Regulations Under the Federal Import Milk Act

Forms and Documents

Document Name	Status
Form Form FDA 1996 Sanitary Inspection of Dairy Farms Form and Instruction	Modified
Form Form FDA 1815 Permits Granted on Certificates Form and Instruction	Modified
Form Form FDA 1993 Application for Permit Form and Instruction	Modified
Form Form FDA 1997 Sanitary Inspection of Plants Form and Instruction	Modified
Form Form FDA 1994 Tuberculin test Form and Instruction	Modified
Form Form FDA 1995 Physical Examination of Cows Form and Instruction	Modified
0212_Supporting Statement_2024.docx Supporting Statement A	2024-07-18

IC Document Collections

IC ID	Document Title	Status
5813	Sanitary Inspection of Dairy Farms Form and Instruction	Modified
187441	Pasteurization; Equipment and Methods	Modified
187440	Permits Granted on Certificates Form and Instruction	Modified
187439	Application for Permit Form and Instruction	Modified
187438	Sanitary Inspection of Plants Form and Instruction	Modified
187437	Tuberculin test Form and Instruction	Modified
187436	Physical Examination of Cows Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0212	ICR Reference No: 202402-0910-006
Status: Received in OIRA	Previous ICR Reference No: 202107-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
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	Date Submitted to OIRA: 07/26/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	08/31/2024
Responses	206	206
Time Burden (Hours)	307	307
Cost Burden (Dollars)	0	0

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Abstract: The Federal Import Milk Act (FIMA) 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. The purpose of the collection is to ensure compliance with FIMA. Respondents are foreign dairy farms and plants engaged in the importation of milk and/or cream into the United States.

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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:
	89 FR 20221	03/21/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 59739	07/23/2024
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
Application for Permit	Form FDA 1993	Application for Permit
Pasteurization; Equipment and Methods
Permits Granted on Certificates	Form FDA 1815	Permits Granted on Certificates
Physical Examination of Cows	Form FDA 1995	Physical Examination of Cows - Report
Sanitary Inspection of Dairy Farms	Form FDA 1996	Farm Inspection Report
Sanitary Inspection of Plants	Form FDA 1997	Score Card for Milk Plants
Tuberculin test	Form FDA 1994	Tuberculin Test

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ICR Summary of Burden

	Total Request	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	206	206	0	0	0	0
Annual Time Burden (Hours)	307	307	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: $23,876

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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? No

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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: 07/26/2024

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