[Federal Register Volume 72, Number 39 (Wednesday, February 28, 2007)]
[Notices]
[Pages 9007-9008]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-3445]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0193]


Guidance for Industry: Eligibility Determination for Donors of 
Human Cells, Tissues, and Cellular and Tissue-Based Products; 
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: 
Eligibility Determination for Donors of Human Cells, Tissues, and 
Cellular and Tissue-Based Products (HCT/Ps),'' dated February 2007. The 
guidance document assists establishments with making eligibility 
determinations for donors of human cells, tissues, and cellular and 
tissue-based products. The guidance announced in this document 
finalizes the draft guidance, ``Guidance for Industry: Eligibility 
Determination for Donors of Human Cells, Tissues, and Cellular and 
Tissue-Based Products (HCT/Ps),'' dated May 2004. This guidance also 
finalizes the draft guidance, ``Guidance for Industry: Preventive 
Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-
Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by 
Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/
Ps),'' dated June 2002 (Docket No. 2002D-0266).

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: Paul E. Levine, 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: Eligibility Determination for Donors of Human 
Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),'' 
dated February 2007. The guidance announced in this document assists 
HCT/P establishments with complying with the requirements under part 
1271 (21 CFR part 1271), subpart C. These regulations require HCT/P 
establishments to perform an eligibility determination for most cell 
and tissue donors, based on donor testing and screening for relevant 
communicable disease agents and diseases. This guidance applies only to 
cells and tissues procured on or after the effective date of the 
regulations contained in part 1271, subpart C (effective date May 25, 
2005). This guidance does not replace the guidance on 21 CFR part 1270, 
``Guidance for Industry: Screening and Testing of Donors of Human 
Tissue Intended for Transplantation,'' dated July 29, 1997, which 
continues to apply to certain tissues recovered before May 25, 2005.
    In the Federal Register of June 25, 2002 (67 FR 42789), FDA 
announced the availability of the draft guidance entitled ``Guidance 
for Industry: Preventive Measures to Reduce the Possible Risk of 
Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant 
Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular 
and Tissue-Based Products (HCT/Ps),'' dated June 2002. The draft 
guidance provides information intended to assist manufacturers of HCT/
Ps in minimizing the risk of transmission of CJD and vCJD by HCT/P 
donors that have been possibly exposed to the agents of CJD and vCJD.
    In the Federal Register of May 25, 2004 (69 FR 29835), FDA 
announced the availability of the draft guidance entitled ``Guidance 
for Industry: Eligibility Determination for Donors of Human Cells, 
Tissues, and Cellular and Tissue-Based Products (HCT/Ps),'' dated Ma 
2004. The draft guidance provided to HCT/P establishments 
recommendations for the appropriate screening and testing of cell and 
tissue donors for relevant communicable disease agents and diseases, 
and recommendations for complying with the regulations for eligibility 
determination for donors of HCT/Ps.
    FDA issued these two draft guidances to assist manufacturers in 
minimizing the risk of communicable disease transmission by donors of 
HCT/Ps. FDA received numerous comments on the two draft guidances and 
those comments were considered as the guidance was finalized. Based on 
these comments and additional data, FDA has identified West Nile Virus, 
Sepsis, and Vaccinia as relevant communicable disease agents or 
diseases (RCDAD). On the other hand, FDA has not included severe acute 
respiratory syndrome (SARS-CoV) as an RCDAD in this guidance because 
there has been no laboratory-confirmed person-to-person transmission of 
SARS-CoV worldwide since July 2003. In addition, the guidance 
recommends nucleic acid amplification testing (NAT) for human 
immunodeficiency virus (HIV) and hepatitis C virus (HCV) for both 
living and cadaveric donors. The guidance also modifies and/or 
clarifies the following:
    <bullet> Recommendations for risk factors for vCJD;
    <bullet> Physical examination of a living HCT/P donor;
    <bullet> Exceptions to the requirement for determining donor 
eligibility and appropriate labeling;
    <bullet> Screening criteria for HIV-1 group O, viral hepatitis, 
syphilis, Chlamydia trachomatis and Neisseria gonorrhea;
    <bullet> Deferral criteria for receipt of human-derived clotting 
factors;
    <bullet> Procedures for communicable disease testing laboratories;
    <bullet> FDA's approach to identifying new RCDADs; and
    <bullet> Use of gestational carriers or surrogates.
    The guidance announced in this document finalizes the previously 
described draft guidances dated June 2002 and May 2004. 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

[[Page 9008]]

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 No. 0910-0543. The collections of information in part 
1271, subpart D have been approved under OMB Control No. 0910-0559.

III. Comments

    Interested persons may, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) written or electronic comments 
regarding the guidance announced in this document. 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.htmor http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: February 21, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-3445 Filed 2-27-07; 8:45 am]
BILLING CODE 4160-01-S