SUPPORTING STATEMENT FOR REPORTS OF CORRECTIONS AND REMOVALS

21 CFR PART 806

A. JUSTIFICATION

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

The Food and Drug Administration (FDA) is amending its regulation in 21
CFR Part 806 - Medical Devices; Reports of Corrections and Removals
(Attachment A), to eliminate the requirement for distributors to submit
reports to FDA. The amendments are being made to implement section
519(f) (21 U.S.C. 360i(f)) of the Federal Food, Drug, and Comestic Act
(the act) (21 U.S.C. 301), as amended by the Food and Drug
Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115)
(Attachment B).

The information collection requirements in part 806 prior to this direct
final rule have been approved by OMB and assigned control number
0910-0359. 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). During that period
of time, no reports of corrections or removals were submitted by
distributors. For that reason, FDA did not include distributors among
the respondents estimated in the collection burden for the requirements
previously approved by OMB. Because distributors were not included in
that earlier estimate and because FDAMA now has eliminated requirements
for distributor reporting, FDA has determined that estimates of the
reporting burden Secs. 806.10 and 806.20 should remain the same.

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 manufacturers 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\. [How, By Whom, and For What Purpose Information Is Used]{.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 dangerous and 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 the users of the devices.

3\. [Consideration of Information Technology]{.underline}

In the **Federal Register** of March 20, 1997 (62 FR 13430) (Attachment
C), 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\. [Identification of Duplication and Similar Information Already
Available]{.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 this this direct final
regulation.

5\. [Small Businesses]{.underline}

The information collection will not have a significant impact on a
substantial number of small entities. FDA's Division of Small
Manufacturers Assistance (DSMA) and small business representatives in
its six regional offices, aid small businesses subject to medical device
regulations. FDA's scientific and administrative staff also provide
assistance upon request or through public meetings.

6\. [Consequences of Less Frequent Information Collection]{.underline}

FDA does not require a specific frequency for this collection. Written
reports are to be submitted to FDA only if a manufacturer or importer of
a device undertakes a corrective or removal action to reduce a risk to
health posed by the device or to remedy a violation of the act.

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

This information collection is consistent with 5 CFR 1320.6.

8\. [Consultations Outside FDA]{.underline}

In the **Federal Register** of August 7, 1998 (63 FR 42229), FDA
published a direct Final Rule. (Attachment C). There were no comments
received.

9\. [Payments or Gifts to Respondents]{.underline}

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

10\. [Confidentiality of Information]{.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) (Attachment K). 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\. [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\. [Burden and Cost to Respondents]{.underline}

Based on previous experience, FDA estimates a total annual cost of
\$396,000 to comply with this regulation; \$264.000 to prepare and
assemble written reports required by 21 CFR 806.10, and

\$132,000 to maintain records of corrections and removals required by 21
CFR 806.20 that will not have to be reported to the agency.

FDA estimates the burden of this collection of information as follows:

Table 1\--Estimated Annual Reporting Burden^1^

  ------------ ------------- -------------- ----------- ------------ ------------
  21 CFR       No. of        Annual         Total       Hours per    Total Hours
  Section      Respondents   Frequency per  Annual      Response     
                             Response       Responses                

  806.10       88            1              880         10           8,800
  ------------ ------------- -------------- ----------- ------------ ------------

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

Table 2\--Estimated Annual Recordkeeping Burden^1^

  ----------- --------------- --------------- ----------- -------------- ----------
  21 CFR      No. of          Annual          Total       Hours per      Total
  Section     Recordkeepers   Frequency of    Annual      Recordkeeper   Hours
                              Recordkeeping   Records                    

  806.20      440             1               440         10             4,400
  ----------- --------------- --------------- ----------- -------------- ----------

^1^ 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 \$30 per staff-hour, the cost to
prepare and assemble a report is \$300 (10 staff-hours x \$30 per
staff-hour). For the estimated 880 reports, the final total cost would
be \$264,000 (880 reports x 300 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 \$30 per staff hour. For the estimated 440
records, the total cost would be \$132,000 (440 records x 300 per
record).

13\. [Estimated Annual Cost to Respondents 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\. [Estimated Annual Cost to Government]{.underline}

FDA estimates that the Federal government will use 1 FTE's to implement
the Reports of Corrections and Removals regulations required by section
519(f) of the act. Based on a cost of [\$55,969]{.underline} (the
agency's average cost of an FTE, including benefits) per position at the
GS-13 grade level, the estimated annual cost is
[\$6155,659.]{.underline}

[FTE]{.underline} [Cost Per FTE]{.underline} [Total Cost]{.underline}

11 \$52,867 \$581,537

15\. [Changes in Burden]{.underline}

There are no changes in the estimated reporting and recordkeeping
burdens.

16\. [Publication of Results]{.underline}

No tabulation of the data is planned or anticipated.

17\. [Exemption for Display of Effective Date]{.underline}

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

18\. [Exception to Certification Statement]{.underline}

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

B. Collection of Information Using Statistical Methods

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