[Federal Register: January 26, 2004 (Volume 69, Number 16)]
[Page 3586-3587]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0329]

Agency Information Collection Activities: Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
on How To Use E-Mail To Submit Information to the Center for Veterinary 

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice.


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

DATES:  Fax written comments on the collection of information by 
February 25, 2004.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management

[[Page 3587]]

Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
rm. 4B-41, 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, 21 CFR 11.2--( OMB Control N0. 0910-

    The Center for Veterinary Medicine (CVM) is responsible for 
developing and administering guidances that explain how to adhere to 
the electronic records; electronic signatures regulations (part 11 (21 
CFR part 11)). These regulations allow sponsors to submit part or all 
of records to FDA electronically in lieu of paper, unless the paper 
records are specifically required by regulation, if the requirements of 
part 11 are met, and the documents to be submitted electronically are 
identified in Public Docket No. 92S-0251. These regulations comply with 
the Government Paperwork Elimination Act (GPEA) (Public Law 105-277). 
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.
    This guidance document describes the procedures persons who submit 
information to CVM should follow, if they want to file submissions 
electronically. This guidance instructs those who wish to submit 
information to CVM by e-mail to first register with the center. 
Registration entails sending a letter, on paper or electronically, to 
CVM with a sponsor password and the names, phone numbers, mail and e-
mail addresses of a sponsor coordinator and each person who will submit 
information electronically to CVM. Other information collection 
provisions relate to electronic submissions by individuals and 
electronic submissions to make changes to the sponsor's registration. 
CVM will use all the information submitted to process electronic 
submissions. The likely respondents to this collection of information 
are new animal drug sponsors.
    In the Federal Register of August 7, 2003 (68 FR 47077), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    We estimate the burden for this collection of information as 

             Table 1.--Estimated Annual Reporting Burden\1\
 FDA Form       No. of      Frequency      Total    Hours per    Total
    No.      Respondents       per        Annual     Response    Hours
                             Response    Responses
3,538       70             2            140         .5         70
\1\ There are no capital costs or operating and maintenance costs
  associated with this collection of information.

    The estimate of the times required for record preparation is based 
on agency communication with industry. Other information needed to 
calculate the total burden hours are derived from agency records and 

    Dated: January 16, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-1494 Filed 1-23-04; 8:45 am]