[Federal Register Volume 62, Number 99 (Thursday, May 22, 1997)]
[Notices]
[Pages 28027-28032]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13428]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Announcement 746]


Preventing Alcohol-Exposed Pregnancies Among High-Risk Women in 
Special Settings; 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 funds for a cooperative agreement 
program for the identification of settings in which high proportions of 
childbearing-age women are at risk of an alcohol-exposed pregnancy, and 
for the pilot-testing of model intervention programs aimed at reducing 
their risk. Women at greatest risk of an alcohol-exposed pregnancy are 
those who are drinking at moderate to heavy levels (including binge 
drinking) and are planning for, or are at risk of, becoming pregnant.
    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 to improve the quality of life. 
This announcement is related to the priority areas of Substance Abuse: 
Alcohol and Other Drugs, and Maternal and Infant Health. (To order a 
copy of ``Healthy People 2000,'' see section WHERE TO OBTAIN ADDITIONAL 
INFORMATION.)

Authority

    This program is authorized under Sections 301 and 317(k)(2) of 
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. 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 
organizations, and governments and their agencies. Thus, universities, 
colleges, research institutions, hospitals, community-based 
organizations and other public and private organizations, State and 
local health departments or their bona fide agents, and small, 
minority- and/or women-owned non-profit businesses are eligible for 
these cooperative agreements. Also eligible to apply are other non-
profit health, family planning, and substance abuse treatment 
providers, managed care organizations, and federally recognized Indian 
tribal governments.

    Note: Effective January 1, 1996, Public Law 104-65 states that 
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 
(cooperative agreement), contract, loan, or any other form.

Availability of Funds

    Approximately $900,000 will be available in FY 1997 to award up to 
3 cooperative agreements. It is expected that the awards will range 
from $250,000 to $300,000. Projects will begin on or about September 
30, 1997, and will be made for a 12-month budget period within a 
project period of up to 3 years. The funding estimate may vary and is 
subject to change.
    Continuation awards within the project period will be made on the 
basis of satisfactory progress and the availability of funds.

Use of Funds Restrictions on Lobbying

    Applicants should be aware of restrictions on the use of HHS funds 
for lobbying of Federal or State legislative bodies. Under the 
provisions of 31 U.S.C. Section 1352 (which has been in effect since 
December 23, 1989), recipients (and their subtier contractors) are 
prohibited from using appropriated Federal funds (other than profits 
from a Federal contract) for lobbying Congress or any Federal agency in 
connection with the award of a particular contract, grant, cooperative 
agreement, or loan. This includes grants/cooperative agreements that, 
in whole or in part, involve conferences for which Federal funds cannot 
be used directly or indirectly to encourage participants to lobby or to 
instruct participants on how to lobby.
    In addition, the FY 1997 HHS Appropriations Act, which became 
effective October 1, 1996, expressly prohibits the use of 1997 
appropriated funds for indirect or ``grass roots'' lobbying efforts 
that are designed to support or defeat legislation pending before State 
legislatures. This new law, Section 503 of Pub. L. No. 104-208, 
provides as follows:
    Sec. 503(a) No part of any appropriation contained in this Act 
shall be used, other than for normal and recognized executive-
legislative relationships, for publicity or propaganda purposes, for 
the preparation, distribution, or use of any kit, pamphlet, booklet, 
publication, radio, television, or video presentation designed to 
support or defeat legislation pending before the Congress, . . . except 
in presentation to the Congress or any State legislative body itself.
    (b) No part of any appropriation contained in this Act shall be 
used to pay the salary or expenses of any grant or contract recipient, 
or agent acting for such recipient, related to any activity designed to 
influence legislation or appropriations pending before the Congress or 
any State legislature.
    Department of Labor, Health and Human Services, and Education, and 
Related Agencies Appropriations Act, 1997, as enacted by the Omnibus 
Consolidated Appropriations Act, 1997, Division A, Title I, Section 
101(e), Pub. L. No. 104-208 (September 30, 1996).

Definitions and Background

Definitions

    An alcohol-exposed pregnancy is one in which a woman consumes 
moderate to heavy amounts of alcohol, or engages in binge drinking 
during the pregnancy. Moderate amounts of alcohol are defined as 7-13 
drinks per week; heavy amounts of alcohol are defined as 14 or more 
drinks per week; and binge drinking is defined as 5 or more drinks on 
any one occasion. A woman who is at high risk for an alcohol-exposed 
pregnancy is one who engages in moderate to heavy alcohol use or binge 
drinking, is sexually active, and is not effectively practicing 
contraception. A high-risk setting is any site in which a large 
proportion of the women served in the site meet the above definition of 
high risk.

Background

    Fetal Alcohol Syndrome (FAS) is one of the leading preventable 
causes of birth defects and developmental disabilities in the United 
States. In addition to FAS, which is caused by heavy prenatal alcohol 
use, studies have documented more subtle growth and neurodevelopmental 
deficits among

[[Page 28028]]

children whose mothers drank at lower levels (equivalent to seven 
drinks per week during pregnancy). Reported prevalence rates for 
alcohol use by women during pregnancy include 18 percent (National 
Institute of Drug Abuse (NIDA)) to 20 percent (National Center for 
Health Statistics (NCHS)) for any reported use; 1 percent for moderate-
heavy use (7 drinks per week or greater) (Behavioral Risk Factor 
Surveillance System (BRFSS)); and 2 percent for binge drinking (5 or 
more drinks on any one occasion) (BRFSS). Reported rates of alcohol use 
for childbearing-age women in general include 45 percent for any 
reported use (NCHS); 5 percent for 7 or more drinks per week (BRFSS); 
and 11 percent for binge drinking (BRFSS).
    Important risk factors associated with heavy alcohol use among 
childbearing-age women include use of tobacco and other drugs, co-
existing psychiatric conditions, history of sexual or physical abuse 
during childhood and/or adulthood, and a previous alcohol-exposed 
pregnancy. CDC studies have found that the strongest predictor of 
alcohol use during pregnancy is the level of alcohol use prior to 
pregnancy. Women who were drinking 9 or more drinks per week before 
pregnancy were 5 times more likely to drink during pregnancy than those 
who were drinking 2 drinks per week or less prior to pregnancy. Other 
CDC studies using data from the NCHS and the BRFSS have identified 
additional socio-demographic and maternal characteristics associated 
with moderate-heavy alcohol use during pregnancy. These include, but 
are not limited to, women who: are age 35 years and older; are members 
of minority race-ethnicity groups; have an annual household income of 
$l0,000 or less; currently smoke; or receive no prenatal health care.
    Previous CDC efforts have shown that collaboration among grantees, 
CDC program personnel, and experts external to CDC, has been successful 
in developing effective interventions that address complex behaviors. 
An essential strategy for preventing alcohol-exposed pregnancies among 
women who are heavy alcohol users is referral for alcohol treatment 
services. However, given the high relapse rate among problem drinkers 
(50 percent), such efforts must be coupled with strategies which 
address pregnancy postponement until the risk of prenatal alcohol use 
can be overcome. Among women who are drinking at moderate levels, but 
levels that could be hazardous if pregnant, a reduction in drinking 
level may be possible with simple advice and counseling from a health 
care provider. However, among both groups of women, family planning 
health education and services should be provided to facilitate 
postponement of pregnancy until the alcohol level is reduced.
    Recent research has shown that brief interventions to facilitate 
reduction in alcohol use which incorporate assessment, feedback, 
consequences of behavior and self-help materials for goal setting and 
behavior change can reduce problem drinking among clients in health 
care settings. Other successful approaches have focused on creating 
conditions which assist clients in reducing their ambivalence about 
changing a health risk behavior, which results in a stronger commitment 
to change.
    Studies in contraceptive decision making and in the promotion of 
condom use in the prevention of sexually transmitted diseases have 
employed a cognitive model, Theory of Reasoned Action (TRA), in 
designing successful behavior change interventions. Knowledge gained 
from studies employing these and other approaches may have important 
implications for the design of innovative interventions for assisting 
childbearing-age women to avoid alcohol use during pregnancy by 
engaging participants in a dual program which addresses high-risk 
drinking and pregnancy postponement.

Purpose

    The purposes of this announcement are to:
    A. Identify settings which have a high proportion of women who 
binge drink and/or drink alcohol at moderate to heavy levels and are at 
risk of pregnancy.
    B. Develop, implement and evaluate interventions which assist binge 
drinkers and/or moderate to heavy drinkers in reducing their drinking 
below risk levels and actively engage all clients in a plan for 
pregnancy postponement until risk drinking or alcohol abuse problems 
have been addressed.
    C. Disseminate, as appropriate, generalizable interventions for the 
prevention of alcohol-exposed pregnancies.
    Settings in which high-risk populations may be accessed include 
Sexually Transmitted Disease (STD) clinics, Women, Infants, and 
Children (WIC) clinics, mental health programs, social services 
settings, drug and alcohol treatment centers, and correctional systems. 
In addition, hospitals with high prevalence rates of prenatal alcohol 
use among their obstetrical populations may constitute an important 
setting for identifying women at high risk for an alcohol-exposed 
pregnancy.
    The intervention to be developed will include: (1) counseling 
regarding the consequences of alcohol use during pregnancy; (2) brief 
advice and counseling for moderate to heavy drinkers to reduce intake 
levels or referral to treatment options in the community for alcohol-
dependent drinkers; and (3) reproductive health education regarding 
contraceptive methods, provision of contraceptive services, and client 
follow-up. Interventions will be designed to be delivered to high-risk 
clients in the clinic or agency setting by project personnel.

Program Requirements

    The applicant must:
    Identify two different high-risk settings in which epidemiologic 
and intervention activities will be conducted. Applicants must justify 
their choice of each high-risk setting with prevalence rates that 
demonstrate problem drinking among the target population. Each setting 
should document an annual population of at least 500 high-risk women. 
The applicant must implement and evaluate model interventions for 
preventing alcohol-exposed pregnancies in these two settings. 
Intervention demonstration activities must be conducted in a cohort of 
50-100 high-risk women.
    An affirmative response to the above requirement is required to 
qualify for the full objective review. This page should be included as 
the first page of the application and titled ``Program Requirements.''

Cooperative Activities

    In conducting activities to achieve the purpose of this cooperative 
agreement, the recipient will be responsible for the activities under 
A. (Recipient Activities) below, and CDC will be responsible for 
activities under B. (CDC Activities) below:

A. Recipient Activities

    1. Collaborate with other cooperative agreement recipients to:
    a. Design study activities which include developing an 
epidemiologic survey and model interventions (including protocols) 
which will be implemented in the targeted populations.
    b. Develop data collection instruments, study procedures, and an 
evaluation plan to determine the effectiveness of the interventions.
    2. Implement an epidemiologic survey which characterizes the target

[[Page 28029]]

population in terms of the prevalence and patterns of alcohol use, 
prevalence of characteristics associated with heavy alcohol use, 
reproductive health status (e.g., parity, contraceptive practices, 
current sexual activity, fertility), alcohol treatment histories, and 
psychiatric co-morbidities.
    3. Collect and analyze information that describes barriers to 
contraception and to alcohol abuse treatment among the target 
population including:
    a. Knowledge, attitudes, and beliefs about alcohol use, 
contraception, and alcohol use during pregnancy;
    b. Accessibility of services for contraception and dealing with 
alcohol abuse problems;
    c. Peer group norms toward alcohol use and use of contraceptives; 
and
    d. Sexual partner and family member attitudes toward contraception 
and alcohol use.
    4. Implement a model intervention in the high-risk target sites, 
including quality assurance (QA) procedures to assure that protocols 
for piloted interventions are being properly implemented.
    5. In Year 03 of the project, participate in a meeting with other 
funded sites to define the most promising approaches which should be 
incorporated into a common intervention protocol for possible testing 
in a randomized clinical trial.
    6. Develop a manuscript describing the target populations chosen by 
the applicant and the results of the specific interventions tested by 
the individual applicant.
    7. Collaborate with other funded study sites in developing a single 
manuscript collectively describing the various interventions piloted in 
the various high-risk settings by applicants funded under this 
cooperative agreement.

B. CDC Activities

    CDC staff will collaborate with cooperative agreement recipients, 
providing guidance and coordination throughout the duration of the 
project. Activities that will be conducted by the CDC include:
    1. Participate in developing protocols for the epidemiologic survey 
of the targeted sites and the intervention to be tested; outline data 
to be collected at the targeted sites; develop standardized data 
collection instruments and procedures; and establish a timetable for 
study activities.
    2. Assist in the overall coordination of the development, 
implementation, and evaluation of the intervention.
    3. Provide leadership and current scientific information on 
relevant intervention approaches and provide oversight of epidemiologic 
and intervention research design to ensure adherence to appropriate 
scientific standards.
    4. Conduct periodic site visits to observe and discuss development 
and implementation of study activities.
    5. Coordinate the compilation of a monograph and other documents 
describing interventions tested and resulting recommendations, to be 
distributed appropriately.
    6. Maintain a multi-site data base to develop reports and other 
publications, when appropriate.
    7. Cooperate in preparation and publication of study results.

Technical Reporting Requirements

    An original and two copies of semiannual progress reports are 
required of all grantees. Time lines for the semiannual reports will be 
established at the time of award. An original and 2 copies of the 
Financial Status Report (FSR) are required no later than 90 days after 
the end of the budget period. A final program report and FSR are due no 
later than 90 days after the end of the project period. All reports 
will be submitted to the Grants Management Branch, Procurement and 
Grants Office, CDC.

Application Content

    Applications must be developed in accordance with PHS Form 5161-1 
(Revised 7/92, OMB Number 0937-0189). All material must be typewritten, 
double-spaced pages, with type no smaller than 10 CPI (12 point), on 
8.5'' x 11'' paper, with at least 1'' margins, headings and footers, 
unbound and printed on one side only. Number each page clearly, and 
provide a complete index to the application and appendices. Do not 
include any spiral or bound materials or pamphlets. All graphics, maps, 
overlays, etc., should be in black and white and meet the above 
criteria.
    The first page of the application should contain the response to 
the Program Requirements section and be marked ``Program 
Requirements.''
    The applicant should provide a detailed description of first-year 
activities and briefly describe future-year objectives and activities. 
Do not include a detailed budget or detailed budget justification as 
part of the Program Narrative.

A. Abstract

    A one-page, single-spaced, typed abstract must be submitted with 
the application. The heading should include the title of the grant 
program, project title, organization name and address, project director 
and telephone number. The abstract should briefly summarize the program 
for which funds are requested, the activities to be undertaken, and the 
applicant's organization and composition. The abstract should follow 
the printed forms and precede the Program Narrative.

B. Program Narrative (Not to Exceed 25 Pages)

    The Program Narrative Section should not exceed 25, double-spaced 
pages (excluding attachments). The program narrative should address the 
following:
    1. Background: Briefly describe:
    a. Understanding of the problem of FAS and other conditions 
associated with prenatal alcohol use, and why the applicant is 
interested in participating in a project aimed at preventing alcohol-
exposed pregnancies;
    b. Sociodemographic characteristics of the population of 
childbearing-age women targeted by the applicant including age 
distribution, race/ ethnicity, marital status, parity, income, 
education, and behavioral characteristics available (e.g., smoking 
status);
    c. Alcohol use patterns of the women in the target group including 
levels (e.g., moderate, heavy, and binge drinking) and patterns of use 
among pregnant and non-pregnant women, rates of alcoholism, rates of 
alcohol treatment, and any other relevant data available (i.e., 
alcohol-related injuries and deaths);
    d. Reproductive patterns of the targeted population including 
number of live births per year, abortion rates, fertility rates, 
prenatal care rates, and contraceptive use rates;
    e. Geographic area in which the clients reside (urban, rural), 
transportation systems available, etc.;
    f. Full range of services supplied to the target population by the 
applicant;
    g. Other general health care resources available to clients in the 
target population as well as specific services for alcohol treatment 
and family planning.
    2. Organization: Briefly describe:
    a. How the applicant will access women in the high-risk settings 
being targeted;
    b. Current working relationship between the applicant and the 
public health department, family planning service providers, and 
alcohol and substance abuse treatment providers as appropriate;
    c. Proposed organization structure, with lines of authority, for 
implementing and managing the study activities. Staff should include a

[[Page 28030]]

principal investigator (recommend at least 10 percent time of an 
individual at the doctorate level with published research to provide 
oversight); a project coordinator who oversees all study activities 
including the epidemiologic component; an intervention coordinator who 
assures implementation of the model intervention and oversees data 
collection for this component; data entry and clerical support;
    d. Current working relationship with any research, academic, or 
scientific groups, or community-based or other affiliated 
organizations;
    e. Strategy for recruitment of study participants in the target 
group;
    f. Plans for conducting this study while meeting other current 
clinical or research commitments;
    g. 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 institution review committees;
    h. The proposed plan for the inclusion of racial and ethnic 
minority populations for appropriate representation.
    3. Capacities: Describe the capacity and experience of the 
applicant and the clinical/agency site(s) in which the intervention 
study will be conducted including:
    a. Description of previous behavioral and women's health research 
conducted;
    b. Description of the setting in which participants will be 
recruited into the study, and the commitment to designate office and 
operating space for the study;
    c. Commitment to begin study implementation by January 1, 1998, 
including letters of commitment from study sites to begin participation 
by this date.
    4. Current Level of Service Delivery: Provide data from the past 
year on the following:
    a. The number of women in the high-risk target group who are seen/
accessed annually by the applicant (e.g., must see at least 500 high-
risk women per year in each setting);
    b. Proportion of clients seen in one year who are ongoing versus 
new (intervention implementation requires the ability to track 50-100 
high-risk women over one year);
    c. Rate of return appointments versus those lost to follow-up;
    d. Description of any other studies currently under way in the 
proposed study site.
    5. Approach:
    a. Describe, in summary, the approach to be taken by the applicant 
in implementing this cooperative agreement including identification of 
appropriate staff to perform essential study activities; recruitment of 
participants for intervention implementation; delivery of the essential 
components of the intervention; follow-up of clients in the 
intervention project; and quality assurance of quantitative data 
collected and protocol implementation.
    b. Identification of potential problem areas in the implementation 
of survey and intervention activities in projected study sites.
    6. Assurances: The applicant must provide the following:
    a. Assurance that study documents will be handled and stored to 
ensure confidentiality and assure retention;
    b. Assurance that project staff will be hired in a timely manner;
    c. Assurance that key project personnel (or designees if the 
individuals filling these positions have not been employed at the time) 
will meet with CDC in Atlanta within 1 month of award to discuss 
initial study activities.
    7. Budget and Line-Item Justification: This section must include a 
detailed first-year budget and narrative justification with future 
annual projections. The applicant should describe the program purpose 
for each budget item. For contracts contained within the application 
budget, applicants should name the contractor, if known; describe the 
services to be performed; justify the use of a third party; and provide 
a breakdown of and justification for the estimated costs of the 
contracts, the kinds of organizations or parties to be selected, the 
period of performance, and the method of selection.
    Budget should include travel for the key study personnel to meet 3 
times per year with CDC and may include incentives for subjects to 
maintain participation in study activities.

Review and Evaluation Criteria

    Upon receipt, applications will be reviewed by CDC staff for 
completeness and affirmative response as outlined under the previous 
heading, ``Program Requirements.'' Incomplete applications and 
applications that are not responsive will be returned to the applicant 
without further consideration.
    An Objective Review of applications that are successful in the 
preliminary review will then be conducted according to the following 
criteria:

A. Applicant's Understanding of the Problem (20%)

    The extent to which the applicant demonstrates an understanding of 
the problem of FAS and other alcohol-related birth defects, alcohol use 
patterns of childbearing-age women, and the maternal risk factors which 
contribute to harmful alcohol use during pregnancy. Also, a 
demonstrated understanding of the process of changing alcohol use 
behavior and of why pregnancy postponement is an important strategy for 
preventing alcohol-exposed pregnancies.

B. Description of the Target Population and Outline of Approach (50%)

    The extent to which the applicant has provided a full and 
comprehensive description of the target population, including available 
statistics which provide reasonable justification for designating the 
group targeted as high risk for an alcohol-exposed pregnancy, as well 
as an overall description of the approach to be taken in conducting the 
epidemiologic survey and delivering the model interventions. How the 
applicant will address alcohol assessment, counseling and referral for 
problem drinking, and provision of family planning services to high-
risk clients should be clearly stated. Applicant must also provide 
adequate demonstration of its ability to access a study population of 
at least 500 high-risk women annually, and to follow a cohort of 50-100 
high-risk women for intervention activities.
    The degree to which the applicant has met the CDC Policy 
requirements regarding the inclusion of women, ethnic, and racial 
groups in the proposed project. This includes: (a) The proposed plan 
for the inclusion of racial and ethnic minority populations for 
appropriate representation; (b) The proposed justification when 
representation is limited or absent; (c) A statement as to whether the 
design of the study is adequate to measure differences when warranted; 
and (d) A statement as to whether the plans for recruitment and 
outreach for study participants include the process of establishing 
partnerships with community(ies) and recognition of mutual benefits.

C. Capacity to Conduct Project Activities and Begin Study Operations in 
a Timely Fashion (30%)

    The extent to which the applicant has provided information to 
support its ability to conduct the activities of the cooperative 
agreement including documentation of previous research experience in 
behavioral science research focusing on women's health issues, and/or 
addictive disorders; documentation of institutional support for the 
project; demonstrated ability to

[[Page 28031]]

identify qualified personnel to fill key positions (including principal 
investigator, project coordinator, and intervention coordinator) and 
begin study activities in a timely fashion; and a description of how 
space required for the study will be acquired or designated.

D. Budget Justification and Adequacy of Facilities (Not Scored)

    The budget will be evaluated for the extent to which it is 
reasonable, clearly justified, and consistent with the intended use of 
the cooperative agreement funds. The applicant shall describe and 
indicate the availability of facilities and equipment necessary to 
carry out this project.

E. Human Subjects Review (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.

Funding Preferences

    In making awards, priority consideration may be given to: (1) 
ensuring a racial/ethnic balance; and (2) ensuring rural, urban, and 
national geographic distribution among the grantees.

Executive Order 12372 Review

    Applications are subject to the 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 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 of each affected State. A 
current list of SPOCs is included in the application kit. If SPOCs have 
any State process recommendations on applications, they should 
reference Announcement 746 and forward them to 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 321, Mailstop E-13, Atlanta, Georgia 30305, 
no later than 60 days after the application deadline date. The granting 
agency 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 reference Announcement 746 and forward them to 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 321, Mailstop E-13, Atlanta, Georgia 
30305, no later than 60 days after the application deadline date. The 
granting agency does not guarantee to ``accommodate or explain'' 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(ies) 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 (SF424).
    B. A summary of the project that should be titled ``Public Health 
System Impact Statement'' (PHSIS), not to exceed one page, and include 
the following:
    1. A description of the target population(s) to be served;
    2. A summary of primary prevention activities to be implemented and 
evaluated;
    3. A description of the coordination plans with the community 
working partners for developing, implementing, and evaluating the 
primary prevention activities.
    If the State and/or local health official should desire a copy of 
the entire application, it may be obtained from the SPOC or directly 
from the applicant.

Catalog of Federal Domestic Assistance Number

    The Catalog of Federal Domestic Assistance number assigned to this 
program is 93.283.

Other Requirements

A. Paperwork Reduction Act

    Projects that involve the collection of information from 10 or more 
individuals and funded by this cooperative agreement program will be 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act.

B. Human Subjects

    If the proposed project involves 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 with the 
appropriate 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.

C. Confidentiality

    All personal identifying information obtained in connection with 
the delivery of services provided to any person in any program carried 
out under this cooperative agreement cannot be disclosed unless 
required by a law of a State or political subdivision or unless such a 
person provides written, voluntary informed consent.
    1. Nonpersonal identifying, unlinked information, which preserves 
the individual's anonymity, derived from any such program may be 
disclosed without consent:
    a. In summary, statistical, or other similar form, or
    b. For clinical or research purposes.
    2. Personal identifying information: Recipients of CDC funds who 
must obtain and retain personally identifying information as part of 
their CDC-approved work plan must:
    a. Maintain the physical security of such records and information 
at all times;
    b. Have procedures in place and staff trained to prevent 
unauthorized 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

[[Page 28032]]

    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 
DHHS certificate of confidentiality may be required for some projects.

D. Women, Racial and Ethnic Minorities

    It is the policy of the Centers for Disease Control and Prevention 
(CDC) to ensure that individuals of 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.

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 July 22, 1997.
    A. Deadline: 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 independent review group. (Applicant must request a 
legible dated U.S. Postal Service postmark or obtain a legible dated 
receipt from a commercial carrier or U.S. Postal Service. Private 
metered postmarks shall not be acceptable proof of timely mailing.)
    B. Late Applications: Applications which do not meet the criteria 
in A.1. or 2., are considered late applications. Late applications will 
not be reviewed 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 phone number and will need to 
refer to Announcement 746. A complete program description and 
information on application procedures are contained in the application 
package. Business management technical assistance, and an application 
package 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, Georgia 30305, telephone (404) 842-
6535; Internet: [email protected].
    FAS programmatic assistance may be obtained from Dr. Louise Floyd 
at telephone (770) 488-7370, Internet: [email protected], or Gregg Leeman at 
telephone (770) 488-7268, Internet: [email protected], 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-15, Atlanta, Georgia 30341-3724.
    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 746 when requesting information 
and submitting an application.
    Potential applicants may obtain a copy of ``Healthy People 2000'' 
(Full report; Stock No. 017-001-00474-0) or ``Healthy People 2000'' 
(Summary report; Stock No. 017-001-00473-1) referenced in the 
``Introduction'' through the Superintendent of Documents, Government 
Printing Office, Washington, DC 20402-9325, telephone (202) 512-1800.

    Dated: May 16, 1997.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 97-13428 Filed 5-21-97; 8:45 am]
BILLING CODE 4163-18-P