Establishing a List of U.S. Dairy Producers for Export

Forms and Documents

Document Name	Status
OMB Justification Memo 0509 for 83-C Change Request 6-8-2016.docx Justification for No Material/Nonsubstantive Change	2016-06-08
0509 - DLM Mockups 2016_05_20.docx Supplementary Document	2016-05-24
0509 83_C Correction Worksheet OMB Request for approval-052016.docx Justification for No Material/Nonsubstantive Change	2016-05-24
0509 SS Part A 2014.doc Supporting Statement A	2014-07-07

IC Document Collections

IC ID	Document Title	Status
46483	Occasional Update of Information by Firms on the List of U.S. Dairy Producers for Export Other-DLM Mockups	Modified
46482	Biennial Update of Infomation by Firms Already on the List of U.S. Dairy Producers For Export Other-DLM Mockups	Modified
37675	New Written Request to be Placed on the List of U.S. Dairy Producers for Export Other-DLM Mockups	Modified

ICR Details

OMB Control No: 0910-0509	ICR Reference No: 201605-0910-016
Status: Historical Active	Previous ICR Reference No: 201407-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Establishing a List of U.S. Dairy Producers for Export
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/10/2016
	Date Received in OIRA: 05/26/2016
Terms of Clearance: At the time of the next revision/extension, FDA should report on efforts to phase-out the paper-based collection and revise burden estimates based on electronic submissions.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2017	09/30/2017	09/30/2017
Responses	300	0	300
Time Burden (Hours)	338	0	338
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR supports an agency program by which respondents may be included on an established list of U.S. dairy firms who wish to export to foreign countries. Respondents who wish to be included on the list will voluntarily send information to FDA, including the name and address of the firm and the manufacturing plant, a list of products presently shipped and expected to be shipped in the future, and identities of agencies that inspect the plant, plant number and copy of last inspection.

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Authorizing Statute(s): US Code: 21 USC 371 Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 9221	02/18/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 29777	05/23/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Occasional Update of Information by Firms on the List of U.S. Dairy Producers for Export
New Written Request to be Placed on the List of U.S. Dairy Producers for Export
Biennial Update of Infomation by Firms Already on the List of U.S. Dairy Producers For Export

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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	300	300	0	0	0	0
Annual Time Burden (Hours)	338	338	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:

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Annual Cost to Federal Government: $2,995

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

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Common Form ICR:  No

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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: 05/26/2016

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