[Federal Register Volume 65, Number 126 (Thursday, June 29, 2000)]
[Notices]
[Pages 40108-40109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16394]
[[Page 40108]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00D-1316]
Draft Guidance for Industry on How to Use E-Mail to Submit a
Request for a Meeting or Teleconference to the Office of New Animal
Drug Evaluation; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance for industry (#88) entitled ``How to
Use E-Mail to Submit a Request for a Meeting or Teleconference to the
Office of New Animal Drug Evaluation'' in the Center for Veterinary
Medicine (CVM). This draft guidance is neither final nor is it in
effect at this time. The purpose of this draft guidance document is to
provide guidance to new animal drug sponsors (sponsors) on how to
submit a request for a meeting or teleconference about a new animal
drug submission as an e-mail attachment by Internet. These electronic
submissions are part of CVM's ongoing initiative to provide a method
for paperless submissions. This draft guidance implements provisions of
the Government Paperwork Elimination Act (GPEA).
DATES: Submit written comments on the draft guidance at any time,
however, comments should be submitted by August 28, 2000, to ensure
their adequate consideration in preparation of the final document.
Submit written comments on the collection of information requirements
by August 28, 2000.
ADDRESSES: Submit written comments on the draft guidance to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. Comments should be identified with
the full title of the draft guidance and the docket number found in
brackets in the heading of this document.
Copies of the draft guidance document entitled ``How to Use E-Mail
to Submit a Request for a Meeting or Teleconference to the Office of
New Animal Drug Evaluation'' may be obtained on the Internet from the
CVM home page at http://www.fda.gov/cvm/. Persons without Internet
access may submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville,
MD 20855. Send one self-addressed adhesive label to assist that office
in processing your requests.
Submit written comments on the collection of information
requirements to the Dockets Management Branch (address above). Comments
should be identified with the docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Janis R. Messenheimer, Center for
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7578, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of March 20, 1997 (62 FR 13430), FDA
published the Electronic Records; Electronic Signatures final
regulation. This regulation (part 11 (21 CFR part 11)) provides for the
voluntary submission of parts or all of regulatory records in
electronic format without an accompanying paper copy. This rule also
established public docket number 92S-0251 to provide a permanent
location for a list of the documents or parts of documents that are
acceptable for submission in electronic form without paper records and
the agency units to which such submissions may be made. CVM will
identify in this public docket the types of documents that may be
submitted in electronic form as those documents that are identified in
final guidances or regulations. This docket is accessible on the
Internet at http://www.fda.gov/ohrms/dockets/dockets/92s0251/92s0251.htm.
The electronic submission of requests for meetings and
teleconferences is part of CVM's ongoing initiative to provide a method
for paperless submissions. The draft guidance implements provisions of
the GPEA. The GPEA of 1998 (Public Law 105-277) requires Federal
agencies, by October 21, 2003, to provide for: (1) The option of the
electronic maintenance, submission, or disclosure of information, if
practicable, as a substitute for paper; and (2) the use and acceptance
of electronic signatures, when practicable.
In order to submit requests for meetings or teleconferences by e-
mail, sponsors should first register and follow the instructions in
draft guidance for industry (#108) ``How to Use E-Mail to Submit
Information to CVM'' when it becomes final.
On request, CVM will hold meetings and/or teleconferences to assist
sponsors with new animal drug submissions and general questions.
Currently, meeting and teleconference requests are submitted to CVM on
paper. CVM would like to allow sponsors to request meetings and
teleconferences in a manner more efficient and time saving to them.
This draft guidance will give sponsors the option to submit a request
for a meeting or teleconference as an e-mail attachment by the
Internet.
II. Significance of Guidance
This Level 1 draft guidance is being issued consistent with FDA's
good guidance practices (62 FR 8961, February 27, 1997). The draft
guidance represents the agency's current thinking on submitting a
request for a meeting or teleconference about new animal drug
submissions by e-mail. It does not create or confer any rights for or
on any person and will not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statute, regulations, or both.
III. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (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 before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing a notice
of the proposed collection of information set forth 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,
[[Page 40109]]
when appropriate, and other forms of information technology.
Title: How to Use E-Mail to Submit a Request for a Meeting or
Teleconference to the Office of New Animal Drug Evaluation.
Description: As part of new animal drug development, sponsors often
meet with CVM scientists to formulate a rational approach to studies to
be conducted and to discuss how to meet the statutory requirements for
new animal drug approval under section 512 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360b). Requests for meetings and
teleconferences about NAD submissions are currently submitted on paper
to CVM. CVM is responsible for developing and administering a guidance
that explains how to adhere to the Electronic Records; Electronic
Signatures regulations (part 11). These regulations provide for the
voluntary submission of parts or all of regulatory records in
electronic format without an accompanying paper copy and complies with
the GPEA. The GPEA requires Federal agencies, by October 21, 2003, 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.
This draft guidance describes the procedure for persons who are new
animal drug sponsors to submit a request for a meeting or
teleconference to the Office of New Animal Drug Evaluation by e-mail on
FDA Form No. 3489. The information of the sponsors should include on
the form: The sponsor's name and address, a list of requested
participants, an indication of audio-visual needs, and an agenda. The
likely respondents to this collection of information are sponsors who
will be conducting clinical investigations under 21 CFR 511.1(b).
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual
FDA Form No. No. of Frequency per Total Annual Hours per Total Hours
Respondents Respondent Responses Response
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3489 190 .88 168 0.69 116
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The estimates in table 1 of this document resulted from discussions
with new animal drug sponsors. The estimated burden includes requests
for meetings or teleconferences submitted by e-mail and on paper.
IV. Comments
This draft guidance document is being distributed for comment
purposes only and is not intended for implementation at this time.
Interested persons may submit to the Dockets Management Branch (address
above) written comments regarding this draft guidance document. Submit
written comments by August 28, 2000, to ensure adequate consideration
in preparation of the final guidance. Two copies of any comments are to
be submitted, except that individuals may submit one copy. Comments are
to be identified with the docket number found in brackets in the
heading of this document. Written comments concerning the information
collection requirements must be received by August 28, 2000. A copy of
the draft guidance and received comments are available for public
examination in the Dockets Management Branch between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: June 16, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-16394 Filed 6-26-00;10:07 am]
BILLING CODE 4160-01-F