[Federal Register: December 17, 2003 (Volume 68, Number 242)]
[Notices]
[Page 70273-70278]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17de03-82]
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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:
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.dunandbradstreet.com or
call 1-866-705-5711. For more information, see the CDC web site at:
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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: CIPERT@cdc.gov.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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: DZK8@cdc.gov.
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: gxc8@cdc.gov.
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: vbk5@cdc.gov.
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