[Federal Register Volume 65, Number 26 (Tuesday, February 8, 2000)]
[Notices]
[Pages 6214-6216]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-2767]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N-2912]


Review of Supplemental Applications for Approved New Animal 
Drugs; Center Responsibility and Standards for Prompt Review; 
Availability of Draft Guidance

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  As required by the Food and Drug Administration Modernization 
Act of 1997 (FDAMA), the Food and Drug Administration's (FDA) Center 
for Veterinary Medicine (CVM) is making available information regarding 
the approval of supplemental applications for approved new animal 
drugs. CVM is publishing standards for the prompt review of 
supplemental applications and referencing an existing guidance that 
describes how supplemental applications may qualify for priority 
review. CVM is also designating an

[[Page 6215]]

individual within the Center who is responsible for encouraging the 
prompt review of supplemental applications and for working with 
sponsors to facilitate the development and submission of data to 
support supplemental applications. Further, CVM is describing its 
efforts to collaborate with other organizations and persons to identify 
published and unpublished studies that may support supplemental 
applications and to encourage sponsors to submit supplemental 
applications based on such studies. In addition, CVM is announcing the 
availability of a draft guidance entitled ``Guidance for Industry: 
Development of Supplemental Applications for Approved New Animal 
Drugs.'' This draft guidance explains how drug sponsors can use data 
submitted in support of an original application to support supplemental 
applications.

DATES:  Written comments should be submitted by May 8, 2000. Written 
comments on the existing guidance entitled ``CVM's Program Policy and 
Procedures Guide 1240.3135,'' which describes how supplemental 
applications qualify for priority review, may be submitted at any time.

ADDRESSES:  Submit written requests for single copies of ``Guidance for 
Industry: Development of Supplemental Applications for Approved New 
Animal Drugs'' or ``CVM's Program Policy and Procedures Guide 
1240.3135'' to the Communications Staff (HFV-12), Center for Veterinary 
Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, 
MD 20855. Send one self-addressed adhesive label to assist that office 
in processing your request. Copies of the draft guidance and the 
existing guidance may be obtained on the Internet at http://www.fda.gov/cvm.
    Submit written comments on the draft guidance, ``Guidance for 
Industry: Development of Supplemental Applications for Approved New 
Animal Drugs'' to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit written comments on CVM's ``Program Policy and Procedures Guide 
1240.3135'' to the Policy and Regulations Team (HFV-6), Center for 
Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, 
Rockville, MD 20855.

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 Place, Rockville, MD 20855, 301-
827-7577.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 403 of the FDAMA (Pub. L. 105-115) instructs FDA to provide 
certain information regarding approval of supplemental applications for 
approved products. Among other things, section 403 requires that FDA do 
the following: (1) Section 403(a) requires that the agency publish 
standards for the prompt review of supplemental applications; (2) 
section 403(b)(1) requires that FDA provide guidance to ``clarify 
circumstances in which published matter may be the basis for the 
approval of a supplemental application''; (3) section 403(b)(2) 
requires that FDA provide guidance that specifies ``data requirements 
that will avoid duplication of previously submitted data by recognizing 
the availability of data previously submitted in support of an original 
application.'' (4) section 403(b)(3) requires that FDA provide guidance 
that defines supplemental applications that are eligible for priority 
review; (5) section 403(c) requires that FDA designate an individual 
within each Center to be responsible for encouraging the prompt review 
of supplemental applications and working with sponsors to facilitate 
development and submission of data to support supplemental 
applications; and (6) section 403(d) requires the implementation of 
programs and policies to foster collaboration between FDA and other 
organizations and persons to identify published and unpublished studies 
that might support supplemental applications and to encourage sponsors 
to submit supplemental applications based on such studies.
    This document and the guidance documents discussed in it fulfill 
the requirements of section 403(a), (b)(2), (b)(3), and (c). This 
document also discusses FDA's continuing efforts at collaboration as 
required by section 403(d). Section 403(b)(1) will be addressed in a 
future Federal Register notice.

II. Section 403(a): Standards

    Section 403(a) of FDAMA requires that FDA publish ``standards for 
the prompt review of supplemental applications submitted for approved 
articles * * *.'' The legislative history of this section indicates 
that these performance standards should cover supplements submitted for 
changes in product use.
    Section 512(c)(1) of the Food, Drug, and Cosmetic Act (the act) (21 
U.S.C. 360b(c)(1))sets a 180-day time frame for review of new animal 
drug applications (NADA's). This time frame applies to all 
applications, including supplements to approved applications.
    The agency intends to use the performance goals set forth in the 
fiscal year (FY) 2001 performance plan to fulfill the requirement of 
the FDAMA that it establish standards for the prompt review of efficacy 
supplements. In FY 2000, the agency's goal is to review and act on 65 
percent of NADA's and abbreviated new animal drug applications 
(ANADA's), including supplemental applications, within 180 days of 
receipt. For FY 2001, the goal is 70 percent.
    To facilitate prompt reviews, CVM encourages sponsors of 
supplemental applications to work closely with CVM personnel through 
presubmission conferences or other means to aid CVM in assuring that 
supplemental applications are reviewed promptly.

III. Section 403(b)(2)(i): Specify Data Requirements That Will 
Avoid Duplication of Previously Submitted Data by Recognizing the 
Availability of Data Previously Submitted in Support of an Original 
Application

    CVM has developed and is announcing the availability of a draft 
guidance, ``Guidance for Industry: Development of Supplemental 
Applications for Approved New Animal Drugs'' that represents the 
agency's current thinking. The Center designates two categories of 
supplemental new animal drug applications (NADA's), Category I and 
Category II. Ordinarily, for Category I supplemental NADA's, FDA does 
not require a reevaluation of any of the safety or effectiveness data 
in the parent application. For Category II supplemental NADA's, FDA may 
ordinarily require drug sponsors to submit new data. Therefore, the 
Center may be required to reevaluate certain safety or effectiveness 
data in the original application. The draft guidance lists the types of 
supplemental NADA's that fall into each of the categories, and it 
provides an overview of issues that drug sponsors should consider with 
respect to safety and effectiveness data and data supporting the 
environmental and manufacturing controls technical sections when 
seeking the approval of Category II supplemental NADA's.
    The draft guidance is organized by type of Category II supplement. 
For each type (e.g., a change in the amount of drug administered per 
dose), the document provides a table and comments. The table lists each 
technical section for which information would be required for approval 
of the supplement

[[Page 6216]]

and whether the information in a previously approved application is 
sufficient or new information would be needed. Comments provide 
additional information to assist the sponsor. In this way, the draft 
guidance specifies data requirements that will avoid duplication of 
previously submitted data. It also refers drug sponsors to related 
guidance documents that will aid them in the preparation of 
supplemental NADA's.
    This draft guidance 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 statute, regulations, or both.

IV. Section 403(b)(3): Define Supplemental Applications That Are 
Eligible for Priority Review

    When CVM determines that a product represents an important advance 
in animal health, it may expedite the review of original and 
supplemental applications. The circumstances in which CVM may make such 
a determination are outlined in an existing guidance entitled ``CVM 
Program Policy and Procedures Guide 1240.3135,'' available at the 
address above.

V. Section 403(c): Responsibilities of Centers

    FDA has designated the following individual within CVM to be 
responsible for encouraging prompt review of supplemental applications 
for approved articles and for working with sponsors to facilitate the 
development and submission of data to support the approval of 
supplemental applications in accordance with section 403(c) of FDAMA:
    Director, Office of New Animal Drug Evaluation (ONADE), Center for 
Veterinary Medicine, (HFV-100), Food and Drug Administration, 7500 
Standish Place, Rockville MD 20855, 301-594-1620.

VI. Section 403(d): Collaboration to Identify Published and 
Unpublished Studies

    CVM currently collaborates with the U.S. Department of Agriculture 
(USDA) National Research Support Project #7 (NRSP-7) and others, 
including state agencies, extension agents, universities, the National 
Coordinator for Aquaculture NADA's, and other USDA agencies, to 
encourage sponsors to make supplemental applications for minor use new 
animal drugs by encouraging development of Public Master Files (PMF's). 
Minor use new animal drugs are drugs used in minor animal species or 
drugs used in any animal species for the control of a disease that 
occurs infrequently or occurs in limited geographic areas. Minor 
species are defined in 21 CFR 514.1(d). PMF's contain public data from 
unpublished and published studies that can be used in conjunction with 
data already available in a major use product's original NADA to 
support a supplemental NADA. The majority of approved minor use drugs 
have been approved as supplements to products approved for use in major 
species.
    In a notice entitled ``Proposals to Increase the Legal Availability 
of Animal Drugs for Minor Species and Minor Uses; Availability'' 
published in the Federal Register (63 FR 58056, October 29, 1998), CVM 
proposed other methods of collaboration to make data available for 
minor use supplemental applications.
    In addition, CVM frequently participates in discussions with animal 
industry trade associations to help clarify the new animal drug 
approval process. These discussions encourage university researchers 
and others to identify or initiate studies that may be used to support 
supplemental applications.

VII. Comments

    The draft guidance discussed in section III of this 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. Written comments may be submitted at any time, 
however, comments should be submitted by May 8, 2000, to ensure 
adequate consideration in preparation of the final document. Comments 
should be identified with the full title of the draft guidance and the 
docket number found in brackets in the heading of this document. 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.

    Dated: January 24, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-2767 Filed 2-7-00; 8:45 am]
BILLING CODE 4160-01-F