Document ID: FDA-2010-N-0055-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry on How to Submit a Protocol Without Data in Electronic Format to the Center for Veterinary Medicine
Posted Date: 2010-02-18T05:00Z

[Federal Register: February 18, 2010 (Volume 75, Number 32)]
[Notices]               
[Page 7277-7278]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18fe10-37]                         

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the reporting requirements for 
the information collection activity ``Guidance for Industry on How to 
Submit a Protocol Without Data in Electronic Format to the Center for 
Veterinary Medicine.''

DATES:  Submit written or electronic comments on the collection of 
information by April 19, 2010.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Denver Presley, Jr., Office of the 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

[[Page 7278]]

Guidance for Industry on ``How to Submit a Protocol Without Data in 
Electronic Format to the Center for Veterinary Medicine''--21 CFR 
58.120 and 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. 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 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
             21 CFR Section/FDA Form 3536                  Respondents         per Response         Responses\2\         Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.117(b) and 58.120                                                  40                   1.8                 72                .20               14.4
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs 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 July 1, 2005, and June 30, 2006, (72 x 
.20 hours per response = 14.4 total hours).

    Dated: February 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3026 Filed 2-17-10; 8:45 am]
BILLING CODE 4160-01-S