Exports: Notification and Recordkeeping Requirements

Forms and Documents

Document Name	Status
0482 ss 5-7-08.doc Supporting Statement A	2008-05-07

IC Document Collections

IC ID	Document Title	Status
6183	Exports: Notification and Recordkeeping Requirements	Modified
184868	Exports: Notification and Recordkeeping Requirements	New

ICR Details

OMB Control No: 0910-0482	ICR Reference No: 200805-0910-003
Status: Historical Active	Previous ICR Reference No: 200504-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Exports: Notification and Recordkeeping Requirements
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: 07/01/2008
	Date Received in OIRA: 05/13/2008
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2011	36 Months From Approved	06/30/2008
Responses	2,160	0	2,065
Time Burden (Hours)	39,120	0	43,214
Cost Burden (Dollars)	0	0	0

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Abstract: FDA will use the information in the records to determine whether an exporter has complied with the export requirements in the FFDC Act and the PHS Act and, in situations where FDA is required by law to notify an appropriate health official in a foreign country, to determine where a product was exported so that the agency can provide notice to the foreign country.

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Authorizing Statute(s): US Code: 21 USC 381 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:
	73 FR 4874	01/28/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 26119	05/08/2008
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Exports: Notification and Recordkeeping Requirements
Exports: Notification and Recordkeeping Requirements

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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	2,160	2,065	0	95	0	0
Annual Time Burden (Hours)	39,120	43,214	0	-4,094	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Due to a decrease in the number of respondents, as well as the amount of time needed to prepare a response, the total burden hours decreased from OMB's current inventory of 43,214 to 39,120.

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Annual Cost to Federal Government: $104,000

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 05/13/2008

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