Supporting Statement - Medical Devices; Device Tracking

A. Justification

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

On August 16, 1993, the Food and Drug Administration (FDA) issued final
rules establishing regulations for tracking certain medical devices (58
FR 43442). See Attachment (Attach.) 1A. These regulations implemented
section 519(e) of the Federal Food, Drug, and Cosmetic Act (act), as
amended by the Safe Medical Devices Act of 1990 (Pub. L. 101-629) (SMDA)
and the Medical Device Amendments of 1992 (Pub. L. 102-300). See Attach.
1B, 1C, and 1D.

Under the SMDA, section 519(e) mandated that any person registered as
manufacturing a device meeting the criteria in section 519(e)(1) must
track that device by statute. Under section 519(e)(2), the manufacturer
of a device designated by FDA as requiring tracking was required to
track that designated device. Device tracking regulations went into
effect on August 29, 1993, (21 CFR 821) (Attach. 1E). They establish
requirements for manufacturer tracking systems and distributor
reporting, and contain illustrative lists of 19 device types that FDA
believes meet the criteria requiring mandatory tracking, under the SMDA,
and a list of 7 device types designated by FDA to require tracking,
under the SMDA.

Effective February 19, 1997, section 519(e) was amended by the FDA
Modernization Act of 1997 (Pub. L. 105-115) (FDAMA). See Attach. 2A.
Amended section 519(e)(1) provides 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 (Attach. 2B).
Amended section 519(e)(2) provides that patients may refuse to release,
or refuse permission to release, their names, addresses, social security
numbers, or other identifying information for tracking purposes.

FDA is issuing a final rule (Attach. 2C), which is the subject of this
supporting statement, to conform current tracking regulations (21 CFR
821) to changes in tracking provisions effected by FDAMA. Previously, 26
device types were tracked under the SMDA. Presently, under FDAMA, 17
device types are tracked per orders issued by FDA. It is no longer
necessary for current tracking regulations to list example devices
believed to meet SMDA mandatory tracking criteria, or to list devices
designated by FDA to require tracking, under the SMDA. Deletion of these
lists is a change in this final rule.

On May 30, 2000, the Office of Management and Budget (OMB) approved the
information collection related to the tracking of medical devices as it
pertains to the previous rule approved in 1993. The approved information
collection was assigned OMB Control No. 0910-0442. . At that time, OMB
stated: "OMB files comment on this collection as it pertains to the new
proposed rule, and FDA will resubmit this collection with any changes
along with the final rule. In drafting the final rule and paperwork
submission, FDA should consider uses of appropriate technology (e.g.
electronic submission of information) that could reduce burden."

FDA is requesting approval from the Office of Management and Budget
(OMB) for information collections in this final rule to amend the
tracking regulations, \"Medical Devices; Devices Tracking,\" 21 CFR 821,
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 device manufacturers, subject to
FDA tracking orders, to adopt a tracking method which can provide, upon
FDA request: \-\-- within 3 days, for all tracked devices, prior to
distribution to patients, data about distributors, \-\-- within 10 days,
for tracked devices for single patient use, after distribution to
patients, data about the devices, shipping, use, patients, and
physicians, and \-\-- within 10 days, for tracked devices for multiple
patient use, after distribution to multiple distributors, data about the
devices, shipping, multiple distributors, use, patients, and physicians.

**821.25(b) - Recordkeeping -** Requires manufacturers of tracked
devices to keep current records of tracking data per the standard
operating procedure (SOP).

**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 (third party disclosure) -** 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 (third party disclosure)-** Requires that final
distributors, upon distributing to the patient tracked devices intended
for single patient use, provide manufacturers with data about patient
identities, the devices, use dates, physicians, and other usage

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

**821.30(d) - Reporting -** Requires distributors, final distributors,
or multiple distributors to make available for auditing, upon a
manufacturers written request, required tracking information records.

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 permitted by patients (see item 10 below). This
data is to be used by manufacturers and, as necessary, by FDA 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 such devices. Thus 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 the collection of information that
tracks devices to distributors and patients. Legal impediments prevent
using Social Security and Internal Revenue Service data that might help
locate patients, with tracked implants, who are lost to follow-up.

Under FDAs Quality System regulation (21 CFR 820.160) (Attach. 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. Thus, duplicative
reporting is minimal.

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

FDA attempts to minimize the impact by aiding small business in dealing
with tracking through guidance provided by CDRHs Division of Small
Manufacturers Assistance (DSMA), and its scientific and compliance
staffs.

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

FDA does not require a specific collection frequency, reviewing tracking
data during 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 5CFR 1320.6]{.underline}

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

8.  [Consultations Outside FDA]{.underline}

FDA published a proposed rule on April 25, 2000 (Tab B). FDA received
one public comment on the proposed rule. The comment received maintained
that infusion pumps should be tracked on the basis of high-risk uses
(per FDA\'s February 1999 guidance) rather than on operating technology,
i.e., whether or not they are electromechanical infusion pumps (per
FDA\'s January 2000 guidance). The commenter claimed that FDA\'s
position in the January 2000 guidance \"...would, again, make enteral
feeding pumps which are electromechanical in nature, subject to
tracking, while unfairly exempting enteral feeding pumps which are not
electromechanical.\"

The issue raised by the comment is outside the scope of the regulation.
Specifically, the comment relates to the appropriateness of the issuance
of orders that were issued pursuant to section 519(e) as amended by
FDAMA, prior to the existence of this proposed regulation. The comment
also relates to the appropriateness of guidance that was published prior
to the existence of this proposed regulation. Since the issuance of
these orders relating to infusion pumps took place under authority that
was independent of the proposed regulation, the appropriateness of the
order's issuance is not within the scope of this regulation.

FDA does note, however, that, in describing the criteria for triggering
the issuance of the future orders that will be issued under the
regulation, the regulation mirrors the language of the statute. If the
commenter has concerns about the issuance of previous orders relating to
infusion pumps, the firm may request an exemption from the tracking
regulations, and may also submit comments on the guidance relating to
the application of tracking requirements to infusion pumps.

In addition, on May 30, 2000, the Office of Management and Budget (OMB)
approved the information collection related to the tracking of medical
devices as it pertains to the previous rule approved in 1993. The
approved information collection was assigned OMB Control No. 0910-0442.
At that time, OMB stated: "OMB files comment on this collection as it
pertains to the new proposed rule, and FDA will resubmit this collection
with any changes along with the final rule. In drafting the final rule
and paperwork submission, FDA should consider uses of appropriate
technology (e.g. electronic submission of information) that could reduce
burden."

FDA notes that the proposed rule, and now the final rule, provides for
broad use of electronic submission for this information collection in
accordance with FDA's regulations governing electronic submission of
information (21 CFR part 11). FDA addresses the minor changes from the
proposed rule in item 12 below.

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. Though they are not respondents, patients receiving tracked
devices may refuse to provide personal identifying data under 821.55(a).
See Attach. 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. Burden estimates for information collections are
based on data and methods set forth in FDAs 1999 analysis, Cost
Assessment of Medical Device Tracking, (Attach. 6). That analysis
estimates industry costs for current device tracking systems through the
year 2006 and cost savings for devices no longer tracked under FDAMA.
Burdens, shown in the tables and described below, are average annual
figures for the years 1999-2001.

**Table 1.**

**Estimated Average 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)    | 19      | 1              | 19       | 2     | 38    |
+--------------+---------+----------------+----------+-------+-------+
| 821.30(a),   | 17,000  | 65             | 1        | 0     | 18    |
| (b)          |         |                | ,105,000 | .1666 | 4,093 |
+--------------+---------+----------------+----------+-------+-------+
| 821.30(c)(2) | 1       | 1              | 1        | 28    | 28    |
+--------------+---------+----------------+----------+-------+-------+
| 821.30(d)    | 17,000  | 13             | 221,000  | 0     | 3     |
|              |         |                |          | .1666 | 5,497 |
+--------------+---------+----------------+----------+-------+-------+
| Total        |         |                |          |       |       |
+--------------+---------+----------------+----------+-------+-------+

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    | 209      | 41,331      | 8,638,179  | 0.2899     | 2,      |
| .25(b) |          |             |            |            | 504,208 |
+--------+----------+-------------+------------+------------+---------+
| 821    | 209      | 1           | 209        | 25.49      | 5       |
| .25(c) |          |             |            |            | ,328^2^ |
+--------+----------+-------------+------------+------------+---------+
| 821.25 | 209      | 1,007       | 210,463    | 0.2899     | 61,013  |
| (c)(3) |          |             |            |            |         |
+--------+----------+-------------+------------+------------+---------+
| Total  |          |             |            |            |         |
+--------+----------+-------------+------------+------------+---------+

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

2\. Includes one-time burden of 1,584 hours.

2\. Respondents. FDA has issued tracking orders to 209 manufacturers to
track 13 types of devices intended to be implanted for more than one
year (hereinafter referred to as tracked implants) and 4 types of
life-sustaining or life-supporting devices used outside device user
facilities (hereinafter referred to as tracked l/s-l/s devices). See
Attach. 4.

FDA estimates that the total number of distributor respondents, subject
to tracking reporting requirements, is approximately 17,000
distributors. This figure is a combined total that includes
distributors, final distributors, and multiple distributors, as defined
in the regulation, and is based on estimates from sources as follows:

\- 171 wholesalers, electromedical equipment (SIC code 5047-03-04, Dun &
Bradstreet),

\- 1,252 retailers, hospital equipment and supplies (SIC code 599-09-04,
Dun & Bradstreet),

\- 10,500 home care dealers/medical equipment rental companies (median
of 6,000 to 15,000 dealer estimate, Health Industry Distributors
Association, and includes the 5,046 equipment rental company estimate
(SIC code 7352-00-00), Dun & Bradstreet)

\- 5,057 community hospitals in the U.S. (Hospital Statistics. Health
Forum, an American Hospital Association Company. 1999. Table 3. p 8.
(16,980 (total) rounded to 17,000.)

3\. Tracked implant devices. Using implantation procedures data from the
National Center for Health Statistics for 1993 through 1996, FDA applies
a 2% annual growth rate to estimate number of procedures for tracked
implant devices from 1997 through 2006. See Attach. 6. Table 3 shows
1993-1996 figures, and Table 4, projections through 2001. FDA issued
tracking orders for dura mater implants in December 1998 and for
abdominal aortic aneurysm (AAA) stent grafts in September 1999. Data for
these devices are first considered in the appropriate years.

**Table 3**.

**Number of Implantation Procedures Per Tracked Implants (1993 - 1996)**

+--------------------+------+---------+----------+---------+---------+
| **Device Type**    | *    | *       | **Number | *       | *       |
|                    | *ICD | *Number | of**     | *Number | *Number |
|                    | Numb | of**    |          | of      | of**    |
|                    | er** |         | **Pr     | Pro     |         |
|                    |      | **Pro   | ocedures | cedures | **Pro   |
|                    |      | cedures | in       | in      | cedures |
|                    |      | in      | 1994**   | 1995**  | in      |
|                    |      | 1993**  |          |         | 1996**  |
+====================+======+=========+==========+=========+=========+
| Implantable        | 37.8 | 123,000 | 139,000  | 136,000 | 155,000 |
| Pacemaker Pulse    |      |         |          |         |         |
| Generator          |      |         |          |         |         |
+--------------------+------+---------+----------+---------+---------+
| Cardiovascular     | 37.  | 108,000 | 131,000  | 128,000 | 132,000 |
| Permanent          | 70-3 |         |          |         |         |
| Implantable        | 7.76 |         |          |         |         |
| Pacemaker          |      |         |          |         |         |
| Electrode          |      |         |          |         |         |
+--------------------+------+---------+----------+---------+---------+
| Replacement Heart  | 35.2 | 58,000  | 54,000   | 61,000  | 69,000  |
| Valve              |      |         |          |         |         |
+--------------------+------+---------+----------+---------+---------+
| Automatic          | 37.9 | 21,000  | 21,000   | 27,000  | 26,000  |
| Implantable        |      |         |          |         |         |
| Cardiove           |      |         |          |         |         |
| rter/Defibrillator |      |         |          |         |         |
+--------------------+------+---------+----------+---------+---------+
| Implanted          | 2.93 | 2,000   | 2,000    | 2,000   | 2,000   |
| Cerebellar         |      |         |          |         |         |
| Stimulator         |      |         |          |         |         |
+--------------------+------+---------+----------+---------+---------+
| Implanted          | 3    | 2,000   | 2,000    | 2,000   | 2,000   |
| Dia                | 4.85 |         |          |         |         |
| phragmatic/Phrenic |      |         |          |         |         |
| Nerve Stimulator   |      |         |          |         |         |
+--------------------+------+---------+----------+---------+---------+
| Implantable        | 8    | 7,000   | 7,000    | 6,000   | 9,000   |
| Infusion Pumps     | 6.06 |         |          |         |         |
+--------------------+------+---------+----------+---------+---------+
| Temporomandibular  | 7    | 2,000   | 2,000    | 2,000   | 6,000   |
| Joint\*            | 6.92 |         |          |         |         |
+--------------------+------+---------+----------+---------+---------+
| Ventricular Bypass | 37.  | 33,000  | 35,000   | 48,000  | 56,000  |
| (Assist) Device    | 61-3 |         |          |         |         |
|                    | 7.63 |         |          |         |         |
+--------------------+------+---------+----------+---------+---------+
| Dura Mater         | 2.12 | 6,000   | 6,000    | 8,000   | 6,000   |
+--------------------+------+---------+----------+---------+---------+
| Abdominal Aortic   | \--  | n/a     | n/a      | n/a     | n/a     |
| Aneurysm Grafts    |      |         |          |         |         |
+--------------------+------+---------+----------+---------+---------+

\* This product category includes: Temporomandibular Joint (TMJ)
Prosthesis, Glenoid Fossa Prosthesis, and Mandibular Condyle Prosthesis.

Numbers of implantations correspond to numbers of distributed tracked
implants. FDA assumes that tracked implants are distributed directly
from manufacturers to final distributors, which are mostly hospitals.

**Table 4.**

**Tracked Implants - Estimates of Annual Distribution and Total Tracked
Devices (1994 -2001)**

**(Based on Implantation Procedure Data)**

  -------------------------------------------------------------------------
  **End of Year** **New Implants   **Previous Implants** **Total Tracked**
                  \***                                   
  --------------- ---------------- --------------------- ------------------
  1994            393,000          0                     393,000

  1995            412,000          393,000               805,000

  1996            457,000          805,000               1,262,000

  1997            466,140          1,262,000             1,728,140

  1998            475,463          1,728,140             2,203,603

  1999\*\*        491,339          2,203,603             2,694,942

  2000\*\*\*      516,166          2,694,942             3,211,108

  2001            526,489          3,211,108             3,737,598
  -------------------------------------------------------------------------

\* Represents estimated number of tracked implants distributed annually.

\*\* Estimated distribution for dura mater implants is included in
1999 - 2001, et al estimates.

\*\*\* Estimated distribution for abdominal aortic aneurysm grafts is
included in 2000 - 2001, et al estimates.

4\. Tracked l/s-l/s devices. In its Cost Assessment document (Attach.
6), FDA uses unit shipment data and forecasts from 1992 and 1994
published sources, in combination with various growth rates to estimate
annual sales/distribution of four types of tracked l/s-l/s devices. See
Table 5. below (excerpted from Attach.6).

**Table 5.**

**Tracked Life-Sustaining or Life-Supporting Devices -Estimated Number
of Units ( 1991-2001**)

+-----+-------+-------+-------+-------+-------+------+-------+------+
|     | *     | **    | **DC  |       |       | **   |       |      |
|     | *Brea | Conti | -Defi |       |       | Infu |       |      |
|     | thing | nuous | brill |       |       | sion |       |      |
|     | Freq  | Ven   | ators |       |       | Pum  |       |      |
|     | uency | tilat | and   |       |       | ps** |       |      |
|     | Monit | ors** | Padd  |       |       |      |       |      |
|     | ors** |       | les** |       |       | **(e |       |      |
|     |       |       |       |       |       | lect |       |      |
|     |       |       |       |       |       | rome |       |      |
|     |       |       |       |       |       | chan |       |      |
|     |       |       |       |       |       | ical |       |      |
|     |       |       |       |       |       | onl  |       |      |
|     |       |       |       |       |       | y)** |       |      |
+=====+=======+=======+=======+=======+=======+======+=======+======+
| **  | **    | **    | *     | *     | **    | *    | **    | **T  |
| Yea | Total | Total | *Alte | *Phys | Total | *Syr | Ambul | otal |
| r** | Un    | Un    | rnate | ician | Un    | inge | atory | Uni  |
|     | its** | its** | Care  | O     | its** | Uni  | Un    | ts** |
|     |       |       | Un    | ffice |       | ts** | its** |      |
|     |       |       | its** | Un    |       |      |       |      |
|     |       |       |       | its** |       |      |       |      |
+-----+-------+-------+-------+-------+-------+------+-------+------+
| 1   | n/a   | n/a   | 1     | 3,150 | 1     | n/a  | n/a   | n/a  |
| 991 |       |       | 4,000 |       | 7,150 |      |       |      |
+-----+-------+-------+-------+-------+-------+------+-------+------+
| 1   | n/a   | n/a   | 1     | 3,591 | 2     | n/a  | n/a   | n/a  |
| 992 |       |       | 7,850 |       | 1,441 |      |       |      |
+-----+-------+-------+-------+-------+-------+------+-------+------+
| 1   | n/a   | n/a   | 2     | 4,094 | 2     | n/a  | n/a   | n/a  |
| 993 |       |       | 2,759 |       | 6,852 |      |       |      |
+-----+-------+-------+-------+-------+-------+------+-------+------+
| 1   | 1     | 4,300 | 2     | 4,667 | 3     | 23   | 3     | 54   |
| 994 | 2,200 |       | 9,017 |       | 3,684 | ,600 | 0,900 | ,500 |
+-----+-------+-------+-------+-------+-------+------+-------+------+
| 1   | 1     | 4,700 | 3     | 5,320 | 4     | 26   | 3     | 60   |
| 995 | 2,300 |       | 6,997 |       | 2,317 | ,200 | 4,500 | ,700 |
+-----+-------+-------+-------+-------+-------+------+-------+------+
| 1   | 1     | 5,100 | 4     | 6,065 | 5     | 29   | 3     | 66   |
| 996 | 2,800 |       | 7,171 |       | 3,236 | ,100 | 7,500 | ,600 |
+-----+-------+-------+-------+-------+-------+------+-------+------+
| 1   | 1     | 5,600 | 6     | 6,914 | 6     | 32   | 4     | 73   |
| 997 | 3,300 |       | 0,144 |       | 7,058 | ,300 | 0,800 | ,100 |
+-----+-------+-------+-------+-------+-------+------+-------+------+
| 1   | 1     | 6,200 | 7     | 7,882 | 8     | 35   | 4     | 79   |
| 998 | 3,900 |       | 6,683 |       | 4,565 | ,700 | 4,100 | ,800 |
+-----+-------+-------+-------+-------+-------+------+-------+------+
| 1   | 1     | 6,900 | 9     | 8,986 | 10    | 39   | 4     | 86   |
| 999 | 4,500 |       | 7,771 |       | 6,757 | ,300 | 7,300 | ,600 |
+-----+-------+-------+-------+-------+-------+------+-------+------+
| 2   | 1     | 7,700 | 12    | 1     | 13    | 43   | 5     | 93   |
| 000 | 5,100 |       | 4,658 | 0,244 | 4,902 | ,000 | 0,400 | ,400 |
+-----+-------+-------+-------+-------+-------+------+-------+------+
| 2   | 1     | 8,387 | 15    | 1     | 17    | 47   | 5     | 101  |
| 001 | 5,569 |       | 8,939 | 1,678 | 0,617 | ,105 | 4,571 | ,676 |
+-----+-------+-------+-------+-------+-------+------+-------+------+

*B. Burden Estimates- Reporting*

1\. Under 821.2, manufacturers, importers, or distributors, including
final distributors, and multiple distributors, may request exemptions
and variances from tracking requirements. These requests must meet the
requirements for citizen petitions under 21 CFR 10.30. FDA's burden
estimates for citizen petitions are approved under OMB control number
0910-0183.

The estimate for 821.2 assumes requesters would need about 12 additional
hours per petition to provide information not required under 10.30, such
as suitable alternative tracking methods justifying a variance. FDA has
received an average of four requests a year for exemptions and variances
from manufacturers, distributors, final distributors, multiple
distributors, and trade associations in behalf of such firms. Burdens
for distributors, final distributors, and multiple distributors to
submit variance or exemption requests, under 821.30(e) are included in
the estimate for 821.2.

2\. 821.25(a) requires manufacturers to adopt a tracking method that can
provide, upon FDA request \-\--within 3 working days, for all tracked
devices, prior to distribution to patients, data about the distributors,
\-\--within 10 workings days, for tracked devices for single patient
use, after distribution to patients, data about the devices, shipping,
patients, use, and physicians, and \-\-- within 10 working days, for
tracked devices for multiple patient use, after distribution to multiple
distributors, data about the devices, shipping, multiple distributors,
use, patients, and physicians.

FDA has never requested such deadline disclosures. Assuming one
occurrence a year, FDA estimates it would take a firm some 20 hours to
provide location data for all tracked devices within 3 days, and 56
hours to identify all patients and/or multiple distributors possessing
tracked devices.

3\. 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 noncompliance would be
reported. FDA believes it would receive no more than 19 notices in any
year. This assumes manufacturers annually audit about 5% of the data
reported by distributors against database entries and that some 10% of
audited records (approximately 19,000) might be inaccurate and require
further follow-up. FDA believes only 0.1% of further audited data might
represent repetitive distributor noncompliance and that it would take
about 2 hours per incident to report repeated distributor noncompliance
to FDA.

4\. Under 821.30(a), distributors, final distributors, and multiple
distributors must report receipt related data to manufacturers, upon
acquiring tracked devices. Under 821.30(b), final distributors of
tracked devices, intended to be used by a single patient over the useful
life of the device, must report patient and usage related information,
upon distributing the devices to patients. The agency estimates
distributor reporting burdens for tracked implants and tracked l/s-l/s
devices as follows.

[Distributor reporting for tracked implants]{.underline}: Tracked
implants are tracked devices intended for single patient usage. FDA
assumes hospitals, for the most part, are the direct recipients of
tracked implants. As final distributors, they must report both the
receipt and implantation of tracked implants, but FDA believes most, in
practice, make only one report to manufacturers at implantation. 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), in lieu of reporting the receipt of
tracked devices back to the manufacturers. Thus, only one report is
attributed to final distributors of tracked implants in FDAs estimate.

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 (new implants per Table 4). For 1999 - 2001,
the average number of new implants per year is estimated as 508,567
devices, per Table 4. The average annual burden for distributor
reporting for these devices would be: 508,567 (average number of new
implants) x 1 final distributor per device x 1 data report per final
distributor x 0.1666 hours per report = 84,727 hours.

[Distributor reporting for tracked l/s-l/s devices]{.underline}: FDA
estimates there are from one to three, or a median of two, distributors
or multiple distributors in distribution chains for three types of
tracked l/s-l/s devices, that is: tracked breathing frequency monitors
(infant apnea monitors), continuous ventilators, and DC-defibrillators
and pads. There are no final distributors for tracked l/s-l/s devices
because each device is intended for multiple patient usage. See
schematic chart of distribution chains for tracked devices, Attach. 7.
Each distributor or multiple distributor would make one data report per
device received during the year. See Table 6 for annual distribution.

For 1999 - 2001, the average number of total units (Table 5) and new
devices (Table 6) of the above three types of tracked l/s-l/s devices
distributed per year would be 157,035, as estimated per Table 5 . The
average annual burden for distributor reporting for these three types of
tracked l/s-l/s devices is estimated as: 155,322 (average number of new
devices) x 2 distributors or multiple distributors per device x 1 data
report per distributor or multiple distributor x 0.1666 hours per report
= 51,751 hours.

FDA estimates there are from one to five, or a median of 3, distributors
or multiple distributors in distribution chains for one type of tracked
l/s-l/s device, ie., electromechanical infusion pumps that are tracked.
See Attach. 7 schematic chart. For 1999 - 2001, the average number of
total units (Table 5) and new devices (Table 6) of tracked
electromechanical infusion pumps distributed per year would be 95,272
devices, as estimated per Table 6. The average annual burden for
distributor reporting for this one type of tracked l/s-l/s device would
be: 95,272 (average number of new devices) x 3 distributors or multiple
distributors x 1 data report x 0.1666 hours = 47,615 hours.

**Table 6.**

**Tracked Life-Sustaining or Life Supporting Devices - Estimated
Distribution**

+-----+-----+--------------+----------+------------+------+--------+
| **  | *** |              | ***      |            | **%  | **Au   |
| End | Bre |              | Infusion |            | A    | dits** |
| of  | ath |              | Pumps*** |            | udit |        |
| Yea | ing |              |          |            | ed** | **per  |
| r** | Fre |              |          |            |      | Year** |
|     | que |              |          |            |      |        |
|     | ncy |              |          |            |      |        |
|     | Mon |              |          |            |      |        |
|     | ito |              |          |            |      |        |
|     | rs, |              |          |            |      |        |
|     | C   |              |          |            |      |        |
|     | ont |              |          |            |      |        |
|     | inu |              |          |            |      |        |
|     | ous |              |          |            |      |        |
|     | Ven |              |          |            |      |        |
|     | til |              |          |            |      |        |
|     | ato |              |          |            |      |        |
|     | rs, |              |          |            |      |        |
|     | &   |              |          |            |      |        |
|     | De  |              |          |            |      |        |
|     | fib |              |          |            |      |        |
|     | ril |              |          |            |      |        |
|     | lat |              |          |            |      |        |
|     | ors |              |          |            |      |        |
|     | *** |              |          |            |      |        |
+=====+=====+==============+==========+============+======+========+
|     | **  | **Average \# | **New    | **Average  |      |        |
|     | New | of           | D        | \# of      |      |        |
|     | Dev | Dis          | evices** | Distr      |      |        |
|     | ice | tributors/** |          | ibutors/** |      |        |
|     | s** |              |          |            |      |        |
|     |     | **Data       |          | **Data     |      |        |
|     |     | Reports**    |          | Reports**  |      |        |
+-----+-----+--------------+----------+------------+------+--------+
| 1   | 50, | 2            | 54,500   | 3          | 5%   | 2      |
| 994 | 184 |              |          |            |      |        |
+-----+-----+--------------+----------+------------+------+--------+
| 1   | 59, | 2            | 60,700   | 3          | 5%   | 2      |
| 995 | 317 |              |          |            |      |        |
+-----+-----+--------------+----------+------------+------+--------+
| 1   | 71, | 2            | 66,600   | 3          | 5%   | 2      |
| 996 | 136 |              |          |            |      |        |
+-----+-----+--------------+----------+------------+------+--------+
| 1   | 85, | 2            | 73,100   | 3          | 5%   | 1      |
| 997 | 958 |              |          |            |      |        |
+-----+-----+--------------+----------+------------+------+--------+
| 1   | 1   | 2            | 79,800   | 3          | 5%   | 1      |
| 998 | 04, |              |          |            |      |        |
|     | 665 |              |          |            |      |        |
+-----+-----+--------------+----------+------------+------+--------+
| 1   | 1   | 2            | 86,600   | 3          | 5%   | 1      |
| 999 | 28, |              |          |            |      |        |
|     | 157 |              |          |            |      |        |
+-----+-----+--------------+----------+------------+------+--------+
| 2   | 1   | 2            | 93,400   | 3          | 5%   | 1      |
| 000 | 57, |              |          |            |      |        |
|     | 702 |              |          |            |      |        |
+-----+-----+--------------+----------+------------+------+--------+
| 2   | 1   | 2            | 101,676  | 3          | 5%   | 1      |
| 001 | 94, |              |          |            |      |        |
|     | 572 |              |          |            |      |        |
+-----+-----+--------------+----------+------------+------+--------+

5\. 821.30(c)(1) requires multiple distributors to keep written records,
containing patient identity and other information, each time a tracked
device is distributed to patients (or users). This requirement does not
impose a paperwork burden. The required information is customer, and
related information, which is recorded and/or kept on a daily basis by
device rental and leasing firms, and other multiple distributors, as a
customary and usual business practice, for purposes of billing,
inventory control, liability protection, and other fiscal accounting.

6\. Under 821.30(c)(2), multiple distributors must provide data on
current users of tracked devices, current device locations, and other
information, within 5 working days of a request from a manufacturer, or
within 10 working days of a request from FDA. FDA is unaware of any
manufacturer making such a request, nor has the agency made such a
request. Assuming one multiple distributor receives one request in a
year from both a manufacturer and FDA, the agency estimates the multiple
distributor would need from 3 to 4 days, or a median of 3.5 days, to
comply.

7\. 821.30(d) requires distributors, final distributors, or multiple
distributors to make available for auditing, upon a manufacturers
written request, records required under this tracking regulation. FDA is
unaware of manufacturers making written audit requests. However,
distributors, final distributors, and multiple distributors do incur a
burden in responding to manufacturer requests to verify data pursuant to
manufacturer auditing of tracking system data. FDA assumes most such
data verification is accomplished by telephone during distributor audit
responses, which includes responses from final distributors and multiple
distributors as well.

FDAs estimate of the burden for distributor audit responses assumes:
manufacturers audit database entries for 5% of tracked devices
distributed; entries in tracking system databases approximate, in number
and amount, data reported by distributors (data reports); and, each
audited database entry prompts one distributor audit response. FDA
estimates that all distributors will take 10 minutes (0.1666 hours) to
verify data. FDA allows that 10% of audited data might be found
noncompliant, i.e., discrepant, and would require further follow-up
responses from distributors to confirm, correct, or update data.

[Distributor audit responses for tracked implants]{.underline}: Certain
final distributors that handle tracked implants would be asked by
manufacturers to verify data for 5% of the total number of implants
actively tracked (total tracked implants in Table 7 = new implants +
previous implants in Table 4). Data for dura mater and AAA stent grafts
must be audited twice a year because the devices are in the first three
years of tracking. FDA adjusts for these devices by factoring in the
percentage they constitute of total tracked devices (shown in Table 7).
Data for all other tracked implants are audited once a year.

For 1999 - 2001, the average number of total tracked implants tracked
per year amounts to 3,214,549 devices, as estimated per Tables 4 and 7
as follows: 491,339 + 2,203,603 devices (for 1999) + 516,166 + 2,694,942
devices (for 2000) + 526,489 + 3,211,108 devices for (2001) 3. The
average annual burden for distributor audit responses regarding data for
tracked implants, audited once a year, is estimated as: 3,214,549
devices (average number of 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) x .996 (percentage of entries
audited once a year) x 1 distributor audit response per audited record x
0.1666 hours (10 minutes) per response = 26,678 hours.

Adding 10% for additional responses to follow-up verification of
noncompliant data increases the burden to 29,346 hours. Applying the
above formula to the 0.37% (average percentage) of total tracked
implants whose data are audited twice a year results in an additional
635 burden hours (includes 10% for additional follow-ups).

[Distributor audit responses for tracked l/s-l/s devices]{.underline}:
Distributors and multiple distributors of three types of tracked l/s-l/s
devices, that is, breathing frequency (infant apnea) monitors,
continuous ventilators, and DC-defibrillators would be asked to verify
audited data for these devices. Only the data for new devices
distributed each year would be audited. For 1999 - 2001, the average
number of new devices for these three types of tracked l/s-l/s devices
would be 160,144 devices, as estimated per Table 6 as follows: 128,157
devices (for 1999) + 157,702 devices (for 2000) + 194,572 devices (for
2001) 3.

The average annual burden for distributor audit responses regarding data
for these three types of tracked l/s-l/s devices would be: 160,144
devices (average number of new devices distributed per year) x 2 data
reports per device ( based on mean number of distributors or multiple
distributors in distribution chains) x 1 database entry per distributor
data report x .05 (percentage of entries audited) x 1 distributor audit
response per audited record x 0.1666 hours per response = 2668 hours.
Adding 10% for additional responses to verify noncompliant data
increases the burden to 2,935 hours.

For 1999 - 2001, the average number of total units(Table 5), and new
devices (Table 6), for tracked electromechanical infusion pumps
distributed per year would be 93,892 new devices, as estimated per Table
6 as follows: 86,600 devices (for 1999) + 93,400 devices (for 2000) +
101,676 devices (for 2001) 3. The average annual burden for distributor
audit responses regarding data for these devices is estimated as: 93,892
devices (average number of new devices) x 3 reports (based on mean
number of distributors or multiple distributors) x 1 database entry x
.05 entries audited x 1 distributor response x 0.1666 hours = 2,346
hours. Adding 10% for additional follow-up responses by distributors
increases the burden to 2,581 hours.

The total burden for 821.30(d) would be 35,497 hours (29,436 + 635 +
2935 + 2581).

**Table 7**

**Tracked Implants: Estimated Distribution and Audit Frequency**

  --------------------------------------------------------------------------------------
  **End of   **Total     **%         ***Tracked                ***Tracked   
  Year**     Tracked**   Audited**   Since                     Since        
                                     1994***                   1999***      
  ---------- ----------- ----------- ------------ ------------ ------------ ------------
                                     **% of       **Audits per **% of       **Audits per
                                     Total**      Year**       Total**      Year**

  1994       393,000     5%          100%         2            n/a          n/a

  1995       805,000     5%          100%         2            n/a          n/a

  1996       1,262,000   5%          100%         2            n/a          n/a

  1997       1,728,140   5%          100%         1            n/a          n/a

  1998       2,203,603   5%          100%         1            n/a          n/a

  1999\*     2,694,942   5%          99.8%        1            0.2%         2

  2000\*\*   3,211,108   5%          99.6%        1            0.4%         2

  2001       3,737,598   5%          99.5%        1            0.5%         2
  --------------------------------------------------------------------------------------

\* Procedural data for dura mater is included in the 1999 through 2001
estimates.

\*\* Procedural data for abdominal aortic aneurysm grafts is included in
the 2000 through 2001 estimates

*C. Burden Estimates- Recordkeeping*

8\. 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 data
from distributors (distributor data reports), registering patients,
making database entries, and auditing entries against distributor data.
Audit activities are estimated separately ( 821.25(c)(3)).

[Database for tracked implants]{.underline}: For this estimate, and in
its Cost Assessment (Attach. 6), FDA uses a consulted implant
manufacturers estimate that his firm conducts some 2.5 database
transactions at a cost of about \$5 per transaction. Using a composite
wage rate of \$17.25 for involved personnel, each transaction costing
\$5 would take personnel approximately 17 minutes (0.2899 hour) to
complete. For 1999-2001, the average number of total tracked implants
actively tracked per year amounts to 3,214,549 devices, as estimated per
Table 7 as follows: 2,694,942 devices (for 1999) + 3,211,108 devices
(for 2000) + 3,737,598 devices (for 2001) 3. The average annual burden
for database transactions for tracked implants is estimated as:
3,214,549 (average number of total tracked implants) x 2.5 database
transactions per year x 0.2899 hours per transaction = 2,329,744 hours.

[Database for tracked l/s-l/s devices]{.underline}: For three types of
tracked l/s-l/s devices, i.e., tracked breathing frequency monitors,
continuous ventilators, and DC-defibrillators, the average annual burden
for database transactions would be: 160,144 devices (average number of
new devices distributed per year) (128,157devices (for 1999) + 157,702
devices (for 2000) + 194,572 devices (for 2001) 3, per Table 6) 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 = 92,851 hours.

For one type of tracked l/s-l/s device, i.e., electromechanical infusion
pumps, the average annual burden would be: 93,892 devices (average
number of new devices distributed per year) (86,600 devices (for 1999) +
93,400 devices (for 2000) + 101,676 devices (for 2001) 3, per Table 6) x
3 distributors or multiple distributors x 1 data report x 1 transaction
x 0.2899 hour per transaction = 81,658 hours.

9\. Under 821.25(c), manufacturers must establish SOPs for collecting,
maintaining, and auditing tracking data. Two dura mater manufacturers
and one AAA stent graft manufacturer would have one- time burdens. FDA
estimates these three firms 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), including the development of audit
SOPs. This amounts to 1,584 hours (3 firms x 3 months x 22 working days
per month x 8 hours per day). There would be no such burdens for 206
manufacturers that have tracking systems in place.

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,
i.e., 22 days x 8 hours per day = 18 hours. Over the next 3 years, 617
firms would annually revise tracking SOPs as follows: 204 firms
(excludes dura mater firms) for 1999, 206 firms (excludes dura mater
firms for the first year, and 209 firms (includes all) for the second
and third year. The total annual burden for revising SOPs for 3 years
would amount to: 624 firms x 18 hours per firm = 11,232 hours. The
annual burden would be 3,744 hours (11,232/3). Thus, the total burden
for 821.25(c) would be 5,328 hours (1,584 hours + 3,744 hours).

10\. 821.25(c)(3) requires that the auditing SOP of manufacturers
include a quality assurance program that has audit procedures to be run
for each tracked device product for the first 3 years of distribution
and once a year thereafter. As discussed under 821.30(d), FDAs burden
estimate for manufacturer auditing assumes firms would audit 5% of
records for products, based on numbers of devices actively tracked
(implants) each year, or distributed (tracked l/s-l/s devices) each
year. Tracking database entries, corresponding in numbers and kind, to
distributor data reports (and, for tracked implants, implanted patient
reports) would be verified by phone through distributor data responses
or patient contacts. FDA provides for 10% further follow-ups for
noncompliance, i.e., to change inaccurate or update data. Burdens are
estimated for auditing data for tracked implants and tracked l/s-l/s
products as follows below.

[Manufacturer auditing for tracked implants]{.underline}: Using the same
\$5 per tracking transaction figure that was used for database
maintenance estimates, FDA assumes auditing transactions would take 17
minutes (0.2899 hours). Manufacturers would audit data for total tracked
implants, as shown in Table 7. Total tracked implants correspond to
amounts actively tracked each year (new implants + previous implants in
Table 4) and take into account devices distributed in previous years
that are implanted and continue to be tracked for eight subsequent
years, the approximate lifetime of implants that FDA uses.

On average, about 99.63% (99.8% (for 1999) + 99.6% (for 2000) + 99.5%
(for 2001) 3, per Table 7) of the data audited (i.e. 5% of the total
database entries corresponding to the average number of total tracked
devices for 1999 - 2001) would be audited once a year and 10% of this
data would be further audited. On average, about .37% of the 5% of
database entries audited (the approximate amount comprised by database
entries for dura mater and AAA stents) would be audited twice.

For 1999 - 2001, the average annual burden for auditing tracked implants
requiring one audit per year would be : 3,214,549 devices (average
number of total tracked implants actively tracked each year) (2,694,942
devices (for 1999) + 3,211,108 devices (for 2000) + 3,737,598 devices
(for 2001) 3, per Table 7) x 1 final distributor data report per new
implant upon implantation (or 1 implanted patient report per previous
implant distributed) per database entry x .05 (percentage of database
entries audited) x .996 (average percentage of entries audited once per
year) x .2899 hours (17 minutes) per audit transaction = 46,423 hours.
Adding 10% for follow-up auditing increases the burden to 51,065 hours.

Applying the above formula to database entries for tracked implants
requiring 2 audits per year (an average .0037 of total tracked devices)
results in 345 hours. A 10% additional follow-up rate makes 380 burden
hours.

[Manufacture auditing for tracked l/s-l/s devices]{.underline}: For
breathing frequency (infant apnea) monitors, continuous ventilator, and
DC-defibrillators the data for new devices distributed each year would
be audited. For 1999-2001, the average annual burden for these devices
would be: 160,144 devices (average number of new devices distributed per
year) (128,157 devices (for 1999) + 157,702 devices (for 2000) + 194,572
devices (for 2001) 3, per Table 6) x 2 data reports per device (based on
the mean of the number of distributors or multiple distributors in
distribution chains) x 1 database entry per distributor or multiple
distributor data report x .05 (percentage of entries audited) x .2899
hours = 4,642 hours. Adding 10% for additional follow-up results in
5,106 hours.

Applying the above formula to 93,892 electromechanical infusion pumps
that are tracked l/s-l/s devices (average number of new devices), having
a mean of 3 distributors or multiple

*D. Annualized Cost - Estimates*

Based on average annual burdens, derived over 1999 - 2001, FDA estimates
that respondents will expend approximately \$3,499,973 (\$3.5 million)
to comply with reporting requirements, and approximately \$44,402,648
(\$44.4 million) to comply with recordkeeping requirements of the
tracking regulation, as proposed for amendment in this proposed rule.
Recordkeeping costs include one-time costs of about \$56,580. See Table
8. Below.

**Table 8.**

**Estimated Average Annual Costs**

+----------+----------------------------------+-----+-------+--------+
| **Type** | **CFR**                          | **T | **H   | **T    |
|          |                                  | ota | ourly | otal** |
| **       | **Section**                      | l** | Wage  |        |
| Burden** |                                  |     | Ra    | **An   |
|          |                                  | *   | tes** | nual** |
|          |                                  | *An |       |        |
|          |                                  | nua | **(Co | **C    |
|          |                                  | l** | mposi | osts** |
|          |                                  |     | te)** | \*     |
|          |                                  | **H |       |        |
|          |                                  | our |       |        |
|          |                                  | s** |       |        |
|          |                                  | \*  |       |        |
+==========+==================================+=====+=======+========+
| **Rep    | 821.2 (including 821.30(e)):     | 48  | \$    | \      |
| orting** | Exemption/variance requests      |     | 25.13 | $1,206 |
+----------+----------------------------------+-----+-------+--------+
|          | 821.25(a): Manufacturers provide | 76  | \$    | \      |
|          | data in 3, 10, or 10 days        |     | 17.25 | $1,311 |
+----------+----------------------------------+-----+-------+--------+
|          | 821.25(d): Manufacturers report  | 38  | \$    | \      |
|          | distributor non-compliance       |     | 31.46 | $1,195 |
+----------+----------------------------------+-----+-------+--------+
|          | 821.30(a),(b): Distributors,     | 1   | \$    | \$2,9  |
|          | final distributors and multiple  | 85, | 15.82 | 34,215 |
|          | distributors report data upon    | 475 | \*\*  |        |
|          | receipt and when distributed to  |     |       |        |
|          | patients.                        |     |       |        |
+----------+----------------------------------+-----+-------+--------+
|          | 821.30(c)(2): Multiple           | 28  | \$    | \$483  |
|          | distributors provide data in 5   |     | 17.25 |        |
|          | days to manufacturers and FDA    |     |       |        |
|          | upon request.                    |     |       |        |
+----------+----------------------------------+-----+-------+--------+
|          | 821.30(d): Distributors, final   | 35, | \$    | \$5    |
|          | distributors, and multiple       | 497 | 15.82 | 61,563 |
|          | distributors provide records     |     | \*\*  |        |
|          | upon written audit requests by   |     |       |        |
|          | manufacturers (or verify data as |     |       |        |
|          | requested during manufacturer    |     |       |        |
|          | auditing of tracking systems).   |     |       |        |
+----------+----------------------------------+-----+-------+--------+
| *        |                                  |     |       |        |
| *Total** |                                  |     |       |        |
|          |                                  |     |       |        |
| **(Repo  |                                  |     |       |        |
| rting)** |                                  |     |       |        |
+----------+----------------------------------+-----+-------+--------+
| *        | 821.25(b): Manufacturers         | 2,5 | \$    | \$43,1 |
| *Recordk | register patients and record and | 04, | 17.25 | 98,364 |
| eeping** | maintain current data in         | 253 |       |        |
|          | implementing tracking system     |     |       |        |
|          | databases                        |     |       |        |
+----------+----------------------------------+-----+-------+--------+
|          | 821.25(c): Manufacturers develop | 4,  | \$    | \$1    |
|          | and implement tracking systems   | 236 | 35.72 | 51,310 |
|          | and draft SOPs, including audit  |     |       | \*\*\* |
|          | SOP within quality assurance     |     |       |        |
|          | program                          |     |       |        |
+----------+----------------------------------+-----+-------+--------+
|          | 821.25(c)(3): Manufacturers      | 61, | \$    | \$1,0  |
|          | audit data in implementing audit | 042 | 17.25 | 52,975 |
|          | SOP.                             |     |       |        |
+----------+----------------------------------+-----+-------+--------+
| *        |                                  |     |       |        |
| *Total** |                                  |     |       |        |
|          |                                  |     |       |        |
| **(      |                                  |     |       |        |
| Recordke |                                  |     |       |        |
| eping)** |                                  |     |       |        |
+----------+----------------------------------+-----+-------+--------+

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

\* Annual averages for the period 1999 - 2001.

\*\* Not a composite rate.

\*\*\* Includes estimated one-time costs of \$56,580 (1,584 hours
(821.25(c) x \$35.72)

Wage rates shown above are based on figures found in the 1997 National
Occupational Employment and Wage Estimates, U.S. Dept. Of Labor, Bureau
of Labor Statistics, at http:// stats.bls.gov/oes/national/ (28 June
1999).

The composite hourly wage rate of \$25.13 assumes the following
participation by personnel at manufacturers, and comparable personnel at
various type distributors: 20 percent, by the general manager/top
executive (\$41.03 per hour, including 40% for benefits); 70 percent, by
managers or supervisors (\$21.87 per hour, including benefits); and 10
percent, by secretaries (\$16.13 per hour, including benefits).

The composite hourly wage rate of \$17.25 assumes the following
participation by personnel at manufacturers, and comparable personnel at
multiple distributors (821.30(c)(2): 10% by managers/ supervisors
(\$21.87 per hour, including 40% for benefits); 45% by computer
operators (\$17.57 per hour, including 40% for benefits), and 45% by
audit clerks (\$15.88/hr, including 40% for benefits).

The composite hourly wage rate of \$31.46 assumes the equal
participation at manufacturers of general managers (\$41.03 per hour,
including 40% for benefits x .5) and managers/supervisors (\$21.87 per
hour, including benefits x .5). .

The \$15.82 hourly wage rate for personnel at the various type
distributors is the 1997 figure of \$11.30 given by the Bureau of Labor
Statistics (as noted above) for shipping, receiving, and traffic clerks,
with the addition of 40% for benefits (\$11.30 x 1.40).

The \$35.72 composite hourly wage rate of \$35.72 assumes the 50 percent
expenditure at manufacturers of general manager/top executive time
(\$41.03 per hour, including 40% for benefits); 40 percent, computer
programmer time (\$33.98 per hour, including benefits); and 10 percent,
secretarial time (\$16.13 per hour, including benefits)

13\. [Estimates of Other Total Annual Cost Burden to Respondents or
Recordkeepers]{.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 209 tracked device manufacturers will be inspected once every two
years under FDAs Quality System (Q/S) inspection program. The field
force will spend about 1 hour per inspection to check tracking systems,
using a significant points check list. Headquarters will spend about 10
minutes (10/60 hour or 0.1666 hour) reviewing checklist results. Total
hours would be 121 hours (104 firms inspected per year x 1 hour per
inspection) + (104 checklist results x 0.1666 hour per headquarters
review per checklist).

Based on a cost of \$92,296 per full time equivalent (FTE) position (40
hours per week x 52 weeks per year) \-\-- the average salary, including
benefits, of involved FDA employees \-\-- the annualized cost to FDA
would be about \$5,369 (\$92,296 x 121/2080 hours = \$5,369).

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

Under OMB Control No. 0910-0442, OMB approved a burden of 10,175,490
responses and 2,790,693 burden hours. At that time, there were 207
manufacturers tracking devices. In 2000, FDA ordered three manufacturers
that did not previously track devices to track their devices cleared for
marketing and FDA rescinded a previous tracking order issued to one
firm. Therefore, 209 manufacturers currently track devices (207
previous + 3 additional - 1 rescinded). FDA has no reason to believe
that the change in the number of manufacturers will result in a change
in the number of devices implanted. The change will only result in
differences in market share.

The analysis for §821.25(c) changes because of the additional
manufacturers that received tracking orders since the publication of the
April 2000 proposal. As described above, three additional manufacturers
received orders, and one was rescinded, the analysis of §821.25(c) is
changed by the additional manufacturers.

Under §821.25(c), manufacturers must establish standard operating
procedures (SOP's) for collecting, maintaining, and auditing tracking
data. FDA estimates the three new firms 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 (SOP\'s), including
the development of audit SOP\'s. This amounts to 1,584 hours (3 firms x
3 months x 22 working days per month x 8 hours per day).

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:

Attach. 1A: Final rule of August 16, 1993

Attach. 1B: FFD&C Act, section 519(e), as added by the SMDA

Attach. 1C: SMDA, section 2(b)

Attach. 1D: Medical Device Amendments of 1992, section 2

Attach. 1E: Tracking regulations, codified in 21 CFR 821

Attach. 2A: FDA Modernization Act of 1997, section 211

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

Attach. 2C: Final Rule to Amend Tracking Regulation

Attach. 3: Quality System Regulation, 21 CFR 820.160 Distribution

Attach. 4: Guidance on Medical Device Tracking, includes list of types
of tracked devices

Attach. 5: January 15, 1998 Public Meeting, Attendees and Speakers

Attach. 6: Cost Assessment of Medical Device Tracking

Attach. 7: Schematic Chart, Distribution Chains for Tracked Devices

Chron:trkpras9.wpd

drafted: 6/18,22,23/99

revised: 8/16/99

revised: 9/14-16, 20-21per P. Schlosburg/K. Parker (9/9) comments

revised: 10/4-12

revised: 11/19-23, per P. Schlosburg/K. Parker (11/9, 11/19) comments.

Revised: 11/30-12/1, per P. Schlosburg/K. Parker (11/30) comments

Edits: 12/3,6 (changed date format from 1999- to 1999: at beginning of
date series; then, Edits: 12/6: changed from 1999: at beginning to for
1999\" at end of date series, per P Schlosburg; added costs
table/explanation wage rates.

Edits: 12/13 (changed date format from for 1999\" at end to (for 1999,
2000, 2001)at end.

Edits: 12/17 (changed distributors to 17,000 in text and tables) per L
Barons 12/17 reg flex revision.