99-34039. Draft ``Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture;'' Availability  

  • [Federal Register Volume 65, Number 1 (Monday, January 3, 2000)]
    [Notices]
    [Pages 134-135]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 99-34039]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    [Docket No. 99D-5046]
    
    
    Draft ``Guidance for Industry: Changes to an Approved 
    Application: Biological Products: Human Blood and Blood Components 
    Intended for Transfusion or for Further Manufacture;'' Availability
    
    AGENCY: Food and Drug Administration, HHS.
    
    ACTION: Notice.
    
    -----------------------------------------------------------------------
    
    SUMMARY: The Food and Drug Administration (FDA) is announcing the 
    availability of a draft guidance document entitled ``Guidance for 
    Industry: Changes to an Approved Application: Biological Products: 
    Human Blood and Blood Components Intended for Transfusion or for 
    Further Manufacture.'' The draft guidance document applies to the 
    manufacture of all licensed Whole Blood, blood components, Source 
    Plasma, and Source Leukocytes. The draft guidance document, when 
    finalized, is intended to assist manufacturers in determining which 
    reporting mechanism is appropriate for a change to an approved license 
    application for Whole Blood, blood components, Source Plasma, and 
    Source Leukocytes.
    
    DATES: Submit written comments at any time, however, comments should be 
    submitted by April 3, 2000, to ensure their adequate consideration in 
    preparation of the final document.
    
    ADDRESSES: Submit written requests for single copies of ``Guidance for 
    Industry: Changes to an Approved Application: Biological Products: 
    Human Blood and Blood Components Intended for Transfusion or for 
    Further Manufacture'' to the Office of Communication, Training, and 
    Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and 
    Research (CBER), Food and Drug Administration, 1401 Rockville Pike, 
    Rockville, MD 20852-1448. Send one self-addressed adhesive label to 
    assist the office in processing your requests. The document may also be 
    obtained by mail by calling the CBER Voice Information System at 1-800-
    835-4709 or 301-827-1800, or by fax by calling the FAX Information 
    System at 1-888-CBER-FAX or 301-827-3844. See the SUPPLEMENTARY 
    INFORMATION section for electronic access to the draft guidance 
    document.
         Submit written comments on the document to the Dockets Management 
    Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
    1061, Rockville, MD 20852.
    
    FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for 
    Biologics Evaluation and Research (HFM-17), Food and Drug 
    Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
    6210.
    
    SUPPLEMENTARY INFORMATION:
    
     I. Background
    
         FDA is announcing the availability of a draft guidance document 
    entitled ``Guidance for Industry: Changes to an Approved Application: 
    Biological Products: Human Blood and Blood Components Intended for 
    Transfusion or for Further Manufacture.'' The draft guidance document 
    is intended to assist licensed manufacturers in determining which 
    reporting mechanism is appropriate for a change to an approved license 
    application for Whole Blood, blood components, Source Plasma, and 
    Source Leukocytes. Recommendations are provided for postapproval 
    changes in product, labeling, production process, quality controls, 
    equipment, and facilities.
         In the Federal Register of July 24, 1997 (62 FR 39890), FDA 
    published the final rule entitled ``Changes to an Approved 
    Application.'' The final rule amended the biologics regulations in 
    Sec. 601.12 (21 CFR 601.12) to reduce unnecessary reporting burdens on 
    applicants licensed to manufacture biological products under the Public 
    Health Service Act. Under Sec. 601.12, a change to an approved product, 
    labeling, production process, quality controls, equipment, or 
    facilities is required to be reported to FDA in the following manner: 
    (1) A supplement requiring approval prior to distribution; (2) a 
    supplement submitted at least 30 days prior to distribution of the 
    product made using the change; or (3) an annual report, depending on 
    its potential to have an adverse effect on the identity, strength, 
    quality, purity, or potency of the biological product as they may 
    relate to the safety or effectiveness of the product. In addition, FDA 
    made available a guidance document entitled ``Guidance for Industry: 
    Changes to an Approved Application: Biological
    
    [[Page 135]]
    
    Products'' published in the Federal Register of July 24, 1997 (62 FR 
    39904).
         On December 2, 1997 (62 FR 56193, October 29, 1997), CBER held a 
    public workshop entitled ``Workshop on the Biologics License 
    Application (BLA) for Blood Products, and Reporting Changes to an 
    Approved Application.'' The workshop was intended for firms that 
    manufacture licensed human blood products, including products for 
    transfusion and source materials for further manufacture. The workshop 
    discussion focused on the application procedures, forms, and 
    documentation needed for the BLA and how changes to an approved 
    application are to be reported to FDA.
         In response to comments received from industry requesting guidance 
    specifically for blood and blood components, CBER has developed the 
    draft guidance document for the manufacturers of licensed Whole blood 
    and blood components intended for transfusion and for further 
    manufacture into both injectable and noninjectable products. The draft 
    guidance document, when finalized, will replace the recommendations in 
    the ``Guidance for Industry: Changes to an Approved Application: 
    Biological Products'' for Whole Blood, blood components, Source Plasma, 
    and Source Leukocytes. The ``Guidance for Industry: Changes to an 
    Approved Application: Biological Products'' remains applicable for all 
    other biological products.
         This draft guidance document represents the agency's current 
    thinking on changes to an approved application for all licensed human 
    blood and blood components intended for transfusion or for further 
    manufacture. It does not create or confer any rights for or on any 
    person and does not operate to bind FDA or the public. An alternative 
    approach may be used if such approach satisfies the requirement of the 
    applicable statute, regulations, or both. As with other guidance 
    documents, FDA does not intend this document to be all-inclusive and 
    cautions that not all information may be applicable to all situations. 
    The document is intended to provide information and does not set forth 
    requirements.
    
     II. Comments
    
         This draft guidance document is being distributed for comment 
    purposes only, and is not intended for implementation at this time. 
    Interested persons may submit to the Dockets Management Branch (address 
    above) written comments regarding this draft guidance document. Submit 
    written comments at any time, however, comments should be submitted by 
    April 3, 2000, to ensure adequate consideration in preparation of the 
    final document. Two copies of any comments are to be submitted, except 
    individuals may submit one copy. Comments should be identified with the 
    docket number found in the brackets in the heading of this document. A 
    copy of the document and received comments are available for public 
    examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
    Monday through Friday.
    
     III. Electronic Access
    
         Persons with access to the Internet may obtain the document at 
    http://www.fda.gov/cber/guidelines.htm.
    
        Dated: December 22, 1999.
    Margaret M. Dotzel,
    Acting Associate Commissioner for Policy.
    [FR Doc. 99-34039 Filed 12-30-99; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Published:
01/03/2000
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
99-34039
Dates:
Submit written comments at any time, however, comments should be submitted by April 3, 2000, to ensure their adequate consideration in preparation of the final document.
Pages:
134-135 (2 pages)
Docket Numbers:
Docket No. 99D-5046
PDF File:
99-34039.pdf