[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