31530 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Notices

this mission, seven NLTN offices were

established at various sites throughout

the nation giving all states and

territories access to laboratory training

through this Network.

NLTN staff was charged with (1)

Assessing the training needs (2)

developing programs, (3) delivering

training and, (4) evaluating the

effectiveness of the training. Staff in the

seven offices must meet unique needs in

the geographical area for which they are

responsible. Assessing need is

particularly important because more

than 100,000 laboratories are doing

16,380 different tests of 631 analytes.

NLTN staff must determine the most

efficient and effective means to provide

training where the greatest need exits.

Need for training in laboratories may

be dependent on where the laboratories

are located and what population they

serve. For example, small laboratories in

physicians’ offices (POLs) may have

very different needs than large,

independent laboratories, hospital or

state laboratories. Manufacturers

develop different products for

laboratories that test in high volumes

and can afford very sophisticated

equipment than for small laboratories

that do a limited number of tests.

Education and training of personnel in

the laboratories also very considerably.

Current training needs are vastly

different for people who have complete

bachelor’s degrees in medical

technology or a science and those who

have no formal laboratory education.

This information collection request is

for clearance of a bank of questions from

which NLTN staff may periodically

select certain ones to use in survey to

assess needs—and for flexibility to

develop questions in specified formats

to address specific practices related to

the many tests available. This will allow

the NLTN to focus on the appropriate

lab type, target audience and test.

Respondents

Number of

respondents

Number

of responses/

respondent

Avg.

burden/response

(in

hrs.)

Laboratory ....... 2,800 1 0.5

The total annual burden is 1400. Send

comments to Desk officer, CDC; Human

Resources and Housing Branch, New

Executive Office Building, Room 10235;

Washington, DC 20503.

Dated: June 14, 1996.

Wilma G. Johnson,

Acting Associate Director of Policy Planning

And Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–15718 Filed 6–19–96; 8:45 am]

BILLING CODE 4163–18–P

Agency for Health Care Policy and

Research

Notice of Health Care Policy and

Research; Special Emphasis Panel

Meeting

In accordance with section 10(a) of

the Federal Advisory Committee Act (5

U.S.C., Appendix 2) announcement is

made of the following special emphasis

panel scheduled to meet during the

month of July 1996:

Name: Health Care Policy and Research

Special Emphasis Panel.

Date and Time: July 10, 1996, 9:30 a.m.

Place: DoubleTree Hotel, 1750 Rockville

Pike, Conference Room TBA, Rockville,

Maryland 20852.

Open July 10, 9:30 a.m. to 9:45 a.m.

Closed for remainder of meeting.

Purpose: This Panel is charged with

conducting the initial review of grant

applications proposing medical effectiveness

research. The three main areas of emphasis

are: (1) Determining what clinical

interventions are most effective, cost

effective, and appropriate; (2) methods and

data to advance effectiveness research; and

(3) dissemination and evaluation of the

impact of research findings on clinical

practice and outcomes.

Agenda: The open session of the meeting

on July 10, from 9:30 a.m. to 9:45 a.m., will

be devoted to a business meeting covering

administrative matters. During the closed

session, the committee will be reviewing and

discussing grant applications dealing with

health services research issues. In accordance

with the Federal Advisory Committee Act,

section 10(d) of 5 U.S.C. Appendix 2 and 5

U.S.C. 552b(c)(6), the Administrator, AHCPR,

has made a formal determination that this

latter session will be closed because the

discussions are likely to reveal personal

information concerning individuals

associated with the grant applications. This

information is exempt from mandatory

disclosure.

Anyone wishing to obtain a roster of

members or other relevant information

should contact Linda Blankenbaker, Agency

for Health Care Policy and Research, Suite

400, 2101 East Jefferson Street, Rockville,

Maryland 20852, Telephone (301) 594–1437

x1603.

Agenda items for this meeting are subject

to change as priorities dictate.

Dated: June 12, 1996.

Clifton R. Gaus,

Administrator.

[FR Doc. 96–15717 Filed 6–19–96; 8:45 am]

BILLING CODE 4160–90–M

Notice of Health Care Policy and

Research; Special Emphasis Panel

Meeting

In accordance with section 10(a) of

the Federal Advisory Committee Act (5

U.S.C., Appendix 2) announcement is

made of the following special emphasis

panel scheduled to meet during the

month of July 1996:

Name: Health Care Policy and Research

Special Emphasis Panel.

Date and Time: July 9, 1996, 9:30 a.m.

Place: Agency for Health Care Policy and

Research, 2101 E. Jefferson Street, Suite 400,

Rockville, Maryland 20852.

Open July 9, 9:30 a.m. to 9:45 a.m.

Closed for remainder of meeting.

Purpose: This Panel is charged with

conducting the initial review of grant

applications proposing medical effectiveness

research. The three main areas of emphasis

are: (1) Determining what clinical

interventions are most effective, cost

effective, and appropriate; (2) methods and

data to advance effectiveness research; and

(3) dissemination and evaluation of the

impact of research findings on clinical

practice and outcomes.

Agenda: The open session of the meeting

on July 9, from 9:30 a.m. to 9:45 a.m., will

be devoted to a business meeting covering

administrative matters. During the closed

session, the committee will be reviewing and

discussing grant applications dealing with

health services research issues. In accordance

with the Federal Advisory Committee Act,

section 10(d) of 5 U.S.C., Appendix 2 and 5

U.S.C., 552b(c)(6), the Administrator,

AHCPR, has made a formal determination

that this latter session will be closed because

the discussions are likely to reveal personal

information concerning individuals

associated with the grant applications. This

information is exempt from mandatory

disclosure.

Anyone wishing to obtain a roster of

members or other relevant information

should contact Linda Blankenbaker, Agency

for Health Care Policy and Research, Suite

400, 2101 East Jefferson Street, Rockville,

Maryland 20852, Telephone (301) 594–1437

x1603.

Agenda items for this meeting are subject

to change as priorities dictate.

Clifton R. Gaus,

Administrator.

[FR Doc. 96–15723 Filed 6–19–96; 8:45 am]

BILLING CODE 4160–90–M

Centers for Disease Control and

Prevention

[Announcement 601]

Prevention of HIV Infection in Youth at

Risk: Developing Community-Level

Strategies That Work

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Notices 31531

availability of fiscal year (FY) 1996

funds for a cooperative agreement

program for the prevention of HIV

infection in youth at risk.

CDC is committed to achieving the

health promotion and disease

prevention objectives of ‘‘Healthy

People 2000,’’ a national activity to

reduce morbidity and mortality and

improve the quality of life. This

announcement is related to the priority

area of Human Immunodeficiency Virus

(HIV) Infection. (For ordering a copy of

‘‘Healthy People 2000,’’ see the section

‘‘WHERE TO OBTAIN ADDITIONAL

INFORMATION.’’)

Authority

This program is authorized under

Sections 301 and 317(k)(2), of the Public

Service Health Act (42 U.S.C. 241 and

247b(k)(2)) as amended.

Smoke-Free Workplace

CDC strongly encourages all

recipients to provide a smoke-free

workplace and to promote the nonuse 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. Thus, universities,

colleges, research institutes, hospitals,

other public and private organizations,

State and local health departments or

their bona fide agents or

instrumentalities, federally recognized

Indian tribal governments, Indian tribes

or Indian tribal organizations, and

small, minority- and/or women-owned

businesses are eligible to apply.

Each applicant must demonstrate

collaboration with community-based

organizations (CBOs) that have histories

of familiarity with, access to, and

success working with the target

population. Collaboration with CBOs

will be demonstrated through letters

from the organizations stating their

willingness to participate in the

proposed project. It is the intention of

this announcement to stimulate

collaborative, interdisciplinary research

between research institutions and

public health agencies and CBOs;

therefore, applications by agencies

taking the lead with teams composed of

collaborators from each of the other

entities are encouraged. The application

should be submitted by the lead

institution, agency, or organization.

Applicants who have conducted

formative research on the target

population are encouraged to apply.

Note: Organizations described in section

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

1986 that engage in lobbying are not eligible

to receive Federal grant/cooperative

agreement funds.

Availability of Funds

Approximately $2.8 million will be

available in FY 1996 to fund

approximately six awards. It is expected

that the average award will be $500,000,

ranging from $400,000 to $900,000.

Awards are expected to begin on or

about September 30, 1996, and will be

made for a 12-month budget period

within a project period of up to five

years (two years for all Phase I

recipients and three additional years for

successful recipients of Phase II.

Approximately three Phase I recipients

will receive Phase II funding through a

competitive announcement). Funding

estimates may vary and are subject to

change.

Phase II competition will in part

include the following factors:

1. Have completed their formative

research and summaries, pilot-testing,

data reduction, and final Phase I report;

2. Have established access to the

target population in sufficient numbers

to provide meaningful sample sizes for

intervention and control areas;

3. Have demonstrated that their

proposed catchment areas are minimally

affected by confounding factors of

competing interventions and research;

4. Have demonstrated data collection

and analysis capacity to execute the

protocols for data analysis and

evaluation of impact;

5. Be able to implement the common

intervention selected through

consensus, including having a sufficient

number of trained staff to devote fulltime to the intervention and;

6. Have written the final draft of at

least one publication on Phase I data.

Continuation awards within the

project period will be made on the basis

of satisfactory progress and the

availability of funds.

Definitions

Youths are defined as persons 15 to

25 years of age. Men who have sex with

men (MSM) are men who have sex with

men, regardless of their declared sexual

identity. Young men who have sex with

men (YMSM) are males 15 to 25 years

of age who have sex with other males,

express intention to have sex with other

males, or acknowledge sexual attraction

to other males. Communities can be

groups defined by behavior (sexual

orientation, IV drug use), by

identification (ethnicity, sexual

identity), by geographic boundaries, or

by places where people are available for

education (schools, prisons). Catchment

area is the contiguous geographic area

that encompasses at least one access site

and that is distinct in geography and

population membership. Access site is a

location within a catchment area where

the target population congregates and is

available for intervention. Communitylevel intervention is an approach to HIV

prevention that (1) Results from a

mobilization of community members

and institutions; (2) can be expected to

reach a large proportion of the

population at risk in their daily setting;

(3) may involve the use of outreach and

facility-based services; and (4) can be

expected to alter individual behaviors

and community norms. Community

assessment is the systematic collection

and critical analysis of data to

determine the adequacy and

effectiveness of specific services,

infrastructure, and formal and informal

resources available to a community.

Multi-site is defined as the same or

similar intervention, sampling methods

and measurements used in multiple

sites, but does not imply a nationally

representative sample of sites.

Purpose

This program is to conduct research

that will develop and evaluate

approaches to encourage youth who

engage in risky behaviors associated

with HIV acquisition and transmission

to change these behaviors. This program

also seeks to develop methods that may

build on evaluated, community-level

intervention efforts, and where

advisable, previous work, but will focus

entirely on YMSM, including those who

are members of racial or ethnic

minorities.

Funds will be used in two phases to

develop, implement, analyze, and

evaluate an effective community-level

behavioral change intervention, with

potential for sustainability, to prevent

HIV in YMSM who engage in high-risk

behaviors related to the acquisition and

transmission of HIV.

Phase I of the research program will

focus on formative research to

characterize populations, identify

constraints on and opportunities for

behavior change, and identify

components of a targeted intervention

and determine its feasibility.

Approximately six awards will be made

for a 12-month budget period within a

project period of up to two years.

Phase II of the research program will

focus on the implementation of a

common intervention protocol,

randomization of catchment areas, and
31532 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Notices

systematic analysis and evaluation of

the intervention’s impact. Eligible

applicants for Phase II will be recipients

of Phase I. Phase II will be competitively

announced. Approximately three

awards will be made for a 12-month

budget period within a project period of

up to three years.

The intervention for this project will

be based on the combined formative

research completed by award recipients

in Phase I and will be implemented in

Phase II. Although CDC is not requiring

proposals for Phase II intervention

activities at this time, a brief description

of Phase II is included here for the

applicants’ information. In the first eight

months of Phase II, recipients will

conduct two to three baseline

assessments. The recipients then will

implement, analyze, and evaluate the

impact of the community-level

intervention. Examples of behaviors that

may be appropriate for the intervention

to address are:

1. Maintaining abstinence;

2. Reducing high-risk sexual

behaviors among sexually active YMSM

and;

3. Using barrier methods when

engaging in sexual activity.

By the end of the 5-year project,

recipients and participating agencies

will produce guidelines for technology

transfer of the intervention to control

sites and other interested organizations.

Recipients are also encouraged to assist

participating agencies in developing the

skills to sustain successful intervention

components after the study.

Applicants must agree to follow the

intervention and implementation

protocol developed jointly by recipients

with input from CDC project officers. It

is anticipated that the Phase II protocol

for intervention, analysis, and

evaluation will be a common protocol

with many components that are

applicable to all study areas. Such a

protocol also will permit tailoring to

individual communities to

accommodate variations (e.g., cultural,

geographic) among them. YMSM

representing diverse segments of the

target population should participate

actively in research and intervention

design and review in Phase I and Phase

II.

Program Requirements

Work performed under this agreement

will be the result of collaborative efforts

among recipients, resulting in common

protocols and methods across sites.

Individual recipients will be responsible

for research design, intervention

development and implementation, data

collection and analysis, and publication.

CDC will coordinate these collaborative

efforts and expects to work closely with

each award recipient.

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

under A. (Recipient Activities), and

CDC will be responsible for the

activities listed under B. (CDC

Activities).

A. Recipient Activities

1. Characterize the HIV risk of the

target population and any subgroups in

at least two matched catchment areas

and prioritize the subgroups according

to probable risk and other criteria.

a. The recipient will have proposed in

their application at least two catchment

areas that are matched in:

(1) Population demographic

characteristics:

(2) Risk behaviors;

(3) Population sizes;

(4) Numbers of the same types of

access sites (e.g., bars, bookstores, parks)

and;

(5) Other relevant variables.

b. During Phase I, the recipient will

further study the proposed catchment

areas to finalize selection of catchment

areas for conducting the Phase II

intervention:

(1) The selected catchment areas must

be geographically discrete and have less

than 10% overlap of the target

population in each area.

(2) The catchment areas will be places

where (a) hundreds of eligible subjects

can be reached, (b) that have an

estimated high HIV seroprevalence rate

among youth, and (c) that, ideally, have

minimal confounding factors introduced

by ongoing or proposed HIV prevention

efforts.

(3) After Phase I, the catchment areas

will be randomly assigned to a study

condition—the intervention or

comparison.

c. The recipient will characterize the

target population and any of its

subgroups in each catchment area.

d. The recipient will document, using

whatever qualitative and quantitative

data are available, that the targeted

populations and any of their subgroups

in the selected catchment areas are at

risk for HIV infection and will prioritize

the subgroups according to the relative

risk.

e. The recipient will justify its

identifications of catchment areas,

access sites, subgroup, and YMSM

accessible at those sites in terms of the

potential to address the research goals of

this program announcement and in

terms of ultimately translating the

research findings into HIV prevention

activities among the target populations.

By the end of Phase I, the recipient

will have finalized the selection of a

minimum of two matched catchment

areas and conducted research to justify

the selection of catchment areas,

determine the demographic

characterization of the target population

and any subgroups, and justify selection

of a particular subgroup. The recipient

also will have identified sites within the

catchment areas where YMSM are

accessible both for interviewing and for

the intervention and will have secured

commitment of collaborating

organizations in these catchment areas

and access sites to participate in Phase

II and to be randomly assigned to a

research condition.

2. Conduct qualitative and

quantitative behavioral research of

YMSM at risk in the study catchment

areas.

a. The recipient will build a multi

disciplinary research team and program

support capability:

(1) A multi disciplinary team should

be assembled with the appropriate

expertise to undertake Phase I activities.

Such a team will include experienced

senior researchers, technical staff, and

support staff and will be led by

behavioral scientists;

(2) The team will have CBO members

or collaborators and;

(3) The team will involve persons

from the target population in research

and intervention design.

b. The recipient will develop a

common protocol to conduct the

behavioral research:

(1) The research will include sexual

behavior, partner characteristics, social

networks, substance abuse behavior,

trading sex for money or drugs,

perceptions of social norms, attitudes,

self-efficacy, perceptions of current HIV

interventions, health-care-seeking

behaviors, health-information-seeking

behaviors, developmental issues

influencing the above, and structural

influences on behavior to identify

which segments or subgroups of YMSM

would be best served by the

intervention;

(2) Questionnaires and survey

instruments will be constructed at a

literacy level appropriate to the target

population;

(3) The research will involve members

of the targeted population and other

community partners in determining

which types, designs, and deliveries of

interventions would be (a) best accepted

and most influential in their

communities, (b) most likely to work

synergistically with other community

efforts, (c) most likely to stimulate

changes in community norms, and (d)

most likely to be sustained.

The recipient will demonstrate further

understanding of factors influencing the
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Notices 31533

behavior of YMSM, document the

participation of the target population in

the formative research design and their

contribution in development of the

intervention to be pilot-tested, and

propose a sound theoretical and datadriven approach to influencing

behaviors of YMSM.

3. Use an existing or develop and

conduct a community assessment and

document HIV interventions and

research involving the target population

in the catchment areas.

a. The purpose of the community

assessment is to determine:

(1) Community-wide needs for HIV/

AIDS prevention among YMSM;

(2) Existing and potential capacity;

(3) Available resources and;

(4) Current prevention efforts and

further understand key issues (e.g.,

identifying access sites, influences of

political climate) relevant to intervening

with the target population.

b. Recipients will:

(1) Review community needs

assessments and community planning

documents and;

(2) Summarize what is known about

the proposed communities, and if

necessary, recipients will develop, in

collaboration with CDC and other

recipients, a common assessment

instrument to be implemented in Phase

I.

c. Part of the community assessment

must include:

(1) The current activities and

functions of the health department’s

HIV program in the catchment areas;

(2) Implications of the formative

research and potential interventions on

those activities and functions and;

(3) The HIV community planning

priorities related to YMSM.

The recipient will have produced a

summary synthesizing knowledge of the

community’s HIV needs and planning,

participated in cross-site

implementation of the assessment

instrument, as appropriate, and

analyzed and reported the results of the

assessment.

4. In partnership with persons from

relevant communities, other recipients,

and CDC project officers, develop an

appropriate community-level

intervention to reduce HIV risk

behaviors in the target population.

a. Recipients will collaborate in

developing a common intervention and

research protocol for all recipients to

implement in Phase II:

(1) The basis for the intervention

should include (a) the recipient’s

experience with the target population,

(b) formative research from Phase I, and

(c) a review of current primary

prevention strategies and research;

(2) The intervention selection should

be a logical result of program

requirements 4.a.(1)(a-c) above, but not

be limited to their exclusive

consideration;

(3) The intervention approach should

be culturally sensitive, developmentally

appropriate, and suitable for the target

population’s literacy level and should

stimulate community action,

mobilization, and adoption of a

supportive environment and community

norms and;

(4) An effective community-level

intervention for these youth may

combine several elements, e.g., (a)

efficient targeting of outreach, (b)

development of an environment

supportive of long-term HIV/AIDS risk

reduction, and (c) links to local

resources that encourage healthy

behaviors.

b. Local resources that encourage

healthy behaviors may include:

(1) STD treatment and prevention

services;

(2) Substance abuse treatment

facilities;

(3) Shelters or drop-in facilities for

runaway and homeless youth;

(4) Mental health clinics;

(5) Other health care facilities such as

community health centers;

(6) Facilities ‘‘without walls’’ that

provide outreach to street youth and;

(7) Providers of foster care and

supervised independent living.

c. Recipients will participate in

monthly conference calls with CDC

project officers and other recipients.

d. Each recipient will travel to Atlanta

or another location and participate with

other recipients and CDC

representatives in four meetings during

Phase I. At one of these meetings, the

Phase II intervention design and

protocols for pilot testing will be

established.

e. The protocols for the Phase II

intervention will be finalized at a later

meeting.

At the end of Phase I, the recipient

will have summarized activities and

participated in the development of a

common intervention, research

protocol, operational plan, process and

impact objectives, analysis strategies,

and evaluation instruments for Phase II.

5. Through pilot-testing, determine

the feasibility and sustainability of

implementing the proposed

intervention, including cost, acceptance,

and participation by the target

population.

a. During the second year of Phase I,

components of the collaboratively

developed intervention will be pilottested by the recipients to determine

modifications in design,

implementation, and other relevant

considerations.

These considerations may include:

(1) The likelihood that the

intervention will change behavior

among YMSM;

(2) The probable level of acceptability

of the intervention to the target

populations and to the communities

around the intervention access sites;

(3) The recipient’s potential for

recruiting, training, and retaining

intervention workers;

(4) The acceptability of intervention

workers to the targeted population;

(5) The likelihood that the

intervention will stimulate changes in

community norms;

(6) Clarity of or difficulties with data

collection instruments;

(7) The projected overall cost of the

intervention component;

(8) The likelihood that the

intervention can be maintained during

the entirety of Phase II;

(9) The likelihood that successful

components of the intervention will be

institutionalized in the community after

Phase II and;

(10) More effective ways for project

staff to systematically focus resources

(i.e., financial and personnel).

b. Recipients with substantial,

previously collected formative data from

their finalized catchment areas may

pilot-test potential intervention

components in the first year of Phase I

instead of collecting additional

formative data.

Recipients will have conducted and

reported pilot-test results of one or more

components of the common

intervention. The primary expectation at

the completion of Phase I is a finalized

common protocol for implementation,

analysis, and evaluation, including

validated instruments, for a communitylevel intervention that can reasonably be

expected to influence behaviors related

to HIV transmission in the study

population.

6. Recipients and CDC project officers

collaboratively develop a common

research protocol for the proposed

intervention to be conducted during

Phase II

a. The recipients, in collaboration

with CDC, will select and develop a

common research protocol, including:

(1) A common research design;

(2) Operational plan and;

(3) Analysis and evaluation methods

and instruments.

b. The protocol will include a withincatchment-area sampling strategy and

mechanisms for obtaining the consent

and protecting the confidentiality of

study subjects.
31534 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Notices

c. Analysis and evaluation plans will

be developed concurrently with

intervention plans.

d. Recipients will establish a set of

outcomes to determine the effectiveness

or impact of the intervention that are

measurable, valid, and reliable in terms

of behavioral and social science

theories. It is expected that the

evaluation will measure changes in

behaviors, intentions, and attitudes and

the target population’s awareness and

acceptance of the intervention.

e. To evaluate a common intervention,

the recipients and CDC project officers

must:

(1) Reach consensus concerning the

specific outcomes to target;

(2) Develop methods of measuring

these outcomes, including common data

collection instruments and;

(3) Pilot-test measures and

instruments.

Recipients will have established a

common research protocol, operational

plan, process and impact objectives, and

instruments for systematically analyzing

and evaluating the intervention in Phase

II. Each recipient must agree, if selected

for continuation into Phase II, to

implement this common protocol and

accept randomization of their selected

catchment areas (as specified above).

7. Manage, analyze, and interpret

data.

a. Data from the Phase I activities

must be collected, managed, and stored

securely and confidentially.

b. Recipients will use common

computer and data management

systems.

c. Recipients will be primarily

responsible for site-specific analyses.

d. Recipients will share data for

aggregate analyses with CDC project

officers.

Recipients will have common

computer and data management systems

and will have submitted the cleaned

data on their intervention trials to CDC

project officers.

B. CDC Activities

1. Host a meeting of the recipients to

plan the research program (e.g., the

format for community assessments).

CDC will host approximately three

additional meetings of recipients during

Phase I to promote progress toward

national objectives.

2. Act as mediator on the recipients’

collaborative design or selection of the

assessment plan and instruments,

research protocol, operational plan,

objectives, analysis strategies, and

evaluation instruments.

3. Provide technical assistance on

pilot testing the common intervention,

or elements thereof, and on tailoring the

collaboratively designed, common

intervention for local applications.

4. Provide scientific and technical

coordination of the general operation of

this HIV prevention project and of the

specific Phase I activities in order to

keep all recipients on track with the

common protocols and their timelines.

5. Conduct the random selection of

intervention and control catchment

areas among those presented by each

recipient, according to a randomization

protocol collaboratively determined by

the recipients.

6. Coordinate cross-site aggregation of

data and its analysis.

7. Conduct site visits to assess

program progress and mutually solve

problems, as needed.

At approximately month 12 of the

project, recipients and CDC project

officers will meet to design the common

intervention and pilot tests of its

components. At approximately month

20 of the project, recipients and CDC

project officers will meet to finalize the

common intervention for Phase II. At

approximately month 22 of the project,

applications for a competing

continuation award for the

implementation and evaluation of

community-level intervention (Phase II)

will be due. Supplementary guidance

for Phase II awards will be provided to

the recipients of Phase I awards.

Evaluation Criteria

Applications will be reviewed and

evaluated according to the following

criteria:

1. Applicant’s Team (15 points)

The extent to which all items in the

application content element are

addressed, including the extent to

which the applicant has:

a. Involved other key organizations on

the project team;

b. Clearly defined the responsibilities

of these other organizations;

c. Involved team members in planning

and developing the application and

demonstrated their commitment to the

project (as evidenced by letters of

support or memoranda of agreement)

and;

d. Previously worked with other team

members, including potential CBO

collaborators if they are not part of the

team.

2. Research and Intervention

Capability (20 points)

The extent to which all items in the

application content element are

addressed:

a. Capacity of the applicant research

team to conduct the proposed research

as evidenced by their previous related

research;

b. Experience with multisite research

designs and formative research on

MSM;

c. Extent of the team’s familiarity

with, access to, and good working

relations with MSM, as evidenced by

service or research involving this

population and;

d. Capacity of the team to conduct

behavioral interventions as evidenced

by description of their previous

experience.

3. Identification of Catchment Areas

(20 points)

The extent to which all items in the

application content element are

addressed:

a. Extent to which the catchment

areas meet matching criteria (e.g.,

matched population demographics, risk

behaviors, population sizes that are

similar and of sufficient size, access

sites), and the extent to which the

matching was based on available data;

b. Extent to which the target

populations within the catchment areas

have similar rates of HIV infection and

the extent to which the rates are based

on available data and;

c. Thoroughness of description of

potential conflict between the proposed

research and other research or

prevention efforts in the catchment

areas.

4. Proposed Research Plan—

Formative and Intervention (25 points)

The extent to which all items in the

application content element are

addressed:

a. Quality of the proposed formative

research plan, sampling strategies,

sample size estimates, power analysis,

and mechanisms to obtain subjects’

consent and protect their

confidentiality;

b. Appropriateness of the theoretical

bases for the proposed intervention;

c. Quality of the type of multi-site

intervention proposed and its likelihood

to yield new insights on opportunities

for long-term risk reduction among the

targeted population and;

d. Feasibility of the strategy to involve

the target population and affected

communities in the research and

intervention design and to inform them

of research results:

(1) The proposed plan for the

inclusion of racial and ethnic minority

populations for appropriate

representation;

(2) The proposed justification when

representation is limited or absent;

(3) A statement as to whether the

design of the study is adequate to

measure differences when warranted

and;

(4) A statement as to whether the

plans for recruitment and outreach for
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Notices 31535

study participants include the process

of establishing partnerships with

community(ies) and recognition of

mutual benefits will be documented.

5. Project Management (20 points):

The extent to which all items in the

application content element are

addressed:

a. Adequacy of staffing to carry out

proposed activities (i.e., sufficient in

number, percentage of time

commitments, behavioral scientists in

key project positions, and

qualifications), as evidenced by their

curriculum vitae and position

descriptions;

b. Adequacy of facilities, data

processing and analysis capacity, and

systems for management of data security

and participant confidentiality and;

c. Extent to which the applicant

demonstrates assurance of compliance

with the multisite research requirements

(e.g., randomization of catchment areas

and common protocol, data collection,

and computer and data management

systems).

6. Budget (Not scored)

Extent to which the budget is

reasonable, itemized, clearly justified,

and consistent with the intended use of

the funds.

7. Human Subjects (Not scored)

The applicant must clearly state

whether or not human subjects will be

used in research.

Funding Preferences

CDC’s intention is to achieve a longterm health benefit for youth at risk for

HIV infection. This announcement is

exclusively for proposals that address

HIV risk reduction for YMSM.

Consideration will be given to obtaining

diversity of target population subgroups and geographic representation

among proposals selected for funding.

YMSM of color are of particular interest.

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 Van Malone, 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 E15, Atlanta, GA 30305, no

later than 30 days after the application

deadline (the appropriation for this

financial assistance program was

received late in the fiscal year and

would not allow for an application

receipt date which would accommodate

the 60-day State recommendation

process period). The granting agency

does not guarantee to ‘‘accommodate or

explain’’ for 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 the CDC, they should

forward them to Van Malone, 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 E15, Atlanta, GA 30305. This

should be done no later than 30 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 local 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 exceed

one page, and include 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.

If the State and/or local health official

should desire a copy of the entire

application, it may be obtained from the

Single Point of Contact (SPOC) or

directly from the applicant.

Catalog of Federal Domestic Assistance

Number

The Catalog of Federal Domestic

Assistance number is 93.941.

Other Requirements

Paperwork Reduction Act

Projects that involve the collection of

information from 10 or more individuals

and funded by 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. 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. The applicant will be

responsible for providing assurance in

accordance with the appropriate

guidelines and form provided in the

application kit.

Racial and Ethnic Minorities

It is the policy of the Centers for

Disease Control and Prevention (CDC)

and the Agency for Toxic Substances

and Disease Registry (ATSDR) to ensure

that individuals of the various racial

and ethnic groups will be included in

CDC/ATSDR-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 racial and ethnic minority

populations are appropriately

represented in applications for research

involving human subjects. Where clear

and compelling rationale exist that
31536 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Notices

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 47947–47951,

dated Friday, September 15, 1995.

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 be an employee

(or designated representative) of a State

or local health department. The names

of the review panel members must be

listed on the Assurance of Compliance

for 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.

Application Submission and Deadlines

1. Preapplication Letter of Intent

A non-binding letter of intent-toapply is required from potential

applicants. An original and two copies

of the letter should be submitted to the

Grants Management Branch, CDC (see

‘‘Applications’’ for the address). It

should be postmarked no later than July

19, 1996. The letter should identify the

announcement number, name of

principal investigator, and specify the

activity(ies) to be addressed by the

proposed project. The letter of intent

does not influence review or funding

decisions, but it will enable CDC to plan

the review more efficiently, and will

ensure that each applicant receives

timely and relevant information prior to

application submission.

2. Applications

An original and two copies of the

application PHS Form 5161–1 (OMB

Number 0937–0189) must be submitted

to Van Malone, 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–15, Atlanta, GA

30305, on or before August 21, 1996.

3. Deadlines

A. Applications shall be considered as

meeting the deadline if they are either:

1. Received on or before the deadline

date; or

2. 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 shall not be

acceptable as proof of timely mailing.)

B. Applications that do not meet the

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

considered late applications. Late

applications will not be considered in

the current competition and will be

returned to the applicant.

Where to Obtain Additional

Information

To receive additional written

information call (404) 332–4561. You

will be asked to leave your name,

address, and telephone number and will

need to refer to Announcment 601. 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 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–15, Atlanta, GA 30305,

telephone (404) 842–6634, email:

<asm1@opspgo1.em.cdc.gov>.

Programmatic technical assistance may

be obtained from Robert Kohmescher,

Division of HIV/AIDS Prevention,

National Center for HIV/STD/TB

Prevention, Centers for Disease Control

and Prevention (CDC), 1600 Clifton

Road, NE., Mailstop E–44, Atlanta, GA

30333, telephone (404) 639–8302, email:

<rnk1@cidhiv2.em.cdc.gov>.

Please refer to Announcement 601

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.

Internet Home Page

The announcement will be available

on one of two Internet sites on the

publication date: CDC’s home page at

<http://www.cdc.gov>, or at the

Government Printing Office home page

(including free access to the Federal

Register) at <http://

www.access.gpo.gov.>.

There may be delays in mail delivery

and difficulty in reaching the CDC

Atlanta offices during the 1996 Summer

Olympics. Therefore, CDC suggests

using Internet, following all instructions

in this announcement and leaving

messages on the contact person’s voice

mail for more timely responses to any

questions.

Dated: June 13, 1996.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–15570 Filed 6–19–96; 8:45 am]

BILLING CODE 4163–18–P

Health Resources and Services

Administration

Maternal and Child Health Services;

Federal Set-Aside Program;

Continuing Education and

Development Cooperative Agreements

AGENCY: Health Resources and Services

Administration (HRSA) DHHS.

ACTION: Pre-application technical

assistance telephone conference.

SUMMARY: The HRSA is conducting a

pre-application technical assistance

telephone conference concerning the

fiscal year 1996 funding available under

Public Law 104–134 for Maternal and

Child Health (MCH) Special Projects of

Regional and National Significance

(SPRANS) Continuing Education and

Development (CED) cooperative

agreements. An Availability of Funds

notice for these CED cooperative

agreements was published in the

Federal Register on April 26, 1996 at 61

FR 18613. These CED cooperative

agreements are intended to support

national education, information, and

public policy projects in maternal and

child health. Two categories of CED

cooperative agreements will be awarded

this year: 1 concerned with resource,

educational and analytic activities; and

the other concerned with populationfocused analytic and related activities.

PURPOSE: To encourage and stimulate

development of high quality

applications. The telephone conference

will offer programmatic and technical

assistance and an overview of the

requirements for funding projects in

both categories. Further, it will provide

an opportunity for prospective