Guidance Medical Device ISO 13485: 2003 Voluntary Audit Report Submission Pilot Program

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
ISO Audit Report Pilot Program Guidance Rev(9).doc	Supplementary Document	Uploaded 2011-07-05	Available
Final_-_ISO_13485_AR_Submission_Pilot_SS PRA Clean 1.13.12.doc	Supporting Statement A	Uploaded 2012-01-19	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
198427	Recurring	Other-Submission Report	New
198426	First Year (one time)	Other-Submission Report	New

ICR Details

OMB Control No: 0910-0700	ICR Reference No: 201107-0910-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Guidance Medical Device ISO 13485: 2003 Voluntary Audit Report Submission Pilot Program
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/06/2012
	Date Received in OIRA: 07/07/2011
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2015	36 Months From Approved
Responses	2,133	0	0
Time Burden (Hours)	27,186	0	0
Cost Burden (Dollars)	63,990	0	0

---

Abstract: This contains the collections associted with the FDA guidance document "Guidance for Industry, Third Parties and Food and Drug Administration Staff: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program."

---

Authorizing Statute(s): US Code: 21 USC 374 (g)(7) Name of Law: Federal Food, Drug, and 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:
	75 FR 28257	05/20/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 39880	07/07/2011
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

IC Title	Form No.	Form Name
First Year (one time)
Recurring

---

ICR Summary of Burden

table that charts list 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	2,133	0	0	2,133	0	0
Annual Time Burden (Hours)	27,186	0	0	27,186	0	0
Annual Cost Burden (Dollars)	63,990	0	0	63,990	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: FDA will begin a voluntary pilot program as described in this guidance document and will evaluate the outcomes of the pilot program at the end of this period. The proposed collections of information are necessary to satisfy the previously mentioned statutory requirements for implementing this voluntary submission pilot program.

---

Annual Cost to Federal Government: $1,073,200

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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

---

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: 07/07/2011

---