[Federal Register Volume 72, Number 15 (Wednesday, January 24, 2007)]
[Notices]
[Pages 3149-3150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-978]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0017]
Guidance for Industry: Certain Human Cells, Tissues, and Cellular
and Tissue-Based Products Recovered From Donors Who Were Tested for
Communicable Diseases Using Pooled Specimens or Diagnostic Tests;
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: Certain
Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Recovered From Donors Who Were Tested for Communicable Diseases Using
Pooled Specimens or Diagnostic Tests'' dated January 2007. The guidance
document provides establishments that make HCT/P donor eligibility
determinations with recommendations concerning the donor eligibility
requirements contained in 21 CFR part 1271, subpart C, which became
effective on May 25, 2005. The guidance applies only to certain HCT/Ps
that were not regulated as HCT/Ps before May 25, 2005, and that were
recovered from donors beginning on or after the May 25, 2005, and
within 30 days of the date of publication of this document in the
Federal Register. This guidance has an immediate implementation date
because FDA has determined that prior public participation is not
feasible or appropriate. In certain cases, donor retesting needs to be
initiated quickly, and the availability of certain HCT/Ps may be
critical to their intended recipients.
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: Valerie A. Butler, 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: Certain Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps) Recovered From Donors Who
[[Page 3150]]
Were Tested for Communicable Diseases Using Pooled Specimens or
Diagnostic Tests'' dated January 2007. The guidance document provides
establishments that make HCT/P donor eligibility determinations with
recommendations concerning the donor eligibility requirements under
part 1271 (21 CFR part 1271), subpart C, when donors of certain HCT/Ps
were tested for communicable diseases using pooled specimens or
diagnostic tests. The effective date of the regulations contained in
part 1271, subpart C, was May 25, 2005 (69 FR 29785, May 25, 2004). The
guidance is applicable to certain HCT/Ps that were not regulated as
HCT/Ps before May 25, 2005, and that were recovered from donors on or
after May 25, 2005, and within 30 days of the date of publication of
this document in the Federal Register. FDA has determined that donor
retesting, in certain cases, needs to be conducted in a timely manner
in order to be feasible, and the availability of certain HCT/Ps may be
critical to their intended recipients.
The guidance is being issued consistent with FDA's good guidance
practices regulation Sec. 10.115 (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 part 1271, subpart C, have been approved
under OMB control number 0910-0543; the collections of information in
part 1271, subpart D, and Form FDA-3486 have been approved under OMB
control number 0910-0559.
III. Comments
FDA is soliciting public comment, but is implementing this guidance
immediately in accordance with Sec. 10.115(g)(2) and (3) without
initially seeking prior comment because the agency has determined that
prior public participation is not feasible or appropriate. In certain
cases, donor retesting needs to be initiated quickly, and the
availability of certain HCT/Ps may be critical to their intended
recipients. 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 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: January 17, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-978 Filed 1-23-07; 8:45 am]
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