[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