Notice: Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Industry on How to Submit Information in 
Electronic Format to the Center for Veterinary Medicine Using the Food 
and Drug Administration Electronic Submission Gateway

Federal Register: February 5, 2010 (Volume 75, Number 24)            
                  Page 6038-6039

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 Center for Veterinary Medicine's (CVM's) ``Guidance for Industry on 
How to Submit Information in Electronic Format to the Center for 
Veterinary Medicine Using the FDA Electronic Gateway.''

DATES: Submit written or electronic comments on the collection of 
information by April 6, 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 (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 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 6039]]

Guidance for Industry on How to Submit Information in Electronic Format 
to the Center for Veterinary Medicine Using the FDA Electronic 
Submission Gateway--21 CFR 11.2 (OMB Control Number 0910-0454)--
Extension)

    CVM accepts certain types of submissions electronically with no 
requirement for a paper copy. These types of documents are listed in 
public docket 97S-0251 as required by 21 CFR 11.2. CVM's ability to 
receive and process information submitted electronically is limited by 
its current information technology capabilities and the requirements of 
the Electronic Records; Electronic Signatures final regulation. CVM's 
guidance entitled ``Guidance for Industry: How to Submit Information in 
Electronic Format to CVM Using the FDA Electronic Submission Gateway'' 
outlines general standards to be used for the submission of any 
information by e-mail.
    The likely respondents are sponsors for new animal drug 
applications.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
 21 CFR Section/         No. of        Annual Frequency     Total Annual        Hours per
  FDA Form 3538       Respondents        per Response       Responses\2\         Response         Total Hours
----------------------------------------------------------------------------------------------------------------
11.2                              40                1.3                 52                .08                4.2
----------------------------------------------------------------------------------------------------------------
\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 (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, 
(52 x hours per response (.08) =4.2 total hours).

    Dated: January 29, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-2523 Filed 2-4-10; 8:45 am]
BILLING CODE 4160-01-S