01-17254. ``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.

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 The guidance document announced in this notice finalizes the draft guidance document entitled “Guidance for Industry: CBER Pilot Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained from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 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.