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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form FDA 3613c Supplementary Information Non-Clinical Research Use Only Certificate	Form and Instruction	Modified	Available
Form FDA 3613b Supplementary Information Certificate of a Pharmaceutical Product	Form and Instruction	Modified	Repair queued
Form FDA 3613 Supplementary Information Certificate to Foreign Government Requests	Form and Instruction	Modified	Available
Form FDA 3613e Food Export Certificate Application	Form and Instruction	New	Available
Form FDA3613d "Certificate" (Exports) Application	Form and Instruction	New	Repair queued
Form FDA 3613c Supplementary Information Non-Clinical Research Use Only Certificate	Form and Instruction	New	Available
Form FDA 3613b Supplementary Information Certificate of a Pharmaceutical Product	Form and Instruction	New	Repair queued
Form FDA 3613a Supplementary Information Certificate of Exportability Requests	Form and Instruction	New	Available
Form FDA 3613 Supplementary Information Certificate to Foreign Government Requests	Form and Instruction	New	Available
Form FDA 3613e Food Export Certificate Application	Form and Instruction	New	Available
Form FDA 3613d Certificate (Exports) Application-Office of Cosmetics and Colors	Form and Instruction	New	Available
Form FDA 3613e Food Export Certificate Application	Form and Instruction	Modified	Available
Form FDA 3613 Supplementary Information Certificate to Foreign Government Requests	Form and Instruction	Modified	Available
Form FDA 3613b Supplementary Information Certificate of a Pharmaceutical Product	Form and Instruction	Modified	Available
Form FDA 3613c Supplementary Information Non-Clinical Research Use Only Certificate	Form and Instruction	Modified	Available
Form FDA 3613a Supplementary Information Certificdate of Exportability Requests	Form and Instruction	Modified	Available
Form FDA 3613 Supplementary Information Certificate to Foreign Government Requests	Form and Instruction	Modified	Available
Form FDA 3613b Supplementary Information Certificate of a Pharmaceutical Product	Form and Instruction	Modified	Available
0498_ss_8-20-10 HHS requested change 9-30-10.doc	Supporting Statement A	Uploaded 2010-09-30	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
6208	CBER Export Certificate (FDA 3613, 3613b, 3613c)	Form and Instruction	Modified	Supplementary Information Non-Clinical Research Use Only Certificate
6208	CBER Export Certificate (FDA 3613, 3613b, 3613c)	Form and Instruction	Modified	Supplementary Information Certificate of a Pharmaceutical Product
6208	CBER Export Certificate (FDA 3613, 3613b, 3613c)	Form and Instruction	Modified	Supplementary Information Certificate to Foreign Government Requests
194830	Costs of certificates	Form and Instruction	New	Food Export Certificate Application
194830	Costs of certificates	Form and Instruction	New	"Certificate" (Exports) Application
194830	Costs of certificates	Form and Instruction	New	Supplementary Information Non-Clinical Research Use Only Certificate
194830	Costs of certificates	Form and Instruction	New	Supplementary Information Certificate of a Pharmaceutical Product
194830	Costs of certificates	Form and Instruction	New	Supplementary Information Certificate of Exportability Requests
194830	Costs of certificates	Form and Instruction	New	Supplementary Information Certificate to Foreign Government Requests
194829	CFSAN Export Certificate-Office of Food Safety (FDA 3613e)	Form and Instruction	New	Food Export Certificate Application
194828	CFSAN Export Certificate-Office of Cosmetics and Colors (FDA 3613d)	Form and Instruction	New	Certificate (Exports) Application-Office of Cosmetics and Colors
188598	CFSAN Export Certificate-Office of Nutrition, Labeling and Supplements (FDA 3613e)	Form and Instruction	Modified	Food Export Certificate Application
188597	CVM Export Certificate (FDA 3613, 3613b)	Form and Instruction	Modified	Supplementary Information Certificate to Foreign Government Requests
188597	CVM Export Certificate (FDA 3613, 3613b)	Form and Instruction	Modified	Supplementary Information Certificate of a Pharmaceutical Product
188596	CDRH Export Certificate (FDA 3613, 3613a, 3613c)	Form and Instruction	Modified	Supplementary Information Non-Clinical Research Use Only Certificate
188596	CDRH Export Certificate (FDA 3613, 3613a, 3613c)	Form and Instruction	Modified	Supplementary Information Certificdate of Exportability Requests
188596	CDRH Export Certificate (FDA 3613, 3613a, 3613c)	Form and Instruction	Modified	Supplementary Information Certificate to Foreign Government Requests
188595	CDER Export Certificate (FDA 3613b)	Form and Instruction	Modified	Supplementary Information Certificate of a Pharmaceutical Product

ICR Details

OMB Control No: 0910-0498	ICR Reference No: 201010-0910-002
Status: Historical Inactive	Previous ICR Reference No: 200903-0910-006
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: Improperly submitted and continue	Conclusion Date: 12/08/2010
Retrieve Notice of Action (NOA)	Date Received in OIRA: 10/12/2010
Terms of Clearance: Under the terms of 5 CFR 1320, OMB considers this collection to have been improperly submitted. FDA has failed to meet the previously established terms of clearance. The Agency has neither made this collection available electronically, nor has it submitted to OMB a timeline for coming into compliance with GEPA. Please resubmit with a detailed timeline for GEPA compliance.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2010	36 Months From Approved	12/31/2010
Responses	24,272	0	24,272
Time Burden (Hours)	39,333	0	39,333
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:
	75 FR 16137	03/31/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 61495	10/05/2010
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
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 Certificdate of Exportability Requests ,   Supplementary Information Non-Clinical Research Use Only Certificate
CFSAN Export Certificate-Office of Cosmetics and Colors (FDA 3613d)	FDA 3613d	Certificate (Exports) Application-Office of Cosmetics and Colors
CFSAN Export Certificate-Office of Food Safety (FDA 3613e)	FDA 3613e	Food Export Certificate Application
CFSAN Export Certificate-Office of Nutrition, Labeling and Supplements (FDA 3613e)	FDA 3613e	Food Export Certificate Application
CVM Export Certificate (FDA 3613, 3613b)	FDA 3613, FDA 3613b	Supplementary Information Certificate to Foreign Government Requests ,   Supplementary Information Certificate of a Pharmaceutical Product
Costs of certificates	FDA 3613, FDA 3613a, FDA 3613b, FDA 3613c, FDA3613d, FDA 3613e	Supplementary Information Certificate to Foreign Government Requests ,   Supplementary Information Certificate of Exportability Requests ,   Supplementary Information Certificate of a Pharmaceutical Product ,   Supplementary Information Non-Clinical Research Use Only Certificate ,   "Certificate" (Exports) Application ,   Food Export Certificate Application

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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: 10/12/2010

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