Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substantial Evidence of Effectiveness of New Animal Drugs, 7047 [E7-2497]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 72, Number 30 (Wednesday, February 14, 2007)]
[Notices]
[Page 7047]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-2497]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.4(a)                                                              190                 4,546                860              632.6            544,036
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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