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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:
201502-0910-003
Status:
Historical Active
Previous ICR Reference No:
201305-0910-001
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:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
03/20/2015
Retrieve Notice of Action (NOA)
Date Received in OIRA:
02/10/2015
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
03/31/2018
36 Months From Approved
03/31/2015
Responses
14,490
0
78,343
Time Burden (Hours)
25,018
0
50,942
Cost Burden (Dollars)
2,535,750
0
3,107,462
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:
79 FR 68277
11/14/2014
30-day Notice:
Federal Register Citation:
Citation Date:
80 FR 6728
02/06/2015
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
3
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 3613b)
FDA 3613b
Supplementary Information Certificate of a Pharmaceutical Product
CDRH Export Certificate (FDA 3613, 3613a, 3613c)
FDA 3613a, FDA 3613c, FDA 3613
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 3613a, FDA 3613b
Supplementary Information Certificate to Foreign Government Requests
,
Supplementary Information Certificate of Exportability 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
14,490
78,343
0
-67,918
4,065
0
Annual Time Burden (Hours)
25,018
50,942
0
-34,054
8,130
0
Annual Cost Burden (Dollars)
2,535,750
3,107,462
0
-2,563,737
1,992,025
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
Yes
Burden Reduction Due to:
Changing Forms
Short Statement:
Program change #1: In addition to the certificates for which we are seeking approval in this ICR FDA also issues export certificates for CDER and CFSAN. Both CDER and CFSAN have initiated their own ICRs for their export certificates as their process has changed based on electronic submission of this information. They each wish to have their ICRs approved separately under different OMB approval numbers. This program change resulted in a decrease for this ICR in responses, total burden and annual cost burden. Program change #2: CVM already had in place the issuance of certificates for animal drugs. In January 2011, section 801(e)(4)(A) was amended by the Food Safety Modernization Act (FSMA) to provide authorization for export certification fees for food and animal feed. This program change resulted in an increase of both respondents and burden hours from 855 to 1,848. Adjustment #1: CDRH experienced an increase in the number of export certificates issued over the past three years. This adjustment resulted in an increase in responses from 6,463 to 10,528 and an increase in burden hours from 12,926 to 21,056. (A difference of 4,065 and 8,130, respectively.) Adjustment #2: Also removed from the list of ICs was the IC entitled, "Cost of Certificates" which was an erroneous entry of 50,942 responses and $3,107,462. This, we believe, was an attempt to record a separate IC for the cost of CFSAN certificates.
Annual Cost to Federal Government:
$3,000,000
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:
Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@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:
02/10/2015
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