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	Repair queued
Form FDA 3613b Supplementary Information Certificate of a Pharmaceutical Product	Form and Instruction	Modified	Available
Form FDA 3613a Supplementary Information Certificate 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 3613e Food Export Certificate Application	Form and Instruction	Removed	Available
Form FDA 3613e Food Export Certificate Application	Form and Instruction	Removed	Available
Form FDA 3613d Office of Cosmetics and Colors "Certificate" (Exports) Application	Form and Instruction	Removed	Repair queued
Form FDA 3613e Food Export Certificate Application	Form and Instruction	Removed	Available
Form FDA 3613b Supplementary Information Certificate of a Pharmaceutical Product	Form and Instruction	Modified	Available
Form FDA 3613a Supplementary Information Certificate 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 3613c Supplementary Information Non-Clinical Research Use Only Certificate	Form and Instruction	Modified	Available
Form FDA 3613a Supplementary Information Certificate 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	Removed	Available
0498 ss 2-5-15.doc	Supporting Statement A	Uploaded 2015-02-06	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 of Exportability Requests
6208	CBER Export Certificate (FDA 3613, 3613b, 3613c)	Form and Instruction	Modified	Supplementary Information Certificate to Foreign Government Requests
201669	Costs of Certificates	Form and Instruction	Removed	Food Export Certificate Application
201668	CFSAN Export Certificate-Office of Food Safety (FDA3613e)	Form and Instruction	Removed	Food Export Certificate Application
201667	CFSAN Export Certificate-Office of Cosmetics and Colors (FDA 3613d)	Form and Instruction	Removed	Office of Cosmetics and Colors "Certificate" (Exports) Application
188598	CFSAN Export Certificate-Office of Nutrition, Labeling and Supplements (FDA 3613e)	Form and Instruction	Removed	Food Export Certificate Application
188597	CVM Export Certificate (FDA 3613, 3613b)	Form and Instruction	Modified	Supplementary Information Certificate of a Pharmaceutical Product
188597	CVM Export Certificate (FDA 3613, 3613b)	Form and Instruction	Modified	Supplementary Information Certificate of Exportability Requests
188597	CVM Export Certificate (FDA 3613, 3613b)	Form and Instruction	Modified	Supplementary Information Certificate to Foreign Government Requests
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 Certificate 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	Removed	Supplementary Information Certificate of a Pharmaceutical Product

ICR Details

OMB Control No: 0910-0498	ICR Reference No: 201502-0910-003
Status: Historical Active	Previous ICR Reference No: 201305-0910-001
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: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/20/2015
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/10/2015
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2018	36 Months From Approved	03/31/2015
Responses	14,490	0	78,343
Time Burden (Hours)	25,018	0	50,942
Cost Burden (Dollars)	2,535,750	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 that FDA certify that the products meet the requirements of sections 801(e) or 802 or other requirements of the Act. The Act does not require FDA to issue certificates for food, including animal feeds, food and feed additives, and dietary supplements, or cosmetics. However, since foreign governments may require certificates for these types of products, the agency intends to continue to provide this service as resources permit. Section 801(e)(4) of the Act also provides that FDA may charge a fee of up to $175 if FDA issues a certificate within 20 days of receipt of a complete request for such a certificate. This fee may vary depending on the product type, but it will not exceed $175.

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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
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 68277	11/14/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 6728	02/06/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

table that charts list of burden

IC Title	Form No.	Form Name
CBER Export Certificate (FDA 3613, 3613b, 3613c)	FDA 3613, FDA 3613a, FDA 3613b, FDA 3613c	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
CDER Export Certificate (FDA 3613b)	FDA 3613b	Supplementary Information Certificate of a Pharmaceutical Product
CDRH Export Certificate (FDA 3613, 3613a, 3613c)	FDA 3613a, FDA 3613c, FDA 3613	Supplementary Information Certificate to Foreign Government Requests ,   Supplementary Information Certificate of Exportability Requests ,   Supplementary Information Non-Clinical Research Use Only Certificate
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
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 3613a, FDA 3613b	Supplementary Information Certificate to Foreign Government Requests ,   Supplementary Information Certificate of Exportability Requests ,   Supplementary Information Certificate of a Pharmaceutical Product
Costs of Certificates	FDA 3613e	Food Export Certificate Application

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ICR Summary of Burden

table that charts list 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	14,490	78,343	0	-67,918	4,065	0
Annual Time Burden (Hours)	25,018	50,942	0	-34,054	8,130	0
Annual Cost Burden (Dollars)	2,535,750	3,107,462	0	-2,563,737	1,992,025	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: Changing Forms

Short Statement: Program change #1: In addition to the certificates for which we are seeking approval in this ICR FDA also issues export certificates for CDER and CFSAN. Both CDER and CFSAN have initiated their own ICRs for their export certificates as their process has changed based on electronic submission of this information. They each wish to have their ICRs approved separately under different OMB approval numbers. This program change resulted in a decrease for this ICR in responses, total burden and annual cost burden. Program change #2: CVM already had in place the issuance of certificates for animal drugs. In January 2011, section 801(e)(4)(A) was amended by the Food Safety Modernization Act (FSMA) to provide authorization for export certification fees for food and animal feed. This program change resulted in an increase of both respondents and burden hours from 855 to 1,848. Adjustment #1: CDRH experienced an increase in the number of export certificates issued over the past three years. This adjustment resulted in an increase in responses from 6,463 to 10,528 and an increase in burden hours from 12,926 to 21,056. (A difference of 4,065 and 8,130, respectively.) Adjustment #2: Also removed from the list of ICs was the IC entitled, "Cost of Certificates" which was an erroneous entry of 50,942 responses and $3,107,462. This, we believe, was an attempt to record a separate IC for the cost of CFSAN certificates.

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Annual Cost to Federal Government: $3,000,000

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: 02/10/2015

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