[Federal Register: January 7, 2004 (Volume 69, Number 4)]
[Page 923]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0424]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Substantial Evidence 
of Effectiveness of New Animal Drugs

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
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 
February 6, 2004.

ADDRESSES: The Office of Management and Budget 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 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

Substantial Evidence of Effectiveness of New Animal Drugs--21 CFR Part 
514 (OMB Control Number 0910-0356)--Extension

    Congress enacted the Animal Drug Availability Act of 1996 (ADAA) 
(Public Law 104-250) on October 9, 1996. As directed by ADAA, FDA 
published a regulation under Sec.  514.4(a) (21 CFR 514.4(a)), to 
further define substantial evidence in a manner that encourages the 
submission of new animal drug applications (NADAs) and supplemental 
NADAs and encourages dose range labeling. Under ADAA, substantial 
evidence is the standard that a sponsor must meet to demonstrate the 
effectiveness of a new animal drug for its intended use under the 
conditions suggested in its proposed labeling. Section 514.4(a) gives 
FDA greater flexibility to make case-specific scientific determinations 
regarding the number and types of adequate and well-controlled studies 
that will provide, in an efficient manner, substantial evidence that a 
new animal drug is effective. FDA believes this regulation will reduce 
the number of adequate and well-controlled studies necessary to 
demonstrate the effectiveness of certain combination new animal drugs, 
will eliminate the need for an adequate and well-controlled dose 
titration study, and may, in limited instances, reduce or eliminate the 
number of adequate and well-controlled field investigations necessary 
to demonstrate by substantial evidence the effectiveness of a new 
animal drug. Table 1 of this document represents the estimated burden 
of meeting the substantial evidence standard.
    In the Federal Register of September 19, 2003 (68 FR 54905), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 

                                 Table 1.--Estimated Annual Reporting Burden\1\
  21 CFR                        Annual Frequency        Total Annual
 Section   No. of Respondents     per Response           Responses        Hours per Response      Total Hours
514.4(a)         190                   4.5                 860                  632.6           544,036
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    Dated: December 30, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-256 Filed 1-6-04; 8:45 am]