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

ICR 200703-0910-008

OMB: 0910-0454

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
0000-00-00
ICR Details
0910-0454 200703-0910-008
Historical Active 200401-0910-006
HHS/FDA
Guidance for Industry on How to Use E-Mail Submit Information to the Center for Veterinary Medicine
Extension without change of a currently approved collection   No
Regular
Approved without change 05/15/2007
Retrieve Notice of Action (NOA) 03/14/2007
  Inventory as of this Action Requested Previously Approved
05/31/2010 36 Months From Approved 05/31/2007
140 0 140
11 0 70
0 0 0

CVM is responsible for developing and administering guidances that explain how to adhere to the Electronic Records; Electronic Signatures regulation (part 11 (21 CFR part 11)). These regulations comply with the Government Paperwork Elimination Act (GPEA), (Public Law 105-277). The GPEA requires Federal agencies 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 by October 21, 2003. This guidance describes the procedures persons who submit information to CVM should follow if they want to file electronically.

None
None

Not associated with rulemaking

  71 FR 65533 11/08/2006
72 FR 7044 02/14/2007
No

1
IC Title Form No. Form Name
Guidance for Industry on How to Use E-Mail Submit Information to the Center for Veterinary Medicine

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 140 140 0 0 0 0
Annual Time Burden (Hours) 11 70 0 0 -59 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$392
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Saleda Perryman

  No

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.
03/14/2007


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