[Federal Register Volume 65, Number 126 (Thursday, June 29, 2000)]
[Notices]
[Pages 40108-40109]
From the Federal Register Online via the Government Printing 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Draft Guidance for Industry on How to Use E-Mail to Submit a 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availability of the draft guidance for industry (#88) entitled ``How to 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 This draft guidance is neither final nor is it in 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 The purpose of this draft guidance document is to 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 This draft guidance implements provisions of 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DATES: Submit written comments on the draft guidance at any time, 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ADDRESSES: Submit written comments on the draft guidance to the Dockets 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the full title of the draft guidance and the docket number found in 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    Copies of the draft guidance document entitled ``How to Use E-Mail 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access may submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 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: 
jmessenh@cvm.fda.gov.

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
----------------------------------------------------------------------------------------------------------------
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