[Federal Register: August 7, 2003 (Volume 68, Number 152)]
[Notices]
[Page 47077-47078]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07au03-50]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0329]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on How to Use E-Mail to Submit
Information 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 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
persons using e-mail to electronically submit information to the Center
for Veterinary Medicine (CVM).
DATES: Submit written or electronic comments on the collection of
information by October 6, 2003.
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, rm. 1061, 5630 Fishers Lane,
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, Office of Management
Programs (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 renewal of an existing collection, before submitting the
collection to OMB for approval. To comply with this requirement, FDA is
publishing notice of the proposed collection of information listed in
this document.
With respect to the following collection of information, FDA
invites comments on: (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 47078]]
Guidance for Industry on How to Use E-Mail to Submit Information to the
Center for Veterinary Medicine--21 CFR 11.2 (OMB Control Number 0910-
0454)--Extension
CVM is responsible for developing and administering guidances that
explain how to adhere to the Electronic Records; Electronic Signatures
regulations (part 11 (21 CFR part 11)). These allow sponsors to submit
part or all of records to FDA electronically in lieu of paper, unless
the paper records are specifically required by regulation, if the
requirement of part 11 are met, and the documents to be submitted
electronically are identified in Docket No. 92S-0251. These regulations
comply with the Government Paperwork Elimination Act (GPEA) (Public Law
105-277). The GPEA requires Federal agencies to give persons who are
required to maintain, submit, or disclose information the option of
doing so electronically when practicable as a substitute for paper by
October 21, 2003.
This guidance document describes the procedures persons who submit
information to CVM should follow if they want to file submissions
electronically. This guidance instructs those who wish to submit
information to CVM by e-mail to first register with the center.
Registration entails sending a letter, on paper or electronically, to
CVM with a sponsor password and the names, phone numbers, mail, and e-
mail addresses of a sponsor coordinator, and each person who will
submit information electronically to CVM. Other information collection
provisions relate to electronic submissions by individuals and
electronic submissions to make changes to the sponsor's registration.
CVM will use all the information submitted to process electronic
submissions. The likely respondents to this collection of information
are new animal drug sponsors.
We estimate the burden for this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency per
No. of Respondents Respondent Total Annual Responses Hours per Response Total Hours
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70 2 140 .5 70
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of the times required for record preparation is based
on agency communication with industry. Other information needed to
calculate the total burden hours is derived from agency records and
experience.
Dated: July 30, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-20060 Filed 8-6-03; 8:45 am]
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