[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 The draft
guidance provides to HCT/P establishments recommendations for the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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers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 The draft guidance may also be obtained by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INFORMATION section for electronic access to the draft guidance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Submit written comments on the draft guidance to the Division of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]
BILLING CODE 4160-01-S