Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices

ICR 201202-0910-003

OMB: 0910-0577

Federal Form Document

Forms and Documents
Supporting Statement A
IC Document Collections
ICR Details
0910-0577 201202-0910-003
Historical Active 200902-0910-002
Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices
Extension without change of a currently approved collection   No
Approved with change 05/11/2012
Retrieve Notice of Action (NOA) 02/07/2012
  Inventory as of this Action Requested Previously Approved
05/31/2015 36 Months From Approved 05/31/2012
404 0 1,000
40 0 100
0 0 0

This information collection covers the third-party disclosures associated with section 502 (21 U.S.C. 352) of the Federal Food, Drug, and Cosmetic Act, which, among other things, establishes requirements that the label or labeling of a medical device must meet so that it is not misbranded and subject to regulatory action.

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

Not associated with rulemaking

  76 FR 59704 09/27/2011
77 FR 5812 02/06/2012

IC Title Form No. Form Name
Establishments listing less than 10 SUDs
Establishments listing 10 or more SUDs

  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 404 1,000 0 0 -596 0
Annual Time Burden (Hours) 40 100 0 0 -60 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
The number of disclosures has decreased from 1,000 to 404 due to a decrease in the number of SUDs listed by reprocessors. This adjustment has resulted in a 60-hour decrease of the total hour burden.

Daniel Gitteson 3017965156 [email protected]


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:
    (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;
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.

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