View Information Collection Request (ICR) Package
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Burden
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Common Form Info.
Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
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:
0910-0546
ICR Reference No:
201602-0910-010
Status:
Historical Active
Previous ICR Reference No:
201304-0910-002
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CVM
Title:
Food Additive Petitions, 21 CFR Part 571, Center for Veterinary Medicine
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:
04/06/2016
Retrieve Notice of Action (NOA)
Date Received in OIRA:
03/02/2016
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
04/30/2019
36 Months From Approved
05/31/2016
Responses
35
0
19
Time Burden (Hours)
189,600
0
51,700
Cost Burden (Dollars)
0
0
0
Abstract:
A food additive shall be deemed to be unsafe unless its use is permitted by a regulation which prescribes the condition(s) under which it may safely be used, or unless it is exempted by regulation for investigational use. Therefore, certain information must be submitted by a petition in order to establish the safety of a food additive and to secure the issuance of a regulation permitting its use in animal food.
Authorizing Statute(s):
US Code:
21 USC 409(a)
Name of Law: Federal Food, Drug and Cosmetic 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:
80 FR 63795
10/21/2015
30-day Notice:
Federal Register Citation:
Citation Date:
81 FR 10250
02/29/2016
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
5
IC Title
Form No.
Form Name
Amendment of Petitions
Complex Category- Complex Food Additive Petitions
Complex category - Investigational Food Additive Files
Moderate Category - Non-complex Food Additive Petitions
Moderate category - Investigational Food Additive Files
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
35
19
0
0
16
0
Annual Time Burden (Hours)
189,600
51,700
0
0
137,900
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
Information collection reflects agency adjustments attributable to change in number of respondents. These changes are discussed more fully in the agency's supporting statement.
Annual Cost to Federal Government:
$47,100
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
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:
Domini Bean 301 796-5733 domini.bean@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:
03/02/2016
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