Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications

Forms and Documents

Document Name	Status
0523_Supporting Statement.doc Supporting Statement A	2016-09-06

IC Document Collections

IC ID	Document Title	Status
6241	Request for designation	Modified

ICR Details

OMB Control No: 0910-0523	ICR Reference No: 201608-0910-013
Status: Historical Active	Previous ICR Reference No: 201308-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: OC
Title: Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/06/2016
	Date Received in OIRA: 09/07/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2019	36 Months From Approved	12/31/2016
Responses	84	0	59
Time Burden (Hours)	2,016	0	1,416
Cost Burden (Dollars)	0	0	0

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Abstract: The ICR collects information from sponsors who wish to obtain a determination from the Agency classification and primary jurisdiction of a medical product. Sponsors submit information as provided in Agency regulations regarding combination products, including description of the product, proposed use or indications, description of all known modes of action, etc. The information submitted is reviewed so that a classification and jurisdiction determination can be made.

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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:
	81 FR 46935	01/28/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 61223	09/06/2016
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
Request for designation

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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	84	59	0	0	25	0
Annual Time Burden (Hours)	2,016	1,416	0	0	600	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: FDA has adjusted the total number of responses (an increase of 25 responses) and the total annual hour burden (an increase of 600 hours). The increase is due to the number of respondents who submitted requests for designation over the past three years. There was an adjusted increase of $63,850.80 (previously $134,826) to the total annual cost to the Federal Government due to the increase of responses.

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Annual Cost to Federal Government: $198,676

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

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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: 09/07/2016

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