[Federal Register Volume 71, Number 72 (Friday, April 14, 2006)]
[Notices]
[Pages 19524-19525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-5528]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0206]


Guidance for Industry on Exocrine Pancreatic Insufficiency Drug 
Products--Submitting New Drug Applications; 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 guidance for industry entitled ``Exocrine Pancreatic 
Insufficiency Drug Products--Submitting NDAs.'' This guidance is 
intended to assist manufacturers of exocrine pancreatic insufficiency 
drug products in preparing and submitting documentation to meet new 
drug application (NDA) requirements for the drug products.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to 
assist that

[[Page 19525]]

office in processing your requests. Submit written comments on the 
guidance to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.

FOR FURTHER INFORMATION CONTACT: Maureen Dewey, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 5195, Silver Spring, MD 20993-0002, 301-
796-0845.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Exocrine Pancreatic Insufficiency Drug Products--Submitting 
NDAs.'' On April 28, 2004 (69 FR 23410), FDA announced that all 
exocrine pancreatic insufficiency drug products are new drugs and that 
manufacturers who wish to continue to market these products must submit 
applications as required by section 505 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 355) and 21 CFR part 314. The Federal 
Register announcement stated that FDA is prepared to accept NDAs for 
these products, including applications submitted under section 
505(b)(2) of the act. This guidance is intended to assist manufacturers 
of currently marketed exocrine pancreatic insufficiency drug products 
in preparing and submitting documentation to meet NDA requirements for 
the drug products.
    Also on April 28, 2004 (69 FR 23414), FDA announced the 
availability of the draft version of this guidance. A number of 
comments were received, and the agency considered them carefully as it 
finalized the guidance. Although the guidance has not changed 
substantially, the following changes are noteworthy: (1) In the 
Background section, the scope of the guidance was clarified; (2) in the 
Chemistry, Manufacturing, and Controls section, several items were 
further explained; (3) in the Nonclinical Pharmacology and Toxicology 
section, two points were additionally clarified; (4) in the Safety 
subsection, the recommended dosage was updated; and (5) in the 
References section, two additional references were added and one 
reference was deleted.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on submitting NDAs for exocrine pancreatic 
insufficiency drug products. 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 
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management 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 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: April 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-5528 Filed 4-13-06; 8:45 am]
BILLING CODE 4160-01-S