Guidance for Industry on How to Submit Information in Electronic Format to the Center for Veterinary Medicine Using the FDA Electronic Submission Gateway
Guidance for Industry on How
to Submit Information in Electronic Format to the Center for
Veterinary Medicine Using the FDA Electronic Submission
Gateway
Extension without change of a currently approved collection
This information collection request
collects information from sponsors of new animal drug applications
who wish to submit pre-market information to Center for Veterinary
Medicine (CVM) using the FDA Electronic Submissions Gateway (ESG).
These types of documents are listed in public docket
FDA-1992-S-0039 as required by 21 CFR 11.2. CVM's guidance # 108
entitled "Guidance for Industry: How to Submit Information in
Electronic Format to CVM Using the FDA Electronic Submission
Gateway," outlines general standards to be used for the submission
of any electronic information to CVM using the FDA ESG, including
how to register with CVM's Electronic Submission System
(ESS).
Our estimated burden for the
information collection reflects an overall increase of 17 hours and
a corresponding increase of 213 responses. We attribute this
adjustment to the reauthorizations of both the Animal Drug User Fee
Act and the Animal Generic Drug User Fee Act, which require
sponsors to submit information electronically to CVM’s Office of
New Animal Drug Evaluation. Because of this requirement, sponsors
are now registering to use the CVM ESS in greater numbers than in
previous years.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.