[Federal Register Volume 66, Number 89 (Tuesday, May 8, 2001)]
[Notices]
[Page 23266]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11454]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0006]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; New Animal Drug Application, Form FDA 356 V

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by June 
7, 2001.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.
New Animal Drug Application, 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 new animal 
drug application (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 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                 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 of information.

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

    Dated: May 2, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-11454 Filed 5-7-01; 8:45 am]
BILLING CODE 4160-01-S