[Federal Register Volume 78, Number 89 (Wednesday, May 8, 2013)]
[Notices]
[Pages 26785-26786]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10889]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0722]


Guidance for Industry: Implementation of an Acceptable 
Abbreviated Donor History Questionnaire and Accompanying Materials for 
Use in Screening Frequent Donors of Blood and Blood Components; 
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: 
Implementation of an Acceptable Abbreviated Donor History Questionnaire 
and Accompanying Materials for Use in Screening Frequent Donors of 
Blood and Blood Components'' dated May 2013. The guidance document 
recognizes the abbreviated donor history questionnaire and accompanying 
materials (aDHQ documents), version 1.3 dated December 2012, prepared 
by the AABB Donor History Task Force, as an acceptable mechanism for 
collecting blood donor history information from frequent donors of 
blood and blood components that is consistent with FDA's requirements 
and recommendations for collecting donor history information. The aDHQ 
documents will provide blood establishments that collect blood and 
blood components with a specific process for administering questions to 
frequent donors of blood and blood components to determine their 
eligibility to donate. The guidance announced in this notice finalizes 
the draft guidance of the same title dated October 2011.

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 (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 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: Tami Belouin, 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: Implementation of an Acceptable Abbreviated 
Donor History Questionnaire and Accompanying Materials for Use in 
Screening Frequent Donors of Blood and Blood Components'' dated May 
2013. The guidance document recognizes the aDHQ documents, version 1.3 
dated December 2012, prepared by the AABB Donor History Task Force, as 
an acceptable mechanism for collecting blood donor history information 
from frequent donors of blood and blood components that is consistent 
with FDA's requirements and recommendations. The aDHQ User Brochure 
defines a frequent donor as a donor who has previously donated two 
times using the full-length donor history questionnaire, one donation 
of which occurred within the previous 6 months. The aDHQ documents will 
provide blood establishments that collect blood and blood components 
with a specific process for administering questions to frequent donors 
of blood and blood components to determine their eligibility to donate. 
The guidance also advises licensed manufacturers who choose to 
implement the acceptable aDHQ documents on how to report the 
manufacturing change consisting of the implementation of the aDHQ 
documents under 21 CFR 601.12.
    In the Federal Register of October 24, 2011 (76 FR 65735), FDA 
announced the availability of the draft guidance of the same title 
dated October 2011. FDA received some comments on the draft guidance 
and those comments were considered as the guidance was finalized. A 
summary of changes includes: Referencing the most current version of 
the acceptable aDHQ documents, clarifying that the full-length and 
abbreviated questionnaires are designed to be implemented together, and 
editorial changes to improve clarity. The guidance announced in this 
notice finalizes the draft guidance dated October 2011.
    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 601.12 and Form FDA 356(h) have 
been approved under OMB control number 0910-0338; and the collections 
of information in 21 CFR 640.63 have been approved under OMB control 
number 0910-0116.

[[Page 26786]]

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

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: May 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-10889 Filed 5-7-13; 8:45 am]
BILLING CODE 4160-01-P