[Federal Register Volume 72, Number 119 (Thursday, June 21, 2007)]
[Notices]
[Page 34260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-11997]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0108]


Guidance for Industry: Informed Consent Recommendations for 
Source Plasma Donors Participating in Plasmapheresis and Immunization 
Programs; 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: Informed 
Consent Recommendations for Source Plasma Donors Participating in 
Plasmapheresis and Immunization Programs,'' dated June 2007. The 
guidance document further explains the requirements and recommendations 
for the informed consent of donors of Source Plasma in plasmapheresis 
and immunization programs. The guidance document is designed to assist 
blood establishments that are planning to apply for licensure or 
revising their existing informed consent procedures. The guidance 
announced in this notice finalizes the draft guidance of the same title 
dated April 2006. This guidance supersedes the draft guidance document 
entitled ``Draft Reviewer's Guide: Informed Consent for Plasmapheresis/
Immunization,'' dated October 1995.

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: Joseph L. Okrasinski Jr., 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: Informed Consent Recommendations for Source 
Plasma Donors Participating in Plasmapheresis and Immunization 
Programs,'' dated June 2007. The guidance further explains the 
requirements in Sec.  640.61 (21 CFR 640.61) and makes recommendations 
for the informed consent of donors of Source Plasma in plasmapheresis 
and immunization programs. The guidance discusses informed consent 
issues applicable to all Source Plasma donors, including describing the 
hazards of the procedures, the importance of affording the donor an 
opportunity to ask questions, and the potential consequences for the 
donor if the results of tests for communicable disease agents are 
reactive, positive, or outside of normal limits. The guidance also 
discusses additional informed consent issues for a donor who is 
participating in an immunization program. The information in the 
guidance will assist those establishments applying for licensure as 
well as those establishments that are revising their existing informed 
consent procedures.
    In the Federal Register of Thursday, April 27, 2006 (71 FR 24857), 
FDA announced the availability of the draft guidance of the same title 
dated April 2006. FDA received several comments on the draft guidance, 
and those comments were considered as the guidance was finalized. The 
guidance announced in this notice finalizes the draft guidance dated 
April 2006. This guidance will supersede the draft guidance document 
entitled ``Draft Reviewer's Guide: Informed Consent for Plasmapheresis/ 
Immunization,'' dated October 1995.
    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 Sec.  640.61 and 21 CFR 640.66 have been 
approved under OMB control number 0910-0116.

III. Comments

    Interested persons may, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) written or electronic comments 
regarding the 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 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: June 13, 2007.
Randall W. Lutter,
Acting Deputy Commissioner for Policy.
[FR Doc. E7-11997 Filed 6-20-07; 8:45 am]
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