[Federal Register: November 3, 2004 (Volume 69, Number 212)]
[Page 64071-64072]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0179]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; New Animal Drug 
Application, Form FDA 356 V

ACTION: Notice.


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

DATES: Fax written comments on the collection of information by 
December 3, 2004.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written

[[Page 64072]]

comments be faxed to the Office of Information and Regulatory Affairs, 
OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974.

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: 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 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 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.
    In the Federal Register of May 19, 2004 (69 FR 28930), FDA 
published a 60-day notice soliciting comments on the collection of 
information requirements. In response to that notice, no comments were 
    FDA estimates the burden of this collection of information as 

                                                     Table 1.--Estimated Annual Reporting Burden\1\
                                                                        Annual Frequency       Total Annual
                 21 CFR Section                   No. of Respondents      per Response          Responses        Hours per Response      Total Hours
514.1 and 514.6                                             190                    7.39             1,405                  211.6            297,298
514.8                                                       190                    7.39             1,405                   30               42,150
514.11                                                      190                    7.39             1,405                    1                1,405
558.5(i)                                                      1                    1                    1.0                  5                    5
Total                                                                                                                                       340,858
\1\ There are no capitol costs or operating and maintenance costs associated with this collection of information.

    The estimate of the burden hours required for reporting are based 
on FY 2003 data. The burden estimate includes original NADAs, 
supplemental NADAs and amendments to unapproved applications.
    The burden estimate for obtaining a waiver (filing a petition) from 
labeling requirements for certain drugs intended for use in animal feed 
or drinking water was derived from data by FDA's Division of Animal 
Feeds in the Center for Veterinary Medicine.

    Dated: October 27, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-24446 Filed 11-2-04; 8:45 am]