[Federal Register Volume 65, Number 126 (Thursday, June 29, 2000)]
[Notices]
[Pages 40104-40106]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 00-16392]


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

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Draft Guidance for Industry on How to Use E-Mail to Submit a 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.

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

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availability of the draft guidance for industry (#86) entitled ``How to 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 This draft guidance is neither final nor is it in 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 The draft guidance document is intended to provide 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 This draft guidance implements provisions of 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DATES: Submit written comments on the draft guidance at any time, 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ADDRESSES: Submit written comments on the draft guidance to the Dockets 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the full title of the draft guidance document and the docket number 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    Copies of the draft guidance document entitled ``How to Use E-Mail 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

[[Page 40105]]

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of the draft guidance to the Communications Staff (HFV-12), Center for 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 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

[[Page 40106]]

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\
------------------------------------------------------------------------
                              Annual
 FDA Form       No. of      Frequency      Total    Hours per    Total
    No.      Respondents       per        Annual     Response    Hours
                             Response    Responses
------------------------------------------------------------------------
3487        190            1.7          324         0.81       262
------------------------------------------------------------------------
\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]
BILLING CODE 4160-01-F