[Federal Register Volume 69, Number 97 (Wednesday, May 19, 2004)]
[Notices]
[Pages 28930-28931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11253]


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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://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