Document ID: FDA-2009-D-0533-0008
Agency: fda
Document Type: Notice
Title: Guidance for Industry:  Recommendations for Blood Establishments; Availability: Training of Back-UpPersonnel, Assessment of Blood Donor Suitability, and Reporting Certain Changes to an Approved Application
Posted Date: 2010-12-03T05:00Z

[Federal Register Volume 75, Number 232 (Friday, December 3, 2010)]
[Notices]
[Pages 75483-75484]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30388]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0533]

Guidance for Industry: Recommendations for Blood Establishments: 
Training of Back-Up Personnel, Assessment of Blood Donor Suitability, 
and Reporting Certain Changes to an Approved Application; 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 document entitled ``Guidance for Industry: 
Recommendations for Blood Establishments: Training of Back-Up 
Personnel, Assessment of Blood Donor Suitability and Reporting Certain 
Changes to an Approved Application'' dated November 2010. The guidance 
document provides recommendations to blood establishments for training 
of back-up personnel, assessment of blood donor suitability, and how to 
report certain changes to an approved license application to FDA. The 
guidance announced in this document finalizes the draft guidance 
entitled ``Draft Guidance for Industry: Recommendations for the 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'' dated November 2009. The guidance announced in this document 
also is superseding certain recommendations in two previous guidances, 
the guidance document entitled ``Guidance for Industry: Changes to an 
Approved Application: Biological Products: Human Blood and Blood 
Components Intended for Transfusion or for Further Manufacture'' dated 
July 2001 and the guidance document entitled ``Guidance for Industry: 
Streamlining the Donor Interview Process: Recommendations for Self-
Administered Questionnaires'' dated July 2003.

DATES: Submit either electronic or written comments on agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Communication, Outreach and Development (HFM-40), Center 
for Biologics Evaluation and Research, 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 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 electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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 document entitled 
``Guidance for Industry: Recommendations for Blood Establishments: 
Training of Back-Up Personnel, Assessment of Blood Donor Suitability 
and Reporting Certain Changes to an Approved Application'' dated 
November 2010. The guidance document provides recommendations to blood 
establishments for training of back-up personnel, assessment of blood 
donor suitability, and reporting certain changes to an approved license 
application to FDA.
    In the Federal Register of November 19, 2009 (74 FR 59982), FDA 
announced the availability of the draft guidance 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'' (November 2009). At 
that time, we anticipated that the rapid spread of pandemic (H1N1) 2009 
virus had the potential to cause disruptions in the blood supply and 
that the usual practices for ensuring blood availability in response to 
local disasters (i.e., hurricanes) would not be applicable or 
sufficient under a severe pandemic scenario. Since we issued the draft 
guidance, the H1N1 influenza pandemic has waned in the United States 
and disruptions in the blood supply have not been observed. Therefore, 
we are not finalizing those recommendations set forth in the draft 
guidance that referred to blood donor deferral and blood product 
management specific to the pandemic (H1N1) 2009 virus. Instead, we are 
finalizing those recommendations contained in the draft guidance that 
are of general

[[Page 75484]]

applicability (i.e., regardless of the existence of a pandemic or other 
emergency situation) as to training of back-up personnel, assessing 
blood donor suitability, and reporting certain changes to an approved 
application for licensed blood establishments. FDA received a few 
comments on the draft guidance in connection with these recommendations 
and those comments were considered as the guidance was finalized. In 
addition, editorial changes were made to improve clarity. The guidance 
announced in this document finalizes the draft guidance dated November 
2009.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 606 have been approved under 
OMB control number 0910-0116. The collections of information for 21 CFR 
part 601 have been approved under OMB control number 0910-0338.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen 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 guidance at 
either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: November 24, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30388 Filed 12-2-10; 8:45 am]
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