[Federal Register Volume 67, Number 217 (Friday, November 8, 2002)]
[Notices]
[Page 68142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-28472]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99N-2912]
Final Guidance for Industry on the Development of Supplemental
Applications for Approved New Animal Drugs; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a final guidance for industry ([numsign]82) entitled
``Guidance for Industry: Development of Supplemental Applications for
Approved New Animal Drugs.'' This guidance explains how and when drug
sponsors may use data collected for original new animal drug
applications (NADAs) to support the technical sections of a
supplemental NADA. The guidance also explains when the Center may,
under existing statutes or regulations, require the submission of new
data. Finally, the guidance delineates the instances in which a sponsor
will generally need to file a new NADA rather than a supplemental
application.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of the final
guidance to the Communications Staff (HFV-12), Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855. Send one self-addressed adhesive label to assist that office
in processing your requests. Submit written comments on the final
guidance 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. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
final guidance document.
FOR FURTHER INFORMATION CONTACT: Marilyn N. Martinez, Office of New
Animal Drug Evaluation (HFV-130), Center for Veterinary Medicine, Food
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-
827-7577, e-mail: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
On November 21, 1997, the Food and Drug Administration
Modernization Act (FDAMA) (Public Law 105-115) was signed into law.
Section 403 of FDAMA requires FDA to provide information regarding
approval of supplemental applications for approved products.
Section 403(b)(2) of FDAMA requires that FDA issue guidance on
specific data requirements for supplemental NADAs in order to prevent
duplication of previously submitted data. In the Federal Register of
February 8, 2000 (65 FR 6214), FDA announced the availability of a
draft guidance for industry entitled ``Guidance for Industry:
Development of Supplemental Applications for Approved New Animal
Drugs.'' The draft guidance illustrated the various types of
supplemental applications and their dependence on new data. This draft
guidance explained how and when drug sponsors could use data accepted
in support of an original application to support supplemental
applications. The draft guidance also explained when a sponsor should
submit a new NADA rather than a supplemental NADA. The agency received
no comments on the draft guidance. The content of the final guidance is
the same as the draft.
``Guidance for Industry: Development of Supplemental Applications
for Approved New Animal Drugs'' demonstrates the agency's dedication to
assisting the sponsor in creating a project development strategy and to
fostering a discussion between the sponsor and the agency. With this in
mind, the guidance is organized in a user-friendly format with two
distinctive sections. The first section separates supplemental
applications into two categories: Category I includes applications that
do not ordinarily require additional data and category II includes
applications that may require additional data. The guidance then lists
the 14 types of supplemental applications in each category as well as
the instances in which a sponsor generally will need to file a new NADA
rather than a supplemental NADA.
The second section is dedicated to clarification of category II
supplemental applications and the data to meet the technical section
requirements. The data CVM would recommend be submitted for each
category II supplement are provided in tables. The tables indicate if:
(1) New data will generally be needed, (2) existing data included in a
previously approved application will generally suffice, or (3) the
nature of the supplemental application will dictate whether or not new
data are generally needed. A comment section follows each table
providing explanations and suggestions to the sponsor. The guidance
also cross-references several FDA documents relating to the processing
of supplemental applications, providing further assistance to the
sponsor.
This final level 1 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 the development of
supplemental applications for approved new animal drugs. 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
As with all of FDA's guidances, the public is encouraged to submit
written or electronic comments pertinent to this guidance. FDA will
periodically review the comments in the docket and, where appropriate,
will amend the guidance. The agency will notify the public of any such
amendments through a notice in the Federal Register.
Interested persons may submit to the Dockets Management Branch (see
ADDRESSES) written or electronic comments on this final guidance at any
time. Two copies of any comments are to be submitted, except that
individuals may submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this document. The
final guidance 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/cvm.
Dated: October 10, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-28472 Filed 11-7-02; 8:45 am]
BILLING CODE 4160-01-S