[Federal Register: July 11, 2001 (Volume 66, Number 133)]
[Notices]
[Page 36287-36288]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11jy01-102]
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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draft guidance document entitled ``Guidance for Industry: CBER Pilot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