Revised FDA Form 3210 Application for Establishment License for Manufacture of Biological Products (4/94); Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 94D-0386]

Revised FDA Form 3210 Application for Establishment License for

Manufacture of Biological Products (4/94); 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 the revised FDA Form 3210 Application for Establishment

License for Manufacture of Biological Products (4/94). This form

replaces the previous edition of FDA Form 3210 (12/88). FDA Form 3210

is used by manufacturers to apply for licensure of a facility for the

manufacture of biological products regulated under the Public Health

Service Act. The form has been revised because of inadequacies in the

previous form that resulted in requests by the agency for supplemental

information. The revised form is intended to shorten review time and

decrease expenditure of resources for both the agency and industry.

DATES: FDA will continue to accept submissions using the previous Form

3210 (12/88) until August 28, 1995.

FOR FURTHER INFORMATION CONTACT: Timothy W. Beth, Center for Biologics

Evaluation and Research (HFM-635), Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852-1448, 301-594-3074.

ADDRESSES: Submit written requests for single copies of the revised FDA

Form 3210 Application for Establishment License for Manufacture of

Biological Products (4/94) to Division of Congressional and Public

Affairs (HFM-11), Center for Biologics Evaluation and Research (CBER),

Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-

1448, 301-594-1800. Requests should be identified with the docket

number found in brackets in the heading of this document. Send two

self-addressed adhesive labels to assist that office in processing your

requests. The form may also be obtained by calling the CBER FAX

Information System at 301-594-1939 from a FAX machine with a touch tone

phone attached or built in. FDA Form 3210 Application for Establishment

License for Manufacture of Biological Products (4/94) is available for

public examination in the Dockets Managements Branch (HFA-305), Food

and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD

20857, between 9 a.m. and 4 p.m., Monday through Friday.

SUPPLEMENTARY INFORMATION: FDA is making available revised FDA Form

3210 Application for Establishment License for Manufacture of

Biological Products (4/94). The form was revised due to inadequacies in

the old form which made the application review process cumbersome and

difficult for both the agency and industry. In the past, the review

process was often significantly lengthened because of requests by the

agency for supplemental information from the manufacturer in order to

ensure the safety, purity, potency, and efficacy of manufactured

biological products. The revised form details more specifically the

information that is required for establishment licensure. FDA believes

that the revised form will expedite the review process by reducing the

need for supplemental information requests and responses.

The revised form solicits information from the manufacturer in the

following areas: (1) General information (names and addresses); (2)

water systems; (3) heating ventilation and air conditioning systems;

(4) raw materials and ancillary facilities; (5) source materials; (6)

propagation of host systems; (7) intermediate processing; (8)

formulation and final product preparation; (9) computer systems; (10)

support areas; (11) quality control areas; (12) animal facilities for

testing; (13) animal facilities for production; (14) calibration and

validation; and (15) records.

In addition, the revised form also requires the following

information to be submitted: A description of the lot numbering system,

an organizational chart, an environmental assessment report, written

agreements, curriculum vitae for key manufacturing and responsible

personnel, and an overview of the current good manufacturing practices

(CGMP) training program. A comments section is provided on the revised

form for additional information that the manufacturer deems to be

appropriate but may not be covered under other sections.

Manufacturers preparing to submit applications for establishment

licensure should now utilize the revised (4/94) form. FDA will continue

to accept submissions using the previous (12/88) form until August 28,

1995. Because the old form does not address specific questions and

issues that are present on the revised form, additional review cycles

should be anticipated when using the previous form.

Under the Paperwork Reduction Act of 1980 (Pub. L. 96-511) all

forms requesting a collection of information [[Page 10593]] on

identical items from 10 or more public respondents must be approved by

the Office of Management and Budget (OMB) and must display a valid OMB

control number and expiration date.

In accordance with the Paperwork Reduction Act, in the Federal

Register of February 4, 1994 (59 FR 5436), a notice announced the

proposed revision of FDA Form 3210 Application For Establishment

License for Manufacture of Biological Products. OMB approval for the

revised FDA Form 3210 was obtained on April 30, 1994, and given OMB

approval number 0910-0124; expiration date April 30, 1997.

Dated: February 17, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95-4766 Filed 2-24-95; 8:45 am]

BILLING CODE 4160-01-F