[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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]
BILLING CODE 4160-01-S