[Federal Register Volume 66, Number 133 (Wednesday, July 11, 2001)]
[Notices]
[Pages 36287-36288]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-17254]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1341]


``Guidance for Industry: CBER Pilot Licensing Program for 
Immunization of Source Plasma Donors Using Immunogen Red Blood Cells 
Obtained from an Outside Supplier;'' 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 document entitled ``Guidance for Industry: CBER Pilot 
Licensing Program for Immunization of Source Plasma Donors Using 
Immunogen Red Blood Cells Obtained from an Outside Supplier'' dated 
July 2001. The guidance document is intended to assist manufacturers of 
Source Plasma who wish to participate in the Center for Biologics 
Evaluation and Research (CBER) pilot program for Red Blood Cell 
immunization. The pilot program would allow a licensed manufacturer of 
Source Plasma to self-certify conformance to specific criteria and 
recommendations described by CBER in the guidance document in lieu of 
submission of a detailed biologics license application supplement 
filing. The guidance document announced in this notice finalizes the 
draft guidance document entitled ``Guidance for Industry: CBER Pilot 
Licensing Program for Immunization of Source Plasma Donors Using 
Immunogen Red Blood Cells Obtained from an Outside Supplier'' dated 
June 2000.

DATES: Submit written comments on agency guidances at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the

[[Page 36288]]

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 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.

FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, 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 document entitled 
``Guidance for Industry: CBER Pilot Licensing Program for Immunization 
of Source Plasma Donors Using Immunogen Red Blood Cells Obtained from 
an Outside Supplier'' dated July 2001. The guidance document is 
intended to assist those applicants who qualify and wish to participate 
in CBER's Red Blood Cells Immunization Program (RBCIP) pilot. A 
manufacturer is qualified if it: (1) Holds an unsuspended and unrevoked 
biologics license for Source Plasma, (2) seeks to supplement the 
license to include an RBCIP, (3) plans to use already thawed and 
deglycerolized Immunogen Red Blood Cells (IRBC) from an outside 
supplier, and (4) has identified an outside supplier of IRBC who holds 
an unsuspended and unrevoked biologics license for Source Plasma that 
already includes CBER's authorization for an RBCIP.
    In the Federal Register of July 18, 2000 (65 FR 44537), FDA 
announced the availability of a draft guidance document entitled 
``Guidance for Industry: CBER Pilot Licensing Program for Immunization 
of Source Plasma Donors Using Immunogen Red Blood Cells Obtained from 
an Outside Supplier'' dated June 2000. FDA received no comments from 
the public on this draft guidance document. The guidance document 
announced in this notice finalizes the draft guidance document with 
minor editorial changes.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115; 65 FR 56468, September 19, 2000). 
This guidance document represents the agency's current thinking on a 
pilot program specific to the immunization of Source Plasma donors 
using IRBC obtained from an outside supplier, either from an outside 
manufacturer, under a contractural agreement, or from an outside 
facility under the same managerial control as the applicant facility. 
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 
statutes and regulations.

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 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 or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: June 27, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-17254 Filed 7-10-01; 8:45 am]
BILLING CODE 4160-01-S