[Federal Register Volume 72, Number 30 (Wednesday, February 14, 2007)]
[Notices]
[Page 7047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-2497]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N -0431]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Substantial Evidence
of Effectiveness of New Animal Drugs
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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.
DATES: Fax written comments on the collection of information by March
16, 2007.
ADDRESSES: 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: FDA Desk Officer,
FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the
Chief Information Officer (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
514.4(a) (OMB Control Number 0910-0356)--Extension
Section 512(d)(1)(E) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360(d)(1)(E)), requires FDA to issue an order
refusing to approve a new animal drug application (NADA), if there is a
lack of substantial evidence that a new animal drug will have the
effect it is purported or represented to have under the conditions of
use prescribed in the proposed labeling. Therefore, substantial
evidence must be submitted to us as part of the NADA to establish
effectiveness of a drug. Section 21 CFR 514.4(a) specifies requirements
for submitting adequate and well-controlled studies to provide
substantial evidence of effectiveness for a new animal drug. This
information collection requirement provides for submissions of
substantial evidence of effectiveness information via electronic
submissions to the Center for Veterinary Medicine (CVM).
CVM is continuously seeking ways through advances in information
technology to reduce the burden on the government and sponsors. The
Center continues to look at what information can be submitted
electronically and will permit electronic submission of data to NADA
files as technology and resources permit.
In the Federal Register of November 2, 2006 (71 FR 64535), FDA
published a 60-day notice in the Federal Register soliciting public
comment on the proposed collection of information collection
requirements. In response to that notice, no comments were received.
The likely respondents for this collection of information are
sponsors of NADA applications.
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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514.4(a) 190 4,546 860 632.6 544,036
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate for the annual reporting burden for this collection of
information was derived from discussion with industry and agency
records.
Dated: February 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-2497 Filed 2-13-07; 8:45 am]
BILLING CODE 4160-01-S