[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]
BILLING CODE 4160-01-S