[Federal Register: January 7, 2004 (Volume 69, Number 4)]
[Notices]
[Page 923]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07ja04-46]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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21 CFR Annual Frequency Total Annual
Section No. of Respondents per Response Responses Hours per Response Total Hours
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514.4(a) 190 4.5 860 632.6 544,036
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: December 30, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-256 Filed 1-6-04; 8:45 am]
BILLING CODE 4160-01-S