Establishing and Maintaining Lists of U.S.Product Manufacturers/Processors With Interest in Exporting CFSAN-Regulated Products

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
46483	Occasional Update of Information	Modified
46482	Biennial Update of Infomation	Modified
37675	New Written Request to be Placed on the List	Modified
236914	Third-Party Certification Information (including updates)	New

ICR Details

OMB Control No: 0910-0509	ICR Reference No: 201907-0910-016
Status: Active	Previous ICR Reference No: 201806-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Establishing and Maintaining Lists of U.S.Product Manufacturers/Processors With Interest in Exporting CFSAN-Regulated Products
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/23/2019
	Date Received in OIRA: 07/18/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2022	36 Months From Approved	11/30/2020
Responses	5,190	0	4,200
Time Burden (Hours)	22,288	0	3,100
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR supports agency programs by which respondents who satisfy specified criteria may voluntarily be included on established lists of those wanting to export FDA-regulated products 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
	Other Documents for OIRA Review

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 56350	11/13/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 27331	06/12/2019
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
New Written Request to be Placed on the List
Biennial Update of Infomation
Occasional Update of Information
Third-Party Certification Information (including updates)

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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	5,190	4,200	0	0	990	0
Annual Time Burden (Hours)	22,288	3,100	0	0	19,188	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: We have upgraded the electronic reporting module (ELM) for respondents to the collection and have consolidated like information collections from OMB Control Nos. 0910-0320 and 0910-0839. Overall this reflects an increase in responses from 4,200 to 5,190 (+990 responses) and a corresponding increase in burden hours from 3,100 to 22,288 hours (+19,188 hours).

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Annual Cost to Federal Government: $20,036

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: 07/18/2019

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