[Federal Register Volume 64, Number 17 (Wednesday, January 27, 1999)]
[Notices]
[Pages 4118-4119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1794]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-1218]
Blood Standards; Pilot Program for Gamma Irradiated Blood and
Blood Components and Draft ``Guidance for Industry: Gamma Irradiation
of Blood and Blood Components: A Pilot Program for Licensing;''
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing its
intent to establish a pilot program for licensed blood product
manufacturers seeking to market irradiated blood components in
interstate commerce. FDA is also announcing the availability for public
comment of a draft guidance document entitled ``Guidance for Industry:
Gamma Irradiation of Blood and Blood Components: A Pilot Program for
Licensing.'' FDA is proposing a pilot program that would allow a
manufacturer to self-certify conformance to specific criteria as a
substitute for the Center for Biologics Evaluation and Research (CBER)
review of information submitted in a biologics license application
(BLA) supplement filing. Instead of submitting a BLA supplement with
supporting operating procedures and data derived from validation and
quality control testing, the manufacturer would submit an application
form (FDA Form 356h), a self-certification statement that provides that
the manufacturer is in compliance with all applicable FDA regulations
and meets the criteria for gamma irradiated blood and blood components
set forth in the draft guidance document entitled ``Guidance for
Industry: Gamma Irradiation of Blood and Blood Components: A Pilot
Program for Licensing,'' as well as written request to the CBER
Director for an exception to filing a detailed supplement. This action
is part of FDA's continuing effort to achieve the objectives of the
President's ``Reinventing Government'' initiatives and is intended to
reduce unnecessary burdens for industry without diminishing public
health protection.
DATES: Written comments on the proposed pilot program and draft
guidance document may be submitted at any time, however, comments
should be submitted by April 27, 1999, to ensure their adequate
consideration in preparation of the final document and for the
initiation of the pilot program.
ADDRESSES: Submit written requests for single copies of ``Guidance for
Industry: Gamma Irradiation of Blood and Blood Components: A Pilot
Program for Licensing'' to the Office of Communication, Training, and
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and
Research, 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 and letters of interest on the proposed
pilot program and the draft guidance document to the Dockets Management
Branch (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Steven F. Falter, 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 its intent to launch a pilot program for licensed
blood product manufacturers seeking to market irradiated blood
components in interstate commerce. The pilot program provides that FDA
will review for completeness FDA Form 356h, the self-certification, and
written request for an exception to filing a detailed supplement and at
FDA discretion will schedule a prelicense inspection within 90 days of
receipt of the self-certification to confirm conformance with
applicable Federal regulations and the recommended criteria contained
in the draft guidance document.
To participate in the program a manufacturer must already be
licensed for nonirradiated blood components and should be ready for a
prelicense inspection at the time it forwards FDA Form 356h, self-
certification, and request for exception to FDA. If, during the
prelicense inspection, FDA finds significant deficiencies in quality
assurance, manufacturing facilities, or product safety, purity,
potency, or effectiveness, FDA may withdraw the manufacturer from the
pilot program and the manufacturer will be required to submit a BLA
supplement with complete supporting documentation
[[Page 4119]]
prior to marketing irradiated blood components in interstate commerce.
FDA intends the pilot program to span approximately 1 year, but the
actual length of the program depends on the number of manufacturers
participating in the program. FDA intends to begin the pilot program 30
days after a final notice announcing the initiation of the program and
the availability of the final guidance document is published in the
Federal Register. At the end of the pilot program, FDA will evaluate
the program for efficiency and effectiveness. FDA will make this
analysis available to the public upon its completion. If the program
proves to be efficient and effective, FDA will consider extending the
program to other blood products.
FDA also is announcing the availability of a draft guidance
document entitled ``Guidance for Industry: Gamma Irradiation of Blood
and Blood Components: A Pilot Program for Licensing.'' This draft
guidance document is intended to help manufacturers of irradiated blood
components comply with the regulations in Title 21 of the Code of
Federal Regulations and to provide criteria acceptable for the
manufacture of irradiated blood components. At this time, the draft
guidance document is being made available for comment purposes only and
is not intended for use by the industry. The agency has adopted good
guidance practices (GGP's) that set forth the agency's policies and
procedures for the development, issuance, and use of guidance documents
(62 FR 8961, February 27, 1997). This document is being issued as a
draft level 1 guidance document consistent with GGP's.
This draft guidance document represents the agency's current
thinking with regard to gamma irradiation of blood and blood components
intended for transfusion. 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
requirements 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
FDA is soliciting the following from the public: (1) Comments on
the draft guidance document, (2) comments concerning the public's
interest in a pilot program that would allow licensure by self-
certification, a written request for exception to filing a detailed
supplement, and an inspection in lieu of a complete application review,
and (3) letters of interest from manufacturers who would consider
participating in the pilot program.
The 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 and the
pilot program, including those comments expressing interest in
participating in the pilot program. Written comments may be submitted
at any time, however, comments should be submitted by April 27, 1999,
to ensure adequate consideration in preparation of the final document
and the pilot program. Two copies of any comments are to be submitted,
except that 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 by
using the World Wide Web (WWW). For WWW access, connect to CBER at
``http://www.fda.gov/cber/guidelines.htm''.
Dated: January 20, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-1794 Filed 1-26-99; 8:45 am]
BILLING CODE 4160-01-F
