Document ID: FDA-2010-N-0055-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance on How to Electronically Submit a Protocol Without Data to the Center for Veterinary Medicine
Posted Date: 2010-04-29T04:00Z

[Federal Register: April 29, 2010 (Volume 75, Number 82)]
[Notices]               
[Page 22598-22599]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29ap10-75]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0055]

 
Agency Information Collection Activities; Submission for Office 
and Management and Budget Review; Comment Request; Guidance for 
Industry on How to Submit a Protocol Without Data in Electronic Format 
to the Center for Veterinary Medicine

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 June 1, 
2010.

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: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0524. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of 
Information

[[Page 22599]]

Management, Food and Drug Administration, 1350 Piccard Dr., Rockville, 
MD 20850, 301-796-3793.

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 Submit a Protocol Without Data in 
Electronic Format to the Center for Veterinary Medicine--(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 for which CVM and the sponsor 
consider this 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. The establishment of a process 
for acceptance of the electronic submission of protocols for studies 
conducted by sponsors in support of new animal drug applications, 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. Further, this guidance also electronically implements 
provisions of the Government Paperwork Elimination Act (GPEA). The GPEA 
required Federal agencies, by October 21, 2003, to provide the 
following: (1) The option of the electronic maintenance, submission, or 
disclosure of information, if practicable, as a substitution for paper 
and (2) the use and acceptance of electronic signatures, where 
applicable. FDA Form 3536 is used 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.
    The likely respondents are sponsors of new animal drug 
applications.
    FDA estimates the burden for this collection of information as 
follows:

                                                      Table 1--Estimated Annual Reporting Burden\1\
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                                                        Number of        Annual Frequency       Total Annual          Hours per
          21 CFR Section/  Form No. 3536               Respondents         per Response         Responses \2\          Response          Total Hours
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514.117(b) & 58.120                                                40                  1.8                    72                 20                 14.4
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\1\ There are no capital or operating and maintenance costs associated with this collection of information.
\2\ Electronic submissions received between January 1, 2008, and December 31, 2008.

    The number of respondents in table 1 of this document is the number 
of sponsors registered to make electronic submissions (40). The number 
of total annual responses is based on a review of the actual number of 
such submissions made between January 1, 2008, and December 31, 2008, 
(72 x hours per response (.20) = 14.4 total hours)).

    Dated: April 26, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10023 Filed 4-28-10; 8:45 am]
BILLING CODE 4160-01-S