[Federal Register: January 21, 2003 (Volume 68, Number 13)]

[Rules and Regulations]               

[Page 2689-2691]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr21ja03-6]                         





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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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