[Federal Register Volume 65, Number 126 (Thursday, June 29, 2000)]
[Notices]
[Pages 40106-40107]
From the Federal Register Online via the Government Printing 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Draft Guidance for Industry on How to Use E-Mail to Submit a 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availability of the draft guidance for industry (#87) entitled ``How to 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 This draft guidance is neither final 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 The purpose of this draft guidance 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 This draft guidance implements 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DATES: Submit written comments on the draft guidance at any time, 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ADDRESSES: Submit written comments on the draft guidance to the Dockets 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the full title of the draft guidance and the docket number found in 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    Copies of the draft guidance document entitled ``How to Use E-Mail 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requests for single copies of the draft guidance to the Communications 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: 
jmessenh@cvm.fda.gov.

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