[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.

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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availability of a draft guidance document entitled ``Guidance for 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 The draft guidance document applies to the 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 The draft guidance document, when 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INFORMATION section for electronic access to the draft guidance 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