[Federal Register: April 14, 2006 (Volume 71, Number 72)]
[Notices]
[Page 19524-19525]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14ap06-54]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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