[Federal Register: February 16, 2001 (Volume 66, Number 33)]
[Notices]
[Page 10701-10702]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16fe01-93]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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:
jmessenh@cvm.fda.gov.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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