12208 Federal Register / Vol. 62, No. 50 / Friday, March 14, 1997 / Notices

disclosure of client-identifying

information;

c. Obtain informed client consent by

explaining the risks of disclosure and

the recipient’s policies and procedures

for preventing unauthorized disclosure;

d. Provide written assurance to this

effect including copies of relevant

policies; and

e. Obtain assurances of confidentiality

by agencies to which referrals are made.

Assurance of compliance with these

and other processes to protect the

confidentiality of information will be

required of all recipients. A Department

of Health and Human Services (DHHS)

certificate of confidentiality may be

required for some projects.

G. Women, Racial and Ethnic Minorities

It is the policy of the Centers for

Disease Control and Prevention (CDC) to

ensure that individuals of both sexes

and the various racial and ethnic groups

will be included in CDC-supported

research projects involving human

subjects, whenever feasible and

appropriate. Racial and ethnic groups

are those defined in OMB Directive No.

15 and include American Indian,

Alaskan Native, Asian, Pacific Islander,

Black and Hispanic. Applicants shall

ensure that women, racial and ethnic

minority populations are appropriately

represented in applications for research

involving human subjects. Where a clear

and compelling rationale exists that

inclusion is inappropriate or not

feasible, this situation must be

explained as part of the application.

This policy does not apply to research

studies when the investigator cannot

control the race, ethnicity, and/or sex of

subjects. Further guidance to this policy

is contained in the Federal Register,

Vol. 60, No. 179, pages 47949–47951,

dated Friday, September 15, 1995.

H. Capability Assessment

Some applicants may be required to

participate in a fiscal Recipient

Capability Assessment prior to the

award of funds.

Application Submission and Deadline

The original and two copies of the

application PHS Form 5161–1 (Revised

7/92, OMB Number 0937–0189) must be

submitted to Joanne Wojcik, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 321,

Mailstop E–13, Atlanta, Georgia 30305,

on or before May 20, 1997.

1. Deadline: Applications shall be

considered as meeting the deadline if

they are either;

a. Received on or before the deadline

date; or

b. Sent on or before the deadline date

and received in time for submission to

the special emphasis panel review

committee. For proof of timely mailing,

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 will

not be acceptable as proof of timely

mailing.

2. Late Applications:

Applications that do not meet the

criteria in 1.a. or 1.b. above are

considered late. 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 telephone number and will

need to reference Announcement 727.

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 Joanne

Wojcik, Grants Management Specialist,

Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

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

Mailstop E–13, Atlanta, GA 30305,

telephone (404) 842–6535 or internet

address <jcw6@cdc.gov>.

Programmatic technical assistance

may be obtained from Chester L.

Pogostin, D.V.M., M.P.A., Centers for

Disease Control and Prevention (CDC),

National Center for Injury Prevention

and Control, Division of Violence

Prevention, Mailstop K–60, Atlanta,

Georgia 30333, telephone (770) 488–

4279; Internet: clp3@cdc.gov.

This and other CDC announcements

are available through the CDC homepage

on the Internet. The address for the CDC

homepage is http://www.cdc.gov.

CDC will not send application kits by

facsimile or express mail.

Please refer to Announcement

Number 727 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 D.C., 20402–9325,

telephone (202) 512–1800.

Dated: March 10, 1997.

Joseph R. Carter,

Acting Associate Director for Management

and Operations Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–6497 Filed 3–13–97; 8:45 am]

BILLING CODE 4163–18–P

[Announcement Number 731]

Research Projects for Health

Promotion for Persons With

Disabilities and Prevention of

Secondary Conditions; Notice of

Availability of Funds for Fiscal Year

1997

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1997

competitive grant and cooperative

agreement funds. Part 1 of this

Announcement will support research

grants to: (a) Measure the magnitude of

secondary conditions in specified

populations of persons who have a

disability; (b) determine the risk and

protective factors that contribute to or

avert the occurrence of secondary

conditions; (c) conduct and measure the

effectiveness of health promotion

interventions designed to prevent

secondary conditions; and/or (d)

understand the prevention effectiveness

and cost-effectiveness of interventions.

Part 2 of this Announcement will

support one cooperative agreement

project to prevent the occurrence of

pressure sores and other selected

secondary conditions among persons

with spinal cord injury.

CDC is committed to achieving the

health promotion and disease

prevention objectives described in

‘‘Healthy People 2000,’’ a national

activity to reduce morbidity and

mortality and improve the quality of

life. This Announcement is related to

the Healthy People 2000 category of

Preventive Services. (For ordering a

copy of ‘‘Healthy People 2000,’’ see the

section Where to Obtain Additional

Information.)

Authority

This program is authorized by Section

301(a) (42 U.S.C. 241(a)) and Section

317 (42 U.S.C. 247b) of the Public

Health Service Act, as amended.

Smoke-Free Workplace

CDC strongly encourages all grant

recipients to provide a smoke-free

workplace and promote the non-use of
Federal Register / Vol. 62, No. 50 / Friday, March 14, 1997 / Notices 12209

all tobacco products. Public Law 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 for this program

are public and private non-profit

entities, including universities;

university-affiliated systems including

not-for-profit medical centers; research

institutions and rehabilitation hospitals;

State health departments and other

related State government agencies;

disability service groups such as

advocacy and voluntary organizations

and independent living centers; and

federally recognized Indian Tribal

Governments.

Note: An organization described in section

501(c)(4) of the Internal Revenue Code of

1986 which engages in lobbying activities

shall not be eligible to receive Federal funds

constituting an award, grant, contract, loan,

or any other form.

Availability of Funds

This Announcement has two separate

components as noted in the

INTRODUCTION section. Under Part 1,

it is anticipated that approximately

$1,800,000 will be available in FY 1997

to support 6 to 8 research grant projects,

with an expected range of awards from

$220,000 to $280,000 each. Under Part

2, it is estimated that approximately

$250,000 will be available in FY 1997 to

support one cooperative agreement to

prevent the occurrence of pressure sores

and other selected secondary conditions

among persons with spinal cord injury.

Awards are expected to be made on or

before August 1, 1997, for a twelvemonth budget period within a project

period of up to three years. Funding

estimates are subject to change,

including funds to be awarded in

continuation years based on

documented progress toward objectives,

the quality of continuation year work

plans, evidence of cost-sharing, and the

availability of funds.

This program has no statutory

matching requirement. However,

applicants should document their

financial support for a portion of project

costs, such as salaries for key staff and

tangible contributions by collaborating

agencies. Applicants should also

demonstrate their capacity to increase

cost-sharing over time, and identify

other funding sources to assist in project

activities.

Use of Funds

Grant funds may be used to support

personnel services, supplies,

equipment, travel, subcontracts, and

other services directly related to project

activities consistent with the approved

scope of work. Project funds may not be

used to supplant other available

applicant or collaborating agency funds,

for construction, for lease or purchase of

facilities or space, or for patient care.

Project funds may not be used for

individualized preventive measures

(direct patient support) such as for

wheelchairs, medical appliances, or

assistive technology unless specifically

approved by the funding agency.

Purpose

The purpose of grant awards under

Part 1 is to develop better understanding

of the secondary conditions that occur

among prescribed groups of persons

with disabilities. These awards will

allow grantees to measure the risk

factors and protective factors for

preventing secondary conditions, and to

assess the cost- and preventioneffectiveness of interventions targeted to

the needs of persons with disabilities.

The purpose of the Part 2 cooperative

agreement award is to design, conduct,

and report the findings of a model

project to prevent pressure sores and

other selected secondary conditions

among persons with spinal cord injury.

This project should explore the

feasibility of a home-based intervention;

e.g., a public health nurse visitation

program addressing medical, social, and

environmental factors associated with

the development of pressure sores and

other selected secondary conditions.

Projects receiving funds for either Part

1 or Part 2 are expected to design,

document, and publish the results of

their research in a manner that promotes

generalizability so that academic

institutions, State and local agencies,

disabilities service programs, and other

organizations concerned with public

health and health promotion programs

for persons with disabilities and

rehabilitation can benefit. Project

activities must provide evidence that all

project programs will involve and be

accessible to persons with disabilities.

Background—General

The CDC Office on Disability and

Health (proposed, current nameDisabilities Prevention Program) has

provided grant funds to universities,

rehabilitation hospitals, and State

agencies since 1988 to increase

understanding of the disabling process

and conduct research to prevent

secondary conditions. Those research

grants have focused on the frequency,

severity, cost, and significance of a

specific, or a range of secondary

conditions associated with a prescribed

primary disability (e.g., spinal cord

injury, traumatic brain injury, fetal

alcohol syndrome, cerebral palsy, and

the late effects of polio).

Background for Part 1

Part 1 of the research emanating from

this Announcement is designed to

examine, understand, and document the

participation of persons with disabilities

within their social environment as

related to a particular disability domain.

Disability domains are categories of

activities that individuals perform in

everyday life. Applicants should

propose grant activities in at least one

of the following disability domains: (1)

Mobility (locomotion); (2) personal care/

home management; (3) communication;

and (4) learning. Descriptions and

examples within these disability

domains are as follows:

1. Mobility (locomotion) refers to an

individual’s ability to perform

distinctive activities associated with

moving; both himself and objects, from

place to place. Examples of underlying

conditions or diagnoses include spinal

cord injury, cerebral palsy, arthritis,

lower limb loss, blindness, or stroke.

Secondary conditions may include

urinary tract infections, cardiovascular

deficit due to sedentary lifestyle,

pressure sores, results from falls, bowel

obstruction, dependence on assistive

devices and its economic impact, lack of

access to medical care, and social

isolation.

2. Personal Care/Home Management

refers to an individual’s ability to

perform basic self-care activities such as

feeding, bladder and bowel care,

personal hygiene, dressing, financial

management, and homemaking.

Examples of underlying conditions or

diagnoses include asthma, arthritis,

stroke, osteoporosis, paraplegia, or

multiple sclerosis. Secondary

conditions may include lack of physical

fitness, incontinence, weight gain, poor

nutrition, and emotional dependence.

3. Communication refers to an

individual’s ability to generate and

express messages, and to receive and

understand messages. Examples of

underlying conditions or diagnoses

include cerebral palsy, deafness,

aphasia from varied pathology, or

congenital speech impediments.

Secondary conditions may include

family dysfunction, isolation, and

constraints and barriers in employment

opportunity.

4. Learning refers to an individual’s

ability to profit from daily experiences,
12210 Federal Register / Vol. 62, No. 50 / Friday, March 14, 1997 / Notices

and includes aspects of receiving,

processing, remembering, and using

information. Examples of underlying

conditions or diagnoses include mental

retardation, spina bifida, fetal alcohol

syndrome, or traumatic brain injury.

Secondary conditions may include

depression, behavioral problems,

increased family stress, and poor

academic and vocational performance.

Note that the examples listed above

are illustrative, and not intended to be

exhaustive; several secondary

conditions may apply to more than one

disability domain. Because of limited

funds and other resources available, this

Announcement does not include

disabilities created by psychiatric

diagnoses, although mental health

issues may be appropriately included as

secondary conditions.

The model of health promotion used

for Part 1 of this Announcement

assumes a goal of promoting health and

preventing secondary conditions among

persons with disabilities. The basic

conceptual model is represented by the

International Classification of

Impairments, Disabilities, and

Handicaps (ICIDH). Revisions proposed

to the ICIDH framework include

definitions and concepts consistent with

a broader perspective of the disabling

process. Of particular importance is the

utility of this paradigm for data

collection, given its classification of

disabilities and related variables.

Definitions referenced in this framework

are presented below:

1. Participation refers to the product

of the interactions between the

individual and the environment, and is

delineated by the outcomes of that

interaction. The intent of this dimension

is to document the nature and extent of

a person’s involvement in life activities.

This dimension is broadly analogous to

the term ‘‘Handicap’’ in the ICIDH

(World Health Organization, 1980)

model and the term ‘‘Disability’’ in the

Institute of Medicine (IOM, 1991)

model.

2. Environment refers to the physical,

social, and cultural contexts in which

the individual acts. Elements of the

environment create the backdrop for the

individual’s participation, as facilitators

or hindrances.

3. Impairment refers to loss or

abnormality in a body structure, organ,

or system as a consequence of disease,

injury, or congenital disorder. In the

context of health experience, an

impairment is any loss or abnormality of

psychological, physiological, or

anatomical structure or function.

4. Disability refers to any restriction or

lack of ability to carry out simple or

complex activities of everyday life. It is

the manifestation of an underlying

impairment, but may vary by age or

developmental stage.

5. Health Promotion is the effort to

educate persons with a disability about

the relationship between protective and

risk factors and secondary conditions,

and to increase behaviors consistent

with a healthy lifestyle. Health

promotion concerns those behaviors

that affect health status and are under

the direct control of persons who have

a disability.

6. Secondary Conditions are those

physical, medical, cognitive, emotional,

or psychosocial conditions, (to which

persons with a disability are more

vulnerable by virtue of an underlying

condition), including adverse outcomes

in health, wellness, participation, and

quality of life.

7. Protective Factors are biological,

environmental (social and physical),

and lifestyle or behavioral

characteristics that reduce or mitigate

the risk for adverse health outcomes,

enhance coping skills, induce a positive

mediating influence against the effects

of secondary conditions, and/or

promote health.

8. Risk Factors are biological,

environmental (social and physical),

and lifestyle or behavioral

characteristics that increase the risk for

adverse health outcomes. Identifying

such factors can contribute to

determining a course of action during

the disabling process, including the

development of preventive

interventions.

9. Quality of Life is associated with

the concept of well-being, encompassing

both physical and psychosocial

determinants. Components of quality of

life include performance of social roles,

physical status, emotional status, social

interactions, economic status, and selfperceived or subjective health status.

Background for Part 2

Pressure sores are the most common

and costly complication among persons

with spinal cord injury. There are an

estimated 200,000 persons with spinal

cord injury in the United States. Almost

all persons with spinal cord injury will

experience at least one pressure sore in

their lifetime. Although estimates vary,

the prevalence of pressure sores may be

more than 20 percent among persons

with spinal cord injury. One study

showed that the average institutional

costs (for acute care and rehabilitation

hospitalizations) for pressure sores were

$92,723. The overall cost of hospital

stays and economic loss due to pressure

sores may be over $6 billion each year

(regardless of underlying condition).

Pressure sores are lesions caused by

unrelieved pressure, trauma, friction,

and/or moisture which damages the

skin and then the underlying tissues.

Much is known about the factors

associated with pressure sore

development and treating pressure sores

once they occur. Pressure sores are also

considered the secondary condition

most amenable to prevention among

persons with spinal cord injury. As part

of rehabilitation, persons with spinal

cord injury are taught how to care for

their skin and how to prevent pressure

sores once they leave the hospital

environment and return home. Despite

this training, persons with spinal cord

injury continue to experience pressure

sores.

Despite what is known about the

factors associated with the development

of pressure sores, little is known about

why persons with spinal cord injury do

not optimize skin care and other

behaviors to prevent pressure sores from

occurring. One study, conducted by the

Arkansas State Spinal Cord

Commission, found initial success with

an in-home education program in which

the incidence of pressure sores

decreased by 19 percent. In long-term

follow-up, however, the incidence of

pressure sores actually increased among

program participants.

Because few such programs have been

developed and implemented, little is

known about community-based

prevention programs for the prevention

of pressure sores. The emphasis here is

prevention and early intervention rather

than treatment. Recognizing that

individual situations vary, assessment

of risk for developing pressure sores and

education for prevention should be

done in the context of individual needs,

strengths, and environment. Applicants

should use available information on

pressure sore prevention in the postrehabilitation, community setting to

develop a model program and plan, and

implement and evaluate the feasibility

of doing a home-visitation program.

Program Requirements for Part 1

Applicants must design, develop, and

evaluate health promotion programs or

conduct an epidemiologic study that

will contribute to a national information

base for the prevention of secondary

conditions. CDC has indicated the

following four areas for emphasis under

Part 1 of this Announcement and

applicants must develop their proposals

to respond to one of these four areas.

1. Development of reliable and valid

measurements to assess Participation

among persons with disabilities, and

characteristics of the Environment

which influence that participation.
Federal Register / Vol. 62, No. 50 / Friday, March 14, 1997 / Notices 12211

Applicants may choose to work across

disability domains. These are evolving

dimensions to the ICIDH framework to

replace the ‘‘Handicap’’ dimension.

There is a pressing need to clarify and

understand these dimensions and

characteristics. There is a benefit in

having the capacity to assess

empirically the influence of

environment on participation in life

activities for persons with disabilities.

The need to assess these dimensions to

improve the health status, expand

research emphasis, and develop policy

regarding persons with disabilities is

both timely and critical.

2. Work toward measuring the costeffectiveness of one or more

intervention strategy(ies) designed to

minimize the effects of or prevent

selected secondary condition(s). In

order to guide the conduct of cost-utility

and cost-effectiveness analysis in

federally funded programs, the PHS

recently developed consensus-based

Cost-Effectiveness Recommendations

which have direct applicability to

research on the prevalence and

consequences of secondary conditions.

Applying cost-utility and/or costeffectiveness analytic techniques

improves the basis for the allocation of

health care resources across a broad

range of secondary conditions among

many preventive, therapeutic,

rehabilitative, and public health

interventions. The PHS CostEffectiveness Recommendations

emphasize standardization of methods,

adoption of the societal perspective in

conducting analyses, and use of the

summary measure known as the

‘‘quality-adjusted life year’’ (QALY) as a

comparable metric for recording the

effects of different interventions. Thus,

there is both an opportunity and a need

to establish basic prevention strategies

that focus on common secondary

conditions, and to apply methods that

evaluate their comparative costeffectiveness, so that successful

strategies and approaches can be

generalized and replicated in other

settings. Reference citations for these

published recommendations are

presented in the Bibliography, which is

an attachment to this Announcement.

3. Identification and measurement of

protective factors and risk factors within

a disability domain, and measurement

of the effectiveness of preventive

interventions that focus on an identified

age group that includes: (a) Children; (b)

youth; and/or (c) older adults. Given the

paucity of research on secondary

conditions generally, there is even less

data available on specific age groups

within the population which may be

even more susceptible to developing

secondary conditions.

4. Identification and measurement of

protective factors and risk factors within

a disability domain, and measurement

of the effectiveness of preventive

interventions among specified

populations that include women and/or

ethnic minority groups, or a

combination of the two. Among persons

with disabilities, susceptibility to

secondary conditions may be higher in

particular populations. Emphasis

should be given to populations

considered to be at greatest risk.

Program Requirements for Part 2

Applicants must develop proposals to

address pressure sores and other

selected secondary conditions among

persons with spinal cord injury. The

model program proposed should be

home-based and able to collect

information on and address medical,

social, and environmental factors

associated with the development and

progression of pressure sores and other

selected secondary conditions.

Applicants should address the

development, implementation, and

appropriate evaluation of a home-based

model project to prevent pressure sores

and other selected secondary conditions

among persons with spinal cord injury.

The emphasis of the project should be

to assess the feasibility of the program,

including access to persons with spinal

cord injury, recruiting and retaining

study participants, logistical

management and support of a homebased visitation program, and

educational materials for the prevention

of pressure sores and other selected

secondary conditions. Applicants

should consider addressing persons

with spinal cord injury at greatest risk

of secondary conditions, including

persons of low socioeconomic status or

persons considered medically

underserved. A close working

relationship between the recipient and

CDC is expected.

Applicants for Part 2 should develop

a prevention program based on a public

health nurse, home-visit model. The

project should include the following

elements:

1. Collect, compile, and analyze

information relevant to the prevention

of pressure sores and other selected

secondary conditions among persons

with spinal cord injury;

2. Develop a program consisting of the

following phases:

a. A twelve month planning/

recruitment phase where the recipient

explores existing materials relevant to

the program, identifies and selects other

secondary conditions to be addressed,

identifies educational materials to be

used for the prevention of pressure sores

and the other identified secondary

conditions, hires and trains home

visitation staff, and identifies and

recruits study participants.

b. An implementation phase where

the home visitation project is

implemented (data collection,

education) in the target population.

c. A monitoring phase where the

intervention project continues with the

monitoring of the intervention, the

occurrence of pressure sores, the

occurrence of other secondary

conditions, and associated risk factors.

d. A follow-up phase for continued

monitoring and evaluation.

3. Develop and implement the

methods (both scientific and

operational) for collecting data to assess

the impact of the intervention.

4. Determine how data will be

maintained including format and

databases, and confidentiality

protections.

5. Obtain the necessary clearances

and agreements to proceed with all

aspects of the proposed project,

including appropriate human subjects

clearances and agreements with other

organizations and individuals needed to

complete the project. This specifically

includes working with CDC to obtain

human subjects clearances and approval

for data collection activities.

6. Identify or develop, and pilot test

data collection instruments.

7. Establish baseline rates for pressure

sores or other secondary conditions

within the target group. Identify

potential data sources to provide

baseline information or data for

comparison.

8. Monitor progress toward

achievement of project goals through the

use of realistic, measurable, timeoriented objectives for all phases of the

project.

9. Develop collaborative relationships

with voluntary, community-based

public and private organizations

addressing issues important to persons

with spinal cord injury. These could

include centers for independent living,

and local chapters of the Paralyzed

Veterans of America and the National

Spinal Cord Injury Association.

Cooperative Agreement Activities (Part

2 Only)

In conducting activities to achieve the

purposes of Part 2 of this

Announcement, the recipient shall be

responsible for activities listed under A.

(Recipient Activities), and CDC shall be

responsible for activities listed under B.

(CDC Activities):

A. Recipient Activities:
12212 Federal Register / Vol. 62, No. 50 / Friday, March 14, 1997 / Notices

1. Collect, compile, and analyze

information relevant to the prevention

of pressure sores and other selected

secondary conditions among persons

with spinal cord injury.

2. Develop a home-visit prevention

model program consistent with the

public health nurse approach and

framework.

3. Implement the home visitation

project (data collection, education) in

the target population.

4. Monitor the intervention, the

occurrence of pressure sores, the

occurrence of other secondary

conditions, and associated risk factors.

5. Provide for ongoing project

evaluation.

6. Provide for final dissemination of

the products of the research including

conclusions and recommendations

suitable for broad replication in other

prevention settings.

B. CDC Activities:

1. Provide technical consultation on:

existing materials relevant to the

program (educational materials to be

used for the prevention of pressure sores

and the other identified secondary

conditions), the selection of other

secondary conditions to be targeted, and

the identification and recruitment of

study participants.

2. Participate in program planning

and development.

3. Participate in the development of

the evaluation aspects of the project.

4. Provide consultation in the

development of data collection

instruments, methods, and procedures.

Application Contents—Part 1

1. Describe the applicant

organization’s current activities that

relate to the prevention of secondary

conditions. Define the populations

included and the scope of any current

research, specific health promotion or

training interventions, and the outcomes

and use made of such interventions and

services.

2. Provide the rationale and basis for

both the selection of a disability

domain(s) and the selected area for

emphasis for the proposed research

agenda.

3. Discuss how the applicant

organization is in an advantageous

position to conduct the proposed

project, and describe the special

competencies residing in the applicant

organization for conducting the project.

4. Describe the applicant’s experience

and prior performance in similar

programs that would be beneficial in

carrying out the proposed project and

outline the function and identity of all

collaborating organizations in the

proposed project.

5. Describe the existing or proposed

linkages and formal collaborations to

meet all operational and epidemiologic

requirements for achieving the goals and

objectives of the research agenda,

including timely access to needed data

and study populations and clients

related to the selected area for emphasis.

6. Present letters and agreements that

demonstrate commitment and support

and provide tangible evidence of

appropriate collaboration.

7. Describe the data to be collected,

accessed, or developed to conduct the

proposed project, and the methods for

collecting data from specified sources.

Discuss the strengths and weaknesses of

each data source relative to the

proposed project. Explain how the

standardization and uniformity of data

will be addressed to make the

information useful to other

organizations.

8. Present the design of the study

proposal or intervention that includes:

(a) Providing case definitions; (b)

outlining methods of enrolling and

managing cases, clients, or cohorts; (c)

describing plans to ascertain cases and

estimate sample size or study power; (d)

describing study methods and an

analytical plan; (e) describing how the

confidentiality of cases identified

through the project will be protected;

and (f) how the research will be

evaluated.

9. Present the plan for dissemination

of findings and recommendations.

Indicate the prospects for replicating the

research in the development of

interventions that will benefit other

populations, including applications for

national use.

10. Describe the placement of the

project within the applicant

organization and outline how it will

function to meet the objectives of the

grant. Provide an organizational chart

illustrating the placement of the project

and how it will interact with partner

entities.

11. Present the management plan,

incorporating methods and time frames

for conducting the project including

staff selection and appointment, intra/

inter-agency agreements, data access

negotiations, management oversight,

and development of training or health

promotion material. Provide curriculum

vitae for identified key personnel.

12. Present overall goals and

objectives for the entire three year

project period, including detailed and

specific goals and quarterly objectives

with timelines, in a work plan that

covers the first two budget years.

13. Present the methods, approach,

and designation of responsibilities for

evaluation of the management elements

of the project over the duration of the

grant.

14. Present what will occur to assure

that all project activities and facilities

will permit full access to minorities,

both sexes, and persons with

disabilities, and to provide

opportunities for persons with

disabilities to participate in research

operations.

15. Prepare specific budget and cost

projections with full narrative

justification, for all listed budget class

categories, identifying both Federal and

non-Federal sources. Indicate the

amount and categories of applicant costsharing in the total budget. Provide

projections and commitments (citing

sources of funding) for cost-sharing in

both the second and third years of the

project period.

16. Human Subjects: This section

must describe the degree to which

human subjects may be at risk and the

assurance that the project will be subject

to initial and continuing review by the

appropriate institutional review

committees.

Evaluation Criteria—Part 1 (Total 100

Points)

Under Part 1, applications for

Secondary Conditions Research will be

reviewed and evaluated for technical

merit based on the following factors:

1. Evidence of Understanding: (15

Points)

Evaluation will be based on:

a. The applicant’s description of the

public health significance of secondary

conditions and adherence to the

purposes of this Announcement, with

an emphasis on the applicant’s capacity

to reach the populations proposed.

b. The organizational rationale for

determining the disability domain(s) for

project operations, and for addressing

one of the areas for emphasis outlined

in the Program Requirements section for

Part 1.

2. Research Resources and

Organizational Capacity: (20 Points)

Evaluation will be based on:

a. The capability of the applicant to

conduct the project, taking into account

its institutional experience and current

activities in the field proposed for this

research.

b. The ability of the applicant to

ensure timely access to necessary

population-based data related to the

selected area for emphasis.

c. The capacity of the applicant to

identify and work with selected targeted

activities and expeditiously gather

required information about the clients

or populations under investigation.
Federal Register / Vol. 62, No. 50 / Friday, March 14, 1997 / Notices 12213

d. The applicant’s capacity to provide

evidence of effective collaborations and

research linkages enabling the applicant

to meet all protocol development and

operational research requirements for

the project.

3. Research Approach: (35 Points)

Evaluation will be based on:

a. The extent to which the proposed

methods, sources of data, process for

identifying individuals and cohorts with

disabilities, and/or conducting health

promotion programs will be employed

and function to address the selected

area for emphasis in this

Announcement.

b. The overall strength of the research

design including: (1) The rationale and

appropriateness of the study protocol

and methods; (2) the quality and scope

of the data collection and data analysis

plan; (3) the power of the scientific

dimensions in the design, including

sample size, measurements, etc; (4) the

scope of the plan to assure

confidentiality as applicable to the

protocol; and (5) the process by which

the research will be evaluated,

including expected outcomes. For

applicants selecting the second area for

emphasis pertaining to costeffectiveness, evaluation of the

proposed methods will also be based on

adherence to generally accepted

techniques for conducting and reporting

on cost-utility or cost-effectiveness

analyses.

c. The overall information

dissemination plan for presenting and

publishing the findings and

recommendations of the research, and

the potential for generalizability and

replicability of the study.

4. Management Plan and Project Goals

and Objectives: (30 Points)

Evaluation will be based on:

a. The description of the management

plan and approach, including the

project’s location within the applicant

organization, and the described process

by which the applicant will meet the

goals and objectives of the proposed

research agenda.

b. The presentation of the specified

tasks and responsibilities for all

positions proposed for financial

assistance, and for other personnel

contributing to the requirements of the

project.

c. The applicability of the proposed

goals and specific objectives related to

the conduct of the project, including

proposed timelines.

d. The process for overall evaluation

of the management of the project,

including the assignment of

responsibility for ongoing review of

specified components.

e. The extent to which the application

furnishes evidence that project activities

will be fully accessible to minorities,

both sexes, and persons with

disabilities, and will include

opportunities for persons with

disabilities to participate in project

activities.

5. Project Budget: (Not Scored)

This criteria includes the adequacy of

the project application budget in

relation to program operations,

collaborations, and services; the extent

of cost-sharing; and the extent to which

the budget is reasonable, clearly

justified, accurate, and consistent with

the purpose of this Announcement.

6. Human Subjects: (Not Scored)

The extent to which the applicant

complies with the Department of Health

and Human Services Regulations (45

CFR Part 46) regarding the protection of

human subjects.

Application Contents—Part 2

1. Describe the impact of pressure

sores and other proposed secondary

conditions.

2. Describe the applicant

organization’s current activities related

to the prevention of pressure sores and

other secondary conditions among

persons with spinal cord injuries.

Define the populations included.

3. Describe the target population, the

rationale for selection of that

population, and whether and why the

population is considered undeserved.

4. Discuss how the applicant

organization is in an advantageous

position to conduct the proposed

project, and describe the special

competencies residing in the applicant

organization for conducting the project.

5. Describe the applicant’s prior

experience and performance in similar

programs that would be beneficial in

carrying out the proposed project and

outline the function and identity of all

collaborating organizations in the

proposed project.

6. Describe the existing and proposed

linkages and formal collaborations to

meet all operational and epidemiologic

requirements for achieving the goals and

objectives of the project. Letters and

agreements that demonstrate

commitment and support and provide

tangible evidence of collaboration for

specific aspects of the proposed

research must be included.

7. Present the design of the study

proposal or intervention that includes:

(a) Providing case definitions; (b)

outlining methods of enrolling and

managing cases, clients, or cohorts; (c)

describing plans to ascertain cases; (d)

describing study methods and an

analytical plan; (e) describing how the

confidentiality of cases identified

through the project will be protected;

and (f) how the research will be

evaluated.

8. Describe the data to be collected,

accessed, or developed to conduct the

proposed project, and the methods for

collecting data from specified sources.

Discuss the strengths and weaknesses of

each data source to the proposed

project.

9. Present the plan for dissemination

of findings and recommendations.

Indicate the prospects for replicating the

research in the development of

interventions that will benefit other

populations, including applications for

national use.

10. Describe the placement of the

project within the applicant

organization and outline how it will

function to meet the objectives of the

cooperative agreement. Provide an

organizational chart illustrating the

placement of the project and how it will

interact with partner entities.

11. Describe the management plan,

incorporating methods and time frames

for conducting the project in operational

areas including staff selection and

appointment, protocol development,

intra/inter-agency agreements, data

access negotiations, study population

monitoring and tracking systems, data

analysis, and development of training or

health promotion material. Provide

curriculum vitae for identified key

personnel.

12. Present overall goals and

objectives for the entire three year

project period, including detailed and

specific goals and quarterly objectives

with timelines, in a work plan that

covers the first two budget years.

13. Present the plan, methods,

approach, and designation of

responsibilities for evaluation of the

management elements of the project

over the duration of the project.

14. Present what will occur to assure

that all project activities and facilities

will permit full access to persons with

disabilities, and to provide

opportunities for persons with

disabilities to participate in research

operations.

15. Prepare specific budget and cost

projections with full narrative

justification, for all listed budget class

categories, identifying both Federal and

non-Federal sources. Indicate the

amount and categories of applicant costsharing in the total budget. Provide

projections and commitments (citing

sources of funding) for cost-sharing in
12214 Federal Register / Vol. 62, No. 50 / Friday, March 14, 1997 / Notices

both the second and third years of the

project period.

16. Human Subjects: This section

must describe the degree to which

human subjects may be at risk and the

assurance that the project will be subject

to initial and continuing review by the

appropriate institutional review

committees.

Evaluation Criteria—Part 2 (Total 100

Points)

Under Part 2, applications for the

Prevention of Pressure Sores and other

Secondary Conditions among Persons

with Spinal Cord Injury will be

reviewed and evaluated for technical

merit based on the following factors:

1. Evidence of Understanding: (15

Points)

Evaluation will be based on:

a. The applicant’s description of the

public health significance of pressure

sores and other secondary conditions (as

chosen by the applicant).

b. The rationale for determining the

target population of persons with spinal

cord injury.

2. Research Resources and

Organizational Capacity: (20 Points)

Evaluation will be based on evidence

of:

a. The capability of the applicant to

conduct the project, taking into account

prior history of conducting research and

disseminating results in peer-reviewed

publications and in presentations.

b. The ability of the applicant to

ensure timely access to the population,

including prior history of working with

the target population.

c. The capacity of the applicant to

identify and work with its selected

targeted activities and expeditiously

gather required information from the

program participants and other

populations related to the program

activities.

d. The applicant’s capacity to provide

evidence of effective collaborations and

research linkages (i.e., letters of

commitment) enabling the applicant to

meet all protocol development and

operational research requirements for

the project.

3. Research Approach: (35 Points)

Evaluation will be based on:

a. The extent to which the proposed

methods, sources of data, process for

identifying individuals and cohorts with

spinal cord injuries will be employed to

address the Program Requirements

section for Part 2.

b. The overall strength of the research

design including: (1) The rationale and

appropriateness of the study protocol;

(2) the quality of the data collection

plan; (3) the scope of the plan to assure

confidentiality as applicable to the

protocol; and (4) the process by which

the research will be appropriately

evaluated, including expected

outcomes.

c. The overall information

dissemination plan for presenting and

publishing the findings and

recommendations of the research, and

the potential for generalizability and

replicability of the study.

4. Management Plan and Project Goals

and Objectives: (30 Points)

Evaluation will be based on:

a. The description of the management

plan and approach.

b. The presentation of the specified

tasks and responsibilities for all

positions proposed for financial

assistance, and for other personnel

contributing to the requirements of the

project.

c. The applicability of the proposed

goals and specific objectives related to

the conduct of the project, including

proposed timelines.

d. The proposed process for overall

evaluation of the management of the

project, including the assignment of

responsibility for ongoing review of

specified components.

e. The extent to which the application

furnishes evidence that project activities

will be fully accessible to persons with

disabilities, and will include

opportunities for persons with

disabilities to participate in project

activities.

5. Project Budget: (Not Scored)

This criteria includes the adequacy of

the project budget in relation to program

operations, collaborations, and services;

the extent of cost-sharing; and the extent

to which the budget is reasonable,

clearly justified, accurate, and

consistent with the purpose of this

Announcement.

6. Human Subjects: (Not Scored)

The extent to which the applicant

complies with the Department of Health

and Human Services Regulations (45

CFR Part 46) regarding the protection of

human subjects.

Reporting Requirements

Narrative progress reports will be

required twice annually; and will be

due 30 days after the close of each sixmonth period based on the starting date

of the project. An original and four

copies of the narrative progress report

should be submitted to the CDC Grants

Management Branch at dates to be

specified in the Notice of Grant Award.

An original and two copies of the

Financial Status Report is required no

later than 90 days after the end of each

budget period.

Funding Priorities

Under Part 1, four areas are listed for

emphasis within the Program

Requirements section. To the extent that

there are a sufficient number of highranking applications, CDC plans to

make awards in all four areas of

emphasis. Part 1 applications will be

reviewed by an internal CDC review

panel.

Under Part 2, CDC plans to fund one

project to address pressure sore

prevention among persons with spinal

cord injury. Part 2 applications will be

reviewed by a Special Emphasis Panel

(SEP) with knowledge and expertise in

pressure sores and/or epidemiology and

public health. The SEP may consist of

a physiatrist, a physical therapist, an

epidemiologist, a program management

official, and a person with a disability

or family member of a person with a

disability.

Special Instructions

Applicants must submit a separate,

typed abstract or summary of their

proposal consisting of no more than two

double-spaced pages as a cover to their

application. Applicants should include

a table of contents for both the project

narrative and attachments. Applicants

must denote the component of this

Announcement (Part 1 or Part 2) for

which they are submitting a proposal.

The budget narrative and full budget

justification must be placed

immediately after the table of contents

and abstract for the main application.

Applicants should follow the

application contents section for the

selected component of this

Announcement, as those elements are

arranged to be compatible with the

respective evaluation criteria.

The main body of the application

narrative should not exceed 50 doublespaced pages. Pages must be numbered

and printed on only one side of the

page. All material must be typewritten;

with 10 characters per inch type (12

point) on 8–1⁄2′′ by 11′′ white paper with

at least 1 margins, headers and footers

(except for applicant-produced forms

such as organizational charts, graphs

and tables, etc.). Applications must be

held together only by rubber bands or

metal clips, and not bound together in

any other way.

Attachments to the application should

be held to a minimum in keeping to

those items required by this

Announcement. Other columns on the

Standard Form 424A budget sheet
Federal Register / Vol. 62, No. 50 / Friday, March 14, 1997 / Notices 12215

should be used to define and certify

other cost-sharing, with the specific

sources identified and documented in

the budget narrative.

CDC expects to sponsor annual

project workshops for all grantees. By

virtue of accepting an award, projects

have agreed to use grant or cooperative

agreement funds to travel to and

participate in these workshops.

Applicants should budget travel funds

to attend a workshop in Atlanta during

the first year.

Executive Order 12372

Applications are not subject to the

Intergovernmental Review of Federal

Programs as governed by Executive

Order 12372.

Public Health System Reporting

Requirements

This program is not subject to the

Public Health System Reporting

Requirements.

Catalog of Federal Domestic Assistance

(CFDA)

The Catalog of Federal Domestic

Assistance number is 93.184.

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. Applicants will be

responsible for providing assurance in

accordance with the appropriate

guidelines and forms provided in the

application kit.

In addition to other applicable

committees, Indian Health Service (IHS)

institutional review committees also

must review the project if any

component of IHS will be involved or

will support the research. If any

American Indian community is

involved, its tribal government must

also approve that portion of the project

applicable to it.

Paperwork Reduction Act

Projects that involve the collection of

information from 10 or more

individuals, and funded by grants/

cooperative agreements will be subject

to review by the Office of Management

and Budget (OMB) under the Paperwork

Reduction Act.

Animal Subjects

If the proposed project involves

research on animal subjects, the

applicant must comply with the ‘‘PHS

Policy on Humane Care and Use of

Laboratory Animals by Awardee

Institutions.’’ An applicant organization

proposing to use vertebrate animals in

PHS-supported activities must file an

Animal Welfare Assurance with the

Office of Protection from Research Risks

at the National Institutes of Health.

Women and Minority Inclusion Policy

It is the policy of CDC to ensure that

women and racial and ethnic groups

will be included in CDC-supported

research projects involving human

subjects, whenever feasible and

appropriate. Racial and ethnic groups

are those defined in OMB Directive

Number 15 and include American

Indian, Alaska Native, Asian, Pacific

Islander, Black, and Hispanic.

Applicants shall ensure that women,

racial, and ethnic minority populations

are appropriately represented in

applications for research involving

human subjects. Where clear and

compelling rationale exist that inclusion

is inappropriate or not feasible, this

situation must be explained as part of

the application. In conducting the

review of applications for scientific

merit, review groups will evaluate

proposed plans for inclusion of

minorities and both sexes as part of the

scientific assessment and assigned

score. This policy does not apply to

research studies when the investigator

cannot control the race, ethnicity, and/

or sex of subjects. Further guidance to

this policy is contained in the Federal

Register, Vol.60, No. 179, Friday,

September 15, 1995, pages 47947–

47951.

Application Submission and Deadline

A. Pre-Application 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

Officer whose name is noted in section

B below. The letter should be

postmarked no later than 30 days prior

to the submission deadline. The letter of

intent should identify the

Announcement Number; name the

proposed project director; and in a

paragraph, describe the scope of the

proposed project. The letter will not

influence review or funding decisions,

but it will enable CDC to plan the

review more efficiently and ensure that

each applicant receives timely and

relevant information prior to application

submission.

B. Application Submission

Applicants should submit an original

and four copies of the application (PHS

Form 398—OMB Number 0925–0001

revised 5/95), and adhere to the

ERRATA Instruction Sheet contained in

the Grant Application Kit. Applications

must be submitted to Mr. Ron Van

Duyne, 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 E–13, Atlanta,

Georgia 30305, on or before Thursday,

May 15, 1997.

1. Deadline: Applications will be

considered as meeting the deadline if

they are either:

a. Received on or before the deadline

date; or

b. Sent on or before the deadline date

and received in time for submission to

the objective review group. (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 will not be

acceptable as proof of timely mailing.)

2. Late Applications: Applications

that do not meet the criteria in 1.a. or

1.b. above are considered late. 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 your name, address, and

telephone number and will need to refer

to Announcement Number 731. You

will receive a complete program

description, information on application

procedures, and application forms. In

addition, this Announcement and the

bibliography attachment for Part 1 is

also available through the CDC Home

Page on the Internet. The address for the

CDC Home Page is http://www.cdc.gov.

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), East

Paces Ferry Road, NE., Room 321,

Mailstop E–13, Atlanta, Georgia 30305,

telephone number (404) 842–6814.

(Internet address: glj2@cdc.gov).

For Part 1 applications, program

assistance may be obtained from Joseph
12216 Federal Register / Vol. 62, No. 50 / Friday, March 14, 1997 / Notices

B. Smith, Office on Disability and

Health, National Center for

Environmental Health, CDC, 4770

Buford Highway, Building 101, Mailstop

F–29, Atlanta, Georgia 30341, telephone

(770) 488–7082. (Internet address:

jos4@cdc.gov). Epidemiologic and

research-related technical assistance is

available from Donald J. Lollar, Ed.D. at

the same address, telephone (770) 488–

7094. (Internet address: dcl5@cdc.gov).

For Part 2 applications, program

assistance may be obtained from

Douglas R. Browne, National Center for

Injury Prevention and Control, CDC,

4770 Buford Highway, Building 101,

Mailstop F–41, Atlanta, Georgia 30341,

telephone (770) 488–4031. Internet

address: drb7@cdc.gov. Epidemiologic

and research-related technical

assistance is available from Joe Sniezek,

M.D., M.P.H. at the same address and

telephone number. Internet address:

jes6@cdc.gov. A packet of background

information for Part 2 is available by

contacting the above listed CDC staff.

Potential applicants may obtain a

copy of ‘‘Healthy People 2000’’ (Full

Report; Stock number 017–001–00474–

0) or ‘‘Healthy People 2000’’ (Summary

Report; Stock number 017–001–00473–

1) through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

telephone (202) 512–1800.

Dated: March 7, 1997.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–6489 Filed 3–13–97; 8:45 am]

BILLING CODE 4163–18–P

Food and Drug Administration

[Docket No. 97N–0036]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information

regarding the Cosmetic Product

Voluntary Reporting Program has been

approved by the Office of Management

and Budget (OMB) under the Paperwork

Reduction Act of 1995. This document

announces the OMB approval number.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Wolff, Office of Information

Resources Management (HFA–80), Food

and Drug Administration, 5600 Fishers

Lane, rm. 16B–19, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: In the

Federal Register of December 23, 1996

(61 FR 67556), the agency announced

that the proposed information collection

had been submitted to OMB for review

and clearance. In accordance with the

Paperwork Reduction Act of 1995 (44

U.S.C. 3501–3520), OMB has approved

the information collection and assigned

OMB control number 0910–0030. The

approval expires on January 31, 2000.

Under 5 CFR 1320.5(b), an agency may

not conduct or sponsor, and a person is

not required to respond to, a collection

of information unless the collection

displays a valid control number.

Dated: March 7, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–6524 Filed 3–13–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96N–0497]

I. D. Russell Co. Laboratories;

Withdrawal of Approval of NADA

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

approval of a new animal drug

application (NADA) held by I. D.

Russell Co. Laboratories. The NADA

provides for use of 10 percent

sulfaquinoxaline powder for making

animal feed and 20 percent

sulfaquinoxaline liquid. The sponsor

requested the withdrawal of approval

because the products are no longer

being marketed.

EFFECTIVE DATE: March 24, 1997.

FOR FURTHER INFORMATION CONTACT:

Dianne T. McRae, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1623.

SUPPLEMENTARY INFORMATION: I. D.

Russell Co. Laboratories, 1301 Iowa

Ave., Longmont, CO 80501, is the

sponsor of NADA 6–776, which

provides for use of 10 percent

sulfaquinoxaline powder for feed and 20

percent sulfaquinoxaline liquid. I. D.

Russell Co. Laboratories requested that

FDA withdraw approval of NADA 6–

776 because the products are no longer

being marketed.

Therefore, under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Center for Veterinary Medicine (21 CFR

5.84), and in accordance with § 514.115

Withdrawal of approval of applications

(21 CFR 514.115), notice is given that

approval of NADA 6–776 and all

supplements and amendments thereto is

hereby withdrawn, effective March 24,

1997.

Dated: February 3, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–6474 Filed 3–13–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket Nos. 95P–0061, 95S–0117, 95S–

0126, and 95S–0135]

Expiration Dates for Patents Extended

by the Uruguay Round Agreements

Act; Submission by Applicants of New

Drug and New Animal Drug

Applications; Withdrawal of Notice

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing a

notice published in the Federal Register

of July 21, 1995 (60 FR 37652), which

announced the agency’s position on

patent information submitted by

applicants of new drug applications

(NDA’s) and new animal drug

applications (NADA’s). On April 4,

1996, the U.S. Court of Appeals for the

Federal Circuit issued a decision

establishing the correct method for

calculating patent term expiration dates

for certain patents that are subject to

both the Uruguay Round Agreements

Act (URAA) and the patent term

extension provisions of the U.S. Code.

All NDA and NADA applicants should

calculate patent term expiration dates in

conformance with the court’s decision

and submit corrected patent term

expiration dates to the agency.

DATES: NDA and NADA applicants that

have already submitted patent term

expiration dates should submit patent

term expiration dates calculated in

accordance with this notice by April 14,

1997.

ADDRESSES: Two copies of amended

patent information pertaining to human

drug products regulated under section

505 of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C. 355) by

the Center for Drug Evaluation and

Research (CDER) should be submitted to

the assigned reviewing division. The

submission should bear the pertinent

NDA number.

Two copies of amended patent

information pertaining to human drug

products regulated under section 505 of

the act by the Center for Biologics