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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0509 Supporting Statement 2013.doc	Supporting Statement A	Uploaded 2013-03-22	Available

IC Document Collections

Information collection document groups

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

ICR Details

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
	Date Received in OIRA: 03/25/2013
Terms of Clearance:

table that charts list comparision

	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

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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.

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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:
	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

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

table that charts list of burden

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

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ICR Summary of Burden

table that charts list 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.

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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

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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: 03/25/2013

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