[Federal Register Volume 66, Number 15 (Tuesday, January 23, 2001)]
[Notices]
[Pages 7497-7498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1870]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0006]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; New Animal Drug Application, Form FDA 356 V, 21 CFR 
Part 514

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 reinstatement of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on requirements for submission of 
a new animal drug application (NADA).

DATES: Submit written or electronic comments on the collection of 
information by March 26, 2001.

ADDRESSES: Submit electronic comments on the collection of information 
via the Internet at: http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. Submit written comments on the collection of 
information to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20857. 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 Information 
Resources Management (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 reinstatement 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 listed below.
    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.

[[Page 7498]]

New Animal Drug Application (NADA), Form FDA 356 V--21 CFR Part 
514--(OMB Control No. 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 a NADA, before 
interstate marketing is allowed. The regulations implementing statutory 
requirements for NADA approval have been codified under 21 CFR part 
514. NADA applicants generally use a single form, FDA 356 V. 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's 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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                                                                           Annual
        Form No.                 21 CFR section            No. of       frequency per      Total annual      Hours per response         Total hours
                                                         respondents      response          responses
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Form FDA 356 V            514.1 and 514.6                  190               8.33          1,582                   211.6              334,751
                          514.8                            190               8.33          1,582                    30                 47,460
                          514.11                           190               8.33          1,582                     1                  1,582
Total                                                                                                                                383,793
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\1\ There are no capital costs or operating and maintenance costs associated with this collection.

    The estimate of the burden hours required for reporting are based 
on fiscal year 1999 data. The burden estimate includes original NADA's, 
supplemental NADA's, and amendments to unapproved applications.

    Dated: January 16, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-1870 Filed 1-22-01; 8:45 am]
BILLING CODE 4160-01-F