Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002

Forms and Documents

Document Name	Status
0510--83C memo requesting consolidation w0569.docx Justification for No Material/Nonsubstantive Change	2021-01-14
0510_Supporting Statement_consolidation w-0569.docx Supporting Statement A	2021-01-14

IC Document Collections

IC ID	Document Title	Status
6226	Medical Devices; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) Instruction	Unchanged
245320	Notification of the intent to use an Accredited Person Other-Guidance	New

ICR Details

OMB Control No: 0910-0510	ICR Reference No: 202101-0910-004
Status: Received in OIRA	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	Date Submitted to OIRA: 01/14/2021

	Requested	Previously Approved
Expiration Date	08/31/2022	08/31/2022
Responses	11	1
Time Burden (Hours)	230	80
Cost Burden (Dollars)	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
Notification of the intent to use an Accredited Person
Medical Devices; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA)

---

ICR Summary of Burden

	Total Request	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

---

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

---