**Supporting Statement For**

# Medical Devices; Inspection by Accredited Persons Program

**Under the Medical Device User Fee and Modernization Act**

**Of 2002 (MDUFMA)**

**0910-0510**

## A. JUSTIFICATION 

1.  [**Circumstances Necessitating Information Collection**]{.underline}

The Federal Food, Drug and Cosmetic Act was amended by the Medical
Device

User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107-250) on

October 26, 2002. Section 201 of MDUFMA requires that not later than 180

days of enactment of MDUFMA, FDA publish in the Federal Register,

criteria to accredit or deny accreditation to persons who wish to
conduct

inspections of eligible manufacturers of class II and class III medical
devices. In

addition, FDA must accredit persons pursuant to the published criteria
not later than one year after enactment of MDUFMA.

FDA published a Federal Register Notice on April 28, 2003 (68 FR 22400)
announcing the criteria it will use to accredit persons to inspect
eligible device manufacturers and the availability of a guidance
entitled "Implementation of the Inspection by Accredited Persons Program
Under the Medical Device User Fee and Modernization Act of 2002;
Accreditation Criteria: Guidance for Industry, FDA Staff, and Third
Parties." The guidance further describes the criteria FDA will use to
accredit persons that wish to conduct inspections of eligible
manufacturers of class II and class III medical devices. The guidance
also addresses the format and content of accreditation applications and
the evaluation process FDA will use in qualifying firms to participate
in this program.

**[Purpose and use of Information]{.underline}**

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.

Manufacturers may continue to have FDA perform inspections or, if
eligible, they may utilize an Accredited Person. FDA will serve as the
accreditation body. FDA will begin accepting applications immediately
following approval by OMB of the proposed collection of information.
Because the statute requires the agency to make accreditation decisions
by no later than one year after MDUFMA\'s enactment (October 26, 2003),
FDA intends to stop accepting applications on August 25, 2003.

2.  **[Use of Information Technology and Burden Reduction]{.underline}**

> Accredited persons must have the capability to interface with FDA\'s
> electronic data systems, including the FDA Internet websites, and the
> CDRH Facts-On-Demand system. At a minimum, this would require a
> computer system with a modem and an independent facsimile machine. FDA
> will rely extensively on the use of our electronic systems for timely
> dissemination of guidance documents to Accredited Persons and other
> interested parties. FDA will accept alternative technology if the
> technology is compatible with FDA's technology. FDA will accept
> electronic submissions from any applicant that wishes to submit in
> this format.

3.  **[Efforts to Identify Duplication and Use of Similar
    Information]{.underline}**

> FDA is the only Federal Agency responsible for the collection of this
> information. Therefore, duplication with other data sources is
> nonexistent.

5.  **[Impact on Small Businesses or Other Small Entities]{.underline}**

Participation in the Inspection by Accredited Persons program is
entirely voluntary.

FDA will provide information on its procedures and criteria, through
guidance documents and training programs.

6.  **[Consequences of Collecting the Information Less
    Frequently]{.underline}**

Accredited persons conduct inspections in the same manner as those
conducted

by FDA.

7.  **[Special Circumstances Relating to the Guidelines of 5 CFR
    1320.5]{.underline}**

This proposed collection is consistent with 5 CFR 1320.5, except for 5
CFR 1320(d)(2)(ii). FDA is requesting 10 hard copies for each Accredited
Person application to provide a copy to each of the 10 members
(reviewers) of the Third Party Recognition Board. This will be a group
review requiring consensus of the Board.

8.  **[Consultation Outside the Agency]{.underline}**

Notice has been published in the Federal Register of July 10, 2003 (68
FR 41160) soliciting comments on this information collection prior to
its submission to the Office of Management and Budget (OMB) as required
by 5 CFR 1320.8(d). No comments were received.

9.  **[Explanation of Any Payment or Gift to Respondents]{.underline}**

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

10. **[Assurance of confidentiality Provided to
    Respondents]{.underline}**

> FDA will post on its internet site, a list of persons who are
> accredited. Information submitted by accredited persons will be
> available for disclosure by FDA in accordance with the Freedom of
> Information Act (FOIA).

11. **[Justification for Sensitive Questions]{.underline}**

> This information collection does not concern questions of a sensitive
> nature, such as sexual behavior and attitudes, religious beliefs or
> other matters considered private.

12. **[Estimate of Hour Burden Including Annualized Hourly
    Costs]{.underline}**

FDA estimates the burden of this information collection as follows:

TABLE 1. ESTIMATED ANNUAL REPORTING BURDEN^1^

+-------------+-------------+-------------+----------+----------+-----+
| Item        | No. of      | Annual      | Total    | Hours    | To  |
|             | Respondents | Frequency   | Annual   | per      | tal |
|             |             | per         | R        | Response |     |
|             |             | Response    | esponses |          | Ho  |
|             |             |             |          |          | urs |
+-------------+-------------+-------------+----------+----------+-----+
| Request for | 15          | 1           | 25       | 80       | 2   |
| Ac          |             |             |          |          | 000 |
| creditation |             |             |          |          |     |
|             |             |             |          |          |     |
| (1^st^      |             |             |          |          |     |
| Year)       |             |             |          |          |     |
+-------------+-------------+-------------+----------+----------+-----+
| Request for | 10          | 1           | 10       | 15       | 150 |
| Ac          |             |             |          |          |     |
| creditation |             |             |          |          |     |
|             |             |             |          |          |     |
| (2^nd^      |             |             |          |          |     |
| Year)       |             |             |          |          |     |
+-------------+-------------+-------------+----------+----------+-----+
| Request for | 5           | 1           | 5        | 80       | 400 |
| Ac          |             |             |          |          |     |
| creditation |             |             |          |          |     |
|             |             |             |          |          |     |
| (3^rd^      |             |             |          |          |     |
| Year)       |             |             |          |          |     |
+-------------+-------------+-------------+----------+----------+-----+
| Total Hours |             |             |          |          | 2,  |
|             |             |             |          |          | 550 |
+-------------+-------------+-------------+----------+----------+-----+

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

**Explanation of Reporting Burden Estimate**

FDA based these estimates on conversations with industry, trade
association representatives, and internal FDA estimates. There are only
75 bodies worldwide that would be qualified to serve as Accredited
Persons for inspections. The expectation is that 25 bodies will apply
and meet the minimum standard the first year. Under MDUFMA we can only
accredit 15 persons during the first year. All of these bodies should
have the requested information readily available. We estimate it will
take no more than 80 hours to assemble this information per respondent
(25 x 80 = 2000).

Under MDUFMA only 15 may be accredited the first year. We expect the 10
lowest ranking (the ones not accredited the first year), will reapply
the following year with an updated application. Thus the time required
to prepare their application will be significantly less than preparing
an entire application (10 x 15 = 150 hours).

The preparation time is increased again for the third year because new
applicants may apply the third year (5 x 80 = 400 hours). Once an
organization is accredited, it will not be required to reapply. Thus
applying for accreditation is a one time expenditure of time and
resources.

13. **[Estimate of Other Total Annual Cost to Respondents or
    Recordkeepers]{.underline}**

There are no operating and maintenance costs or capital costs associated
with this

collection of information.

14. **[Annualized Cost to the Federal Government]{.underline}**

> FDA estimates that approximately 2.5 staff-years will be devoted to
> this activity during **the first year** of this program at a cost of
> \$300,000.00. During the **second year**, approximately 1 staff-year
> will be used at a cost of \$100,000.00. The **third year**
> approximately 0.5 staff-years will be used at a cost of \$50,000.00.
> The **total cost** over the three year period is estimated at
> \$450,000.00 involving the total use of 4 staff-years. These expenses
> include both the application reviews and the training of accepted
> applicants.

15. **[Explanation for Program Changes of Adjustments]{.underline}**

> This is a new collection.

16. **[Plans for Tabulation and Publication and Project Time
    Schedule]{.underline}**

> No publication of information for statistical use is planned.

17. **[Reason(s) Display of OMB Expiration Date Is
    Inappropriate]{.underline}**

> N/A

18. **[Exceptions to Certification for Paperwork Reduction Act
    Submissions]{.underline}**

> FDA is not requesting any exemption from the certification statement
> identified in Item 19 of OMB Form 83-I