Interstate Shellfish Dealer's Certificate

Forms and Documents

Document Name	Status
Form Form FDA 3038 Interstate Shellfish Dealer's Certificate Form and Instruction	Modified
Form Form FDA 3038 Submission of NSSP Compliance Documentation Form and Instruction	New
0021 NSSP Equivalence Determination Molluscan Shellfish Notice 9 MARCH 2018.pdf Supplementary Document	2019-04-24
0021 Shellfish SSA 2019 Final.pdf Supporting Statement A	2019-04-24

IC Document Collections

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

ICR Details

OMB Control No: 0910-0021	ICR Reference No: 201903-0910-001
Status: Active	Previous ICR Reference No: 201603-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
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: 05/30/2019
	Date Received in OIRA: 04/24/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2022	36 Months From Approved	05/31/2019
Responses	2,293	0	2,280
Time Burden (Hours)	231	0	228
Cost Burden (Dollars)	0	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. 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:
	83 FR 26699	06/08/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 17170	04/24/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Submission of NSSP Compliance Documentation	Form FDA 3038	Interstate Shellfish Dealer's Certificate
Interstate Shellfish Dealer's Certificate	Form FDA 3038	Interstate Shellfish Dealer's Certificate

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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	2,293	2,280	0	13	0	0
Annual Time Burden (Hours)	231	228	0	3	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 is being revised to introduce a program change. This is discussed more fully in our supporting statement at questions 1, 8, and 15.

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Annual Cost to Federal Government: $40,720

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

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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: 04/24/2019

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