
Public Law 110–457, directs the U.S.
Secretary of Health and Human Services
(HHS), upon receipt of credible
information that a non-U.S. citizen, nonLawful Permanent Resident (alien) child
may have been subjected to a severe
form of trafficking in persons and is
seeking Federal assistance available to
victims of trafficking, to promptly
determine if the child is eligible for
interim assistance. The law further
directs the Secretary of HHS to
determine if a child receiving interim
assistance is eligible for assistance as a
victim of a severe form of trafficking in
persons after consultation with the
Attorney General, the Secretary of
Homeland Security, and
nongovernmental organizations with
expertise on victims of severe forms of
trafficking.
In developing procedures for
collecting the necessary information
from potential child victims of
trafficking, their case managers,
attorneys, or other representatives to
allow HHS to grant interim eligibility,
HHS devised a form. HHS has
determined that the use of a standard
form to collect information is the best
way to ensure requestors are notified of
their option to request assistance for
child victims of trafficking and to make
prompt and consistent determinations
about the child’s eligibility for
assistance.
Specifically, the form asks the
requestor for his/her identifying
information, for information on the
child, information describing the type of
trafficking and circumstances
surrounding the situation, and the
strengths and needs of the child. The
form also asks the requestor to verify the
information contained in the form
because the information could be the
basis for a determination of an alien
child’s eligibility for federally funded
benefits. Finally, the form takes into
consideration the need to compile
information regarding a child’s
circumstances and experiences in a nondirective, child-friendly way, and assists
the potential requestor in assessing
whether the child may have been
subjected to trafficking in persons.
The information provided through the
completion of a Request for Assistance
for Child Victims of Human Trafficking
form will enable HHS to make prompt
determinations regarding the eligibility
of an alien child for interim assistance,
inform HHS’ determination regarding
the child’s eligibility for assistance as a
victim of a severe form of trafficking in
persons, facilitate the required
consultation process, and enable HHS to
assess and address potential child
protection issues.
Respondents: Representatives of
governmental and nongovernmental
entities providing social, legal, or
protective services to alien persons
under the age of 18 (children) in the
United States who may have been
subjected to severe forms of trafficking
in persons.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Request for Assistance for Child Victims of Human Trafficking .....................
jlentini on DSKJ8SOYB1PROD with NOTICES
Instrument
200
1
1
200
Estimated Total Annual Burden
Hours: 200.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
VerDate Mar<15>2010
18:02 May 09, 2011
Jkt 223001
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
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The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
E:\FR\FM\10MYN1.SGM
10MYN1
]]>Agencies
[Federal Register Volume 76, Number 90 (Tuesday, May 10, 2011)]
[Notices]
[Pages 27059-27060]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11401]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://www.hhs.gov/nvpo/nvac/subgroups/vaccinesafety.html.
2. Electronic responses are preferred and may be addressed to
vaccinesafetyRFI@hhs.gov.
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
vaccinesafetyRFI@hhs.gov.
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 (https://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. (https://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
https://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]
BILLING CODE 4150-44-P
