[Federal Register Volume 66, Number 36 (Thursday, February 22, 2001)]
[Notices]
[Pages 11173-11174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-4419]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1314]


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 guidance for industry (#87) entitled ``How to Use 
E-Mail to Submit a Notice of Intent to Slaughter for Human Food 
Purposes.'' The purpose of this document is to provide guidance to new 
animal drug sponsors (sponsors) on how to submit an electronic notice 
of intent to slaughter for human food purposes (slaughter notices) to 
the Center for Veterinary Medicine (CVM) and the U.S. Department of 
Agriculture (USDA). This electronic submission is part of CVM's ongoing 
initiative to provide a method for paperless submissions. This guidance 
implements provisions of the Government Paperwork Elimination Act 
(GPEA).

DATES: Submit written comments at any time.

ADDRESSES: Submit written requests for single copies of this 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 guidance to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance 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 June 29, 2000 (65 FR 40106), FDA 
published the notice of availability of the draft guidance entitled 
``How to Use E-Mail to Submit a Notice of Intent to Slaughter for Human 
Food Purposes.'' Interested persons were given 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 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 92N-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 an 
e-mail attachment by Internet, as those documents are identified in 
final guidance or regulations. This docket is accessible on the 
Internet at http://

[[Page 11174]]

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 
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.
    Section 512(j) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360(b)(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)), which requires that sponsors obtain 
authorization to slaughter these animals for use as human food. Under 
Sec. 511.1(b)(5), CVM issues to sponsors a slaughter authorization 
letter 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.
    Before submitting slaughter notices by e-mail, sponsors should 
first register and follow the instructions in the guidance for industry 
(#108) entitled ``How to Use E-mail to Submit Information to the Center 
for Veterinary Medicine.''

II. Significance of Guidance

    This Level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115; 65 FR 56468, September 
19, 2000). The guidance represents the agency's current thinking about 
using e-mail to submit a slaughter notice. This guidance does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirement of the applicable statutes and 
regulations.

III. Paperwork Reduction Act of 1995

    In the notice announcing the availability of the draft version of 
this guidance, FDA published a notice of the proposed collection of 
information related to the guidance. The Federal Register notice also 
requested comments on the burden estimates for the guidance documents. 
No comments were received on the estimated annual reporting burden. The 
annual reporting burden estimate of 27 hours therefore remains 
unchanged. In the Federal Register of September 21, 2000 (65 FR 57192), 
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 guidance document have been 
approved under OMB control number 0910-0450. This approval expires 
November 30, 2003. 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cvm.

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 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 that individuals may submit 
one copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. 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: February 14, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-4419 Filed 2-21-01; 8:45 am]
BILLING CODE 4160-01-S