**SUPPORTING STATEMENT FOR**

**MEDICAL DEVICES; DEVICE TRACKING**

**OMB Control Number 0910-0442**

**A. JUSTIFICATION**

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

On August 16, 1993, the Food and Drug Administration (FDA) issued a
final rule establishing regulations for tracking certain medical devices
(58 FR 43442). See Attachment 1A. This regulation implemented section
519(e) of the Federal Food, Drug, and Cosmetic Act (the act), as amended
by the Safe Medical Devices Act of 1990 (Public Law 101-629) (SMDA). See
Attachments 1B and 1C.

Under the SMDA, section 519(e) mandated that any person registered as a
manufacturer of a device meeting the criteria in section 519(e)(1) must
track that device. Section 519(e)(1) describes the types of devices that
manufacturers must track: (1) A device the failure of which would be
reasonably likely to have serious adverse health consequences and which
is (a) a permanently implantable device or (b) a life-sustaining or
life- supporting device used outside a device user facility, or (2) any
other device which the Secretary may designate. In implementing the SMDA
provisions, the regulations established requirements for manufacturer
tracking systems and distributor reporting.

Effective February 19, 1997, section 519(e) was amended by the FDA
Modernization Act of 1997 (Public Law 105-115) (FDAMA). See Attachment
2A. Amended section 519(e)(1) provided FDA with discretionary authority
to issue orders that require a manufacturer to track a class II or class
III device if its failure would be reasonably likely to have serious
adverse health consequences, or it is intended to be implanted in the
human body for more than one year, or it is life-sustaining or
life-supporting and used outside a device user facility (Attachment 2B).
Amended section 519(e)(2) provides that patients may refuse permission
to release, their names, addresses, social security numbers, or other
identifying information for tracking purposes. On February 8, 2002, FDA
issued a final rule (67 FR 5943) to conform existing tracking
regulations (21 CFR 821) to changes in tracking provisions effected by
FDAMA. See Attachment 2C. Currently, 16 device types are tracked per
orders issued by FDA.

On May 15, 2002, the Office of Management and Budget (OMB) approved the
collection of information in the final rule to amend the tracking
regulations entitled, \"Medical Devices; Device Tracking.\" The approved
information collection was assigned OMB Control No. 0910-0442 and
expires April 30, 2005. FDA now is requesting an extension of OMB
approval for the information collection requirements in 21 CFR Part 821.

A description of the information collection requirements are as follows:

**§821.2 - Reporting -** Provides that manufacturers, importers, or
distributors may request an exemption or variance from one or more
tracking requirements.

**§821.25(a) - Reporting -** Requires manufacturers of tracked devices
to adopt a tracking method which can provide certain information to FDA
within defined timeframes.

**§821.25(b) - Recordkeeping -** Requires manufacturers of tracked
devices to keep current records of tracking data according to their
standard operating procedures (SOPs).

**§821.25(c) and (c)(3) - Recordkeeping-** Requires manufacturers to
establish SOPs for collecting, maintaining, and auditing tracking data
and to incorporate in a quality assurance program, procedures for
auditing devices twice annually for the first three years of tracking,
and annually thereafter.

**§821.25(d) - Reporting** - Requires manufacturers to notify FDA of
distributors, final distributors, or multiple distributors not
maintaining or reporting required information.

**§821.30(a) - Reporting -** Requires distributors, final distributors,
and multiple distributors, upon acquiring tracked devices, to provide
manufacturers with data about the distributors, the devices, receipt,
and other usage.

**§821.30(b) - Reporting -** Requires that final distributors of tracked
devices intended for single patient use, upon distribution to patients,
provide manufacturers with data about patient identities (if permitted),
the devices, use dates, physicians, and other information.

**§821.30(c)(2) - Reporting** - Requires multiple distributors to
provide data on current users of tracked devices, current device
locations, and other information, within 5 working days of a
manufacturer's request or within 10 working days of FDA's request.

**§821.30(d) - Reporting -** Requires all distributors to make required
tracking information records available for auditing, upon a
manufacturer's written request.

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

Tracking information is collected to facilitate identifying the current
location of tracked devices, and patients (or end-users) possessing the
devices, to the extent that patients permit the collection of
identifying information (see item 10). Manufacturers and, as necessary,
FDA use the data to expedite recalling distributed devices that are
dangerous or defective, and to facilitate the timely notification of
patients or licensed practitioners of risks associated with the devices.
So far FDA has not found it necessary to utilize tracking information
for these purposes.

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

Respondents have complete flexibility to use tracking system procedures,
computer technology, and automation that reduce the time needed to
compile tracking information. Based on inspections conducted to date,
FDA believes that manufacturers and distributors keep at least 90% of
these records in electronic format. If FDA requests submission of
reports, FDA expects that manufacturers will also submit at least 90% of
these reports in electronic format.

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

FDA is the only agency requiring an information collection that tracks
devices to patients and distributors. Legal impediments prevent using
Social Security and Internal Revenue Service data that might help locate
patients with tracked implants lost to follow-up.

Under FDA's Quality System regulation (21 CFR §820.160) (Attachment 3),
manufacturers must maintain distribution records identifying initial
consignees of devices. Under §821.30(a), some device distributors might
report to manufacturers tracking data already contained in initial
consignee records. In practice, FDA believes many final distributors,
such as hospitals receiving tracked implants directly from
manufacturers, rely on manufacturer records identifying initial
consignees as fulfilling the intent of §821.30(a). They only report,
under 821.30(b), when tracked implants are implanted in patients and not
when they are received. Also, many distributors and multiple
distributors of tracked life-sustaining or life-supporting devices do
not receive the devices directly from manufacturers. Consequently,
duplicative reporting is minimal.

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

FDA helps to minimize the impact by aiding small business in dealing
with tracking through guidance provided by the Center for Devices and
Radiological Health's Division of Small Manufacturers, International,
and Consumer Assistance (DSMICA) and its scientific and compliance
staffs.

6\. [Consequence of Collecting the Information Less
Frequently]{.underline}

FDA does not require a specific collection frequency, because the agency
reviews tracking data during an FDA inspection or upon FDA request.
Failure of manufacturers to record, and of distributors to report, data
upon the distribution and patient receipt of tracked devices could delay
the expeditious recall of distributed devices that are dangerous or
defective.

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

This information collection is consistent with the guidelines prescribed
in 5 CFR 1320.6.

8.  [Consultations Outside FDA]{.underline}

From 20002-2004, FDA consulted the following individuals about the
burden associated with this information collection. They did not
recommend any changes to the regulation.

-   Tara Treherne, Philips Medical Center, 2301 5^th^ Ave., Suite 200,
    Seattle, WA 98121

-   Robert Fleming, Mettler Electronics Corporation, 1333 South Claudina
    Street, Anaheim, CA 92805

-   Doug Mechlenburg, Respironics, Inc., 1501 Ardmore Boulevard,
    Pittsburgh, PA 15221

In addition, FDA continually meets with respondents affected by this
collection through its medical device inspection program and through
other meetings and correspondence received. On May 5, 2003, FDA also
issued a guidance document entitled "Guidance for Industry and FDA
Staff: Medical Device Tracking," which revised and superseded FDA's
previous guidance on medical device tracking released on January 24,
2000.

In the Federal Register of November 30, 2004 (69 FR 69604), the FDA
solicited comments on this information collection (Attachment 7). No
comments were received.

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

No payment or gift is provided to respondents.

10\. [Confidentiality of Information]{.underline}

Tracking data identifying customers or patients, either reviewed by or
submitted to FDA, is treated as confidential in accordance with 21 CFR
Part 20. Although patients are not respondents, patients receiving
tracked devices may refuse to provide personal identifying data under
§821.55(a). See Attachment 2B.

11\. [Sensitive Questions]{.underline}

Required tracking information does not include questions pertaining to
sexual behavior, attitude, religious beliefs, or to other matters
commonly considered private or sensitive in nature.

12\. [Estimates of Burden Hours, Explanation, and Annualized Costs to
Respondents]{.underline}

*A. Background Facts and Assumptions:*

1\. [Average figures]{.underline}. Burden estimates for information
collections are based on data and methods from FDA's 1999 analysis,
[Cost Assessment of Medical Device Tracking]{.underline} (Attachment
5). That analysis estimates industry costs for device tracking systems
from 1997-2006 and cost savings for devices no longer tracked under
FDAMA. Burden hours shown in Tables 1 and 2 are average annual figures
for the years 2002-2004. Numbers have been rounded up.

**Table 1. - Estimated Annual Reporting Burden ^1^**

+--------------+---------+----------------+----------+-------+-------+
| **CFR**      | **No.   | **Annual       | **Total  | **    | **To  |
|              | of**    | Frequency**    | Annual** | Hours | tal** |
| **Section**  |         |                |          | per** |       |
|              | *       | **of           | **Res    |       | **Ho  |
|              | *Respon | Response**     | ponses** | **    | urs** |
|              | dents** |                |          | Respo |       |
|              |         |                |          | nse** |       |
+==============+=========+================+==========+=======+=======+
| 821.2 (also  | 4       | 1              | 4        | 12    | 48    |
| 821.30(e))   |         |                |          |       |       |
+--------------+---------+----------------+----------+-------+-------+
| 821.25(a)    | 1       | 1              | 1        | 76    | 76    |
+--------------+---------+----------------+----------+-------+-------+
| 821.25(d)    | 22      | 1              | 22       | 2     | 44    |
+--------------+---------+----------------+----------+-------+-------+
| 821.30(a),   | 17,000  | 72             | 1        | 0     | 20    |
| (b)          |         |                | ,222,725 | .1666 | 3,706 |
+--------------+---------+----------------+----------+-------+-------+
| 821.30(c)(2) | 1       | 1              | 1        | 28    | 28    |
+--------------+---------+----------------+----------+-------+-------+
| 821.30(d)    | 17,000  | 15             | 259,186  | 0     | 4     |
|              |         |                |          | .1666 | 3,180 |
+--------------+---------+----------------+----------+-------+-------+
| Total        |         |                |          |       | 24    |
|              |         |                |          |       | 7,082 |
+--------------+---------+----------------+----------+-------+-------+

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** |             |            |            |         |
+========+==========+=============+============+============+=========+
| 821    | 229      | 46,260      | 10,593,433 | 0.2899     | 3,      |
| .25(b) |          |             |            |            | 071,036 |
+--------+----------+-------------+------------+------------+---------+
| 821    | 229      | 1           | 229        | 63.0       | 14,430  |
| .25(c) |          |             |            |            |         |
+--------+----------+-------------+------------+------------+---------+
| 821.25 | 229      | 1,124       | 257,454    | 0.2899     | 74,636  |
| (c)(3) |          |             |            |            |         |
+--------+----------+-------------+------------+------------+---------+
| Total  |          |             |            |            | 3,      |
|        |          |             |            |            | 160,102 |
+--------+----------+-------------+------------+------------+---------+

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

2\. [Respondents]{.underline}. FDA has issued orders to 229
manufacturers who are required to track 12 types of devices intended to
be implanted for more than one year (referred to as tracked implants)
and 4 types of life-sustaining or life-supporting devices used outside
device user facilities (referred to as tracked l/s-l/s devices).

FDA's estimate of 17,000 distributor respondents subject to tracking
reporting requirements is contained in FDA's cost assessment (Attachment
5). The number of distributors is derived from Dun and Bradstreet
sources on medical equipment wholesalers, retailers, home care dealers,
and equipment rental companies. The Health Forum, an American Hospital
Association Company, provided statistics on hospitals.

3\. [Medical procedure estimates]{.underline}. Using implantation
procedures data from the National Center for Health Statistics for
1993-1996, FDA applied a 2% annual growth rate to estimate the number of
procedures for tracked implant devices from 1997-2006. See Attachment 5.
The assessment also used unit shipment data in combination with various
growth rates to estimate annual sales/distribution for the tracked
l/s-l/s devices over the same time period. The average number of new
tracked implants for the time period 2002-2004 is 483,497 devices. The
average total number of tracked implants is 3,941,684. The average total
number of tracked l/s-l/s devices is 369,612.

*B. Burden Estimates- Reporting*

**B-1.** **Section 821.2.** Under §821.2, manufacturers, importers, or
distributors may request exemptions and variances from tracking
requirements. FDA assumes requesters would need 12 hours to prepare a
request. FDA has received an average of four requests a year for
exemptions and variances. Burdens for all distributors to submit
variance or exemption requests under §821.30(e) are included in the
estimate for §821.2. \[4 requests for exemptions/variances per year x 12
hours per response = [48 hours]{.underline}\]

**B-2. Section 821.25(a).** Under §821.25(a), device manufacturers
subject to FDA tracking orders must adopt a tracking method which can
provide certain device, patient, and distributor information to FDA
within 3-10 working days. Assuming one occurrence a year, FDA estimates
it would take a firm 20 hours to provide FDA with location data for all
tracked devices and 56 hours to identify all patients and/or multiple
distributors possessing tracked devices. \[20 hours + 56 hours = [76
hours]{.underline}\]

**B-3. Section 821.25(d).** Under §821.25(d) manufacturers must notify
FDA of distributor noncompliance with reporting requirements. FDA is
unaware of receiving any such notices and assumes only repeated
noncompliances would be reported. Based on the number of audits
manufacturers conduct annually, FDA estimates it would receive no more
than 22 notices in any year. FDA believes that it would take 2 hours per
incident to report repeated distributor noncompliance to FDA. \[22
reports x 2 hours = [44 hours]{.underline}\]

**B-4.** **Section 821.30(a**) **and (b)** Under §821.30 (a)and (b),
distributors must report specified data to manufacturers upon acquiring
tracked devices as well as upon distributing the devices to patients.

[Distributor reporting for tracked implants]{.underline}: FDA assumes
that hospitals are the direct recipients of tracked implants. FDA
believes most hospitals rely on manufacturer distribution records
identifying initial consignees of devices, as required by the Quality
System regulation (21 CFR §820.160) (Attachment 3), in lieu of reporting
the receipt of tracked devices back to the manufacturers. Consequently,
only one report is attributed to final distributors of tracked implants.
FDA estimates it would take 10 minutes (0.1666 hours) for final
distributors to report tracking data for each tracked implant
distributed during the year. For 2002-2004, the estimated average number
of new implants per year is 483,497 devices. The average annual burden
for distributor reporting would be 80,551 hours. \[483,497 new tracked
implants x 1 final distributor per device x 1 data report per final
distributor x 0.1666 hours per report = [80,551 hours]{.underline}\]

[Distributor reporting for tracked l/s-l/s devices]{.underline}: FDA
estimates there are a median of two distributors or multiple
distributors in distribution chains for tracked l/s-l/s devices.
(Attachment 6) Each distributor or multiple distributor would make one
data report per device received during the year. The average annual
burden for distributor reporting for the tracked l/s-l/s devices is
estimated as 123,155 hours. \[369,612 tracked l/s-l/s devices x 2
distributors or multiple distributors per device = 739,224 x 1 data
report per distributor/multiple distributor x 0.1666 hours per report =
[123,155 hours]{.underline}\]

[The total burden for Section 821.30(a) and (b) is 203,706
hours]{.underline}. \[80,551 hours (implants) + 123,155 hours (l/s-l/s
devices) = [203,706 hours]{.underline}\]

**B-6. Section 821.30(c)(2)**. Under §821.30(c)(2), multiple
distributors must provide data on current users of tracked devices,
current device locations, and other information, upon request from a
manufacturer or FDA. FDA has not made such a request and is not aware of
any manufacturer making a request. Assuming one multiple distributor
receives one request in a year from either a manufacturer or FDA, the
agency estimates the multiple distributor would need 3.5 days to comply.
\[8 hours/day x 3.5 days/response = [28 hours]{.underline}\]

**B-7.** **Section 821.30(d).** Under §821.30(d) distributors must
verify data or make required records available for auditing, if a
manufacturer provides a written request.

FDA's estimate of the burden for distributor audit responses assumes
that manufacturers audit database entries for 5% of tracked devices
distributed. Each audited database entry prompts one distributor audit
response. FDA estimates that distributors will take 10 minutes (0.1666
hours) to verify data. FDA estimates that 10% of audited data might be
found discrepant and would require further follow-up from distributors.

[Distributor audit responses for tracked implants]{.underline}: The
estimated percentage of database entries audited once a year for
2002-2004 is 99.2 %. The percentage of entries audited twice a year is
0.8%. The average number of total implants tracked per year is
3,941,684. See Attachment 5. The average annual burden for distributor
audit responses regarding data for tracked implants audited once a year
is estimated as follows:

-   3,941,684 average total tracked implants x 1 data report per device
    from final distributors x 1 database entry per data report x .05
    (percentage of database entries audited) = 197,084 devices.

-   197,084 devices x 1 distributor audit response per audited record x
    .992 (percentage of entries audited once a year) = 195,507 devices.

-   195,507 devices x 0.1666 hours (10 minutes) per response = 32,571
    hours.

-   Adding 10% for additional responses to follow-up verification of
    noncompliant data increases the burden by 3,257 hours. \[(195,507 x
    0.1 = 19,551 devices requiring follow-up x 0.1666 hours per response
    = 3,257 hours\].

The total number of hours for tracked implants audited once a year,
including follow-up, is 35,828 hours. \[32,571 hours + 3,257 hours =
[35,828 total hours]{.underline}\]

The average number of distributor audit responses for tracked implants
audited twice a year is approximately 1,577. \[total number of audit
responses (197,084) minus distributor audit responses for tracked
implants audited once a year (197,507) = 1,577\]. The average annual
burden for distributors is estimated as follows: \[(1,577 devices x 2
times audited = 3,154) x 0.1666 (10 minutes) per response = 525 hours.\]
Adding 53 hours (10%) for follow-up brings the burden to 578 hours.
\[525 hours + 53 hours = [578 total hours]{.underline}\]

[The total burden for auditing tracked implants is 36,406
hours.]{.underline} \[35,828 hours for implants audited once/year + 578
hours for implants audited twice/year = [36,406 hours]{.underline}\]

[Distributor audit responses for tracked l/s-l/s devices]{.underline}:
Distributors and multiple distributors of tracked l/s-l/s devices would
be asked to verify audited data for these devices. The average annual
burden for distributor audit responses is estimated below:

-   369,612 devices (average number of new l/s-l/s devices distributed
    per year) x 2 data reports per device (based on mean number of
    distributors or multiple distributors in distribution chains) =
    739,224 reports.

-   739,224 reports x 1 database entry per distributor data report x .05
    (percentage of entries audited) = 36,961 reports.

-   36,961 reports x 1 distributor audit response per audited record x
    0.1666 hours per response = 6,158 hours.

-   Adding 10% for additional responses to verify noncompliant data
    increases the burden by 616 hours to 6,774 hours \[(36,961 x 0.1 =
    3,696) x 0.1666 hours per response = 616 hours\].

[The total burden for auditing tracked l/s-l/s devices is 6,774
hours]{.underline}. \[6,158 hours of distributor audit responses + 616
hours of distributor audit follow-up = [6,774 total hours]{.underline}\]

\[[The total burden for Section 821.30(d) is 43,180 hours]{.underline}
\[36,406 hours for implant audits + 6,774 hours for l/s-l/s audits =
[43,180 hours]{.underline}\]

*C. Burden Estimates- Recordkeeping*

**C-1. Section 821.25(b)** Under §821.25(b) manufacturers must maintain
current tracking records in accordance with standard operating
procedures (SOPs). To maintain databases, manufacturers conduct
transactions, such as receiving distributor data reports , registering
patients, making database entries, and auditing entries against
distributor data. Audit activities are estimated separately under **C-3,
Section 821.25(c)(3).**

[Database for tracked implants]{.underline}: In FDA's cost assessment,
FDA used a consulted implant manufacturer's estimate that the
representative firm conducts approximately 2.5 database transactions per
tracked implant. Each transaction would take personnel approximately 17
minutes (0.2899 hour) to complete. The estimated average annual burden
for database transactions for tracked implants is 2,856,735 hours.
\[3,941,684 devices (average number of tracked implants for 2002-2004) x
2.5 database transactions per year x 0.2899 hours (17 minutes) per
transaction = [2,856,735 hours]{.underline}\].

[Database for tracked l/s-l/s devices]{.underline}: For tracked l/s-l/s
devices, FDA assumes a similar number of database transactions per
device (2.5) and time for transactions (17 minutes).

The average annual burden for database transactions involving tracked
l/s-l/s devices is 214,301 hours. \[369,612 devices (average number of
new devices distributed per year per) x 2 distributors or multiple
distributors per device (based on the mean number in distribution
chains) x 1 data report per distributor x 1 database transaction per
report x 0.2899 hour (17 minutes) per transaction = [214,301
hours]{.underline}\]

[The total burden for Section 821.25(b) is 3,071,036 hours]{.underline}
\[2,856,735 hours for tracked implants + 214,301 hours for tracked
l/s-l/s devices [= 3,071,036 total hours]{.underline}\]

**C-2. Section 821.25(c)** Under §821.25(c), manufacturers must
establish SOPs for collecting, maintaining, and auditing tracking data.
FDA estimates that the 20 new manufacturers would take an average of two
staff months to plan and develop a tracking system, and one month to
draft and implement standard operating procedures (SOPs). One month
equal 22 working days at 8 hours per day. The estimated time for the new
manufacturers with a one-time burden is 10,560 hours. \[20 new
manufacturing firms x 66 working days x 8 hours per day = 1-time burden
of [10,560 hours]{.underline}\]

Manufacturers with tracking systems in place would review and/or revise
their tracking system SOPs on an annual basis, expending approximately
10 percent of the amount of time spent originally in drafting the SOPs
\[22 days x 8 hours per day\] x 0.1 = 18 hours. From 2002-2004,
approximately 215 firms would annually revise tracking SOPs.The average
annual burden for revising SOPs from 2002-2004 is 3,870 hours. \[215
firms x 18 hours per firm = [3,870 hours]{.underline}\]

Section 821.25(c)(3) requires that the manufacturer's auditing SOP
include a quality assurance program with procedures for statistically
relevant sampling. As discussed under §821.30(d), FDA's burden estimate
for manufacturer auditing assumes firms would audit 5% of records for
products, based on numbers of tracked implant devices each year or
distributed tracked l/s-l/s devices each year. FDA provides for 10%
further follow-ups for noncompliance, i.e., to change inaccurate or
update data. Burdens for auditing data for tracked implants and tracked
l/s-l/s products are estimated below.

[Manufacturer auditing for tracked implants]{.underline}: Manufacturers
would audit data for total tracked implants. FDA assumes auditing
transactions would take 17 minutes (0.2899 hours). For 2002-2004, the
average annual burden for auditing tracked implants requiring one audit
per year would be 3,941,684 devices x 1 final distributor data report
per new implant upon implantation per database entry x .05 (5% of
database entries audited) (197,084) x 1.0 (average percentage of entries
audited once per year) x .2899 hours (17 minutes) per audit transaction
= 57,135 hours. Adding 10% for follow-up auditing (5,714) increases the
burden to 62,849 hours \[57,135 + 5,714 = [62,849 hours]{.underline}).

[Manufacture auditing for tracked l/s-l/s devices]{.underline} The data
for new l/s-l/s devices distributed each year would be audited. For
2002-2004, the average annual burden for these devices is estimated at
11,787 hours. \[369,612 devices (average number of new
devicesdistributed annually) x 2 data reports per device (based on the
mean of the number of distributors or multiple distributors in
distribution chains) (739,224) x 1 database entry per distributor or
multiple distributor data report x .05 (percentage of entries audited)
(36,961) x .2899 hours = 10,715 hours. The 10% for follow up auditing
(1,072) increases the burden to [11,787 hours]{.underline}\].

[The total burden for manufacturer auditing of tracked implants (62,849)
and l/s-l/s devices (11,787) is]{.underline} [74,636 hours]{.underline}.

*D. Annualized Cost - Estimates*

Based on average annual burdens from 2002-2004, FDA estimates that
respondents will expend approximately \$2,881,800 (\$2.9 million) to
comply with reporting requirements, and approximately \$52,507,772
(\$52.5 million) to comply with recordkeeping requirements of the
tracking regulation. Recordkeeping costs include one-time costs of
approximately \$442,147. Table 3 shows burden hours and costs associated
with each provision in the medical device tracking regulation that
requires reporting or recordkeeping.

**Table 3. -** **Estimated Average Annual Costs^1^**

+----------+----------------------------------+-----+--------+-------+
| **Type** | **CFR**                          | **T | **     | **To  |
|          |                                  | ota | Hourly | tal** |
| **       | **Section**                      | l** | Wage   |       |
| Burden** |                                  |     | R      | **Ann |
|          |                                  | *   | ates** | ual** |
|          |                                  | *An |        |       |
|          |                                  | nua | **(    | **Co  |
|          |                                  | l** | Compos | sts** |
|          |                                  |     | ite)** |       |
|          |                                  | **H |        |       |
|          |                                  | our |        |       |
|          |                                  | s** |        |       |
+==========+==================================+=====+========+=======+
| **Rep    | 821.2 (including 821.30(e)):     | 48  | \      | \$    |
| orting** | Exemption/variance requests      |     | $36.97 | 1,775 |
+----------+----------------------------------+-----+--------+-------+
|          | 821.25(a): Manufacturers provide | 76  | \      | \$    |
|          | data in 3, 10, or 10 days        |     | $16.50 | 1,254 |
+----------+----------------------------------+-----+--------+-------+
|          | 821.25(d): Manufacturers report  | 44  | \      | \$    |
|          | distributor non-compliance       |     | $47.44 | 2,087 |
+----------+----------------------------------+-----+--------+-------+
|          | 821.30(a),(b): Distributors,     | 2   | \      | \     |
|          | final distributors and multiple  | 03, | $11.65 | $2,37 |
|          | distributors report data upon    | 706 |        | 3,175 |
|          | receipt and when distributed to  |     |        |       |
|          | patients.                        |     |        |       |
+----------+----------------------------------+-----+--------+-------+
|          | 821.30(c)(2): Multiple           | 28  | \      | \$462 |
|          | distributors provide data in 5   |     | $16.50 |       |
|          | days to manufacturers and FDA    |     |        |       |
|          | upon request.                    |     |        |       |
+----------+----------------------------------+-----+--------+-------+
|          | 821.30(d): Distributors, final   | 43, | \      | \$50  |
|          | distributors, and multiple       | 180 | $11.65 | 3,047 |
|          | distributors provide records     |     |        |       |
|          | upon written audit requests by   |     |        |       |
|          | manufacturers (or verify data as |     |        |       |
|          | requested during manufacturer    |     |        |       |
|          | auditing of tracking systems).   |     |        |       |
+----------+----------------------------------+-----+--------+-------+
| *        |                                  |     |        | \     |
| *Total** |                                  |     |        | $2,88 |
|          |                                  |     |        | 1,800 |
| **(Repo  |                                  |     |        |       |
| rting)** |                                  |     |        |       |
+----------+----------------------------------+-----+--------+-------+
| *        | 821.25(b): Manufacturers         | 3,0 | \      | \$    |
| *Recordk | register patients and record and | 71, | $16.50 | 50,67 |
| eeping** | maintain current data in         | 036 |        | 2,094 |
|          | implementing tracking system     |     |        |       |
|          | databases                        |     |        |       |
+----------+----------------------------------+-----+--------+-------+
|          | 821.25(c): Manufacturers develop | 14, | \      | \$60  |
|          | and implement tracking systems   | 430 | $41.87 | 4,184 |
|          | and draft/review/revise SOPs,    |     |        |       |
|          | including audit SOP within       |     |        |       |
|          | quality assurance program        |     |        |       |
+----------+----------------------------------+-----+--------+-------+
|          | 821.25(c)(3): Manufacturers      | 74, | \      | \     |
|          | audit data in implementing audit | 636 | $16.50 | $1,23 |
|          | SOP.                             |     |        | 1,494 |
+----------+----------------------------------+-----+--------+-------+
| *        |                                  |     |        | \$    |
| *Total** |                                  |     |        | 52,50 |
|          |                                  |     |        | 7,772 |
| **(      |                                  |     |        |       |
| Recordke |                                  |     |        |       |
| eping)** |                                  |     |        |       |
+----------+----------------------------------+-----+--------+-------+

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

Wage estimates used in Table 3 are based on figures found in the May
2003 National Industry-Specific Occupational Employment and Wage
Estimates, U.S. Department of Labor, Bureau of Labor Statistics, at
http://bls.gov/oes/2003/may/oessrci.htm.

The composite hourly wage rate of \$36.97 assumes the following
participation by personnel at manufacturers and comparable personnel at
various type distributors: 20% by the general manager/top executive
(\$59.59 per hour); 70% by managers or supervisors (\$34.01 per hour);
and 10% by secretaries (\$12.21 per hour).

The composite hourly wage rate of \$16.50 assumes the following
participation by personnel at manufacturers and comparable personnel at
multiple distributors: 10% by managers/ supervisors (\$34.01 per hour);
45% by computer operators (\$15.44 per hour), and 45% by audit clerks
(\$13.66 per hour).

The composite hourly wage rate of \$47.44 assumes the following
participation at manufacturers: 50% by general managers (\$48.90 per
hour) and 50% by managers/supervisors (\$34.01 per hour).

The hourly wage rate of \$11.65 is for shipping, receiving, and traffic
clerks at the various type distributors. (This is not a composite rate.)

The composite hourly wage rate of \$41.97 assumes the following
participation by manufacturing personnel: 50% by general managers/top
executives (\$59.59 per hour); 40% by computer programmers (\$27.04 per
hour); and 10% percent by secretaries (\$12.58 per hour).

13\. [Estimates of Other Total Annual Cost Burden to
Respondents]{.underline}

No capital and start-up, operating and maintenance, or other costs not
identified in item 12 above are estimated for this information
collection.

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

The 229 manufacturers will be inspected once every two years under FDA's
Quality System (Q/S) inspection program. The field force will spend one
hour per inspection to check tracking systems. Headquarters will spend
about 10 minutes reviewing results. Total hours would be 133 hours (114
firms inspected per year x 1 hour/inspection = 114 hours) + (114
checklist results x 0.1666 hour/headquarters review per checklist = 19).

Based on an average wage estimate for involved FDA employees of \$84,227
per full time equivalent (FTE) position (40 hours per week x 52 weeks
per year), the annualized cost to FDA would be about \$5,382. \[\$84,227
x 133/2080 hours (0.0693) = \$5,382\]

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

Under OMB Control No. 0910-0442, OMB previously approved a burden of
10,175,490 responses and 2,790,693 burden hours. FDA is estimating the
current burden at 10,851,241 responses and 3,407,184 burden hours.
Burden hours also include a one-time burden of 10,560 hours under
section 821.25(c) for the 20 new manufacturers to establish SOPs for
collecting, maintaining, and auditing tracking data for the first time.
FDA does not believe that the change in the number of manufacturers will
result in a change in the number of devices tracked, only differences in
market share. Increases in the number of devices are consistent with the
growth patterns projected in FDA's cost assessment.

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

Tracking information collections are not collected as part of a
statistical analysis.

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

FDA is not seeking approval to not display the OMB expiration date for
OMB approval.

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

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

**ATTACHMENTS**

**1A**: Final rule, Medical Devices; Device Tracking, August 16, 1993
(58 FR 43442)

**1B**: Federal Food Drug, and Cosmetic Act (FFD&C Act), section 519(e),
as added by the Safe Medical Devices Act of 1990 (SMDA)

**1C**: SMDA, Section 3

**2A**: Food and Drug Administration Modernization Act of 1997 (FDAMA),
section 211

**2B**: FFD&C Act, section 519(e), as amended by FDAMA

**2C**: Final rule, Medical Devices; Device Tracking, February 8, 2002
(67 FR 5943)

**3**: Quality System Regulation, 21 CFR 820.160 Distribution

**4**: Guidance For Industry and FDA Staff: Medical Device Tracking, May
5, 2003 (includes list of types of tracked devices)

**5**: Cost Assessment of Medical Device Tracking

**6**: Schematic Chart, Distribution Chains for Tracked Devices

7\. 60 Day Federal Register Notice