Establishing and Maintaining Lists of U.S. Milk Product Manufacturers/Processors With Interest in Exporting

Forms and Documents

Document Name	Status
0509 Export Listing Module (ELM) Screenshots for PRA.pdf Supplementary Document	2018-06-11
0509 June 2018 Non sub change memo.pdf Justification for No Material/Nonsubstantive Change	2018-06-11
0509 ss 10-3-2017.docx Supporting Statement A	2017-10-03

IC Document Collections

IC ID	Document Title	Status
46483	Occasional Update of Information Other-DLM Screens	Unchanged
46482	Biennial Update of Infomation Other-DLM Screens	Unchanged
37675	New Written Request to be Placed on the List Other-DLM Screens	Unchanged

ICR Details

OMB Control No: 0910-0509	ICR Reference No: 201806-0910-001
Status: Historical Active	Previous ICR Reference No: 201708-0910-015
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Establishing and Maintaining Lists of U.S. Milk Product Manufacturers/Processors With Interest in Exporting
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/14/2018
	Date Received in OIRA: 06/11/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2020	11/30/2020	11/30/2020
Responses	4,200	0	4,200
Time Burden (Hours)	3,100	0	3,100
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR supports an agency program by which respondents may be included on an established list of U.S. dairy firms who wish to export to foreign countries. Respondents who wish to be included on the list will voluntarily send information to FDA, including the name and address of the firm and the manufacturing plant, a list of products presently shipped and expected to be shipped in the future, and 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 301 et. seq. 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:
	82 FR 27485	06/15/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 46074	10/03/2017
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
New Written Request to be Placed on the List
Biennial Update of Infomation
Occasional Update of Information

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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	4,200	4,200	0	0	0	0
Annual Time Burden (Hours)	3,100	3,100	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: This information collection reflects agency adjustments. The total annual number of responses increased from 125 to 2,000 (an increase of 1,875 responses) and the total annual burden increased from 338 to 3,100 hours (an increase of 2,762 hours).

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Annual Cost to Federal Government: $6,316

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? 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: 06/11/2018

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