Exports: Notification and Recordkeeping Requirements

Forms and Documents

Document	Type	Status	Availability
0482 SS Deeming Revision Final 5.2016.docx	Supporting Statement A	Uploaded 2016-05-12	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
6183	Non-Tobacco - 1.101(d) -- CBER		Modified
213495	Tobacco Products - 1.101(b)		Modified
213494	Office of International Programs Only (Non-Tobacco) - 1.101(b)		Modified
213327	Non-Tobacco - 1.101(b),(c),(e) -- (CBER, CDER, & CDRH)		Modified
213326	Non-Tobacco - 1.101(d) -- (CDRH)		Modified
184868	Non-Tobacco - 1.101(d) -- CDER		Modified

ICR Details

OMB Control No: 0910-0482	ICR Reference No: 201601-0910-011
Status: Historical Active	Previous ICR Reference No: 201410-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: ORA
Title: Exports: Notification and Recordkeeping Requirements
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: 06/27/2016
	Date Received in OIRA: 05/12/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	36 Months From Approved	12/31/2017
Responses	12,239	0	11,678
Time Burden (Hours)	198,873	0	186,531
Cost Burden (Dollars)	0	0	0

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Abstract: FDA will use the information 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:
0910-AG38	Final or interim final rulemaking	81 FR 28973	05/10/2016

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 23141	04/25/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 28973	05/10/2016
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Non-Tobacco - 1.101(d) -- CDER
Non-Tobacco - 1.101(d) -- (CDRH)
Non-Tobacco - 1.101(b),(c),(e) -- (CBER, CDER, & CDRH)
Non-Tobacco - 1.101(d) -- CBER
Office of International Programs Only (Non-Tobacco) - 1.101(b)
Tobacco Products - 1.101(b)

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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	12,239	11,678	0	561	0	0
Annual Time Burden (Hours)	198,873	186,531	0	12,342	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: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The Food and Drug Administration (FDA) issued a final rule to deem products meeting the statutory definition of “tobacco product” to be subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law. This final rule extends the Agency’s “tobacco product” authorities to all other categories of products that meet the statutory definition of “tobacco product” in the FD&C Act, except accessories of such newly deemed tobacco products.

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Annual Cost to Federal Government: $526,277

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]? 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: 05/12/2016

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