[Federal Register Volume 78, Number 38 (Tuesday, February 26, 2013)]
[Notices]
[Pages 13071-13072]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04384]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0487]


Guidance for Industry: Implementation of an Acceptable Full-
Length and Abbreviated Donor History Questionnaires and Accompanying 
Materials for Use in Screening Donors of Source Plasma; 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 Full-Length and Abbreviated Donor 
History Questionnaires and Accompanying Materials for Use in Screening 
Donors of Source Plasma'' dated February 2013. The guidance document 
recognizes the standardized full-length and abbreviated donor history 
questionnaires and accompanying materials, version 1.2 dated September 
2012, as an acceptable mechanism that is consistent with FDA's 
requirements and recommendations for collecting Source Plasma donor 
history information. The Plasma Protein Therapeutics Association (PPTA) 
Source Plasma donor history questionnaires and accompanying materials 
(SPDHQ documents) will provide blood establishments that collect Source 
Plasma with a specific process for administering questions to Source 
Plasma donors to determine their eligibility to donate. The guidance 
announced in this notice finalizes the draft guidance of the same title 
dated July 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.

[[Page 13072]]

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 Full-Length 
and Abbreviated Donor History Questionnaires and Accompanying Materials 
for Use in Screening Donors of Source Plasma'' dated February 2013. The 
guidance document recognizes the standardized full-length and 
abbreviated donor history questionnaires and accompanying materials, 
version 1.2 dated September 2012, prepared by the PPTA, as an 
acceptable mechanism that is consistent with FDA's requirements and 
recommendations for collecting Source Plasma donor history information. 
The SPDHQ documents will provide blood establishments that collect 
Source Plasma with a specific process for administering questions to 
Source Plasma donors to determine their eligibility to donate. The 
guidance also advises Source Plasma manufacturers who choose to 
implement the acceptable SPDHQ documents on how to report the 
manufacturing change consisting of the implementation of the SPDHQ 
under 21 CFR 601.12.
    In the Federal Register of July 22, 2011 (76 FR 44013), FDA 
announced the availability of the draft guidance of the same title 
dated July 2011. FDA received no comments on the draft guidance. A 
summary of changes includes: Referencing the most current version of 
the acceptable SPDHQ documents, clarifying that the full-length and 
abbreviated questionnaires are designed to be implemented together, and 
making a few editorial changes to improve clarity. The guidance 
announced in this notice finalizes the draft guidance dated July 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 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.

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: February 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04384 Filed 2-25-13; 8:45 am]
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