Regulations Under the Federal Import Milk Act

Forms and Documents

Document Name	Status
Form Form FDA 1996 Regulations Under the Federal Import Milk Act Form and Instruction	Modified
Form Form FDA 1815 Regulations Under the Federal Import Milk Act Form and Instruction	Modified
Form Form FDA 1993 Regulations Under the Federal Import Milk Act Form and Instruction	Modified
Form Form FDA 1997 Regulations Under the Federal Import Milk Act Form and Instruction	Modified
Form Form FDA 1994 Regulations Under the Federal Import Milk Act Form and Instruction	Unchanged
Form Form FDA 1995 Regulations Under the Federal Import Milk Act Form and Instruction	Unchanged
0212 FIMA SSA 2021 Ext.docx Supporting Statement A	2021-07-07

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	Unchanged
187436	Regulations Under the Federal Import Milk Act Form and Instruction	Unchanged

ICR Details

OMB Control No: 0910-0212	ICR Reference No: 202107-0910-004
Status: Received in OIRA	Previous ICR Reference No: 201806-0910-003
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: 07/08/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	08/31/2021
Responses	206	410
Time Burden (Hours)	307	609
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:
	85 FR 70182	11/04/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 31327	06/11/2021
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
Regulations Under the Federal Import Milk Act	Form FDA 1996	Farm Inspection Report
Regulations Under the Federal Import Milk Act	Form FDA 1995	Physical Examination of Cows - Report
Regulations Under the Federal Import Milk Act	Form FDA 1815	Permits Granted on Certificates
Regulations Under the Federal Import Milk Act	Form FDA 1997	Score Card for Milk Plants
Regulations Under the Federal Import Milk Act	Form FDA 1993	Application for Permit
Regulations Under the Federal Import Milk Act	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	410	0	0	-204	0
Annual Time Burden (Hours)	307	609	0	0	-302	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: Based on a review of the information collection since our last OMB approval, we have decreased our burden estimate. The estimated number of respondents and hours per response are based on our experience with the import milk permit program and the average number of import milk permit holders over the past 3 years. However, we have not received any responses in the last 3 years; therefore, we estimate that one or fewer to be submitted annually.

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Annual Cost to Federal Government: $20,986

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: 07/08/2021

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