Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices

Forms and Documents

Document Name	Status
0577_Supporting Statement.pdf Supporting Statement A	2018-04-12

IC Document Collections

IC ID	Document Title	Status
6300	Establishments listing less than 10 SUDs Other-Guidance	Modified
201993	Establishments listing 10 or more SUDs Other-Guidance	Modified

ICR Details

OMB Control No: 0910-0577	ICR Reference No: 201803-0910-001
Status: Active	Previous ICR Reference No: 201504-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices
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: 06/25/2018
	Date Received in OIRA: 04/13/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2021	36 Months From Approved	06/30/2018
Responses	422	0	422
Time Burden (Hours)	43	0	43
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information from reprocessors of single-use devices (SUDs). If the original SUD or an attachment to it prominently and conspicuously bears the name of the manufacturer, then the reprocessor of the SUD is required to identify itself by name, abbreviation, or symbol, in a prominent and conspicuous manner on the device or attachment to the device. Information concerning the identification of the name of a reprocessor of single-use devices is necessary so that users do not misattribute adverse events associated with a reprocessed device to the original manufacturer. When reporting adverse events involving the use of reprocessed single-use devices, health care providers may mistakenly believe that the reprocessed device is a new product from the original manufacturer of the device and not from the reprocessor. The information and records generated under this labeling requirement will be used so that physicians, hospital staff, and patients can associate a particular device with a particular manufacturer. This is especially important in the event of a recall, warning, patient injury, or product malfunction.

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Authorizing Statute(s): US Code: 21 USC 352(u) Name of Law: null
  

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:
	82 FR 60207	12/19/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 15154	04/09/2018
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
Establishments listing less than 10 SUDs
Establishments listing 10 or more SUDs

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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	422	422	0	0	0	0
Annual Time Burden (Hours)	43	43	0	0	0	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:

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Annual Cost to Federal Government: $3,075,291

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: 04/13/2018

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