Exports: Notification and Recordkeeping Requirements

Forms and Documents

Document	Type	Status	Availability
SUPPORTING STATEMEN FINAL 10-15-14.doc	Supporting Statement A	Uploaded 2014-10-15	Available

IC Document Collections

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

ICR Details

OMB Control No: 0910-0482	ICR Reference No: 201410-0910-001
Status: Historical Active	Previous ICR Reference No: 201107-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
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 with change	Conclusion Date: 12/23/2014
	Date Received in OIRA: 10/17/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2017	36 Months From Approved	12/31/2014
Responses	11,678	0	2,160
Time Burden (Hours)	186,531	0	39,120
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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 38036	07/03/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 61643	10/14/2014
Did the Agency receive public comments on this ICR? No

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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	11,678	2,160	0	663	8,855	0
Annual Time Burden (Hours)	186,531	39,120	0	14,586	132,825	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: The estimated total annual hourly burden for this collection of information is expected to be 186,531 hours, which is an increase of 147,411 hours from the currently OMB approved burden (from 39,120 hours to 186,531). There are several reasons for this increase in hours: a. Reporting Burden: The number of respondents is expected to decrease from 400 to 73 based on the actual number of export notification reports received over the past three years. However, although number of entities reporting is expected to decrease, the average number of responses for each of the three respective Centers is expected to increase significantly (from 3 to 193 for CBER, 3 to 180 for CDER, and 3 to 130 for CDRH), resulting in an increase of 132,825 hours (from 18,000 OMB currently approved burden hours to 150,825 projected burden hours). The expected increase in the number of responses per respondent is also based on the actual number of export notification reports received over the past three years. b. Recordkeeping Burden. Recordkeeping burden is expected to increase by 14,586 hours, from 21,120 to 35,706 hours due to the addition of reporting requirements in section 1.101(b) for the Office of International Programs (4,158 hour increase) and the Center for Tobacco Products (10,428 hour increase.) CTP's tobacco product recordkeeping requirements under § 1.101(b) from OMB Information collection 0910-0690 resulted in CTP's hourly burden increase of 10,428 recordkeeping hours. Once the renewal of this collection of information has been approved by OMB, the information collection under OMB No. 0910-0690 will be discontinued.

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Annual Cost to Federal Government: $502,154

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: 10/17/2014

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