View Information Collection Request (ICR) Package
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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:
0910-0021
ICR Reference No:
202408-0910-010
Status:
Active
Previous ICR Reference No:
202205-0910-007
Agency/Subagency:
HHS/FDA
Agency Tracking No:
HFP
Title:
Interstate Shellfish Dealer's Certificate
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
07/29/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/26/2025
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
07/31/2028
36 Months From Approved
07/31/2025
Responses
2,363
0
2,293
Time Burden (Hours)
266
0
231
Cost Burden (Dollars)
0
0
0
Abstract:
The information collected is used to compile, publish, and distribute a listing of approved sources of State and international certified shellfish dealers/shippers. Individual State food control officials and the food industry use the list to determine certified sources of shellfish. The information collection is also used to collect samples of shellfish along with associated sample metadata. We administer the collection in an effort to help prevent and suppress the spread of communicable diseases through shellfish, which pose a unique public health concern in that the safety of molluscan shellfish directly reflects the cleanliness of the waters where they are grown.
Authorizing Statute(s):
US Code:
42 USC 243
Name of Law: Public Health and Welfare; Federal-State Cooperation
US Code:
21 USC 372
Name of Law: FFDCA; Examinatins and Investigations
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:
89 FR 103832
12/19/2024
30-day Notice:
Federal Register Citation:
Citation Date:
90 FR 26308
06/20/2025
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
Interstate Shellfish Dealer's Certificate
3038, 3038 - p 2
Interstate Shellfish Dealer’s Certificate
,
Interstate Shellfish Dealer’s Certificate
Submission of NSSP Compliance Documentation
Form FDA 3038
Interstate Shellfish Dealer's Certificate
Submission of Samples and Analytical Results
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
2,363
2,293
0
70
0
0
Annual Time Burden (Hours)
266
231
0
35
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
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:
No
Burden Reduction Due to:
Short Statement:
The information collection reflects program changes. We have added the submission of samples and associated information as a third element to the information collection and have therefore increased our burden estimate by 35 hours and 70 responses annually. We have made no adjustments to the remaining to collection elements.
Annual Cost to Federal Government:
$93,092
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?
No
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:
06/26/2025
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