[Federal Register Volume 62, Number 42 (Tuesday, March 4, 1997)]
[Proposed Rules]
[Pages 9721-9722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-5240]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. 97N-0068]


Proposed Approach to Regulation of Cellular and Tissue-Based 
Products; Availability and Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of proposed regulatory approach; public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a document entitled, ``Proposed Approach to Regulation 
of Cellular and Tissue-Based Products.'' In addition, FDA is announcing 
a public meeting to solicit information and views from the interested 
public on the agency's proposed regulatory approach for such products. 
These actions are taken in response to the Administration's 
``Reinventing Government'' initiative which seeks to streamline 
regulatory requirements to ease the burden on regulated industry, while 
providing adequate protection to the public health.

DATES: Written comments may be submitted at any time; however, comments 
should be submitted by April 17, 1997, to ensure their adequate 
consideration in preparing FDA's final approach to the regulation of 
cellular and tissue-based products.
    The public meeting will be held on March 17, 1997, from 8 a.m. to 
4:30 p.m. Submit written notices of participation by March 10, 1997, 
including a summary of the presentation, which will be submitted to the 
docket, and approximate time requested.
    Registration is not required; however, groups are asked to limit 
the number of individuals attending because of the anticipated broad 
interest in the meeting and the limited available seating.

ADDRESSES: The public meeting will be held at the Parklawn Bldg., 
conference rooms D and E, 5600 Fishers Lane, Rockville, MD 20857.
    Submit written requests for single copies of the document 
``Proposed Approach to Regulation of Cellular and Tissue-Based 
Products'' to the Office of Communication, Training and Manufacturer's 
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 that office in 
processing your request. The document may also be obtained by mail or 
by calling the CBER Voice information System at 1-800-835-4709, or 301-
827-1800, or FAX at 1-888-CBER-FAX, or 301-827-3844.
    Persons with access to the Internet may obtain the document using 
the world wide web (WWW) or bounce-back-e-mail. For WWW access, connect 
to CBER at ``http://www.fda.gov/cber/cberftp.html''. To receive the 
document by bounce-back e-mail, send a message to
``CELL [email protected]''.
    Submit written comments on the document to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 
1-23, Rockville, MD 20857. Two copies of any comments are to be 
submitted, except individuals may submit one copy. Requests and 
comments should be identified with the docket number found in the 
brackets in the heading of this document. A copy of the document and 
received comments are available for public examination in the Dockets 
Management Branch, address above, between 9 a.m. and 4 p.m., Monday 
through Friday.

FOR FURTHER INFORMATION CONTACT:
    For information regarding the meeting or to submit a notice of 
intent to participate: Martha A. Wells, Center for Biologics Evaluation 
and Research (HFM-305), Food and Drug Administration, 1401 Rockville 
Pike, Rockville, MD 20852-1448, 301-827-0967, FAX 301-827-2844.
    For information regarding this document: Sharon A. Carayiannis, 
Center for Biologics Evaluation and Research (HFM-630), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-
3074.

SUPPLEMENTARY INFORMATION: 
    FDA is announcing the availability of a document entitled 
``Proposed Approach to Regulation of Cellular and Tissue-Based 
Products.'' This document is being issued as a part of FDA's continuing 
effort to reduce unnecessary burdens for industry without diminishing 
public health protection.
    FDA has designed a new regulatory framework for cells and tissues. 
The document describes this new approach, which FDA believes would 
provide adequate protection of public health, both from the risks of 
transmission of communicable disease and from the risks of therapies 
that may be ineffective or dangerous, while enabling investigators to 
develop new therapies and products with as little regulatory burden as 
possible. The proposed approach would encompass, but not be limited to, 
the regulation of the following: Human tissue intended for 
transplantation, currently regulated under 21 part CFR 1270; 
demineralized bone; reproductive tissue; heart valves; peripheral blood 
hematopoietic stem cells; placental/umbilical cord blood hematopoietic 
stem cells; somatic cell therapy products; and gene therapy products.
    The approach does not encompass vascularized organs or minimally-
manipulated bone marrow, transfusable blood products (e.g., whole 
blood, red blood cells, platelets, and plasma), tissues derived from 
animals, products used in the propagation of cells or tissues, or 
products that are secreted by or extracted from cells or tissues (e.g., 
human milk, collagen, urokinase, cytokines, and growth factors and 
hormones). Such products generally raise different safety and 
effectiveness issues, and generally are covered by other rules, 
regulations, and/or

[[Page 9722]]

standards. The agency intends to implement this regulatory plan in a 
step-by-step fashion and to issue through notice and comment rulemaking 
new regulatory requirements.
    The regulatory approach focuses on five overarching public health 
and regulatory concerns, which can be stated as the following 
questions:
    (1) How can the transmission of communicable disease be prevented?
    (2) What processing controls are necessary, e.g., to prevent 
contamination that could result in an unsafe or ineffective product, 
and to preserve integrity and function so that products will work as 
they are intended?
    (3) How can clinical safety and effectiveness be assured?
    (4) What labeling is necessary, and what kind of promotion is 
permissible, for proper use of the product?
    (5) Should manufacturers notify FDA when they process and market 
tissue products?
With these concerns in mind, FDA categorized cells and tissues and 
their uses by their risk relative to each concern, so as to enable the 
agency to provide only that level of oversight relevant to each of the 
individual areas of concern. Thus, under the plan, cells and tissues 
would be regulated with a tiered approach based on risk and the 
necessity for FDA review.
    In addition to making this document available, FDA is announcing a 
public meeting to discuss the proposed approach to the regulation of 
cellular and tissue-based products. At the public meeting FDA intends 
to present a brief overview of the proposed regulatory approach and 
provide an opportunity for public comments on the approach. Individuals 
who wish to make a presentation should contact Martha A. Wells, address 
above. FDA will determine the time available for presentations based on 
the number of participants. As time permits, those who did not submit a 
notice of participation will be given an opportunity to speak at the 
end of the meeting. FDA is requesting that those persons making oral 
presentations also submit their statements in writing, as described 
below, to ensure their adequate consideration.
    Although all members of the public will have an opportunity to 
comment on the proposed regulations when they are published, interested 
persons who wish to comment on the agency's proposed approach to the 
regulation should submit written comments on the document, ``Proposed 
Approach to Regulation of Cellular and Tissue-Based Products,'' and 
written comments in response to the public meeting to Dockets 
Management Branch (address above). Written comments may be submitted at 
anytime, however, comments should be submitted by April 17, 1997, to 
assure their adequate consideration. Two copies of any comments are to 
be submitted, except individuals may submit one copy. Comments and 
information are to be identified with the docket number found in 
brackets in the heading of this document. A copy of the document and 
received comments may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday.
    Written comments on this document and comments received in response 
to the public meeting will be considered in determining whether 
revisions to the document are warranted and in preparing any future 
rulemaking.

    Dated: February 26, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-5240 Filed 2-28-97; 2:13 pm]
BILLING CODE 4160-01-F