[Federal Register Volume 65, Number 126 (Thursday, June 29, 2000)]
[Notices]
[Pages 40109-40111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16395]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00D-1315]
Draft Guidance for Industry on How to Use E-Mail to Submit
Information to the Center for Veterinary Medicine; 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availability of the draft guidance for industry (#108) entitled ``How
to Use E-Mail to Submit Information to the Center for Veterinary
Medicine.'' This draft guidance is neither final nor is it in effect at
this time. The draft guidance document is intended to provide guidance
on how to submit information to the Center for Veterinary Medicine
(CVM) 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 This draft guidance implements provisions of the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DATES: Submit written comments on the draft guidance at any time,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 information collection 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ADDRESSES: Submit written comments on the draft guidance to the Dockets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the full title of the draft guidance document and the docket number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Copies of the draft guidance document entitled ``How to Use E-Mail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 Information to the Center for Veterinary Medicine'' 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single copies of the draft guidance to the Communications Staff (HFV-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:
[[Page 40110]]
I. Background
In the Federal Register of March 20, 1997 (62 FR 13430), FDA
published the electronic records and 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 which 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 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.
CVM accepts certain types of submissions by e-mail with no
requirement for a paper copy. These types of documents are listed in
public docket number 92S-0251 as required by Sec. 11.2. CVM's ability
to receive and process information submitted electronically is limited
by its current information technology capabilities and the requirements
of the electronic records and electronic signatures regulation. This
guidance outlines general standards which should be used for the
submission of any information by e-mail.
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 represent's the agency's current thinking about using e-mail
to submit information electronically. 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, regulation, 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 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, when appropriate, and other forms of
information technology.
Title: How to Use E-Mail to Submit Information to the Center for
Veterinary Medicine.
Description: CVM is responsible for developing and administering
guidances that explain how to adhere to the electronic records and
electronic signatures regulations (part 11). The electronic records and
electronic signatures regulations provide for the voluntary submission
of parts or all of regulatory records in electronic format without an
accompanying paper copy. These regulations comply 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.
The draft guidance document describes the procedures for persons
who are sponsors of new animal drugs who wish to file submissions by e-
mail. The draft guidance instructs those who wish to submit information
to CVM by e-mail to first register with them. Registration entails
sending a letter to CVM with a sponsor password and the names, phone
numbers, and mail and e-mail addresses of a sponsor coordinator and any
person who will submit information electronically to CVM. This letter
is sent on paper and electronically. Other information collection
provisions described in the guidance are the submission of e-mails with
the individual passwords of those who submit information electronically
and e-mails with any changes to the sponsor's registration. CVM will
use all the information submitted to process electronic submissions.
Description of Respondents: The likely respondents to this
collection of information are new animal drug sponsors.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden \1\
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Annual
No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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190 0.74 140 1 140
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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.
IV. Comments
The 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 document. 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.
[[Page 40111]]
Submit written comments concerning the information collection
requirements to the Dockets Management Branch by August 28, 2000. A
copy of the document 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. 00-16395 Filed 6-26-00; 10:07 am]
BILLING CODE 4160-01-F