[Federal Register Volume 65, Number 138 (Tuesday, July 18, 2000)]
[Notices]
[Pages 44537-44538]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18059]



[[Page 44537]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1341]


Blood Standards; Pilot Program for Licensing and Draft ``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availability for public comment of a draft guidance document entitled 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 is announcing its intent to 
establish a pilot program for licensed manufacturers of Source Plasma 
seeking to supplement their licenses to include a Red Blood Cell 
Immunization Program (RBCIP). The pilot program is intended to allow 
self-certification in lieu of submission to FDA of a detailed biologics 
license application (BLA) supplement. The draft guidance document 
provides criteria for participating in the pilot program and for 
manufacturing, quality control, and labeling of products in an RBCIP. 
FDA intends to determine if this pilot program streamlines the process 
for licensing and is more efficient and effective without compromising 
the health of the donor or product safety, purity, and potency.

DATES: Submit written comments at any time, however, comments are to be 
submitted by September 18, 2000, to ensure their adequate consideration 
in preparation of the final document.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Guidance for Industry: CBER Pilot 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, 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, 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 on the draft 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: About participation in the pilot 
program: Mary Ann Denham, Center for Biologics Evaluation and Research 
(HFM-375), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448, 301-827-3543.
    About this notice: 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 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. The draft 
guidance document is intended to assist those manufacturers who wish to 
participate in CBER's RBCIP pilot program. CBER is proposing a pilot 
program that would allow a licensed manufacturer of Source Plasma to 
self-certify conformance to specific criteria prescribed as part of a 
pilot program in lieu of 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 would submit: (1) An application form 
(Form FDA 356h); (2) a self-certification statement that provides that 
the manufacturer is in compliance with all applicable FDA regulations 
and meets the recommended criteria for RBCIP using immunogen Red Blood 
Cells obtained from an outside supplier, set forth in 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; and (3) a 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 in the draft guidance document. To participate in 
the program a manufacturer of Source Plasma must: (1) Hold an 
unsuspended and unrevoked biologics license for Source Plasma; (2) seek 
to supplement the license to include a RBCIP; (3) plan to use immunogen 
Red Blood Cells (IRBC), already thawed and deglycerolized, obtained per 
written agreement from an outside supplier; and (4) have identified an 
outside supplier of IRBC who holds an unsuspended and unrevoked 
biologics license for Source Plasma that already includes CBER's 
authorization for a RBCIP. The manufacturer should be ready for a 
prelicense inspection at the time it forwards Form FDA 356h, self-
certification, and a 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 in 
interstate commerce Source Plasma from donors immunized with IRBC 
obtained from an outside supplier.
    If there is adequate interest in the pilot program, FDA will 
announce its implementation in the Federal Register and will conduct 
the pilot program for approximately 1 year. At the end of the pilot 
program period, FDA will evaluate the pilot program for efficiency and 
effectiveness. If the pilot program proves to be efficient and 
effective without compromising the health of the donor or product 
safety, purity, or potency, FDA intends to permit qualified 
manufacturers of Source Plasma to continue with the self-certification 
option. FDA is also announcing 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. At this 
time, the draft guidance document is

[[Page 44538]]

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 draft guidance document is being issued as a 
draft level 1 guidance document consistent with the GGP's.
    This draft guidance document represents the agency's current 
thinking on immunization of Source Plasma donors using IRBC obtained 
from an outside supplier. It does not create or confer any rights for 
or on any person and does not operate to bind FDA or the public. 
However, manufacturers should conform to the specific criteria set 
forth in this draft guidance document for voluntary participation in 
this program. 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 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

    This draft guidance document is being distributed for comment 
purposes only and is not intended for implementation at this time. CBER 
intends to revise this draft guidance document based on comments 
received from the public. 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 are to be 
submitted by September 18, 2000, to ensure adequate consideration in 
preparation of the final 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.

    Dated: July 5, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-18059 Filed 7-17-00; 8:45 am]
BILLING CODE 4160-01-F