[Federal Register Volume 68, Number 242 (Wednesday, December 17, 2003)]
[Notices]
[Pages 70273-70278]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-31083]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Efficacy Trials of Parenting Programs for Fathers

    Announcement Type: New.
    Funding Opportunity Number: 04055.
    Catalog of Federal Domestic Assistance Number: 93.136.
    Key Dates: Letter of Intent Deadline: January 16, 2004.
    Application Deadline: February 18, 2004.

I. Funding Opportunity Description

    Authority: This program is authorized under section 391(a)(1) of 
the Public Health Service Act, [42 U.S.C. section 280b(a)(1), as 
amended].
    Purpose: The purpose of the program is to examine the efficacy of 
parenting programs for high-risk fathers, expectant fathers, or father 
surrogates of children age birth to two and/or age three to five for 
the prevention of child maltreatment and the promotion of positive 
parenting behaviors. This program addresses the ``Healthy People 2010'' 
focus area of Injury and Violence Prevention.
    Measurable outcomes of the program will be in alignment with the 
following performance goal for the National Center for Injury 
Prevention and Control: Conduct a targeted program of research to 
reduce injury-related death and disability.
    Outcomes to be assessed include:
    [sbull] Knowledge and attitudes towards parenting, including 
perceptions of self-reported parenting competence;
    [sbull] Changes in daily parental behavior and parenting style;
    [sbull] Mothers' perceptions of fathers' support;
    [sbull] Mothers' and fathers' reports of fathers' involvement in 
care giving;
    [sbull] Incidence of neglect, and physical, sexual, and emotional 
abuse; and
    [sbull] Incidence of unintentional injuries.
    Research Objectives: Research suggests that most cases of serious 
child physical abuse and fatality are caused by fathers or father 
figures (Anderson, Ambrosino, Valentine, & Lauderdale, 1983; Bergman, 
Larsen, & Mueller, 1986; Brewster et al., 1998; Daley & Piliavin, 1982; 
Hicks & Gaughan, 1995; Jason & Andereck, 1983; Rosenthal, 1988). 
Although there is little research on the determinants of abuse among 
fathers or father figures, it appears that they may have similar 
characteristics to those of physically abusive mothers: greater 
perceived stress and distress, greater physiological reactivity, lack 
of social support, negative perceptions of their children, and 
inaccurate knowledge or expectations of developmentally appropriate 
complex child behaviors (Milner, 1998).
    Recruiting fathers in prevention programs is a major challenge. 
However, some prevention and awareness programs have been developed to 
teach experienced and new fathers the basics in caring for infants and 
young children. Such programs provide men with a safe environment to 
discuss their concerns about fatherhood and learn basic childcare 
skills. Participants report high rates of satisfaction and show low 
levels of attrition. However, more rigorous evaluation of such programs 
is needed to establish their potential impact.
    Research funded under this announcement is expected to address this 
important gap in the prevention literature (i.e., efficacy studies of 
interventions that are designed to reduce the above types of parenting 
characteristics). The ultimate aim of such an approach is to assess 
whether interventions designed to teach expectant, new, experienced, 
and surrogate fathers the basics in caring for infants and young 
children, can reduce risk factors for child maltreatment.
    At a minimum, competitive applicants will provide theoretical 
rationale and empirical evidence in support of a specific extant 
parenting course directed toward fathers whose intimate partners are 
currently expecting or have children under the age of five, and conduct 
a rigorous efficacy study.
    Priority will be given to efficacy studies of primary prevention 
parenting programs that focus on the determinants of abuse among 
expectant, new, experienced or surrogate fathers, over those that focus 
on criminal justice responses (e.g., arrest strategies).
    Priority will also be given to proposals that:
    [sbull] Propose more stringent and rigorous evaluation designs, 
including: Experimental and quasi-experimental designs with appropriate 
baseline/pre-intervention data, post-intervention data, and at least 
one follow-up collection point; data from at least one comparison or 
control group; and data from multiple sources.
    [sbull] Propose data analytic plans that are appropriate to the 
intervention, research design and hypotheses, data collection measures, 
and project period, and that anticipate and evaluate the effect of 
threats to the internal and external validity of the specified research 
design.
    [sbull] Target traditionally underserved communities.
    Activities: Awardee activities for this program are as follows:
    1. Design and conduct research, including formative research and 
pilot testing to address the described goals of this cooperative 
agreement.
    2. Collaborate with CDC scientists in the development of the human 
subjects protocol for the CDC Institutional Review Board (IRB) by all 
cooperating institutions participating in the research project.
    3. Obtain approval of the study protocol by the recipient's local 
IRB.
    4. Implement and evaluate project delivery.
    5. Write and disseminate reports of research activities to 
regional, state, and local partners.
    6. Conduct one reverse site visit to meet with CDC staff in Atlanta 
on an annual basis.
    7. Complete all required reports as specified under ``Reporting''.
    8. Analyze data and publish findings in peer-reviewed journals.
    In a cooperative agreement, CDC staff is substantially involved in 
the program activities, above and beyond routine grant monitoring.
    CDC Activities for this program are as follows:
    (1) Provide scientific and programmatic consultation. CDC will 
collaborate with project staff on decision-analyses, programmatic 
issues, and dissemination of the study results in publications and 
presentations.
    (2) Assist in the development of a research protocol for 
Institutional Review Board (IRB) review by all cooperating institutions 
participating in the research.
    (3) The CDC IRB will review and approve the protocol initially and 
on at least an annual basis until the research project is completed.
    (4) CDC staff will monitor and review scientific and operational 
accomplishments of the project through conference calls, site visits, 
and review of technical reports.

II. Award Information

    Type of Award: Cooperative Agreement. CDC involvement in this 
program is listed in the Activities Section above. Fiscal Year Funds: 
2004 Approximate Total Funding: $500,000.
    Approximate Number of Awards: One.
    Approximate Average Award: N/A.

[[Page 70274]]

    Floor of Award Range: $250,000.
    Ceiling of Award Range: $500,000.
    Anticipated Award Date: September 1, 2004.
    Budget Period Length: 12 months.
    Project Period Length: Four years.
    Throughout the project period, CDC's commitment to continuation of 
awards will be conditioned on the availability of funds, evidence of 
satisfactory progress by the recipient (as documented in required 
reports), and the determination that continued funding is in the best 
interest of the Federal Government.

III. Eligibility Information

    III.1. Eligible applicants: Applications may be submitted by public 
and private nonprofit and for profit organizations and by governments 
and their agencies, such as:
    [sbull] Public nonprofit organizations;
    [sbull] Private nonprofit organizations;
    [sbull] For profit organizations;
    [sbull] Small, minority, women-owned businesses;
    [sbull] Universities;
    [sbull] Colleges;
    [sbull] Research institutions;
    [sbull] Hospitals;
    [sbull] Community-based organizations;
    [sbull] Faith-based organizations;
    [sbull] Federally recognized Indian tribal governments;
    [sbull] Indian tribes;
    [sbull] Indian tribal organizations;
    [sbull] State and local governments or their Bona Fide Agents (this 
includes the District of Columbia, the Commonwealth of Puerto Rico, the 
Virgin Islands, the Commonwealth of the Northern Marianna Islands, 
American Samoa, Guam, the Federated States of Micronesia, the Republic 
of the Marshall Islands, and the Republic of Palau)
    [sbull] Political subdivisions of States (in consultation with 
States).
    A Bona Fide Agent is an agency/organization identified by the State 
as eligible to submit an application under the State eligibility in 
lieu of a State application. If you are applying as a bona fide agent 
of a State or local government, you must provide a letter from the 
State or local government as documentation of your status. Place this 
documentation behind the first page of your application form.
    III.2. Cost Sharing or Matching: Matching funds are not required 
for this program.
    III.3. Other Eligibility Requirements: If your application is 
incomplete or non-responsive to the requirements listed below, it will 
not be entered into the review process. You will be notified that your 
application did not meet submission requirements. The following 
applicant requirements are:
    [sbull] A principal investigator who has documented prior training 
and experience in conducting efficacy and effectiveness trials.
    [sbull] A principal investigator who has conducted research, 
published the findings in peer-reviewed journals, and has specific 
authority and responsibility to carry out the proposed project.
    [sbull] Demonstrated experience on the applicant's project team in 
conducting, evaluating, and publishing violence prevention and related 
research in peer-reviewed journals.
    [sbull] Effective and well-defined working relationships within the 
performing organization and with outside entities, which will ensure 
implementation of the proposed activities.
    [sbull] The overall match between the applicant's proposed research 
objectives and the program priorities as described under the heading, 
``Research Objectives''.
    [sbull] The requested funding amount should not be greater than the 
ceiling of the award range.
    [sbull] It is especially important to include an abstract that 
reflects the study's focus, because the abstract will be used to help 
determine the responsiveness of the application.
    [sbull] Principal investigators (PI's) are encouraged to submit 
only one proposal in response to this program announcement. With few 
exceptions (e.g., research issues needing immediate public health 
attention), only one application per PI will be funded under this 
announcement.

    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.

IV. Application and Submission Information

    IV.1. Address to Request Application Package: To apply for this 
funding opportunity, use application form PHS 398 (OMB number 0925-0001 
rev. 5/2001). Forms and instructions are available in an interactive 
format on the CDC web site, at the following Internet address: 
www.cdc.gov/od/pgo/forminfo.htm.
    Forms and instructions are also available in an interactive format 
on the National Institutes of Health (NIH) web site at the following 
Internet address: http://grants.nih.gov/grants/funding/phs398/phs398.html.
    If you do not have access to the Internet, or if you have 
difficulty accessing the forms on-line, you may contact the CDC 
Procurement and Grants Office Technical Information Management Section 
(PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to 
you.
    IV.2. Content and Form of Application Submission: Letter of Intent 
(LOI): CDC requests that you send a LOI if you intend to apply for this 
program. Although the LOI is not required, not binding, and does not 
enter into the review of your subsequent application, your LOI will be 
used to gauge the level of interest in this program, and to allow CDC 
to plan the application review. Your LOI must be written in the 
following format:
    [sbull] Maximum number of pages: Two;
    [sbull] Single spaced;
    [sbull] Font size: 12-point unreduced;
    [sbull] Paper size: 8.5 by 11 inches;
    [sbull] Page margin size: One inch;
    [sbull] Printed only on one side of page;
    [sbull] Written in English, avoid jargon.
    Your LOI must contain the following information:
    [sbull] Descriptive title of the proposed research;
    [sbull] Name, address, e-mail address and telephone number of the 
Principal Investigator;
    [sbull] Names of other key personnel;
    [sbull] Participating institutions;
    [sbull] Number and title of this Program Announcement (PA).
    Application: Follow the PHS 398 application instructions for 
content and formatting of your application. See Attachment 1 of this 
announcement for guidance on how to complete Form 398 for this Program 
Announcement.
    You must include a research plan with your application. The 
research plan should be no more than 25 pages (8.5 inches by 11 
inches), single-spaced, printed on one side only, with one-inch margins 
on all sides, and unreduced 12 point font.
    Your application will be evaluated on the criteria listed under 
Section V. Application Review Information, so it is important to follow 
them, as well as the Research Objectives and the Administrative and 
National Policy Requirements (AR's), in laying out your research plan.
    Your research plan should address activities to be conducted over 
the entire project period. The research plan should consist of the 
following information: 1. Abstract. It is especially important to 
include an abstract that reflects the study's focus, because the 
abstract will be used to help determine the responsiveness of the 
application.
    2. Program Goals and Objectives. Describe the goals and objectives 
the proposal is designed to achieve in the short and long term. 
Specific research

[[Page 70275]]

questions and hypotheses should also be included.
    3. Program Participants. Describe the population from which the 
sample will be drawn and the method by which they will be selected. In 
addition, the proposal should provide evidence that the recipient (or 
collaborating partner) has access to the target population, and that 
participation in the fathering program will be adequate.
    4. Intervention. Describe the proposed strategies or components of 
the intervention and the plan for implementing the efficacy study. 
Proposals should explicate the theoretical and empirical justification 
for the potential effectiveness of the intervention for reducing child 
maltreatment. The proposal should describe incidence, prevalence, 
morbidity, and/or mortality rates associated with child maltreatment 
within the location or setting in which the intervention component(s) 
will occur, and describe the relevance of this setting to the strategy 
and desired outcomes.
    5. Evaluation Design. Describe the proposed design, methods and 
analysis plan for assessing the efficacy of the intervention. The 
specific type of evaluation method chosen should reflect the nature of 
the intervention, feasibility, and ethical considerations. Potential 
threats to the validity of the study should be described along with how 
such threats will be recognized and addressed. The status of all 
necessary measurement instruments should be described. If any materials 
are not extant, the methods and time frame for measure development, 
pilot testing, and validation should be given. For data collected from 
archival records (e.g., hospital records, police records, etc.) the 
proposal should discuss issues of accessibility, reliability, and 
validity of those data.
    6. Project Management. Provide evidence of the expertise, capacity, 
and community support necessary to successfully implement the efficacy 
study of programs for fathers or father surrogates. Each existing or 
proposed position for the project should be described by job title, 
function, general duties, level of effort and allocation of time. 
Management operation principles, structure, and organization should 
also be noted.
    7. Collaborative Efforts. List and describe the current and 
proposed collaborations with government, health, or children's 
agencies, community- or faith-based organizations, minority 
organizations, and other researchers. Include letters of support and 
memoranda of understanding that specify the nature of past, present, 
and proposed collaborations, and the products/services/activities that 
will be provided by and to the applicant.
    8. Data sharing and release: Describe plans for the sharing and 
release of data (See AR-25 for additional information).
    9. Project Budget. Provide a detailed budget for each activity 
undertaken, with accompanying justification of all operating expenses 
that is consistent with the stated objectives and planned activities of 
the project. This program announcement does not use the modular budget 
format.
    You are required to have a Dun and Bradstreet Data Universal 
Numbering System (DUNS) number to apply for a grant or cooperative 
agreement from the Federal government. Your DUNS number must be entered 
in item 11 of the face page of the PHS 398 application form. The DUNS 
number is a nine-digit identification number, which uniquely identifies 
business entities. Obtaining a DUNS number is easy and there is no 
charge. To obtain a DUNS number, access www.dunandbradstreet.com or 
call 1-866-705-5711. For more information, see the CDC web site at: 
http://www.cdc.gov/od/pgo/funding/pubcommt.htm.
    IV.3. Submission Dates and Times: LOI Deadline Date: January 16, 
2004. Application: February 18, 2004.
    Explanation of Deadlines: Applications must be received in the CDC 
Procurement and Grants Office by 4 p.m. Eastern Time on the deadline 
date. If you send your application by the United States Postal Service 
or commercial delivery service, you must ensure that the carrier will 
be able to guarantee delivery of the application by the closing date 
and time. If CDC receives your application after closing due to: (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, you will be given the opportunity to 
submit documentation of the carrier's guarantee. If the documentation 
verifies a carrier problem, CDC will consider the application as having 
been received by the deadline.
    This announcement is the definitive guide on application submission 
address and deadline. It supersedes information provided in the 
application instructions. If your application does not meet the 
deadline above, it will not be eligible for review, and will be 
discarded. You will be notified that your application did not meet the 
submission requirements.
    CDC will not notify you upon receipt of your application. If you 
have a question about the receipt of your application, first contact 
your courier. If you still have a question, contact the PGO-TIM staff 
at: 770-488-2700. Before calling, please wait two to three days after 
the application deadline. This will allow time for applications to be 
processed and logged.
    4. Intergovernmental Review of Applications: Executive Order 12372 
does not apply to this program.
    5. Funding Restrictions: Restrictions, which must be taken into 
account while writing your budget, are as follows: None.
    If you are requesting indirect costs in your budget, you must 
include a copy of your indirect cost rate agreement. If your indirect 
cost rate is a provisional rate, the agreement must be less than 12 
months of age.
    6. Other Submission Requirements: LOI Submission Address: Submit 
your LOI by express mail, delivery service, fax, or e-mail to: Robin 
Forbes, CDC, NCIPC, 4770 Buford Hwy, NE, Mailstop K-62, Atlanta, GA 
30341, Phone: 770-488-4037, Fax: 770-488-1662, Email: [email protected].
    Application Submission Address: Submit the signed original and five 
copies of your application by mail or express delivery service to: 
Technical Information Management--PA 04055, CDC Procurement 
and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
    Applications may not be submitted electronically at this time.

V. Application Review Information

    V.1. Criteria: You are required to provide measures of 
effectiveness that will demonstrate the accomplishment of the various 
identified objectives of the cooperative agreement. Measures of 
effectiveness must relate to the performance goals stated in the 
``Purpose'' section of this announcement. Measures must be objective 
and quantitative, and must measure the intended outcome. These measures 
of effectiveness must be submitted with the application and will be an 
element of evaluation.
    The goals of CDC-supported research are to advance the 
understanding of biological systems, improve the control and prevention 
of disease, and enhance health. In the written comments, reviewers will 
be asked to evaluate the application in order to judge the likelihood 
that the proposed research will have a substantial impact on the 
pursuit of these goals.
    The scientific review group will address and consider each of the 
following criteria in assigning the application's overall score, 
weighting

[[Page 70276]]

them as appropriate for each application. The application does not need 
to be strong in all categories to be judged likely to have major 
scientific impact and thus deserve a high priority score. For example, 
an investigator may propose to carry out important work that by its 
nature is not innovative, but is essential to move a field forward.
    The criteria are as follows:
    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?
    Approach: Are the conceptual framework, design, methods, and 
analyses adequately developed, scientifically rigorous, well 
integrated, and appropriate to the aims of the project? Does the 
applicant acknowledge potential problem areas and consider alternative 
tactics?
    Innovation: Does the project employ novel concepts, approaches or 
methods? Are the aims original and innovative? Does the project 
challenge existing paradigms or develop new methodologies or 
technologies?
    Investigator: Is the investigator appropriately trained and well 
suited to carry out this work? Is the work proposed appropriate to the 
experience level of the principal investigator and other researchers 
(if any)?
    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?
    Additional Review Criteria: In addition to the above criteria, the 
following items will be considered in the determination of scientific 
merit and priority score:
    Intervention: Is the potential effectiveness of the proposed 
intervention within the target community theoretically justified and 
supported with epidemiologic, methodological, and behavioral research? 
How feasible is the implementation of the intervention as proposed? Can 
the intervention reasonably be predicted to produce the expected 
reductions in risk factors for child maltreatment? Is the setting of 
implementation appropriate?
    Protection of Human Subjects From Research Risks: Does the 
application adequately address the requirements of title 45 CFR part 46 
for the protection of human subjects? This will not be scored; however, 
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.
    Inclusion of Women and Minorities in Research: Does the application 
adequately address the CDC Policy requirements regarding the inclusion 
of woman, 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; and (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.
    Inclusion of Children as Participants in Research Involving Human 
Subjects: The NIH maintains a policy that children (i.e., individuals 
under the age of 21) must be included in all human subjects research, 
conducted or supported by the NIH, unless there are scientific and 
ethical reasons not to include them. This policy applies to all initial 
(Type 1) applications submitted for receipt dates after October 1, 
1998.
    All investigators proposing research involving human subjects 
should read the ``NIH Policy and Guidelines'' on the inclusion of 
children as participants in research involving human subjects that is 
available at: http://grants.nih.gov/grants/funding/children/children.htm.
    Budget: The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.
    V.2. Review and Selection Process: Applications will be reviewed 
for completeness by the Procurement and Grants Office (PGO) and for 
responsiveness of eligibility information by the National Center for 
Injury Prevention and Control (NCIPC). Incomplete applications and 
applications that are non-responsive to the eligibility criteria will 
not advance through the review process. You will be notified that your 
application did not meet submission requirements.
    Applications that are complete and responsive to the PA will be 
subjected to a preliminary evaluation (streamline review) by a peer 
review committee, the Initial Review Group (IRG), convened by NCIPC to 
determine if the application is of sufficient technical and scientific 
merit to warrant further review by the IRG. CDC will withdraw from 
further consideration applications judged to be noncompetitive and 
promptly notify the principal investigator or 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:
    1. The primary review will be a peer review conducted by the IRG. 
All applications will be reviewed for scientific merit in accordance 
with the review criteria listed above. Applications will be assigned a 
priority score based on the National Institutes of Health (NIH) scoring 
system of 100-500 points.
    2. The secondary review will be conducted by the Science and 
Program Review Subcommittee (SPRS) of NCIPC's Advisory Committee for 
Injury Prevention and Control (ACIPC). The ACIPC Federal agency experts 
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). ACIPC 
Federal agency experts will be encouraged to participate in 
deliberations when 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 ACIPC 
Federal agency experts 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 those considered 
by the SPRS.
    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.
    3. All applicants will receive a written critique. The factors to 
be considered will include:

[[Page 70277]]

    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 and objectives stated in ``Healthy People 2010,'' the 
Institute of Medicine report, ``Reducing the Burden of Injury,'' and 
the ``CDC Injury Research Agenda.''
    All awards will be determined by the Director of the NCIPC based on 
priority scores assigned to applications by the IRG, recommendations by 
the secondary review committee, e.g., NCIPC's Advisory Committee for 
Injury Prevention and Control (ACIPC), consultation with NCIPC senior 
staff, and the availability of funds.

VI. Award Administration Information

    VI.1. Award Notices: If your application is to be funded, you will 
receive a Notice of Grant Award (NGA) from the CDC Procurement and 
Grants Office. The NGA shall be the only binding, authorizing document 
between the recipient and CDC. The NGA will be signed by an authorized 
Grants Management Officer, and mailed to the recipient fiscal officer 
identified in the application.
    VI.2. Administrative and National Policy Requirements: 45 CFR Part 
74 and 92. For more information on the Code of Federal Regulations, see 
the National Archives and Records Administration at the following 
Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
    The following additional requirements apply to this project:

[sbull] AR-1 Human Subjects Requirements
[sbull] AR-2 Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
[sbull] AR-8 Public Health System Reporting Requirements
[sbull] AR-9 Paperwork Reduction Act Requirements
[sbull] AR-10 Smoke-Free Workplace Requirements
[sbull] AR-11 Healthy People 2010
[sbull] AR-12 Lobbying Restrictions
[sbull] AR-13 Prohibition on Use of CDC Funds for Certain Gun Control 
Activities
[sbull] AR-14 Accounting System Requirements
[sbull] AR-15 Proof of Non-Profit Status
[sbull] AR-16 Security Clearance Requirement
[sbull] AR-21 Small, Minority, and Women-Owned Business
[sbull] AR-22 Research Integrity
[sbull] AR-23 States and Faith-Based Organizations
[sbull] AR-24 Health Insurance Portability and Accountability Act 
Requirements
[sbull] AR-25 Release and Sharing of Data

    Starting with the December 1, 2003 receipt date, all NCIPC 
funded investigators seeking more than $500,000 in total costs in a 
single year are expected to include a plan describing how the final 
research data will be shared/released or explain why data sharing is 
not possible. Details on data sharing/release, including the 
timeliness and name of the project data steward, should be included 
in a brief paragraph immediately following the Research Plan Section 
of the PHS 398 form. References to data sharing/release may also be 
appropriate in other sections of the application (e.g., background 
and significance, human subjects requirements, etc.) The content of 
the data sharing/release plan will vary, depending on the data being 
collected and how the investigator is planning to share the data. 
The data sharing/release plan will not count towards the application 
page limit and will not factor into the determination scientific 
merit or priority scores. Investigators should seek guidance from 
their institutions, on issues related to institutional policies, 
local IRB rules, as well as local, State and Federal laws and 
regulations, including the Privacy Rule.
    Further detail on the requirements for addressing data sharing 
in applications for NCIPC funding may be obtained by contacting 
NCIPC program staff or visiting the NCIPC internet web site: at 
http://www.cdc.gov/ncipc/osp/sharing_policy.htm.

    Additional information on these requirements can be found on the 
CDC web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.
    VI.3. Reporting: You must provide CDC with an original, two copies, 
and a disk of the following reports:
    1. Interim progress report, (PHS 2590, OMB Number 0925-0001, rev. 
5/2001) no less than 90 days before the end of the budget period. The 
progress report will serve as your non-competing continuation 
application, and must contain the following elements:
    a. Current Budget Period Activities Objectives.
    b. Current Budget Period Financial Progress.
    c. New Budget Period Program Proposed Activity Objectives.
    d. Detailed Line-Item Budget and Justification.
    e. Additional Requested Information.
    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.

VII. Agency Contacts

    For general questions about this announcement, contact: Technical 
Information Management Section, CDC Procurement and Grants Office, 2920 
Brandywine Road, Atlanta, GA 30341, Telephone: (770) 488-2700.
    For scientific/research program technical assistance, contact: 
Joanne Klevens, PhD., Epidemiologist, Prevention Development and 
Evaluation Branch, Division of Violence Prevention, National Center for 
Injury Prevention and Control, 4770 Buford Highway, NE., M/S: K-60, 
Atlanta, GA 30341, Telephone: (770) 488-1386, E-mail: [email protected].
    For questions about peer review, contact: Gwen Cattledge, 
Scientific Review Administrator, Centers for Disease Control and 
Prevention, National Center for Injury Prevention and Control, 4770 
Buford Highway, NE., Mailstop: K-02, Atlanta, GA 30341, Telephone: 
(770) 488-1430, E-mail: [email protected].
    For budget assistance, contact: Van King, Grants Management 
Specialist, CDC Procurement and Grants Office, 2920 Brandywine Road, 
Atlanta, GA 30341, Telephone: (770) 488-2751, E-mail: [email protected].

VIII. Other Information

Attachment 1

    Errata Sheet:

Special Instructions for PHS-398, Rev. 11/2002

ANNOUNCEMENT 04055

SECTION I--PREPARING YOUR APPLICATION

B. GENERAL INSTRUCTIONS (Page 3)

    Use English only and avoid jargon and unusual abbreviations. 
Type the application.

FORMAT SPECIFICATIONS

    The content section of the Program Announcement refers to ``the 
Research Plan.'' The research plan should consist of items listed in 
the program announcement. Use only standard size fonts in black 
print that can be photocopied and easily read, do not use photo 
reduction or compressed print. Draw all graphs, diagrams, tables, 
and charts in black ink. Do not include photographs, oversized 
documents, or materials that cannot be photocopied in the body of 
the application.
    The ONLY item that should be used to keep the application 
together is a rubber band. Please do not use spiral binders, 3-ring 
notebooks, envelopes, binder clips, etc.
    Do not submit an incomplete application. An application will be 
considered incomplete and returned if it is illegible, if it fails 
to follow the instructions, or if the material presented is 
insufficient to permit an adequate review. Unless specifically 
required by these instructions (e.g., human subjects certification, 
changes in other support), do not send supplementary or corrective 
material pertinent to the application after the receipt date without 
its

[[Page 70278]]

being specifically solicited or agreed to by prior discussion with 
the Grants Management Specialist.

PAGE LIMITATIONS AND CONTENT REQUIREMENTS (Page 4)

    Disregard Page Limits under Research Plan, Sections a-d and 
adhere to the prescribed guidance in the Program Announcement.

C. SPECIFIC INSTRUCTIONS BUDGET INSTRUCTIONS (Page 11)

    This Announcement does not use the modular budget format. 
Disregard instructions regarding the dollar limitations. PHS 398 
Form Page 4 and Form Page 5 are required to be submitted by all 
applications regardless of the dollar amount requested.
    Human Subject Research (Section 8.e, Pages 18-19)
    Ensure that the application addresses the issue of Inclusion of 
Women and Ethnic and Racial Minorities in Research Involving Human 
Subjects. The application could be determined as non-responsive if 
this issue is not covered within the research plan.

SECTION II--SUBMITTING YOUR APPLICATION

    Send the Application to the following address: Technical 
Information Management--PA 04055 CDC Procurement and Grants 
Office, 2920 Brandywine Road, Atlanta, Georgia 30341-4146.

PLEASE DO NOT SEND THE APPLICATION TO THE NATIONAL INSTITUTES OF HEALTH

    Disregard all instructions under Section A. INSTRUCTIONS (Page 
31)
    Disregard Sections B-D (Pages 34-35). Please refer to the 
Program Announcement Application Review Information (Section V) for 
the applicable CDC review process.
    Disregard Section M, First Paragraph (Pages 53-54); Section N 
(Pages 54-55) and Section O (Pages 55-56); and all pages following 
Page 56.

    Dated: December 10, 2003.
Edward Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 03-31083 Filed 12-16-03; 8:45 am]
BILLING CODE 4163-18-P