[Federal Register Volume 60, Number 38 (Monday, February 27, 1995)]
[Notices]
[Pages 10592-10593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-4766]



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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