[Federal Register Volume 67, Number 215 (Wednesday, November 6, 2002)]
[Notices]
[Pages 67631-67632]
From the Federal Register Online via the Government Publishing 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``Draft Guidance for Industry: The Administrative New Animal Drug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availability of a draft guidance for industry ([numsign]132) entitled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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance document to the Communications Staff (HFV-12), Center for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INFORMATION section for electronic access to the draft guidance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Submit written comments on the draft guidance document to the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with the full title of the draft guidance document and the docket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: [email protected].
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]
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