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

Forms and Documents

Document Name	Status
0509 CoverMemotoOMB 2006.doc Supplementary Document	2006-12-13
0509 Attachment A 21 USC371(h).doc Supplementary Document	2006-12-12
0509 Attachment B 21 CFR 20 89.doc Supplementary Document	2006-12-12
0509 ss 12-14-2006.doc Supporting Statement A	2006-12-14

IC Document Collections

IC ID	Document Title	Status
46483	Establishing a List of U.S. Dairy Producers for Export to Chile Other-Other	New
46482	Establishing a List of U.S. Dairy Producers for Export to Chile Other-Other	New
37675	Establishing a List of U.S. Dairy Producers for Export to Chile Other-Other	Modified

ICR Details

OMB Control No: 0910-0509	ICR Reference No: 200612-0910-006
Status: Historical Active	Previous ICR Reference No: 200503-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No:
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: 01/30/2007
	Date Received in OIRA: 12/18/2006
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2010	36 Months From Approved	01/31/2007
Responses	95	0	50
Time Burden (Hours)	91	0	150
Cost Burden (Dollars)	0	0	0

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Abstract: This guidance from the Food and Drug Administration provides instructions on the process for firms to seek inclusion on the list of U.S. dariy firms that export or intend to export to Chile. Under this guidance, U.S. firms that want to be placed on the list will send information to FDA (e.g., 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:
	71 FR 43202	07/31/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 70972	12/07/2006
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
Establishing a List of U.S. Dairy Producers for Export to Chile
Establishing a List of U.S. Dairy Producers for Export to Chile
Establishing a List of U.S. Dairy Producers for Export to Chile

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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	95	50	0	45	0	0
Annual Time Burden (Hours)	91	150	0	-59	0	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: The decrease in burden is due to the decrease in the number of U.S. firms that submitted new requests to be placed on the list.

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Annual Cost to Federal Government: $2

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 12/14/2006

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