Document ID: FDA-2009-D-0533-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic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
Posted Date: 2009-11-19T05:00Z

[Federal Register: November 19, 2009 (Volume 74, Number 222)]
[Notices]               
[Page 59982-59983]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19no09-54]                         

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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Draft Guidance for Industry: Recommendations for the Assessment 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availability of a draft document entitled ``Draft Guidance for 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 This draft guidance 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draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Outreach and Development (HFM-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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