[Federal Register Volume 74, Number 222 (Thursday, November 19, 2009)]
[Notices]
[Pages 59982-59983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-27729]
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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Draft Guidance for Industry: Recommendations for the Assessment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.
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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availability of a draft document entitled ``Draft Guidance for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 This draft guidance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draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Outreach and Development (HFM-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 The draft guidance may also be obtained by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 http://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.
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\1\ http://www.cdc.gov/h1n1flu/infectioncontrol.
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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 http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/guidances/default.htm or http://www.regulations.gov.
Dated: November 13, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-27729 Filed 11-18-09; 8:45 am]
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