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

Forms and Documents

Document Name	Status
Form FDA 3613a Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802 Form and Instruction	Modified
Form FDA 3613a Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802 Form and Instruction	New
Form FDA 3613a Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802 Form and Instruction	New
Form FDA 3613b Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802 Form and Instruction	New
Form FDA 3613a Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802 Form and Instruction	New
0498 ss 2-18-09.doc Supporting Statement A	2009-03-04

IC Document Collections

IC ID	Document Title	Status
6208	Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802 Form and Instruction	Modified
188598	Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802 Form and Instruction	New
188597	Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802 Form and Instruction	New
188596	Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802 Form and Instruction	New
188595	Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802 Form and Instruction	New

ICR Details

OMB Control No: 0910-0498	ICR Reference No: 200903-0910-006
Status: Historical Active	Previous ICR Reference No: 200601-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802
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: 05/29/2009
	Date Received in OIRA: 03/30/2009
Terms of Clearance: Previous terms of clearance stated "FDA shall make this collection electronically submittable as soon as possible to be in compliance with the Government Paperwork Elimination Act." Three years later, these forms are still not electronically submittable. Therefore, clearance is provided for 18 months. Upon resubmission, FDA should provide a timeframe under which FDA expects to come into compliance with the GPEA.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2010	36 Months From Approved	05/31/2009
Responses	24,272	0	14,213
Time Burden (Hours)	39,333	0	21,170
Cost Burden (Dollars)	0	0	0

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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 382 Name of Law: FFDCA
   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 76655	12/17/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 9247	03/03/2009
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802	FDA 3613a, FDA 3613, FDA 3613d, FDA 3613e, FDA 3613b, FDA 3613c	Supplementary Information Certificate of Exportability Requests ,   Supplementary Information Certificate to Foreign Government Requests ,   Supplementary Information Certificate of a Pharmaceutical Product ,   Supplementary Information Non-Clinical Research Use Only Certificate ,   Office of Cosmetics and Colors "Certificate" Export Application ,   Food Export Certificate Application
Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802	FDA 3613a, FDA 3613, FDA 3613b, FDA 3613c, FDA 3613d, FDA 3613e	Supplementary Information Certificate of Exportability Requests ,   Supplementary Information Certificate to Foreign Government Requests ,   Supplementary Information Certificate of a Pharmaceutical Product ,   Supplementary Information Non-Clinical Research Use Only Certificate ,   Office of Cosmetics and Colors "Certificate" Export Application ,   Food Export Certificate Application
Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802	FDA 3613a, FDA 3613, FDA 3613b, FDA 3613c, FDA 3613d, FDA 3613e	Supplementary Information Certificate of a Pharmaceutical Product ,   Supplementary Information Non-Clinical Research Use Only Certificate ,   Office of Cosmetics and Colors "Certificate" Export Application ,   Food Export Certificate Application ,   Supplementary Information Certificate of Exportability Requests ,   Supplementary Information Certificate to Foreign Government Requests
Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802	FDA 3613a, FDA 3613, FDA 3613b, FDA 3613c, FDA 3613d, FDA 3613e	Supplementary Information Certificate of Exportability Requests ,   Supplementary Information Certificate to Foreign Government Requests ,   Supplementary Information Certificate of a Pharmaceutical Product ,   Supplementary Information Non-Clinical Research Use Only Certificate ,   Office of Cosmetics and Colors "Certificate" Export Application ,   Food Export Certificate Application
Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802	FDA 3613b, FDA 3613c, FDA 3613d, FDA 3613e, FDA 3613a, FDA 3613	Supplementary Information Certificate of Exportability Requests ,   Supplementary Information Certificate to Foreign Government Requests ,   Supplementary Information Certificate of a Pharmaceutical Product ,   Supplementary Information Non-Clinical Research Use Only Certificate ,   Office of Cosmetics and Colors "Certificate" Export Application ,   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	24,272	14,213	0	0	10,059	0
Annual Time Burden (Hours)	39,333	21,170	0	0	18,163	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:

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Annual Cost to Federal Government: $423,500

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)? 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: 03/30/2009

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