Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program

Forms and Documents

Document Name	Status
0569_Supporting Statement_2018.pdf Supporting Statement A	2018-04-12

IC Document Collections

IC ID	Document Title	Status
6291	Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program Instruction	Modified

ICR Details

OMB Control No: 0910-0569	ICR Reference No: 201803-0910-010
Status: Active	Previous ICR Reference No: 201411-0910-011
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program
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: 05/17/2018
	Date Received in OIRA: 04/13/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2021	36 Months From Approved	05/31/2018
Responses	10	0	20
Time Burden (Hours)	150	0	300
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): US Code: 21 USC 374(g) 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 55379	11/21/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 15846	04/12/2018
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program

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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	10	20	0	0	-10	0
Annual Time Burden (Hours)	150	300	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: The information collection reflects adjustments since last OMB approval. We have updated the estimated number of respondents based on the number of notifications received in recent years. We have reduced the number of respondents from 20 to 10 which results in a decrease in annual responses by 10 and a corresponding decrease in annual burden hours by 150.

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Annual Cost to Federal Government: $260,286

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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