[Federal Register Volume 66, Number 164 (Thursday, August 23, 2001)]
[Notices]
[Pages 44356-44357]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-21246]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0278]


Draft ``Guidance for Industry: Submitting Type V Drug Master 
Files to the Center for Biologics Evaluation and Research;'' 
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 draft document entitled ``Guidance for Industry: 
Submitting Type V Drug Master Files to the Center for Biologics 
Evaluation and Research '' dated August 2001. The draft guidance 
document discusses Type V Drug Master Files (DMF) submitted to the 
Center for Biologics Evaluation and Research (CBER). The draft guidance 
document describes the circumstances in which CBER will accept a Type V 
Drug Master File without a letter of intent from the DMF holder. The 
information in the DMF may be used to support an application or 
supplement, such as an investigational new drug application (IND), 
biologics license application (BLA), or a new drug application (NDA) 
submitted to CBER.

DATES: Submit written or electronic comments on the draft guidance to 
ensure their adequate consideration in preparation of the final 
document by November 21, 2001. General comments on agency guidance 
documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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electronic access to the draft guidance document.
    Submit written comments on the document to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, 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 document entitled 
``Guidance for Industry: Submitting Type V Drug Master Files to the 
Center for Biologics Evaluation and Research '' dated August 2001. The 
draft guidance document discusses Type V DMFs submitted to CBER. The 
draft guidance document describes the circumstances in which CBER will 
accept a Type V DMF without a letter of intent to FDA from the DMF 
holder. A drug master file is a submission of information to FDA that 
may be used to provide confidential detailed information about 
facilities, processes, or articles used in the manufacturing, 
processing, packaging, and storing of human drugs and biological 
products. The information in the DMF may be used to support an 
application or supplement, such as an IND, BLA, or an NDA.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115; 65 FR 56468, September 
19, 2000). The

[[Page 44357]]

draft guidance document represents the agency's current thinking on 
submitting Type V Drug Master Files to CBER. 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

    The draft document is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Dockets Management Branch (address above) written 
comments regarding this draft guidance document. Submit written or 
electronic comments to ensure adequate consideration in preparation of 
the final document by November 21, 2001. 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: August 13, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-21246 Filed 8-22-01; 8:45 am]
BILLING CODE 4160-01-S