Federal Register / Vol. 62, No. 190 / Wednesday, October 1, 1997 / Notices 51479

public health capacity development; (5)

provides on-site epidemiologic

consultation to national ministries of

health and international organizations

as required; (6) provides on-site

technical assistance, consultation, and

training to other countries and

international organizations in applied

communications, publications

management, health information

systems development and management,

and health economics.

Effective Date: September 19, 1997.

David Satcher,

Director.

[FR Doc. 97–25946 Filed 9–30–97; 8:45 am]

BILLING CODE 4160–18–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0390 ]

Guidance for the Submission of

510(k)’s for Solid State X–Ray Imaging

Devices; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance entitled

‘‘Guidance for the Submission of

510(k)’s for Solid State X-ray Imaging

Devices.’’ The draft guidance is neither

final nor is it in effect at this time. This

draft guidance applies to a new category

of medical devices, Solid State X-ray

Imagers (SSXI), and is currently

available for comment. This draft

guidance is intended to provide

guidance to the significant number of

premarket (510(k)) submissions

resulting from this new technology. The

draft guidance addresses the type of

data needed by the Center for Devices

and Radiological Health (CDRH) to

establish the substantial equivalence of

an SSXI to a previously cleared

conventional radiographic film/screen

system, fluoroscopic image intensified

imaging system, or SSXI.

DATES: Written comments by December

30, 1997.

ADDRESSES: Submit written requests for

single copies of ‘‘Guidance for the

Submission of 510(k)’s for Solid State Xray Imaging Devices’’ to the Division of

Small Manufacturers Assistance (HFZ–

200), Center for Devices and

Radiological Health, Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850. Send two selfaddressed adhesive labels to assist that

office in processing your requests.

Submit written comments on ‘‘Guidance

for the Submission of 510(k)’s for Solid

State X-ray Imaging Devices’’ to the

contact person listed below.

FOR FURTHER INFORMATION CONTACT:

Robert J. Doyle, Center for Devices and

Radiological Health (HFZ–476), Food

and Drug Administration, 1350 Piccard

Dr., Rockville, MD 20850, 301–594–

1212.

SUPPLEMENTARY INFORMATION: The final

version of this guidance will provide

instruction concerning the type of data

needed by CDRH to clear a new category

of medical devices, SSXI’s, for

marketing via section 510(k) of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 360(k)). This new

category of medical devices is intended

to replace conventional x-ray film/

screen systems and image intensifier

based fluoroscopic and image recording

systems. As solid state imaging

technology continues to progress, FDA

anticipates a significant number of

premarket (510(k)) submissions to be

based on this new technology. By

issuing the guidance, FDA hopes to

receive a larger percentage of complete

premarket submissions upon submittal.

This will avoid the need for additional

information requests which are time

consuming for both FDA and

manufacturers.

Under the Medical Device

Amendments to the act, a device may be

cleared for marketing via a 510(k)

premarket notification. To do so, the

device must be shown to be

substantially equivalent to a legally

marketed predicate device. This

guidance sets forth nonclinical and

clinical data necessary to establish the

substantial equivalence of the new

device to the identified predicate

device(s).

This draft guidance document

represents the agency’s current thinking

on the data necessary to establish the

substantial equivalence of SSXI to a

previously cleared device. It does not

create or confer any rights for or on any

person and does not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the requirements of the

applicable statute, regulations, or both.

Interested persons may, on or before

December 30, 1997, submit to the

contact person (address above) written

comments regarding this draft guidance.

Persons with access to the Internet may

obtain the draft guidance via the World

Wide Web (WWW) at ‘‘http://

www.fda.gov/cdrh’’.

Dated: July 31, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–25992 Filed 9–30–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Public Health Service

Centers for Disease Control and

Prevention; Statement of Organization,

Functions, and Delegations of

Authority

Part C (Centers for Disease Control

and Prevention) of the Statement of

Organization, Functions, and

Delegations of Authority of the

Department of Health and Human

Services (45 FR 67772–76, dated

October 14, 1980, and corrected at 45 FR

69296, October 20, 1980, as amended

most recently at 62 FR 46751, dated

September 4, 1997) is amended to

reflect the organizational structure for

mine safety and health research

functions within the National Institute

for Occupational Safety and Health

(NIOSH), Centers for Disease Control

and Prevention.

Section C–B, Organization and

Functions, is hereby amended as

follows:

After the functional statement for the

Contracts and Purchases Branch

(CA582), Procurement and Grants Office

(CA58), Office of Program Support

(CA5), insert the following:

Contracts Management Branch

(Pittsburgh) (CA583). (1) Provides

leadership, direction, procurement

options and approaches in developing

specifications/statements of work and

contract awards; (2) Executes research

and development contracts for all of

NIOSH.

Revise the functional statement for

the Office of Administrative and

Management Services (CC11) to insert

the following as item (4) and renumber

the remaining items accordingly: (4)

provides management information,

advice, and guidance to CDC/OPS

regarding the conduct and the

evaluation of Staff Office procurement

activities with respect to their

effectiveness in meeting NIOSH’s

administrative and programmatic needs.

After the functional statement for the

Office of Administrative and

Management Services (CC11), insert the

following:

Administrative Services Branch

(Pittsburgh) (CC112). (1) Provides basic

facilities operations, maintenance, and
51480 Federal Register / Vol. 62, No. 190 / Wednesday, October 1, 1997 / Notices

support functions for the offices,

laboratories, and grounds at the

Pittsburgh Research laboratory; (2)

provides access to library and

information services for Pittsburgh

laboratory personnel; (3) facilitates

procurement support for the Laboratory;

(4) coordinates Institute activities and

overall operations with the facility

management activities of the other

Agencies operating at the Bruceton

Research Center.

After the functional statement for the

Administrative Services Branch

(Cincinnati) (CC113), insert the

following:

Administrative Services Branch

(Spokane) (CC114). (1) Provides basic

facilities operations, maintenance, and

support functions for the offices,

laboratories, and grounds at the

Spokane Research Laboratory; (2)

provides access to library, information

services, and computer access to the

CDC network for Spokane Research

Laboratory personnel; (3) provides sitewide safety and health program support,

site environmental compliance

activities, employee assistance

programs, and employee wellness

programs; (4) provides procurement and

budget support for the Laboratory; (5)

provides material management

functions, including inventory control

for accountable property, and

warehouse supply for daily operations.

After the functional statement for the

Management Systems Branch (CC115),

insert the following:

Procurement Branch (Pittsburgh)

(CC116). (1) Plans, directs, and conducts

the acquisition of equipment, materials,

and non-personnel services in support

of the NIOSH Pittsburgh operations; (2)

executes contracts for repairs, and

capitol improvements to NIOSH

Pittsburgh facilities.

After the functional statement for the

Regional Operations Branch (CC134),

insert the following:

Pittsburgh Research Laboratory (CC2).

(1) Provides leadership for prevention of

work-related illness, injury, and

fatalities of miners; (2) carries out the

surveillance of fatal and non-fatal

traumatic injuries, occupational

diseases, health and safety hazards, and

the use of control technology and

protective equipment for prevention of

injury and disease in mining; (3)

conducts research on the measurement,

monitoring, and control of dust and

other toxic substances to which miners

may be exposed; (4) conducts laboratory

and field research to evaluate and

control hearing loss and occupational

noise exposure in mining; (5) conducts

field investigations and laboratory

studies on mining injuries and the

means for their prevention; (6) conducts

laboratory and field investigations to

better understand the causes of

catastrophic events that may lead to

fatalities, such as fires, explosions, and

structural or ground failures; (7)

develops sensors, predictive models,

and engineering controls to reduce

miners risk for injury or death; (8)

translates research findings, new control

technology concepts, and newly

identified approaches to health and

safety problems affecting miners into

usable effective interventions; (9)

utilizes the unique facilities and

resources of the Laboratory as a National

resource in collaboration with other

NIOSH units as well as other

Departments and Agencies of the

government.

Surveillance, Statistics, and Research

Support Activity (CC22). (1) Collects

and analyzes health and safety data

related to mining occupations in order

to report on the overall incidence,

prevalence and significance of

occupational safety and health problems

in mining; (2) describes trends in

incidence of mining-related fatalities,

morbidity, and traumatic injury; (3)

conducts surveillance on the use of new

technology, the use of engineering

controls, and the use of protective

equipment in the mining sector; (4)

coordinates surveillance activities with

other NIOSH surveillance initiatives; (5)

provides statistical and computer

support for surveillance and research

activities of the Laboratory; (6) analyzes

and assists in the development of

research protocols for developing

studies; (7) conducts mining-relevant

risk analyses and assists with

interpretations for development of

NIOSH policy or documents.

Extramural Coordination and

Information Dissemination Activity

(CC23). (1) Collaborates with research

staff to translate findings from

laboratory research to produce

compelling products that motivate the

mining sector to engage in improved

injury control and disease prevention

activities; (2) incorporates

recommended control technologies,

work practices, and findings of

technological feasibility into NIOSH

policy documents and testimony; (3)

coordinates with other health

communication, health education, and

information dissemination activities

within the Institute to ensure that

mining research information is

effectively integrated in the NIOSH

dissemination and intervention

strategies; (4) serves as the laboratory

focal point for partnerships with labor,

industry and academia and other

government agencies to foster missionrelevant responsive research; (5) assists

in the development of mission-relevant

CRADAs and patents; (6) coordinates

mission-relevant technical assistance

and response activities; (7) coordinates

mining grants and cooperative

agreements with the NIOSH Office of

Extramural Coordination and Special

Projects.

Dust and Toxic Substance Control

Branch (CC24). (1) Develops, plans, and

implements a program of research to

develop or improve personal and area

direct reading instruments for

measuring mining contaminants

including but not limited to respirable

dust, silica, and other toxic substances

and mixtures; (2) conducts field tests,

experiments, and demonstrations of

new technology for monitoring and

assessing mine air quality; (3) designs,

plans, and implements laboratory and

field research to develop airborne

hazard reduction control technologies;

(4) carries out field surveys in mines to

identify work organization strategies

that could result in reduced dust or

toxic substance exposure; (5) evaluates

the performance, economics, and

technical feasibility of engineering

control strategies, novel approaches,

and the application of new or emerging

technologies for underground and

surface mine dust and toxic substance

control systems; (6) develops and

evaluates implementation strategies for

using newly developed monitors and

control technology for exposure

reduction or prevention.

Hearing Loss Prevention Branch

(CC25). (1) Plans and conducts

laboratory and field research on noiseinduced hearing loss in miners; (2)

conducts field dosimetric and

audiometric surveys to assess the extent

and severity of the problem and to

identify those mining segments in

greatest need of attention and to

objectively track progress in meeting

loss prevention goals; (3) conducts field

and laboratory research to identify noise

generation sources and to identify those

areas most amenable to intervention

activities; (4) develops, tests, and

demonstrates new control technologies

for noise reduction; (5) evaluates

technical and economic feasibility of

controls; (6) develops, evaluates, and

recommends implementation strategies

to promote the adoption and use of

noise reduction technology.

Mining Injury Prevention Branch

(CC26). (1) Conducts laboratory, field,

and computer modeling research to

focus on human physiological

capabilities and limitations and their

interactions with mining jobs, tasks,

equipment, and the mine work

environment; (2) assesses the health and
Federal Register / Vol. 62, No. 190 / Wednesday, October 1, 1997 / Notices 51481

safety relevance of mining equipment

design features using scientific and

engineering techniques, and analyses of

reported case-studies of mining

incidents that lead to traumatic injuries

or fatalities; (3) designs and conducts

epidemiological research studies to

identify and classify risk factors that

cause, or may cause, traumatic injuries

to miners; (4) designs, builds, and tests

proposed interventions, including

demonstrations of proposed

technologies using laboratory mock-ups,

full-scale demonstrations at the

laboratory’s experimental mines, or

through field evaluation in operating

mines; (5) evaluates and recommends

implementation strategies for injury

prevention and control technologies

developed by the Laboratory.

Disaster Prevention and Response

Branch (CC27). (1) Conducts laboratory

and field investigations of catastrophic

events such as explosions and

catastrophic structural or ground

failures to better understand cause and

effect relationships that initiate such

events; (2) designs and implements

appropriate intervention strategies; (3)

develops, tests, and promotes the use of

disaster prediction and risk evaluation

systems for control or reduction of risk;

(4) develops criteria and tests for

explosives to determine their suitability

for mine use and transportation; (5)

evaluates and recommends

implementation strategies for disaster

prevention; (6) assists in the

development and evaluation of

curricula for mine rescue, firefighting,

and the use of life support (self-rescuer)

equipment, in conjunction with other

health education, health

communication, and other information

and education activities of the Institute.

Following the functional statement for

the Division of Surveillance, Hazard

Evaluations, and Field Studies (CC5),

insert the following:

Spokane Research Laboratory (CC6).

(1) Provides leadership for prevention of

work-related illness, injury, and death

in the extractive industries in the

Western United States; (2) conducts

surveillance and tracks trends of fatal

and non-fatal traumatic injuries,

occupational diseases, health and safety

hazards, and the use of control

technology in the extractive industries,

with a focus on unique Western issues

such as those associated with deep

metal mines, Western coal mines, and

precious metal deposits; (3) conducts

field investigations, health hazard

evaluations, and laboratory studies of

occupational diseases, injuries, and

fatalities with focus on western-area

mineral-extractive industries; (4)

conducts laboratory and field

investigations to better understand the

causes of catastrophic events that may

lead to multiple injuries and fatalities,

such as collapse of underground

workings, massive slope failures, and

the collapse of mining facilities; (5)

develops, tests, and demonstrates

sensors, predictive models, and

engineering control technologies to

reduce miners risk for injury or death;

(6) develops and recommends

appropriate criteria for new standards,

NIOSH policy, documents, or testimony

related to health and safety in the

extractive industries.

Extramural Coordination and

Information Dissemination Activity

(CC62). (1) Coordinates with other

education and information

dissemination activities within the

Institute to assure that coordinated and

comprehensive mining research

information is effectively integrated into

the NIOSH dissemination and

intervention strategies; (2) serves as the

laboratory focal point for partnerships

with labor, industry and academia

involved with Western extractive

industries; (3) assists in the

development of mission-relevant

CRADAs and patents; (4) coordinates

mission-relevant technical assistance

and response activities for the western

United States.

Mining Surveillance and Statistics

Support Activity (CC63). (1) Describes

trends in incidence of mining-related

fatalities, morbidity, and traumatic

injury; (2) conducts surveillance on the

use of new technology and the use of

engineering controls; (3) coordinates the

surveillance activities with other

Institute-wide surveillance initiatives;

(4) provides statistical support for all

surveillance and research activities of

the Laboratory; (5) assists in the

development of research protocols; (6)

communicates the results of

surveillance activities to researchers to

assist in the planning and prioritization

of future studies.

Mining Injury and Disease Prevention

Branch (CC64). (1) Designs and

conducts field and laboratory research

studies to identify and classify risk

factors that cause, or may cause,

traumatic injuries or illness to miners;

(2) designs, builds, and tests proposed

interventions to reduce risk of injury or

disease, and conducts demonstrations of

proposed control technologies; (3)

assesses the health and safety

implications of mining equipment

design features using scientific and

engineering techniques; (4) evaluates

and recommends implementation

strategies for injury and disease

prevention and the effective utilization

of control technologies developed by the

laboratory.

Catastrophic Failure Detection and

Prevention Branch (CC65). (1) Conducts

laboratory and field investigations of

catastrophic events such as collapse of

underground workings, massive slope

failures, collapse of mine facilities, or

other events that lead to traumatic

injuries or fatalities; (2) develops

computer visualization models to

simulate mine conditions and test

alternative mining methods and

approaches for risk reduction and

catastrophic failure prevention; (3)

develops, tests, and promotes the use of

catastrophic failure prediction and risk

evaluation systems; (4) evaluates and

recommends implementation strategies

for catastrophic failure prevention.

Dated: September 4, 1997.

David Satcher,

Director.

[FR Doc. 97–25947 Filed 9–30–97; 8:45 am]

BILLING CODE 4160–18–M

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Notice of Availability of a Draft Revised

Recovery Plan for the Chittenango

Ovate Amber Snail (Novisuccinea

Chittenangoensis) for Review and

Comment

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Notice of document availability.

SUMMARY: The U.S. Fish and Wildlife

Service announces the availability for

public review of a draft revised

Recovery Plan for the Chittenango ovate

amber snail (Novisuccinea

Chittengangoensis). The Chittenango

ovate amber snail is a terrestrial species

with only one known population, which

is located in the Chittenango Falls State

Park in Madison County, New York. It

was listed as a threatened species in

July 1978, and the initial recovery plan

was completed in March 1983. This

species was listed due to its rarity and

population decline; since listing, habitat

protection and captive propagation

activities have been implemented, but

the species’ status remains exceedingly

precarious. The primary threat to the

Chittenango ovate amber snail is

considered to be over-competition by an

introduced snail, Succiena sp B.

Additionally, potential threats persist

from habitat changes and inadvertent

human disturbance. The revised

recovery objective for this species is to

stabilize it by maintaining, to the extent

possible, the extant Chittenango ovate