[Federal Register: May 25, 2004 (Volume 69, Number 101)]
[Notices]               
[Page 29835]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25my04-116]                         



[[Page 29835]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0193]

 
Draft ``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 draft document entitled ``Guidance for Industry: 
Eligibility Determination for Donors of Human Cells, Tissues, and 
Cellular and Tissue-Based Products (HCT/Ps)'' dated May 2004. The draft 
guidance provides to HCT/P establishments recommendations for the 
appropriate screening and testing of cell and tissue donors for 
evidence of relevant communicable diseases. These recommendations would 
assist HCT/P establishments in complying with the requirements for the 
eligibility determination for donors of HCT/Ps.

DATES: Submit written or electronic comments on the draft guidance by 
August 23, 2004, to ensure their adequate consideration in preparation 
of the final guidance. General omments 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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, 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 The draft guidance may also be obtained by 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 Center for Biologics and Research Voice Information 
System at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 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    Submit written comments on the draft guidance to the Division of 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: Paula S. McKeever, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled 
``Guidance for Industry: Eligibility Determination for Donors of Human 
Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps)'' dated 
May 2004. Because of their nature as derivatives of the human body, 
HCT/Ps pose a risk of transmitting communicable diseases. For this 
reason, FDA is publishing a final rule ``Eligibility Determination for 
Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products 
(HCT/Ps)'' elsewhere in this issue of the Federal Register. These 
donor-eligibility requirements, which are contained in part 1271 (21 
CFR part 1271), subpart C, are part of the minimum requirements 
applicable both to HCT/Ps regulated solely under these regulations and 
section 361 of the Public Health Service Act and to those HCT/Ps also 
subject to regulation as drugs, devices, and/or biological products.
    In the draft guidance, FDA is providing recommendations to HCT/P 
establishments on how to comply with the requirements in 21 CFR part 
1271, subpart C. The recommendations address the following topics:
     Elements of the donor eligibility determination, including 
procedures and recordkeeping;
     Donor screening, including review of risk factors for, and 
clinical and physical evidence of, relevant communicable diseases;
     Donor testing, including general testing for all HCT/Ps 
and testing specific for some types of HCT/Ps (e.g., reproductive cells 
and tissues); and
     Exceptions to donor screening and testing.
    The draft guidance would apply to cells and tissues recovered on or 
after the effective date of the final rule published elsewhere in this 
issue of the Federal Register. Part 1271 also contains other 
requirements applicable to HCT/Ps (e.g., current good tissue practice 
requirements), which are not addressed in the draft guidance.
    We previously have issued a separate draft guidance document 
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. We 
intend to issue a single final guidance document that incorporates our 
guidance on CJD and vCJD with the substance of this document into a 
final guidance on donor eligibility.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance 
document, when finalized, will 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 of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 USC 3501-3520). The 
collection(s) of information addressed in the guidance document has 
been submitted to OMB for review in accordance with the PRA under the 
regulations governing donor-eligibility determination for donors of 
HCT/Ps (part 1271).

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 to the Division of Dockets Management (see ADDRESSES) 
written or electronic comments 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 draft 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 draft 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 27, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-11246 Filed 5-20-04; 8:45 am]

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