52344 Federal Register / Vol. 62, No. 194 / Tuesday, October 7, 1997 / Notices

NIOSH seeks to obtain materials,

including reports and research findings,

to evaluate the health risks of

occupational exposure to inorganic lead.

Examples of requested information

include, but are not be limited to, the

following:

1. Occupational (environmental)

exposure data.

2. Data on the effectiveness of

engineering controls, work practices,

training, personal protective equipment

and other activities used to limit

workers’ exposure.

3. Identification of industries or

occupations where intermittent or low

concentrations of inorganic lead may

occur.

4. Descriptions of work practices and

engineering controls used to reduce

workplace exposure.

5. Case reports or other health data

that demonstrate adverse health effects

in workers exposed to inorganic lead at

or below the OSHA PEL and any

information pertinent to evaluating the

feasibility of establishing a more

protective exposure limit. Case reports

and health data should be submitted

without personal identifiers.

6. Information regarding methods for

BLL determination that could be used

routinely in the workplace (e.g.,

determination of BLLs using portable

equipment). NIOSH is evaluating

whether the routine biological

monitoring of inorganic lead exposed

workers (through BLLs) may be a more

appropriate measure than airborne

concentrations for estimating the

potential for developing adverse health

effects.

This information will be used by

NIOSH to determine the need for

developing new recommendations for

lowering the occupational exposure to

inorganic lead and improving strategies

for monitoring inorganic lead exposure.

All information received in response

to this notice will be available for public

examination and copying at the NIOSH

Docket Office, 4676 Columbia Parkway,

Cincinnati, Ohio 45226.

References

43 FR 52952, November 14, 1978. Chapter

XVII—Occupational Safety and Health

Administration, Department of Labor; Part

1910—Occupational safety and health

standards: occupational exposure to lead.

58 FR 26590, May 4, 1993. Occupational

Safety and Health Administration: lead

exposure in construction; interim final rule.

(To be codified at 29 CFR 1926.)

NIOSH [1978]. Criteria for a recommended

standard . . . occupational exposure to

inorganic lead, revised criteria. Rockville,

MD: U.S. Department of Health, Education,

and Welfare, Public Health Service, Center

for Disease Control, National Institute for

Occupational Safety and Health, DHEW

(NIOSH) Publication No. 78–158.

Dated: September 29, 1997.

Linda Rosenstock, MD., MPH.,

Director, National Institute for Occupational

Safety and Health (NIOSH), Centers for

Disease Control and Prevention (CDC).

[FR Doc. 97–26516 Filed 10–6–97; 8:45 am]

BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Oak Ridge Workshop; Energy-Related

Health Research Needs; Notice of a

Meeting

The National Center for

Environmental Health (NCEH) of the

Centers for Disease Control and

Prevention (CDC), in collaboration with

the Department of Energy (DOE), the

National Institute for Occupational

Safety and Health, CDC, and the Agency

for Toxic Substances and Disease

Registry (ATSDR) announces the

following meeting.

Name: Oak Ridge Workshop on EnergyRelated Health Research Needs.

Times And Dates: 2 p.m.-9 p.m., October

30, 1997. 8:30 a.m.–12 noon, October 31,

1997.

Place: Ramada Inn and Suites, 420 South

Illinois Avenue, Oak Ridge, Tennessee

37830, telephone 423/483–4371, FAX 423/

483–5972.

Status: Open to the public, limited only by

the space available. The meeting room

accommodates approximately 50 people.

Purpose: To solicit individual input from

scientists, representatives of State and local

health departments, DOE facility managers,

workers, and the public regarding health

research needs in and around the Oak Ridge

DOE facility. The results of this workshop

and similar workshops at other locations will

be used to set the short- and long-range

research plan for health studies at DOE

facilities.

Matters To Be Discussed: The workshop

will be divided into three breakout sessions

which will include the following topics: (1)

worker health studies, (2) environmental

health studies, and (3) communications and

community involvement.

Agenda items are subject to change as

priorities dictate.

Due to circumstances beyond our control,

it was necessary to reschedule the original

meeting dates of September 22–23, 1997, to

October 30–31, 1997.

Contact Person for More Information:

Michael J. Sage, Deputy Chief, Radiation

Studies Branch, Division of Environmental

Hazards and Health Effects, NCEH, CDC,

4770 Buford Highway, NE, (F–35), Atlanta,

Georgia 30341–3724, telephone 770/488–

7040, FAX 770/488–7044.

Dated: October 1, 1997.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 97–26495 Filed 10–6–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97M–0416]

Johnson and Johnson Professional,

Inc.; Premarket Approval of the S–ROM

Poly-Dial Constrained Liner

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Johnson

and Johnson Professional, Inc.,

Raynham, MA, for premarket approval,

under the Federal Food, Drug, and

Cosmetic Act (the act), of the S–ROM

Poly-Dial Constrained Liner. After

reviewing the recommendation of the

Orthopedic and Rehabilitation Devices

Panel, FDA’s Center for Devices and

Radiological Health (CDRH) notified the

applicant, by letter of June 20, 1997, of

the approval of the application.

DATES: Petitions for administrative

review by November 6, 1997.

ADDRESSES: Written requests for copies

of the summary of safety and

effectiveness data and petitions for

administrative review to the Dockets

Management Branch (HFA–305), Food

and Drug Administration,12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Hany W. Demian, Center for Devices

and Radiological Health (HFZ–410),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2036.

SUPPLEMENTARY INFORMATION: On

December 26, 1996, Johnson and

Johnson Professional, Inc., Raynham,

MA, 02767–0350, submitted to CDRH an

application for premarket approval of

the S–ROM Poly-Dial Constrained Liner.

The device is a constrained acetabular

liner and is indicated for use as a

component of a total hip dislocation due

to a history of prior dislocation, bone

loss, joint or soft tissue laxity,

neuromuscular disease, or

intraoperative instability.

On June 10, 1997, the Orthopedic and

Rehabilitation Devices Panel of the