Regulations Under the Federal Import Milk Act

Forms and Documents

Document Name	Status
Form FDA1996 Regulations Under the Federal Import Milk Act Form and Instruction	Modified
Form FDA1815 Regulations Under the Federal Import Milk Act Form and Instruction	Modified
Form FDA1993 Regulations Under the Federal Import Milk Act Form and Instruction	Modified
Form FDA1997 Regulations Under the Federal Import Milk Act Form and Instruction	Modified
Form FDA1994 Regulations Under the Federal Import Milk Act Form and Instruction	Modified
Form FDA1995 Regulations Under the Federal Import Milk Act Form and Instruction	Modified
FDA1815.pdf Supplementary Document	2012-06-26
FDA1993.pdf Supplementary Document	2012-06-26
FDA1997.pdf Supplementary Document	2012-06-26
FDA1994.pdf Supplementary Document	2012-06-26
FDA1995.pdf Supplementary Document	2012-06-26
FDA1996.pdf Supplementary Document	2012-06-26
0212 Supporting Statement 2012.doc Supporting Statement A	2012-06-26

IC Document Collections

IC ID	Document Title	Status
5813	Regulations Under the Federal Import Milk Act Form and Instruction	Modified
187441	Regulations Under the Federal Import Milk Act	Modified
187440	Regulations Under the Federal Import Milk Act Form and Instruction	Modified
187439	Regulations Under the Federal Import Milk Act Form and Instruction	Modified
187438	Regulations Under the Federal Import Milk Act Form and Instruction	Modified
187437	Regulations Under the Federal Import Milk Act Form and Instruction	Modified
187436	Regulations Under the Federal Import Milk Act Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0212	ICR Reference No: 201206-0910-010
Status: Historical Active	Previous ICR Reference No: 200812-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Regulations Under the Federal Import Milk Act
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: 08/31/2012
	Date Received in OIRA: 06/27/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2015	36 Months From Approved	08/31/2012
Responses	410	0	1,634
Time Burden (Hours)	609	0	2,426
Cost Burden (Dollars)	0	0	0

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Abstract: The Federal Import Milk Act prohibits the imporation of milk and cream into the United States unless the shipper holds a valid Import Milk permit from the Food and Drug Administration. The act requires that all cows be healthy and that the dairy farm and processing plant be in good sanitary condition.

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Authorizing Statute(s): US Code: 21 USC 141-149 Name of Law: Federal Import Milk Act
  

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 23732	04/20/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 38301	06/27/2012
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Regulations Under the Federal Import Milk Act	FDA1994	Tuberculin Test
Regulations Under the Federal Import Milk Act	FDA1997	Sanitary inspections of plants
Regulations Under the Federal Import Milk Act	FDA1993	Application for permit
Regulations Under the Federal Import Milk Act	FDA1815	Permits granted on certificates
Regulations Under the Federal Import Milk Act
Regulations Under the Federal Import Milk Act	FDA1996	Dairy Farm Sanitation Report
Regulations Under the Federal Import Milk Act	FDA1995	Physical examination of cows

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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	410	1,634	0	0	-1,224	0
Annual Time Burden (Hours)	609	2,426	0	0	-1,817	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: FDA decreased the estimated number of respondents. This decrease affected five ICs. The decrease in respondents is due to the decrease in the number of firms importing milk and/or cream into the United States. FDA also corrected two ICs for reporting that was inadvertently over-reported.

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Annual Cost to Federal Government: $16,020

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: 06/27/2012

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