View Information Collection Request (ICR) Package
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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:
0910-0509
ICR Reference No:
201303-0910-005
Status:
Historical Active
Previous ICR Reference No:
201001-0910-014
Agency/Subagency:
HHS/FDA
Agency Tracking No:
19179
Title:
Establishing a List of U.S. Dairy Producers for Export to Chile
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:
05/23/2013
Retrieve Notice of Action (NOA)
Date Received in OIRA:
03/25/2013
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
05/31/2016
36 Months From Approved
05/31/2013
Responses
138
0
128
Time Burden (Hours)
139
0
124
Cost Burden (Dollars)
0
0
0
Abstract:
This collection is effectuated by a guidance that provides instructions on the process for firms seeking inclusion on an agency list of U.S. dariy firms that export or intend to export to Chile. U.S. firms that want to be placed on the list will send information to FDA including name and address of the firm and the manufacturing plant, list of products presently shipped and expected to be shipped in the future, identities of agencies that inspect the plant, plant number and copy of last inspection.
Authorizing Statute(s):
US Code:
21 USC 371
Name of Law: FFDCA
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:
77 FR 68128
11/15/2012
30-day Notice:
Federal Register Citation:
Citation Date:
78 FR 16511
03/15/2013
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
3
IC Title
Form No.
Form Name
Biennial Update of Infomation by Firms Already on the List of U.S. Dairy Producers For Export to Chile
New Written Request to be Placed on the List of U.S. Dairy Producers for Export to Chile
Occasional Update of Information by Firms on the List of U.S. Dairy Producers for Export to Chile
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
138
128
0
0
10
0
Annual Time Burden (Hours)
139
124
0
0
15
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 has increased from 124 hours to 139 hours. This adjustment is a result of an increase in the estimated number of new firms that will apply to be added to the list, from 15 to 25 respondents.
Annual Cost to Federal Government:
$2,966
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:
03/25/2013
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