[Federal Register Volume 71, Number 216 (Wednesday, November 8, 2006)]
[Notices]
[Pages 65534-65535]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18908]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0436]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Industry on How To Use E-Mail To Submit A 
Study Protocol

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 extending OMB approval of 
existing reporting requirements for the information collection activity 
on guidance for industry on ``How to Use E-Mail to Submit a Study 
Protocol.''

DATES: Submit written or electronic comments on the collection of 
information by January 8, 2007.

ADDRESSES:  Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. 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 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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.

Guidance for Industry on ``How to Use E-Mail to Submit a Study 
Protocol--21 CFR 58.120; 21 CFR 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 that CVM and the sponsor consider 
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. Establishing 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. CVM's guidance on how to submit a 
study protocol electronically implements provisions of the Government 
Paperwork Elimination Act (GPEA). The GPEA requires Federal agencies, 
by October 21, 2003, to provide for 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 is also seeking an extension of an existing paperwork clearance 
for form FDA 3536 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\1\:

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 21 CFR Section/         No. of        Annual Frequency     Total Annual        Hours per
   FDA Form No.       Respondents        per Response       Responses\2\         Response         Total Hours
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514.117(b),                       25                4.2                103                .20               20.6
 58.120/Form 3536
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\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.


[[Page 65535]]

    The number of respondents in Table 1 of this document is the number 
of sponsors registered to make electronic submissions (25). 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. 103 x 
hours per response (.20) = 20.6 total hours.

    Dated: November 2, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-18908 Filed 11-7-06; 8:45 am]
BILLING CODE 4160-01-S