[Federal Register Volume 65, Number 184 (Thursday, September 21, 2000)]
[Notices]
[Page 57192]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24204]



[[Page 57192]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1504]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Guidance for Industry on How to Use E-Mail to Submit 
Information to the Center for Veterinary Medicine

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the collection of information by 
October 23, 2000.

ADDRESSES: Submit written comments on the collection of information to 
Office of Information and Regulatory Affairs, OMB, New Executive Office 
Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attention: 
Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Guidance for Industry on How to Use E-Mail to Submit Information to 
the Center for Veterinary Medicine

    Description: The Center for Veterinary Medicine (CVM), is 
responsible for developing and administering guidances that explain how 
to adhere to the electronic records and electronic signatures 
regulations (21 CFR 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 Government Paperwork 
Elimination Act, (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 
practical, as a substitute for paper.
    This guidance document describes the procedures for persons who are 
sponsors of new animal drugs who wish to file submissions by e-mail. 
The guidance document 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 for this 
collection of information are new animal drug sponsors. In the Federal 
Register of June 29, 2000 (65 FR 40109), FDA announced availability of 
this guidance as a draft document and requested public comment. In 
response to this notice, no comments were received on the estimated 
annual reporting burden. We therefore believe the annual reporting 
burden estimate of 140 hours should remain unchanged.

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

    Dated: September 14, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-24204 Filed 9-20-00; 8:45 am]
BILLING CODE 4160-01-F