Solicitation of Written Comments on Draft National Vaccine Advisory Committee Vaccine Safety Working Group Recommendations to the Immunization Safety Office, 16872-16873 [E9-8399]
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Federal Register / Vol. 74, No. 69 / Monday, April 13, 2009 / Notices
member of the public who would like to
participate in this session is encouraged
to contact the Executive Secretary at
his/her earliest convenience. It is
requested that those who wish to have
printed material distributed to the
Committee provide thirty (30) copies of
the document to be distributed to the
Executive Secretary, ACBSA, prior to
close of business April 27, 2009. If it is
not possible to provide 30 copies of the
material to be distributed, then
individuals are requested to provide at
a minimum one (1) copy of the
document(s) to be distributed prior to
the close of business April 27, 2009. It
also is requested that any member of the
public who wishes to provide comments
to the Committee utilizing electronic
data projection submit the necessary
material to the Executive Secretary prior
to close of business April 27, 2009.
Dated: April 8, 2009.
Jerry A. Holmberg,
Executive Secretary, Advisory Committee on
Blood Safety and Availability.
[FR Doc. E9–8398 Filed 4–10–09; 8:45 am]
BILLING CODE 4140–41–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation of Written Comments on
Draft National Vaccine Advisory
Committee Vaccine Safety Working
Group Recommendations to the
Immunization Safety Office
AGENCY: Department of Health and
Human Services, Office of the Secretary.
ACTION: Notice.
SUMMARY: The National Vaccine
Program Office (NVPO) is soliciting
public comment on the National
Vaccine Advisory Committee (NVAC)
Vaccine Safety Working Group draft
Recommendations to the Centers for
Disease Control and Prevention’s
Immunization Safety Office (ISO).
DATES: Comments on the NVAC Vaccine
Safety Working Group draft report
should be received no later than 5 p.m.
on May 13, 2009.
ADDRESSES: Electronic responses are
preferred and may be addressed to
vaccinesafetyRFI@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 715–H, Washington, DC
20201, Attention: Vaccine Safety RFI.
FOR FURTHER INFORMATION CONTACT: Ms.
Kirsten Vannice, National Vaccine
Program Office, Department of Health
and Human Services, Hubert H.
VerDate Nov<24>2008
18:51 Apr 10, 2009
Jkt 217001
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.
SUPPLEMENTARY INFORMATION:
I. Background
Ensuring the optimal safety of
vaccines and immunizations is
important to everyone. The National
Vaccine Program Office (NVPO) is
located within the Office of Public
Health and Science, 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. NVPO also
has responsibility for managing and
providing support services for the
National Vaccine Advisory Committee
(NVAC). NVAC is a statutory Federal
advisory committee that was established
to provide advice and make
recommendations to the Director of the
National Vaccine Program on matters
related to the Program’s responsibilities.
The Assistant Secretary for Health
serves as Director of the National
Vaccine Program.
The Centers 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 (https://www.cdc.gov/
vaccinesafety). ISO has drafted a fiveyear scientific agenda that identifies
vaccine safety issues to consider for
scientific study, in addition to any new
questions that may arise. The draft ISO
Scientific Agenda can be found at:
https://www.cdc.gov/vaccinesafety/
00_pdf/draft_agenda_
recommendations_080404.pdf and the
addendum at https://www.cdc.gov/
vaccinesafety/00_pdf/
draft_recommendations_add_080410
.pdf.
Since not all questions and issues can
be addressed at once, setting priorities
is also important, and ISO has requested
a review of the draft Scientific Agenda
by the National Vaccine Advisory
Committee (NVAC) for the purpose of
identifying gaps and setting priorities.
The NVAC Vaccine Safety Working
Group has written a draft report of
recommendations on the content and
priorities of the draft ISO Scientific
Agenda. The draft report may be found
at https://www.hhs.gov/nvpo/nvac/
reports.html.
Through this request for information
(RFI) HHS is seeking comments from
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everyone, including stakeholders and
the broad public, on the NVAC Vaccine
Safety Working Group draft report.
Comments received will be available for
public viewing on the NVAC Vaccine
Safety Working Group Web site (https://
www.hhs.gov/nvpo/nvac/
vaccinesafety.html).
II. Information Request
NVPO, on behalf of the NVAC
Vaccine Safety Working Group, requests
input on the draft Working Group report
(https://www.hhs.gov/nvpo/nvac/
reports.html). In addition to general
comments, NVPO is seeking input on
any additional gaps not addressed in the
ISO Scientific Agenda nor the NVAC
Vaccine Safety Working Group draft
report, and/or prioritization criteria and
its application to the ISO Scientific
Agenda.
Please limit comments to 6 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 have their
comments posted and will not be
considered.
The submission of written materials
in response to the RFI should not
exceed six pages, 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 https://www.hhs.gov/
nvpo/nvac/vaccinesafety.html. You may
access public comments received from
this RFI by going to the above Web site.
E:\FR\FM\13APN1.SGM
13APN1
16873
Federal Register / Vol. 74, No. 69 / Monday, April 13, 2009 / Notices
Dated: March 31, 2009.
Bruce G. Gellin,
Deputy Assistant Secretary for Health,
Director, National Vaccine Program Office,
U.S. Department of Health and Human
Services.
[FR Doc. E9–8399 Filed 4–10–09; 8:45 am]
BILLING CODE 4150–44–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–09–08AU]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Maryam Daneshvar,
CDC Acting Reports Clearance Officer,
1600 Clifton Road, MS–D74, Atlanta,
GA 30333 or send an e-mail to
omb@cdc.gov.
Comments are invited 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)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Canada, as well as single-site studies in
the United States, allude to a problem
of timely referral and diagnosis for
patients with cancer. Despite the advent
of new diagnostics and therapeutics for
patients with chronic hematological
malignancies, the size and scope of a
potential problem regarding their
referral from primary care providers to
specialists is not well-defined in the
current literature.
CDC proposes to conduct a one-time
study to collect qualitative and
quantitative information on optimal and
sub-optimal referral patterns for patients
with confirmed or suspected chronic
hematologic malignancies. Information
will be collected to identify specific
factors related to delays in diagnosis
and/or referral to appropriate medical
specialists. Information will be collected
through in-depth interviews with
hematologic cancer patients, in-depth
interviews and focus groups with
primary care providers, interviews with
specialists in hematology and oncology
in Texas, and a one-time postal survey
to a sample of primary care providers in
Massachusetts.
The ultimate goal is to develop tools
that will improve the awareness,
diagnosis, and referral of persons with
chronic hematological cancers by
primary care providers.
There are no costs to respondents
other than their time.
Proposed Project
Assessing Problem Areas in Referrals
for Chronic Hematologic Malignancies
and Developing Interventions to
Address Them—New—Division of
Cancer Prevention and Control, National
Center for Chronic Disease Prevention
and Health Promotion (NCCDPHP),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
One of the six aims of the Institute of
Medicine’s Crossing the Quality Chasm
report is to improve the timeliness of
care for patients. Data from Europe and
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondents
Community
Hematologists
Oncologists.
and
Patients .............................................
Primary Care Providers (PCP) .........
Total ...........................................
VerDate Nov<24>2008
18:51 Apr 10, 2009
Number of
respondents
Form name
Number of
responses per
respondent
Avg. burden
per response
(in hrs)
Total burden
(in hours)
Hematologists
and
Oncologists
Interview
Phone
Recruitment
Script.
Hematologists
and
Oncologists
Interview Guide.
Patient Interview Phone Recruitment
Script.
Patient Interview Guide ....................
PCP Survey Cover Letter .................
PCP Survey ......................................
PCP Opt-Out Card ...........................
PCP Survey Reminder Letter ...........
PCP Interview Phone Recruitment
Script.
PCP Interview Guide ........................
PCP Focus Group Phone Recruitment Script.
PCP Focus Group Guide .................
100
1
2/60
3
18
1
1.5
27
50
1
2/60
2
18
250
150
100
200
100
1
1
1
1
1
1
1.5
2/60
20/60
2/60
2/60
3/60
27
8
50
3
7
5
18
50
1
1
1.5
3/60
27
3
18
1
2
36
...........................................................
........................
........................
........................
198
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E:\FR\FM\13APN1.SGM
13APN1
]]>Agencies
[Federal Register Volume 74, Number 69 (Monday, April 13, 2009)]
[Notices]
[Pages 16872-16873]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-8399]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Solicitation of Written Comments on Draft National Vaccine
Advisory Committee Vaccine Safety Working Group Recommendations to the
Immunization Safety Office
AGENCY: Department of Health and Human Services, Office of the
Secretary.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Vaccine Program Office (NVPO) is soliciting
public comment on the National Vaccine Advisory Committee (NVAC)
Vaccine Safety Working Group draft Recommendations to the Centers for
Disease Control and Prevention's Immunization Safety Office (ISO).
DATES: Comments on the NVAC Vaccine Safety Working Group draft report
should be received no later than 5 p.m. on May 13, 2009.
ADDRESSES: Electronic responses are preferred and may be addressed to
vaccinesafetyRFI@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 715-H, Washington, DC
20201, Attention: Vaccine Safety RFI.
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.
SUPPLEMENTARY INFORMATION:
I. Background
Ensuring the optimal safety of vaccines and immunizations is
important to everyone. The National Vaccine Program Office (NVPO) is
located within the Office of Public Health and Science, 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.
NVPO also has responsibility for managing and providing support
services for the National Vaccine Advisory Committee (NVAC). NVAC is a
statutory Federal advisory committee that was established to provide
advice and make recommendations to the Director of the National Vaccine
Program on matters related to the Program's responsibilities. The
Assistant Secretary for Health serves as Director of the National
Vaccine Program.
The Centers 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 (https://www.cdc.gov/vaccinesafety). ISO has drafted a
five-year scientific agenda that identifies vaccine safety issues to
consider for scientific study, in addition to any new questions that
may arise. The draft ISO Scientific Agenda can be found at: https://www.cdc.gov/vaccinesafety/00_pdf/draft_agenda_recommendations_080404.pdf and the addendum at https://www.cdc.gov/vaccinesafety/00_pdf/draft_recommendations_add_080410.pdf.
Since not all questions and issues can be addressed at once,
setting priorities is also important, and ISO has requested a review of
the draft Scientific Agenda by the National Vaccine Advisory Committee
(NVAC) for the purpose of identifying gaps and setting priorities. The
NVAC Vaccine Safety Working Group has written a draft report of
recommendations on the content and priorities of the draft ISO
Scientific Agenda. The draft report may be found at https://www.hhs.gov/nvpo/nvac/reports.html.
Through this request for information (RFI) HHS is seeking comments
from everyone, including stakeholders and the broad public, on the NVAC
Vaccine Safety Working Group draft report. Comments received will be
available for public viewing on the NVAC Vaccine Safety Working Group
Web site (https://www.hhs.gov/nvpo/nvac/vaccinesafety.html).
II. Information Request
NVPO, on behalf of the NVAC Vaccine Safety Working Group, requests
input on the draft Working Group report (https://www.hhs.gov/nvpo/nvac/reports.html). In addition to general comments, NVPO is seeking input
on any additional gaps not addressed in the ISO Scientific Agenda nor
the NVAC Vaccine Safety Working Group draft report, and/or
prioritization criteria and its application to the ISO Scientific
Agenda.
Please limit comments to 6 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 have their comments posted and will not be considered.
The submission of written materials in response to the RFI should
not exceed six pages, 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 https://www.hhs.gov/nvpo/nvac/vaccinesafety.html. You may access public comments received from this
RFI by going to the above Web site.
[[Page 16873]]
Dated: March 31, 2009.
Bruce G. Gellin,
Deputy Assistant Secretary for Health, Director, National Vaccine
Program Office, U.S. Department of Health and Human Services.
[FR Doc. E9-8399 Filed 4-10-09; 8:45 am]
BILLING CODE 4150-44-P
