Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

Centers for Disease Control and Prevention (CDC)

Components of Participating Organizations

National Institute for Occupational Safety and Health (NIOSH)

Funding Opportunity Title

Continuation of the National Mesothelioma Virtual Bank for Translational Research (U24)

Mechanism of Support

U24 Resource-Related Projects – Cooperative Agreements

Announcement Type

Reissue of RFA-OH-08-002

Funding Opportunity Announcement (FOA) Number

RFA-OH-11-002

Catalog of Federal Domestics Assistance (CFDA) Number(s)

93.262

Category of Funding Activity

Health

FOA Purpose

The National Institute for Occupational Safety and Health (NIOSH) announces the availability of funds for fiscal year (FY) 2011 to support one cooperative agreement (U24) for continuation of the National Mesothelioma Virtual Bank for Translational Research.

Key Dates
Publication Date

December  23, 2010

Letter of Intent Due Date

February 15, 2011

Application Due Date

Received by March 15, 2011

Scientific Merit Review

April 2011

Secondary Review

May 2011

Start Date

September 1, 2011

Expiration Date

March 16, 2011

Due Dates for E.O. 12372

Executive Order 12372 does not apply to this program.

NOTE: The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this funding opportunity announcement (FOA) might 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 CDC will direct applicants elsewhere for that information.

It is critical that applicants follow the instructions in the PHS 398 Grant Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Paper applications must be submitted using PHS 398 Forms.

Note: The Research Strategy component of the Research Plan is limited to 15 pages.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

The goal of the NIOSH research program is to develop an understanding of the risks and conditions that are associated with occupational diseases and injuries, to explore methods for reducing risks and for preventing or minimizing exposure to hazardous conditions in the workplace, and to translate significant scientific findings into prevention practices and products that will effectively reduce work-related illnesses and injuries. Specific research priorities are derived from the National Occupational Research Agenda (NORA), which is used by NIOSH for determining how best to carry out its mission of providing national and world leadership guidance in preventing work-related illnesses and injuries. Detailed information about NORA can be found at http://www.cdc.gov/niosh/nora/. One NORA Cross-Sector Program, Cancer, Reproductive and Cardiovascular Disease, is particularly relevant to this RFA.

Malignant mesothelioma is a rare form of cancer that presents as a malignant growth in the sac lining (mesothelium) of the chest (the pleura), or the abdominal cavity (the peritoneum) or the lining around the heart (the pericardium).  Asbestos exposure through inhalation of asbestos fibers is the main cause of mesothelioma. Because asbestos mineral fibers are flame and heat resistant, pliable, strong, refractory to corrosive chemicals, and provide insulation, asbestos has been used to insulate buildings from heat and protect against fire (it has been especially important in the shipbuilding industry), in fabric to make protective suits, as a brake liner (e.g. in automobiles and railroad rolling stock) and for engine gaskets, and in making filters (e.g. in the chemical industry). Thus, Americans have been exposed to asbestos in the workplace since its use became wide-spread in the mid- to late-nineteenth century.

Although the use of asbestos has been significantly reduced since the 1970s, mesothelioma is still a significant occupational health burden. Each year, in the United States, approximately 2,500 people are diagnosed with mesothelioma (~20% female and ~4% Black). This is because the latency period for mesothelioma is 20-50 years, with the average patient age of 70 years at the time of diagnosis. Furthermore, the risk of asbestos exposure continues today in many occupational settings, and in buildings such as homes, offices and schools, in which asbestos was previously used or installed and remains present. The incidence of mesothelioma continues to rise in the U.S. and worldwide. The peak incidence worldwide is expected in 2020, and in the U.S. it is predicted that there will be approximately 71,000 new cases between 2003 and 2054. Early diagnosis is critical if treatment is to be effective and markers for early detection are needed. In addition, treatment modalities remain difficult.

Increased research efforts on mesothelioma will aid in the discovery of more effective treatments to combat this deadly disease. The National Mesothelioma Virtual Bank (NVBM) for Translational Research at the University of Pittsburgh was established in 2006 to serve as a unique resource for these research efforts. Published information on the NMVB for Translational Research is available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2533341/.

Purpose

The purpose of the virtual mesothelioma registry and tissue bank is to provide a resource for investigators engaged in the research of mesothelioma. It is intended to provide biospecimens (blood, plasma, white blood cells, and normal and mesothelioma tissues) together with demographic data (age, sex, race, occupational history and other epidemiologic information), and clinical data (stage, treatment and survival information). Additionally, the virtual registry and tissue bank could also serve as a repository and offer a library of reagents and data (e.g.,antibodies, genomic, transcriptomic and proteomic data) for sharing among investigators.

The goal is to provide a resource that will assist in development of early markers of disease, biomarkers of stage and prognosis, as well as improved treatment modalities. Specifically, it will provide access to biospecimens for research on biomarkers for early detection (e.g., tissues, plasma proteins), susceptibility (e.g., DNA or white blood cells), epidemiologic research (e.g., occupational history and death certificate information), and clinical research (improved prognosis through improvements in treatment). Through this RFA, the awardee will maintain and expand the current National Mesothelioma Virtual Bank for Translational Research, improving its capability to serve as a resource for biomedical research and the clinical science community.

A virtual registry and tissue bank is one in which participating institutions will make available their independent stores of mesothelioma tissue for public access and use through a centralized internet-based database or registry. This registry is used for data recording and collection related to each tissue sample. Each participating institution is responsible for the data entry and updates into the registry for each of their samples. The recipient of this cooperative agreement will manage, and further enhance the development and utility of the NMVB for Translational Research.

Research Objectives

The objectives of this research are to:

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New
Renewal
The OER Glossary and the PHS 398 Grant Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIOSH anticipates that $1,028,000 will be available in FY 2011, and that one award will be made under this FOA. Awards issued under this FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Ceiling and Floor of Individual Award Range

Ceiling level of funding for the program: $1,028,000 total costs (including direct and indirect costs) per year, for up to 5 years.

Floor level of funding for the program: None

Project Period Length

The maximum project period is 5 years. Throughout the project period, NIOSH’s commitment to continuation of awards will be contingent on available 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.

HHS/CDC grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants
 
Applicant institutions must have an established registry and tissue bank with capability for functioning as a national virtual registry and tissue bank, one in which participating institutions will make available their independent stores of mesothelioma tissue for public access and use through a centralized internet-based database or registry. This virtual registry and tissue bank must be able to provide a resource for investigators engaged in the research of mesothelioma, to include biospecimens (blood, plasma, white blood cells, and normal and mesothelioma tissues) together with demographic data (age, sex, race, occupational history and other epidemiologic information), and clinical data (stage, treatment and survival information).

Eligible Organizations

Higher Education Institutions:

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For Profit Organizations

Governments

Other

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 applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required.

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are not allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS 398 Grant Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization 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 HHS/CDC support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS 398 Grant Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a unique DUNS number) is allowed.

HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. HHS/CDC will not accept any application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Obtaining an Application Package

The new version of the PHS 398 application and instructions (revised 6/2009) must be used. Forms and instructions can be obtained at http://grants.nih.gov/grants/forms.htm.

2. Content and Form of Application Submission

Applicants must follow the instructions in the PHS 398 Grant Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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 NIOSH staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Price Connor, Ph.D.
Scientific Review Officer
Office of Extramural Programs
National Institute for Occupational Safety and Health (NIOSH)
Centers for Disease Control and Prevention (CDC)

For US Mail:
1600 Clifton Road NE, MS E-74
Atlanta, GA 30333
For FedEx:
2400 Century Center
4th floor
Atlanta, GA 30345
Telephone: 404-498-2511
Fax: 404-498-2571
E-Mail: SPC3@cdc.gov

Page Limitations

All page limitations described in this individual FOA must be followed.

For this FOA, the Research Strategy section is limited to 15 pages

Research Plan Components

All instructions in the PHS 398 Grant Application Guide must be followed.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide.

Appendix

Appendices are optional. NIOSH, AHRQ and NIH issued a notice on 15 April 2010 about limits on appendix materials that may be submitted with grant applications. Appendix materials must be well organized, clearly labeled as to the relevant section of the application, and ordered similarly to the application contents.

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide, with the following modifications:

·         An application that does not observe the required page limits may not be considered in the review process.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates.

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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.

Pre-award costs are not allowed.

6. Other Submission Requirements and Information

Applications must be submitted following the instructions described in the PHS 398 Grant Application Guide.  ONLY Paper applications will be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

Applications exceeding page limits or requests for greater than $1,028,000 total costs (including direct and indirect costs) per year, for up to 5 years, will be considered nonresponsive and will not be reviewed.

Applications must be received on or before the due date in Part I. Overview Information.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and for responsiveness by CDC/NIOSH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Section V. Application Review Information

1. Criteria

All applications submitted to CDC/NIOSH in support of public health research are evaluated for scientific and technical merit through the CDC peer review system. Applications should be relevant to the NIOSH mission and specifically to mesothelioma research. Only the review criteria described below will be considered in the review process.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the proposed research further develop the concept and usefulness of a virtual registry and tissue bank? Will the proposed research further enhance access of the clinical science community to mesothelioma tissue and data resources?

Investigator(s)    

Are the PD/PIs, collaborators, and other researchers well suited to the project? Have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the PI describe how the enhanced NMVB for Translational Research will serve as a unique resource for researchers in this field and how the research team will collaborate with other related resources to further enhance the utility of the virtual registry and tissue bank?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Is the project fully described and does it include a plan for dissemination of results?  Does the project have a well-developed and conceived evaluation plan?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Does the applicant provide evidence of existing systems and/or infrastructure that are critical to the success of the proposal? Does the applicant have an existing NMVB for Translational Research or other actual or virtual registry and tissue bank? Has the applicant addressed how it will work with the existing registry and bank to maintain, enhance and improve the bank through this new cooperative agreement?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Confidentiality

Because of the sensitive nature of an internet-based registry, applicants need to specifically address how confidentiality issues will be handled in the reporting and use of data from the internet-based registry. Does the applicant describe the type of information that will be collected related to the tissues and other biospecimens included in the virtual registry and bank, and how this information will be used and protected?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the HHS/CDC Requirements under AR-1 Human Subjects Requirements.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Inclusion of Women and Racial and Ethnic Minorities in Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Renewals

For Renewals (formerly called competing continuation applications), the committee will consider the progress made in the last funding period.

Resubmissions

Not applicable.

Revisions

Not applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Resource Sharing Plans

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

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIOSH, in accordance with HHS (http://grants1.nih.gov/grants/peer/) and CDC (http://aops-mas-iis.cdc.gov/Policy/Doc/policy357.pdf) peer review procedures using the stated review criteria.

As part of the scientific peer review, all applications will:

·         Be discussed and assigned an overall impact/priority score.

Applications will be assigned to NIOSH and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the HHS Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, HHS/CDC will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. Pre-award costs are not allowed.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All HHS/CDC grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA. For these terms of award, see the HHS Grants Policy Statement Part II: Terms and Conditions of Award, Overview of Terms and Conditions of Award and Requirements for Specific Types of Grants. Additional requirements are available at the following internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

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 U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) 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 HHS/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 HHS/CDC as defined below. The grantee is strongly encouraged to review the HHS grant policy statement, for aid with post award administration, at http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.

2.A.1 Project Director (PD)/Principal Investigator (PI) Rights and Responsibilities

The recipient will have the primary responsibility for all management, administrative and scientific aspects of the research including all data, resources, and operations. This includes the following:

2.A.2 HHS/CDC Responsibilities

NIOSH Program Official (PO)

The NIOSH Program Official will be responsible for normal programmatic stewardship of the award and will be named in the notice of award. The PO will:

NIOSH Project Scientist

NIOSH anticipates having substantial scientific involvement during the conduct of this activity in the form of technical assistance, collaboration, guidance and coordination. A NIOSH Project Scientist may be involved and, if so, will have responsibilities that include the following:

The NIOSH Project Scientist/Collaborator will be named in the award notice and will work closely with the NIOSH PO. Should more than one NIOSH Project Scientist be involved, there will be only one NIOSH vote reached by consensus.

2.A.3 Areas of Joint Responsibility

Coordinating/Steering Committee

The awardee will manage the NMVB for Translational Research with collaboration, consultation and guidance from CDC/NIOSH. A Coordinating/Steering Committee will be established by the recipient and will consist of: 1) the Principal Investigators 2) two other representatives from the awardee institution; 3) two members from each tissue/data accruing site; 4) a patient advocate; 5) the NIOSH Program Official; and 6) the NIOSH Project Scientist. Additional members may be added by majority approval.

The Coordinating/Steering Committee will help guide activities undertaken by the NMVB for Translational Research. This will include a) proper operating policies, b) a Manual of Standard Operations for procedures to access, process and distribute tissue; c) uniform quality control methods, e) rules for access to the clinical and outcome data associated with the accrued cases; and f) ensuring that adequate security and confidentiality are maintained.

An annual Face-to-Face meeting of the Coordinating/Steering Committee will be held to discuss progress, important findings, and challenges. These meetings will also provide an opportunity for critical discussions on enhancing partnerships, new collaborations and future directions.

Dispute Resolution Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIOSH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIOSH staff voting, one NIOSH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the HHS Grants Policy Statement.

An annual report suitable for public distribution will be provided to the NIOSH PO at the end of each calendar year.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated, no more than 90 days after the end of the project period.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.FSRS.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Scientific/Research Contact(s)

Joan F. Karr, Ph.D.
Office of Extramural Programs
National Institute for Occupational Safety and Health (NIOSH)
Centers for Disease Control and Prevention (CDC)
1600 Clifton Road NE, MS E-74
Atlanta, GA 30333 USA
Telephone: 404-498-2506
Fax: 404-498-2571
Email: GZK8@cdc.gov

Peer Review Contact(s)

Price Connor, Ph.D.
Office of Extramural Programs
National Institute for Occupational Safety and Health (NIOSH)
Centers for Disease Control and Prevention (CDC)
1600 Clifton Road NE, MS E-74
Atlanta, GA 30333 USA
Telephone: 404-498-2511
Fax: 404-498-2571
E-Mail: SPC3@cdc.gov

Financial/Grants Management Contact(s)

Maryann P. Monroe
Acquisition & Assistance Field Branch
Procurement and Grants Office (PGO)
Centers for Disease Control and Prevention (CDC)
P.O. Box 18070, 626 Cochrans Mill Road
Pittsburgh, PA 15236-0070
Telephone: 412-386-5075
Fax: 412-386-6429
Email: ZIA2@cdc.gov

General Questions and Application Submission Contact(s)

Technical Information Management Section (TIMS)
HHS/CDC Procurement and Grants Office (PGO)
2920 Brandywine Road
Atlanta, GA 30341
Telephone 770-488-2700
Email: PGOTIM@cdc.gov

Hours: Monday - Friday, 9am - 5pm Standard Time

Pre-Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

Hours: 24 hours a day, 7 days a week; closed on Federal holidays

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Hours: Monday - Friday, 7am - 8pm Eastern Time

Section VIII. Other Information

All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of the Federal Mine Safety and Health Act, Section 501(a), 30 U.S.C 1(NOTE) & 951(a; Public Health Service Act, Section 301(a) and 405, 42 U.S.C 241 and 284; Occupational Safety and Health Act of 1970, Section 20(a) and 21(a), 29 U.S.C 669(a) & 670(a); Executive Order Federal Regulations 42 CFR 52 and 45, Part 74 and 92.

Federal Citations

Use of Animals in Research:

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar3

SF424: Part III, Section 2.2

Human Subjects Protection:

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar1

SF424: Part III, Section 2.1

Data and Safety Monitoring Plan:

http://grants.nih.gov/grants/guide/notice-files/not98-084.html

SF424: Part II, Section 4.1.5

Sharing Research Data:

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar25

SF424: Part III, Section 4.5

Policy for Genome-Wide Association Studies (GWAS):

http://grants.nih.gov/grants/gwas/ 

SF424: Part III, Section 1.5.3

Sharing of Model Organisms:

http://grants.nih.gov/grants/policy/model_organism/index.htm     

SF424: Part III, Section 1.5.2

Inclusion of Women and Racial and Ethnic Minorities in Research: http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar2

SF424: Part II, Section 4.2

Inclusion of Persons under the Age of 21 in Research: http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar28

SF424: Part II, Section 4.4

Publications:
HHS Grants Policy Statement (Intellectual Property-Rights in Data & Publications)

Health Insurance Portability and Accountability Act Requirements:
http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar24

SF424: Part III, Section 4.2

URLs in HHS/CDC Grant Applications or Appendices:

SF424: Part I, Section 4.2

Healthy People 2020:

http://www.health.gov/healthypeople

Authority and Regulations:

HHS Grants Policy Statement

Smoke-Free Workplace:

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar10

Public Law 103-227

Pro-Children Act of 1994.

SF424: Part III, Section 2.11

HIV/AIDS Confidentiality Provisions

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar4

HIV Program Review Panel

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar5

Patient Care

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar6

Executive Order 12372 Review

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar7

Public Health System Reporting

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar8

Paperwork Reduction Act

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar9

Lobbying Restrictions

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar12

Prohibition of Use of CDC Funds for Certain Gun Control Activities

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar13

Accounting System Requirements

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar14

Proof of Non-profit Status

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar15

Security Clearance

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar16

Peer and Technical Reviews of Final Reports of Health Studies – HHS/ATSDR

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar17

Cost Recovery – HHS/ATSDR

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar18

Third Party Agreements – HHS/ATSDR

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar19

Small, Minority and Women-owned Business

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar21

Research Integrity

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar22

Compliance with Executive Order 13279

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar23

National Historic Preservation Act of 1966 (Public Law 89-665, 80 Stat. 915)

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar26

Conference Disclaimer and Use of Logos

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar27


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
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