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View Information Collection (IC) List
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0620
ICR Reference No:
201707-0910-005
Status:
Historical Active
Previous ICR Reference No:
201406-0910-018
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CVM
Title:
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
08/28/2017
Retrieve Notice of Action (NOA)
Date Received in OIRA:
07/27/2017
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2020
36 Months From Approved
08/31/2017
Responses
293
0
293
Time Burden (Hours)
4,922
0
4,922
Cost Burden (Dollars)
0
0
0
Abstract:
This ICR collects information from respondents who wish to make a drug legally available to veterinarians and animal owners for the treatment of a minor animal species (species other than cattle, horses, swine, chickens, turkeys, dogs, and cats). Respondents to the collection are sponsors of these products. FDA reviews the information collected to identify potential problems concerning the safety and effectiveness of the new animal drug.
Authorizing Statute(s):
US Code:
21 USC 369ccc-1
Name of Law: Minor Use and Minor Species Animal Health Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
81 FR 93689
12/21/2016
30-day Notice:
Federal Register Citation:
Citation Date:
82 FR 33507
07/20/2017
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
516.123
516.125
516.129
516.141
516.141 - Recordkeeping
516.143
516.145
516.161
516.163
516.165
516.165 - Recordkeeping
New Animal Drugs for Minor Use and Minor Species: Recordkeeping
New Animal Drugs for Minor Use and Minor Species: Reporting
ICR Summary of Burden
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
293
293
0
0
0
0
Annual Time Burden (Hours)
4,922
4,922
0
0
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
The burden for the information collection remains unchanged.
Annual Cost to Federal Government:
$139,851
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
07/27/2017
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