[Federal Register Volume 71, Number 209 (Monday, October 30, 2006)]
[Notices]
[Pages 63327-63328]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18068]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0198]


Guidance for Industry on Implementation of Acceptable Full-Length 
Donor History Questionnaire and Accompanying Materials for Use in 
Screening 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 Acceptable Full-Length Donor History Questionnaire 
and Accompanying Materials for Use in Screening Donors of Blood and 
Blood Components,'' dated October 2006. The guidance document provides 
blood establishments that collect blood and blood components intended 
for transfusion or for further manufacture with advice on reporting to 
FDA a manufacturing change consisting of the implementation of a 
standardized full-length donor history questionnaire and accompanying 
materials (DHQ documents). The guidance document addresses which DHQ 
documents are acceptable, and establishes the process for FDA to 
recognize other DHQ documents in the future. The guidance announced in 
this notice finalizes the draft guidance entitled ``Guidance for 
Industry: Acceptable Full-Length Donor History Questionnaire and 
Accompanying Materials for Use in Screening Human Donors of Blood and 
Blood Components'' dated April 2004.

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

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Communication, Training, and Manufacturers Assistance 
(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 written comments on the guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Brenda R. Friend, 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 Acceptable Full-Length Donor 
History Questionnaire and Accompanying Materials for Use in Screening 
Donors of Blood and Blood Components,'' dated October 2006. The 
guidance document provides blood establishments that collect blood and 
blood components intended for transfusion or for further manufacture 
with advice on reporting to FDA a manufacturing change consisting of 
the implementation of DHQ documents. Acceptable DHQ documents (DHQ 
documents that provide licensed and unlicensed manufacturers with one 
means of complying with the FDA requirements for collecting donor 
history information) will provide manufacturers with a specific process 
for administering questions to donors of blood and blood components to 
determine their eligibility to donate. The guidance document advises 
licensed manufacturers who choose to implement acceptable DHQ documents 
on how to report the manufacturing change to FDA, and recognizes the 
Donor History Questionnaire Version No. 1.1 dated June 2005 (v.DHQ-
1.1), prepared by the AABB (formerly known as the American Association 
of Blood Banks) Donor History Task Force, as acceptable DHQ documents.
    In the future, FDA may recognize other DHQ documents as acceptable, 
and intends to make all of the acceptable DHQ documents available on 
FDA's Web site. FDA believes that acceptable DHQ documents will assist 
manufacturers in complying with the regulations under 21 CFR 640.3 and 
640.63. The guidance also advises licensed manufacturers of blood and 
blood components who choose to implement acceptable DHQ documents on 
how to report the manufacturing change to FDA under 21 CFR 601.12.
    In the Federal Register of May 12, 2004 (69 FR 26399), FDA 
announced the availability of the draft guidance entitled ``Guidance 
for Industry: Acceptable Full-Length Donor History Questionnaire and 
Accompanying Materials for Use in Screening Human Donors of Blood and 
Blood Components'' dated April 2004. This draft guidance contained the 
full-length donor history questionnaire and accompanying materials 
(Version No. 1, dated April 2004) (v.DHQ-1). FDA received several 
comments on the draft guidance and those comments were considered as 
the guidance was finalized. A summary of changes to the guidance 
includes the following: (1) Added a statement to direct inquiries 
regarding the v.DHQ-1.1 or other AABB DHQ documents to the task force; 
(2) clarified how to implement acceptable DHQ documents, including 
v.DHQ-1.1, and the self-administration of these documents; and (3) 
added a separate Web site link to access all DHQ documents that FDA has 
recognized as acceptable. In addition, FDA received many comments on 
the v.DHQ-1, and forwarded these comments to the task force. In 
response, the task force submitted updated DHQ documents (v.DHQ-1.1), 
for FDA's review. The guidance announced in this notice finalizes the 
draft guidance dated April 2004, and refers to the v.DHQ-1.1.
    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 606.160 have been approved under 
OMB control numbers 0910-0116; those in 21 CFR 601.12 have been 
approved under 0910-0338.

III. Comments

    Interested persons may, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) written or electronic comments 
regarding the

[[Page 63328]]

guidance. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in the brackets in the heading of this document. A copy of the guidance 
and received comments are available for public examination 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/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: October 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-18068 Filed 10-27-06; 8:45 am]
BILLING CODE 4160-01-S