[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comment of a draft guidance document entitled ``Guidance for Industry: 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set forth in the draft guidance document entitled ``Guidance for 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DATES: Written comments on the proposed pilot program and draft 
guidance document may be submitted at any time, however, comments 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