[Federal Register Volume 71, Number 81 (Thursday, April 27, 2006)]
[Notices]
[Pages 24857-24858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-6314]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0108]


Draft ``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 draft document entitled ``Guidance for Industry: 
Informed Consent Recommendations for Source Plasma Donors Participating 
in Plasmapheresis and Immunization Programs,'' dated April 2006. The 
draft guidance document further explains the requirements on informed 
consent as they relate to plasmapheresis and immunization programs. The 
draft guidance document is designed to assist blood establishments 
planning to apply for licensure or those revising their existing 
informed consent forms in determining whether the documents include all 
the appropriate information. This draft guidance, when finalized, will 
supersede the draft guidance document entitled ``Draft Reviewer's 
Guide: Informed Consent for Plasmapheresis/Immunization,'' dated 
October 1995.

DATES: Submit written or electronic comments on the draft guidance by 
July 26, 2006 to ensure their adequate consideration in the preparation 
of the final guidance. General comments on agency guidance documents 
are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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, 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 The draft guidance may also be 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 the CBER Voice Information System 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    Submit written comments on the draft guidance to the Division of 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 draft document entitled 
``Guidance for Industry: Informed Consent Recommendations for Source 
Plasma Donors Participating in Plasmapheresis and Immunization 
Programs,'' dated April 2006. The draft guidance further explains the 
requirements under part 640 (21 CFR part 640) in 21 CFR 640.61 for the 
informed consent forms for the donors as they relate to plasmapheresis 
and immunization programs. The information in the draft guidance will 
assist those establishments applying for licensure as well as those 
establishments that are revising their existing informed consent forms. 
The draft guidance discusses information that is recommended for the 
informed consent forms. This information includes, but is not limited 
to, the following: Clarity of the language in the informed consent 
form, length and frequency of the procedures, possible adverse 
reactions, side affects that may occur, opportunities to ask questions, 
and discussion concerning Acquired Immunodeficiency Syndrome (AIDS). 
Also discussed in the draft guidance is the use of a separate informed 
consent form for a donor who is participating in an immunization 
program including one which involves an Investigational New Drug (IND), 
and its recommended informational content, such as the discussion of 
the general risks and precautions involved, and suggestions for the 
health and welfare of the participants. This draft guidance when 
finalized will supersede the draft guidance document entitled, ``Draft 
Reviewer's Guide: Informed Consent for Plasmapheresis/Immunization,'' 
dated October 1995.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will

[[Page 24858]]

represent the agency'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

    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 the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information under Sec. Sec.  640.61 and 640.66 was 
approved under OMB control number 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 written or electronic comments to the Division of Dockets 
Management (see ADDRESSES) regarding the draft guidance. Submit written 
or electronic comments to ensure adequate consideration in preparation 
of the final 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: April 19, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-6314 Filed 4-26-06; 8:45 am]
BILLING CODE 4160-01-S