[Federal Register Volume 76, Number 141 (Friday, July 22, 2011)]
[Notices]
[Pages 44013-44014]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-18472]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry: Implementation of Acceptable Full-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 draft document entitled ``Guidance for Industry: 
Implementation of Acceptable Full-Length and Abbreviated Donor History 
Questionnaires and Accompanying Materials for Use in Screening Donors 
of Source Plasma'' dated July 2011. The draft guidance document 
recognizes the standardized full-length and abbreviated donor history 
questionnaires and accompanying materials, version 1.0.1 dated December 
2010, 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.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 20, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Outreach and Development (HFM-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 The draft guidance may also be obtained by 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 draft 
guidance document.
    Submit electronic comments on the draft 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 draft document entitled 
``Guidance for Industry: Implementation of Acceptable Full-Length and 
Abbreviated Donor History Questionnaires and Accompanying Materials for 
Use in Screening Donors of Source Plasma'' dated July 2011. The draft 
guidance document recognizes the standardized full-length and 
abbreviated donor history questionnaires and accompanying materials, 
version 1.0.1 dated December 2010, 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.
    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 requirement of the applicable statutes 
and regulations.

II. Paperwork Reduction Act of 1995

    This draft 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

[[Page 44014]]

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 No. 0910-0338; 21 CFR 640.63 have been approved under OMB 
Control No. 0910-0116.

III. Comments

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. 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 draft guidance 
at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: July 18 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-18472 Filed 7-21-11; 8:45 am]
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