[Federal Register Volume 65, Number 126 (Thursday, June 29, 2000)]
[Notices]
[Pages 40106-40107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16393]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00D-1314]
Draft Guidance for Industry on How to Use E-Mail to Submit a
Notice of Intent to Slaughter for Human Food Purposes; 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availability of the draft guidance for industry (#87) entitled ``How to
Use E-Mail to Submit a Notice of Intent to Slaughter for Human Food
Purposes'' in the Center for Veterinary Medicine (CVM) and U.S.
Department of Agriculture (USDA). This draft guidance is neither final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 The purpose of this draft guidance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 notice of intent to slaughter for human food
purposes (slaughter notices) as an e-mail attachment by Internet. This
electronic submission is 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 This draft guidance implements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DATES: Submit written comments on the draft guidance at any time,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ADDRESSES: Submit written comments on the draft guidance to the Dockets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the full title of the draft guidance and the docket number found in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Copies of the draft guidance document entitled ``How to Use E-Mail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 Notice of Intent to Slaughter for Human Food Purposes'' 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requests for single copies of the draft guidance to the Communications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 (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 slaughter notices 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 slaughter notices 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 the Center
for
[[Page 40107]]
Veterinary Medicine'' when it becomes final.
Section 512(j) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360b(j)) gives FDA the authority to issue regulations
setting out conditions for marketing animals treated with
investigational new animal drugs for food use. Under this authority,
FDA issued Sec. 511.1(b)(4) (21 CFR 511.1(b)(4)) that requires that
sponsor obtain authorization to slaughter these animals for food. Under
Sec. 511.1(b)(5), CVM issues a slaughter authorization letter to
sponsors that sets the terms under which the animals treated with
investigational new animal drugs may be slaughtered. USDA also monitors
the slaughter of animals treated with investigational new animal drugs
under the authority of the Meat Inspection Act (21 U.S.C. 601-95). To
assist CVM and USDA with this monitoring, the slaughter authorization
states that sponsors must submit slaughter notices each time such
animals are to be slaughtered unless CVM waives the notice in the
authorization letter. Currently, slaughter notices are submitted to CVM
on paper. This guidance will give sponsors the option to submit a
slaughter notice as an e-mail attachment to CVM and USDA 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 about using e-mail to
submit a slaughter notice. 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, when appropriate, and other forms of
information technology.
Title: How to Use E-Mail to Submit a Notice of Intent to Slaughter
for Human Food Purposes.
Description: Under Sec. 511.1(b)(5), CVM issues slaughter
authorizations for food animals treated with investigational new animal
drugs. To assist CVM with the monitoring of the slaughter of food
animals treated with investigational new animal drugs, the slaughter
authorization letter CVM sends to sponsors states that they must submit
slaughter notices each time such animals are to be slaughtered unless
the authorization letter waives that notice. Currently, slaughter
notices are submitted to CVM on paper (OMB Control No. 0910-0117). This
draft guidance will give sponsors the option to submit a slaughter
notice as an e-mail attachment to CVM by the Internet.
The draft guidance describes the procedures for persons who are
sponsors of new animal drugs and who wish to file a slaughter notice on
FDA Form No. 3488 by e-mail. The information that should be filed on
the form includes: Identify the sponsor, the animals to be slaughtered,
and the compound used to treat the animals. The likely respondents to
this collection of information are sponsors who have conducted clinical
investigations under Sec. 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 Frequency Total Annual
FDA Form No. No. of Respondents per Response Responses Hours per Response Total Hours
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3488 190 0.35 66 0.41 27
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Submitting a slaughter notice electronically represents a new
medium for submission of information currently submitted on paper. The
reporting burden for compilation and submission of this information on
paper is included in OMB clearance of the information collection
provisions of Sec. 511.1 (OMB Control No. 0910-0117). The estimates in
table 1 of this document reflect the burden associated with putting the
same information on FDA Form No. 3488 and resulted from discussions
with sponsors about the time necessary to complete this form.
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. 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. 00-16393 Filed 6-26-00; 10:07 am]
BILLING CODE 4160-01-F