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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0498
ICR Reference No:
202303-0910-018
Status:
Active
Previous ICR Reference No:
202208-0910-015
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
OIRA Conclusion Action:
Approved without change
Conclusion Date:
03/31/2023
Retrieve Notice of Action (NOA)
Date Received in OIRA:
03/27/2023
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
04/30/2024
04/30/2024
04/30/2024
Responses
19,431
0
19,431
Time Burden (Hours)
30,606
0
30,606
Cost Burden (Dollars)
3,400,425
0
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 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, 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 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:
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
Agency Contact:
Rachel Showalter 202 693-2146 Showalter.Rachel@dol.gov
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:
03/27/2023
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