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availability of a draft guidance document entitled ``Guidance for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 The draft guidance document applies to the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 The draft guidance document, when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INFORMATION section for electronic access to the draft guidance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