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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:
201305-0910-001
Status:
Historical Active
Previous ICR Reference No:
201210-0910-004
Agency/Subagency:
HHS/FDA
Agency Tracking No:
19441
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 with change
Conclusion Date:
05/20/2013
Retrieve Notice of Action (NOA)
Date Received in OIRA:
05/08/2013
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
03/31/2015
03/31/2015
03/31/2015
Responses
78,343
0
78,343
Time Burden (Hours)
50,942
0
50,942
Cost Burden (Dollars)
3,107,462
0
3,107,462
Abstract:
Section 801(e)(4) of the act provides that persons exporting certain FDA-regulated products may request FDA to certify that the products meet the requirements of Sections 801(e) or 802 of the FD&C Act, or other requirements of the act. This section of the law requires FDA to issue export certificates within 20 days of receipt of the request and to charge firms up to $175 for the certificates.
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
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
8
IC Title
Form No.
Form Name
CBER Export Certificate (FDA 3613, 3613b, 3613c)
FDA 3613, FDA 3613b, FDA 3613c
Supplementary Information Certificate to Foreign Government Requests
,
Supplementary Information Certificate of a Pharmaceutical Product
,
Supplementary Information Non-Clinical Research Use Only Certificate
CDER Export Certificate (FDA 3613b)
FDA 3613b
Supplementary Information Certificate of a Pharmaceutical Product
CDRH Export Certificate (FDA 3613, 3613a, 3613c)
FDA 3613, FDA 3613a, FDA 3613c
Supplementary Information Certificate to Foreign Government Requests
,
Supplementary Information Certificate of Exportability Requests
,
Supplementary Information Non-Clinical Research Use Only Certificate
CFSAN Export Certificate-Office of Cosmetics and Colors (FDA 3613d)
FDA 3613d
Office of Cosmetics and Colors "Certificate" (Exports) Application
CFSAN Export Certificate-Office of Food Safety (FDA3613e)
FDA 3613e
Food Export Certificate Application
CFSAN Export Certificate-Office of Nutrition, Labeling and Supplements (FDA 3613e)
FDA 3613e
Food Export Certificate Application
CVM Export Certificate (FDA 3613, 3613b)
FDA 3613, FDA 3613b
Supplementary Information Certificate to Foreign Government Requests
,
Supplementary Information Certificate of a Pharmaceutical Product
Costs of Certificates
FDA 3613e
Food Export Certificate Application
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
78,343
78,343
0
0
0
0
Annual Time Burden (Hours)
50,942
50,942
0
0
0
0
Annual Cost Burden (Dollars)
3,107,462
3,107,462
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:
$3,127,732
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
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:
Domini Bean 301 796-5733 domini.bean@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:
05/08/2013
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