[Federal Register Volume 65, Number 75 (Tuesday, April 18, 2000)]
[Proposed Rules]
[Pages 20774-20775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9581]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 210, 211, 820, and 1271

[Docket No. 97N-484S]


Suitability Determination for Donors of Human Cellular and 
Tissue-Based Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening for 90 
days the comment period for the proposed rule concerning suitability 
determinations for donors of human cellular and tissue-based products. 
The proposed rule was published in the Federal Register of September 
30, 1999 (64 FR 52696). This action is being taken in response to 
requests for an extension to allow interested parties, including State 
and local officials, additional time for review and to submit comments.

DATES: Submit written comments on the proposed rule by July 17, 2000.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Paula S. McKeever, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 30, 
1999 (64 FR 52696), FDA published a proposed rule to require 
manufacturers of human cellular and tissue-based products to screen and 
test the donors of cells and tissue used in those products for risk 
factors for and clinical evidence of relevant communicable disease 
agents and diseases. As part of that regulatory action, the agency 
proposed to amend the current good manufacturing practice regulations 
that apply to human cellular and tissue-based products regulated as 
drugs, medical devices, and/or biological products to incorporate the 
new donor-suitability procedures into existing good manufacturing 
practice regulations. Interested persons were given until December 29, 
1999, to submit written comments on the proposed rule.
    On November 19, 1999, a comment was submitted to the docket by a 
professional association requesting a 60-day extension of the comment 
period on the proposed rule. The comment requests additional time to 
allow an ad hoc group of experts assembled by the organization to 
complete the collection and analysis of scientific data on 
transmissible spongiform encephalopathies and Creutzfeld-Jakob Disease. 
The association also noted the recent publication of the proposed rule 
entitled ``Standards for Privacy of Individually Identifiable Health 
Information'' by the Department of Health and Human Services (64 FR 
59918, November 3, 1999), and requested an opportunity to evaluate the 
potential impact of that proposed rule in relation to the September 30, 
1999, proposed rule. On December 1, 1999, a second comment requested an 
extension to at least January 31, 2000.
    In addition, FDA has learned that the State of California and other 
jurisdictions have enacted legislation and issued regulations governing 
tissue donor suitability. Because those laws might conflict with 
provisions in the September 30, 1999, proposed rule, FDA has invited 
State officials to participate in this rulemaking. The agency would 
appreciate comment on: (1) The need for uniform national standards for 
donor suitability determinations to prevent communicable disease 
transmission

[[Page 20775]]

through human cellular and tissue-based products, (2) the scope of such 
proposed national requirements and their impact upon State laws, (3) 
FDA's proposal not to preempt State laws on legislative consent for 
cornea transplants, and (4) any issues raised by this proposed rule 
possibly affecting State laws and authorities. To allow sufficient time 
for this to occur, as well as to allow all interested persons 
additional time to evaluate information and submit meaningful comments, 
the agency is reopening the comment period for 90 days.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding the proposed rule by July 
17, 2000. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
proposed rule and received comments may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 10, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-9581 Filed 4-17-00; 8:45 am]
BILLING CODE 4160-01-F