Federal Register / Vol. 65, No. 113 / Monday, June 12, 2000 / Notices 36817

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of Respondents

Annual Frequency per Response

Total Annual

Responses

Hours per Response Total Hours

801.150(e) 90 20 1,800 4 7,200

Total 7,200

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

FDA’s estimate of the burden is based

on actual data obtained from industry

during the past 3 years where there are

approximately 90 firms subject to this

requirement.

No burden has been estimated for the

recordkeeping requirement in

§ 801.150(a)(2) because these records are

maintained as a usual and customary

part of normal business activities. Under

5 CFR 1320.3(b)(2), the time, effort, and

financial resources necessary to comply

with a collection of information are

excluded from the burden estimate if

the reporting, recordkeeping, or

disclosure activities needed to comply

are usual and customary because they

would occur in the normal course of

activities.

Dated: June 5, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–14701 Filed 6–9–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 00M–0811, 00M–1215, 00M–

1216, 00M–0915, 99M–4619, 00M–0901,

99M–4763, 00M–0424, 00M–1073, 00M–0577,

00M–0579, 00M–0599, 00M–0445, 00M–0580,

00M–0578, 00M–0810, 00M–0809, 00M–1212]

Medical Devices; Availability of Safety

and Effectiveness Summaries for

Premarket Approval Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is publishing a

list of premarket approval applications

(PMA’s) that have been approved. This

list is intended to inform the public of

the availability of safety and

effectiveness summaries of approved

PMA’s through the Internet and the

agency’s Dockets Management Branch.

ADDRESSES: Summaries of safety and

effectiveness are available on the

Internet at http://www.fda.gov/cdrh/

pmapage.html. Copies of summaries of

safety and effectiveness are also

available by submitting a written

request to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Please cite

the appropriate docket number as listed

in table 1 in the SUPPLEMENTARY

INFORMATION section of this document

when submitting a written request.

FOR FURTHER INFORMATION CONTACT:

Kathy M. Poneleit, Center for Devices

and Radiological Health (HFZ–402),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2186.

SUPPLEMENTARY INFORMATION: In the

Federal Register of January 30, 1998 (63

FR 4571), FDA published a final rule to

revise §§ 814.44(d) and 814.45(d) (21

CFR 814.44(d) and 814.45(d)) to

discontinue publication of individual

PMA approvals and denials in the

Federal Register. Instead, revised

§§ 814.44(d) and 814.45(d) state that

FDA will notify the public of PMA

approvals and denials by posting them

on FDA’s Internet home page at http://

www.fda.gov; by placing the summaries

of safety and effectiveness on the

Internet and in FDA’s Dockets

Management Branch; and by publishing

in the Federal Register after each

quarter a list of available safety and

effectiveness summaries of approved

PMA’s and denials announced in that

quarter.

FDA believes that this procedure

expedites public notification of these

actions because announcements can be

placed on the Internet more quickly

than they can be published in the

Federal Register, and FDA believes that

the Internet is accessible to more people

than the Federal Register.

In accordance with section 515(d)(3)

of the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 360e(d)(3)),

notification of an order approving,

denying, or withdrawing approval of a

PMA will continue to include a notice

of opportunity to request review of the

order under section 515(g) of the act.

The 30-day period for requesting

reconsideration of an FDA action under

§ 10.33(b) (21 CFR 10.33(b)) for notices

announcing approval of a PMA begins

on the day the notice is placed on the

Internet. Section 10.33(b) provides that

FDA may, for good cause, extend this

30-day period. Reconsideration of a

denial or withdrawal of approval of a

PMA may be sought only by the

applicant; in these cases, the 30-day

period will begin when the applicant is

notified by FDA in writing of its

decision.

The following is a list of approved

PMA’s for which summaries of safety

and effectiveness were placed on the

Internet in accordance with the

procedure explained previously from

January 1, 2000, through March 31,

2000. There were no denial actions

during this period. The list provides the

manufacturer’s name, the product’s

generic name or the trade name, and the

approval date.

TABLE 1.—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMA’S MADE AVAILABLE JANUARY 1, 2000,

THROUGH MARCH 31, 2000

PMA Number/Docket No. Applicant Trade Name Approval Date

P970005/00M–0811 Kremer Laser Eye Center Kremer Exciber Laser System (Serial

#KEA940202)

July 30, 1998

P970055/00M–1215 Biotrin International, Ltd. Biotrin Parvovirus IgM EIA (V619IMUS) August 6, 1999

P970054/00M–1216 Biotrin International, Ltd. Biotrin Parvovirus IgG EIA (V519IGUS) August 6, 1999

P980049/00M–0915 ELA Medical, Inc. Defender II Model 9201 Implantable Cardiovascular DefibrillatorSeptember 15, 1999

H990003/99M–4619 American Medical Systems ActiconTM Neosphincter September 20, 1999

36818 Federal Register / Vol. 65, No. 113 / Monday, June 12, 2000 / Notices

TABLE 1.—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMA’S MADE AVAILABLE JANUARY 1, 2000,

THROUGH MARCH 31, 2000—Continued

PMA Number/Docket No. Applicant Trade Name Approval Date

P850022(S9)/00M–0901 Biolectron Inc. SpinalPak Stimulator September 24, 1999

H990005/99M–4763 Nitinol Medical Technologies CardioSEAL Septal Occlusion System September 28, 1999

P930034(S12)/00M–0424 Summit Technology SVS Apex Plus Excimer Laser

Workstation w/the Emphasis Discs

October 21, 1999

P910066(S11)/00M–1073 Orthologic Corp. OrthologicTM 1000 Bone Growth StimulatorDecember 17, 1999

P990035/00M–0577 Sunlight Ultrasound Technologies, Ltd.The SunlightTM Omnisense Ultrasound

Bone Sonometer

January 20, 2000

P990066/00M–0579 GE Medical Systems Senographe 2000D January 28, 2000

H990011/00M–0599 Nitinol Medical Technologies CardioSEAL Septal Occlusion System February 1, 2000

P980040/00M–0445 Allergan Inc. Sensar Soft Acrylic UV–Light Absorbing

Posterior Chamber Intraocular Lens

February 3, 2000

P990016/00M–0580 McCue Corporation, Inc. McCue CUBAClinical Ultraonic Bone

Sonometry System w/CUBAplus+V4.1.0

February 15, 2000

P940034(S8)/00M–0578 Gen-Probe Incorporated Gen-Probe AmplifiedTM Mycobacterium

Tuberculosis Direct (MTD) Test

February 15, 2000

P900009(S6)/00M–0810 Smith & Nephew Inc. Exogen 2000 or Sonic Accelerated Fracture Healing SystemFebruary 22, 2000

P990023/00M–0809 Alcon Labs Cellugel Ophthalmic Viscosurgical DeviceFebruary 24, 2000

P950019(S9)/00M–1212 United States Surgical Corp. Ray Threaded Fusion Cage (TFC) w/InstrumentationMarch 2, 2000

Dated: May 23, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–14702 Filed 6–9–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of Inspector General

Draft OIG Compliance Program for

Individual and Small Group Physician

Practices

AGENCY: Office of Inspector General

(OIG), HHS.

ACTION: Notice and comment period.

SUMMARY: This Federal Register notice

seeks the comments of interested parties

on draft compliance guidance

developed by the Office of Inspector

General (OIG) for individual and small

group physician practices. Through this

notice, the OIG is setting forth its

general views on the value and

fundamental principles of individual

and small group physician practices’

compliance programs, and the specific

elements that these practices should

consider when developing and

implementing an effective compliance

program.

DATES: To ensure consideration,

comments must be delivered to the

address provided below by no later than

5 p.m. on July 27, 2000.

ADDRESSES: Please mail or deliver

written comments to the following

address: Office of Inspector General,

Department of Health and Human

Services, Attention: OIG–7P–CPG, Room

5246, Cohen Building, 330

Independence Avenue, S.W.,

Washington, D.C. 20201.

We do not accept comments by

facsimile (FAX) transmission. In

commenting, please refer to file code

OIG–7P–CPG. Comments received

timely will be available for public

inspection as they are received,

generally beginning approximately 2

weeks after publication of a document,

in Room 5541 of the Office of Inspector

General at 330 Independence Avenue,

S.W., Washington, D.C. 20201 on

Monday through Friday of each week

from 8 a.m. to 4:30 p.m.

FOR FURTHER INFORMATION CONTACT:

Kimberly Brandt, Office of Counsel to

the Inspector General, (202) 619–2078.

SUPPLEMENTARY INFORMATION:

Background

By issuing compliance program

guidance, the OIG seeks to engage the

private health care community in

combating fraud and abuse. In the last

few years, the OIG has developed and

issued compliance program guidance

directed at the following segments of the

health care industry: Hospitals; home

health agencies; clinical laboratories;

third-party medical billing companies;

suppliers of durable medical equipment,

prosthetics, orthotics and supplies;

hospices; Medicare+Choice

organizations; and nursing facilities.

The development of these types of

compliance program guidance is based

on the OIG’s belief that health care

providers and related entities can use

internal controls more effectively to

monitor adherence to applicable Federal

health care statutes, regulations and

program requirements.

Copies of these compliance program

guidances can be found on the OIG

website at http://www.hhs.gov/oig.

Developing Draft Compliance Program

Guidance for Individual and Small

Group Physician Practices

On September 8, 1999, the OIG

published a solicitation notice seeking

information and recommendations for

developing formal guidance for

individual and small group physician

practices (64 FR 48846). In response to

that solicitation notice, the OIG received

83 comments from various outside

sources. In developing this notice for

formal public comment, we have

considered those comments, as well as

previous OIG publications, such as

other compliance program guidance and

Special Fraud Alerts. In addition, we

have also taken into account

investigations and audits conducted by

the OIG, and have consulted with the

Health Care Financing Administration

and the Department of Justice.

This draft compliance program

guidance for individual and small group

physician practices contains seven

elements that the OIG has determined

are fundamental to an effective

compliance program:

• Implementing written policies;

• Designating a compliance officer/

contact;