[Federal Register Volume 65, Number 126 (Thursday, June 29, 2000)]
[Notices]
[Pages 40104-40106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16392]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00D-1313]
Draft Guidance for Industry on How to Use E-Mail to Submit a
Notice of Final Disposition of Animals Not Intended for Immediate
Slaughter; 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availability of the draft guidance for industry (#86) entitled ``How to
Use E-Mail to Submit a Notice of Final Disposition of Animals Not
Intended for Immediate Slaughter'' in the Center for Veterinary
Medicine (CVM). This draft guidance is neither final nor is it in
effect at this time. The draft guidance document is intended to provide
guidance to new animal drug sponsors (sponsors) on how to submit a
notice of final disposition of animals not intended for immediate
slaughter (NFDA) 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 This draft guidance implements provisions of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DATES: Submit written comments on the draft guidance at any time,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ADDRESSES: Submit written comments on the draft guidance to the Dockets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the full title of the draft guidance document and the docket number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Copies of the draft guidance document entitled ``How to Use E-Mail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 a Notice of Final Disposition of Animals Not Intended for
Immediate Slaughter'' may be obtained on the
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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of the draft guidance to the Communications Staff (HFV-12), Center for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 and 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 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 NFDA's is part of CVM's ongoing
initiative to provide a method for paperless submissions. It reflects
the principles behind 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.
In order to submit NFDA's by e-mail, sponsors should first register
and follow the instructions in draft guidance for industry (#108)
entitled ``How to Use E-Mail to Submit Information to the Center for
Veterinary Medicine'' when it becomes final.
CVM monitors the final disposition of food animals treated with
investigational new animal drugs in situations where the treated
animals do not enter the human food chain immediately at the completion
of the investigational study. Monitoring of the final disposition of
such food animals is consistent with its responsibility to protect the
public health under the Federal Food, Drug, and Cosmetic Act (the act).
In addition, acceptable standards of study conduct such as those set
out in Sec. 514.117 (21 CFR 514.117) would include sponsors accounting
for the disposition of all animals treated with investigational new
animal drugs. Furthermore, CVM requests this information because some
animals are held for 30 days after the investigational drug withdrawal
period ends and CVM does not request a notice of intent to slaughter
for human food purposes for these animals. Animals held for this period
may still be sent for slaughter, however. CVM issues a slaughter
authorization letter to investigational new animal drug sponsors that
sets the terms under which animals treated with investigational new
animal drugs may be slaughtered (Sec. 511.1(b)(5) (21 CFR
511.1(b)(5))). Also in this letter, CVM requests that sponsors submit
NFDA's for animals that are treated with investigational new animal
drugs and are not intended for immediate slaughter. NFDA's have
historically been submitted to CVM on paper. This draft guidance will
give sponsors the option to submit an NFDA as an e-mail attachment to
CVM via 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 an NFDA. 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 statutes, 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 Final Disposition of
Animals Not Intended for Immediate Slaughter.
Description: CVM monitors the final disposition of food animals
treated with investigational new animal drugs in situations where the
treated animals do not enter the human food chain immediately at the
completion of the investigational study. CVM believes that monitoring
of the final disposition of such food animals is consistent with its
responsibility to protect the public health under the act. In addition,
CVM believes that acceptable standards of study conduct such as those
set out in Sec. 514.117 would include sponsors accounting for the
disposition of all animals treated with investigational new animal
drugs. Furthermore, CVM requests this information because some animals
are held for 30 days after the investigational drug withdrawal period
ends and CVM does not request a notice of intent to slaughter for human
food purposes for these animals. Animals held for this period may still
be sent for slaughter, however.
The draft guidance document describes the procedures for persons
who are sponsors of new animal drugs who wish to file an NFDA
electronically on FDA Form #3487. The information sponsors should
include on the form includes the sponsor's name and
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address, and information about the treated animals. The likely
respondents to this collection of information are new animal drug
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
FDA Form No. of Frequency Total Hours per Total
No. Respondents per Annual Response Hours
Response Responses
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3487 190 1.7 324 0.81 262
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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 NFDA's
submitted on paper and by e-mail.
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 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.
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 may be seen 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. 00-16392 Filed 6-26-00; 10:07 am]
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