Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus; Availability, 59982-59983 [E9-27729]
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Federal Register / Vol. 74, No. 222 / Thursday, November 19, 2009 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–10–09AI]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an
e-mail to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Proposed Project
Evaluation of the Action Plan for the
National Public Health Initiative on
Diabetes and Women’s Health—New—
National Center for Chronic Disease
Prevention and Health Promotion
(NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Diabetes can have unique and
profound effects on women’s lives and
health. For instance, diabetes is a more
common cause of coronary heart disease
among women than men, and the
prognosis of heart disease is worse for
women with diabetes than men with
diabetes. The burden of diabetes for
women is also unique because the
disease can affect both mothers and
their unborn children. It is projected
that from 2000 to 2025, women will
represent more than half of all cases of
diabetes in the United States.
The National Public Health Initiative
on Diabetes and Women’s Health (‘‘The
Initiative’’) was established to provide
support and resources for the creation
and implementation of a national public
health Action Plan. The Initiative is cosponsored by the American Diabetes
Association (ADA), the American
Association of Diabetes Educators
(AADE), the American Public Health
Association (APHA), the Association of
State and Territorial Health Officials
(ASTHO), and the Centers for Disease
Control and Prevention (CDC).
The Initiative’s Action Plan identifies
gaps in diabetes-related research and
programmatic activities, and strategic
objectives, within the areas of
community health, diabetes state
programs, education and community
outreach, quality of care, research, and
surveillance.
CDC proposes to conduct a survey to
assess collective progress toward
achieving the objectives outlined in the
Action Plan. The survey will also
request information about the specific
strategies, steps, resources and
partnerships that have been employed
to meet the objectives. Respondents will
be the 4 co-sponsors of The Initiative, 20
CDC-funded, state-based diabetes
prevention and control programs
(DPCPs), and approximately 100
private-sector public health
organizations with a focus on diabetes
and/or women’s health. Survey
responses will be compiled into a
progress report and disseminated to
respondents, allowing them to learn
about each other’s activities and the
steps needed to replicate successful
diabetes prevention and control efforts.
Information will be collected once per
year for a period of 3 years, and the
progress report will be updated
annually to reflect recent activities and
progress. Private-sector partners and
state-based partners will submit one
survey response per organization per
year. Co-sponsors will receive a
modified version of the survey. Due to
the size and complexity of the activities
managed by co-sponsors, the cosponsoring organizations will have the
option of submitting multiple survey
responses from different areas of the
organization, in order to capture the full
range of activities conducted. It is
estimated that each co-sponsor will
submit an average of three responses.
Participation in the survey is voluntary.
Information will be collected
electronically through a web-based
survey tool. There are no costs to
respondents other than their time. The
total estimated annualized burden hours
are 66.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Co-Sponsors ...................................................
State-based DPCPs ........................................
Private Sector Partners ...................................
Co-Sponsor Survey ........................................
Partner Survey ...............................................
Partner Survey ...............................................
Dated: November 10, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–27726 Filed 11–18–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0533]
erowe on DSK5CLS3C1PROD with NOTICES
BILLING CODE 4163–18–P
Draft Guidance for Industry:
Recommendations for the Assessment
of Blood Donor Suitability, Blood
Product Safety, and Preservation of
the Blood Supply in Response to
Pandemic (H1N1) 2009 Virus;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
VerDate Nov<24>2008
15:22 Nov 18, 2009
Jkt 220001
PO 00000
Notice.
Frm 00025
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
4
20
100
3
1
1
Avg. burden
per response
(in hrs)
.5
.5
.5
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft document entitled
‘‘Draft Guidance for Industry:
Recommendations for the Assessment of
Blood Donor Suitability, Blood Product
Safety, and Preservation of the Blood
Supply in Response to Pandemic
(H1N1) 2009 Virus’’. This draft guidance
provides recommendations for assessing
blood donor suitability and blood
product safety and maintaining blood
and blood product availability in
response to pandemic (H1N1) 2009
virus. It is intended for establishments
that manufacture Whole Blood and
blood components intended for use in
E:\FR\FM\19NON1.SGM
19NON1
Federal Register / Vol. 74, No. 222 / Thursday, November 19, 2009 / Notices
erowe on DSK5CLS3C1PROD with NOTICES
transfusion and blood components
intended for further manufacture,
including recovered plasma, Source
Plasma and Source Leukocytes.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by December 3, 2009.
The abbreviated comment period is
necessary because pandemic (H1N1)
2009 virus has the potential to cause
disruptions in the blood supply and
given this possibility, the agency needs
to finalize the guidance as soon as
possible.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
the office in processing your requests.
The draft guidance may also be obtained
by mail by calling CBER at 1–800–835–
4709 or 301–827–1800. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Benjamin A. Chacko, Center for
Biologics Evaluation and Research
(HFM–17), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Guidance for
Industry: Recommendations for the
Assessment of Blood Donor Suitability,
Blood Product Safety, and Preservation
of the Blood Supply in Response to
Pandemic (H1N1) 2009 Virus’’ dated
November 2009. This draft guidance
provides recommendations for assessing
blood donor suitability and blood
product safety and maintaining blood
and blood product availability in
response to pandemic (H1N1) 2009
virus. It is intended for establishments
that manufacture Whole Blood and
blood components intended for use in
VerDate Nov<24>2008
15:22 Nov 18, 2009
Jkt 220001
transfusion and blood components
intended for further manufacture,
including recovered plasma, Source
Plasma and Source Leukocytes. At the
present time, FDA is working with other
HHS agencies to monitor the pandemic
(H1N1) 2009 virus and its potential
impact on blood availability and blood
safety. The agency notes that the Centers
for Disease Control and Prevention
(CDC) has issued a document entitled
‘‘Interim Infection Control Guidance on
2009 H1N1 Influenza for Personnel at
Blood and Plasma Collection
Facilities.’’1 We recognize the
importance of the CDC
recommendations for infection control
in blood and plasma collection
establishments.
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent FDA’s current thinking on this
topic. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
The draft guidance refers to
previously approved collections of
information found in FDA regulations.
The collection of information in 21 CFR
part 606 has been approved under OMB
control number 0910–0116. The
collection of information for 21 CFR
part 601 has been approved under OMB
control number 0910–0338.
III. Comments
The draft guidance is being
distributed for comment purposes only
and is not intended for implementation
at this time. Interested persons may, at
any time, submit to the Division of
Dockets Management (see ADDRESSES)
written or electronic comments
regarding the draft guidance. Submit a
single copy of electronic comments or
two paper copies of any mailed
comments, except that individuals may
submit one paper copy. Comments are
to be identified with the docket number
found in brackets in the heading of this
document. A copy of the draft guidance
and received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
1 https://www.cdc.gov/h1n1flu/infectioncontrol.
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
59983
https://www.fda.gov/Biologics
BloodVaccines/GuidanceCompliance
RegulatoryInformation/guidances/
default.htm or https://
www.regulations.gov.
Dated: November 13, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–27729 Filed 11–18–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of Committee: Vaccines and
Related Biological Products Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on Tuesday, December 15, 2009,
from 1:30 p.m. to approximately 5 p.m.
Location: National Institutes of
Health, Bldg. 29, conference rm. 121.
The public is welcome to attend the
meeting at the specified location where
a speakerphone will be provided. Public
participation in the meeting is limited to
the use of the speakerphone in the
conference room. Important information
about transportation and directions to
the NIH campus, parking, and security
procedures is available on the Internet
at https://www.nih.gov/about/visitor/
index.htm. Visitors must show two
forms of identification, one of which
must be a government-issued photo
identification such as a Federal
employee badge, driver’s license,
passport, green card, etc. Detailed
information about security procedures is
located at https://www.nih.gov/about/
visitorsecurity.htm. Due to the limited
available parking, visitors are
encouraged to use public transportation.
Contact Person: Christine Walsh or
Denise Royster, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
E:\FR\FM\19NON1.SGM
19NON1
]]>Agencies
[Federal Register Volume 74, Number 222 (Thursday, November 19, 2009)]
[Notices]
[Pages 59982-59983]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-27729]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0533]
Draft Guidance for Industry: Recommendations for the Assessment
of Blood Donor Suitability, Blood Product Safety, and Preservation of
the Blood Supply in Response to Pandemic (H1N1) 2009 Virus;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft document entitled ``Draft Guidance for
Industry: Recommendations for the Assessment of Blood Donor
Suitability, Blood Product Safety, and Preservation of the Blood Supply
in Response to Pandemic (H1N1) 2009 Virus''. This draft guidance
provides recommendations for assessing blood donor suitability and
blood product safety and maintaining blood and blood product
availability in response to pandemic (H1N1) 2009 virus. It is intended
for establishments that manufacture Whole Blood and blood components
intended for use in
[[Page 59983]]
transfusion and blood components intended for further manufacture,
including recovered plasma, Source Plasma and Source Leukocytes.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by December 3, 2009. The abbreviated comment period is necessary
because pandemic (H1N1) 2009 virus has the potential to cause
disruptions in the blood supply and given this possibility, the agency
needs to finalize the guidance as soon as possible.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Outreach and Development (HFM-
40), Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in
processing your requests. The draft guidance may also be obtained by
mail by calling CBER at 1-800-835-4709 or 301-827-1800. See the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance
document.
Submit written comments on the guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Benjamin A. Chacko, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft document entitled
``Guidance for Industry: Recommendations for the Assessment of Blood
Donor Suitability, Blood Product Safety, and Preservation of the Blood
Supply in Response to Pandemic (H1N1) 2009 Virus'' dated November 2009.
This draft guidance provides recommendations for assessing blood donor
suitability and blood product safety and maintaining blood and blood
product availability in response to pandemic (H1N1) 2009 virus. It is
intended for establishments that manufacture Whole Blood and blood
components intended for use in transfusion and blood components
intended for further manufacture, including recovered plasma, Source
Plasma and Source Leukocytes. At the present time, FDA is working with
other HHS agencies to monitor the pandemic (H1N1) 2009 virus and its
potential impact on blood availability and blood safety. The agency
notes that the Centers for Disease Control and Prevention (CDC) has
issued a document entitled ``Interim Infection Control Guidance on 2009
H1N1 Influenza for Personnel at Blood and Plasma Collection
Facilities.''\1\ We recognize the importance of the CDC recommendations
for infection control in blood and plasma collection establishments.
---------------------------------------------------------------------------
\1\ https://www.cdc.gov/h1n1flu/infectioncontrol.
---------------------------------------------------------------------------
The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent FDA's current thinking on this topic. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
The draft guidance refers to previously approved collections of
information found in FDA regulations. The collection of information in
21 CFR part 606 has been approved under OMB control number 0910-0116.
The collection of information for 21 CFR part 601 has been approved
under OMB control number 0910-0338.
III. Comments
The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may, at any time, submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments regarding the draft guidance.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. A copy of the draft guidance and
received comments are available for public examination in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/guidances/default.htm or https://www.regulations.gov.
Dated: November 13, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-27729 Filed 11-18-09; 8:45 am]
BILLING CODE 4160-01-S
