[Federal Register: May 19, 2004 (Volume 69, Number 97)]
[Notices]
[Page 28930-28931]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19my04-60]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0179]
Agency Information Collection Activities; Proposed Collection;
Comment Request; New Animal Drug Application, FDA Form 356 V
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the reporting requirements for
sponsors submitting a new animal drug application (NADA), for marketing
a drug for animal use.
DATES: Submit written or electronic comments on the collection of
information by July 19, 2004.
ADDRESSES: Submit electronic comments on the collection of information
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on
the collection of information to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1472.
SUPPLEMENTARY INFORMATION: Under 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, including each proposed extension of an existing
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 proposed collection of information, FDA invites
comments on these topics: (1) Whether
[[Page 28931]]
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.
New Animal Drug Application, FDA Form 356 V--21 CFR Part 514 (OMB
Control Number 0910-0032)--Extension
FDA has the responsibility under the Federal Food, Drug, and
Cosmetic Act (the act), for the approval of new animal drugs that are
safe and effective. Section 512(b) of the act (21 U.S.C. 360b(b)),
requires that a sponsor submit and receive approval of an NADA, before
interstate marketing is allowed. The regulations implementing statutory
requirements for NADA approval have been codified under part 514 (21
CFR part 514). NADA applicants generally use a single form, FDA 356V.
The NADA must contain, among other things, safety and effectiveness
data for the drug, labeling, a list of components, manufacturing and
controls information, and complete information on any methods used to
determine residues of drug chemicals in edible tissues. While the NADA
is pending, an amended application may be submitted for proposed
changes. After an NADA has been approved, a supplemental application
must be submitted for certain proposed changes, including changes
beyond the variations provided for in the NADA and other labeling
changes. An amended application and a supplemental application may omit
statements concerning which no change is proposed. This information is
reviewed by FDA scientific personnel to ensure that the intended use of
an animal drug, whether as a pharmaceutical dosage form, in drinking
water, or in medicated feed, is safe and effective. The respondents are
pharmaceutical firms that produce veterinary products and commercial
feed mills.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
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514.1 and 514.6 190 7.39 1405 211.6 297,298
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514.8 190 7.39 1405 30 42,150
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514.11 190 7.39 1405 1 1,405
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Total burden hours 340,853
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The estimate of the burden hours required for reporting are based
on fiscal year 2003 data. The burden estimate includes original NADAs,
supplemental NADAs and amendments to unapproved applications.
Dated: May 12, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-11253 Filed 5-18-04; 8:45 am]
BILLING CODE 4160-01-S