Research (OER)
9000 Rockville Pike
Bethesda, Maryland 20892
and Human Services (HHS)
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Department of Health and Human Services
Participating Organizations
Centers
for Disease Control and Prevention (CDC), at http://www.cdc.gov
Components of Participating
Organizations
National Center on Birth Defects and
Developmental Disabilities (NCBDDD/CDC) at http://www.cdc.gov/ncbddd/
Title: Prevention of the Complications of Bleeding Disorders through Hemophilia Treatment Centers
The CDC policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.
Authority: This program is authorized under Sections 311, 317(k)(2) and 317(C) of the Public Health Service Act , (42 U.S.C., Section 243, 247b(k)(2) and 247b-4), as amended.
Announcement Type:
New
Request For Applications (RFA) Number: RFA-DD-06-005
Catalog of Federal Domestic Assistance Number(s):
93.283
Centers for
Disease Control and Prevention – Investigations and Technical Assistance See
available CFDA numbers at http://12.46.245.173/cfda/cfda.html
Key Dates
Release Date: March 24, 2006
Letter of Intent Receipt Date: April 5, 2006
Application
Receipt Date: May 5, 2006
Peer Review Date: Approximately eight (8) weeks after application receipt date
Secondary
Review Date: Approximately three (3) weeks after peer review date
Earliest
Anticipated Start Date: September 1, 2006
Additional
Information to Be Available Date: N/A
Expiration
Date: May 6, 2006
Due Date for E.O. 12372
Executive
Order 12372 does not apply to this program.
Additional Overview Content
Executive Summary
The purpose of this program is to:
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1.
Research Objectives
Section II. Award Information
1.
Mechanism(s) of Support
2.
Funds Available
Section III. Eligibility Information
1.
Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.
Cost Sharing or Matching
3.
Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1.
Address to Request Application Information
2.
Content and Form of Application Submission
3.
Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application
C. Application Processing
4.
Intergovernmental Review
5.
Funding Restrictions
6.
Other Submission Requirements
Section V. Application Review Information
1.
Criteria
2.
Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3.
Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1.
Award Notices
2.
Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1.
Principal Investigator Rights and Responsibilities
2. CDC
Responsibilities
3.
Collaborative Responsibilities
3. Reporting
Section VII. Agency Contact(s)
1.
Scientific/Research Contact(s)
2.
Peer Review Contact(s)
3.
Financial/ Grants Management Contact(s)
4. General Questions Contact(s)
Section VIII. Other Information - Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
The CDC and NCBDDD are committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA). This RFA addresses “Healthy People 2010” priority area(s) of Maternal, Infant, and Child Health, and is in alignment with NCBDDD performance goal(s) to prevent birth defects and developmental disabilities. The specific goal is to work toward results that all people, and especially those at greatest risk for health disparities, will achieve their optimal lifespan with the best possible health at every stage of life.
For more information, see www.health.gov/healthypeople and www.whitehouse.gov/omb/mgmt-gpra/.
Hereditary defects in one or more of the clotting factors cause abnormal and sometimes life-threatening bleeding. Approximately 18,000 U.S. persons, primarily males, are affected by hemophilia A or B, the most common and severe of the clotting factor deficiencies. An estimated 1% of the U.S. population (2.5 million) has von Willebrand Disease (VWD), a hereditary disorder that affects both men and women equally and is characterized by excessive bleeding following trauma and during menstruation for reproductive-aged women.
Hemophilia is a complex disorder that can have chronic disease manifestations that are difficult and expensive to treat. Optimal care to prevent these complications requires a multi-disciplinary team approach. In the United States, hemophilia treatment centers (HTCs) have developed a model of care delivery called comprehensive care which includes specialized prevention, diagnostic, and treatment programs designed to provide family-centered education, state-of-the-art treatment, research, and support services for individuals and families living with bleeding disorders.
Since 1975, Congress has provided federal funding through the Maternal and Child Health Bureau and the Centers for Disease Control and Prevention (CDC) for infrastructure support to hemophilia treatment centers for both care and prevention services as well as public health programs including education, outreach, and surveillance for persons with bleeding disorders. CDC has provided support to this network of HTCs through regional grants since 1996. Currently, the federal HTC system comprises 135 centers throughout the United States and its territories. Of the approximately 18,000 persons with hemophilia in the United States, 67% attend a local HTC for preventive care and management.
The application should be constructed so as to enhance the capacity of hemophilia treatment centers as a public health prevention network to monitor blood safety among recipients of blood products; monitor the extent and progression of joint disease; and to provide data to describe the health status and extent of complications of the target populations of persons with bleeding disorders. Expansion of the original data protocol will provide information about newborns, delivery, women with bleeding disorders, rare bleeding disorders, quality of life, and physical activity. These are the major components of the program that all applicants should address in their proposals.
CDC has established the Universal Data Collection (UDC) project to monitor the safety of the nation's blood supply for persons being treated with blood products, as well as to monitor the occurrence of joint complications experienced by persons with hemophilia. The UDC is conducted through the network of specialized health-care centers that serve persons with various blood disorders covered by this announcement.
The types of data gathered through the UDC project consist of:
In developing the application and work plan, applicants should include a potential research focus on at least one of the opportunities listed below to enhance program impact. Program goals to be addressed include:
To meet the purposes of this announcement, applicants should be prepared and indicate in their application how they will conduct specific objectives and activities within prescribed timeframes. The regional core center applicants should indicate how they will:
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism(s) of Support
This funding opportunity will use the U01 award mechanism.
This funding opportunity uses the just in time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see https://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.
The CDC U01 is a cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with CDC staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".
2. Funds Available
The NCBDDD intends to commit approximately $6,800,000 in FY 2006 to fund approximately 12 awards. Awards are expected to range between $300,000 and $850,000 with an average award of $567,000, and will include both direct and indirect costs. An applicant may request up to a five year project period. Awards are expected to be made to support the core center and other collaborating HTC performance sites in that region.
All estimated funding amounts are subject to availability of funds.
Facilities and administrative costs requested by
consortium participants are not included in the direct cost limitation; see NOT-OD-05-004.
Section
III. Eligibility Information
1. Eligible Applicants
1.A. Eligible
Institutions
Assistance will be provided only to hemophilia regional core centers, defined as public or private non-profit entities that provide regional services and support to a network of comprehensive hemophilia treatment centers (HTCs) within their regional catchment area. A HTC is defined as a specialty, prevention, diagnostic and treatment program with the goal of providing family-centered, state-of-the-art medical and psycho-social evaluation and care, dental, education, genetic, research, and support services for individuals and families with bleeding disorders. The eligible applicants noted below must provide continuing evidence of this status and declaration as the regional HTC to be eligible. Such evidence should be provided in the application to included directly behind the face (cover) page of the application (PHS 398).
Eligible applicants are limited to those previously funded under CDC Program Announcement 01049. They include: (1) University of Massachusetts-Worcester; (2) Mt. Sinai School of Medicine, New York; (3) University of Pennsylvania; (4) University of North Carolina at Chapel Hill; (5) Hemophilia Foundation of Georgia; (6) Hemophilia Foundation of Michigan; (7) Great Lake Hemophilia Foundation Inc: (8) University of Colorado Health Science Center; (9) University of Texas at Houston; (10) Children’s Mercy Hospitals and Clinics (11) Children’s Hospital of Orange County; and (12) Oregon Health Sciences University.
The foundation work developed by these institutions and begun five years ago was an investment in that concept with precisely the goals that this RFA intends to accomplish. There is great advantage to the government and to the individuals at risk for hemophilia and bleeding disorders to have these institutions continue to serve as the fulcrum of resources and capacity to extend, expand, and grow on what these projects have achieved over the past five years. It is appropriate to now permit these projects to take the many approached identified and found successful and continue to direct it to the populations that can now benefit from these established programs and the large client base that these institutions can reach. That is the primary purpose of this work as CDC sustains this foundation of knowledge and builds upon it to achieve greater understanding of hemophilia allowing prompt intervention and action.
1.B.
Eligible Individuals
Any individual with the skills, knowledge, and resources
necessary to carry out the proposed research is invited to work with their
institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for CDC programs.
2. Cost Sharing or Matching
Cost sharing,
matching funds, or cost participation is not required under this announcement.
The most current Grants Policy Statement can be found at: https://grants.nih.gov/grants/policy/gps/
3. Other Special Eligibility Criteria
If your application is incomplete or non-responsive to the special requirements listed in this section, it will not be entered into the review process.
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.
Section IV. Application and Submission Information
1. Address to Request Application
Information
The
PHS 398 application instructions are available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an
interactive format. Applicants must use the currently approved version of the
PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: GrantsInfo@nih.gov.
CDC Telecommunications for the hearing impaired: TTY 770-488-2783.
2. Content and Form of Application Submission
Applications
must be prepared using the most current PHS 398 research grant application
instructions and forms. Applications must have a Dun & Bradstreet (D&B)
Data Universal Numbering System number as the universal identifier when
applying for Federal grants or cooperative agreements. The D&B number can
be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The
D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and number
of this funding opportunity must be typed on line 2 of the face page of the
application form and the YES box must be checked.
3. Submission Dates and Times
All requested information must be received in the CDC Procurement and Grants Office by 4:00 p.m. Eastern Time on the deadline date. If you submit your application by the United States Postal Service or commercial delivery service, you must ensure that the carrier will be able to guarantee delivery by the closing date and time. If CDC receives your submission 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 submission as having been received by the deadline.
This announcement is the definitive guide on LOI and application content, submission address, and deadline. It supersedes information provided in the application instructions. If your application does not meet the deadline described in Section IV.3.A,, it will not be eligible for review, and will be discarded. You will be notified that you did not meet the submission requirements
Otherwise, CDC will not notify you upon receipt of your
submission. If you have a question about the receipt of your application,
first contact your courier. If you still have a question, contact the PGO-TIMS
staff at: 770-488-2700. Before calling, please wait two to three days after
the submission deadline. This will allow time for submissions to be processed
and logged.
3.A.
Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt
Date: April 5, 2006
Application Receipt Date(s): May 5, 2006
Peer
Review Date: Eight (8) weeks after receipt of the applications under this
announcement
Secondary
Review Date: Three (3) weeks after the conclusion of the peer review
Earliest Anticipated Start Date: September 1, 2006
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CIO staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed in Section IV.3.A.
The letter of intent should be sent to:
Dr. M. Chris Langub
Office of Public Health Research/Office of the Director
Centers for Disease Control and Prevention
1600 Clifton Road, NE, Mailstop D-72
Atlanta, GA 30333
Telephone:
(404) 639-4640
Fax:
(404) 639-4903
E-Mail: eeo6@cdc.gov
3.B.
Sending an Application
Applications follow the PHS 398 application instructions for content and formatting of your applications. If the instructions in this announcement differ in any way from the PHS 398 instructions, follow the instructions in this announcement.
Applications
must be prepared using the research grant applications found in the PHS 398
instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, and one signed photocopy in one package to:
Technical Information Management Section – RFA
DD06-005
Procurements and Grants Office
Centers
for Disease Control and Prevention
2920 Brandywine Road
Atlanta, GA 30341
At the
time of submission, four additional copies of the application, and all
appendices must be sent to:
Dr. M.
Chris Langub
Office of Public Health Research/Office of the Director
Centers
for Disease Control and Prevention
1600 Clifton Road, NE, Mailstop D-72
Atlanta, GA 30333
Telephone:
(404) 639-4640
Fax:
(404) 639-4903
E-Mail: eeo6@cdc.gov
3.C.
Application Processing
Applications
must be received on or before the application receipt date(s) described
above (Section IV.3.A.). If an application is received after that date, it will
be returned to the applicant without review. Upon receipt, applications will be
evaluated for completeness responsiveness by the NCBDDD and PGO. Incomplete
and non-responsive applications will not be reviewed.
4. Intergovernmental Review
Executive Order 12372 does not apply to this program.
5. Funding Restrictions
All
CDC awards are subject to the terms and conditions, cost principles, and other
considerations described in the PHS Grants Policy Statement.
Restrictions, which must be taken into account while writing your budget, are as follows:
6. Other
Submission Requirements
Awardees must agree to the
"Cooperative Agreement Terms and Conditions of Award" in Section VI "Award Administration Information".
Your research plan should address activities to be conducted over the entire project period. If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement. If your rate is a provisional rate, the agreement should be less than 12 months of age.
Your project plan should address activities to be conducted over the entire project period.
Plan for Sharing
Research Data
The precise content of the
data-sharing plan will vary, depending on the data being collected and how the
investigator is planning to share the data. Applicants may wish to describe
briefly the expected schedule for data sharing, the format of the final
dataset, the documentation to be provided, whether or not any analytic tools
also will be provided, whether or not a data-sharing agreement will be required
and, if so, a brief description of such an agreement (including the criteria
for deciding who can receive the data and whether or not any conditions will be
placed on their use), and the mode of data sharing (e.g., under their own auspices
by mailing a disk or posting data on their institutional or personal website,
through a data archive or enclave). References to data sharing may also be
appropriate in other sections of the application.
All applicants must include a plan for sharing research
data in their application. The data sharing policy is available at http://www.cdc.gov/od/pgo/funding/ARs.htm under Additional Requirements 25 Release and Sharing of Data. All investigators
responding to this funding opportunity should include a description of how
final research data will be shared, or explain why data sharing is not
possible.
The
reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score.
Sharing Research
Resources
PHS
policy requires that grant awardee recipients make unique research resources
readily available for research purposes
to qualified individuals within the scientific community after publication (PHS
Grants Policy Statement https://grants.nih.gov/grants/policy/gps/8postnew.htm#phs.) Investigators responding to this funding
opportunity should include a description of how final research data will be
shared, or explain why data sharing is not possible.
The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590. http://www.cdc.gov/od/pgo/forminfo.htm). See Section VI.3. Reporting.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be
considered in the review process.
The following will be considered in making funding
decisions:
2. Review and Selection Process
Applications
that are complete and responsive to the RFA will be evaluated for scientific
and technical merit by an appropriate peer review group convened by OPHR in
accordance with the review criteria stated below.
As
part of the initial merit review, all applications will:
The goals of CDC-supported research are to advance the understanding of health promotion and prevention of disease, injury, and disability, and enhance preparedness. 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.
Significance: Does
this study address an important problem? If the aims of the application are
achieved, how will scientific knowledge or clinical practice be advanced? What
will be the effect of these studies on the concepts, methods, technologies,
treatments, services, or preventative interventions that drive this field?
Approach: Are the
conceptual or clinical framework, design, methods, and analyses adequately
developed, well integrated, well reasoned, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
Innovation: Is the
project original and innovative? For example: Does the project challenge
existing paradigms or clinical practice; address an innovative hypothesis or
critical barrier to progress in the field? Does the project develop or employ
novel concepts, approaches, methodologies, tools, or technologies for this
area?
Investigators: Are the
investigators 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? Does the investigative team bring
complementary and integrated expertise to the project (if applicable)?
Environment: Does the
scientific environment in which the work will be done contribute to the
probability of success? Do the proposed studies benefit from unique features of
the scientific environment, or subject populations, or employ useful
collaborative arrangements? Is there evidence of institutional support?
2.A. Additional
Review Criteria:
In
addition to the above criteria, the following items will continue to be
considered in the determination of scientific merit and the priority score:
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Additional CDC Requirements under AR-1 Human Subjects Requirements can be found on http://www.cdc.gov/od/pgo/funding/ARs.htm.
Inclusion of
Women and Minorities in Research:
Does
the application adequately address the CDC Policy requirements regarding the
inclusion of women, ethnic, and racial groups, and children in the proposed
research? This includes: (1) The proposed plan for the inclusion of both sexes
and racial and ethnic minority populations, and children 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.
2.B.
Additional Review Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
2.C. Sharing
Research Data
Data Sharing Plan: The reasonableness of the data
sharing plan or the rationale for not sharing research data will be assessed by
the reviewers. However, reviewers will not factor the proposed data sharing
plan into the determination of scientific merit or the priority score. The
presence of a data sharing plan will be part of the terms and conditions of the
award. The funding organization will be responsible for monitoring the data
sharing policy.
2.D.
Sharing Research Resources
PHS
policy requires that grant recipients make unique research resources readily
available for research purposes
to qualified individuals within the scientific community after publication (PHS
Grants Policy Statement https://grants.nih.gov/grants/policy/gps/8postnew.htm#phs.) Investigators responding to this funding
opportunity should include a description of how final research data will be
shared, or explain why data sharing is not possible.
The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590 http://www.cdc.gov/od/pgo/forminfo.htm ). See Section VI.3.Reporting.
Program
staff will be responsible for the administrative review of the plan for sharing
research resources.
3. Anticipated Announcement and Award Dates
The CDC
Procurement and Grants will notify successful applicants in a pre-award
conference call and providing the notice of award. The anticipated award date
is September 1, 2006.
Section VI. Award Administration Information
1. Award Notices
After
the peer review of the application is completed, the Principal Investigator
will also receive a written critique called a Summary Statement.
Those applicants
under consideration for funding will be contacted by CDC for additional
information.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the Grants Management Officer (GMO) is the authorizing document. This document will be mailed and/or emailed to the recipient fiscal officer identified in the application.
Selection of the application for award is not an authorization to begin performance. Any cost incurred before receipt of the NoA is at the recipient’s risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See also Section IV.5. Funding Restrictions.
2. Administrative and National Policy Requirements
The Code of Federal Regulations 45 CFR Parts 74 and 92 have details about policy requirements. 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.
Additional requirements can be found in Section VIII. Other Information of this document or on the CDC website at the following
Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm. These
will be incorporated into the NoA by reference.
2.A. Cooperative
Agreement Terms and Conditions of Award
The
following special terms of award are in addition to, and not in lieu of,
otherwise applicable OMB administrative guidelines, HHS grant administration
regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and
local Governments are eligible to apply), and other HHS, PHS, and CDC grant
administration policies.
The administrative
and funding instrument used for this program will be the cooperative agreement,
an "assistance" mechanism (rather than an "acquisition"
mechanism), in which substantial CDC programmatic involvement with the awardees
is anticipated during the performance of the activities. Under the cooperative
agreement, the CDC purpose is to support and stimulate the recipients'
activities by involvement in and otherwise working jointly with the award
recipients in a partnership role; it is not to assume direction, prime
responsibility, or a dominant role in the activities. Consistent with this
concept, the dominant role and prime responsibility resides with the awardees
for the project as a whole, although specific tasks and activities may be
shared among the awardees and the CDC as defined below.
2.A.1. Principal Investigator Rights and Responsibilities
The
Principal Investigator will have the primary responsibility for oversight of all management,
administrative, and scientific aspects of the project.
Awardees will retain custody of and have primary rights to
the data and software developed under these awards, subject to Government
rights of access consistent with current HHS, PHS, and CDC policies.
2.A.2. CDC Responsibilities
In a
cooperative agreement, CDC staff is substantially involved in the program
activities, above and beyond routine project monitoring.
There are two separate CDC scientific roles – Scientific Collaborator and Scientific Program Administrator
In this cooperative agreement, a CDC Scientist (Scientific Collaborator) within the National Center on Birth Defects and Developmental Disabilities (NCBDDD) is an equal partner with scientific and programmatic involvement during the conduct of the project through technical assistance, advice, and coordination.
Scientific Collaborators will:
CDC
Scientific Program Administrator (SPA)
The CDC NCBDDD Office of Extramural Research (OER) will appoint a SPA, apart
from the NCBDDD Scientific Collaborator who will:
2.A.3.
Collaborative Responsibilities
The planning and implementation of the cooperative aspects of the study will be
effected by a Coordinating Committee consisting of the Principal Investigator
from organizations receiving awards under this announcement and the CDC
Scientific Collaborator; and will address issues of common concern throughout
the life of the project. Organizations serving as sub-contractors under
awarded projects are not considered members of the Coordinating Committee.
At periodic Coordination Committee meetings among recipients, the group will: (1) make recommendations on the study protocol and data collection approaches; (2) discuss common protocols as they relate to all data; (3) discuss the target populations that have been or will be recruited; (4) identify and recommend solutions to unexpected study problems; and (5) discuss ways to efficiently coordinate study activities and best practices.
Each full member will have one
vote. Awardee members of the Coordinating Committee (including a CDC member)
should accept and implement policies approved by the Committee. The Committee
decisions are used to implement the objectives of the project activities in a
consistent way.
3. Reporting
You must provide CDC with an
original, plus two hard copies of the following reports:
These reports must be forward by U.S. Postal Service or Express Delivery to the Grants Management Specialist listed in the “Agency Contacts” section of this announcement.
Although the financial plans of the CIO(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon 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.
We encourage your inquiries concerning this funding
opportunity and welcome the opportunity to answer questions from potential
applicants. Inquiries may fall into three areas: scientific/research, peer
review, and financial or grants management issues:
1. Scientific/Research Contacts:
Dr. Don
Lollar
Acting,
Director Office of Extramural Programs
National Center on Birth Defects and
Developmental Disabilities
Centers
for Disease Control and Prevention
1600 Clifton Road, MS E87
Atlanta, GA 30333
Telephone:
(404) 498-3041
Fax:
(404)-498-3050
E-Mail:
dcl5@cdc.gov
2. Peer Review Contacts:
Dr. M. Chris Langub
Office of Public Health Research/Office of the Director
Centers
for Disease Control and Prevention
1600 Clifton Road, NE, Mailstop D-72
Atlanta, GA 30333
Telephone:
(404) 639-4640
Fax:
(404) 639-4903
E-Mail:
eeo6@cdc.gov
3. Financial or Grants Management
Contacts:
LaKasa Wyatt
Grants Management Specialist
Procurement and Grants Office
Centers for Disease Control and Prevention
2920
Brandywine Road
Atlanta, GA 30341
Telephone: (770) 488-2728
E-Mail: lwyatt@cdc.gov
4. General Questions Contacts:
Technical
Information Management Section
Procurement and Grants Office
Centers
for Disease Control and Prevention
2920 Brandywine Road
Atlanta, GA 30341
Telephone: (770) 488-2700
Email: PGOTIM@cdc.gov
Section VIII. Other Information
Required Federal Citations
Human Subjects Protection:
Federal
regulations (45CFR46) require that applications and proposals involving human
subjects must be evaluated with reference to the risks to the subjects, the
adequacy of protection against these risks, the potential benefits of the
research to the subjects and others, and the importance of the knowledge gained
or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Additional CDC Requirements under AR-1 Human Subjects Requirements can be found
on http://www.cdc.gov/od/pgo/funding/ARs.htm.
Requirements for Inclusion of Women and Racial and Ethnic Minorities
in Research
It is the policy of the Centers for Disease Control and
Prevention (CDC) and the Agency for Toxic Substances and Disease Registry
(ATSDR) to ensure that individuals of both sexes and the various racial and
ethnic groups will be included in CDC/ATSDR-supported research projects
involving human subjects, whenever feasible and appropriate. Racial and ethnic
groups are those defined in OMB Directive No. 15 and include American Indian or
Alaska Native, Asian, Black or African American, Hispanic or Latino, Native
Hawaiian or Other Pacific Islander. Applicants shall ensure that women, racial
and ethnic minority populations are appropriately represented in applications
for research involving human subjects. Where clear and compelling rationale
exist that inclusion is inappropriate or not feasible, this situation must be
explained as part of the application. This policy does not apply to research
studies when the investigator cannot control the race, ethnicity, and/or sex of
subjects. Further guidance to this policy is contained in the Federal Register,
Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995.
Paperwork Reduction Act Requirements
Under the
Paperwork Reduction Act, projects that involve the collection of information
from 10 or more individuals and funded by a grant or a cooperative agreement
will be subject to review and approval by the Office of Management and Budget
(OMB).
Smoke-Free
Workplace Requirements
CDC strongly encourages all
recipients to provide a smoke-free workplace and to promote abstinence from all
tobacco products. Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities that receive Federal funds in which education,
library, day care, health care, or early childhood development services are
provided to children.
In addition no part of CDC appropriated funds, shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature.
Any activity designed to influence action in regard to a particular piece of pending legislation would be considered "lobbying." That is lobbying for or against pending legislation, as well as indirect or "grass roots" lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies.
The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation
It remains permissible to use CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training, and foster safe and healthful environments.
Recipients of CDC grants and cooperative agreements need to be careful to prevent CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publications, and "grassroots" activities that relate to specific legislation, recipients of CDC funds should give close attention to isolating and separating the appropriate use of CDC funds from non-CDC funds. CDC also cautions recipients of CDC funds to be careful not to give the appearance that CDC funds are being used to carry out activities in a manner that is prohibited under Federal law.
Accounting
System Requirements
The services of a certified public
accountant licensed by the State Board of Accountancy or the equivalent must be
retained throughout the project as a part of the recipient's staff or as a
consultant to the recipient's accounting personnel. These services may include
the design, implementation, and maintenance of an accounting system that will
record receipts and expenditures of Federal funds in accordance with accounting
principles, Federal regulations, and terms of the cooperative agreement or
grant.
Capability Assessment
It may be necessary to conduct an
on-site evaluation of some applicant organization's financial management
capabilities prior to or immediately following the award of the grant or
cooperative agreement. Independent audit statements from a Certified Public
Accountant (CPA) for the preceding two fiscal years may also be required.
Proof of Non-profit Status
Proof of nonprofit status must be
submitted by private nonprofit organizations with the application. Any of the
following is acceptable evidence of nonprofit status: (a) a reference to the
applicant organization's listing in the Internal Revenue Service's (IRS) most
recent list of tax-exempt organizations described in section 501(c)(3) of the
IRS Code; (b) a copy of a currently valid IRS tax exemption certificate; (c) a
statement from a State taxing body, State Attorney General, or other
appropriate State Official certifying that the applicant organization has a
nonprofit status and that none of the net earnings accrue to any private
shareholders or individuals; (d) a certified copy of the organization's
certificate of incorporation or similar document that clearly establishes
nonprofit status; (e) any of the above proof for a State or national parent
organization and a statement signed by the parent organization that the
applicant organization is a local nonprofit affiliate.
Small,
Minority, And Women-owned Business
It is a national policy to place a
fair share of purchases with small, minority and women-owned business firms. The
Department of Health and Human Services is strongly committed to the objective
of this policy and encourages all recipients of its grants and cooperative
agreements to take affirmative steps to ensure such fairness. In particular,
recipients should:
Research Integrity
The signature of the
institution official on the face page of the application submitted under this
Funding Opportunity Announcement is certifying compliance with the Department
of Health and Human Services (DHHS) regulations in Title 42 Part 93, Subparts
A-E, entitled PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT.
The regulation places requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the DHHS Office of Research Integrity (http://ori.hhs.gov./policies/statutes.shtml).
For example:
Section
93.301 Institutional assurances.(a) General policy. An institution with PHS supported biomedical or
behavioral research, research training or activities related to that research
or research training must provide PHS with an assurance of compliance with this
part, satisfactory to the Secretary. PHS funding components may authorize
[[Page 28389]] funds for biomedical and behavioral research, research training,
or activities related to that research or research training only to
institutions that have approved assurances and required renewals on file with
ORI. (b) Institutional Assurance. The responsible institutional official must assure
on behalf of the institution that the institution-- (1) Has written policies
and procedures in compliance with this part for inquiring into and
investigating allegations of research misconduct; and (2) Complies with its own
policies and procedures and the requirements of this part.
Compliance with Executive Order 13279
Faith-based
organization are eligible to receive federal financial assistance, and their
applications are evaluated in the same manner and using the same criteria as
those for non-faith-based organizations in accordance with Executive Order
13279, Equal Protection of the Laws for Faith-Based and Community
Organizations. All applicants should, however, be aware of restrictions on the
use of direct financial assistance from the Department of Health and Human
Services (DHHS) for inherently religious activities. Under the provisions of
Title 45, Parts 74, 87, 92 and 96, organizations that receive direct financial
assistance from DHHS under any DHHS program may not engage in inherently religious
activities, such as worship, religious instruction, or proselytization as a
part of the programs or services funded with direct financial assistance from
DHHS. If an organization engages in such activities, it must offer them
separately, in time or location, from the programs or services funded with
direct DHHS assistance, and participation must be voluntary for the
beneficiaries of the programs or services funded with such assistance.
A religious organization that participates in the DHHS funded programs or services will retain its independence from Federal, State, and local governments, and may continue to carry out its mission, including the definition, practice, and expression of its religious beliefs, provided that it does not use direct financial assistance from DHHS to support inherently religious activities such as those activities described above. A faith-based organization may, however, use space in its facilities to provide programs or services funded with financial assistance from DHHS without removing religious art, icons, scriptures, or other religious symbols. In addition, a religious organization that receives financial assistance from DHHS retains its authority over its internal governance, and it may retain religious terms in its organization=s name, select its board members on a religious basis, and include religious references in its organization=s mission statements and other governing documents in accordance with all program requirements, statutes, and other applicable requirements governing the conduct of DHHS funded activities.
For further guidance on the use of DHHS direct financial assistance see Title 45, Code of Federal Regulations, Part 87, Equal Treatment for Faith-Based Organizations, and visit the internet site: http://www.whitehouse.gov/government/fbci/.
Health Insurance Portability and
Accountability Act Requirements
Recipients of this grant award
should note that pursuant to the Standards for Privacy of Individually
Identifiable Health Information promulgated under the Health Insurance
Portability and Accountability Act (HIPAA) (45 CFR Parts 160 and 164) covered
entities may disclose protected health information to public health authorities
authorized by law to collect or receive such information for the purpose of
preventing or controlling disease, injury, or disability, including, but not
limited to, the reporting of disease, injury, vital events such as birth or
death, and the conduct of public health surveillance, public health
investigations, and public health interventions. The definition of a public
health authority includes a person or entity acting under a grant of authority
from or contract with such public agency. CDC considers this project a public
health activity consistent with the Standards for Privacy of Individually
Identifiable Health Information and CDC will provide successful recipients a
specific grant of public health authority for the purposes of this project.
Release and Sharing of Data
The Data Release Plan is the
Grantee's assurance that the dissemination of any and all data collected under
the CDC data sharing agreement will be released as follows:
a. In a
timely manner.
b. Completely,
and as accurately as possible.
c. To
facilitate the broader community.
d. Developed
in accordance with CDC policy on Releasing and Sharing Data.
April 16, 2003, http://www.cdc.gov/od/foia/policies/sharing.htm, and in full compliance with the 1996 Health Insurance Portability and Accountability Act (HIPPA), (where applicable), The Office of Management and Budget Circular A110, (2000) revised 2003, www.whitehouse.gov/omb/query.html?col=omb&qt=Releasing+and+Sharing+of+Data and Freedom of Information Act (FOIA), www.4.law.cornell.edu/uscode/5/5/552/html.
Applications must include a copy of the applicant's Data Release Plan. Applicants should provide CDC with appropriate documentation on the reliability of the data. Applications submitted without the required Plan may be ineligible for award. Award will be made when reviewing officials have approved an acceptable Plan. The successful applicant and the Program Manager will determine the documentation format. CDC recommends data is released in the form closest to micro data and one that will preserve confidentiality.
In cooperative endeavors CDC supports the efforts of NIH on the following:
Data and Safety Monitoring Plan:
Data
and safety monitoring is required for all types of clinical trials, including
physiologic toxicity and dose-finding studies (phase I); efficacy studies
(Phase II); efficacy, effectiveness and comparative trials (Phase III).
Monitoring should be commensurate with risk. The establishment of data and
safety monitoring boards (DSMBs) is required for multi-site clinical trials
involving interventions that entail potential risks to the participants (NIH
Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, https://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Inclusion of Children as Participants in Clinical
Research:
The
NIH maintains a policy that children (i.e., individuals under the age of 21)
must be included in all clinical research, conducted or supported by the NIH,
unless there are scientific and ethical reasons not to include them.
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 (https://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject Participants:
NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH applications for research involving human
subjects and individuals designated as key personnel. The policy is available
at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Public Access to Research Data through the Freedom of Information Act:
The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a project
that is supported in whole or in part with Federal funds and (2) cited publicly
and officially by a Federal agency in support of an action that has the force
and effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment. NIH
has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
URLs in NIH Grant Applications or Appendices:
All
applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH solicitation,
Internet addresses (URLs) should not be used to provide information necessary
to the review because reviewers are under no obligation to view the Internet
sites. Furthermore, we caution reviewers that their anonymity may be
compromised when they directly access an Internet site.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
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Department of Health and Human Services (HHS) |
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