Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802

Forms and Documents

Document Name	Status
Form FDA 3613 CBER Export Certificate (FDA 3613, 3613b, 3613c) Form and Instruction	Modified
Form FDA 3613e Costs of Certificates Form and Instruction	Modified
Form FDA 3613e CFSAN Export Certificate-Office of Food Safety (FDA3613e) Form and Instruction	Modified
Form FDA 3613d CFSAN Export Certificate-Office of Cosmetics and Colors (FDA 3613d) Form and Instruction	Modified
Form FDA 3613e CFSAN Export Certificate-Office of Nutrition, Labeling and Supplements (FDA 3613e) Form and Instruction	Modified
Form FDA 3613 CVM Export Certificate (FDA 3613, 3613b) Form and Instruction	Modified
Form FDA 3613 CDRH Export Certificate (FDA 3613, 3613a, 3613c) Form and Instruction	Modified
Form FDA 3613b CDER Export Certificate (FDA 3613b) Form and Instruction	Modified
0498 CFSAN Justification Memo for 83C Change Request 2013.doc Justification for No Material/Nonsubstantive Change	2013-05-20
0498 OCAC Enter New App ScreenShots.docx Supplementary Document	2013-05-01

IC Document Collections

IC ID	Document Title	Status
6208	CBER Export Certificate (FDA 3613, 3613b, 3613c) Form and Instruction	Modified
201669	Costs of Certificates Form and Instruction	Modified
201668	CFSAN Export Certificate-Office of Food Safety (FDA3613e) Form and Instruction	Modified
201667	CFSAN Export Certificate-Office of Cosmetics and Colors (FDA 3613d) Form and Instruction	Modified
188598	CFSAN Export Certificate-Office of Nutrition, Labeling and Supplements (FDA 3613e) Form and Instruction	Modified
188597	CVM Export Certificate (FDA 3613, 3613b) Form and Instruction	Modified
188596	CDRH Export Certificate (FDA 3613, 3613a, 3613c) Form and Instruction	Modified
188595	CDER Export Certificate (FDA 3613b) Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0498	ICR Reference No: 201305-0910-001
Status: Historical Active	Previous ICR Reference No: 201210-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: 19441
Title: Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802
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 with change	Conclusion Date: 05/20/2013
	Date Received in OIRA: 05/08/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2015	03/31/2015	03/31/2015
Responses	78,343	0	78,343
Time Burden (Hours)	50,942	0	50,942
Cost Burden (Dollars)	3,107,462	0	3,107,462

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Abstract: Section 801(e)(4) of the act provides that persons exporting certain FDA-regulated products may request FDA to certify that the products meet the requirements of Sections 801(e) or 802 of the FD&C Act, or other requirements of the act. This section of the law requires FDA to issue export certificates within 20 days of receipt of the request and to charge firms up to $175 for the certificates.

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Authorizing Statute(s): US Code: 21 USC 381 Name of Law: FFDCA
   US Code: 21 USC 382 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

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
CFSAN Export Certificate-Office of Cosmetics and Colors (FDA 3613d)	FDA 3613d	Office of Cosmetics and Colors "Certificate" (Exports) Application
CFSAN Export Certificate-Office of Food Safety (FDA3613e)	FDA 3613e	Food Export Certificate Application
Costs of Certificates	FDA 3613e	Food Export Certificate Application
CBER Export Certificate (FDA 3613, 3613b, 3613c)	FDA 3613, FDA 3613b, FDA 3613c	Supplementary Information Certificate to Foreign Government Requests ,   Supplementary Information Certificate of a Pharmaceutical Product ,   Supplementary Information Non-Clinical Research Use Only Certificate
CDER Export Certificate (FDA 3613b)	FDA 3613b	Supplementary Information Certificate of a Pharmaceutical Product
CDRH Export Certificate (FDA 3613, 3613a, 3613c)	FDA 3613, FDA 3613a, FDA 3613c	Supplementary Information Certificate to Foreign Government Requests ,   Supplementary Information Certificate of Exportability Requests ,   Supplementary Information Non-Clinical Research Use Only Certificate
CVM Export Certificate (FDA 3613, 3613b)	FDA 3613, FDA 3613b	Supplementary Information Certificate to Foreign Government Requests ,   Supplementary Information Certificate of a Pharmaceutical Product
CFSAN Export Certificate-Office of Nutrition, Labeling and Supplements (FDA 3613e)	FDA 3613e	Food Export Certificate Application

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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	78,343	78,343	0	0	0	0
Annual Time Burden (Hours)	50,942	50,942	0	0	0	0
Annual Cost Burden (Dollars)	3,107,462	3,107,462	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:

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Annual Cost to Federal Government: $3,127,732

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: 05/08/2013

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