[Federal Register Volume 69, Number 82 (Wednesday, April 28, 2004)]
[Notices]
[Page 23414]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-9653]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0206]


Draft Guidance for Industry on Exocrine Pancreatic Insufficiency 
Drug Products--Submitting New Drug Applications; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Exocrine 
Pancreatic Insufficiency Drug Products--Submitting NDAs.'' Elsewhere in 
this issue of the Federal Register, FDA is announcing that all exocrine 
pancreatic insufficiency drug products are new drugs requiring approved 
new drug applications (NDAs) for marketing. This draft guidance is 
intended to aid sponsors of exocrine insufficiency drug products in 
submitting NDAs for the drug products.

DATES: Submit written or electronic comments on the draft guidance by 
June 28, 2004. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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 office in processing your requests. Submit written comments 
on the draft guidance to the Division of Dockets Management (HFA-305), 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access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Monika Houstoun, Center for Drug 
Evaluation and Research (HFD-180), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-7310.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Exocrine Pancreatic Insufficiency Drug Products--Submitting 
NDAs.'' Elsewhere in this issue of the Federal Register, FDA is 
announcing that all exocrine pancreatic insufficiency drug products are 
new drugs. The document states 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 document states that FDA is 
prepared to accept NDAs for these products, including applications 
submitted under section 505(b)(2) of the act. This draft guidance is 
intended to assist manufacturers of exocrine pancreatic insufficiency 
drug products in preparing and submitting documentation to meet NDA 
requirements for the drug products.
    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the agency's current thinking on issues 
concerning applications, including applications under section 505(b)(2) 
of the act, 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 on the draft guidance. 
Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments or two paper copies of any written 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. The draft guidance and 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 15, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-9653 Filed 4-27-04; 8:45 am]
BILLING CODE 4160-01-S