[Federal Register Volume 68, Number 13 (Tuesday, January 21, 2003)]
[Rules and Regulations]
[Pages 2689-2691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-1207]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1271
[Docket No. 97N-484R]
Human Cells, Tissues, and Cellular and Tissue-Based Products;
Establishment Registration and Listing
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; delay of effective date.
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SUMMARY: The Food and Drug Administration (FDA) is further delaying,
until January 21, 2004, the effective date for requiring establishments
that engage in the recovery, screening, testing, processing, storage,
or distribution of all human cells, tissues, and cellular and tissue-
[[Page 2690]]
based products (HCT[sol]Ps) not currently regulated under section 361
of the Public Health Service Act (PHS Act) and part 1270 (21 CFR part
1270) to register with FDA and list their HCT[sol]Ps. FDA is taking
this action to help ensure that the effective date for this rule is
closer to the effective date of the anticipated finalization of the
remaining proposed rules involving HCT[sol]Ps.
DATES: The effective date for 21 CFR 207.20(f), 807.20(d), and
1271.3(d)(2) that published in the Federal Register on January 19, 2001
(66 FR 5447) is delayed from January 21, 2003, to a new effective date
of January 21, 2004.
FOR FURTHER INFORMATION CONTACT: Paula S. McKeever, 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
We, FDA, are putting in place a new comprehensive approach to the
regulation of HCT[sol]Ps. The goal of the new approach is to improve
protection of the public health without imposing unnecessary
restrictions on research, development, or the availability of new
products. The new comprehensive approach to the regulation of different
types of HCT[sol]Ps is intended to be commensurate with the public
health risks presented, enabling us to use our resources more
effectively, increase consistency, and improve efficiency.
Since 1997, when we announced our comprehensive regulatory approach
for HCT[sol]Ps, we have published three proposed rules and finalized
one of them:
[sbull] The registration proposed rule: ``Establishment
Registration and Listing for Manufacturers of Human Cellular and
Tissue-Based Products (63 FR 26744, May 14, 1998);
[sbull] The registration final rule: ``Human Cells, Tissues, and
Cellular and Tissue-Based Products; Establishment Registration and
Listing'' (66 FR 5447, January 19, 2001);
[sbull] The donor-suitability proposed rule: ``Suitability
Determination for Donors of Human Cellular and Tissue-Based Products''
(64 FR 52696, September 30, 1999); and
[sbull] The GTP (good tissue practices) proposed rule: ``Current
Good Tissue Practice for Manufacturers of Human Cellular and Tissue-
Based Products; Inspection and Enforcement'' (66 FR 1508, January 8,
2000).
When the donor-suitability and the GTP proposed rules are
finalized, the implementation of the comprehensive regulatory approach
for HCT[sol]Ps will be complete.
In all three proposed rules, we used the term ``human cellular and
tissue-based products.'' In the registration final rule, we changed
this term to ``human cells, tissues, and cellular and tissue-based
products'' (HCT[sol]Ps) in response to public comment. This change in
terminology is a clarification and does not affect the scope of the
definition in 21 CFR 1271.3(d), which continues to encompass an array
of articles containing or consisting of human cells or tissues, and
intended for implantation, transplantation, infusion, or transfer into
human recipients, including investigational products. In the final
rule, HCT[sol]P is defined to include HCT[sol]Ps at all stages of
manufacture, from recovery through distribution.
Initially, we had intended to finalize and implement the
registration proposed rule at the same time we finalized and
implemented the two other HCT[sol]P rules that would make up part 1271
(21 CFR part 1271) in its entirety. However, we issued the registration
final rule, before finalizing the two remaining portions of part 1271
because of concerns raised about the safety of human tissue, which led
us to believe that accelerating the collection of basic information
about the rapidly growing tissue industry was vital. Because the
registration final rule was published before the other two final rules,
we decided to implement staggered effective dates so that certain
HCT[sol]Ps would fall within the scope of the new rule later when GTP
requirements and enforcement provisions are finalized. This would
ensure that certain products, such as heart valves and dura mater that
are currently regulated as devices, would not be unintentionally and
prematurely shifted into an incomplete regulatory scheme. Therefore, in
the final registration rule, we required registration and listing first
by those establishments that engage in the recovery, screening,
testing, processing, storage, or distribution of human tissue intended
for transplantation currently regulated under section 361 of the PHS
Act (42 U.S.C. 264) and the regulations in part 1270. Establishments
that manufactured HCT[sol]Ps described in Sec. 1271.3(d)(1) were
required to register within 30 days after the effective date of the
registration final rule, i.e., May 4, 2001. Establishments that
manufacture all other HCT[sol]Ps, as described in Sec. 1271.3(d)(2),
were required to register 2 years after publication of the registration
final rule, by January 21, 2003.
The registration final rule also established Sec. Sec. 207.20(f)
and 807.20(d) (21 CFR 207.20(f) and 807.20(d)), which required
establishments that manufacture HCT[sol]Ps regulated as drugs,
biological products, and devices to register and list their products
following the procedures in part 1271 instead of the procedures in 21
CFR parts 207 and 807. The effective date of Sec. Sec. 207.20(f) and
807.20(d) is also staggered until January 21, 2003, because Sec. Sec.
207.20(f) and 807.20(d) is not applicable until Sec. 1271.3(d)(2)
becomes effective. We expected to have finalized the donor suitability
and the GTP proposed rules by this date. However, we will not complete
the rulemaking process for the proposed donor suitability and GTP rules
by January 21, 2003.
II. Reason for Staggered Effective Dates
Staggering the effective dates of this regulation permitted us to
begin collecting important registration and listing information from
those establishments currently regulated under part 1270, while
continuing to proceed through rulemaking to develop the remainder of
part 1271. We believed that this action would prevent an unintentional
gap in the regulation of certain currently regulated HCT[sol]Ps, permit
an orderly implementation process, and avoid duplicative information
collection. If we instead implemented the registration final rule for
all HCT[sol]Ps at the same time, certain HCT[sol]Ps, such as heart
valves and dura mater that are currently regulated as devices, would no
longer be regulated as devices but rather would shift into the
regulatory scheme under part 1271. By implementing a staggered
effective date for such products, we avoided a premature shift that
essentially would have left these products unregulated until the donor
suitability and GTP rulemaking process is completed. FDA also staggered
the effective dates of the registration final rule to ensure the
orderly implementation of the HCT[sol]P regulations.
III. Need for Further Delay of Effective Date
In the registration final rule, we stated that unanticipated delays
in completing the rulemaking for the remainder of part 1271 could
occur, and if so, we would consider whether to extend the staggered
effective date for some or all of the affected HCT[sol]Ps. Due to the
numerous comments submitted to FDA regarding the proposed donor
suitability and GTP rules, we will not be able to finalize these rules
by January 21, 2003. We have concluded that implementing the
registration final rule under the
[[Page 2691]]
staggered effective date for the remaining HCT[sol]Ps would be contrary
to the public interest in that certain products would become
unregulated unless and until the GTP and donor suitability rules are
finalized. For HCT[sol]Ps subject to the staggered effective date,
requiring registration without adequate enforcement provisions, such as
those proposed in the GTP rule, would be premature and possibly
ineffective. Establishments that manufacture HCT[sol]Ps covered by the
staggered effective date have been registering voluntarily, and FDA is
willing to continue accepting such voluntary registrations.
FDA, for good cause based on the reasons stated previously, finds
that notice and public procedure to delay the effective date are
unnecessary and contrary to the public interest (5 U.S.C.
553(b)(3)(B)). Therefore, we are delaying the effective date of
Sec. Sec. 207.20(f), 807.20(d), and 1271.3(d)(2) for 1 year. The new
effective date is January 21, 2004.
Dated: January 8, 2003.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 03-1207 Filed 1-17-03; 8:45 am]
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