Federal Register / Vol. 60, No. 96 / Thursday, May 18, 1995 / Notices 26727

banking and permissible for bank

holding companies. Unless otherwise

noted, such activities will be conducted

throughout the United States.

The application is available for

immediate inspection at the Federal

Reserve Bank indicated. Once the

application has been accepted for

processing, it will also be available for

inspection at the offices of the Board of

Governors. Interested persons may

express their views in writing on the

question whether consummation of the

proposal can ‘‘reasonably be expected to

produce benefits to the public, such as

greater convenience, increased

competition, or gains in efficiency, that

outweigh possible adverse effects, such

as undue concentration of resources,

decreased or unfair competition,

conflicts of interests, or unsound

banking practices.’’ Any request for a

hearing on this question must be

accompanied by a statement of the

reasons a written presentation would

not suffice in lieu of a hearing,

identifying specifically any questions of

fact that are in dispute, summarizing the

evidence that would be presented at a

hearing, and indicating how the party

commenting would be aggrieved by

approval of the proposal.

Comments regarding the application

must be received at the Reserve Bank

indicated or the offices of the Board of

Governors not later than June 1, 1995.

A. Federal Reserve Bank of New

York, (William L. Rutledge, Senior Vice

President) 33 Liberty Street, New York,

New York 10045:

1. Swiss Bank Corporation, New York,

New York; to acquire SBC Capital

Markets Inc., New York, New York, and

thereby indirectly acquire Government

Pricing Information System, Inc., New

York, New York, and thereby engage in

data processing activities, pursuant to §

225.25(5)(7) of the Board’s Regulation Y.

Board of Governors of the Federal Reserve

System, May 12, 1995.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 95–12215 Filed 5–17–95; 8:45 am]

BILLING CODE 6210–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Announcement 565]

Health Services Research in

Occupational Safety and Health;

Availability of Funds for Fiscal Year

1995

Introduction

The Centers for Disease Control and

Prevention (CDC), the National Institute

for Occupational Safety and Health

(NIOSH), announces the availability of

fiscal year (FY) 1995 funds for research

projects relating to health services

research in the field of occupational

safety and health.

The Public Health Service (PHS) is

committed to achieving the health

promotion and disease prevention

objectives of ‘‘Healthy People 2000,’’ a

PHS-led national activity to reduce

morbidity and mortality and improve

the quality of life. This announcement

is related to the priority area of

Occupational Safety and Health. (For

ordering a copy of ‘‘Healthy People

2000,’’ see section ‘‘Where to Obtain

Additional Information.’’)

Authority

This program is authorized under the

Occupational Safety and Health Act of

1970, section 20(a) [29 U.S.C. 669(a)]

and section 22(e)(7) (29 U.S.C.

671(e)(7)).

Smoke-Free Workplace

PHS strongly encourages all grant

recipients to provide a smoke-free

workplace and to promote the non-use

of all tobacco products, and Pub. L.

103–227, the Pro-Children Act of 1994,

prohibits smoking in certain facilities

that receive Federal funds in which

education, library, day care, health care,

and early childhood development

services are provided to children.

Eligible Applicants

Eligible applicants include domestic

and foreign non-profit and for-profit

organizations, universities, colleges,

research institutions, and other public

and private organizations, including

State and local governments and small,

minority and/or woman-owned

businesses.

Availability of Funds

Approximately $1,000,000 is available

in FY 1995 to fund approximately five

research project grants. It is expected

that the average award will be $200,000,

ranging from $150,000 to $250,000 in

total costs (direct and indirect costs per

year). It is expected that the awards will

begin on or about September 1, 1995,

and will be made for a 12-month budget

period within a project period of up to

3 years. Funding estimates may vary

and are subject to change.

Continuation awards within the

project period will be made on the basis

of satisfactory progress and availability

of funds.

Purpose

The purpose of this grant program is

twofold. One major purpose is to

rationally develop an estimated range of

total costs and distribution for the

national burden of occupational injuries

and illnesses by comprehensively

applying existing information (See

Program Interests A.1., below). The

other major purpose is to conduct more

focused research into the systems that

prevent, manage, and compensate

occupational injuries and illnesses, with

particular focus on the experience of the

injured worker as he/she comes into

contact with components of these

systems (See Program Interests 2. to 5.,

below). It is the intent of this program

to support broad research endeavors

which will lead to improved

understanding and appreciation of the

magnitude of the aggregate national

economic burden associated with

occupational injuries and illnesses, as

well as to support more focused

research projects which will lead to

improvements in the delivery of

occupational safety and health services

and the prevention of work-related

injury and illness. Research funded will

examine and evaluate quality, outcome

and costs of services provided in a

variety of settings for healthy and

injured workers.

This is the first Request for Assistance

(RFA) that NIOSH has issued in the area

of Health Services Research. The

agency’s intention in defining the RFA’s

objectives broadly is to encourage

proposals from applicants with a broad

range of research backgrounds,

methodological approaches, and

institutional affiliations to apply their

skills to health services research in

occupational health, and to enter into

collaborative agreements, and with

unions, employers, providers, insurance

carriers and other relevant institutions

and organizations. NIOSH encourages

efforts in which researchers work

closely with employers, worker

representatives, and relevant

government agencies; collaboration with

any or all may assist researchers in

obtaining access to data, and will

increase the likelihood that results of

the study will be usable and used by the
26728 Federal Register / Vol. 60, No. 96 / Thursday, May 18, 1995 / Notices

parties involved. NIOSH also

recognizes, however, that in many

situations collaboration may not be

possible or advantageous.

Program Interests

a. Content Areas

1. The magnitude and distribution of

national costs of occupational injury

and illness. The economic and social

costs of work-related injury and illness

in the United States have not been

adequately described or studied. There

is programmatic interest in

investigations into developing

defensible estimates for the national

economic burden of occupational

injuries and illnesses, as well as into the

cost of failure to prevent occupational

injury and illness in general, as well as

in specific industries and of specific

conditions. There is particular interest

in developing and applying models to

estimate the distribution of these costs.

In most cases involving medical care

or lost wages, workers with

occupational injuries are entitled to

workers compensation benefits.

However, little is known of the costs

(personal and social, economic and noneconomic) of workplace injury and

illness cases that do not enter the

workers compensation system, or are

incompletely compensated by that

system. Further study is needed to

quantify these costs, and to determine

how much, if any, of these costs are

borne by injured workers, employers,

Federal agencies, State and local

government and private philanthropy.

Little is known about the social and

economic consequences of being

diagnosed with occupational injury or

illness. Are workers with occupational

conditions discriminated against or

likely to suffer from job loss as a result

of their condition? Are they at a

disadvantage in the job market? Does

being labeled with an occupational

condition impact their attitude toward

their job or their utilization of the health

care system?

2. The prevention and treatment of

work-related injury and illness through

the delivery of occupational medical

services Given the number and costs of

these conditions, relatively little is

known about the system for delivering

medical treatment for these conditions.

For both emergency and non-emergency

services, there is only limited

information on the extent, quality,

outcome and costs of services provided

by employer-based employee health

services, private physicians,

independent occupational health

clinics, and hospital emergency

departments. There is programmatic

interest in examining the types,

activities, and availability of

occupational medicine service

providers, and their use by employers of

differing sizes and in various industries,

including groups of workers who are

underserved and in need of

occupational health and safety.

Ideally, occupational medical services

provide more than the treatment of

work-related conditions, but are an

integral part of the primary and

secondary prevention of occupational

injury and illness. It is of interest to

examine the involvement and

effectiveness of different types of

providers of occupational medical

services (e.g. in-plant medical

departments, urgent care centers, local

hospitals and group health plans,

independent occupational health

clinics) in primary prevention activities

and how medical providers interact

with other occupational safety and

health professionals. Similarly, the role

and effectiveness of payers for

occupational medical services

(employers and workers compensation

insurance carriers) in encouraging or

discouraging injury and illness

prevention is of interest.

An alternative model for the provision

of occupational health services to

groups of employers in the same

industry or region is through managed

care organizations funded by capitated

payments. These provider groups may

be linked to employer-based coverage

for non-occupational health conditions

(sometimes referred to as 24 hour

coverage), or may be focused solely on

occupational health concerns. There is

programmatic interest in examining and

evaluating capitated models for the

delivery of occupational health services.

3. The experience of the injured

worker in the workers compensation

system. There are few studies on the

quality, cost, access and outcome of the

care received by those workers who

successfully enter the compensation

system. How successful is the system in

meeting its goals? Are the financial

benefits provided adequate to replace

lost earnings and compensate for workrelated disability? Are the medical care

services provided claimants appropriate

and accessible? (For additional

background on these and related

questions, see: Shor, GM. ‘‘Research and

Evaluation in Workers Compensation:

An Assessment and An Agenda.’’

Workers’ Compensation Monitor.

1994,7:18- 24.)

The factors that are associated with a

case being recognized as work-related

and entering the compensation system

are not well understood. In particular,

additional information is needed on the

incentives of the various actors in the

interface of medicine and the workplace

(e.g. workers and their families,

employers, corporate physicians,

personal physicians, group health plans

and insurance carriers, attorneys) that

encourage or discourage an injured

worker from receiving workers

compensation benefits. Are there groups

of workers (defined by health status,

age, gender, occupation, skill, language,

legal status or other characteristic) who

are more or less likely to enter the

workers compensation system, and

should additional efforts be made to

inform groups of injured workers about

their rights to compensation?

In an increasing number of States,

employers are permitted to select the

injured worker’s medical care provider.

There have been few studies comparing

the experience of injured workers in

employer-choice States with those of

workers in employee-choice States. How

do quality, outcome and costs differ in

these States? Are there some subsets of

workers (defined by health status,

wages, skill or other characteristic) who

are better served by one approach or the

other?

The number and proportion of work

injuries treated under workers

compensation managed care is rapidly

increasing, but there is virtually no

published literature evaluating workers

compensation managed care programs.

How does managed care in workers

compensation compare with fee-forservice provision of care, in terms of

quality, outcome and cost? How do

differences in managed care

organization structure and practices

impact quality, outcome and cost? How

has the trend toward managed care for

non-work-related conditions affected

the recognition and treatment of workrelated conditions. Does workers

compensation managed care generate

ethical dilemmas for providers, and if

so, how can they be resolved?

It has been suggested that integrating

or merging the systems to provide

medical services for work-related and

non-work-related conditions will result

in cost savings, although this has been

the subject of some debate. In addition,

it is not known how these changes

might impact workplace-based

prevention of occupational injury and

illness, since in theory, the experience

rating component of workers

compensation premiums provides a

market-based incentive to prevent injury

and illness (although there is also

debate over its actual effectiveness). It is

of programmatic interest to examine the

effects of (1) integration or merger of

these medical care delivery systems;

and (2) uncoupling of workers
Federal Register / Vol. 60, No. 96 / Thursday, May 18, 1995 / Notices 26729

compensation medical benefits from

experience rating. Of interest are the

impact of these policies on the quality,

outcome and cost of care, on indemnity

benefits, and on the primary prevention

of occupational conditions.

Finally, while it is frequently alleged

that fraud is relatively widespread

within the workers compensation

system, there are few if any studies that

address this issue in a rigorous manner.

The extent of fraudulent claims and

practices is unknown, as are the costs of

these activities to workers, employers

and the compensation system. Accurate,

rigorously-gathered information on the

magnitude, costs, and characteristics of

workers compensation fraud on the part

of claimants, employers, health care

providers and carriers are needed in

order to better design and target fraud

reduction programs.

4. Development and evaluation of

treatment guidelines. Outcome of

treatment of occupational injury and

illness, whether or not it is paid for by

the workers compensation system, may

be measured differently than treatment

outcome of non-work-related

conditions. In addition to physiological

outcome, or outcome as it relates to

health status, management and

treatment of occupational conditions

must consider the impact of the

condition and treatment on the worker’s

post-injury wages and ability of the

worker to use their valued skills and

knowledge.

Since workers with occupational

injury or illness may be index cases for

more widespread or prevalent

conditions, treatment guidelines should

include a primary prevention

component. This may involve the

provider having contact with the

employer, union, or other workers at the

workplace from which the index case

emerged, and should therefore take into

consideration issues of confidentiality

and potential discrimination. In

developing these guidelines, it is also

necessary to address issues of worker

education, how information about the

nature, prognosis and prevention of the

condition is transmitted to the worker.

In the development and evaluation of

guidelines for treatment of work-related

conditions, consideration should be

given to economic and social outcomes

in addition to physiologic outcome. To

develop and evaluate these guidelines,

it may be necessary to consider various

ways to conceptualize and measure

‘‘return-to-work,’’ beyond merely the

end of the period in which an injured

worker is not working, and possibly to

develop new measures or indices for

describing the long-term experience of

the injured worker.

5. Workplace based injury and illness

prevention. Workplace health and safety

committees are widely seen as playing

an important role in preventing

occupational injury and illness. In

recent years, several States have enacted

legislation mandating these committees.

Additional data are needed to evaluate

the acceptance of these committees by

employers, unions, workers and others;

and their functioning and effectiveness.

Are they successful in reducing

workplace hazards, and, if so, what

characteristics contribute to their ability

to do so? How successful are other statemandated hazard prevention programs?

Surveillance programs for injury and

illness are widely used as part of larger

work related injury and illness

prevention programs. There are

insufficient data on the effectiveness of

these programs, and on the factors that

increase these programs’ likelihood of

success.

Many workers compensation carriers,

often through loss-control units, offer

hazard prevention consulting services to

employers. There is interest in

examining the experience of these

carriers. In particular, have these

programs been evaluated to measure

their effectiveness in preventing workrelated injury and illness? If so, are

there lessons to be drawn for injury and

illness prevention in general?

Cost-benefit and cost-effectiveness

studies are needed to assess

occupational health programs at all

levels from direct interventions in the

workplace to comprehensive national

programs. Such studies should include

measuring the impact and costs of

Federal or State regulation of workplace

hazards. While many economic analyses

have been done to project the costs of

proposed standards, the actual

economic and social impact of

regulations that have gone into effect is

rarely measured and deserving of study.

B. Methodological Approaches

The purpose of this RFA is to

encourage submission of proposals that

address some of the questions raised

above. Since these questions lend

themselves to a variety of quantitative

and qualitative methodological

approaches, NIOSH encourages

applications from researchers in a range

of academic disciplines. For example,

the development of a comprehensive

and defensible estimated range of the

national economic burden of

occupational injuries and illnesses may

involve expertise representing a variety

of fields (e.g., health economics,

sociology, epidemiology, safety

specialists and occupational medicine.)

Also, the experience of injured workers

in the workers compensation system

could be examined quantitatively, using

traditional economic or epidemiologic

approaches, or could be examined

qualitatively, employing techniques

generally used by anthropologists or

some sociologists. Multi-disciplinary

approaches applied to the same issue

are encouraged.

NIOSH envisions that some

researchers may propose case studies,

examining the experience of workers in

one industry or workplace, or with a

particular work-related condition, while

others will propose studies analyzing

large sets of data previously collected by

compensation systems or carriers, or

health insurers. Economic studies might

be undertaken of costs of work-related

injury, or of regulation, in one industry.

In areas where adequate research has

already been undertaken, programs that

demonstrate the utility of new

approaches to injury and illness

prevention may be considered.

In many of the areas described, the

foundation for analytical research may

not exist, and it may be appropriate for

researchers to apply for preliminary or

descriptive studies that will generate

hypotheses for future endeavors. For

example, it may be difficult to identify

populations of workers with

occupational injury or illness who do

not enter the workers compensation

system. An applicant might propose a

preliminary study to determine the

number and characteristics of workers

who may be work-injured but never

applied for compensation by examining

one or more provider-based data

systems, or by surveying the

memberships of one or more

community-based organizations.

Research and evaluation methods in

occupational health services may also

need additional development. An

applicant might propose to develop and

test a series of quality indicators to be

employed in evaluating occupational

health services.

Applicants may apply for seed money

to develop study protocols and the

methodology for future scientific studies

to address those questions for which

rigorous investigation are needed but

that are not easily accomplished. For

example, although the application of

managed care to workers compensation

medical services has undergone a

dramatic expansion, few scientific

investigations have been conducted on

the extent and impact of this growth. A

descriptive approach that generates

hypotheses might be warranted before

proceeding to analytical and evaluation

studies.

As noted above, it is an objective of

this program to encourage scientists to
26730 Federal Register / Vol. 60, No. 96 / Thursday, May 18, 1995 / Notices

apply their skills to health services

research in occupational health, and to

enter with collaborative agreements

with each other, and ‘‘stakeholder’’

institutions and organizations. In

particular, NIOSH encourages efforts in

which researchers work closely with

employers, unions, and relevant

government agencies in order to assist

researchers in obtaining access to data,

and to increase the likelihood that study

results will be usable and used by the

parties involved.

Inclusion of Minorities and Women in

Study Population

Applicants are required to give added

attention (where feasible and

appropriate) to the inclusion of

minorities and/or women study

populations for research into the

etiology of diseases, research in

behavioral and social sciences, clinical

studies of treatment and treatment

outcomes, research on the dynamics of

health care and its impact on disease,

and appropriate interventions for

disease prevention and health

promotion. Exceptions would be studies

of diseases which exclusively affect

males or where involvement of pregnant

women may expose the fetus to undue

risks. If minorities and/or women are

not included in a given study, a clear

rationale for their exclusion must be

provided.

Evaluation Criteria

1. General

Upon receipt, applications will be

reviewed for completeness and

responsiveness by CDC/NIOSH.

Incomplete applications will be

returned to the applicant without

further consideration. If CDC/NIOSH

staff finds that the application is not

responsive to this announcement, it will

be returned without further

consideration. If the proposed project

involves organizations or persons other

than those affiliated with the applicant

organization, letters of support and/or

cooperation must be included.

2. Peer Review

Applications that are complete and

responsive to the announcement will be

evaluated for scientific and technical

merit by an appropriate peer review

group convened by the CDC in

accordance with the review criteria

stated below. As part of the initial merit

review, a process (triage) may be used

by the initial review group in which

applications will be determined to be

competitive or non-competitive based

on their scientific merit relative to other

applications received in response to this

announcement. Applications judged to

be competitive will be discussed and be

assigned a priority score. Applications

determined to be non-competitive will

be withdrawn from further

consideration and the principal

investigator/program director and the

official signing for the applicant

organization will be promptly notified.

Review criteria for this announcement

are as follows:

a. Scientific, technical, or medical

significance and originality of

proposed research;

b. Appropriateness and adequacy of the

experimental approach and

methodology proposed to carry out

the research;

c. Qualifications and research

experience of the Principal

Investigator and staff, particularly but

not exclusively in the area of the

proposed research;

d. Availability of resources necessary to

perform the research;

e. Adequacy of plans to include both

genders and minorities and their

subgroups as appropriate for the

scientific goals of the research. Plans

for the recruitment and retention of

subjects will also be evaluated.

The review group will critically

examine the submitted budget and will

recommend an appropriate budget and

period of support for each scored

application.

3. Secondary Review

In the secondary (programmatic

importance) review, the following

factors will be considered:

a. Results of the initial review;

b. Magnitude of the problem in terms of

numbers of workers affected;

c. Severity of the disease or injury in the

worker population; and

d. Usefulness to applied technical

knowledge in the identification,

evaluation, and/or control of

occupational safety and health

hazards.

4. Funding Decisions

Applicants will compete for available

funds with all other approved

applications. The following will be

considered in making funding

decisions:

a. Quality of the proposed project as

determined by peer review;

b. Availability of funds; and

c. Program balance among research

areas of the announcement.

Executive Order 12372 Review

This program is not subject to the

Executive Order 12372 review.

Public Health System Reporting

Requirement

This program is not subject to the

Public Health System Reporting

Requirements.

Catalog of Federal Domestic Assistance

Number

The Catalog of Federal Domestic

Assistance number is 93.262.

Other Requirements

Human Subjects

If the proposed project involves

research on human subjects, the

applicant must comply with the

Department of Health and Human

Services Regulations, 45 CFR part 46,

regarding the protection of human

subjects. Assurance must be provided to

demonstrate that the project will be

subject to initial and continuing review

by an appropriate institutional review

committee. The applicant will be

responsible for providing assurance in

accordance with the appropriate

guidelines and form provided in the

application kit.

Application Submission and Deadlines

1. Preapplication Letter of Intent

Although not a prerequisite of

application, a non-binding letter of

intent-to-apply is requested from

potential applicants. The letter should

be submitted to the Grants Management

Branch, CDC (see ‘‘Applications’’ for the

address). It should be postmarked no

later than June 19, 1995. The letter

should identify the announcement

number, name of principal investigator,

and specify the priority area to be

addressed by the proposed project. The

letter of intent does not influence

review or funding decisions, but it will

enable CDC to plan the review more

efficiently, and will ensure that each

applicant receives timely and relevant

information prior to application

submission.

2. Applications

Applicants should use Form PHS–398

(OMB Number 0925–0001) and adhere

to the ERRATA Instruction Sheet for

Form PHS–398 contained in the

application package. The original and

five copies of the application must be

submitted to Henry S. Cassell, III, Grants

Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention, (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Mailstop E13, Atlanta, GA 30305 on or

before July 14, 1995.
Federal Register / Vol. 60, No. 96 / Thursday, May 18, 1995 / Notices 26731

3. Deadlines

A. Applications shall be considered as

meeting a deadline if they are either:

1. Received at the above address on or

before the deadline date; or

2. Sent on or before the deadline date

to the above address, and received in

time for the review process.

(Applicants must request a legibly

dated U.S. Postal Service postmark or

obtain a legibly dated receipt from a

commercial carrier or the U.S. Postal

Service. Private metered postmarks

shall not be accepted as proof of

timely mailing.)

B. Applications which do not meet

the criteria in 3.A.1. or 3.A.2. above are

considered late applications. Late

applications will not be considered in

the current competition and will be

returned to the applicant.

Where to Obtain Additional

Information

To receive additional written

information call (404) 332–4561. You

will be asked to leave your name,

address and phone number and will

need to refer to Announcement 565.

You will receive a complete program

description, information on application

procedures, and application forms.

If you have questions after reviewing

the contents of all the documents,

business management technical

assistance may be obtained from Georgia

L. Jang, Grants Management Specialist,

Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, NE.,

Mailstop E13, Atlanta, GA 30305,

telephone (404) 842–6814.

Programmatic technical assistance may

be obtained from Roy M. Fleming, Sc.D.,

Associate Director for Grants, National

Institute for Occupational Safety and

Health, Centers for Disease Control and

Prevention (CDC), 1600 Clifton Road,

NE., Building 1, Room 3053, Mailstop

D30, Atlanta, GA 30333, telephone (404)

639–3343.

Please refer to Announcement 565

when requesting information and

submitting an application.

Potential applicants may obtain a

copy of ‘‘Healthy People 2000’’ (Full

Report: Stock No. 017–001–00474–0) or

‘‘Healthy People 2000 (Summary

Report, Stock No. 017–001–00473–1)

referenced in the ‘‘Introduction’’

through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

telephone (202) 512–1800.

Dated: May 12, 1995.

Diane D. Porter,

Acting Director, National Institute for

Occupational Safety and Health, Centers for

Disease Control and Prevention (CDC).

[FR Doc. 95–12201 Filed 5–17–95; 8:45 am]

BILLING CODE 4163–19–P

Food and Drug Administration

[Docket No. 95N–0123]

Drug Export; ReviaTM (Naltrexone

Hydrochloride (HCl)) 50 Milligrams

(mg) Film-Coated Tablets

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Dupont Merck has filed an

application requesting approval for the

export of the human drug ReviaTM

(naltrexone HCl) 50 mg film-coated

tablets to Germany.

ADDRESSES: Relevant information on

this application may be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857, and to the contact

person identified below. Any future

inquiries concerning the export of

human drugs under the Drug Export

Amendments Act of 1986 should also be

directed to the contact person.

FOR FURTHER INFORMATION CONTACT:

James E. Hamilton, Center for Drug

Evaluation and Research (HFD–310),

Food and Drug Administration, 7520

Standish Pl., Rockville, MD 20857, 301–

594–3150.

SUPPLEMENTARY INFORMATION: The drug

export provisions in section 802 of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 382) provide that

FDA may approve applications for the

export of drugs that are not currently

approved in the United States. Section

802(b)(3)(B) of the act sets forth the

requirements that must be met in an

application for approval. Section

802(b)(3)(C) of the act requires that the

agency review the application within 30

days of its filing to determine whether

the requirements of section 802(b)(3)(B)

have been satisfied. Section 802(b)(3)(A)

of the act requires that the agency

publish a notice in the Federal Register

within 10 days of the filing of an

application for export to facilitate public

participation in its review of the

application. To meet this requirement,

the agency is providing notice that

Dupont Merck, Dupont Merck Plaza,

Maple Run, Centre Rd., Wilmington, DE

19805, has filed an application

requesting approval for the export of the

human drug ReviaTM (naltrexone HCl)

50 mg film-coated tablets to Germany.

The firm holds an approved new drug

application for an uncoated tablet,

however, this application is for a new

film-coated tablet formulation. This

product is used as an adjunctive

treatment of opioid dependence in

detoxified, formerly opioid dependent

individuals, and in a proposed

indication as an adjunctive treatment for

individuals with alcohol dependence

undergoing psychosocial treatment

programs. The application was received

and filed in the Center for Drug

Evaluation and Research on April 17,

1995, which shall be considered the

filing date for purposes of the act.

Interested persons may submit

relevant information on the application

to the Dockets Management Branch

(address above) in two copies (except

that individuals may submit single

copies) and identified with the docket

number found in brackets in the

heading of this document. These

submissions may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

The agency encourages any person

who submits relevant information on

the application to do so by May 30,

1995, and to provide an additional copy

of the submission directly to the contact

person identified above, to facilitate

consideration of the information during

the 30-day review period.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(sec. 802 (21 U.S.C. 382)) and under

authority delegated to the Commissioner

of Food and Drugs (21 CFR 5.10) and

redelegated to the Center for Drug

Evaluation and Research (21 CFR 5.44).

Dated: May 4, 1995.

Gayle R. Dolecek,

Acting Director, Office of Compliance, Center

for Drug Evaluation and Research.

[FR Doc. 95–12177 Filed 5–17–95; 8:45 am]

BILLING CODE 4160–01–F

National Institutes of Health

National Institute of Dental Research;

Notice of Meeting of NIDR Board of

Scientific Counselors

Pursuant to Pub. L. 92–463, notice is

hereby given of a meeting of the Board

of Scientific Counselors, National

Institute of Dental Research (NIDR), on

June 7–9, 1995, in the Natcher Building,

Conference Room A, National Institutes

of Health, Bethesda, Maryland. The

meeting will be open to the public from

8:55 a.m. to recess on June 8 and from