[Federal Register Volume 75, Number 82 (Thursday, April 29, 2010)]
[Notices]
[Pages 22598-22599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-10023]
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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 [email protected]. 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]
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