Product Jurisdiction and Combination Products

Forms and Documents

Document Name	Status
Form FDA 5003 Requests for Designations: Combination Products reporting and records Form and Instruction	Modified
0523 Product Jursdication Combo Products SSA 2023 EXT.docx Supporting Statement A	2023-11-30
0845 GFI Combo Products Pre RFD FEB 2018.pdf Supplementary Document	2020-10-27
0523 Change Request for 0845 OCT 2020.docx Justification for No Material/Nonsubstantive Change	2020-10-27

IC Document Collections

IC ID	Document Title	Status
6241	Requests for Designations: Combination Products reporting and records Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0523	ICR Reference No: 202311-0910-014
Status: Received in OIRA	Previous ICR Reference No: 202011-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: OC
Title: Product Jurisdiction and Combination Products
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 11/30/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2023
Responses	135	139
Time Burden (Hours)	3,243	3,339
Cost Burden (Dollars)	0	0

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Abstract: The information collection supports sponsor requests to obtain classification and primary jurisdiction designation for a product intended for FDA review. Upon determination of jurisdiction sponsors may submit appropriate marketing applications in accordance with applicable regulations.

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Authorizing Statute(s): US Code: 21 USC 301 Name of Law: FFDCA
  

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:
	88 FR 49467	07/31/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 83554	11/30/2023
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Requests for Designations: Combination Products reporting and records	FDA 5003, FDA 5004, FDA 5005	REQUEST FOR DESIGNATION ,   Pre-REQUEST FOR DESIGNATION-INFORMAL SUBMISSION ,   Pre RFD - Supplemental

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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	135	139	0	0	-4	0
Annual Time Burden (Hours)	3,243	3,339	0	0	-96	0
Annual Cost Burden (Dollars)	0	0	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: The information collection reflects changes and adjustments. As discussed in Question 1, Form FDA 5005 has been discontinued and all of its information consolidated into Form FDA 5004. We also saw an increase in the average number of RFD and a decrease in the average number of pre-FRD submissions received annually, which results in an overall decrease of 4 annual submissions and 96 corresponding burden hours.

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Annual Cost to Federal Government: $371,412

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.     Yes

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: 11/30/2023

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