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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:
0910-0510
ICR Reference No:
202101-0910-004
Status:
Historical Active
Previous ICR Reference No:
201907-0910-007
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDRH
Title:
Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
01/15/2021
Retrieve Notice of Action (NOA)
Date Received in OIRA:
01/14/2021
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2022
08/31/2022
08/31/2022
Responses
11
0
1
Time Burden (Hours)
230
0
80
Cost Burden (Dollars)
0
0
0
Abstract:
Information from this collection will be used by FDA to implement an Inspection by Accredited Persons program that will train and accredit persons that wish to conduct inspections of eligible manufacturers of class II and class III medical devices. This action is required by MDUFMA. This ICR collects information from manufactures of class II or class III medical devices who meet certain eligibility criteria and who intend to use an "accredited person" to conduct an inspection of their establishment. Under the Inspection by Accredited Persons Program, eligible manufacturers may elect to have third parties that have been accredited by FDA conduct some of their inspections instead of FDA. This program allows manufacturers greater control over the timing of their inspections and, in some cases, may reduce the need for multiple inspections of the same establishment.
Authorizing Statute(s):
US Code:
21 USC 374
Name of Law: Food and Drug Cosmetic 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:
84 FR 9352
03/14/2019
30-day Notice:
Federal Register Citation:
Citation Date:
84 FR 34401
07/18/2019
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
Medical Devices; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
Notification of the intent to use an Accredited Person
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
11
1
0
0
10
0
Annual Time Burden (Hours)
230
80
0
0
150
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 requested consolidation of OMB Control Nos. 0910-0510 and 0910-0569. The estimated hour burden has increased by 150 hours as the result of adding the approved burden from OMB Control No. 0910-0569 to this ICR. Because these two information collections are related to the same program, authorized under section 704(g) of the FD&C Act, we believe the estimated burdens described above are most appropriately expressed under one ICR. Additionally, this consolidation may increase administrative efficiency by reducing FDA’s active ICR inventory. Therefore, we request the addition of the information collection in OMB Control No. 0910-0569 to OMB Control No. 0910-0510. Upon approval of this consolidation, we would then terminate OMB Control No. 0910-0569.
Annual Cost to Federal Government:
$540,610
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
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:
01/14/2021
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