[Federal Register Volume 75, Number 232 (Friday, December 3, 2010)]
[Notices]
[Pages 75483-75484]
From the Federal Register Online via the Government Publishing 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guidance announced in this document finalizes the draft guidance
entitled ``Draft Guidance for Industry: Recommendations for the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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