[Federal Register Volume 66, Number 36 (Thursday, February 22, 2001)]
[Notices]
[Pages 11172-11173]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-4313]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1315]


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 guidance for industry (#108) entitled ``How to Use 
E-Mail to Submit Information to the Center for Veterinary Medicine'' 
(CVM). This guidance provides guidelines on how to submit information 
to 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 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 the 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. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.
    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.

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 40109), FDA 
published the notice of availability of the draft guidance entitled 
``How to Use E-Mail to Submit information to the Center for Veterinary 
Medicine'' giving interested persons until August 28, 2000, to submit 
comments. We received no comments.
    In the Federal Register of March 20, 1997 (62 FR 13430), FDA 
published the electronic records; electronic signatures regulation. 
This rule in 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 97S-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. In

[[Page 11173]]

addition, CVM will identify those documents in guidances 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 97S-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; electronic signatures regulation. This guidance 
outlines general standards that should be used for the successful 
electronic submission of any information by e-mail.

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 information electronically. The document does 
not create or confer any rights for or on any person and will not 
operate to bind FDA or the public. Alternative methods may be used as 
long as they satisfy the requirements 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 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 140 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 0910-0453. 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. The 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 14, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-4313 Filed 2-21-01; 8:45 am]
BILLING CODE 4160-01-S