[Federal Register Volume 65, Number 126 (Thursday, June 29, 2000)]
[Notices]
[Pages 40109-40111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16395]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1315]


Draft Guidance for Industry on How to Use E-Mail to Submit 
Information to the Center for Veterinary Medicine; 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availability of the draft guidance for industry (#108) entitled ``How 
to Use E-Mail to Submit Information to the Center for Veterinary 
Medicine.'' This draft guidance is neither final nor is it in effect at 
this time. The draft guidance document is intended to provide guidance 
on how to submit information to the Center for Veterinary Medicine 
(CVM) 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 This draft guidance implements provisions of the 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DATES: Submit written comments on the draft guidance at any time, 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ADDRESSES: Submit written comments on the draft guidance to the Dockets 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the full title of the draft guidance document and the docket number 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    Copies of the draft guidance document entitled ``How to Use E-Mail 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 Information to the Center for Veterinary Medicine'' 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single copies of the draft guidance to the Communications Staff (HFV-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: 
[email protected].

SUPPLEMENTARY INFORMATION:

[[Page 40110]]

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 (part 11 (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 which 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 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.
    CVM accepts certain types of submissions by e-mail with no 
requirement for a paper copy. These types of documents are listed in 
public docket number 92S-0251 as required by Sec. 11.2. CVM's ability 
to receive and process information submitted electronically is limited 
by its current information technology capabilities and the requirements 
of the electronic records and electronic signatures regulation. This 
guidance outlines general standards which should be used for the 
submission of any information by e-mail.

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 represent's the agency's current thinking about using e-mail 
to submit information electronically. 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, regulation, 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 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 Information to the Center for 
Veterinary Medicine.
    Description: CVM is responsible for developing and administering 
guidances that explain how to adhere to the electronic records and 
electronic signatures regulations (part 11). The electronic records and 
electronic signatures regulations provide for the voluntary submission 
of parts or all of regulatory records in electronic format without an 
accompanying paper copy. These regulations comply with the GPEA. The 
GPEA requires Federal agencies, by October 21, 2003, to give persons 
who are required to maintain, submit, or disclose information the 
option of doing so electronically when practicable as a substitute for 
paper.
    The draft guidance document describes the procedures for persons 
who are sponsors of new animal drugs who wish to file submissions by e-
mail. The draft guidance instructs those who wish to submit information 
to CVM by e-mail to first register with them. Registration entails 
sending a letter to CVM with a sponsor password and the names, phone 
numbers, and mail and e-mail addresses of a sponsor coordinator and any 
person who will submit information electronically to CVM. This letter 
is sent on paper and electronically. Other information collection 
provisions described in the guidance are the submission of e-mails with 
the individual passwords of those who submit information electronically 
and e-mails with any changes to the sponsor's registration. CVM will 
use all the information submitted to process electronic submissions.
    Description of Respondents: The likely respondents to this 
collection of information are new animal drug sponsors.
    FDA estimates the burden of this collection of information as 
follows:

             Table 1.--Estimated Annual Reporting Burden \1\
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                    Annual
    No. of      Frequency per   Total Annual    Hours per    Total Hours
  Respondents      Response      Responses      Response
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190             0.74           140            1             140
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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.

IV. Comments

    The 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.

[[Page 40111]]

    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 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. 00-16395 Filed 6-26-00; 10:07 am]
BILLING CODE 4160-01-F