[Federal Register Volume 66, Number 33 (Friday, February 16, 2001)]
[Notices]
[Pages 10701-10702]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-3887]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1316]


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 final 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 final guidance provides guidelines 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 
final guidance implements provisions of the Government Paperwork 
Elimination Act (GPEA).

DATES: Submit written comments at any time.

ADDRESSES: Copies of the final 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 
final 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 final 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 final guidance document and 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 June 29, 2000 (65 FR 40108), FDA 
published the notice of availability of the draft guidance entitled 
``How to Use E-Mail to Submit a Request for a Meeting or Teleconference 
to the Office of New Animal Drug Evaluation'' giving interested persons 
until August 28, 2000, to submit comments. FDA received no comments.
    In the Federal Register of March 20, 1997 (62 FR 13430), FDA 
published the Electronic Records; Electronic Signatures, final 
regulation. This regulation (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 final rule also established 
public docket number 97S-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 are identified in final guidance 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 final guidance implements provisions of 
the GPEA. The GPEA of 1998 (Public Law 105-277) requires Federal 
agencies, by October 21, 2003, to provide: (1) For the option of the 
electronic maintenance, submission, or disclosure of information, if 
practicable, as a substitute for paper; and (2) for the use and 
acceptance of electronic signatures, when practicable.
    On request, CVM will hold meetings and/or teleconferences to assist 
sponsors with new animal drug submissions and general questions. 
Currently, sponsors submit meeting and

[[Page 10702]]

teleconference requests 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 final guidance will give 
sponsors the option to submit a request for a meeting or teleconference 
as an e-mail attachment by the Internet.
    Before submitting requests for meetings or teleconferences by e-
mail, sponsors should first register and follow the instructions in the 
final guidance for industry (#108) entitled ``How to Use E-Mail to 
Submit Information to CVM.''

II. Significance of Guidance

    This Level 1 final guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115; 65 FR 56468, 
September 19, 2000). The final guidance represents the agency's current 
thinking on submitting a request for a meeting or teleconference about 
new animal drug submissions by e-mail. The final guidance does not 
create or confer any rights for or on any person and will not operate 
to bind FDA or the public. An alternative method may be used if such 
approach satisfies the requirements of the applicable statutes and 
regulations.

III. Paperwork Reduction Act of 1995

    In the document announcing the availability of the draft version of 
this guidance (65 FR 40108), FDA published notice of the proposed 
collection of information related to the guidance. The Federal Register 
document also requested comments on the burden estimates for the 
guidance document. No comments were received on the estimated annual 
reporting burden. The annual reporting burden estimate of 116 hours, 
therefore remains unchanged. In the Federal Register of September 21, 
2000 (65 FR 57194), the agency announced that it was submitting the 
collection of information to the Office of Management and Budget (OMB) 
for review and clearance under the Paperwork Reduction Act of 1995. The 
information collection provisions related to this final guidance 
document have been approved under OMB control number 0910-0452. An 
agency may not conduct or sponsor, and a person is not required to 
respond to, a collection of information unless it displays a currently 
valid OMB control number. This approval expires November 30, 2003.

V. Comments

    As with all of FDA's guidances, the public is encouraged to submit 
written comments with new data or other new information pertinent to 
this final guidance. FDA will periodically review the comments in the 
docket and, where appropriate, will amend the guidance. The agency will 
notify the public of any such amendments through a notice in the 
Federal Register.
    Interested persons may, at any time, submit written comments on the 
guidance to the Dockets Management Branch (address above). Two copies 
of any comments are to be submitted, except individuals may submit one 
copy. Comments should be identified with the docket number found in 
brackets in the heading of this document. The 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: February 9, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-3887 Filed 2-15-01; 8:45 am]
BILLING CODE 4160-01-S