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Certification
View Information Collection (IC) List
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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:
202003-0910-012
Status:
Historical Active
Previous ICR Reference No:
201801-0910-007
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:
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:
03/25/2020
Retrieve Notice of Action (NOA)
Date Received in OIRA:
03/19/2020
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
04/30/2021
04/30/2021
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
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.
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
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:
82 FR 56031
11/27/2017
30-day Notice:
Federal Register Citation:
Citation Date:
83 FR 7195
02/20/2018
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 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 3613f)
3613f
Request for Certificates of a Pharmaceutical Product for CDER Products
CDRH Export Certificate (FDA 3613, 3613a, 3613c)
FDA 3613c, FDA 3613, FDA 3613a
Supplementary Information Certificate to Foreign Government Requests
,
Supplementary Information Certificate of Exportability Requests
,
Supplementary Information Non-Clinical Research Use Only Certificate
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
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:
$3,000,000
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?
Uncollected
Agency Contact:
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.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:
03/19/2020
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