[Federal Register Volume 75, Number 95 (Tuesday, May 18, 2010)]
[Notices]
[Page 27790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-11808]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0057]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on How to Submit Information in Electronic Format to the Center for
Veterinary Medicine Using the FDA Electronic Submission Gateway
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
17, 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: 202-395-6974, or e-mailed to [email protected]. All
comments should be identified with the OMB control number 0910-0454.
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.,
P150-400B, 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 Information in Electronic Format
to the Center for Veterinary Medicine Using the FDA Electronic
Submission Gateway (OMB Control Number 0910-0454)--Extension
The Center for Veterinary Medicine (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.
In the Federal Register of February 5, 2010 (75 FR 6038), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
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
Form 3538 Respondents per Response Responses\2\ Respondent 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 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
(52 x hours per response (.08) = 4.2 total hours).
Dated: May 12, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-11808 Filed 5-17-10; 8:45 am]
BILLING CODE 4160-01-S