OMB Control Number 0910-0454

SUPPORTING STATEMENT

GUIDANCE FOR INDUSTRY ON HOW TO USE E-MAIL TO SUBMIT INFORMATION TO THE
CENTER FOR VETERINARY MEDICINE

A. [JUSTIFICATION]{.underline}

1.  [Circumstances Making the Information Collection
    Necessary]{.underline}

CVM is responsible for developing and administering guidances that
explain how to adhere to the Electronic Records; Electronic Signatures
regulations (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
requirement 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 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.

The information collection requirement for which we request OMB approval
is:

FDA Form 3538 -- Reporting -- Electronic Submission System Participant
Password or Addition.

2\. [Purpose and Use of the Information]{.underline}

This guidance document describes the procedures for persons who are
sponsors of new animal drugs who wish to file submissions by e-mail.
Persons filing information electronically agree to follow the criteria
as outlined in the guidance document. The guidance instructs those who
wish to submit information to CVM by e-mail to first register with the
Center. 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. A letter is sent on paper and electronically.
Other information collection provisions described in this guidance are
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. The likely respondents to this collection of
information are new animal drug sponsors.

3\. [Use of Information Technology and Burden Reduction]{.underline}

In the [Federal Register]{.underline} of March 20, 1997 (62 FR 13430),
the FDA published the Electronic Records; Electronic Signatures final
regulation. This regulation (21 CFR 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 the document that are acceptable for submission in
electronic form without paper records and the agency units to which such
submissions may be made.

4\. [Efforts to Identify Duplication and Use of Similar
Information]{.underline}

There are no other regulations or Federal Agencies that require the
submission of the same type information. There are no similar
data/information that could be substituted for that required by these
regulations.

5\. [Impact on Small Business or Other Small Entities]{.underline}

There is no impact on small business or other small entities.

6\. [Consequences of Collecting the Information Less
Frequently]{.underline}

Information will be collected only twice. First, the sponsor will
register by 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. The other
information collection is 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.

7\. [Special Circumstances Relating to the Guidelines of 5 CFR
1320.5]{.underline}

The reporting requirements are consistent with 5 CFR 1320.5.

8\. [Comments in Response to the Federal Register Notice and Efforts to
Consult Outside Agency]{.underline}

In the **Federal Register** of August 7, 2003 (62 FR 47077) FDA
published a notice providing a 60 day comment period on this information
collection. No comments were received.

9\. [Explanation of Any Payment or Gifts to Respondents]{.underline}

There are no payments or gifts to respondents.

10\. [Assurance of Confidentiality Provided to Respondent]{.underline}

CVM needs certain information to ensure the confidentiality, integrity,
security and authentication of data submitted to the Center in
electronic format by e‑mail. This information includes the sponsor
password that will be used by all of the people who will submit
information electronically on the sponsor\'s behalf, and individual
passwords that will be used exclusively by each individual. Use of the
sponsor password to encrypt information sent by e-mail will help assure
the security of submissions. Use of the individual password together
with an individual e-mail address will constitute an electronic
signature. (see 21 CFR 11.200(a)(v).)

11\. [Justification for Sensitive Questions]{.underline}

This information does not contain questions pertaining to sex behavior,
attitude, religious beliefs, or any other matter commonly considered
private or of a sensitive nature.

12. [Estimates of Hour Burden Including Annualized Hourly
    Costs]{.underline}

Table 1 -- Estimated Annual Reporting Burden

  ----------- ------------- ----------- ----------- ----------- -----------
  FDA Form    No. of        Annual      Total       Hours per   Total Hours
  No.         Respondents   Frequency   annual      Response    
                            per         Responses               
                            Response                            

  3538        70            2           140         .5          70
  ----------- ------------- ----------- ----------- ----------- -----------

> ^a^There are no capital costs or operating and maintenance costs
> associated with this collection of information

.

^b^A middle manger salary at \$35/hour.

Estimates from this table resulted from discussions with new animal drug
sponsors.

13\. [Estimate of Other Total Cost Burden to Respondents and
Recordkeepers]{.underline}

CVM used a wage rate of \$35.00 per hour, and multiplied times the total
hour burden estimated above (70 hours), the total cost burden to
respondents is \$2,450 (70 hours X \$35/hour).

14\. [Annualized Cost to the Federal Government]{.underline}

The cost to the federal government to receive and file information
(paper copy or e-mail) would be the essentially the same cost of burden
to industry. A wage rate of \$35.00 per hour is used and multiplied
times the total hour burden estimated above (70 hours), the total cost
to the Federal government is \$2,450 (70 hours X \$35/hour).

15. [Explanation of Program Changes or Adjustments]{.underline}

Reduction in respondents time to file electronically ( adjustment).

16\. [Plans for Tabulation and Publication and Project Time
Schedule]{.underline}

Information is not to be published for statistical use.