Interstate Shellfish Dealer's Certificate

Forms and Documents

Document Name	Status
Form 3038 Interstate Shellfish Dealer's Certificate Form	Modified
Form Form FDA 3038 Submission of NSSP Compliance Documentation Form and Instruction	Modified
0021 Shellfish SSA June 2025 REV.docx Supporting Statement A	2025-06-26

IC Document Collections

IC ID	Document Title	Status
5675	Interstate Shellfish Dealer's Certificate Form	Modified
272319	Submission of Samples and Analytical Results	New
235825	Submission of NSSP Compliance Documentation Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0021	ICR Reference No: 202408-0910-010
Status: Received in OIRA	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	Date Submitted to OIRA: 06/26/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	06/30/2025
Responses	2,363	2,293
Time Burden (Hours)	266	231
Cost Burden (Dollars)	0	0

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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.

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Authorizing Statute(s): US Code: 21 USC 372 Name of Law: FFDCA; Examinatins and Investigations
   US Code: 42 USC 243 Name of Law: Public Health and Welfare; Federal-State Cooperation
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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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

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ICR Summary of Burden

	Total Request	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.

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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

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Common Form ICR:  No

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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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