View Information Collection Request (ICR) Package
Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
Agenda
Reg Review
ICR
This script is used to control the display of information in this page.
Display additional information by clicking on the following:
All
Brief and OIRA conclusion
Abstract/Justification
Legal Statutes
Rulemaking
FR Notices/Comments
IC List
Burden
Misc.
Common Form Info.
Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0485
ICR Reference No:
201808-0910-008
Status:
Historical Active
Previous ICR Reference No:
201501-0910-005
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDRH
Title:
Medical Device Labeling Regulations
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:
10/15/2018
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/13/2018
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
10/31/2021
36 Months From Approved
10/31/2018
Responses
81,908,682
0
60,871,112
Time Burden (Hours)
12,289,240
0
10,690,449
Cost Burden (Dollars)
0
0
0
Abstract:
This ICR collects information from manufacturers, importers, and distributors of medical devices to disclose to health professionals and consumers specific information about themselves or their devices on the label or labeling of their devices. The primary users of the information disclosed on the label or in the labeling of devices are the health professionals who use or prescribe the device or the lay consumers who use the device. The labeling should contain sufficient information for these persons to use the device safely and effectively. FDA may use the information to determine whether there is reasonable assurance of the safety and effectiveness of the device for its intended use.
Authorizing Statute(s):
US Code:
21 USC 352
Name of Law: FD&C Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
83 FR 7728
02/22/2018
30-day Notice:
Federal Register Citation:
Citation Date:
83 FR 44884
09/04/2018
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
Adequate directions for use--801.5
Advertising and promotional materials for ASRs--809.30(d)
Contact lens cleaning solution labeling--800.10(a)(3) and 800.12(c)
Declaration of net quantity of contents--801.62
Dentures; information regarding temporary and emergency use--801.405(c)
Hearing aid records--801.421(d)
Hearing aids, availability of User Instructional Brochure--801.421(c)
Hearing aids, opportunity to review User Instructional Brochure--801.421(b)
Impact resistant lenses; invoices, shipping documents, and records of sale or distribution--801.410(e) and (f)
Labeling for IVDs--809.10(a) and (b)
Labeling for OTC test sample collection systems for drugs of abuse testing--809.10(f)
Labeling for analyte specific reagents--809.10(e)
Labeling for general purpose laboratory reagents--809.10(d)(1)
Labeling of articles intended for lay use in the repairing and/or refitting of dentures--801.405(b)(1)
Labeling of sunlamp products--1040.20(d)
Labeling requirements for hearing aids--801.420(c)(1)
Latex condoms; justification for the application of testing data to the variation of the tested product--801.435(g)
Liquid ophthalmic preparation labeling--800.10(b)(2)
Manufacturer, packer, or distributor information--801.1
Medical Device Labeling Regulations; Recordkeeping
Medical Device Labeling Regulations; Third-Party Disclosure
Menstrual tampons, ranges of absorbency--801.430(e)(2)
Menstrual tampons, sampling plan for measuring absorbency--801.430(f)
Prescription device labeling--801.109
Processing, labeling, or repacking agreement--801.150(a)(2)
Processing, labeling, or repacking; non-sterile devices--801.150(e)
Retail exemption for prescription devices--801.110
Statement of identify--801.61
Technical Data for hearing aids--801.420(c)(4)
User labeling for latex condoms--801.435(b), (c), and (h)
User labeling for menstrual tampons--801.430(d)
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
81,908,682
60,871,112
0
-60,871,112
81,908,682
0
Annual Time Burden (Hours)
12,289,240
10,690,449
0
-10,690,449
12,289,240
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:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
The estimated annual hourly burden, formerly estimated as 10,678,247 hours (2,240,929 recordkeeping and 8,437,318 third-party disclosure) has increased by 1,610,359 hours (1,022,621 recordkeeping and 587,738 third-party disclosure) to a total estimated annual hourly burden of 12,288,606 hours (3,263,550 recordkeeping and 9,025,056 third-party disclosure. The increase is due to adjustments reflecting updated data. We note that ROCIS database is inconsistent with the number of burden hours in the previous Supporting Statement (approved 9/22/2015, supporting statement states 10,678,247 hours, ROCIS states 10,690,449 hours). Upon submitting this Supporting Statement, we will correct the error in ROCIS.
Annual Cost to Federal Government:
$2,573,850
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
Agency Contact:
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov
Common Form ICR:
No
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:
09/13/2018
An official website of the United States government
The .gov means it's official.
The site is secure.
