Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on How To Use E-Mail To Submit a Study Protocol, 7437-7438 [E7-2577]

Agencies

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

[Federal Register Volume 72, Number 31 (Thursday, February 15, 2007)]
[Notices]
[Pages 7437-7438]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-2577]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0436]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
on How To Use E-Mail To Submit a Study Protocol

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 
19, 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

[[Page 7438]]

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:

Guidance for Industry on ``How To Use E-Mail To Submit a Study 
Protocol''--21 CFR 58.120; 21 CFR 514.117(b); (OMB Control Number 0910-
0524)--Extension

    Protocols for nonclinical laboratory studies (safety studies), are 
required under 21 CFR 58.120 for approval of new animal drugs. 
Protocols for adequate and well-controlled effectiveness studies are 
required under 21 CFR 514.117(b). Upon request by the animal drug 
sponsors, the Center for Veterinary Medicine (CVM), reviews protocols 
for safety and effectiveness studies that CVM and the sponsor consider 
to be an essential part of the basis for making the decision to approve 
or not approve an animal drug application or supplemental animal drug 
application. Establishing a process for acceptance of the electronic 
submission of protocols for studies conducted by sponsors in support of 
new animal drug applications (NADAs), is part of CVM's ongoing 
initiative to provide a method for paperless submissions. Sponsors may 
submit protocols to CVM in paper format. CVM's guidance on how to 
submit a study protocol permits sponsors to submit a protocol without 
data as an e-mail attachment via the Internet. CVM's guidance on how to 
submit a study protocol electronically implements provisions of the 
Government Paperwork Elimination Act (GPEA). The GPEA required Federal 
agencies, by October 21, 2003, to provide for the: (1) Option of the 
electronic maintenance, submission, or disclosure of information, if 
practicable, as a substitution for paper; and (2) use and acceptance of 
electronic signatures, where applicable.
    FDA is also seeking an extension of an existing paperwork clearance 
for form FDA 3536 to facilitate the use of electronic submission of 
protocols. This collection of information is for the benefit of animal 
drug sponsors, giving them the flexibility to submit data for review 
via the Internet.
    In the Federal Register of November 8, 2006 (71 FR 65534), FDA 
published a 60-day notice soliciting public comment on the proposed 
collection of information requirements. In response to that notice, no 
comments were received.
    The likely respondents for this collection of information are 
sponsors of NADAs.
    FDA estimates the burden for 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/ Form No.                    Respondents         per Response         Responses\2\         Response         Total Hours
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514.117 ( b)                                                           25                   4.2                103               0.20               20.6
58.120 / Form 3536
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\Electronic submissions received between July 1, 2005, and June 30, 2006.

    The number of respondents in table 1 of this document is the number 
of sponsors registered to make electronic submissions (25). The number 
of total annual responses is based on a review of the actual number of 
such submissions made between July 1, 2005, and June 30, 2006. 103 x 
hours per response (.20) = 20.6 total hours.

    Dated: February 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-2577 Filed 2-14-07; 8:45 am]
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