24144 Federal Register / Vol. 65, No. 80 / Tuesday, April 25, 2000 / Proposed Rules

Using agency: USAF, 366th Wing, Mountain

Home AFB, ID.

* * * * *

Issued in Washington, DC, on April 19,

2000.

Reginald C. Matthews,

Manager, Airspace and Rules Division.

[FR Doc. 00–10243 Filed 4–24–00; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 821

[Docket No. 00N–1034]

Medical Devices; Device Tracking

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend the medical device tracking

regulations. The scope of the regulation

and certain patient confidentiality

requirements must be amended to

conform to changes made in section

519(e) of the Federal Food, Drug, and

Cosmetic Act (the act) by the FDA

Modernization Act of 1997 (FDAMA).

FDA also proposes nonsubstantive

revisions to remove outdated references

or simplify terminology.

DATES: Submit written comments by

July 24, 2000. See section IV of this

document for the proposed effective

date of a final rule based on this

document. Submit written comments on

the information collection requirements

by May 25, 2000.

ADDRESSES: Submit written comments

on the proposed rule to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

Submit written comments regarding the

information collection requirements to

the Office of Information and Regulatory

Affairs Office of Management and

Budget (OMB), New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Chester T. Reynolds, Center for Devices

and Radiological Health (HFZ–300),

Food and Drug Administration, 2094

Gaither Rd., Rockville, MD 20850, 301–

594–4618.

SUPPLEMENTARY INFORMATION:

I. Background

A. The SMDA and Device Tracking

Regulations

The Safe Medical Device Act of 1990

(the SMDA) (Public Law 101–629)

became law on November 28, 1990. It

added mandatory and discretionary

device tracking provisions to the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 301 et seq.) under

new section 519(e) (21 U.S.C. 360i(e)).

As added by the SMDA, new section

519(e)(1) mandated the adoption of a

method of tracking by any person

registered under section 510 of the act

(21 U.S.C. 360) and engaged in the

manufacture of a device if its failure

would be reasonably likely to have

serious adverse health consequences

and the device was either a permanently

implantable device or a life-sustaining

or life-supporting device used outside a

device user facility. New section

519(e)(2) authorized FDA, in its

discretion, to ‘‘designate’’ other devices

that must be tracked, to protect the

public health and safety.

On August 16, 1993, FDA published

in the Federal Register (58 FR 43442)

the final rule setting forth regulations

governing the tracking of medical

devices, as provided by the SMDA

under sections 519(e)(1) and (e)(2) of the

act. Elsewhere in the same Federal

Register (58 FR 43451), FDA published

a rule amending the illustrative list of

those devices FDA considered subject to

tracking under the mandatory criteria

under section 519(e)(1) and the list of

devices FDA designated as subject to

tracking under section 519(e)(2). The

final tracking regulations for medical

devices, including the amended lists of

tracked devices, went into effect on

August 29, 1993, and are currently

codified in part 821 of title 21 of the

Code of Federal Regulations (21 CFR

part 821).

B. FDAMA Tracking Provisions

FDAMA (Public Law 105–115) was

enacted on November 21, 1997. Section

211 of FDAMA amended the tracking

provision in section 519(e)(1) of the act

and became effective on February 19,

1998. Unlike the tracking provisions

under the SMDA, which required

tracking for any device meeting certain

criteria, FDAMA allows FDA discretion

in applying tracking requirements and

provides that tracking requirements can

be imposed only after issuance of an

order.

FDAMA authorizes FDA to issue

orders that require a manufacturer to

adopt a method of tracking 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 1 year, or it is a lifesustaining or life-supporting device

used outside a device user facility. As

amended by FDAMA, section 519(e)(2)

of the act provides that patients

receiving a device subject to tracking

may refuse to release, or refuse

permission to release, their names,

addresses, social security numbers, or

other identifying information for

tracking purposes.

Section 519(e) of the act, as amended

by FDAMA, provides that FDA ‘‘ may by

order require a manufacturer to adopt a

method of tracking.’’ Such an order

specifies to the manufacturer the class II

or class III device(s) to be tracked. FDA

interprets the discretion inherent in

‘‘may’’ to allow the agency to consider

additional relevant factors in

determining whether to issue a tracking

order for a device that meets the criteria

in amended section 519(e)(1) of the act.

The discretionary authority to issue

tracking orders, and the three statutory

criteria that operate independently of

one another in section 519(e)(1) of the

act, allow the agency to accomplish the

intended purpose of device tracking

under FDAMA, as identified by

Congress, i.e., to facilitate the recall of

dangerous or defective devices, under

section 518(e) of the act (S. Rept. 108,

105th Cong., 1st sess. 37 (1997)).

II. Implementation of FDAMA Tracking

Authority

A. Public Meeting/Manufacturer

Notification

On December 18, 1997, FDA

published a Federal Register notice (62

FR 66373) announcing the agency’s

intention to hold a public meeting on

January 15, 1997, in Rockville, MD to

discuss changes in medical device

tracking and postmarket surveillance

authorities under FDAMA. In particular,

the agency was interested in discussing

whether it should consider additional

nonbinding factors to supplement the

statutory criteria, under FDAMA, in

determining whether tracking

requirements should be ordered by

FDA.

On December 19, 1997, FDA sent

letters to manufacturers having

responsibilities to track devices under

section 519(e) of the act. These letters

advised that FDAMA would implement

important statutory changes in medical

device tracking, which had been

authorized previously under the SMDA.

The letters noted FDA’s December 18,

1997, Federal Register notice

announcing the public meeting it would

conduct on January 15, 1998, to discuss

Federal Register / Vol. 65, No. 80 / Tuesday, April 25, 2000 / Proposed Rules 24145

such changes. The letters also advised

that existing device tracking

requirements imposed by previously

issued FDA regulations or FDA orders

would remain in effect until FDA

notified a firm of any changes in its

responsibilities.

At the January 15, 1998, public

meeting, written and oral comments

were received from consumer groups,

clinicians, manufacturers, and device

industry associations. These comments

addressed factors FDA should consider

in requiring tracking and ranged from

FDA consideration of clinical

management issues, and the use of

alternative tracking mechanisms, to

consideration of the likelihood of device

failure.

B. Issuance of New Tracking Orders

On February 11, 1998, FDA issued

orders to manufacturers who would be

required to track their devices under

section 519(e) of the act, as revised by

FDAMA. The orders were issued for 28

types of devices, which the agency

determined met the revised tracking

criteria under FDAMA. The orders

became effective on February 19, 1998,

the effective date of the revised tracking

provision under FDAMA. The 28

devices subject to these new orders

included the 26 device types previously

identified as subject to tracking under

the SMDA criteria in the agency’s

tracking regulation at § 821.20(b)(1),

(b)(2), and (c). Two device types not

previously listed as subject to tracking

in the regulation, namely, arterial stents

and intraocular lenses, were also the

subject of new tracking orders under

FDAMA.

In the Federal Register of March 4,

1998 (63 FR 10638), FDA published a

notice identifying the 28 device types

subject to the orders. The notice

announced, again, FDA’s intention to

review and reconsider the imposition of

tracking requirements for these devices,

in light of its discretionary authority

under FDAMA, to not require the

tracking of devices that meet the

statutory criteria. The notice also

identified 13 devices that met the

statutory criteria and that were subject

to the February 1998 tracking orders,

but that may be removed from the

tracking requirement based on other

factors. Comments were solicited on

which nonbinding factors should be

considered in making such

discretionary tracking determinations.

C. Tracking Guidance Documents and

FDA Reconsideration, Rescission, and

Additional Issuance of Tracking Orders

In the March 4, 1998, Federal

Register, FDA also published a notice of

availability of the guidance document

entitled ‘‘Guidance on Medical Device

Tracking’’ (63 FR 10640). This

document provided guidance to

manufacturers and distributors about

their tracking responsibilities under

section 519(e) of the act, as amended by

FDAMA. It discussed what statutory

and regulatory requirements had

changed, and what requirements

remained the same, and represented

FDA’s current thinking on medical

device tracking under the FDAMA

amendments.

Beginning on August 26, 1998, FDA

issued orders to manufacturers,

rescinding the tracking orders it issued,

effective February 19, 1998, for 14 types

of devices manufactured by firms,

including intraocular lenses and arterial

stents. The agency determined, in its

discretion, that these 14 device types

did not warrant continued tracking

based on the nonbinding factors, even

though the statutory criteria were met.

These nonbinding factors included: (a)

The likelihood of sudden, catastrophic

failure, (b) the likelihood of significant

adverse clinical outcomes, and (c) the

need for prompt professional

intervention.

On December 14, 1998, FDA issued

orders to manufacturers of dura mater

devices, requiring them to track the

devices under section 519(e) of the act,

as amended by FDAMA. These medical

devices met the statutory criteria and

may have significant adverse clinical

outcomes.

In the February 12, 1999, Federal

Register, FDA published a notice of

availability of the revised final guidance

document entitled ‘‘Guidance on

Medical Device Tracking’’ (64 FR 7197).

It replaced the previous final guidance

issued on March 4, 1998. The revised

final guidance of February 12, 1999,

stated the agency’s current thinking on

manufacturer and distributor tracking

responsibilities, and explained statutory

and regulatory requirements that either

changed or remained unchanged under

medical device tracking revisions made

under FDAMA.

The guidance announced on February

12, 1999, provided an updated list of

devices that were subject to tracking

orders. It also provided the factors, such

as the likelihood of sudden, catastrophic

failure or significant, adverse clinical

outcomes, or the need for prompt

professional intervention, that FDA may

use, in addition to the statutory criteria,

in deciding whether to require the

tracking of a device. It mentioned, as

well, FDA’s December 1998 issuance of

tracking orders for dura mater devices.

On September 28, 1999, FDA issued

orders to manufacturers of stent grafts

intended to treat abdominal aortic

aneurysms, requiring them to track the

devices. Upon reviewing premarket

applications, the agency determined

these devices meet the statutory tracking

criteria of amended section 519(e),

because their failure would be

reasonably likely to have serious

adverse health effects. On January 24,

2000, FDA issued a revised ‘‘Guidance

on Medical Device Tracking’’ that

identifies abdominal aortic aneurysm

stent grafts as tracked devices.

Agency experience indicates that

industry and other interested parties

were uncertain whether ‘‘replacement

heart valves’’ subject to tracking include

more than one type of heart valve. The

January 24, 2000, revised guidance

document clarified that the category of

replacement heart valves that must be

tracked is limited to mechanical heart

valves only and does not include human

allograft (tissue) heart valves.

There was similar uncertainty

concerning which infusion pumps must

be tracked. The February 1999 guidance

document identified ‘‘infusion pumps,

except those designated and labeled for

use exclusively for fluids with low

potential risks, such as enteral feeding

or anti-infectives,’’ as types of pumps

subject to tracking. This description

caused difficulty because infusion

pump labeling does not always make

clear the types of fluids the pumps are

intended to deliver. FDA reevaluated

the tracking status of these devices and

clarified, in its January 24, 2000,

guidance that tracking is required only

for electromechanical infusion pumps

used outside device user facilities.

III. Proposed Changes in Tracking

Regulation

On February 19, 1998, FDAMA

amended section 519(e) of the act. By

operation of statute, certain provisions

in the tracking regulation, part 821,

became inconsistent with the tracking

requirements as revised by FDAMA.

This proposed rule revises certain parts

of part 821 to conform with section 519

of the act, as amended. FDA is

proposing to revise the scope of the

tracking requirements, including the

appropriate modification of certain

definitions and certain requirements

relating to patient confidentiality, to

reflect FDAMA’s changes.

In addition to changes in the

proposed regulation that would reflect

the changes already implemented under

FDAMA, FDA proposes to simplify the

regulation in a few nonsubstantive

areas. These include: Removing explicit

references to effective dates of

provisions that have been in effect since

1993 (§ 821.1(c)); removing references to

24146 Federal Register / Vol. 65, No. 80 / Tuesday, April 25, 2000 / Proposed Rules

procedures for filing petitions before

August 29, 1993 (§ 821.2(d)); and

substituting the simple inclusive term,

‘‘tracked devices,’’ in referring to

devices intended for single use or

multiple use that are subject to tracking,

in place of the specific terms, ‘‘lifesustaining or life-supporting devices

used outside device user facilities’’ and

‘‘permanent implants’’ (§ 821.25(a)(2)

and (a)(3)).

Other than the proposed changes

described above, parts of the tracking

regulation that were not affected by

FDAMA remain unchanged. Except for

the nonsubstantive terminology change

noted above, there are no proposed

revisions to: The regulation’s system

and content requirements of tracking;

the obligations of persons other than

device manufacturers, such as

distributors; records and inspection

requirements; and record retention

requirements.

Each of the revisions proposed for

amending the medical devices tracking

regulation is discussed in more detail

below.

1. FDA is proposing to amend § 821.1

Scope, by revising paragraph (a) to

conform its language to the statutory

language in section 519(e) of the act, as

amended by FDAMA.

Previously, under the statutory

tracking provisions of section 519(e)(1)

of the act, as added by the SMDA, the

scope of the tracking regulations in

paragraph (a) applied the requirement to

adopt a method of tracking to any

person who registered under section 510

of the act as the manufacturer of a

device, if the device’s failure would be

reasonably likely to have a serious

adverse health consequence and if it

was either a permanently implantable

device or a life-sustaining or lifesupporting device used outside a device

user facility. The previous SMDA

tracking provision in section 519(e)(2)

also allowed the agency to require, in its

discretion, tracking for any other device

which did not otherwise meet the

statutory tracking criteria in section

519(e)(1).

FDAMA has changed the scope of the

tracking provisions in several ways, as

follows:

a. The tracking provision in section

519(e) of the act does not require

tracking even if the statutory criteria are

met unless FDA issues an order that

directs a manufacturer to track a device.

Under the SMDA, devices that met the

certain statutory criteria were subject to

tracking automatically, even if FDA did

not issue an order.

b. FDAMA allows FDA to exercise

discretion in determining whether a

device which meets the criteria in

section 519(e) shall be tracked. SMDA

did not allow FDA the discretion to

excuse devices from tracking

requirements if the devices met the

statutory criteria.

c. Under FDAMA, the types of

persons subject to tracking are no longer

linked to registration requirements

under section 510 of the act. As

amended, the tracking provision

requires manufacturers who are issued a

FDA tracking order to track the

device(s).

d. FDAMA also modifies the criteria

by which devices may be subject to

tracking. Formerly, under the SMDA’s

section 519(e)(1), tracked devices were

those that ‘‘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 sustaining or life

supporting device used outside a device

user facility * * *.’’

Under revised section 519(e)(1) of

FDAMA, FDA may order a manufacturer

to track only a ‘‘class II or class III

device (A) the failure of which would be

reasonably likely to have serious

adverse health consequences; or (B)

which is (i) intended to be implanted in

the human body for more than 1 year,

or (ii) a life sustaining or life supporting

device used outside a device user

facility.’’

In addition, the agency may no longer

designate a device as one that requires

tracking to protect the public health, if

the device does not meet any of the

criteria for tracked devices in section

519(e) of the act. Former section

519(e)(2) under the SMDA allowed FDA

discretion to order tracking for devices

that did not meet statutory criteria.

FDA is proposing to revise the

language in paragraph (a) of § 821.1 to

conform to the amended statutory

language in section 519(e) of the act.

Under proposed § 821.1(a), the scope of

the tracking regulation would reflect the

revised statutory language in section

519(e)(1) to state tracking may only be

required after certain statutory criteria

are met.

2. FDA is proposing to revise the third

sentence in paragraph (b) in § 821.1,

which describes persons subject to

tracking requirements, by removing the

words, ‘‘must register under section 510

of the act,’’ and substituting the words,

‘‘are subject to tracking orders.’’ As

noted above, this change reflects the

revisions made to section 519(e) by

FDAMA. The revised tracking

requirements, as amended by FDAMA,

are triggered for the manufacturer by the

issuance of a FDA tracking order, not by

registration requirements.

3. FDA is proposing to remove

paragraph (c) from § 821.1 and to

redesignate paragraphs (d) and (e) as

paragraphs (c) and (d), respectively.

Current § 821.1(c) was included in the

final tracking regulations to clarify that

the effective date for the tracking

requirements under the SMDA was

August 29, 1993. Because the

requirements of these regulations have

been in effect since August 29, 1993 and

have been implemented by industry for

more than 5 years, it is not necessary to

include the effective date in the current

regulation.

4. FDA proposes amending § 821.2

Exemptions and variances, by removing

paragraph (d). Paragraph (d) refers to the

procedures that FDA used to handle

tracking petitions received prior to the

August 29, 1993, effective date of the

tracking regulation. Because all of those

petitions have been responded to, there

is no longer any need to include

procedures relating to such petitions.

5. FDA is proposing to amend § 821.3

Definitions, by revising the definition of

‘‘Importer’’ in paragraph (b). ‘‘Importer’’

under the current regulation is defined

as ‘‘the initial distributor of an imported

device who is required to register under

section 510 of the act and § 807.20 of

this chapter. ‘Importer’ does not include

anyone who only performs a service for

the person who furthers the marketing,

i.e., brokers, jobbers, or warehouser.’’

FDA is proposing to remove the

current language, ‘‘required to register

under section 510 of the act and

§ 807.20 of this chapter,’’ from the end

of the first sentence in the definition

and to replace it with the phrase,

‘‘subject to a tracking order.’’ FDA

proposes that ‘‘Importer’’ be defined as

‘‘the initial distributor of an imported

device who is subject to a tracking

order.’’ The remainder of the definition

would be unchanged.

As explained previously, FDAMA

removed the requirement that persons

subject to registration requirements

were automatically required to track

their devices if the devices met certain

criteria. The revised definition of

‘‘importer’’ reflects that tracking

requirements are no longer triggered by

registration requirements and that FDA

must issue an order to such persons

before they can be subject to tracking

requirements.

6. FDA is proposing to amend § 821.3

Definitions, by revising the definition of

‘‘Permanently implantable device’’ in

paragraph (f). A ‘‘ permanently

implantable device’’ is currently defined

as:

* * * a device that is intended to be

placed into a surgically or naturally

formed cavity of the human body to

Federal Register / Vol. 65, No. 80 / Tuesday, April 25, 2000 / Proposed Rules 24147

continuously assist, restore, or replace

the function of an organ system or

structure of the human body throughout

the useful life of the device. The term

does not include any device which is

intended and used only for temporary

purposes or which is intended for

explantation.

Under the statutory tracking criteria

added by the SMDA, section

519(e)(1)(A) required the mandatory

tracking of a ‘‘permanently implantable

device,’’ if its failure was reasonably

likely to have serious adverse health

consequences. To implement this

provision in the absence of further

statutory clarification, FDA defined the

meaning of ‘‘permanently implantable

device’’ in § 821.3(f) to require such

implants to ‘‘continuously assist,

restore, or replace the function of an

organ system or structure of the human

body’’ throughout their useful life.

Implanted devices intended for

temporary use or explantation were not

included in the meaning of the term.

The type of implanted device that

may be subject to tracking under section

519(e), as amended by FDAMA, has

changed and must exceed a minimum

implantation time period. Under the

statutory tracking criteria of FDAMA,

amended section 519(e)(1)(B)(i) now

provides that FDA may order the

tracking of a class II or class III

implanted device, only if the device ‘‘is

intended to be implanted in the human

body for more than 1 year.’’

FDA is proposing to revise the

definition in § 821.3(f) as follows:

Device intended to be implanted in

the human body for more than 1 year

means a device that is intended to be

placed into a surgically or naturally

formed cavity of the human body for

more than 1 year to continuously assist,

restore, or replace the function of an

organ system or structure of the human

body throughout the useful life of the

device. The term does not include any

device which is intended and used only

for temporary purposes or which is

intended for explantation in 1 year or

less.

FDA is proposing to change the type

of implanted device defined under

§ 821.3(f) from ‘‘permanently

implantable device’’ to ‘‘device

intended to be implanted in the human

body for more than 1 year.’’ This

revision reflects the minimum

implantation time period specified by

FDAMA for the type of implanted

device which FDA may order to be

tracked under the revised statutory

criteria of section 519(e). The agency is

also proposing to add the phrase, ‘‘for

more than 1 year,’’ in the first sentence

of the revised definition after the

phrase, ‘‘of the human body.’’ At the

end of the second sentence, FDA is

proposing to add the phrase, ‘‘in 1 year

or less.’’ These latter two revisions

further incorporate into the revised

definition the minimum implantation

time period effected by the FDAMA

amendment.

FDA believes that devices implanted

for more than 1 year must continue to

perform the function for which they

were designed and implanted,

throughout their useful life. FDA

continues to believe that implanted

devices which may remain

‘‘permanently’’ in the body, but whose

function may be replaced by natural or

other processes after a given period of

time, should not be tracked (57 FR

22973, May 29, 1992). Thus, FDA is

proposing to retain the ‘‘continuously

assist, restore, or replace’’ portion of the

current definition as a condition of

meeting the criterion in section

519(e)(1)(B)(i) of the act.

7. FDA is proposing to amend

§ 821.20 Devices subject to tracking, by

revising paragraph (a) to conform to the

tracking provision of section 519(e) of

the act, as amended by FDAMA. Current

paragraph (a) conforms to the tracking

provision that was added to the act

under section 519(e) by the SMDA. It

required the tracking of devices that met

the statutory tracking criteria for devices

in section 519(e) and also required the

tracking of devices that FDA, in its

discretion, designated as requiring

tracking.

Proposed paragraph (a) would

conform to the statutory language of the

revised section 519(e) under FDAMA.

Accordingly, proposed § 821.20(a)

would require the manufacturer of a

class II or class III device to track the

device when ordered by FDA to do so,

under the agency’s discretion, after

making a determination that such a

device is one the failure of which would

be reasonably likely to have serious

adverse health consequences, or is one

which is intended to be implanted in

the human body for more than a year,

or is one which is life-sustaining or lifesupporting and used outside a device

user facility, and is one which warrants

tracking.

8. FDA proposes the further revision

of § 821.20 Devices subject to tracking,

by the removal of paragraph (b),

paragraph (b)(1) and the table in (b)(1),

paragraph (b)(2) and the table in

paragraph (b)(2), and paragraph (c) and

the table in paragraph (c).

Under the SMDA tracking provision

in previous section 519(e) of the act, the

manufacturer of a device was required

by statute to track the device if the

device met the criteria set forth in

section 519(e)(1). FDA was not required

to issue an order for a device included

in this section. It was the manufacturer’s

responsibility to track devices that met

the statutory criteria. Under prior

section 519(e)(2), the manufacturer was

also required to track any device

designated by FDA to require tracking.

This section required FDA to issue an

order.

Current paragraph (b) of § 821.20 sets

out the responsibility of manufacturers

to identify whether their devices met

the criteria for tracking under section

519(e)(1), as added by the SMDA, and

to initiate tracking. To assist

manufacturers, paragraph (b) provided

guidance concerning the types of

devices FDA regarded as subject to

tracking under the criteria in the

regulation and previous section

519(e)(1). This guidance was provided

in the form of an illustrative listing of

example devices. Example devices were

listed for permanently implantable

devices in the table under paragraph

(b)(1). Example devices were listed for

life-sustaining or life-supporting devices

used outside device user facilities in the

table under paragraph (b)(2).

Current paragraph (c) of § 821.20 sets

out FDA’s authority to designate devices

for tracking, under section 519(e)(2) of

the act, as added by the SMDA. The

devices that FDA had designated, by

order, under the SMDA, as subject to

tracking were identified in the table

under paragraph (c).

FDA is proposing to remove current

§ 821.20(b), (b)(1) and its table, (b)(2)

and its table, and (c) and its table

because they no longer reflect the

criteria for tracking, or a correct list of

devices subject to tracking under section

519(e), as revised by FDAMA. Under the

current tracking provisions of section

519(e) (1), as amended by FDAMA, FDA

is given the authority to determine

whether a class II or class III device

meets the criteria, in sections

519(e)(1)(A) or (B), for devices that may

require tracking. This determination is

no longer the responsibility of the

manufacturer, as current § 821.20(b)

indicates.

FDA is authorized, under the current

tracking provision under FDAMA, to

exercise its discretion in determining

whether a class II or class III device,

meeting the criteria for ‘‘trackable’’

devices, warrants tracking. FDA must

then issue a tracking order to the

manufacturer of the class II or class III

device when the agency determines that

the device warrants being subject to the

tracking requirement. Because each

manufacturer of a device requiring

tracking must receive a FDA tracking

order, there is no need for FDA to

24148 Federal Register / Vol. 65, No. 80 / Tuesday, April 25, 2000 / Proposed Rules

provide illustrative lists of example

devices, as was done in current

§ 821.20(b)(1) and (b)(2). Moreover,

because § 821.20(c) and the table under

(c) listed devices subject to tracking

orders under section 519(e)(2) under

SMDA criteria, that list is no longer

relevant under the tracking criteria, as

amended by FDAMA.

As explained above, the current

tracking requirement under section

519(e) of the act, as amended by

FDAMA, is triggered solely by the

issuance of FDA tracking orders. No

useful regulatory purpose would be

served by replacing, in the tracking

regulation at § 821.20, previous

illustrative lists of example devices

requiring tracking under the SMDA,

with lists of device types ordered by

FDA to be tracked under FDAMA.

Current manufacturers with tracking

obligations have been notified by order

and, therefore, do not need to look in

the regulations to determine if FDA

believes their devices meet the tracking

criteria.

Although distributors, final

distributors, and multiple distributors of

tracked devices will not be provided

tracking orders, as manufacturers are,

FDA believes it is more expeditious and

effective to keep such interested parties

apprised of revisions to device types

subject to tracking orders, through the

use of guidance or periodic Federal

Register notices than it is to undergo the

process of changing a list in a

regulation. Tracking guidance or notices

will be made available to interested

parties through the agency’s Internet

and Facts-on-Demand websites. Their

availability also will be announced

through the publication of Federal

Register notices. These procedures will

be followed when appropriate because

of changes in the types of tracked

devices or changes in the agency’s

current thinking. The status and

identification of tracked devices has

already been disseminated successfully

in this fashion through Federal Register

notices published on March 4, 1998 (63

FR 10638 and 63 FR 10640) and

February 12, 1999 (64 FR 7197), and

through tracking guidance documents

made available through the Internet on

these same dates.

9. Because of the proposed removal of

current § 821.20(b), (b)(1), (b)(2) and (c),

FDA is proposing to redesignate current

§ 821.20(d) as § 821.20(b). In proposed

§ 821.20(b), FDA has edited, revised,

and deleted certain provisions of

current § 821.20(d).

Current § 821.20(d) states: ‘‘FDA,

when responding to premarket

notification (510(k)) submissions and

approving premarket approval

applications (PMA’s), will notify the

sponsor that FDA believes the device

meets the criteria of section 519(e)(1)

and therefore should be tracked.’’

Proposed § 821.20(b) states: ‘‘When

responding to premarket notification

submissions and approving premarket

approval applications, FDA will notify

the sponsor by issuing a tracking order

that FDA believes the device meets the

criteria of section 519(e)(1) of the act

and, by virtue of the order, is required

to be tracked.’’

In revising current § 821.20(d)

(proposed redesignated § 821.20(b)),

FDA proposes to modify the language

describing the content of 510(k) and

PMA orders to accurately reflect that

tracking requirements are accomplished

by order under FDAMA.

10. FDA is proposing to amend

§ 821.25 Device tracking system and

content requirements: manufacturer

requirements, by revising the terms used

in the introductory text of paragraphs

(a)(2) and (a)(3) to identify the types of

devices subject to requirements set out

under § 821.25(a)(2)(i) through (a)(2)(vii)

and 821.25(a)(3)(i) through (a)(3)(viii),

respectively.

The current tracking regulation sets

out different types of reporting

requirements based on whether the

device was: (1) Intended for single use

or a permanent implant (§ 821.25(a)(2))

or (2) intended for multiple use

(§ 821.25(a)(3)). In describing the types

of tracked devices that were subject to

the requirements in these paragraphs,

the current regulation restates the

statutory criteria of section 519(e) of the

act, as added by the SMDA, that were

used to subject devices to tracking.

Accordingly, current § 821.25(a)(2)

tracks the SMDA language by describing

those types of devices that were subject

to requirements for single patient use

and implant devices as ‘‘life-sustaining

or life-supporting devices used outside

a device user facility * * * and

permanent implants * * *.’’ Similarly,

current § 821.25(a)(3) tracks the SMDA

language by describing those types of

devices that were subject to

requirements for multiple patient use

devices as ‘‘life-sustaining or life

supporting devices used outside device

user facilities * * * .’’

Proposed § 821.25(a)(2) and (a)(3)

would not change the reporting

requirements for single patient use,

implants, or multiple patient use

devices. Proposed § 821.25(a)(2) and

(a)(3) merely would delete the

descriptions of single use, implants, and

multiple use devices that reflect SMDA

criteria that no longer apply. Instead,

proposed § 821.25(a)(2) and (a)(3)

substitute a description of devices that

are subject to reporting requirements

that is consistent with the section 519(e)

of the act criteria that were amended by

FDAMA. For simplification purposes,

however, FDA is choosing not to fully

restate the revised FDAMA section

519(e) of the act criteria for tracked

devices. Proposed § 821.25(a)(2) and

(a)(3), instead, refer to devices subject to

tracking as ‘‘tracked devices.’’

Accordingly, in the introductory

paragraph of § 821.25(a)(2), FDA is

proposing to remove the phrase, ‘‘for

life-sustaining or life-supporting devices

used outside a device user facility,’’ and

the statement, ‘‘and permanent implants

that are tracked devices.’’ In their place,

FDA is proposing to substitute the

phrase, ‘‘for tracked devices.’’ Similarly,

in the introductory paragraph of

§ 821.25(a)(3), FDA is proposing to

remove the phrase, ‘‘for life-sustaining

or life-supporting devices used outside

device user facilities,’’ and the clause,

‘‘and that are tracked devices.’’ In their

place, FDA is proposing to substitute

the phrase, ‘‘for tracked devices.’’

11. FDA proposes to further amend

§ 821.25 Device tracking system and

content requirements: manufacturer

requirements, by revising paragraphs

(a)(2)(iii) and (a)(3)(iv). These sections

currently state that manufacturers must

provide ‘‘(t)he name, address, telephone

number, and social security number (if

available) of the patient’’ receiving or

using the device. FDA is proposing to

revise these sections by adding, at the

end of each of these paragraphs, the

clause, ‘‘unless not released by the

patient under § 821.55(a);’’.

These proposed changes bring

§ 821.25(a)(2)(iii) and (a)(3)(iv) into

conformance with section 519(e)(2) of

the act which, as amended by FDAMA,

specifically states that patients receiving

a tracked device may refuse to release,

or refuse permission to release, the type

of patient identifying information

required under the current regulatory

requirements.

12. FDA proposes amending § 821.30

Tracking obligations of persons other

than device manufacturers: distributor

requirements by revising paragraphs

(b)(3) and (c)(1)(ii) in identical fashion.

The semicolons at the end of both

regulatory requirements would be

changed to commas and the phrase,

‘‘unless not released by the patient

under § 821.55(a);’’ would be added

following the comma in each

requirement. These revisions are

proposed for the reasons discussed

above under item 11.

13. FDA is proposing to amend

§ 821.55 Confidentiality, by

redesignating current paragraphs (a) and

(b) as paragraphs (b) and (c),

Federal Register / Vol. 65, No. 80 / Tuesday, April 25, 2000 / Proposed Rules 24149

respectively, and by adding new

paragraph (a). Proposed § 821.55(a)

provides that any patient receiving a

tracked device, subject to the

requirements of this regulation, may

refuse to release, or refuse permission to

release, the patient’s name, address,

telephone number, and social security

number, or other identifying

information for tracking purposes. This

change would incorporate the provision

of section 519(e)(2) of the act, as

amended by FDAMA, and discussed in

section III paragraph 11 of this

document previously, into the tracking

regulation.

Because the agency recognized that

the accuracy of information in the

tracking system was dependent, to some

degree, on the cooperation of persons,

such as patients, who were beyond the

manufacturer’s control, it has stated (57

FR 10702 at 10710, March 27, 1992) that

persons required to track devices would

only have to demonstrate a ‘‘good faith’’

effort to collect required tracking

information and document why certain

information was not obtained. This

same position applies to information not

obtainable under section 519(e)(2) of the

act and proposed § 821.55(a).

IV. Effective Date

FDA proposes that any final rule that

may issue based on this proposal

become effective 30 days after the date

of publication of the final rule in the

Federal Register.

V. Environmental Impact

The agency has determined under 21

CFR 25.30 (h) that this proposed action

is of a type that does not individually

or cumulatively have a significant effect

on the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

VI. Analysis of Impacts

FDA has examined the impacts of the

proposed rule under Executive Order

12866 and the Regulatory Flexibility Act

(5 U.S.C. 601–612) (as amended by

subtitle D of the Small Business

Regulatory Fairness Act of 1996 (Public

Law 104–721)), and the Unfunded

Mandates Reform Act (Public Law 104–

4). Executive Order 12866 directs

agencies to assess all costs and benefits

of available regulatory alternatives and,

when regulation is necessary, to select

regulatory approaches that maximize

the benefits (including potential

economic, environmental, public health

and safety, and other advantages;

distributive impacts; and equity). The

Unfunded Mandates Reform Act (in

section 202) requires that agencies

prepare an assessment of anticipated

costs and benefits before proposing any

expenditure by State, local, and tribal

Governments, in the aggregate, or by the

private sector of $100 million in any 1

year. Under the Regulatory Flexibility

Act, unless an agency certifies that a

rule will not have a significant impact

on a substantial number of small

entities, the agency must analyze

regulatory options that would minimize

any significant economic impact of a

rule on small entities.

Regulations implementing the

tracking requirements of the Safe

Medical Devices Act became effective

on August 29, 1993. The purpose of

device tracking is to ensure that

manufacturers of certain devices

establish tracking systems that will

enable them to promptly locate devices

in commercial distribution. Device

tracking systems can reduce serious

risks by facilitating patient notifications

and device recalls. Manufacturers of

certain devices are required to develop,

document, and operate a tracking

system that will allow them a quick

notification to all distributors, health

professionals, or patients of a recall or

the existence of a serious health risk.

The Food and Drug Administration

Modernization Act of 1997 (FDAMA)

amends the scope of devices that may be

subject to tracking requirements, and

requires the agency to issue an ‘‘order’’

notifying manufacturers to adopt a

tracking method. This proposed rule

codifies the FDAMA changes by

amending the 1993 regulation to give

FDA greater flexibility to issue and

rescind tracking orders in response to

changing market risks. In December of

1997, FDA advised manufacturers that

the tracking requirements imposed by

previous FDA regulations would remain

in effect until the agency notified a firm

of any change in responsibilities. On

February 11, 1998, FDA sent current

tracking orders to manufacturers of all

of the device types listed in the 1993

device tracking regulation. Beginning in

August 1998, FDA used its discretionary

authority under FDAMA to rescind

tracking orders for approximately half of

these devices because it was determined

that they did not have a level of risk

warranting device tracking. Later, FDA

issued tracking orders to manufacturers

of two additional devices known to be

associated with serious risks and

limited the scope for two other device

types. The discussion below estimates

the cost consequences attributable to

these changes in the list of devices

required to be tracked.

A recent agency analysis projects that

the cost to industry of maintaining

device tracking systems will rise from

approximately $40 million in 1999, to

$71 million in 2006 (Ref. 1). As detailed

in that analysis, this estimate accounts

for the FDAMA-related changes that: (1)

Add approximately $1.0 million in new

annualized costs to track the additional

devices for which orders were sent in

December 1998, and September 1999,

and (2) save industry approximately

$19.2 million per year by eliminating

tracking for a number of device types

and limiting the scope of another device

to those used outside device user

facilities. Although FDAMA changed

the scope of devices subject to tracking,

no requirements have been added for

devices that are already tracked.

Therefore, the manufacturers and

distributors of devices that are already

being tracked will not incur additional

costs as a result of this proposed rule.

The FDAMA-related changes to the

1993 list of devices result in net savings

to industry of approximately $18.2

million per year (i.e., $19.2 million

minus $1.0 million). In the future, the

total cost of industry device tracking

systems may increase as devices are

added or decrease as devices are

rescinded. FDA could not forecast the

cost or cost savings of such future

actions, however, it is likely that these

would be incurred at the same rate as

they have since the requirements

became effective in 1993.

This proposed rule would also reduce

agency costs by bypassing expensive

rulemaking procedures each time a

device is added to or removed from the

tracking list. This analysis does not

quantify these costs, although a

substantial savings is expected from this

more flexible and efficient system.

FDA has reviewed this proposed rule

and has determined it is consistent with

the regulatory philosophy and

principles identified in the Executive

Order and these two statutes. Because

the costs of the proposed rule total less

than $100 million in any one year, the

proposed rule is not a ‘‘significant

regulatory action’’ under the Executive

Order and FDA is not required to

perform a cost benefit analysis under

the Unfunded Mandates Reform Act.

Although these changes have, so far,

resulted in a net savings to industry, the

manufacturers and distributors of the

two added devices, which are both

implants, will incur additional costs.

The four manufacturers of these devices

will incur total average annualized costs

of approximately $982,000. The agency

is unsure how many distributors are

affected, but estimates that distributors

will incur average annualized costs of

$66,000. High-technology or specialty

items such as implants usually move

directly from the manufacturer to the

24150 Federal Register / Vol. 65, No. 80 / Tuesday, April 25, 2000 / Proposed Rules

1 ‘‘From Producer to Patient: Valuing the Medical

Products Distribution Chain,’’ Ernst & Whinney,

prepared for the Health Industry Distributors

Association, p. III–9.

2 ‘‘Hospital Statistics,’’ Health Forum, an

American Hospital Association Co., 1999 edition,

table 3, p. 8.

3 ‘‘Hospital Statistics,’’ Health Forum, an

American Hospital Association Co., 1999 edition,

table 3, p. 9.

hospital,1 and therefore, the agency

considers the hospital to be the final

and only distributor in the distribution

chain for implantable devices. There are

approximately 5,057 community

hospitals in the United States.2 If only

10 percent of these hospitals implant

the estimated 22,000 units sold per year

of the added devices, the average cost

per hospital would be $130 per year.

Based on 1997 gross revenue estimates

of $564.4 billion for the 5,057

community hospitals,3 this $130 per

hospital cost would be significantly

lower than 1 percent of the $111.6

million average gross revenue per

hospital. Therefore, under the

Regulatory Flexibility Act (5 U.S.C.

605(b)), the agency certifies that the

proposed rule would not have a

significant economic effect on a

substantial number of small entities.

VII. Submission of Comments

Interested persons may, on or before

July 24, 2000, submit to the Dockets

Management Branch (address above)

written comments regarding this

proposal. Two copies of any comments

are to be submitted except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday.

VIII. Paperwork Reduction Act of 1995

A. Summary

This proposed rule contains

information collection provisions that

are subject to review by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act of 1995

(44 U.S.C. 3501–3502). A description of

these provisions is given below with an

estimate of the annual reporting and

recordkeeping burden. Included in the

estimate is the time for reviewing

instructions, searching existing data

sources, gathering and maintaining the

data needed, and completing and

reviewing each collection of

information.

FDA invites comments on: (1)

Whether the proposed collection of

information is necessary for the proper

performance of FDA’s functions,

including whether the information will

have practical utility; (2) the accuracy of

FDA’s estimate of the burden of the

proposed collection of information,

including the validity of the

methodology and assumptions used; (3)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Title: Medical Devices; Device

Tracking (Amended)

Description: FDA is proposing to

amend the device tracking regulation to

conform the regulation to, and

implement, changes made in section

519(e)(1) and (e)(2) of the act by

FDAMA.

This proposed rule revises the scope,

removes the lists of tracked devices, and

amends certain confidentiality

requirements of the current medical

device tracking regulation (part 821).

This proposed rule also proposes to

make certain nonsubstantive revisions

in the tracking regulation to remove

outdated references or to simplify

terminology.

Under the proposed revised scope of

the amended tracking regulation, FDA is

requiring manufacturers of class II or

class III devices, including repackers,

relabelers, and importers of such

devices, when required by tracking

orders issued by FDA for particular

devices, to adopt a method of tracking

the devices throughout distribution to

the device user or patient. Under

proposed additional patient

confidentiality provisions, patients may

refuse, or refuse permission, to release

particular identification information.

Though revisions of certain other

requirements are proposed for

simplification purposes, tracking

requirements are not changed

substantively.

Manufacturers of tracked devices, i.e.,

devices subject to FDA tracking orders,

would continue to be required by the

proposed amended regulation to gather,

record, maintain, and make available

during FDA inspection, and to provide

within 3 or 10 working days, upon FDA

request, information on the location and

current users of tracked devices, and

other use-related information. Upon

receiving tracked devices, distributors,

final distributors, and multiple

distributors must continue to provide

tracked device manufacturers with

device identity and receipt information

and, when applicable, patient identity

and other related usage information.

The purpose of these tracking

requirements, as proposed for revision,

continues to be to facilitate

manufacturers identifying the current

location and identity of all persons

using tracked devices, to the extent

permitted by patients. With this

information, manufacturers of tracked

devices and FDA can expedite the recall

of distributed tracked devices that are

dangerous or defective.

Description of Respondents:

Manufacturers, including repackers,

relabelers, and importers, and

distributors, final distributors, and

multiple distributors involved in the

manufacture and distribution of tracked

devices. FDA estimates the burden of

this collection of information as follows:

TABLE 1.—ESTIMATED AVERAGE ANNUAL REPORTING BURDEN1

21 CFR section No. of respondents Annual frequency of

response Total annual responses Hours perresponse Total hours

821.2 (also 821.30(e)) 4 1 4 12 48

821.25(a) 1 1 1 76 76

821.25(d) 19 1 19 2 38

821.30(a), (b) 17,000 65 1,113,295 0.1666 185,475

821.30(c)(2) 1 1 1 28 28

821.30(d) 17,000 13 213,067 0.1666 35,497

Total 221,162

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

Federal Register / Vol. 65, No. 80 / Tuesday, April 25, 2000 / Proposed Rules 24151

TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of Respondents Annual Frequency

per Response

Total Annual

Responses Hours per Response Total Hours

821.25(b) 207 41,731 8,638,334 0.2899 2,504,253

821.25(c) 207 1 207 20.5 4,2362

821.25(c)(3) 207 1,017 210,562 0.2899 61,042

Total 2,569,531

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

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

B. Background Facts and Assumptions

1. Average Figures

Burden estimates for information

collections are based on data and

methods set forth in FDA’s 1999

analysis, ‘‘Cost Assessment of Medical

Device Tracking,’’ (Ref. 1). 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 1 and 2 of

this document and described elsewhere

in this document, are average annual

figures for the years 1999 to 2001.

2. Respondents

FDA has issued tracking orders to 207

manufacturers to track 13 types of

devices intended to be implanted for

more than 1 year (hereinafter referred to

as ‘‘tracked implants’’) and 4 types of

life-sustaining or life-supporting devices

that are used outside device user

facilities (hereinafter referred to as

‘‘tracked l/s-l/s devices’’). FDA

estimates that some 17,000 distributors,

final distributors, and multiple

distributors are subject to tracking

reporting requirements as follows: 171

wholesalers, electromedical equipment;

1,252 retailers, hospital equipment and

supplies; 10,500 home care dealers/

medical equipment rental companies

(median of 6,000 to 15,000 dealer

estimate); and 5,057 U.S.-community

hospitals (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 percent annual growth rate

to estimate number of procedures for

tracked implant devices from 1997

through 2006 (Ref. 1). Table 3 of this

document shows 1993 to 1996 figures,

and table 4 of this document shows

projections through 2001. FDA issued

tracking orders for dura mater implants

in December 1998 and for abdominal

aortic aneurism (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 TO 1996)

Device Type ICD1 Number

Number of

Procedures in

1993

Number of

Procedures in

1994

Number of

Procedures in

1995

Number of

Procedures in

1996

Implantable pacemaker pulse generator 37.8 123,000 139,000 136,000 155,000

Cardiovascular permanent implantable pacemaker electrode 37.70–37.76 108,000 131,000 128,000 132,000

Replacement heart valve 35.2 58,000 54,000 61,000 69,000

Automatic implantable cardioverter/defibrillator 37.9 21,000 21,000 27,000 26,000

Implanted cerebellar stimulator 2.93 2,000 2,000 2,000 2,000

Implanted diaphragmatic/phrenic nerve stimulator 34.85 2,000 2,000 2,000 2,000

Implantable infusion pumps 86.06 7,000 7,000 6,000 9,000

Temporomandibular joint2 76.92 2,000 2,000 2,000 6,000

Ventricular bypass (assist) device 37.61–37.63 33,000 35,000 48,000 56,000

Dura mater 2.12 6,000 6,000 8,000 6,000

Abdominal aortic aneurysm grafts n/a n/a n/a n/a n/a

1Implantable cardiodefibrillator.

2This product category includes: Temporomandibular joint 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.

24152 Federal Register / Vol. 65, No. 80 / Tuesday, April 25, 2000 / Proposed Rules

TABLE 4.—TRACKED IMPLANTS: ESTIMATES OF ANNUAL DISTRIBUTION AND TOTAL TRACKED DEVICES (1994 TO 2001)

(BASED ON IMPLANTATION PROCEDURE DATA)

End of Year New Implants1 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

19992 491,339 2,203,603 2,694,942

20003 516,166 2,694,942 3,211,108

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

1Represents estimated number of tracked implants distributed annually.

2Estimated distribution for dura mater implants is included in 1999 to 2001, et al., estimates. 3Estimated distribution for abdominal aortic aneurysm stent grafts is included in 2000 and 2001, et al., estimates.

4. Tracked l/s-l/s Devices

FDA uses unit shipment data and

forecasts from 1992 and 1994 published

sources, in combination with various

growth rates (Ref. 1) to estimate annual

sales/distribution of four types of

tracked l/s-l/s devices. See table 5 of

this document.

TABLE 5.—TRACKED LIFE-SUPPORTING DEVICES-ESTIMATED NUMBER OF UNITS (1991 TO 2001)

Year

Breathing

Frequency

Monitors

Continuous

Ventilators

Direct Current Defibrillators and Paddles Infusion Pumps (electromechanical only)

Total Units Total Units

Alternate Care

Units

Physician

Office Units Total Units Syringe Units AmbulatoryUnits Total Units

1991 n/a n/a 14,000 3,150 17,150 n/a n/a n/a

1992 n/a n/a 17,850 3,591 21,441 n/a n/a n/a

1993 n/a n/a 22,759 4,094 26,852 n/a n/a n/a

1994 12,200 4,300 29,017 4,667 33,684 23,600 30,900 54,500

1995 12,300 4,700 36,997 5,320 42,317 26,200 34,500 60,700

1996 12,800 5,100 47,171 6,065 53,236 29,100 37,500 66,600

1997 13,300 5,600 60,144 6,914 67,058 32,300 40,800 73,100

1998 13,900 6,200 76,683 7,882 84,565 35,700 44,100 79,800

1999 14,500 6,900 97,771 8,986 106,757 39,300 47,300 86,600

2000 15,100 7,700 124,658 10,244 134,902 43,000 50,400 93,400

2001 15,569 8,387 158,939 11,678 170,617 47,105 54,571 101,676

Federal Register / Vol. 65, No. 80 / Tuesday, April 25, 2000 / Proposed Rules 24153

C. Burden Estimates

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 filing a citizen

petition under § 10.30 (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, 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. Section 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 working 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 percent of the data

reported by distributors against data

base entries and that some 10 percent of

audited records (approximately 19,000)

might be inaccurate and require further

followup. FDA believes only 0.1 percent

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: 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 FDA’s 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 of

this document). For 1999 to 2001, the

average number of ‘‘new implants’’ per

year is estimated as 511,331 devices, per

table 4 as follows: 491,339 devices (for

1999) + 516,166 devices (for 2000) +

526,489 devices (for 2001) ÷ 3. The

average annual burden for distributor

reporting for these devices would be:

511,331 (average number of ‘‘new

implants’’) x 1 final distributor per

device x 1 data report per final

distributor x 0.1666 hours per report =

85,188 hours.

Distributor reporting for tracked l/s-l/

s devices: 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 direct current (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. Each distributor or multiple

distributor would make one data report

per device received during the year. See

table 6 of this document for annual

distribution.

For 1999 to 2001, the average number

of ‘‘total units’’ (table 5 of this

document) and ‘‘new devices’’ (table 6

of this document) of the above three

types of tracked l/s-l/s devices

distributed per year would be 160,144,

as estimated per table 5 as follows:

14,500 + 6,900 + 106,757 devices (for

1999) + 15,100 + 7,700 + 134,902

devices (for 2000) + 15,569 + 8,387 +

170,617 devices (for 2001) ÷ 3. The

average annual burden for distributor

reporting for these three types of tracked

l/s-l/s devices is estimated as: 160,144

(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 = 53,360 hours.

FDA estimates there are from one to

five, or a median of three, distributors

or multiple distributors in distribution

chains for one type of tracked l/s-l/s

device, that is, electromechanical

infusion pumps that are tracked. For

1999 to 2001, the average number of

‘‘total units’’ (table 5 of this document)

and ‘‘new devices’’ (table 6 of this

document) of tracked electromechanical

infusion pumps distributed per year

would be 93,892 devices, as estimated

per table 6 of this document as follows:

86,600 devices (for 1999) + 93,400

devices (for 2000) + 101,676 devices (for

2001) ÷ 3. The average annual burden

for distributor reporting for this one

type of tracked l/s-l/s device would be:

93,892 (average number of ‘‘new

devices’’) x 3 distributors or multiple

distributors x 1 data report x 0.1666

hours = 46,927 hours.

24154 Federal Register / Vol. 65, No. 80 / Tuesday, April 25, 2000 / Proposed Rules

TABLE 6.—TRACKED LIFE-SUSTAINING OR LIFE SUPPORTING DEVICES—ESTIMATED DISTRIBUTION

End of Year

Breathing Frequency Monitors,

Continuous Ventilators, and

Defibrillators

Infusion Pumps

Percent Audited Audits per Year

New Devices

Average No. of

Distributors/

Data Reports

New Devices

Average No. of

Distributors/

Data Reports

1994 50,184 2 54,500 3 5% 2

1995 59,317 2 60,700 3 5% 2

1996 71,136 2 66,600 3 5% 2

1997 85,958 2 73,100 3 5% 1

1998 104,665 2 79,800 3 5% 1

1999 128,157 2 86,600 3 5% 1

2000 157,702 2 93,400 3 5% 1

2001 194,572 2 101,676 3 5% 1

5. Section 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). The required information 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. Therefore, the burden

hours attributed to this provision are not

included in the burden estimate (5 CFR

1320.3(b)(2)).

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. Section 821.30(d) requires

distributors, final distributors, or

multiple distributors to make available

for auditing, upon a manufacturer’s

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

under 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.

FDA’s estimate of the burden for

distributor audit responses assumes:

Manufacturers audit data base entries

for 5 percent of tracked devices

distributed; entries in tracking system

data bases approximate, in number and

amount, data reported by distributors

(data reports); and, each audited data

base 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

percent of audited data might be found

noncompliant, i.e., discrepant, and

would require further followup

responses from distributors to confirm,

correct, or update data.

Distributor audit responses for tracked

implants: Certain final distributors that

handle tracked implants would be asked

by manufacturers to verify data for 5

percent of the total number of implants

actively tracked (‘‘total tracked’’

implants in table 7 of this document=

‘‘new implants’’ + ‘‘previous implants’’

in table 4 of this document). Data for

dura mater and AAA stent grafts must

be audited twice a year because the

devices are in the first 3 years of

tracking (see 21 CFR 821.25(c)(3)). FDA

adjusts for these devices by factoring in

the percentage they constitute of ‘‘total

tracked’’ devices (shown in table 7 of

this document). Data for all other

tracked implants are audited once a

year.

For 1999 to 2001, the average number

of ‘‘total tracked’’ implants tracked per

year amounts to 3,214,549 devices, as

estimated per tables 4 and 7 of this

document 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 data base entry per data

report x .05 (percentage of data base

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 percent for additional

responses to followup verification of

noncompliant data increases the burden

to 29,346 hours. Applying the above

formula to the 0.37 percent (average

percentage) of total tracked implants

whose data are audited twice a year

results in an additional 635 burden

hours (includes 10 percent for

additional followups).

Distributor audit responses for tracked

l/s-l/s devices: Distributors and multiple

distributors of three types of tracked l/

s-l/s devices, that is, breathing

frequency (infant apnea) monitors,

continuous ventilators, and DCdefibrillators would be asked to verify

audited data for these devices. Only the

data for ‘‘new devices’’ distributed each

year would be audited. For 1999 to

2001, the average number of ‘‘new

devices’’ of these three types of tracked

l/s-l/s devices would be 160,144

devices, as estimated per table 6 of this

document 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 data base 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 =

2,668 hours. Adding 10 percent for

additional responses to verify

Federal Register / Vol. 65, No. 80 / Tuesday, April 25, 2000 / Proposed Rules 24155

noncompliant data increases the burden

to 2,935 hours.

For 1999 to 2001, the average number

of ‘‘total units’’(table 5 of this

document), and ‘‘new devices’’ (table 6

of this document), of 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

electromechanical infusion pumps that

are tracked l/s-l/s 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 data base entry x .05

entries audited x 1 distributor response

x 0.1666 hours = 2,346 hours. Adding

10 percent for additional followup

responses by distributors increases the

burden to 2,581 hours.

TABLE 7.—TRACKED IMPLANTS: ESTIMATED DISTRIBUTION AND AUDIT FREQUENCY

End of Year Total Tracked Percent Audited

Tracked Since 1994 Tracked Since 1999

Percent of Total Audits per Year Percent of Total Audits per Year

1994 393,000 5% 100.0% 2 n/a n/a

1995 805,000 5% 100.0% 2 n/a n/a

1996 1,262,000 5% 100.0% 2 n/a n/a

1997 1,728,140 5% 100.0% 1 n/a n/a

1998 2,203,603 5% 100.0% 1 n/a n/a

19991 2,694,942 5% 99.8% 1 0.2% 2

20002 3,211,108 5% 99.6% 1 0.4% 2

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

1Procedural data for dura mater is included in the 1999 through 2001 estimates.

2Procedural data for abdominal aortic aneurysm stent grafts is included in the 2000 through 2001 estimates.

8. Under § 821.25(b) manufacturers

must maintain current tracking records

in accordance with standard operating

procedures (SOP’s). To maintain data

bases, manufacturers conduct

‘‘transactions,’’ such as receiving data

from distributors (distributor data

reports), registering patients, making

data base entries, and auditing entries

against distributor data. Audit activities

are estimated separately (§ 821.25(c)(3)).

Data base for tracked implants: For

this estimate, and in FDA’s ‘‘Cost

Assessment’’ (Ref. 1), FDA uses a

consulted implant manufacturer’s

estimate that his firm conducts some 2.5

data base 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 to 2001, the average number of

‘‘total tracked’’ implants actively

tracked per year amounts to 3,214,549

devices, as estimated per table 7 of this

document 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 data base

transactions for tracked implants is

estimated as: 3,214,549 (average number

of ‘‘total tracked’’ implants) x 2.5 data

base transactions per year x 0.2899

hours per transaction = 2,329,744 hours.

Data base for tracked l/s-l/s devices:

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 data base transactions 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 of this document)

x 2 distributors or multiple distributors

per device (based on the mean number

in distribution chains) x 1 data report

per distributor x 1 data base 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.

24156 Federal Register / Vol. 65, No. 80 / Tuesday, April 25, 2000 / Proposed Rules

9. Under § 821.25(c), manufacturers

must establish SOP’s 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 (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). There would be no

such burdens for 204 manufacturers that

have had tracking systems in place since

1993.

Manufacturers with tracking systems

in place would review and/or revise

their tracking system SOP’s on an

annual basis, expending approximately

10 percent of the amount of time spent

originally in drafting the SOP’s, i.e., 22

days x 8 hours per day = 18 hours. Over

the 3 years, 1999 to 2001, 617 firms

would annually revise tracking SOP’s as

follows: 204 firms (excludes dura mater

firms) for 1999, 206 firms (includes 2

dura mater firms, excludes 1 AAA stent

firm) for 2000, and 207 firms (includes

all) for 2001. The total annual burden

for revising SOP’s for 3 years would

amount to: 617 firms x 18 hours per firm

= 11,106 hours.

For 1999 to 2001, the average total

annual burden (annualized burden)

would be 4,236 hours: 1, 584 hours

(total one time burdens) + 11,106 hours

(total annual burdens) ÷ 3 years.

10. Section 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), FDA’s burden estimate for

manufacturer auditing assumes firms

would audit 5 percent 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 data base 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 percent

further followups 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: Using the same $5 per

tracking ‘‘transaction’’ figure that was

used for data base 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 of this document.

‘‘Total tracked’’ implants correspond to

amounts actively tracked each year

(‘‘new implants’’ + ‘‘previous implants’’

in table 4 of this document) and take

into account devices distributed in

previous years that are implanted and

continue to be tracked for 8 subsequent

years, the approximate lifetime of

implants that FDA uses.

On average, about 99.63 percent (99.8

percent (for 1999) + 99.6 percent (for

2000) + 99.5 percent (for 2001) ÷ 3, per

table 7 of this document) of the data

audited (i.e. 5 percent of the total data

base entries corresponding to the

average number of total tracked devices

for 1999 to 2001) would be audited once

a year and 10 percent of this data would

be further audited. On average, about

.37 percent of the 5 percent of data base

entries audited (the approximate

amount comprised by data base entries

for dura mater and AAA stents) would

be audited twice.

For 1999 to 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 of this document) x 1 final

distributor data report per ‘‘new

implant’’ upon implantation (or 1

implanted patient report per ‘‘previous

implant’’ distributed) per data base

entry x .05 (percentage of data base

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 percent for followup auditing

increases the burden to 51,065 hours.

Applying the above formula to data

base entries for tracked implants

requiring 2 audits per year (an average

.0037 of total tracked devices) results in

345 hours. A 10 percent additional

followup rate makes 380 burden hours.

Manufacture auditing for tracked l/sl/s devices: For breathing frequency

(infant apnea) monitors, continuous

ventilator, and DC-defibrillators the data

for ‘‘new devices’’ distributed each year

would be audited. For 1999 to 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 of this

document) x 2 data reports per device

(based on the mean of the number of

distributors or multiple distributors in

distribution chains) x 1 data base entry

per distributor or multiple distributor

data report x .05 (percentage of entries

audited) x .2899 hours = 4,642 hours.

Federal Register / Vol. 65, No. 80 / Tuesday, April 25, 2000 / Proposed Rules 24157

Adding 10 percent for additional

followup 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 three distributors or multiple

distributors, would result in 4,083

hours. A 10 percent additional audit

rate makes 4,491 hours.

In compliance with the Paperwork

Reduction Act of 1995 (44 U.S.C.

3507(d)), the agency has submitted the

information collection provisions of this

proposed rule to OMB for review.

Interested persons are requested to send

comments regarding information

collection by May 25, 2000, to the Office

of Information and Regulatory Affairs,

OMB (address above).

IX. References

The following reference has been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

between 9 a.m. and 4 p.m., Monday

through Friday.

1. ‘‘Cost Assessment of Medical

Device Tracking,’’ Economics Staff,

Food and Drug Administration, 1999.

List of Subjects in 21 CFR Part 821

Imports, Medical devices, Reporting

and recordkeeping requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, FDA proposes to

amend part 821 to read as follows:

PART 821—MEDICAL DEVICE

TRACKING REQUIREMENTS

1. The authority citation for 21 CFR

part 821 continues to read as follows:

Authority: 21 U.S.C. 331, 351, 352, 360,

360e, 360h, 360i, 371, 374.

2. Section 821.1 is amended by

revising paragraphs (a) and (b); by

removing paragraph (c); and by

redesignating paragraphs (d) and (e) as

paragraphs (c) and (d), respectively, to

read as follows:

§ 821.1 Scope.

(a) The regulations in this part

implement section 519(e) of the Federal

Food, Drug and Cosmetic Act (the act),

which provides that the Food and Drug

Administration may by order require a

manufacturer to adopt a method of

tracking a class II or class III device, the

failure of which would be reasonably

likely to have serious adverse health

consequences, or which is intended to

be implanted in the human body for

more than 1 year, or which is a lifesustaining or life-supporting device

used outside a device user facility. A

device required by FDA order to be

tracked is subject to this part and is

referred to herein as a tracked device.

(b) These regulations are intended to

ensure that tracked devices can be

traced from the device manufacturing

facility to the person for whom the

device is indicated, that is, the patient.

Effective tracking of devices from the

manufacturing facility, through the

distributor network (including

distributors, retailers, rental firms and

other commercial enterprises, device

user facilities, and licensed

practitioners) and, ultimately, to any

person for whom the device is intended

is necessary for the effectiveness of

remedies prescribed by the act, such as

patient notification (section 518(a) of

the act) or device recall (section 518(e)

of the act). Although these regulations

do not preclude a manufacturer from

involving outside organizations in that

manufacturer’s device tracking effort,

the legal responsibility for complying

with this part rests with manufacturers

who are subject to tracking orders, and

that responsibility cannot be altered,

modified, or in any way voided by

contracts or other agreements.

* * * * *

§ 821.2 [Amended]

3. Section 821.2 Exemptions and

variances is amended by removing

paragraph (d).

4. Section 821.3 is amended by

revising paragraphs (b) and (f) to read as

follows:

§ 821.3 Definitions.

* * * * *

(b) Importer means the initial

distributor of an imported device who is

subject to a tracking order. ‘‘Importer’’

does not include anyone who only

furthers the marketing, i.e., brokers,

jobbers, or warehousers.

* * * * *

(f) Device intended to be implanted in

the human body for more than 1 year

means a device that is intended to be

placed into a surgically or naturally

formed cavity of the human body for

more than 1 year to continuously assist,

restore, or replace the function of an

organ system or structure of the human

body throughout the useful life of the

device. The term does not include any

device which is intended and used only

for temporary purposes or which is

intended for explantation in 1 year or

less.

* * * * *

5. Section 821.20 is amended by

revising paragraph (a), by removing

paragraphs (b) and (c), by redesignating

paragraph (d) as paragraph (b), and by

revising newly redesignated paragraph

(b) to read as follows:

§ 821.20 Devices subject to tracking.

(a) When required by a tracking order

issued by FDA, a manufacturer of any

class II or class III device, the failure of

which would be reasonably likely to

have a serious adverse health

consequence, or which is intended to be

implanted in the human body for more

than a year, or which is life-sustaining

or life-supporting and used outside a

device user facility, shall track that

device in accordance with this part.

(b) When responding to premarket

notification submissions and approving

premarket approval applications, FDA

will notify the sponsor by issuing a

tracking order that states that FDA

believes the device meets the criteria of

section 519(e)(1) of the act and, by

virtue of the order, is required to be

tracked.

6. Section 821.25 is amended by

revising the introductory text of

paragraph (a)(2), paragraph (a)(2)(iii),

the introductory text of paragraph (a)(3),

and paragraph (a)(3)(iv) to read as

follows:

§ 821.25 Device tracking system and

content requirements: manufacturer

requirements.

(a) * * *

(2) Within 10 working days of a

request from FDA for tracked devices

that are intended for use by a single

patient over the life of the device, after

distribution to or implantation in a

patient:

* * * * *

(iii) The name, address, telephone

number, and social security number (if

available) of the patient receiving the

device, unless not released by the

patient under § 821.55(a);

* * * * *

(3) Except as required by order under

section 518(e) of the act, within 10

working days of a request from FDA for

tracked devices that are intended for use

by more than one patient, after the

distribution of the device to the

multiple distributor:

* * * * *

(iv) The name, address, telephone

number, and social security number (if

available) of the patient using the

device, unless not released by the

patient under § 821.55(a);

* * * * *

§ 821.30 [Amended]

7. Section 821.30 Tracking obligations

of persons other than device

manufacturers: distributor requirements

is amended in paragraphs (b)(3) and

24158 Federal Register / Vol. 65, No. 80 / Tuesday, April 25, 2000 / Proposed Rules

(c)(1)(ii) by removing the semicolon at

the end of each paragraph and adding in

its place ‘‘, unless not released by the

patient under § 821.55(a);’’.

8. Section 821.55 is amended by

redesignating paragraphs (a) and (b) as

paragraphs (b) and (c), respectively, and

by adding paragraph (a) to read as

follows:

§ 821.55 Confidentiality.

(a) Any patient receiving a device

subject to tracking requirements under

this part may refuse to release, or refuse

permission to release, the patient’s

name, address, telephone number, and

social security number, or other

identifying information for the purpose

of tracking.

* * * * *

Dated: February 14, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–10251 Filed 4–24–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Bureau of Alcohol, Tobacco and

Firearms

27 CFR Parts 4, 5, and 7

[Notice No. 896; Re: Notice Nos. 884 and

892]

RIN 1512–AB97

Health Claims and Other HealthRelated Statements in the Labeling and

Advertising of Alcohol Beverages;

Cancellation and Rescheduling of

Public Hearings (99R–199P)

AGENCY: Bureau of Alcohol, Tobacco

and Firearms (ATF), Department of the

Treasury.

ACTION: Notice of proposed rulemaking;

cancellation and rescheduling of public

hearings.

SUMMARY: Due to the low number of

requests to present oral comments, the

Bureau of Alcohol, Tobacco and

Firearms (ATF) is announcing the

cancellation of three public hearings

that were to be held concerning health

claims and other health-related

statements in the labeling and

advertising of alcohol beverages. In

addition, the hearings scheduled for

Washington, DC and San Francisco,

California will be limited to two days.

We are also changing the date for

submission of written (or e-mail)

comments.

DATES: The revised hearing dates are:

1. April 25 and April 26, 2000, 10:00

a.m. to 5 p.m., Washington, DC.

2. May 23 and May 24, 2000, 10:00

a.m. to 5 p.m., San Francisco, CA.

Written (or e-mail) comments

addressing Notice Nos. 884 and 892, as

well as comments addressing testimony

presented at the hearings, must be

received on or before June 30, 2000.

ADDRESSES: The hearing locations are:

1. Washington, DC—Washington

Convention Center, 900 Ninth Street,

NW., Washington, DC 20001.

2. San Francisco—Embassy Suites San

Francisco Airport, 150 Anza Boulevard,

Burlingame, CA 94010.

FOR FURTHER INFORMATION CONTACT:

Nancy Kern or Jim Ficaretta,

Regulations Division, Bureau of

Alcohol, Tobacco and Firearms, 650

Massachusetts Avenue, NW.,

Washington, DC 20226 (202–927–8210).

SUPPLEMENTARY INFORMATION:

Background

On February 28, 2000, ATF published

a notice in the Federal Register (Notice

No. 892; 65 FR 10434) announcing the

dates and locations of five public

hearings that we planned to hold

concerning health claims and other

health-related statements in the labeling

and advertising of alcohol beverages.

The notice provided that persons

wishing to testify at the hearings should

submit a written notification to ATF on

or before April 7, 2000. As of April 18,

2000, we had received only seven

requests to testify in Atlanta; seven

requests to testify in Chicago; and three

requests to testify in Dallas. We do not

consider that this constitutes a sufficient

number of requests to justify the

expense of holding these three hearings.

Accordingly, we are canceling the

hearings that were scheduled for

Atlanta, Chicago, and Dallas. Those

persons who requested to appear at

these hearings have been offered several

alternatives, including attending one of

the remaining two scheduled hearings

in Washington, DC and San Francisco,

California, or submitting their written

comments.

The hearings scheduled for

Washington, DC and San Francisco will

be limited to two days. The hearing in

Washington, DC will be held on April

25 and 26, and the hearing in San

Francisco will be held on May 23 and

24. The hearings in both locations will

start at 10:00 a.m.

We will accept written (or e-mail)

comments addressing our earlier notices

on this subject, Notice No. 892 and

Notice No. 884 (October 25, 1999; 64 FR

57413), as well as comments addressing

testimony presented at the forthcoming

hearings, until June 30, 2000. This date

is approximately one month after the

close of the public hearings.

Drafting Information

The author of this document is James

P. Ficaretta, Regulations Division,

Bureau of Alcohol, Tobacco and

Firearms.

Authority and Issuance

This notice is issued under the

authority of 27 U.S.C. 205.

Signed: April 19, 2000.

Bradley A. Buckles,

Director.

[FR Doc. 00–10309 Filed 4–21–00; 10:42 am]

BILLING CODE 4810–31–P

DEPARTMENT OF THE INTERIOR

Office of Surface Mining Reclamation

and Enforcement

30 CFR Part 948

[WV–085–FOR]

West Virginia Regulatory Program

AGENCY: Office of Surface Mining

Reclamation and Enforcement (OSM),

Interior.

ACTION: Proposed rule; public comment

period and opportunity for public

hearing.

SUMMARY: OSM is announcing receipt of

a proposed amendment to the West

Virginia regulatory program under the

Surface Mining Control and

Reclamation Act of 1977 (SMCRA). The

program amendment consists of changes

to the West Virginia regulations (38 CSR

2) contained in House Bill 4223, and

changes to the Code of West Virginia

contained in Senate Bill 614. The

amendments are intended to comply

with the Consent Decree between the

plaintiff and the West Virginia Division

of Environmental Protection (WVDEP)

entered on February 17, 2000, in the

matter of Bragg v. Robertson, No. 2:98–

636 (S.D.W.Va.).

DATES: If you submit written comments,

they must be received on or before 4

p.m. (local time), on May 25, 2000. If

requested, a public hearing on the

proposed amendments will be held at 1

p.m. (local time), on May 22, 2000.

Requests to speak at the hearing must be

received by 4 p.m. (local time), on May

10, 2000.

ADDRESSES: Mail or hand-deliver your

written comments and requests to speak

at the hearing to Mr. Roger W. Calhoun,

Director, Charleston Field Office at the

address listed below.

You may review copies of the West

Virginia program, the proposed

amendment, a listing of any scheduled