[Federal Register Volume 67, Number 90 (Thursday, May 9, 2002)]
[Notices]
[Pages 31323-31326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-11559]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 2072]


Multi-Level Parent Training Effectiveness Trial; Notice of 
Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2002 funds for a cooperative agreement 
or grant program for a Multi-level Parent Training Effectiveness Trial 
to test the implementation of a culturally sensitive and responsive 
parenting program to prevent child maltreatment, specifically child 
physical abuse and neglect. This program addresses the ``Healthy People 
2010'' focus area of injury and violence prevention.
    The purpose of this program is to examine the effectiveness of a 
multi-level parent training program for families with children ages six 
and younger. The research trial will test the effectiveness of a multi-
level intervention program that promotes positive parenting strategies 
in order to prevent child maltreatment. As an effectiveness trial, the 
program is required to examine the broad implementation of 
interventions with demonstrated efficacy rather than to test the 
efficacy of new interventions. The program must examine effects both 
with the individuals directly involved in the interventions, and the 
larger community in which the intervention program is implemented.
    Measurable outcomes of the program will be in alignment with the 
following performance goal for the National Center for Injury 
Prevention and Control: Reduce the risk of child maltreatment.

Methodology

    This cooperative agreement seeks methodologically rigorous 
proposals rigorous designs and direct measures of outcomes with 
extended follow up. Rigorous designs could include experimental designs 
in which families, communities, or other units are randomly assigned to 
the intervention group (with level to be determined by assessment) and 
control or comparison groups, or strong quasi-experimental designs in 
which families, communities, or other units are matched appropriately. 
Minimally, applicants are required to justify their use of the research 
design chosen, and should discuss the merits of the design with respect 
to attributing changes in behavior to the interventions.
    Minimally, applicants are required to conduct measurement pre and 
post-intervention, and one year after the intervention for intervention 
and control/comparison group. Repeated measurement should be 
considered. Measures may require sampling both the individuals directly 
involved in the intervention, and a larger community sample in order to 
examine community-wide effects of the intervention program. For 
example, assessing a community-wide media campaign would require 
community sampling to measures exposure and impact.
    Applicants must include measures of both the positive parenting 
strategies the interventions seek to change and measures of child 
maltreatment. Direct measures of parenting strategies (i.e., behavioral 
observations) utilizing methods such as time sampling or interval 
recording are required, as are child maltreatment incident reports to 
measure program effects on child maltreatment. Standardized, validated

[[Page 31324]]

indirect measures of parenting and child outcomes are also required 
(e.g., ECBI, CBCL, PPI, PSI), along with proxy measures for child 
maltreatment (e.g., CAPI). Finally, measures of social validity (Wolf, 
1978) should be used to assess participant reaction to the goals, 
process, and outcomes of the interventions. Additional measures may of 
course be included at the applicant's discretion.
    Applicants are required to clearly state plans to ensure 
intervention fidelity. Specifically, applicants must describe plans for 
ensuring that the curriculum is implemented as it has been designed. 
Applicants should also describe plans to assess whether staff have been 
successfully trained (i.e., Can staff demonstrate intervention 
delivery?) and whether parents have been successfully trained (i.e., 
Can parents demonstrate the parenting skills taught?). Intervention 
programs that have certification for those trained to deliver the 
intervention are preferred.

B. Eligible Applicants

Maximum Competition

    Applications may be submitted by public and private nonprofit 
organizations and by governments and their agencies; that is, 
universities, colleges, technical schools, research institutions, 
hospitals, other public and private nonprofit organizations, community-
based organizations, faith-based organizations, State and local 
governments or their bona fide agents, including the District of 
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the 
Commonwealth of the Northern Mariana Islands, American Samoa, Guam, the 
Federated States of Micronesia, the Republic of the Marshall Islands, 
and the Republic of Palau, federally recognized Indian Tribal 
Governments, Indian Tribes, or Indian Tribal Organizations.

    Note: Title 2 of the United States Code section 1611 states that 
an organization described in section 501(c)(4) of the Internal 
Revenue Code that engages in lobbying activities is not eligible to 
receive Federal funds constituting an award, grant or loan.

C. Availability of Funds

    Approximately $1.5 million is available in FY 2002 to fund one 
award. It is expected that the award will begin on or about September 
30, 2002, and will be made for a 12 month budget period within a 
project period of up to five years. Funding estimates may change.
    Continuation awards within an approved project period will be made 
on the basis of satisfactory progress as evidenced by required reports 
and the availability of funds.

D. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities under 1. Recipient 
Activities, and CDC will be responsible for the activities listed under 
2. CDC Activities.

1. Recipient Activities

    (a) Design and conduct research to address the described goals of 
this cooperative agreement. This may include formative research or 
pilot work.
    (b) Collaborate with CDC in the development of the human subjects 
protocol for the CDC Institutional Review Board (IRB), implementation 
and evaluation of project delivery.
    (c) Collaborate with CDC to write and disseminate reports of 
research activities to regional, state, and local partners.
    (d) Obtain approval of the study protocol by the recipient's local 
IRB.
    (e) Collaborate with CDC to analyze data, perform cost analyses, 
and publish findings in peer-reviewed journals.

2. CDC Activities

    (a) Provide scientific and technical assistance for the design and 
implementation of this research.
    (b) Collaborate with the grantee in the development of a research 
protocol for IRB review by all collaborating institutions. The CDC's 
IRB will review the protocol initially and on an annual basis until the 
project is complete.
    (c) Collaborate with the grantee in ensuring human subjects 
assurances are in place as needed.
    (d) Participate in the analysis and dissemination of study 
findings.
    (e) Monitor and evaluate the scientific and operational 
accomplishments of the project through conference calls, site visits, 
and review of technical reports.
    (f) Provide cost analyses of the design and implementation of this 
research.

E. Content

Letter of Intent (LOI)

    A LOI is optional for this program. The Program Announcement title 
and number must appear in the LOI. The narrative should be no more than 
two double spaced pages, printed on one side, with one inch margins, 
and unreduced font. The letter should identify the name of the 
principal investigator and briefly describe the scope and intent of the 
proposed research work. The letter of intent does not influence review 
or funding decisions, but the number of letters received will enable 
CDC to plan the review more effectively and efficiently.

Applications

    The Program Announcement title and number must appear in the 
application. Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop the 
application content. Your application will be evaluated on the criteria 
listed, so it is important to follow them in laying out your program 
plan. The narrative should be no more than 40 double spaced pages, 
printed on one side, with one inch margins, and unreduced font. The 
narrative should consist of, at a minimum, a Plan, Objectives, Methods, 
Evaluation and a detailed Itemized Budget.

F. Submission and Deadline

Letter of Intent (LOI)

    On or before June 1, 2002, submit the LOI to the Grants Management 
Specialist identified in the ``Where to Obtain Additional Information'' 
section of this announcement.

Application

    Submit the original and five copies of PHS-398 (OMB Number 0925-
0001) and adhere to the instructions on the Errata Instruction Sheet 
for PHS 398. Forms are available at the following Internet address: 
http://www.cdc.gov/od/pgo/forminfo.htm. Application forms must be 
submitted in the following order:

Cover Letter, Table of Contents, Application, Budget Information Form, 
Budget Justification, Checklist, Assurances, Certifications, Disclosure 
Form, Human Subjects Certification, Indirect Cost Rate Agreement, 
Narrative

    On or before 5 pm Eastern Time June 24, 2002, submit the 
application to the Technical Information Management Section: 2920 
Brandywine Road, Suite, 3000, Atlanta, Georgia 30341.
    Deadline: Applications shall be considered as meeting the deadline 
if they are received before 5 pm Eastern Time on the deadline date. 
Applicants sending applications by the United States Postal Service or 
commercial delivery services must ensure that the carrier will be able 
to guarantee delivery of the application by the closing date and time. 
If an application is received after closing due to the following (1) 
carrier error, when the carrier accepted the package with a guarantee 
for delivery by the closing date and time, or (2) significant weather 
delays or natural disasters, CDC will upon receipt of proper 
documentation, consider the

[[Page 31325]]

application as having been received by the deadline.
    Applications which do not meet the criteria will not be eligible 
for competition and will be discarded. Applicants will be notified of 
their failure to meet the submission requirements.

G. Evaluation Criteria

    Applicants are required to provide Measures of Effectiveness (i.e., 
rigorous designs and direct measures of outcomes with extended follow-
up). Rigorous designs could include experimental designs in which 
families, communities, or other units are randomly assigned tot he 
intervention group (with level to be determined by assessment) and 
control or comparison groups, or strong quasi-experimental designs in 
which families, communities, or other units are matched appropriately. 
Measures of Effectiveness must relate to the National Center for Injury 
Prevention and Control performance goal of reducing the risk of child 
maltreatment.
    Upon receipt, applications will be reviewed by CDC staff for 
completeness and responsiveness as outlined under the Eligible 
Applicants Section (Items 1-5). Incomplete applications and 
applications that are not responsive will be returned to the applicant 
without further consideration. It is especially important that the 
applicant's abstract reflects the project's focus, because the abstract 
will be used to help determine the responsiveness of the application.
    Applications which are complete and responsive may be subjected to 
a preliminary evaluation (triage) by a peer review committee, the 
Injury Research Grant Review Committee (IRGRC), to determine if the 
application is of sufficient technical and scientific merit to warrant 
further review by the IRGRC; CDC will withdraw from further 
consideration applications judged to be noncompetitive and promptly 
notify the principal investigator/program director and the official 
signing for the applicant organization. Those applications judged to be 
competitive will be further evaluated by a dual review process.
    Competitive supplemental grant awards may be made if end of fiscal 
year funds are available, to support research work or activities not 
previously approved by the IRGRC. Competitive supplement applications 
should be clearly labeled to denote their status as requesting 
supplemental funding support. These applications will be reviewed by 
the IRGRC and the secondary review group.
    All awards will be determined by the Director of the NCIPC based on 
priority scores assigned to applications by the primary review 
committee IRGRC, recommendations by the secondary review committee 
Advisory Committee for Injury Prevention and Control (ACIPC), 
consultation with NCIPC senior staff, and the availability of funds.
    1. The primary review will be a peer review conducted by the IRGRC. 
All applications will be reviewed for scientific merit using current 
National Institutes of Health (NIH) criteria to evaluate the methods 
and scientific quality of the application. Factors to be considered 
will include:
    (a) Significance. Does this study address an important problem? If 
the aims of the application are achieved, how will scientific knowledge 
be advanced? What will be the effect of these studies on the concepts 
or methods that drive this field?
    (b) Approach. Are the conceptual framework, design, methods, and 
analyses adequately developed, well-integrated, and appropriate to the 
aims of the project? Does the applicant acknowledge potential problem 
areas and consider alternative tactics? Does the project include plans 
to measure progress toward achieving the stated objectives? Is there an 
appropriate work plan included?
    (c) Innovation. Does the project employ novel concepts, approaches 
or methods? Are the aims original and innovative? Does the project 
challenge or advance existing paradigms, or develop new methodologies 
or technologies?
    (d) Investigator. Is the principal investigator appropriately 
trained and well-suited to carry out this work? Is the proposed work 
appropriate to the experience level of the principal investigator and 
other significant investigator participants? Is there a prior history 
of conducting injury-related research?
    (e) Environment. Does the scientific environment in which the work 
will be done contribute to the probability of success? Does the 
proposed research take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements? Is there 
evidence of institutional support? Is there an appropriate degree of 
commitment and cooperation of other interested parties as evidenced by 
letters detailing the nature and extent of the involvement?
    (f) Ethical Issues. What provisions have been made for the 
protection of human subjects and the safety of the research 
environments? How does the applicant plan to handle issues of 
confidentiality and compliance with mandated reporting requirements, 
e.g., suspected child abuse? Does the application adequately address 
the requirements of 45 CFR part 46 for the protection of human 
subjects? (An application can be disapproved if the research risks are 
sufficiently serious and protection against risks is so inadequate as 
to make the entire application unacceptable.) The degree to which the 
applicant has met the CDC Policy requirements regarding the inclusion 
of women, ethnic, and racial groups in the proposed research. This 
includes:
    1. The proposed plan for the inclusion of both sexes and 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.
    4. 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.
    (g) Study Samples. Are the samples sufficiently rigorously defined 
to permit complete independent replication at another site? Have the 
referral sources been described, including the definitions and 
criteria? What plans have been made to include women and minorities and 
their subgroups as appropriate for the scientific goals of the 
research? How will the applicant deal with recruitment and retention of 
subjects?
    (h) Dissemination. What plans have been articulated for 
disseminating findings?
    (i) Measures of Effectiveness. The Peer Review Panel shall assure 
that measures set forth in the application are in accordance with CDC's 
performance plans (See attachment 4). How adequately has the applicant 
addressed these measures?
    The IRGRC will also examine the appropriateness of the proposed 
project budget and duration in relation to the proposed research and 
the availability of data required for the project.
    2. The secondary review will be conducted by the Science and 
Program Review Committee (SPRS) from the ACIPC. The ACIPC Federal ex 
officio members will be invited to attend the secondary review and will 
receive modified briefing books (i.e., abstracts, strengths and 
weaknesses from summary statements, and project officer's briefing 
materials). Federal ex officio members will be encouraged to 
participate in deliberations when

[[Page 31326]]

applications address overlapping areas of research interest so that 
unwarranted duplication in federally funded research can be avoided and 
special subject area expertise can be shared. The NCIPC Division 
Associate Directors for Science (ADS) or their designees will attend 
the secondary review in a similar capacity as the Federal ex officio 
members to assure that research priorities of the announcement are 
understood and to provide background regarding current research 
activities. Only SPRS members will vote on funding recommendations, and 
their recommendations will be carried to the entire ACIPC for voting by 
the ACIPC members in closed session. If any further review is needed by 
the ACIPC, regarding the recommendations of the SPRS, the factors 
considered will be the same as the factors that the SPRS considered.
    The committee's responsibility is to develop funding 
recommendations for the NCIPC Director based on the results of the 
primary review, the relevance and balance of proposed research relative 
to the NCIPC programs and priorities, and to assure that unwarranted 
duplication of federally funded research does not occur. The Secondary 
Review Committee has the latitude to recommend to the NCIPC Director, 
to reach over better ranked proposals in order to assure maximal impact 
and balance of proposed research. The factors to be considered will 
include:
    (a) The results of the primary review including the application's 
priority score as the primary factor in the selection process.
    (b) The relevance and balance of proposed research relative to the 
NCIPC programs and priorities.
    (c) The significance of the proposed activities in relation to the 
priorities delineated in the National Research Agenda.
    (d) Budgetary considerations.

3. Continued Funding

    Continuation awards made after FY 2002, but within the project 
period, will be made on the basis of the availability of funds and the 
following criteria:
    (a) The accomplishments reflected in the progress report of the 
continuation application indicate that the applicant is meeting 
previously stated objectives or milestones contained in the project's 
annual work plan and satisfactory progress demonstrated through 
presentations at work-in-progress monitoring workshops.
    (b) The objectives for the new budget period are realistic, 
specific, and measurable.
    (c) The methods described will clearly lead to achievement of these 
objectives.
    (d) The evaluation plan will allow management to monitor whether 
the methods are effective.
    (e) The budget request is clearly explained, adequately justified, 
reasonable and consistent with the intended use of grant funds.

H. Other Requirements

Technical Reporting Requirements Applicants are required to provide 
Measures of Effectiveness that will demonstrate the accomplishment of 
the identified objectives of the cooperative agreement. Measures must 
be objective/quantitative, and must measure the intended outcome. These 
Measures of Effectiveness shall be submitted with the application and 
shall be an element of evaluation.

    Provide CDC with original plus two copies of
    1. Semiannual progress reports.
    2. Financial status report, no more than 90 days after the end of 
the budget period.
    3. Final financial and performance reports, no more than 90 days 
after the end of the project period.
    Send all reports to the Grants Management Specialist identified in 
the ``Where to Obtain Additional Information'' section of this 
announcement.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment I of the 
announcement.

AR-1  Human Subjects Requirements
AR-2  Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR-3  Animal Subjects Requirements
AR-4  HIV/AIDS Confidentiality Provisions
AR-5  HIV Program Review Panel Requirements
AR-6  Patient Care
AR-7  Executive Order 12372 Review
AR-8  Public Health System Reporting Requirements
AR-9  Paperwork Reduction Act Requirements
AR-10  Smoke-Free Workplace Requirements
AR-11  Healthy People 2010
AR-12  Lobbying Restrictions
AR-13  Prohibition on Use of CDC Funds for Certain Gun Control 
Activities
AR-14  Accounting System Requirements
AR-15  Proof of Non-Profit Status
AR-16  Security Clearance Requirement
AR-17  Peer and Technical Reviews of Final Reports of Health Studies--
ATSDR
AR-18  Cost Recovery--ATSDR
AR-19  Third Party Agreements--ATSDR
AR-20  Conference Support
AR-21  Small, Minority, Women-Owned Businesses
AR-22  Research Integrity

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under section 301, 317, and 391-394 of 
the Public Health Service Act, [42 U.S.C. sections 241, 247b, and 280b-
280b-3], as amended. The Catalog of Federal Domestic Assistance number 
is 93.136.

J. Where To Obtain Additional Information

    This and other CDC announcements can be found on the CDC home page 
Internet address--http://www.cdc.gov Click on ``Funding'' then ``Grants 
and Cooperative Agreements.''
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from: Angie N. Nation, Grants Management Specialist, Procurement and 
Grants Office, Centers for Disease Control and Prevention, 2920 
Brandywine Road, Room 3000, Atlanta, GA 30341-4146. Telephone number 
(770) 488-2719.
    e-mail address: [email protected].
    For program technical assistance, contact:
    Daniel Whitaker, Behavioral Scientist, Division of Violence 
Prevention, National Center for Injury Prevention and Control, Centers 
for Disease Control and Prevention, 4770 Buford Highway, NE., (K-60), 
Atlanta, GA 30341-3724. Telephone number: (770) 488-4267. e-mail 
address: [email protected].

    Dated: May 3, 2002.
Sandra R. Manning,
CGFM, Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 02-11559 Filed 5-8-02; 8:45 am]
BILLING CODE 4163-18-P