Notice of Availability of Draft Guidance on Allocating and Targeting Pandemic Influenza Vaccine, 61886-61887 [07-5435]
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Federal Register / Vol. 72, No. 211 / Thursday, November 1, 2007 / Notices
roster of committee members may be
obtained from Debbie M. Jackson,
Senior Program Analyst, National
Center for Health Statistics, Centers for
Disease Control and Prevention, 3311
Toledo Road, Room 2339, Hyattsville,
MD 20782, (301) 458–4614,
djackson@cdc.gov; or Marjorie S.
Greenberg, Executive Secretary, NCVHS,
National Center for Health Statistics,
Centers for Disease Control and
Prevention, 3311 Toledo Road, Room
2402, Hyattsville, Maryland 20782,
telephone (301) 458–4245. Information
also is available on the NCVHS home
page of the HHS Web site https://
www.ncvhs.hhs.gov/.
Should you require reasonable
accommodation, please contact the CDC
Office of Equal Employment
Opportunity on (301) 458–4EEO (4336)
as soon as possible.
Dated: October 22, 2007.
James Scanlon,
Deputy Assistant Secretary for Science and
Data Policy, Office of the Assistant Secretary
for Planning and Evaluation.
[FR Doc. 07–5434 Filed 10–31–07; 8:45 am]
BILLING CODE 4151–04–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice of Availability of Draft Guidance
on Allocating and Targeting Pandemic
Influenza Vaccine
Office of the Secretary, Health
and Human Services.
ACTION: Notice of availability.
mstockstill on PROD1PC66 with NOTICES
AGENCY:
SUMMARY: The Department of Health and
Human Services (HHS) and the
Department of Homeland Security
(DHS) are seeking public comment on
the draft Guidance on Allocating and
Targeting Pandemic Influenza Vaccine.
The draft Guidance is now available on
the HHS Web site.
DATES: Submit comments on or before
December 31, 2007.
Instructions for Submitting
Comments: Electronic responses are
preferred and may be addressed to
Panfluvaccine@hhs.gov. Written
responses should be addressed to U.S.
Department of Health and Human
Services, Room 434E, 200 Independence
Avenue, SW., Washington, DC 20201,
Attention: Pandemic Influenza Vaccine
Prioritization Guidance Comments. A
copy of the Notice and the full text of
the draft Guidance are also available on
the PandemicFlu.Gov Web site at
https://www.pandemicflu.gov/vaccine/
prioritization.html and at https://
www.aspe.hhs.gov/panflu/
VerDate Aug<31>2005
19:40 Oct 31, 2007
Jkt 214001
vaccinepriorities.html. Please follow
instructions for submitting responses.
The submission of comments in
response to this notice should not
exceed 25 pages, not including
appendices and supplemental
documents. 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
notice will be available to the public in
the HHS Public Reading Room, 200
Independence Avenue, SW.,
Washington, DC 20201. Please call (202)
690–7453 between 9 a.m. and 5 p.m. to
arrange access.
FOR FURTHER INFORMATION CONTACT: HuiHsing Wong, M.D., Office of the
Assistant Secretary for Planning and
Evaluation, (202) 205–0519.
SUPPLEMENTARY INFORMATION: Influenza
viruses have threatened the health of
animal and human populations for
centuries. A pandemic occurs when a
novel strain of influenza virus emerges
that has the ability to infect and be
passed between humans. Because
humans have little immunity to the new
virus, a worldwide epidemic, or
pandemic, can ensue.
Three human influenza pandemics
occurred in the 20th century. In the
U.S., each pandemic led to illness in
approximately 30 percent of the
population and death in between 2 in
100 and 2 in 1000 of those infected. It
is projected that a modern pandemic,
absent effective control measures, could
result in the death of 200,000 to 2
million people in the U.S. alone.
A critical part of the United States
Government (USG) strategy to control
the spread of a pandemic and reduce its
health and societal impact is through
the use of vaccines. The USG is working
toward a goal of expanding domestic
influenza surge capacity to produce
pandemic influenza vaccines for the
entire population within six months of
a pandemic declaration. However, at the
beginning of a pandemic, the limited
supply of existing pandemic influenza
vaccines will require that their
distribution and administration be
prioritized.
Accordingly, the Homeland Security
Council Implementation Plan for the
National Strategy for Pandemic
Influenza required the Department of
Health and Human Services (HHS) in
coordination with the Department of
Homeland Security (DHS) to convene a
federal interagency working group to
draft a guidance to assist State and local
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
governments, communities, tribal and
territorial governments, and the private
sector in planning an effective and
consistent pandemic response. The USG
embarked on a rigorous and
collaborative process to seek input from
all interested parties in developing a
strategy to emerge from a pandemic
with minimal levels of illness, death,
and disruption to our society and
economy.
The draft Guidance on Allocating and
Targeting Pandemic Influenza Vaccine
outlines the USG’s goal of targeting the
early production of pandemic vaccines
to reduce the impact on health and
minimize disruption to society and the
economy and describes the scientific
and ethical framework for how this
guidance was developed. As part of the
guidance, a tiered prioritization for
vaccines in severe pandemics is being
proposed with the following objectives
considered to be the most important: (1)
Protect those who are essential to the
pandemic response and provide care for
persons who are ill; (2) protect those
who maintain essential community
services; (3) protecting children; and (4)
protect workers who are at greater risk
of infection as a result of their job.
Protecting those who maintain
homeland and national security was
also considered a significant Federal
objective. The ultimate goal of
pandemic vaccination is to provide
vaccines to all persons in the United
States who choose to be vaccinated by
6 months after the declaration of a
pandemic.
With this notice, the USG requests
comment from the public and interested
stakeholders on the draft Guidance on
Allocating and Targeting Pandemic
Influenza Vaccine.
Specifically, the USG invites
comments on the following:
The framework for establishing
pandemic influenza vaccine priorities,
including the—
(1) approach for defining:
a. Target groups,
b. The clusters of target groups in the
categories,
c. The levels within categories,
d. The tiers across categories.
(2) The extent to which the
prioritization guidance addresses the
stated program objectives.
(3) The extent to which the guidance
is likely to lead to fair and ethical
allocation and targeting of pandemic
influenza vaccine across the population.
The text of the draft guidance is
available in html and pdf formats
through the PandemicFlu.Gov Web site
at https://www.pandemicflu.gov/vaccine/
prioritization.html and the HHS Web
site at https://www.aspe.hhs.gov/panflu/
E:\FR\FM\01NON1.SGM
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Federal Register / Vol. 72, No. 211 / Thursday, November 1, 2007 / Notices
vaccinepriorities.html. For those who
may not have Internet access, a hard
copy can be requested from the point of
contact, Hui-Hsing Wong, Office of the
Assistant Secretary for Planning and
Evaluation (202) 205-0519.
Date: October 24, 2007.
RADM W. Craig Vanderwagen,
Assistant Secretary for Preparedness and
Response.
[FR Doc. 07–5435 Filed 10–31–07; 8:45 am]
BILLING CODE 4151–04–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
mstockstill on PROD1PC66 with NOTICES
Advisory Board on Radiation and
Worker Health (ABRWH or Advisory
Board), National Institute for
Occupational Safety and Health
(NIOSH)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC),
announces the following meeting of the
aforementioned committee:
Time and Date: 11 a.m.–4 p.m.,
November 27, 2007.
Place: Audio Conference Call via
Federal Telecommunications System
Conferencing. The USA toll free dial in
number is 1–866–659–0537 with a pass
code of 9933701.
Status: Open to the public, but
without a public comment period.
Background: The Advisory Board was
established under the Energy Employees
Occupational Illness Compensation
Program Act of 2000 to advise the
President on a variety of policy and
technical functions required to
implement and effectively manage the
new compensation program. Key
functions of the Advisory Board include
providing advice on the development of
probability of causation guidelines
which have been promulgated by the
Department of Health and Human
Services (HHS) as a final rule, advice on
methods of dose reconstruction which
have also been promulgated by HHS as
a final rule, advice on the scientific
validity and quality of dose estimation
and reconstruction efforts being
performed for purposes of the
compensation program, and advice on
petitions to add classes of workers to the
Special Exposure Cohort (SEC).
In December 2000, the President
delegated responsibility for funding,
staffing, and operating the Advisory
Board to HHS, which subsequently
delegated this authority to the CDC.
VerDate Aug<31>2005
19:40 Oct 31, 2007
Jkt 214001
NIOSH implements this responsibility
for CDC. The charter was issued on
August 3, 2001, renewed at appropriate
intervals, most recently, August 3, 2007,
and will expire on August 3, 2009.
Purpose: This Advisory Board is
charged with (a) providing advice to the
Secretary, HHS, on the development of
guidelines under Executive Order
13179; (b) providing advice to the
Secretary, HHS, on the scientific
validity and quality of dose
reconstruction efforts performed for this
program; and (c) upon request by the
Secretary, HHS, advising the Secretary
on whether there is a class of employees
at any Department of Energy facility
who were exposed to radiation but for
whom it is not feasible to estimate their
radiation dose, and on whether there is
reasonable likelihood that such
radiation doses may have endangered
the health of members of this class.
Matters To Be Discussed: The agenda
for the conference call includes: FY
2008 New Site Profiles and New
Procedures for SC&A; Procedures to
Select New Contractor for ABRWH;
Work Group Updates; Sandia-Livermore
Update and Future Activities; Chapman
Valve Reports from DOE and DOL; Dow
Chemical Report from DOE; SEC and
Site Profile Matrices Update;
Subcommittee for Dose Reconstruction
Reviews Report of the 4th and 5th Sets
of Individual Dose Reconstructions, and
the Summary Report on the First 100
Cases; Rocky Flats Update; Discussion
of Board Procedures; Status of and Plans
for Future Board Activities; and Board
Working Time.
The agenda is subject to change as
priorities dictate. Because there is not a
public comment period, written
comments may be submitted. Any
written comments received will be
included in the official record of the
meeting and should be submitted to the
contact person below well in advance of
the meeting.
Contact Person for More Information:
Dr. Lewis V. Wade, Executive Secretary,
NIOSH, CDC, 4676 Columbia Parkway,
Cincinnati, Ohio 45226. Telephone
(513) 533–6825, Fax (513) 533–6826.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both CDC
and the Agency for Toxic Substances
and Disease Registry.
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61887
Dated: October 25, 2007.
Elaine L. Baker,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E7–21505 Filed 10–31–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Committee on
Interdisciplinary, Community-Based
Linkages; Notice of Request for
Nominations
SUMMARY: The Health Resources and
Services Administration (HRSA) is
requesting nominations to fill seven (7)
upcoming vacancies on the Advisory
Committee on Interdisciplinary,
Community-Based Linkages (ACICBL).
Authority: 42 U.S.C. 294f, Section 756
of the PHS Act, as amended. The
Advisory Committee is governed by
provisions of Public Law (Pub. L.) 92–
463, as amended (5 U.S.C. Appendix 2)
which sets forth standards for the
formation and use of advisory
committees.
DATES: The Agency must receive
nominations on or before December 31,
2007.
ADDRESSES: All nominations are to be
submitted by mail to Louis D.
Coccodrilli, Designated Federal Official,
ACICBL, Bureau of Health Professions
(BHPr), HRSA, Parklawn Building,
Room 9–05, 5600 Fishers Lane;
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT:
Adriana Guerra, Public Health Fellow,
Division of Medicine and Dentistry, by
e-mail aguerra@hrsa.gov or telephone,
(301) 443–6194.
SUPPLEMENTARY INFORMATION: Under the
authorities that established the ACICBL,
the Federal Advisory Committee Act of
October 6, 1972 (Pub. L. 92–463), and
section 2119 of the Act, 42 U.S.C. 00aa–
19, as added by Public Law 99–660 and
amended, HRSA is requesting
nominations for seven (7) voting
members.
The ACICBL provides advice and
recommendations to the Secretary and
to the Congress concerning policy,
program development and other matters
of significance related to
interdisciplinary, community-based
training grant programs authorized
under sections 751–756, Title VII, Part
D of the Public Health Service Act. The
ACICBL prepares an annual report
describing the activities conducted
E:\FR\FM\01NON1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 211 (Thursday, November 1, 2007)]
[Notices]
[Pages 61886-61887]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-5435]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Notice of Availability of Draft Guidance on Allocating and
Targeting Pandemic Influenza Vaccine
AGENCY: Office of the Secretary, Health and Human Services.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services (HHS) and the
Department of Homeland Security (DHS) are seeking public comment on the
draft Guidance on Allocating and Targeting Pandemic Influenza Vaccine.
The draft Guidance is now available on the HHS Web site.
DATES: Submit comments on or before December 31, 2007.
Instructions for Submitting Comments: Electronic responses are
preferred and may be addressed to Panfluvaccine@hhs.gov. Written
responses should be addressed to U.S. Department of Health and Human
Services, Room 434E, 200 Independence Avenue, SW., Washington, DC
20201, Attention: Pandemic Influenza Vaccine Prioritization Guidance
Comments. A copy of the Notice and the full text of the draft Guidance
are also available on the PandemicFlu.Gov Web site at https://
www.pandemicflu.gov/vaccine/prioritization.html and at https://
www.aspe.hhs.gov/panflu/vaccinepriorities.html. Please follow
instructions for submitting responses.
The submission of comments in response to this notice should not
exceed 25 pages, not including appendices and supplemental documents.
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 notice will be available to the
public in the HHS Public Reading Room, 200 Independence Avenue, SW.,
Washington, DC 20201. Please call (202) 690-7453 between 9 a.m. and 5
p.m. to arrange access.
FOR FURTHER INFORMATION CONTACT: Hui-Hsing Wong, M.D., Office of the
Assistant Secretary for Planning and Evaluation, (202) 205-0519.
SUPPLEMENTARY INFORMATION: Influenza viruses have threatened the health
of animal and human populations for centuries. A pandemic occurs when a
novel strain of influenza virus emerges that has the ability to infect
and be passed between humans. Because humans have little immunity to
the new virus, a worldwide epidemic, or pandemic, can ensue.
Three human influenza pandemics occurred in the 20th century. In
the U.S., each pandemic led to illness in approximately 30 percent of
the population and death in between 2 in 100 and 2 in 1000 of those
infected. It is projected that a modern pandemic, absent effective
control measures, could result in the death of 200,000 to 2 million
people in the U.S. alone.
A critical part of the United States Government (USG) strategy to
control the spread of a pandemic and reduce its health and societal
impact is through the use of vaccines. The USG is working toward a goal
of expanding domestic influenza surge capacity to produce pandemic
influenza vaccines for the entire population within six months of a
pandemic declaration. However, at the beginning of a pandemic, the
limited supply of existing pandemic influenza vaccines will require
that their distribution and administration be prioritized.
Accordingly, the Homeland Security Council Implementation Plan for
the National Strategy for Pandemic Influenza required the Department of
Health and Human Services (HHS) in coordination with the Department of
Homeland Security (DHS) to convene a federal interagency working group
to draft a guidance to assist State and local governments, communities,
tribal and territorial governments, and the private sector in planning
an effective and consistent pandemic response. The USG embarked on a
rigorous and collaborative process to seek input from all interested
parties in developing a strategy to emerge from a pandemic with minimal
levels of illness, death, and disruption to our society and economy.
The draft Guidance on Allocating and Targeting Pandemic Influenza
Vaccine outlines the USG's goal of targeting the early production of
pandemic vaccines to reduce the impact on health and minimize
disruption to society and the economy and describes the scientific and
ethical framework for how this guidance was developed. As part of the
guidance, a tiered prioritization for vaccines in severe pandemics is
being proposed with the following objectives considered to be the most
important: (1) Protect those who are essential to the pandemic response
and provide care for persons who are ill; (2) protect those who
maintain essential community services; (3) protecting children; and (4)
protect workers who are at greater risk of infection as a result of
their job. Protecting those who maintain homeland and national security
was also considered a significant Federal objective. The ultimate goal
of pandemic vaccination is to provide vaccines to all persons in the
United States who choose to be vaccinated by 6 months after the
declaration of a pandemic.
With this notice, the USG requests comment from the public and
interested stakeholders on the draft Guidance on Allocating and
Targeting Pandemic Influenza Vaccine.
Specifically, the USG invites comments on the following:
The framework for establishing pandemic influenza vaccine
priorities, including the--
(1) approach for defining:
a. Target groups,
b. The clusters of target groups in the categories,
c. The levels within categories,
d. The tiers across categories.
(2) The extent to which the prioritization guidance addresses the
stated program objectives.
(3) The extent to which the guidance is likely to lead to fair and
ethical allocation and targeting of pandemic influenza vaccine across
the population.
The text of the draft guidance is available in html and pdf formats
through the PandemicFlu.Gov Web site at https://www.pandemicflu.gov/
vaccine/prioritization.html and the HHS Web site at https://
www.aspe.hhs.gov/panflu/
[[Page 61887]]
vaccinepriorities.html. For those who may not have Internet access, a
hard copy can be requested from the point of contact, Hui-Hsing Wong,
Office of the Assistant Secretary for Planning and Evaluation (202)
205-0519.
Date: October 24, 2007.
RADM W. Craig Vanderwagen,
Assistant Secretary for Preparedness and Response.
[FR Doc. 07-5435 Filed 10-31-07; 8:45 am]
BILLING CODE 4151-04-M
