0569 Ss 2011

Supporting Statement For Requests for Inspection

Under the Inspection by Accredited Persons Program

0910-0569

A. JUSTIFICATION

1. Circumstances Making the Collection of Information Necessary

Section 201 of the Medical Device User Fee and Modernization Act of 2002 amended section 704 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding subsection (g). (21 U.S.C. 374(g).) This amendment authorizes FDA to establish a voluntary third party inspection program applicable to manufacturers of class II or class III medical devices who meet certain eligibility criteria. Under this Inspection by Accredited Persons Program (AP Program), eligible manufacturers may elect to have third parties that have been accredited by FDA (accredited person or AP) conduct some of their inspections instead of FDA. The AP Program applies to manufacturers who currently market their medical devices in the United States and who also market or plan to market their devices in foreign countries. Such manufacturers may need current inspections of their establishments to operate in global commerce.

The applicant must submit the following information in support of a request for approval to use an accredited person:

(1) Information that demonstrates that the applicant manufactures, prepares, propagates, compounds, or processes” class II or class III medical devices;

(2) Information that shows that the applicant markets at least one of the devices in the United States;

(3) Information that demonstrates that the applicant markets or intends to market at least one of the devices in one or more foreign countries and one or both of the following two conditions are met:

One of the foreign countries certifies, accredits, or otherwise recognizes the AP the applicant has selected as a person authorized to conduct inspections of device establishments, or

A statement that the law of a country where the applicant markets or intends to market the device recognizes an inspection by the FDA or by the AP;

(4) Information that shows that the applicant’s most recent inspection performed by FDA, or by an AP under this program, was classified by FDA as either “No Action Indicated (NAI)” or “Voluntary Action Indicated (VAI)”; and

(5) A notice FDA requesting clearance (approval) to use an AP, identifying the AP the applicant selected.

2. Purpose and Use of the Information

This program will allow manufacturers greater control over the timing of their inspections. In addition, because some of the FDA accredited persons, are already recognized by other countries as persons authorized to conduct inspections of device establishments, it is possible that in some cases a single AP inspection will meet the requirements of more than one regulatory authority, thereby reducing the need for multiple inspections of the same establishment. Information from these information collection provisions will be used to determine whether a manufacturer is eligible to participate in the AP program.

3. Use of Information Technology and Burden Reduction

This program allows alternative appropriate technology. Applications and reports can be electronically submitted if the format is approved by FDA.

4. Efforts to Identify Duplication and Use of Similar Information

The FDA is the only Federal agency responsible for the inspection of facilities in which medical devices are manufactured in accordance with the Federal Food, Drug, and Cosmetic Act. Therefore, duplication with other data sources is nonexistent.

5. Impact on Small Business or Other Small Entities

Participation in the AP program is voluntary. As such, there is potentially no impact on small businesses unless they elect to participate in the program. FDA aids small business by providing guidance and information through the Division of Small Manufacturers, International, and Consumer Assistance (DSMICA) and the Device Registration and Listing Branch within the Center for Devices and Radiological Health. DSMICA provides workshops, on-site evaluations, and other technical and nonfinancial assistance to small manufacturers. The workshops make available publications and educational materials, which include medical device establishment and listing requirements. DSMICA also maintains a toll-free “800” telephone number and a website which firms may use to obtain regulatory compliance information.

6. Consequences of Collecting the Information Less Frequently

There is no established frequency for the information collection under the third party review program. Manufacturers may submit requests whenever they wish to use an AP.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

This guidance is consistent with principles in 5 CFR 1320.5.

8. Comments in Response to the Federal Register Notice and Efforts to Consult

Outside Agency

In the FEDERAL REGISTER of May 23, 2011 (76 FR 29764), the FDA requested comments on the information collection. FDA received no comments on the information collection.

9. Explanation of Any Payment or Gift to Respondents

No payment or gifts shall be provided to respondents under this regulation.

10. Assurance of Confidentiality Provided to Respondent

Information regarding APs are available under the Freedom of Information Act and 21 CFR Part 20.

11. Justification for Sensitive Questions

The information required in a request to use an AP does not include questions about sexual behavior, attitude, religious beliefs, or any other matters that are commonly

considered private or sensitive in nature.

12. Estimate of Hour Burden Including Annualized Hourly Costs

12 a. Annualized Hour Burden Estimate

The following is an estimated annual burden hours for participation in the voluntary program:

Estimated Annual Reporting Burden¹

21 U.S. C. Section	No. of Respondents	No. of Responses per Respondent	Total Annual Responses	Average Burden per Response (in hours)	Total Hours
374(g)	100	1	100	15	1,500

^1. There are no capital costs or operating and maintenance costs associated with this collection of information.

There are approximately 8,000 foreign and 10,000 domestic manufacturers of medical devices. Approximately 5,000 of these firms only manufacture class I devices and are, therefore, not eligible for the AP program. In addition, 40 percent of the domestic firms do not export devices and therefore are not eligible to participate in the AP program. Further, 10 to 15 percent of the firms are not eligible due to the results of their previous inspection. FDA estimates there are 4,000 domestic manufacturers and 4,000 foreign manufacturers that are eligible for inclusion under the AP program. Based on communications with industry, FDA estimates that on an annual basis approximately 100 of these manufacturers may submit a request to use an AP in any given year.

12b. Annualized Cost Burden Estimate

Costs to Respondents:

Type of Respondent	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
Regulatory Affairs Specialist	15	$150.00	$2,250.00

For an application for approval to use an AP for an inspection, the total reporting cost to industry is estimated at $2,250 per submission. Approximately 15 hours are required to complete an application. The average to industry per hour for this type of work is $150. The estimated submission cost of $2,250 multiplied by 100 submissions per year equals $225,000, which is the aggregated industry reporting cost.

13. Estimate of the Other Total Annual Costs to Respondents and/or RecordKeepers/Capital Costs

No additional capital or operational expenses are expected as a result of this collection of information.

14. Annualized Cost to the Federal Government

Costs to the government are limited to the time required to review requests for participation in the AP program. FDA estimates that one full time equivalent (FTE) positions consisting of a combination of scientific and engineering professionals and support staff are required for reviewing and processing applications for approval to use an AP for inspections. Based on a cost of $125,000 per position (which is the agency’s average cost of an FTE including their benefits), the estimated annual Federal cost is $125,000.

15. Explanation for Program Changes or Adjustments

There is no change in burden.

16. Plans for Tabulation and Publication and Project Time Schedule

No publication of information for statistical use is planned.

17. Reason(s) Display of OMB Expiration Date is Inappropriate

FDA is not seeking an exemption of display of effective date.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification statement identified in Item 19 of OMB

Form 83-I.