[Federal Register: April 27, 2006 (Volume 71, Number 81)]
[Notices]
[Page 24857-24858]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27ap06-50]
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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draft guidance document further explains the requirements on informed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draft guidance document is designed to assist blood establishments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 This draft guidance, when finalized, will
supersede the draft guidance document entitled ``Draft Reviewer's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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers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 The draft guidance may also be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Submit written comments on the draft guidance to the Division of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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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