2010-10023. 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.

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: [phone], or e-mailed to [e-mail]. 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 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 Burden¹

21 CFR Section/ Form No. 3536	Number of Respondents	Annual Frequency per Response	Total Annual Responses 2	Hours per Response	Total Hours
514.117(b) & 58.120	40	1.8	72	20	14.4
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.