98-32744. Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products  

  • [Federal Register Volume 63, Number 237 (Thursday, December 10, 1998)]
    [Proposed Rules]
    [Pages 68212-68213]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 98-32744]
    
    
    =======================================================================
    -----------------------------------------------------------------------
    
    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    
    21 CFR Parts 207, 807, and 1271
    
    [Docket No. 97N-484R]
    RIN 0910-AB05
    
    
    Establishment Registration and Listing for Manufacturers of Human 
    Cellular and Tissue-Based Products
    
    AGENCY: Food and Drug Administration, HHS.
    
    ACTION: Proposed rule; reopening of comment period.
    
    -----------------------------------------------------------------------
    
    SUMMARY: The Food and Drug Administration (FDA) is reopening the 
    comment period for the proposed rule concerning establishment 
    registration and listing for manufacturers of human cellular and 
    tissue-based products that was published in the Federal Register of May 
    14, 1998 (63 FR 26744). FDA is taking this action in response to a 
    request for an extension and to allow interested parties additional 
    time for review and to submit comments.
    
    DATES: Submit written comments on the proposed rule by February 8, 
    1999.
    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, suite 200N, Rockville, MD 20852-
    1448, 301-827-6210.
    
    SUPPLEMENTARY INFORMATION: In the Federal Register of May 14, 1998 (63 
    FR 26744), FDA published a proposed rule to require manufacturers of 
    certain human cellular and tissue-based products to register with the 
    agency and list their products. In addition, the agency proposed to 
    amend the registration and listing regulations that currently apply to 
    human cellular and tissue-based products regulated as drugs, devices, 
    and/or biological products. Interested persons were given until August 
    12, 1998, to submit written comments on the proposed rule.
    
    [[Page 68213]]
    
        On August 6, 1998, a comment was submitted to the docket requesting 
    that the agency extend the comment period on the proposed rule 60 days. 
    The comment noted that certain information relevant to the rulemaking 
    was not included in the public docket. Because the docket was scheduled 
    to close on August 12, 1998, there was insufficient time to prepare and 
    submit a letter of extension to the docket. However, the agency agrees 
    that an additional period will provide time for interested parties to 
    review the proposed rule and information now placed in the public 
    docket and submit written comments. Therefore, the agency is reopening 
    the comment period for an additional 60 days, until February 8, 1999.
        Interested persons may, on or before February 8, 1999 submit to the 
    Dockets Management Branch (address above) written comments on the 
    proposed rule. 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 are available for 
    public examination in the Dockets Management Branch between 9 a.m. and 
    4 p.m., Monday through Friday.
    
        Dated: December 1, 1998.
    William K. Hubbard,
    Associate Commissioner for Policy Coordination.
    [FR Doc. 98-32744 Filed 12-9-98; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Published:
12/10/1998
Department:
Food and Drug Administration
Entry Type:
Proposed Rule
Action:
Proposed rule; reopening of comment period.
Document Number:
98-32744
Dates:
Submit written comments on the proposed rule by February 8, 1999.
Pages:
68212-68213 (2 pages)
Docket Numbers:
Docket No. 97N-484R
RINs:
0910-AB05: Establishment Registration and Listing of Human Cells and Tissue
RIN Links:
https://www.federalregister.gov/regulations/0910-AB05/establishment-registration-and-listing-of-human-cells-and-tissue
PDF File:
98-32744.pdf
CFR: (3)
21 CFR 207
21 CFR 807
21 CFR 1271