[Federal Register Volume 66, Number 33 (Friday, February 16, 2001)]
[Notices]
[Pages 10700-10701]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-3886]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1313]


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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the final guidance for industry (#86) entitled ``How to 
Use E-Mail to Submit a Notice of Final Disposition of Animals Not 
Intended for Immediate Slaughter'' to the Center for Veterinary 
Medicine (CVM). This final guidance provides guidelines 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. This electronic submission is part of CVM's 
ongoing initiative to provide a method for paperless submissions. This 
final guidance implements provisions of the Government Paperwork 
Elimination Act (GPEA).

DATES: Submit written comments on the final guidance at any time.

ADDRESSES: Submit written comments on the final 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 final guidance and the docket number found in 
brackets in the heading of this document.
    Copies of the final 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 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 final 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.

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 40104), FDA 
published the notice of availability of the draft guidance entitled 
``How to Use E-Mail to Submit a Notice of Final Disposition of Animals 
Not Intended for Immediate Slaughter'' (hereinafter referred to as the 
June 2000 notice). 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 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 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. The docket is accessible on the Internet 
at http://www.fda.gov/ohrms/dockets/dockets/92s0251.htm. 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.
    The electronic submission of NFDA's is part of CVM's ongoing 
initiative to provide a method for paperless submissions. This 
initiative 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.
    Before submitting NFDA's by e-mail, sponsors should first register 
and follow the instructions in final guidance for industry (#108) 
entitled ``How to Use E-Mail to Submit Information to the Center for 
Veterinary Medicine.'' This final guidance is also available at http://www.fda.gov/cvm.
    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 CVM's responsibility to protect 
the public health under the Federal Food, Drug, and Cosmetic Act. In 
addition, acceptable standards of study conduct such as those set out 
in 21 CFR 514.117 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 
sponsors that sets the terms under which animals treated with 
investigational new animal drugs may be slaughtered (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

[[Page 10701]]

paper. This final 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 final guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115; 65 FR 56468, 
September 19, 2000). The final 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 and regulations.

III. Paperwork Reduction Act of 1995

    In the June 2000 notice, 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 
document. No comments were received on the estimated annual reporting 
burden. The annual reporting burden estimate of 262 hours therefore 
remains unchanged. In the Federal Register of September 21, 2000 (65 FR 
57193), 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. 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. The information collection provisions related to this 
final guidance have been approved under OMB control number 0910-0453. 
This approval expires November 30, 2003.

IV. 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 final 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 submit to the Dockets Management Branch 
(address above) written comments on this final guidance at any time. 
Two copies of any comments are to be submitted, except 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 final 
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: February 9, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-3886 Filed 2-15-01; 8:45 am]
BILLING CODE 4160-01-F