Export Certificates for FDA Regulated Products

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form FDA 3613g Certificate To Foreign Government For Device Not Exported From the United States Requests	Form and Instruction	Modified	Available
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	Available
Form FDA 3613a Supplementary Information Certificate of Exportability Requests	Form and Instruction	Modified	Repair queued
Form FDA 3613 Supplementary Information Certificate to Foreign Government Requests	Form and Instruction	Modified	Available
Form FDA 3613 CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g)	Form and Instruction	Modified	Repair queued
Form FDA 3613f REQUEST FOR CERTIFICATE OF A PHARMACEUTICAL PRODUCT FOR CDER PRODUCTS	Form and Instruction	Modified	Available
Form FDA 3613 Request for Certificate Supplementary Information	Form and Instruction	Modified	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 3613 CVM Export Certificate (FDA 3613, 3613a, 3613b)	Form and Instruction	Modified	Repair queued
Form FDA 3613g Certificate To Foreign Government For Device Not Exported From the United States 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 3613 CDRH Export Certificate (FDA 3613, 3613a, 3613c and 3613g)	Form and Instruction	Modified	Repair queued
21 USC 381 Exports under FFDCA.pdf	Supplementary Document	Uploaded 2023-03-25	Repair queued
0498 Export Certs 83-C for 3613g MARCH 2023.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2023-03-25	Repair queued
0498ExportCertsSSA 03-04-24.docx	Supporting Statement A	Uploaded 2024-03-04	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
6208	CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g)	Form and Instruction	Modified	Certificate To Foreign Government For Device Not Exported From the United States Requests
6208	CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g)	Form and Instruction	Modified	Supplementary Information Non-Clinical Research Use Only Certificate
6208	CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g)	Form and Instruction	Modified	Supplementary Information Certificate of a Pharmaceutical Product
6208	CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g)	Form and Instruction	Modified	Supplementary Information Certificate of Exportability Requests
6208	CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g)	Form and Instruction	Modified	Supplementary Information Certificate to Foreign Government Requests
6208	CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g)	Form and Instruction	Modified
217014	CDER Export Certificate (FDA 3613f)	Form and Instruction	Modified	REQUEST FOR CERTIFICATE OF A PHARMACEUTICAL PRODUCT FOR CDER PRODUCTS
217014	CDER Export Certificate (FDA 3613f)	Other-Screenshots of electronic submission of API Drug	Modified
188597	CVM Export Certificate (FDA 3613, 3613a, 3613b)	Form and Instruction	Modified	Request for Certificate Supplementary Information
188597	CVM Export Certificate (FDA 3613, 3613a, 3613b)	Form and Instruction	Modified	SUPPLEMENTARY INFORMATION CERTIFICATE OF A PHARMACEUTICAL PRODUCT
188597	CVM Export Certificate (FDA 3613, 3613a, 3613b)	Form and Instruction	Modified	SUPPLEMENTARY INFORMATION CERTIFICATE OF EXPORTABILITY REQUESTS
188597	CVM Export Certificate (FDA 3613, 3613a, 3613b)	Form and Instruction	Modified	SUPPLEMENTARY INFORMATION CERTIFICATE TO FOREIGN GOVERNMENT REQUESTS
188597	CVM Export Certificate (FDA 3613, 3613a, 3613b)	Form and Instruction	Modified
188596	CDRH Export Certificate (FDA 3613, 3613a, 3613c and 3613g)	Form and Instruction	Modified	Certificate To Foreign Government For Device Not Exported From the United States Requests
188596	CDRH Export Certificate (FDA 3613, 3613a, 3613c and 3613g)	Form and Instruction	Modified	Supplementary Information Non-Clinical Research Use Only Certificate
188596	CDRH Export Certificate (FDA 3613, 3613a, 3613c and 3613g)	Form and Instruction	Modified	Supplementary Information Certificate of Exportability Requests
188596	CDRH Export Certificate (FDA 3613, 3613a, 3613c and 3613g)	Form and Instruction	Modified	Supplementary Information Certificate to Foreign Government Requests
188596	CDRH Export Certificate (FDA 3613, 3613a, 3613c and 3613g)	Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0498	ICR Reference No: 202308-0910-003
Status: Active	Previous ICR Reference No: 202303-0910-018
Agency/Subagency: HHS/FDA	Agency Tracking No: CROSS CENTER
Title: Export Certificates for FDA Regulated Products
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/04/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 04/29/2024
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2027	36 Months From Approved	06/30/2024
Responses	24,533	0	19,431
Time Burden (Hours)	35,708	0	30,606
Cost Burden (Dollars)	4,293,275	0	3,400,425

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Abstract: This information collection supports FDA's export certificate program established under authority of sections 801(e)(4) and 802 of the Federal, Food, Drug, and Cosmetic Act. Respondents to the collection are those seeking to obtain export certificates for FDA-regulated products. We have developed associated forms, and fees not to exceed $175 per certificate may apply.

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Authorizing Statute(s): PL: Pub.L. 116 - 136 3856 Name of Law: CARES Act
   US Code: 21 USC 381; 382 Name of Law: FFDCA; Imports/Exports; Exports of Unapproved Products
  

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:
	88 FR 73349	10/25/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 14882	02/29/2024
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g)	FDA 3613b, FDA 3613, FDA 3613a, FDA 3613c, FDA 3613g	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 To Foreign Government For Device Not Exported From the United States Requests
CDER Export Certificate (FDA 3613f)	FDA 3613f	REQUEST FOR CERTIFICATE OF A PHARMACEUTICAL PRODUCT FOR CDER PRODUCTS
CDRH Export Certificate (FDA 3613, 3613a, 3613c and 3613g)	FDA 3613, FDA 3613a, FDA 3613c, FDA 3613g	Supplementary Information Certificate to Foreign Government Requests ,   Supplementary Information Certificate of Exportability Requests ,   Supplementary Information Non-Clinical Research Use Only Certificate ,   Certificate To Foreign Government For Device Not Exported From the United States Requests
CVM Export Certificate (FDA 3613, 3613a, 3613b)	FDA 3613, FDA 3613b, FDA 3613, FDA 3613a	SUPPLEMENTARY INFORMATION CERTIFICATE TO FOREIGN GOVERNMENT REQUESTS ,   SUPPLEMENTARY INFORMATION CERTIFICATE OF EXPORTABILITY REQUESTS ,   SUPPLEMENTARY INFORMATION CERTIFICATE OF A PHARMACEUTICAL PRODUCT ,   Request for Certificate Supplementary Information

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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	24,533	19,431	0	0	5,102	0
Annual Time Burden (Hours)	35,708	30,606	0	0	5,102	0
Annual Cost Burden (Dollars)	4,293,275	3,400,425	0	0	892,850	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: The estimated burden for the information collection reflects an overall adjustment increase of 5,102 hours and a corresponding increase of 5,102 responses. The increase in CDER export application requests is attributable to the implementation of the eCPP and an increase in drug exports. The increase is offset by a decrease in CVM and CBER export applications attributable to consequences of the pandemic. In addition, revised form instructions related to medical device products are included in the information collection request.

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Annual Cost to Federal Government: $5,000,000

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? No

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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: 04/29/2024

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