Part I Overview Information


United States Department of Health and Human Services (HHS)

Participating Organizations
Centers for Disease Control and Prevention, (NCBDDD, CDC) at  http://www.cdc.gov/ncbddd

Components of Participating Organizations
National Center on Birth Defects and Developmental Disabilities (NCBDDD/ CDC), at http://www.cdc.gov/ncbddd         

Title: Public Health Research Grants on Orofacial Clefts and Craniosynostosis (R01)

The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this announcement may differ from those used by the HHS National Institutes of Health (NIH).  If written guidance for completing this application is not available on the CDC website, then applicants will be directed elsewhere for that information.

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

Instructions for Submission of Electronic Research Applications:

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. 

This FOA must be read in conjunction with the application package instructions included with this announcement on Grants.gov/Apply for Grants (hereafter referred to as, Grants.gov/Apply.)

A registration process is necessary before submission, and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Two steps are required for on time submission:

(1) The application must be successfully received by Grants.gov no later than 5:00 p.m. Eastern Time on the application submission receipt date (see I. Key Dates below).

(2) Applicants must complete a verification step in the Electronic Research Administration (eRA Commons) within two business days of notification. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the eRA CommonsCommons.

Funding Opportunity Announcement (FOA) Number: RFA-DD-07-009

Catalog of Federal Domestic Assistance Number(s):
93.283

Key Dates
Release/Posted Date: March 1, 2007
Letter of Intent Receipt Date: March 12, 2007
Application Submission Receipt Date(s): April 10, 2007
Peer Review Date(s):  June 2007
Council Review Date(s): July 2007
Earliest Anticipated Start Date(s):  September 4, 2007
Additional Information   Not Applicable
Expiration Date:  April 11, 2007

Due Date for E.O. 12372

Executive Order 12372 does not apply to this program.

Additional Overview Content

Executive Summary

Funding Opportunity Announcement Glossary: FOA Glossary Terminology

Table of Contents


Part 1 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 Investigators
    2.Cost Sharing or Matching
    3.Other - Special Eligibility Criteria

Section IV. Application and Submission Information
    1. 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. Submitting an Application to CDC
        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
            1. Recipient Rights and Responsibilities
            2. HHS/CDC Responsibilities
    3. Reporting

Section VII. Agency Contacts
    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 NCBDDD of CDC within HHS is 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 the NCBDDD strategic plan, and accompanying PART goals, concerning research to identify major periconceptional, prenatal, and perinatal risk and protective factors for birth defects, developmental disabilities and pediatric genetic conditions to guide public health practice. 

This RFA also addresses “Healthy People 2010” priority area of Maternal, Infant, and Child Health, and is in alignment with NCBDDD performance goal to prevent or reduce the adverse consequences of Orofacial clefts (OFCs) and craniosynostosis (CS), two types of birth defects and the Healthy People objectives addressing the health of children including those with disabilities.  For more information see http://www.health.gov/healthypeople and http://www.whitehouse.gov/omb/mgmt-gpra/.

As part of a population-based system the applicant’s research plan should address at least two of the 13 priority areas identified below.  Funding priority will be given to applications that are able to incorporate additional priority topics into their planned research.   Applications can include priority topics from the research priorities for OFCs or CS, or some topics from each.

The Priority areas for public health research are:

1.      Priorities for public health research on OFCs with no known genetic cause (e.g. single gene disorder or chromosomal abnormality).

a.      Learning:

Assessing predictive value of early screening tests prior to school entry (approximate age three) on learning outcomes in elementary school years.  Early screening measures could include tests for auditory discrimination, sound blending, short-term automatic memory, and rapid naming. Describe current usage of screening tests (e.g., auditory discrimination, sound blending, short-term automatic memory, rapid naming) among children with OFCs.  Collect current descriptive data on objective measures of reading, phonological processing, and other learning outcomes among elementary school age children with OFCs.  Descriptive data addressing the issue of which interventions are associated with better outcomes would also be helpful.

b.      Improved characterization of phenotype:

Better characterization of phenotypes of OFCs can be accomplished using neuro-imaging, physical exams, and other methods. However, assessment of each approach is needed to determine the optimal methods for accurately characterizing the phenotype. Improved phenotype characterization should enhance our ability to understand the etiology of OFCs by enabling us to group affected infants into more etiologically homogeneous categories.  Using homogeneous categories will improve the likelihood of identifying risk factors and might also be helpful in predicting outcomes and for targeting interventions. 

c.      Role of nutrition and nutritional supplements, obesity, and diabetes in the etiology of OFCs:

Additional studies to better define the role of maternal nutrition and specific nutrients, maternal diabetes, insulin resistance, and obesity in the etiology of OFCs.   Studies should improve our understanding of how nutritional factors, body mass index, adiposity, glucose tolerance, and patterns of weight gain and loss affect OFCs.  Planned studies should consider whether fetal and/or maternal genotype, as well as exogenous exposures such as smoking and folic acid antagonists might modify the role of maternal nutrition, diabetes, and obesity.  Improved measurements (e.g. biomarkers for nutritional intake or medical record assessment of glucose control) should enhance our capacity to understand the possible role of these factors in the etiology of OFCs.

d.      Quality of life:

Assessments of the extent to which quality of life is affected among persons with OFCs.  It is important to determine which factors contribute to quality of life, and whether or not individual phenotypic aspects such as speech, facial appearance, etc. correspond to the measures of overall quality of life.  In assessing quality of life, consideration should be given to: (1) medical care (access to comprehensive care in an interdisciplinary team setting vs. more fragmented care consistent with “Parameters for Evaluation and Treatment of Patients with Cleft Lip/Palate or Other Craniofacial Anomalies” published by the American Cleft Palate-Craniofacial Association); (2) objective measures of educational achievement; (3) psychological well being; (4) out of pocket costs; and (5) impact on caregivers, etc. Consideration should also be given to use of some common, standardized instruments to facilitate comparisons with other chronic childhood conditions, and use of some instruments specific to OFCs to capture the specific issues affecting persons with these disorders.

e.      Longer term medical conditions:

Observational studies on whether the presence of a non-syndromic OFC affects the risk of chronic diseases (e.g. cancer, etc.), mental health (e.g. depression and other affective disorders, anxiety disorders, etc.), and mortality.  Better assessments are needed of the potential longer term consequences of OFCs in order to provide more appropriate recommendations for long term medical care. 

f.       Mental health:

Mental Health disorders should be assessed using objective measures when possible.  In assessing these outcomes, it is important to stratify by type and severity of the OFC when feasible. This research could be done by linking data from long term birth defects surveillance systems to cancer registries (e.g. SEER) or the National Death Index, but might require a collaborative effort from a number of registries to have adequate power.

g.      Timing of diagnosis of OFCs and impact on outcomes:

Evaluations of whether prenatal diagnosis of an OFC compared to postnatal diagnosis impacts the outcome for both the affected child and his/her family.  In assessing the impact of diagnosis timing (prenatal vs. postnatal), it will be important to consider: (1) specific indications for additional prenatal testing that might be associated with prenatal diagnosis such as advanced maternal age; and (2) what type of counseling the parents received following the prenatal diagnosis (e.g. meeting with surgical and feeding experts, etc.).  Important outcomes to be considered include:  (1) parental stress and coping; (2) health care decision-making including selection of health care providers for cleft care; (3) infant outcomes (e.g., feeding, weight gain, number of hospital and/or NICU admissions); and (4) the parents’ perception of whether prenatal or postnatal diagnosis of the OFC was helpful or harmful.

h.      Costs, payer, and access to care:

Updated information is needed on the costs of care for children with OFCs, including costs for medical care, special education, caregivers, loss of productivity, and other out-of-pocket costs.  It is important that information on cost be stratified by the type of cleft.  It is also unclear whether access to care and the outcomes in the affected children are influenced by the payer (private insurance, self-pay, Medicaid, other). Better information on costs and access to care might help identify barriers to optimal outcomes in children with OFCs. 

2.      Priorities for public health research on craniosynostosis (CS) with no known genetic cause (e.g. single gene disorder or chromosomal abnormality).

a.      Neurocognitive outcomes and neuropsychological issues:

Studies to determine whether children with CS experience increased rates of cognitive disability/impaired cognitive functioning or neuropsychological processing difficulties compared to children without CS.  The neuro-cognitive and neuropsychological outcomes might be affected by the age at which surgery is performed, the suture affected, and the surgical technique used.

b.      Improved characterization of phenotype:

Improved characterization of the CS phenotype and standardization of the diagnosis will improve our capacity to assess risk factors and outcomes with more homogeneous case-groups.  Better definition of the appropriate genetic workup, types of radiographic imaging, specialist seen, surface analysis performed; and anthropometric measures taken to complete the clinical diagnosis are needed.

c.      Modifiable risk factors:

Previous studies have suggested some environmental risk factors might have a role in the etiology of CS.  However, findings have been inconsistent, and require further exploration.  Studies should not duplicate methods of the National Birth Defects Prevention Study, but should instead use alternative methods and approaches.

d.      Outcomes:

Assessment of the morbidity and mortality associated with cranial vault surgery for single suture CS.  This includes more accurate measurement of phenotype severity before and after surgery and objective assessments of facial outcomes of surgery, and variation by surgeon or center.  Also assessment should be made in the evaluation of outcomes (issues such as length of stay or blood loss, the need for repeat surgeries, etc.) for those children receiving care in a multidisciplinary team setting versus those receiving care in a non-team setting that might be less coordinated. 

e.      Identification of genetic risk factors for isolated CS:

Identification and evaluation of genes potentially associated with isolated CS.  Variation in genetic risk factors by type of CS (isolated CS, associated CS with other anomalies).  Assessment of the frequency of involvement of known genes in the etiology of CS, as well as identification of new genes should be included.

For the priority areas selected, a comparison population must be selected from the same source population as the case children.  The comparison group should be a random sample and not a convenience sample.  

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 R01 Grant activity code.

2. Funds Available

The NCBDDD intends to commit approximately $900,000 that includes both direct and indirect costs in FY 2007 to fund two awards for the first 12 month budget period.  The applicant may request a project period of up to three years. With two awards to be issued, the approximate entire project period funded amount is approximately $2,700,000. The anticipated start date for new awards is September 4, 2007.

All estimated funding amounts are subject to availability of funds.

CDC will accept and review an application with a budget greater than the ceiling amount.  However, the award issued pursuant to this funding opportunity is contingent upon the availability of funds.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics and meets the criteria necessary to conduct the prescribed work.   Applications may be submitted by public and private nonprofit and for profit organizations and by governments and their agencies, such as:

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.  Attach this documentation behind the first page of your application form or for electronic applications, use a PDF file and attach as “Other Documents” and label as appropriate.

Eligible organizations must have a birth population of at least 250,000 births from which these cases have been systematically ascertained.  This could be 10 years of surveillance data from a geographic region with 25,000 births per year, or five years of surveillance data from a region with 50,000 births per year, or some other combination.  Multi-site information may be used to achieve this birth population, but all sites must have an existing population-based birth defects surveillance to identify eligible cases.  Retrospective data should be limited to a maximum 15 years prior to the time of data collection initiation. 

Children with OFCs and CS should be limited to those with no known genetic cause (e.g., single gene disorder or chromosomal abnormality), and preferably to those with only an isolated OFC or isolated CS with no other unrelated major defects.  Funding preference will be given to research based upon a population with racial/ethnic diversity.

Applicants should avoid duplicating ongoing projects such as the National Birth Defects Prevention Study (Yoon, et al., 2001; Rasmussen et al., 2002), but should instead seek innovative methods and new approaches. 

The applicants must demonstrate existing population-based ascertainment of children with OFCs (ICD-9-CM codes 749.0, 749.1, 749.2) and CS (ICD-9-CM code 756.0) with verification of the specific diagnoses from medical records review and not based solely on codes.

The applicant must furnish evidence of experience with similar research work and success in achieving high participation levels from population-based studies.  Research cannot rely on clinic or hospital-based selection of cases. 

Applications will be reviewed by the Office of Extramural Research, OER, NCBDDD funding office in advance of the formal merit review of applications to document that the evidence presented demonstrates that the applicant fully meets the eligibility requirements. This information should be provided directly behind the face page of the application.  Please make sure to include any of the information again in your application narrative or in descriptions of the collaborating entities as appropriate.

Since this project will be funded for up to three years without further outside competition, CDC feels it is critical that prospective applicants demonstrate their experience, potential and prognosis for success by providing convincing evidence of their experience and capabilities in addressing the major objectives under the requirements of this announcement. The points presented in the eligibility determination component of the application may be expanded on, referred to, and redirected to the project narrative to address the research objectives in this announcement and convey the capacity of the applicant to be fully successful in achieving all aspects and components of this research

1.B. Eligible Investigators

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 or cost participation is not required under this announcement.  The most current HHS Grants Policy Statement is available at: http://www.cdc.gov/od/pgo/funding/HHS_GPS_Oct_2006.doc.

3. Other-Special Eligibility Criteria

If your application is incomplete or non-responsive to the special requirements listed in this section, it will not enter 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


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Instructions for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at the following:

PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional actions an applicant institution/organization should complete before submitting an electronic application, are as follow:

1) Organizational/Institutional Registration in Grants.gov Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Note that if a PD/PI is also an HHS peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the eRA Commons. The HHS/CDC strongly encourages applicants to use the Grants.gov electronic applications process and have organizations and PD/PIs complete all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA); although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact PGO TIMS: Telephone 770-488-2700, Email:  PGOTIM@cdc.gov

HHS/CDC Telecommunications for the hearing impaired: TTY 770-488-2783.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to HHS/CDC.

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, mandatory and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget

Optional Components:
PHS398 Cover Letter File
Research & Related Sub award Budget Attachment(s) Form

3. Submission Dates and Times

See Section IV. 3A for details

3.A. Submission, Review and Anticipated Start Dates
Letter of Intent Receipt Date: March 12, 2007
Application Submission Receipt Date(s): April 10, 2007
Peer Review Date (s):  June 2007
Council Review Date (s): July 2007
Earliest Anticipated Start Date: September 4, 2007

3.A.1. Letter of Intent

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 CDC Program 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. Don Lollar
Acting Director, Office of Extramural Research

U.S. Department of Health and Human Services
Centers for Disease Control and Prevention
National Center on Birth Defects and Developmental Disabilities
1600 Clifton Road, Mailstop E87
Atlanta, GA 30333
Telephone: (404) 498-3041
FAX: (404) 498-3050
E
-Mail: dcl5@cdc.gov

3.B. Submitting an Application to CDC

If the instructions in this announcement differ in any way from the SF424 (R&R) instructions, follow the instructions in this announcement.

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. If submittal of the application is done electronically through Grants.gov (http://www.grants.gov), the application will be electronically time/date stamped by Grants.gov.  Applicants will receive an e-mail notice of receipt from Grants.gov when HHS/CDC receives the application. 

This announcement is the definitive guide on Letter Of Intent (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 HHS/CDC will discard it. You will receive notification that you did not meet the submission requirements.

3.C. Application Processing

HHS/CDC must receive applications on or before 5:00 P.M. Eastern Standard Time on the application submission date(s) described above (Section IV.3.A.). If HHS/CDC receives an application after that submission date and time, the application may be delayed in the review process or not reviewed.

Upon receipt, applications will be evaluated for completeness and responsiveness by NCBDDD and HHS/CDC Procurement and Grants Office (PGO). HHS/CDC will not review incomplete or non-responsive applications.

There will be an acknowledgement of receipt of applications from Grants.gov

4. Intergovernmental Review

Executive Order 12372 does not apply to this program.

5. Funding Restrictions

All HHS/CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement at: http://www.cdc.gov/od/pgo/funding/HHS_GPS_Oct_2006.doc.

Restrictions, which applicants must take into account while writing their budgets, are as follows:

6. Other Submission Requirements

The applicants research plan(s) should address activities they will conduct in the first budget period and over the entire three year project period. 

The HHS/CDC requires the PD/PI to fill in his/her eRA Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov.  . For additional information, see Registration FAQs – Important Tips – Electronic Submission of Grant Applications - Electronic Submission of Grant Applications.

Research Plan Component Sections

While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to HHS/CDC in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used. Do not include any information in a header or footer of the attachments. A header will be system-generated that references the PD/PI. Page numbers for the footer will be system-generated in the complete application, with all pages sequentially numbered; therefore, do not number the pages of your attachments.  Your research plan must not exceed 25 pages. If your research plan exceeds the page limitation, your application may be considered unresponsive and ineligible for review.  Information contained in the appendix as noted below is not included in this page limitation.  

The following materials may be included in the Appendix:

Up to ten publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project. Do not include manuscripts submitted for publication. Applicants should refer to instruction guides and specific Funding Opportunity Announcements (FOAs) to determine the appropriate limit on the number of publications that may be submitted for a particular program. Note that not all grant activity codes allow the inclusion of publications.

Do not to use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the relevant policies and procedures may not be considered in the review process. Applicants are reminded to review specific FOAs for any additional program-specific guidance on Appendix material and other application requirements.

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 should describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation they will provide, 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 the awardee will place any conditions 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.

Thus, the applicant must include a plan for sharing research data in their application. The HHS/CDC data sharing policy is available at http:\\www.cdc.gov\od\pgo\funding\ARs.htmhttp://www.cdc.gov/od/pgo/funding/ARs.htm under Additional Requirements 25 Release and Sharing of Data. 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, the reviewers will not factor the proposed data sharing plan into the determination of scientific merit of the application.

Sharing Research Resources

HHS policy requires that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (please see  http://www.cdc.gov/od/pgo/funding/HHS_GPS_Oct_2006.doc.http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs)  Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by the HHS/CDC 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://grants.nih.gov/grants/funding/2590/2590.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.

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Office of Public Health Research (OPHR) in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The goals of HHS/CDC-supported research are to advance the understanding of health promotion and the prevention of disease, injury, and disability, and enhance preparedness.  In the written comments, evaluate the application to judge the likelihood the proposed research will have a substantial impact on the pursuit of these goals.  Each of these criteria will be addressed by the reviewers and considered in assigning the overall score, weighting them and weighted, as appropriate for each application:

Note that an 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.

Significance: Does this study address an important problem? If the applicant achieves the aims of the application, how will it advance scientific knowledge or clinical practice? What will be the effect of these studies on the concepts, methods, technologies, treatments, 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 applicant will do the work 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 be considered in the determination of scientific merit and the priority score:

Appropriate credit will also be given to the ability of the applicant to incorporate additional priority topics into their planned research.

Protection of Human Subjects from Research Risk: When human subjects are involved, HHS/CDC will assess the available protections from research risk that relate to their participation in the proposed research. [see the Research Plan, Section 2, item 8 on Human Subjects in the SF424 (R&R)] located at, http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements are available on the Internet at the following address:  http://www.cdc.gov/od/pgo/funding/ARs.htm.

INCLUSION OF PERSONS UNDER THE AGE OF 21 IN RESEARCH
The policy of CDC is that persons under the age of 21 must be included in all human subjects’ research that is conducted or supported by CDC, unless there are scientific and ethical reasons not to include them. This policy applies to all CDC-conducted or CDC-supported research involving human subjects, including research that is otherwise exempt in accordance with Sections 101(b) and 401(b) of 45 C.F.R. Part 46, HHS Policy for the Protection of Human Subjects45 C.F.R. Part 46, HHS Policy for the Protection of Human Subjects. Therefore, proposals for research involving human subjects must include a description of plans for including persons under the age of 21. If persons under the age of 21 will be excluded from the research, the application or proposal must present an acceptable justification for the exclusion.

In an extramural research plan, the investigator should create a section titled "Participation of persons under the age of 21." This section should provide either a description of the plans to include persons under the age of 21 and a rationale for selecting or excluding a specific age range, or an explanation of the reason(s) for excluding persons under the age of 21 as participants in the research. When persons under the age of 21 are included, the plan must also include a description of the expertise of the investigative team for dealing with individuals at the ages included, the appropriateness of the available facilities to accommodate the included age groups, and the inclusion of a sufficient number of persons under the age of 21 to contribute to a meaningful analysis relative to the purpose of the study. Scientific review groups at CDC will assess each application as being acceptable or unacceptable in regard to the age-appropriate inclusion or exclusion of persons under the age of 21 in the research project, in addition to evaluating the plans for conducting the research in accordance with these provisions.

The inclusion of children (as defined by the applicable law of the jurisdiction in which the research will be conducted) as subjects in research must be in compliance with all applicable subparts of 45 C.F.R. Part 4645 C.F.R. Part 46, as well as with other pertinent federal laws and regulations.

The policy of inclusion of persons under the age of 21 in CDC-conducted or CDC-supported research activities in foreign countries (including collaborative activities) is the same as that for research conducted in the United States.

Inclusion of Women and Minorities in Research:

Does the application adequately address the HHS/CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research?  This includes: (1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) The proposed justification when representation is limited or absent; (3) A statement as to whether the design of the study is adequate to measure differences when warranted; 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 (see Section 2, item 9 Inclusion or Women and Minorities of the Research Plan component of the SF424 (R&R). 

Care and Use of Vertebrate Animals in Research: If applicants plan to use vertebrate animals in the project, HHS/CDC will assess the five items described under Section 2, item 12 Vertebrate Animals of the Research Plan component of the SF424 (R&R).   Additional HHS/CDC Requirements under AR-3 Animal Subjects Requirements are available on the Internet at the following address:http://www.cdc.gov/od/pgo/funding/ARs.htm

Biohazards: If applicants propose the applicant has proposed materials or procedures that are potentially hazardous to research personnel and/or the environment, HHS/CDC will determine if the proposed protection is adequate

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the number of person months listed for the effort of the PD/PI appropriate for the work proposed?  Is each budget category realistic and justified in terms of the aims and methods?  The evaluation of the budget should not affect the priority score.

2.C. Sharing Research Data

Data Sharing Plan: HHS/CDC will assess the reasonableness of the data sharing plan. 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.

Reviewers will be asked to assess the adequacy of the research sharing plan as proposed in the application.

2.D. Sharing Research Resources

HHS policy requires that recipients of grant awards make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication.  Please see http://www.cdc.gov/od/pgo/funding/HHS_GPS_Oct_2006.docInvestigators responding to this funding opportunity should include a plan on sharing research resources.

Reviewers will be asked to assess the adequacy of the mechanism described for sharing research resources as proposed in the application.

The adequacy of the resources sharing plan will also be considered by Program staff of the funding organization when making recommendations about funding levels. The effectiveness of the resource sharing will also be evaluated as part of the administrative review of each non-competing Grant Progress Report (HHS 2590,http://grants.nih.gov/grants/funding/2590/2590.htm).  See Section VI.3. Reporting.

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.  

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the applicant organization will receive a written critique called a “Summary Statement.”  The applicant organization and the PD/PI will be able to access the Summary Statement via the eRA Commons.

HHS/CDC will contact those applicants under consideration for funding 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.  HHS/CDC will mail and/or e-mail this document 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 Part 74 and Part 92 have details about 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 are available in Section VIII. Other Information of this document or on the HHS/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.
 

The following terms and conditions will be incorporated into the NoA and will be provided to the appropriate institutional official and a courtesy copy to the PD/PI at the time of award.

3. Reporting

The recipient organization must provide HHS/CDC with an original, plus two hard copies of the following reports:

1.      Non-Competing Grant Progress Report, (use form PHS 2590, posted on the HHS/CDC website http://www.cdc.gov/od/pgo/funding/forms.htm and at http://grants.nih.gov/grants/funding/2590/2590.htm, no less than 120 days prior to the end of the current budget period. The progress report will serve as the non-competing continuation application.

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.

The recipient organization must forward these reports by the U.S. Postal Service or express delivery to the Grants Management Specialist listed in the “Agency Contacts” section of the NoA.   Progress reports and Financial status reports should be provided in hard copy format.  

Although the financial plans of the HHS/CDC 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.

Section VII. Agency Contacts


HHS/CDC encourages your inquiries concerning this FOA and welcomes the opportunity to answer questions from potential applicants. Inquiries can 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 Research
U.S. Department of Health and Human Services
National Center on Birth Defects and Developmental Disabilities
Centers for Disease Control and Prevention
1600 Clifton Road, Mailstop E87
Atlanta, GA  30333
Telephone: (404) 498-3041
Fax: (404) 498-3050
E-Mail: dcl5@cdc.gov

2. Peer Review Contacts:

Dr. Juliana Cyril
Office of Public Health Research (OPHR)
U.S. Department of Health and Human Services
Centers for Disease Control and Prevention
1600 Clifton Road, NE, Mailstop D-72
Atlanta, GA 30333
Telephone: (404) 639-4639
Fax: (404) 639-4903
E-Mail: jcyril@cdc.gov

3. Financial or Grants Management Contacts:

Tracey Sims
Grants Management Specialist
U.S. Department of Health and Human Services
CDC Procurement and Grants Office
2920 Brandywine Road
Atlanta, GA  30341
Telephone: (770) 488-2739    
Fax: (770) 488-2777
E-Mail: tsims3@cdc.gov

4. General Questions Contacts:

Technical Information Management Section
CDC Procurement and Grants Office
U.S. Department of Health and Human Services
2920 Brandywine Road
Atlanta, GA  30341
Telephone: 770-488-2700
E-Mail:PGOTIM@cdc.gov  

Section VIII. Other Information


Required Federal Citations

Human Subjects Protection
Federal regulations (45 CFR Part 46) 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 HHS/CDC Requirements under AR-1 Human Subjects Requirements can be found on the Internet at the following address: 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.

INCLUSION OF PERSONS UNDER THE AGE OF 21 IN RESEARCH
The policy of CDC is that persons under the age of 21 must be included in all human subjects’ research that is conducted or supported by CDC, unless there are scientific and ethical reasons not to include them. This policy applies to all CDC-conducted or CDC-supported research involving human subjects, including research that is otherwise exempt in accordance with Sections 101(b) and 401(b) of 45 C.F.R. Part 46, HHS Policy for the Protection of Human Subjects45 C.F.R. Part 46, HHS Policy for the Protection of Human Subjects. Therefore, proposals for research involving human subjects must include a description of plans for including persons under the age of 21. If persons under the age of 21 will be excluded from the research, the application or proposal must present an acceptable justification for the exclusion.

In an extramural research plan, the investigator should create a section titled "Participation of persons under the age of 21." This section should provide either a description of the plans to include persons under the age of 21 and a rationale for selecting or excluding a specific age range, or an explanation of the reason(s) for excluding persons under the age of 21 as participants in the research. When persons under the age of 21 are included, the plan must also include a description of the expertise of the investigative team for dealing with individuals at the ages included, the appropriateness of the available facilities to accommodate the included age groups, and the inclusion of a sufficient number of persons under the age of 21 to contribute to a meaningful analysis relative to the purpose of the study. Scientific review groups at CDC will assess each application as being acceptable or unacceptable in regard to the age-appropriate inclusion or exclusion of persons under the age of 21 in the research project, in addition to evaluating the plans for conducting the research in accordance with these provisions.

The inclusion of children (as defined by the applicable law of the jurisdiction in which the research will be conducted) as subjects in research must be in compliance with all applicable subparts of 45 C.F.R. Part 46,45 C.F.R. Part 46 as well as with other pertinent federal laws and regulations.

The policy of inclusion of persons under the age of 21 in CDC-conducted or CDC-supported research activities in foreign countries (including collaborative activities) is the same as that for research conducted in the United States.

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
HHS/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.



Healthy People 2010
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople .

Lobbying Restrictions
Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby.

In addition no part of HHS/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, HHS/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 HHS/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 HHS/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 HHS/CDC funds should give close attention to isolating and separating the appropriate use of HHS/CDC funds from non-CDC funds. HHS/CDC also cautions recipients of HHS/CDC funds to be careful not to give the appearance that HHS/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 licensed public accountant 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.

Security Clearance Requirement
All individuals who will be performing work under a grant or cooperative agreement in a HHS/CDC-owned or leased facility (on-site facility) must receive a favorable security clearance, and meet all security requirements. This means that all awardee employees, fellows, visiting researchers, interns, etc., no matter the duration of their stay at HHS/CDC must undergo a security clearance process.

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:

  1. Place small, minority, women-owned business firms on bidders’ mailing lists.
  2. Solicit these firms whenever they are potential sources of supplies, equipment, construction, or services.
  3. Where feasible, divide total requirements into smaller needs, and set delivery schedules that will encourage participation by these firms.
  4. Use the assistance of the Minority Business Development Agency of the Department of Commerce, the Office of Small and Disadvantaged Business Utilization, DHHS, and similar state and local offices.

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 (ORI) (http://ori.hhs.gov./policies/statutes.shtml) 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.  HHS/CDC considers this project a public health activity consistent with the Standards for Privacy of Individually Identifiable Health Information and HHS/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 HHS/CDC data sharing agreement will be released as follows:

  1. In a timely manner.
  2. Completely, and as accurately as possible.
  3. To facilitate the broader community.
  4. 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 HHS/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.  HHS/CDC recommends data is released in the form closest to micro data and one that will preserve confidentiality. 

National Historic Preservation Act of 1966

(Public Law 89-665, 80 Stat. 915)

The grantee’s signature on the grant application attests to their: (1) knowledge of the National Historic Preservation Act of 1966 (Public Law 89-665, 80 Stat. 915); and (2) intent to ensure all grant related activities are in compliance with referenced public law, as stated:

a.      Section 106 of the National Historic Preservation Act (NHPA) states:

The head of any Federal agency, having direct or indirect jurisdiction over a proposed Federal or Federally assisted undertaking in any State and the head of any Federal department or independent state agency having authority to license any undertaking,  shall, prior to the approval of the expenditure of any Federal funds on the undertaking or prior to the issuance of any license, as the case may be, take into account the effect of the undertaking on any district, site, building, structure, or object that is included in or is eligible for inclusion in the National Register.  The head of any such Federal agency shall afford the Advisory Council on Historic Preservation established under Title II of this ACT a reasonable opportunity to comment with regard to such undertaking.

b.      Additionally, the NHPA also contains the following excerpt that forbids “anticipatory demolition:”

Each Federal agency shall ensure that the agency will not grant a loan, loan guarantee, permit, license, or other assistance to an applicant who, with intent to avoid the requirements of Section 106 of this Act, has intentionally, significantly, adversely affected a historic property to which the grant would relate or, having legal power to prevent it, allowed such significant adverse effect to occur, unless the agency, after consultation with the Council, determines that circumstances justify granting such assistance despite the adverse effect created or permitted by the applicant.

Conference Disclaimer and Use of Logos

Disclaimer: Where a conference is funded by a grant or cooperative agreement, a subgrant or a contract the recipient must include the following statement on conference materials, including promotional materials, agenda, and internet sites:

“Funding for this conference was made possible [in part] by [insert grant or cooperative agreement award number] from the Centers for Disease Control and Prevention(CDC) or the Agency for Toxic Substances and Disease Registry (ATSDR) .  The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.”

Logos: Neither the HHS nor the CDC (“CDC” includes ATSDR) logo may be displayed if such display would cause confusion as to the source of the conference or give the false appearance of Government endorsement. A non-federal entity’s unauthorized use of the HHS name or logo is governed by U.S.C. § 1320b-10, which prohibits the misuse of the HHS name and emblem in written communication. The appropriate use of the HHS logo is subject to the review and approval of the Office of the Assistant Secretary for Public Affairs (OASPA). Moreover, the Office of the Inspector General has authority to impose civil monetary penalties for violations (42 C.F.R. Part 1003).  Neither the HHS nor the CDC logo can be used on conference materials under a grant, cooperative agreement, contract or co-sponsorship agreement without the expressed, written consent of either the Project Officer or the Grants Management Officer.  It is the responsibility of the grantee (or recipient of funds under a cooperative agreement) to request consent for the use of the logo in sufficient detail to assure a complete depiction and disclosure of all uses of the Government logos, and to assure that in all cases of the use of Government logos, the written consent of either the Project Officer or the Grants Management Officer has been received.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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