[Federal Register Volume 65, Number 51 (Wednesday, March 15, 2000)]
[Notices]
[Pages 13982-13983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-6283]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D-1218]


Blood Standards; Pilot Program for Licensing Gamma Irradiated 
Blood and Blood Components and ``Guidance for Industry: Gamma 
Irradiation of Blood and Blood Components;'' 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 guidance document entitled ``Guidance for Industry: 
Gamma Irradiation of Blood and Blood Components: A Pilot Program For 
Licensing,'' dated February 2000. FDA is also announcing the 
establishment of a pilot program for licensed blood product 
manufacturers seeking to market irradiated blood components in 
interstate commerce. The pilot program is intended to allow self-
certification in lieu of the submission of a detailed biologics licence 
application (BLA) supplement. FDA is initiating the pilot program to 
determine if streamlining the process of licensing will be more 
efficient and effective for both the manufacturer and FDA without 
compromising product safety, purity, and potency.

DATES: Written comments may be submitted at any time. The effective 
date for implementation of the pilot program is April 14, 2000.

ADDRESSES: Submit written requests for single copies of the guidance 
entitled ``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 (CBER), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in 
processing your requests. The guidance 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 guidance document.
    Submit written comments on the guidance document to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.
    Submit requests for participation in the pilot program to Mary Ann 
Denham at the address below.

FOR FURTHER INFORMATION CONTACT: About participation in the pilot 
program:
    Mary Ann Denham, Center for Biologics Evaluation and Research (HFM-
375), Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448, 301-827-2861.
    About this notice:
    Nathaniel L. Geary, Center for Biologics Evaluation and Research 
(HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 
200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance document entitled 
``Guidance for Industry: Gamma Irradiation of Blood and Blood 
Components: A Pilot Program For Licensing,'' dated February 2000. This 
guidance document is intended to assist manufacturers of gamma 
irradiated blood and blood components to self-certify conformance to 
specific criteria as part of a pilot program in lieu of the submission 
of a detailed BLA supplement filing. Instead of submitting a BLA 
supplement with supporting operating procedures and data derived from 
validation and quality control testing, the manufacturer may submit an 
application form (Form FDA 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 guidance document entitled ``Guidance for 
Industry: Gamma Irradiation of Blood and Blood Components: A Pilot 
Program For Licensing,'' dated February 2000, as well as written 
request to the CBER Director for an exception to filing a detailed 
supplement. The pilot program provides that FDA will review for 
completeness Form FDA 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 guidance document.
    This guidance document finalizes the draft guidance entitled 
``Guidance for Industry: Gamma Irradiation of Blood and Blood 
Components: A Pilot Program For Licensing'' that was announced in the 
Federal Register of January 27, 1999 (64 FR 4118).
    To participate in the program a manufacturer should already be 
licensed for nonirradiated blood components and should be ready for a 
prelicense inspection at the time it forwards Form FDA 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 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 will begin the pilot program on April 
14, 2000. At the end of the pilot program, FDA will evaluate the 
program for efficiency and effectiveness and will make this evaluation 
available to the public. If the program proves to be efficient and 
effective, FDA will consider extending the program to other blood 
products.
    This guidance document represents the agency's current thinking on 
gamma irradiation of blood and blood components intended for 
transfusion or for further manufacturing. It does not create or confer 
any rights for or on any person and does not operate to bind FDA or the 
public. If a manufacturer chooses to participate in this voluntary 
program, it should conform to the specific criteria set forth in this 
guidance. Manufacturers who want to use an alternative approach must 
submit a detailed BLA supplement under 21 CFR 601.12 or otherwise 
satisfy FDA that an exemption from that requirement is justified under 
21 CFR 640.120. As with other guidance documents, FDA does not intend 
this guidance document to be all-inclusive and cautions that not all 
information may be applicable to all situations.

II. Comments

    Interested persons, may at any time, submit written comments to the 
Dockets Management Branch (address above) regarding this guidance 
document. Two copies of any comments are to be submitted, except 
individuals may submit one copy. Comments should be

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identified with the docket number found in the brackets in the heading 
of this guidance document. A copy of the guidance 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 guidance 
document using the Internet. For Internet access, connect to CBER at 
http://www.fda.gov/cber/guidelines.htm.

    Dated: March 1, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-6283 Filed 3-14-00; 8:45 am]
BILLING CODE 4160-01-F