[Federal Register Volume 67, Number 215 (Wednesday, November 6, 2002)]
[Notices]
[Pages 67631-67632]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 02-28257]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0449]


``Draft Guidance for Industry: The Administrative New Animal Drug 
Application Process''; 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availability of a draft guidance for industry ([numsign]132) entitled 
``The Administrative New Animal Drug Application Process.'' The 
guidance defines what an administrative new animal drug application 
(NADA) is, the procedures that should be followed before a sponsor 
submits an administrative NADA, and the intended timeframe for review 
of administrative NADAs.

DATES: Submit written or electronic comments on the draft guidance by 
January 21, 2003, to ensure their adequate consideration in preparation 
of the final document. General comments on agency guidance documents 
are welcome at any time.
    Submit written comments on the information collection requirements 
by January 6, 2003.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document to the Communications Staff (HFV-12), Center for 
Veterinary Medicine (CVM), Food and Drug Administration, 7519 Standish 
Pl., Rockville, MD 20855. Send one self-addressed adhesive label to 
assist that office in processing your requests. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.
    Submit written comments on the draft guidance document to the 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. Comments should be identified 
with the full title of the draft guidance document and the docket 
number found in the heading of this document.
    Submit written comments on the collection of information 
requirements to the Dockets Management Branch (address above). Comments 
should be identified with the docket number found in brackets in the 
heading of this document.

FOR FURTHER INFORMATION CONTACT: Gail Schmerfeld, Center for Veterinary 
Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-1796, e-mail: gschmer1@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321 
et seq.) prohibits the introduction into interstate commerce of new 
animal drugs that are not the subject of an approved NADA. Section 
512(b) of the act (21 U.S.C. 360b) and part 514 (21 CFR part 514) 
describe the information that must be submitted to FDA, specifically 
CVM, as part of an NADA. CVM encourages sponsors to submit data for 
review at the most appropriate and productive times in the drug 
development process. Sponsors may submit, and CVM intends to review, 
data in support of discrete technical sections during the investigation 
of the new animal drug. The guidance explains phased review and direct 
review, describes the technical sections, tells sponsors how they 
should submit data or information in support of a technical section for 
review, and tells sponsors how they should submit an administrative 
NADA.
    An administrative NADA is an NADA that is submitted after CVM has 
reviewed all of the technical sections containing the information 
required for the approval of the new animal drug and CVM has issued a 
technical section complete letter for each of those technical sections.

II. Significance of Guidance

    The 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 about the 
administrative NADA process. 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 an approach satisfies the 
requirements of the applicable statutes and regulations.

III. The Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
    Title: The Administrative New Animal Drug Application Process.
    Description: The act prohibits the introduction into interstate 
commerce of new animal drugs that are not the subject of an approved 
NADA. Section 512(b) of the act and the regulations in part 514 
describe the information that must be submitted to FDA, specifically to 
CVM, as part of an NADA.
    CVM encourages sponsors to submit data and information for review 
at the most appropriate and productive times in the drug development 
process rather than submitting all data and information at one time. 
Sponsors may submit, and CVM intends to review, data or information in 
support of discrete technical sections during the investigation of the 
new animal drug. This process is known as phased review. Sponsors may 
submit part or all of the data and information needed to support a 
technical section in a phased submission. The data submitted in

[[Page 67632]]

support of each technical section are covered by an existing paperwork 
clearance under OMB control number 0910-0032. FDA is seeking new 
paperwork clearance for the cover letter, table of contents, and 
summary that should accompany each submission. The cover letter 
identifying the submission as a ``phased submission'' should: (1) 
Describe briefly the purpose of the submission and the information 
contained in it, (2) reference or attach any pertinent documentation 
regarding previous agreements or understandings between the sponsor and 
CVM, (3) identify persons CVM may contact regarding any specifics of 
the submission, and (4) convey any other information the sponsor 
considers important or necessary to facilitate the review of the 
submission. There are potentially eight technical sections: Chemistry, 
manufacturing and controls; effectiveness; target animal safety; human 
food safety; environmental impact; labeling; freedom of information 
(FOI) summary; and, all other information.
    After a sponsor has received technical section complete letters for 
each technical section containing information required for the approval 
of the new animal drug, the sponsor may file an administrative NADA. 
The administrative NADA should include a cover letter identifying the 
submission as an ``Administrative NADA,'' a signed FDA Form 356V, a 
table of contents, summary, copies of the technical section complete 
letters for each required technical section, complete facsimile 
labeling, and the FOI summary.
    The cover letters that should be provided with each submission and 
with the administrative NADA and the copies of technical section 
complete letters represent new paperwork.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                       Annual Frequency    Total Annual
                  No. of Respondents     per Response        Responses    Hours per Response      Total Hours
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Administrative          190                    .24             47                 4                 188
 NADA
 applications
Phased                  190                   1.31            250                 2                 500
 submissions
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA averaged the number of administrative NADA applications and 
phased submissions for the past 2 years. Hours per response took into 
account that cover letters submitted summarized information contained 
in the submission and did not require any new information.

IV. Comments

    The draft guidance 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 (see 
ADDRESSES) written or electronic comments regarding this draft guidance 
document. Submit electronic comments to http://www.fda.gov/dockets/
ecomments. Two copies of any mailed 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.
    Submit written comments concerning the information collection 
requirements to the Dockets Management Branch. A copy of the document 
and received comments may be seen in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    Electronic comments may be submitted on the Internet at http://
www.fda.gov/dockets/ecomments. Once on the Internet site, select 02D-
0449 ``The Administrative New Animal Drug Application Process'' and 
follow the directions. A copy of this document may be obtained on the 
Internet from the CVM home page at http://www.fda.gov/cvm.

    Dated: October 28, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-28257 Filed 11-5-02; 8:45 am]
BILLING CODE 4160-01-S