Federal Register / Vol. 60, No. 77 / Friday, April 21, 1995 / Notices 19943

Other Requirements

Paperwork Reduction Act

Projects that involve the collection of

information from ten or more

individuals and funded by the

cooperative agreement will be subject to

review by the Office of Management and

Budget (OMB) under the Paperwork

Reduction Act.

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 Deadline

The original and two copies of the

application PHS Form 5161–1 (OMB

Number 0937–0189) 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 E–13, Atlanta, GA 30305, on or

before June 20, 1995.

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 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 U.S. Postal Service. Private metered

postmarks will not be acceptable as

proof of timely mailing.)

2. Late Applications: Applications

which do not meet the criteria in 1.A.

or 1.B., 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 531.

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

Adrienne S. Brown, Grants Management

Specialist, 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, GA

30305, telephone (404) 842–6630.

Programmatic technical assistance may

be obtained from Larry D. Edmonds or

David Montanez, State Services, Birth

Defects and Genetic Diseases Branch,

Division of Birth Defects and

Developmental Disabilities, National

Center for Environmental Health,

Centers for Disease Control and

Prevention (CDC), 4770 Buford Highway

NE., Mailstop F–45, Atlanta, GA 30341–

3724, telephone (404) 488–7170.

Please refer to Announcement 531

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: April 14, 1995.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 95–9880 Filed 4–20–95; 8:45 am]

BILLING CODE 4163–18–P

[Announcement 523]

Innovations in Syphilis Prevention in

the United States: Reconsidering the

Epidemiology and Involving

Communities

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1995

funds for cooperative agreements to

conduct research toward substantially

reducing syphilis in the United States,

especially in the southeastern United

States, the region with the highest

syphilis rates. Syphilis is linked to

substantial mortality and morbidity

through congenital syphilis, and

through its ecologic relationship with

and cofactor role in HIV transmission.

Therefore, effective, innovative,

community-based approaches to

syphilis prevention may have an

important multiplier effect on HIV

prevention and adult and infant health

in the communities where syphilis is

most prevalent.

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 Sexually

Transmitted Diseases. (To order a copy

of ‘‘Healthy People 2000,’’ see the

section ‘‘Where to Obtain Additional

Information.’’)

Authority

These cooperative agreements are

authorized under Section 318(b) of the

Public Health Service Act (42 U.S.C.

247c(b)) as amended. Applicable

program regulations are found in part 51

(b), subparts A and F of title 42, Code

of Federal Regulations.

Smoke-Free Workplace

The PHS strongly encourages all grant

recipients to provide a smoke-free

workplace and to promote the non-use

of all tobacco products, and 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

Applications may be submitted by

public and private, nonprofit and forprofit organizations and governments

and their agencies. Universities,

colleges, research institutions, hospitals,

other public and private organizations,

State and local governments or their

bona fide agents, federally recognized

Indian tribal governments, Indian tribes

or Indian tribal organizations, and

small, minority- or women-owned

businesses are eligible to apply.

Applicants must, however, document

collaboration with each of the following

entities:

1. At least one non-profit, public or

private research institution (e.g.,

university, college, hospital, laboratory);

2. A public health agency in State or

local government; and

3. At least one community-based

organization (CBO) or other institution

or agency with a track record for

working with communities affected by

syphilis in the project area. The CBO

does not need to have a record of

working on the problem of sexually

transmitted diseases, only to have
19944 Federal Register / Vol. 60, No. 77 / Friday, April 21, 1995 / Notices

worked with the communities that are

affected.

To be eligible, the project area as

defined under ‘‘Program Requirements’’

must have an incidence of primary and

secondary (P&S) syphilis in calendar

year (CY) 1993 above the PHS year 2000

objective of 10/100,000 and a total of

more than 150 cases of P&S syphilis in

CY 1993.

Availability of Funds

Approximately $1 million is available

in FY 1995 for a 12-month budget

period; the project period for Phase I

(Preparation) is expected to be for two

years. Four to five awards will be

funded for Phase I. The awards are

expected to range from $200,000 to

$250,000, beginning in September 1995.

Shortly before the completion of Phase

I, recipients will compete for

continuation of award in years 3

through 5 (Phase II—Implementation).

Two to three awards are anticipated for

expansion into Phase II research

activities for the remaining three years

of the project period. (Further details on

Phases I and II is presented below under

the heading ‘‘Purpose and Outline of

Program Plan.’’) Funding estimates may

vary and are subject to change.

Continuation awards within an

approved project period will be based

on satisfactory progress and the

availability of funds.

Program Goals

By the end of Phase I (24 months), it

is expected that:

1. Strong partnerships among research

institutions, health departments, and at

least one community-based organization

will have been established or

strengthened.

2. The epidemiology of the

transmission of syphilis will have been

analyzed to identify characteristics and

target interventions to the most

important mechanisms that sustain

syphilis spread and persistence in the

community (Component 1).

3. A programmatic intervention will

have been pilot tested and assessed for

its potential for measurably lowering

syphilis transmission in a defined area

while being acceptable to members of

the affected communities and to

participating organizations or agencies

(Component 2).

4. A sensitive surveillance system for

following trends in syphilis

transmission in a population will have

been implemented and at least one full

year of baseline data collected.

5. A management information system

will have been implemented to track

activities and costs in syphilis

prevention activities (Component 3).

At approximately month 18 of the

project, applications for a competitive

continuation award for the

implementation and evaluation of a

population-level intervention (Phase II)

will be due. Fewer, larger, Phase II

awards are foreseen for interventions

that show the greatest potential impact

and that are based on well-conducted

research from Phase I. Supplementary

guidance for Phase II awards will be

provided to the recipients of Phase I

awards.

Purpose and Outline of Program Plan

The purpose of this announcement is

to generate new knowledge, tools, and

strategies toward sharply reducing

syphilis incidence, particularly in the

southeastern States where incidence is

disproportionately high. Congenital

syphilis is closely linked to newly

acquired syphilis infections in women,

so an intensified focus on syphilis

transmissions is expected to contribute

directly to a principal, short-term PHS

goal of eliminating congenital syphilis.

Phase I and Phase II of the research

program. This research program is

separated into two phases of activity

and funding (Table 1). The fundamental

goal is best understood in the context of

Phase II (years 3 to 5 of the anticipated

5-year project), in which the grantees

will implement and evaluate an

innovative, science-based, cost-effective

approach to reducing the transmission

of syphilis in a project area.

TABLE 1

Phase Project

years

Grantees

(No.) Focus of activities

I ........ 1 and 2 .... 4–5 Preparation for innovative approaches to syphilis control and prevention.

II ....... 3 to 5 ....... 2–3 Implementation of interventions and evaluation of impact on population.

However, CDC is not seeking final

proposals for such Phase II intervention

trials at this time because science-based,

innovative approaches to syphilis

prevention will require multifaceted

preparation and planning. In particular,

communities affected by syphilis should

be represented more substantively than

in the past in developing new

approaches to syphilis prevention. This

announcement, therefore, focuses on

Phase I subject areas and solicits

research proposals that will yield

scientific findings and stimulate the

building of multi-disciplinary research

teams needed to guide and implement

the Phase II intervention trial.

Areas of preparatory research in

Phase I. During Phase I of this program,

three key research components will be

addressed:

1. Innovative uses of epidemiologic

and behavioral science methods and

findings about syphilis transmission in

communities to direct prevention

strategies.

2. Development of a programmatic

intervention and pilot test of that

proposed intervention before large-scale

implementation; development of

partnerships with communities affected

by syphilis.

3. Development of a sensitive syphilis

surveillance activity to be used in

evaluating the efficacy and costeffectiveness of efforts to prevent

syphilis.

Further explanation of these Phase I

activities can be found in the section

‘‘Program Requirements.’’

Program Requirements

This cooperative agreement is

foreseen as an important element in a

national reassessment of our approaches

to syphilis control and prevention. To

achieve the purpose of this program, the

recipient will be responsible for

activities under A. and CDC for

activities under B., below:

A. Recipient Activities

1. Develop an overall framework to

design an effective, innovative approach

to syphilis prevention and to evaluate

its impact on a population.

2. Define a project area. The

geographic area defined as the project

area for this program announcement

must have reported at least 150 cases of

P&S syphilis in 1993. An entire State

could be defined as the project area for

this cooperative agreement, or several

counties could be combined to establish

the minimum number of syphilis cases.

Applications are especially encouraged

from rural areas that meet this minimum

morbidity requirement (150 cases of

P&S syphilis).
Federal Register / Vol. 60, No. 77 / Friday, April 21, 1995 / Notices 19945

3. Undertake the following three

research components during Phase I of

this cooperative agreement:

A. Analyze the epidemiology of

syphilis transmission within the project

area with the goal of identifying more

efficacious and cost-effective ways to

prevent syphilis.

B. Develop an intervention and

conduct a pre-implementation of that

evaluation. In collaboration with

representatives from affected

communities, consider hypotheses

about barriers to or opportunities for

more efficacious and cost-effective

innovations in syphilis prevention.

C. Establish surveillance and

information systems adequate for

monitoring and evaluating innovative

syphilis prevention activities.

Note: Traditional disease surveillance for

syphilis demonstrates substantial year-toyear variability as well as incompletely

understood cyclic oscillations over periods of

5 to 10 years.

During Phase I, you will be expected

to implement: (1) A sensitive,

population-level surveillance system for

syphilis incidence; and (2) a

management information system (MIS)

for estimating the cost of syphilis

prevention, including the costs of

collecting and analyzing program data.

Although components 1 and 2 are

distinct foci of activity that involve

different types of expertise, they are

related in that interventions that do not

focus prevention resources on settings,

social contexts, or individuals who help

maintain syphilis transmission in the

community are unlikely to be effective.

Likewise, components 1 and 3 are

related in that a sensitive surveillance

system that truly reflects incident

syphilis cases should have some direct

relationship to syphilis transmission

events characterized by the

‘‘epidemiologic model’’ of syphilis for

that community.

4. Include affected communities as

partners in the research. Syphilis

generally is concentrated in

communities with limited resources. In

many communities, syphilis is also a

stigmatizing condition and one for

which the most important consequences

(congenital syphilis and facilitation of

HIV transmission) often occur

unrecognized. Furthermore, some past

control efforts and research activities

may have damaged community rapport

with the health departments and with

CDC rather than building trust in a

common purpose. Partnerships with

communities affected by syphilis,

including many African American

communities where racism may have a

continuing effect, is essential to

building trust and to finding solutions.

5. Linkage to other public health

programs. Research on syphilis

prevention in the 1990s should occur in

the context of other major public health

program areas. These include:

A. Prenatal care (required). The first

priority in syphilis prevention is the

elimination of congenital syphilis,

which can be accomplished through

prenatal care for women at risk for

syphilis and the appropriate screening

for and management of syphilis during

pregnancy. However, it is possible that

many pregnant women with syphilis

have a low risk for transmitting syphilis

to other adults, and therefore, are not

central to the persistence of syphilis

among adults in the community.

B. HIV Prevention (required).

Communities, sub-populations, and

individuals with syphilis are probably

at high risk for HIV infection because of

common modes of transmission, the

usually higher prevalence of syphilis

and HIV in the same communities,

infection, and the role of genital ulcer

diseases as cofactors for sexual

transmission of HIV. Syphilis

prevention should be coordinated with

and should reinforce community

intervention strategies and other efforts

to change sexual behavior as are

associated with HIV prevention.

Because syphilis is a curable

communicable disease, screening,

health care seeking, and treatment will

likely play prominent roles in syphilis

prevention. Nonetheless, some effort to

change behavior must be a component

of a responsible syphilis prevention

activity, both to prevent HIV infection

and other STDs in the community from

which one is trying to eliminate

syphilis, and to lower the risk of spread

if syphilis is reintroduced.

C. Substance abuse (optional). A

number of studies have shown that

crack cocaine was closely linked to local

epidemics of syphilis in the late 1980s.

People who inject drugs are at high risk

for STDs. Effective, innovative,

epidemiologically focused syphilis

prevention activities may be augmented

if they are closely linked to substance

abuse treatment. Explain how the

proposed syphilis prevention activities

interact with, and possibly reinforce,

efforts to prevent drug abuse.

D. Correctional systems (optional).

Because of the association of syphilis

with substance abuse and prostitution,

collaboration with the criminal justice

system (e.g., correctional health

programs, probation officers, court

referral, juvenile justice) could result in

highly effective approaches to syphilis

and HIV prevention. Explain any

interaction between the proposed

syphilis prevention activities and

criminal justice programs.

6. Manage, analyze, and interpret

data. Data from the three core activities

in part 3 should be secure and

confidential. In collaboration with CDC,

analyze, interpret, and publish data

promptly in scientific, programmatic,

and policy-making forums. Data should

regularly be communicated to

community partners in language that

they can understand.

7. Build a multidisciplinary research

team and program implementation

capability. Assemble a multidisciplinary

team with the appropriate expertise

(such as in microbiology, medicine,

epidemiology, behavioral sciences,

health care services research) to

undertake each of the enumerated steps

or activities.

8. Implement a unified core protocol

common to all grant recipients that will

be established for component 3 of the

required activities (population-based

surveillance for new syphilis

transmissions) and implemented by

each recipient. The final core

multicenter protocol for component 3

will likely differ somewhat from the

protocol specified by any individual

recipient. Core protocols or common

approaches will be encouraged but will

not be required for other components,

especially component 1.

9. Each grantee will participate with

other recipients and CDC

representatives in as many as four

meetings during the first 24 months,

during which the core protocol for

component 3 will be established, and

strategies for and progress toward

achieving the goals of the program

announcement will be assessed.

10. The recipient will share reports on

progress toward goals with

representatives of communities affected

by syphilis and other involved

organizations, agencies, and persons.

11. The recipients will take the lead

in data analysis and publication of data

from their own research centers, with

participation and support from CDC.

B. CDC Activities

1. Provide scientific and technical

assistance in the general operation of

this syphilis prevention project and in

the three key research components in

Phase I.

2. Within 45 days of the notice of

grant award, host a meeting of the

successful applicants to develop the

core protocol for component 3 and to

plan other aspects of the research

program. CDC will host as many as three

other meetings of investigators during

the first 24 months of the project to
19946 Federal Register / Vol. 60, No. 77 / Friday, April 21, 1995 / Notices

promote progress toward core and

national objectives.

3. Assist in monitoring and evaluating

scientific and operational

accomplishments of this syphilis

elimination project through periodic site

visits for research program reviews,

frequent telephone calls, and review of

technical reports and interim data

analyses.

4. CDC will assist in data analysis and

in the presentation and publication of

data from Phase I and Phase II activities

in scientific, programmatic, and policymaking forums. CDC will actively

participate in evaluating the multicenter

core protocol data for component 3

(surveillance and evaluation).

Review Conditions and Evaluation

Criteria

To be referred to the independent

review group for consideration,

applications must:

1. Document effective partnerships

among research institutions, State or

local health departments, and CBOs;

and

2. Address the specific requirements

in all three research components.

Applications not meeting these two

requirements will be returned to the

applicant without being reviewed.

Applications that meet the preceding

requirements will be evaluated

according to the following criteria:

1. Understanding of Goals, Purpose, and

Context

Understanding of the objectives of

this research and evaluation program as

reflected in statement of research

background, program objectives, and

linkage of the specific activities of Phase

I to a well-articulated vision of what is

needed to substantially reduce the

prevalence of syphilis in the United

States (5 points). Extent the choice of a

project area in which to conduct this

research is appropriate to the research

objectives and is explained and justified

in those terms, and extent in the

proposed project area the epidemiology

of syphilis, barriers to its reduction or

elimination, and resources available to

STD/HIV prevention are well-described

(5 points). (Total, 10 points.)

(APPLICATION CONTENT items 1 and

2.)

2. Quality and Focus of Proposed Phase

I Research

The extent to which excellent

research designs address the three major

components of the program

announcement while avoiding

extraneous efforts. (APPLICATION

CONTENT item 9.)

Component 1: Innovative uses of

epidemiologic methods and findings

about syphilis transmission in

communities to direct prevention

strategies. The extent to which the

proposal is theoretically sound and

reflects detailed knowledge of the

meaning of the underlying data, such as

reported syphilis cases of different

durations (primary, secondary, early

latent, late latent), reports of sexual

contacts among patients, syphilis

seroprevalence from screening data, and

other data sources. The extent to which

the planned approaches to analyzing,

interpreting, and using data are

innovative and likely to yield new

insights into the transmission of

syphilis and the opportunities for

prevention and elimination within the

study community (10 points). The

extent to which the findings might be

directly translated into public health

practice (e.g., changes in screening

criteria or the location for syphilis

serologic testing; changes in PN

practices or priorities; relocation or

reorganization of clinical services;

development of community-based

interventions), and the clarity with

which that potential for translation is

explained in the application (5 points).

(Total, 15 points.)

Component 2: Development of a

programmatic intervention and pilot

test of that proposed intervention before

large-scale implementation; developing

partnerships with communities affected

by syphilis. Choice of an appropriate

potential intervention, based on syphilis

epidemiology in the study region plus

analysis of community, program, or

other factors that compose an important

barrier or opportunity for more effective,

epidemiologic programs (10 points).

Scientifically sound plan for evaluating,

during this pre-implementation phase,

the potential impact of the proposed

intervention on syphilis transmission (5

points) and on community perceptions

and support for those prevention

activities (5 points). The extent to which

the planned research findings from this

component could be directly translated

into public health practice, and the

clarity with which that translation is

explained in the application (5 points).

(Total, 25 points.)

Component 3: Development of a

sensitive syphilis surveillance activity to

serve as a basis for evaluating the

efficacy and cost-effectiveness of

syphilis prevention efforts. The extent to

which the proposal is theoretically

sound for evaluating the sensitivity and

cost-effectiveness of estimating and

following population and subpopulation trends in the transmission of

syphilis (5 points). The extent to which

the proposal demonstrates detailed

familiarity with public health disease

surveillance and the complexity of

trying to change practices in disease

surveillance settings proposed (e.g.,

jails, maternity wards delivery suites) (5

points). Implementation of a

management information system

adequate for a cost-effectiveness

analysis of new approaches to

prevention programs 5 points). (Total,

15 points.)

3. Capacity, Interdisciplinary

Involvement, and Partnerships

Overall ability of a multidisciplinary

research team (including persons in

various academic disciplines, public

health practitioners, and community

collaborators) to perform the technical

aspects of the project(s) (i.e., qualified

and experienced personnel with a

record of excellent scientific

achievement) (15 points); appropriate

facilities and plans for the

administration of the project(s), and a

detailed and realistic schedule for the

specified activities (5 points). (Total, 20

points: APPLICATION CONTENT items

3, 4, 5, and 6.)

4. Inclusion of Affected Communities

The extent to which communities

affected by syphilis are involved in all

parts of these research and

demonstration activities (5 points). The

extent to which the effective work of

one or more CBOs is documented in

attachments to the application and the

collaboration and support of a CBO is

thoroughly incorporated into the work

of the multidisciplinary team (5 points).

(Total, 10 points: APPLICATION

CONTENT items 3 and 6.)

5. Linkage to Related Prevention

Activities

The extent to which the proposed

research agenda and the intervention

reflect awareness of other critical

prevention services in the community

(pre-natal care, HIV, drug abuse,

correctional health) and are synergistic

or at least well-coordinated with those

other preventive health services. (Total,

5 points: APPLICATION CONTENT

item 7.)

In addition, consideration will be

given to the extent to which the budget

is reasonable, clearly justified, and

consistent with the intended use of the

funds. (APPLICATION CONTENT item

8

Funding Priorities

CDC intends to achieve some

geographic diversity of project sites

while retaining a principal focus on

syphilis in the southeastern United
Federal Register / Vol. 60, No. 77 / Friday, April 21, 1995 / Notices 19947

States. It is the intention to fund at least

two Phase I projects that address

syphilis in rural areas in the

southeastern United States, if those

applications are fully competitive.

Interested persons are invited to

comment on the proposed funding

priority. All comments received on or

before May 19, 1995, will be considered

before the funding priority is

established. If the funding priority

should change as a result of any

comments received, a revised

Announcement will be published in the

Federal Register and revised

applications accepted.

Written comments should be

addressed 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 E–16, Atlanta, GA 30305.

Executive Order 12372 Review

Applications are subject to

Intergovernmental Review of Federal

Programs as governed by Executive

Order (E.O.) 12372. E.O. 12372 sets up

a system for State and local government

review of proposed Federal assistance

applications. Applicants (other than

federally recognized Indian tribal

governments) should contact their State

Single Point of Contact (SPOC) as early

as possible to alert them to the

prospective applications and receive

any necessary instructions on the State

process. For proposed projects serving

more than one State, the applicant is

advised to contact the SPOC for each

affected State. A current list of SPOCs

is included in the application kit. If

SPOCs have any State process

recommendations on applications

submitted to CDC, they should send

them 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 E–16, Atlanta, GA 30305, not

later than 60 days after due date for

receipt of applications. The Program

Announcement Number and Program

Title should be referenced on the

document. CDC does not guarantee to

‘‘accommodate or explain’’ State process

recommendations it receives after that

date. Indian tribes are strongly

encouraged to request tribal government

review of the proposed application. If

tribal governments have any tribal

process recommendations on

applications submitted to CDC, they

should forward them to Henry S. Cassell

III, Grants Management Officer, Grants

Management Branch, Centers for

Disease Control and Prevention (CDC),

255 East Paces Ferry Road, NE., Room

300, Mailstop E–16, Atlanta, GA 30305.

This should be done no later than 60

days after the application deadline date.

The granting agency does not guarantee

to ‘‘accommodate or explain’’ for tribal

process recommendations it receives

after that date.

Public Health System Reporting

Requirements

This program is subject to the Public

Health System Reporting Requirements.

Under these requirements, all

community-based nongovernmental

applicants must prepare and submit the

items identified below to the head of the

appropriate State and/or health

agency(s) in the program area(s) that

may be impacted by the proposed

project no later than the receipt date of

the Federal application. The appropriate

State and/or local health agency is

determined by the applicant. The

following information must be

provided:

A. A copy of the face page of the

application (SF 424).

B. A summary of the project that

should be titled ‘‘Public Health System

Impact Statement’’ (PHSIS), not

exceeding one page, and including the

following:

1. A description of the population to

be served;

2. A summary of the services to be

provided; and

3. A description of the coordination

plans with the appropriate State and/or

local health agencies.

Catalog of Federal Domestic Assistance

Number

The Catalog of Federal Domestic

Assistance Number is 93.978,

Preventive Health Services—Sexually

Transmitted Diseases Research,

Demonstration, and Public Information

and Education Grants.

Other Requirements

Paperwork Reduction Act

Projects that involve the collection of

information from 10 or more individuals

and funded by the cooperative

agreement will be subject to review by

the Office of Management and Budget

(OMB) under the Paperwork Reduction

Act.

Confidentiality

Applicants must have in place

systems to ensure the confidentiality of

patient records.

HIV/AIDS Requirements

Recipients must comply with the

document entitled Content of AIDSRelated Written Materials, Pictorials,

Audiovisuals, Questionnaires, Survey

Instruments, and Educational Sessions

(June 1992) (a copy is in the application

kit). To meet the requirements for a

program review panel, recipients are

encouraged to use an existing program

review panel, such as the one created by

the State health department’s HIV/AIDS

Prevention Program. If the recipient

forms its own program review panel, at

least one member must also be an

employee (or a designated

representative) of a State or local health

department. The names of the review

panel members must be listed on the

Assurance of Compliance form CDC

0.1113, which is also included in the

application kit. The recipient must

submit the program review panel’s

report that indicates all materials have

been reviewed and approved.

Before funds can be used to develop

HIV/AIDS-related materials, determine

whether suitable materials are already

available at the CDC National AIDS

Clearinghouse.

Human Subjects

If your project involves research on

human subjects, you must comply with

the Department of Health and Human

Services Regulations, 45 CFR Part 46,

regarding the protection of human

subjects. Provide assurance that the

project will be subject to initial and

continuing review by an appropriate

institutional review committee. You

must provide assurance in accordance

with the guidelines and form 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.

Letters of Intent

Letters of intent are required. On or

before May 15, 1995, submit the original

and two copies of a letter of intent to

submit an application 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 E–16, Atlanta, GA

30305.
19948 Federal Register / Vol. 60, No. 77 / Friday, April 21, 1995 / Notices

Application Submission and Deadline

On or before July 3, 1995, submit the

original and two copies of the

application (Form PHS 5161–1—OMB

Number 0937–0189) and one electronic

copy on disk to: Henry S. Cassell III,

Grants Management Officer,

Procurement and Grants Office, Grants

Management Branch, Centers for

Disease Control and Prevention (CDC),

255 East Paces Ferry Road, NE., Room

300, Mailstop E–16, Atlanta, GA 30305.

1. Deadline: Applications shall be

considered as meeting the deadline if

they are:

A. Received on or before the deadline

or

B. Sent on or before the deadline date

and received in time for submission to

the independent review committee.

(Applicants must request a legibly dated

U.S. Postal Service postmark or obtain

a legibly dated receipt from a

commercial carrier or U.S. Postal

Service. Private metered postmarks will

not be acceptable proof of timely

mailing.)

2. Late Applications: Applications

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

1.B. are considered late applications and

will not be considered in the current

competition and will be returned to the

applicant.

Where to Obtain Additional

Information

A complete program description,

information on application procedures,

an application package, and business

management technical assistance may

be obtained from: Manuel Lambrinos,

Grants Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Mailstop E–16, Atlanta, GA 30305,

telephone (404) 842–6777.

Programmatic technical assistance may

be obtained from: Sevgi Aral, Ph.D.,

Division of STD/HIV Prevention,

National Center for Prevention Services,

Centers for Disease Control and

Prevention (CDC), 1600 Clifton Road,

NE., Mailstop E–02, Atlanta, GA 30333,

telephone (404) 639–8259.

Please refer to Announcement 523

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: April 14, 1995.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 95–9879 Filed 4–20–95; 8:45 am]

BILLING CODE 4163–18–P

Disease, Disability, and Injury

Prevention and Control Special

Emphasis Panel (SEP): Cooperative

Agreements for National/Regional

Minority Organization Human

Immunodeficiency Virus/Sexually

Transmitted Diseases Prevention,

Immunization, and Tuberculosis

Projects—Program Announcement

305b: Amendment of Time and Date

Federal Register Citation of Previous

Announcement 60 FR 13728—dated

March 14, 1995.

This notice announces an amendment

in the time and date of a previously

announced meeting.

Previously Announced Time and

Date: 8:30 a.m.–4:30 p.m., April 18,

1995.

Amendment in Meeting Time and

Date: 8:30 a.m.–4:30 p.m., April 18,

1995. 8:30 a.m.–4:30 p.m., April 19,

1995.

Dated: April 18, 1995.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 95–10009 Filed 4–19–95; 10:14 am]

BILLING CODE 4163–18–M

Food and Drug Administration

[Docket No. 95M–0072]

Cardiac Pacemakers, Inc., Premarket

Approval of VENTAK P2 AICDTM

System: Model 1625 VENTAK P2

Pulse Generator, Model 2835 Software

Module, and Model 2815 VENTAK

ECD External Cardioverter Defibrillator

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Cardiac

Pacemakers, Inc., St. Paul, MN, for

premarket approval, under the Federal

Food, Drug, and Cosmetic Act (the act),

of the VENTAK P2 AICDTM System.

FDA’s Center for Devices and

Radiological Health (CDRH) notified the

applicant, by letter of March 10, 1995,

of the approval of the application.

DATES: Petitions for administrative

review by May 22, 1995.

ADDRESSES: Written requests for copies

of the summary of safety and

effectiveness data and petitions for

administrative review to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, rm. 1–23,

12420 Parklawn Dr., Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Carole C. Carey, Center for Devices and

Radiological Health (HFZ–450), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–8609.

SUPPLEMENTARY INFORMATION: On August

30, 1993, Cardiac Pacemakers, Inc., St.

Paul, MN 55112, submitted to CDRH an

application for premarket approval of

VENTAK P2 AICDTM System consists

of the following: Model 1625 VENTAK

P2 pulse generator; Model 2835

Software Module to be used with

commercially available Cardiac

Pacemakers, Inc., (CPI) Model 2035

Handheld Programmer and Model 6575

or 6577 Telemetry Wand; Model 2815

VENTAK ECD External Cardioverter

Defibrillator (which includes the Model

6873 High Voltage Cable with Model

6838 Thumbscrew, Model 6843 Bipolar

Cable with Model 6838 Thumbscrew,

Model 6874 Bipolar Cable, and related

CPI commercially available

accessories); commercially available

CPI ENDOTAK 60–Series Lead

System and accessories; commercially

available CPI epicardial defibrillation

leads and accessories; and commercially

available pace/sense leads and

accessories. The device is an automatic

implantable cardioverter defibrillator

system and is indicated for the

treatment of patients with ventricular

fibrillation and/or ventricular

tachyarrhythmias who are at high risk of

sudden cardiac death. Such patients are

defined as having experienced the

following situations: (1) The survival of

at least one episode of cardiac arrest

presumably due to hemodynamically

unstable ventricular tachyarrhythmia

not associated with acute myocardial

infarction, and/or (2) a poorly tolerated,

sustained ventricular tachycardia (VT)

and/or ventricular fibrillation (VF)

which recurs spontaneously or can be

induced despite the best antiarrhythmic

drug therapy. Note: The clinical

outcome of hemodynamically stable,

sustained VT patients is not fully

known. A study of the safety and

effectiveness of the VENTAK P2

system on this selected subgroup of VT

patients has not been conducted.

In accordance with the provisions of

section 515(c)(2) of the act (21 U.S.C.

360e(c)(2)) as amended by the Safe

Medical Devices Act of 1990, this