SUPPORTING STATEMENT

**FOR**

**REPORTS OF CORRECTIONS AND REMOVALS**

**21 CFR PART 806**

**OMB Number 0910-0359**

**A. [JUSTIFICATION]{.underline}**

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

> Reports of Corrections and Removals (21 CFR 806) implements section
> 519(f) (21 U.S.C. 360i(f)) of the Federal Food, Drug, and Cosmetic Act
> (the act) (21 U.S.C. 301), as amended by the Food and Drug
> Modernization Act of 1997 (FDAMA) (P.L. 105-115)(Attachment A).
>
> The FDA is requesting approval from the Office of Management and
> Budget (OMB) for the collection of information required by the
> amendments to 21 CFR Part 806 promulgated under the statutory mandate
> of section 519(f) of the act, as amended by FDAMA. Below is a
> description of the information collection requirements in 21 CFR Part
> 806:
>
> **21 CFR 806.10 -- Reporting** -- Each device manufacturer or importer
> shall submit a written report to FDA of any action initiated to
> correct or remove a device to reduce a risk to health posed by the
> device or to remedy a violation of the act caused by the device which
> may present a risk to health within 10-working days of initiating such
> correction or removal.
>
> **21 CFR 806.20(a) -- Recordkeeping** -- each device manufacturer or
> importer of a device who initiates a correction or removal of a device
> that is not required to be reported to FDA, shall keep a record of
> such correction or removal.

**2. [Purpose and Use of the Information]{.underline}**

> The information collected in the reports of corrections and removals
> will be used by FDA to identify marketed devices that have serious
> problems and to ensure that defective devices are removed from the
> market. This will assure that FDA has current and complete information
> regarding these corrections and removals and to determine whether
> recall action is adequate. Failure to collect this information
> prevents FDA from receiving timely information about devices that may
> have a serious effect on the health of users of the devices.

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

> In the Federal Register of March 20, 1997 (62 FR 13430) (Attachment B)
> , FDA published a final rule establishing procedures for electronic
> records, electronic signatures, and electronic submissions.
> Manufacturers or importers may use appropriate technology in
> accordance with this rule to comply with the reports of corrections
> and removals requirements.

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

> FDA is the only federal agency responsible for the collection of this
> information. No data exist from any other source that can be used to
> report corrections and removals subject to this direct final
> regulation.

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

> The information collection will not have a significant impact on a
> substantial number of small entities.
>
> FDA aids small business by providing guidance and information through
> the Division of Small Manufacturers, International, and Consumers
> 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 non-financial
> assistance to small manufacturers. The workshops make available
> publications and educational materials, which include medical device
> establishment and listing requirements. The Division also maintains a
> toll-free 800 telephone number and a website, which firms may use to
> obtain regulatory compliance information.
>
> FDA's small business representatives in its six regional offices and
> scientific and administrative staff also aid small businesses subject
> to medical device regulations by providing assistance upon request or
> through public meetings.

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

> FDA does not require a specific frequency for this collection. A
> manufacturer or importer of a device submits a written report to FDA
> only when it undertakes a corrective or removal action to reduce a
> risk to health posed by the device or to remedy a violation of the act
> that may pose a risk to health.

**7. [Inconsistencies with 5 CFR 1320.6.]{.underline}**

> This information collection is consistent with 5 CFR 1320.6.

8\. **[Comments in Response to the Federal Register Notice and Efforts
to Consult Outside the Agency]{.underline}**

> Notice has been published in the Federal Register on December 14, 2004
> (69 FR 74527) 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) (Attachment C). No comments were received.

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

> No payment or gifts in any manner or form shall be provided to
> respondents under this final regulation.

10\. **[Assurance of Confidentiality Provided to
Respondent]{.underline}**

> Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), the public
> has broad access to government documents. Reports and other
> information submitted to FDA under 21 CFR Part 806 are releasable if
> they fall within the scope of the agency's regulation concerning
> "Public Information" (21 CFR Part 20). However, FOIA exempts
> disclosures of certain government records from mandatory public
> disclosures (5 U.S.C. 522(b)(1-9)). One such provision exempts from
> public disclosure "trade secrets" and "confidential commercial or
> financial information" that is privileged (5 U.S.C. 522(b)(4)).

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

> This information collection does not include questions pertaining to
> 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]{.underline}**

> Based on previous experience, FDA estimates a total annual cost of
> \$206,250 to comply with this regulation; \$159,060 to prepare and
> assemble written reports required by 21 CFR 806.10, and \$47,190 to
> maintain records of corrections and removals required b y 21 CFR
> 806.20 that will not have to be reported to the agency.
>
> **Table 1.**
>
> **Estimated Average Annual Reporting Burden ^1^**

+-----------+------------+----------------+----------+-------+-------+
| **CFR**   | **No. of** | **Annual       | **Total  | **    | **To  |
|           |            | Frequency**    | Annual** | Hours | tal** |
| **        | **Res      |                |          | per** |       |
| Section** | pondents** | **of           | **Res    |       | **Ho  |
|           |            | Response**     | ponses** | **    | urs** |
|           |            |                |          | Respo |       |
|           |            |                |          | nse** |       |
+===========+============+================+==========+=======+=======+
| 806.10    | 482        | 1              | 482      | 10    | 4,820 |
+-----------+------------+----------------+----------+-------+-------+
| > Total   |            |                |          |       | 4,820 |
+-----------+------------+----------------+----------+-------+-------+

> 1\. There are no capital costs or operating and maintenance costs
> associated with this collection of information.
>
> **Table 2.**
>
> **Estimated Average Annual Recordkeeping Burden ^1^**

+--------+----------+-------------+------------+------------+---------+
| *      | **No.    | **Annual    | **Total    | **Hours    | **      |
| *CFR** | of**     | Frequency   | Annual**   | per**      | Total** |
|        |          | of          |            |            |         |
| **Sec  | *        | Reco        | *          | **Record** | **      |
| tion** | *Recordk | rdkeeping** | *Records** |            | Hours** |
|        | eepers** |             |            |            |         |
+========+==========+=============+============+============+=========+
| 806.20 | 143      | 1           | 143        | 10         | 1,430   |
+--------+----------+-------------+------------+------------+---------+
| >      |          |             |            |            | 1,430   |
|  Total |          |             |            |            |         |
+--------+----------+-------------+------------+------------+---------+

> \* There are no capital costs or operating and maintenance costs
> associated with this collection of information.
>
> **21 CFR 806.10 Reporting**
>
> FDA estimates that it would take 10 staff hours to prepare and
> assemble a written report. At an average of \$33 per staff-hour, the
> cost to prepare and assemble a report is \$220 (10 staff-hours x \$33
> per staff-hour). For the estimated 482 reports, the final total cost
> would be \$159,060 (482 reports x \$330 per report).
>
> **21 CFR 806.20 Recordkeeping**
>
> FDA estimates that it would take 10 staff-hours to prepare a written
> record at an average cost of \$33 per staff hours. For the estimated
> 143 records, the total cost would be \$47, 190 (142 records x \$330
> per record).

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

> There are no additional annual cost burdens associated with the
> collection of information beyond what is identified in the annualized
> hourly reporting and recordkeeping burden. No additional capital
> expenditures or related service expenses are required or associated
> with the reporting or recordkeeping requirements other than customary
> and usual business practices or required to achieve regulatory
> compliance with other FDA regulatory requirements.

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

> FDA estimates that the Federal government will use 7 FTE's to
> implement the Reports of Corrections and Removals regulations required
> by section 519(f) of the act. Based on a cost of
> \$[82,319]{.underline} (the agency's average coast of an FTC,
> including benefits) per position at the GS-13 grade level, the
> estimated annual cost is \$[576,233]{.underline}.
>
> [FTE]{.underline} [Cost Per FTE]{.underline} [Total Cost]{.underline}
>
> 7 \$82,319 \$576,233

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

> The estimated reporting and recordkeeping burdens for this collection
> have decreased by 7,040 burden hours since the last approval of this
> information collection by OMB. When preparing the earlier package for
> approval of the information collection requirements in part 806, FDA
> reviewed the reports of corrections and removals submitted in the
> previous 3 years under 21 CFR part 7 (the agency's recall provisions).
> FDA has determined that estimates of the reporting burden in section
> 806.10 and section 806.20 should be revised to reflect a reduction of
> 29% for reports and records submitted under 21 CFR Part 7 due to a
> decrease in recall actions. The time needed to collect information
> should be reduced by 4 hours per record due (reducing number of hours
> per record to 10) to the implementation of a computerized program for
> information collection requirements in 21 CFR Part 806.

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

> No tabulation of the data is planned or anticipated.

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

> FDA is not seeking approval to prevent the display of expiration date
> or OMB approval of this request.

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

> There are no exceptions to the certification statement identified in
> item 19 of OMB Form, 83-1.

[B**. Collection of Information Using Statistical Methods**]{.underline}

> The use of statistical methods is not applicable because all
> corrections and removals of medical devices are subject to the
> reporting or recordkeeping requirements.

**LIST OF ATTACHMENTS:**

Attachment A-Food and Drug Modernization Act of 1997 (FDAMA)(P.L.
105-115)

Attachment B- Electronic Signature Rule

Attachment C- Federal register 60 Day Notice