Records and Reports Concerning Experience with Approved New Animal Drugs

ICR 201001-0910-012

OMB: 0910-0284

Federal Form Document

ICR Details
0910-0284 201001-0910-012
Historical Inactive 200610-0910-004
HHS/FDA
Records and Reports Concerning Experience with Approved New Animal Drugs
Extension without change of a currently approved collection   No
Regular
Improperly submitted and continue 03/29/2010
Retrieve Notice of Action (NOA) 01/29/2010
This collection has been improperly submitted under the terms set out by 5 CFR 1320. The collection is incorrectly listed as an extension when it includes discretionary changes that impact the burden. Please resubmit this collection as a revision.
  Inventory as of this Action Requested Previously Approved
01/31/2010 36 Months From Approved 03/31/2010
43,518 0 43,518
83,555 0 83,555
0 0 0

Section 512 (l) of the Federal Food, Drug and Cosmetic Act (the act)(21 U.S.C.360b(l)and section 514.80 (21 CFR 514.80) of FDA regulations, require applicants of approved new animal drug applications (NADAs) and abbeviated new animal drug applications ( ANADAs) to report adverse drug experiences and product / manufactuing defects. This continuous monitoring of approved NADAs and ANADAs affords the primary means by which FDA obtains information regarding potential problems with the safety and effacy of marketed approved new animal drugs as well as potential product / manufacturing problems.

None
None

Not associated with rulemaking

  74 FR 52967 10/15/2009
75 FR 2865 01/19/2010
Yes

Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
In response to comments received for the 60 day Federal register notice that published May 19,2006,(71 FR 29157 ), FDA made an adjustment for its reporting and recordkeeping burden estimates. The reporting estimate increased from 34,827 hours to 40,957 hours and the recordkeeping burden estimate increased from 34,316 hours to 43,013 hours (Refer to 30 day Federal Register notice; September 22,2006 (71 FR 55484)

$1,079,363
No
No
Uncollected
Uncollected
No
Uncollected
Jonnalynn Capezzuto 3018274659

  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.
01/29/2010


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