Export Certificates for FDA Regulated Products

Forms and Documents

Document Name	Status
Form FDA 3613 CBER Export Certificate (FDA 3613, 3613b, 3613c) 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 Export Certs--83C correcting CDNE form (FDA 3613g)-- 09-01-22.docx Justification for No Material/Nonsubstantive Change	2022-09-06
0498 Export Certs SSA REV 2021.docx Supporting Statement A	2021-03-03
0498 Emergency Revision Request SEP 2020.docx Supplementary Document	2020-09-16

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) Other-Screenshots of electronic submission of API Drug	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: 202208-0910-015
Status: Received in OIRA	Previous ICR Reference No: 202101-0910-012
Agency/Subagency: HHS/FDA	Agency Tracking No: OC
Title: Export Certificates for FDA Regulated Products
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/07/2022

	Requested	Previously Approved
Expiration Date	04/30/2024	04/30/2024
Responses	19,431	19,431
Time Burden (Hours)	30,606	30,606
Cost Burden (Dollars)	3,400,425	3,400,425

---

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.

---

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

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 83091	12/21/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 83091	12/21/2020
Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
CBER Export Certificate (FDA 3613, 3613b, 3613c)	FDA 3613b, FDA 3613, FDA 3613a, 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 3613f)	FDA 3613f	REQUEST FOR CERTIFICATE OF A PHARMACEUTICAL PRODUCT FOR CDER PRODUCTS
CDRH Export Certificate (FDA 3613, 3613a, 3613c)	FDA 3613, FDA 3613a, FDA 3613g, FDA 3613c	Supplementary Information Certificate to Foreign Government Requests ,   Supplementary Information Certificate of Exportability Requests ,   Supplementary Information Non-Clinical Research Use Only Certificate ,   Certificate for Device Not Exported from the United States Requests
CVM Export Certificate (FDA 3613, 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

---

ICR Summary of Burden

	Total Request	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:

---

Annual Cost to Federal Government: $0

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

---

Common Form ICR:  No

---

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: 09/07/2022

---