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

Forms and Documents

Document Name	Status
Form FDA 3613c CBER Export Certificate (FDA 3613, 3613b, 3613c) Form and Instruction	Unchanged
Form 3613f CDER Export Certificate (FDA 3613f) Form and Instruction	Unchanged
Form FDA 3613 CVM Export Certificate (FDA 3613, 3613b) Form and Instruction	Unchanged
Form FDA 3613 CDRH Export Certificate (FDA 3613, 3613a, 3613c) Form and Instruction	Modified
0498 Emergency Revision Request SEP 2020.docx Supplementary Document	2020-09-16
0498_Supporting Statement.doc Supporting Statement A	2018-03-22

IC Document Collections

IC ID	Document Title	Status
6208	CBER Export Certificate (FDA 3613, 3613b, 3613c) Form and Instruction	Unchanged
217014	CDER Export Certificate (FDA 3613f) Form and Instruction	Unchanged
188597	CVM Export Certificate (FDA 3613, 3613b) Form and Instruction	Unchanged
188596	CDRH Export Certificate (FDA 3613, 3613a, 3613c) Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0498	ICR Reference No: 202009-0910-006
Status: Active	Previous ICR Reference No: 202003-0910-012
Agency/Subagency: HHS/FDA	Agency Tracking No: OC
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: Emergency	Approval Requested By: 09/18/2020
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/29/2020
	Date Received in OIRA: 09/16/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2021	6 Months From Approved	04/30/2021
Responses	19,431	0	19,431
Time Burden (Hours)	30,606	0	30,606
Cost Burden (Dollars)	3,400,425	0	3,400,425

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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.

Emergency Justfication: The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was enacted on March 27, 2020. Section 3856 of the CARES Act contained a provision that made the U.S. Food and Drug Administration (FDA) immediately obligated to review and process requests for certifications for devices not exported from the United States. These new certificates will be issued for products that have received FDA marketing authorization, are exempt from 510(k) or are preamendment, and will be shipped from one foreign country to another without entering U.S. commerce. The Food, Drug, and Cosmetic (FD&C) Act anticipates that FDA will issue certifications within 20 days of the establishment’s request for such documentation, and that FDA will collect fees for such certifications, as set forth in section 801(e)(4) of the FD&C Act.

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Authorizing Statute(s): US Code: 21 USC 382 Name of Law: FFDCA
   PL: Pub.L. 116 - 136 3856 Name of Law: CARES Act
   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

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
CDER Export Certificate (FDA 3613f)	3613f	Request for Certificates of a Pharmaceutical Product for CDER Products
CBER Export Certificate (FDA 3613, 3613b, 3613c)	FDA 3613, FDA 3613a, FDA 3613b, FDA 3613c	Supplementary Information Non-Clinical Research Use Only Certificate ,   Supplementary Information Certificate to Foreign Government Requests ,   Supplementary Information Certificate of Exportability Requests ,   Supplementary Information Certificate of a Pharmaceutical Product
CDRH Export Certificate (FDA 3613, 3613a, 3613c)	FDA 3613a, FDA 3613g, 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 ,   SUPPLEMENTARY INFORMATION CERTIFICATE FOR DEVICE NOT EXPORTED FROM THE UNITED STATES REQUESTS
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

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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	19,431	19,431	0	0	0	0
Annual Time Burden (Hours)	30,606	30,606	0	0	0	0
Annual Cost Burden (Dollars)	3,400,425	3,400,425	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: $3,300,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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? Yes

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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: 09/16/2020

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