Part I Overview Information
Department of Health and Human Services
Food and Drug Administration (FDA), (http://www.fda.gov)
Food and Drug Administration (FDA), (http://www.fda.gov)
Components of Participating Organizations
Center for Food Safety and Applied Nutrition (CFSAN) (http://www.fda.gov/Food)
Title: Leveraging FDA Safety Research through Marine Environmental Science Consortium-Dauphin Island Sea Lab Faculty Collaboration and Graduate Student Internship Program (U18)
Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.
Announcement Type: New
Request For Applications (RFA) Number: RFA-FD-09-017
Catalog of Federal Domestic Assistance Number(s)
Release Date: Leave blank
Letters of Intent Receipt Date(s): N/A
Application Receipt Dates(s): August 24, 2009
Peer Review Date(s): August, 2009
Earliest Anticipated Start Date: September, 2009
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: August 25, 2009.
Due Dates for E.O. 12372
Additional Overview Content
Purpose. This FOA issued by the Office of Food Safety is soliciting a sole source cooperative agreement grant application from the Dauphin Island Sea Lab (DISL). FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the ACT) as amended (21 U.S. C. 301 et seq.). In fulfilling its responsibilities under the Act FDA, among other things, directs its activities toward promoting and protecting the public health by ensuring the safety and security of foods (Appendix A). To accomplish its mission, FDA must stay abreast of the latest developments in research and also communicate with stakeholders about complex scientific and public health issues. Increased development of research, education and outreach partnerships with the Marine Environmental Science Consortium-Dauphin Island Sea Lab (DISL) will greatly contribute to FDA’s mission.
The DISL is one of Alabama’s most valuable assets and adds immeasurably to the quality of life in the state and beyond. The DISL network of 21 institutions enrolls students worldwide in degree programs delivered in classrooms, laboratories, education centers and online. The DISL nationally ranked programs, leading-edge research collaborations, and innovative business partnerships provide an environment to support diverse multidisciplinary exchanges with FDA. The scientific, public health and policy expertise within FDA provide opportunities for collaborations that support the DISL mission and strategic themes to provide access to high-quality education, research discovery, and knowledge-based services responsive to both the promises and demands of the state and the nation in the new century.
- Mechanism of Support. This FOA will utilize the U 18 cooperative agreement mechanism
- Funds Available and Anticipated Number of Awards. One.
- Budget and Project Period. The estimated amount of support in FY09 will be for up to $250,000 total costs (direct plus indirect costs). One award proposed for 1-year.
- Eligible Institutions/Organizations. Dauphin Island Sea Lab, Alabama
- Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/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 FDA support.
- Number of multiple PDs/PIs. Not applicable
- Number of Applications. Applicant may submit only one application.
- Resubmissions. Resubmission applications are not permitted in response to this FOA.
- Renewals. Renewal applications are not permitted in response to this FOA.
- Special Date(s). This FOA uses non-standard due dates.
- Application Materials. See Section IV.1 for application materials.
- Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (301) 480-0434
Table of Contents
- Research Objectives
- Mechanism(s) of Support
- Funds Available
- Eligible Applicants
- Eligible Institutions
- Eligible Individuals
- Cost Sharing or Matching
- Other - Special Eligibility Criteria
- Address to Request Application Information
- Content and Form of Application Submission
- Submission Dates and Times
- Receipt, Review and Anticipated Start Dates
- Letter of Intent
- Sending an Application to the NIH
- Application Processing
- Application Assignment
- Receipt, Review and Anticipated Start Dates
- Intergovernmental Review
- Funding Restrictions
- Other Submission Requirements and Information
- Review and Selection Process
- Additional Review Criteria
- Anticipated Announcement and Award Dates
- Award Notices
- Administrative and National Policy Requirements
- Cooperative Agreement Terms and Conditions of Award
- Principal Investigator Rights and Responsibilities
- FDA Responsibilities
- Cooperative Agreement Terms and Conditions of Award
- Scientific/Research Contact(s)
- Financial/ Grants Management Contact(s)
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
The United States Food and Drug Administration (FDA) Gulf Coast Seafood Laboratory (GCSL) and the Marine Environmental Science Consortium of the Dauphin Island Sea Lab (DISL) (the Parties) have a shared interest in scientific progress in the diverse disciplines that directly and indirectly affect seafood safety and human and animal health. The Parties also endorse scientific training for faculty, students and staff to foster a well-grounded foundation in interdisciplinary fields in which academia and government share mutual interest.
The cooperative agreement will establish terms of collaboration between FDA and DISL to support these shared interests that can be pursued through programs of collaborative research, public outreach, cooperative international initiatives, disciplinary training, and exchange of scientists and staff, including a program of graduate student internships.
The types of activities expected to develop from this agreement include:
- Exchanges between university faculty and staff and FDA scientists and staff;
- Educational opportunities for qualified students (graduate), staff members and faculty members in the Parties’ laboratories, classroom and offices;
- Joint meetings for education and research;
- Research collaborations;
- Cooperative international activities including outreach;
- Sharing of unique facilities and equipment for increased cost efficiencies for scientific endeavors;
- Promulgation and communication of identified collaborative efforts through appropriate means; and
- Adjunct, affiliates and research facility appointments for appropriate FDA professional staff, provided that appointment of such candidates will advance specific programmatic objectives of the parties as appropriate, and provided that such appointments comply with university policies on appointment of facility/affiliates.
In an effort to enhance collaborative interactions and communication between both institutions, FDA and DISL will collaborate in the development of regular workshops where faculty from all the institutions within the DISL and FDA scientists and staff share information about on going research, education and outreach efforts of mutual interest.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information
1. Mechanism of Support
This funding opportunity will use a cooperative agreement award mechanism (U18). In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with FDA staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award."
2. Funds Available
The estimated amount of funds available for support in Fiscal Year 2009 will be for up to $250,000 total costs (direct plus indirect costs).
The award will provide twelve (12) months of support contingent upon satisfactory performance in the achievement of project and program reporting.
This award will be funded based on the quality (e.g., how well the grantee responds to the RFA requirements) of the application received and is subject to availability of Federal funds to support the project. In addition, if a cooperative agreement is awarded, the grantee will be informed of any additional documentation that should be submitted to FDA.
The FDA grants policies as described in the DHHS Policy Statement, http://www.hhs.gov/grantsnet/adminis/gpd/index.htm, will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The following organizations/institutions are eligible to apply:
- Dauphin Island Sea Lab - Alabama
There are no other sources that can provide the required proximity to the FDA/GCSL and independent marine fieldwork capability required. The DISL is a diverse institutional consortium of undergraduate and graduate education and research. University programs faculty at the DISL are actively involved in both basic and applied research in coastal waters of the northern Gulf of Mexico. The DISL operates marine research vessels (boats) crewed by faculty and students for field studies and sample collections. DISL possesses extensive laboratory and wet-laboratory resources relevant to the mission of the FDA/GCSL. The DISL is located within 1 mile of the FDA/GCSL which will engage the proposed program of collaboration and internships. This unique circumstance of capability, capacity and proximity is irreplaceable without extended and costly concessions.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are encouraged to apply for the FDA programs.
2. Cost Sharing or Matching
This program does not require cost sharing as defined in the current DHHS Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm
3. Other-Special Eligibility Criteria
Number of Applications. Applicants may submit one application.
Resubmissions. Resubmission applications are not permitted in response to this FOA.
Renewals. Renewal applications are not permitted in response to this FOA.
Section IV. Application and Submission Information
1. Request Application Information
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact Camille Peake, Telephone (301) 827-7175, Email: Camille.Peake@fda.hhs.gov
Telecommunications for the hearing impaired: TTY 301-480-0434.
2. Content and Form of Application Submission
Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.
The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.
3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.
3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date(s): Not applicable.
Application Receipt Date(s): August 24, 2009
Peer Review Date(s): August, 2009
Earliest Anticipated Start Date(s): September, 2009
3.A.1. Letter of Intent
A letter of intent is not required for this funding opportunity.
3.B. Sending an Application to the FDA
Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:
At the time of submission, two additional copies of the application and all appendix material (on CDs only) must be sent to:
Division of Acquisition Support and Grants
Food and Drug Administration; HFA 500
5630 Fishers Lane, Rm. 2139
Rockville, MD 20857
Telephone: (301) 827-7175
3.C. Application Processing
Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the FDA and for responsiveness by the reviewing Institute Incomplete and/or non-responsive applications will not be reviewed.
The FDA will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
5. Funding Restrictions
All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the DHHS Grants Policy Statement. The Grants Policy Statement can be found at http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.
Pre-award costs are allowable. A grantee may, at its own risk and without FDA prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without FDA prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain FDA approval before incurring the cost. FDA prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a renewal award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on FDA either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. FDA expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see DHHS Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.)
6. Other Submission Requirements and Information
The awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administrative Information."
Research Plan Page Limitations
As described in the PHS 398 application and application instruction guide. http://grants.nih.gov/grants/funding/phs398/phs398.html
All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application.
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)
The following resource sharing policies do not apply to this FOA:
- Data Sharing Plan. Not Applicable
- Sharing Model Organisms. Not Applicable
- Genome Wide Association Studies (GWAS). Not Applicable
Section V. Application Review Information
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 FDA and in accordance with FDA peer review procedures using the review criteria stated below.
Please NOTE: The applicant is strongly encouraged to contact the FDA staff to resolve any questions about criteria before submitting an application. Please direct all questions of a technical or scientific nature to the CFSAN program staff, and all questions of an administrative or financial nature to the grants management staff.
The following will be considered in making funding decisions:
- Scientific and technical merit of the proposed project as determined by peer review
- Availability of funds
- Relevance of the proposed project to program priorities
- Information may be added (e.g., Compliance with resource sharing policies)
The FDA is responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. As part of this mission, applications submitted to the FDA for grants or cooperative agreements are evaluated for scientific and technical merit through the FDA peer review system.
Overall Impact. Reviewers will provide an overall impact 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 five core review criteria, and additional review criteria (as applicable for the project proposed).
Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, 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?
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?
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?
Additional Review Criteria. As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
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.
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.
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.
Resubmission Applications: Not Applicable.
Renewal Applications. Not Applicable
Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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.
Additional Review Considerations. As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Select Agent Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
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 an e-mail from the project officer
If the application is under consideration for funding, FDA may request information from the applicant prior to making the award. For details, applicants may refer to the HHS Grants Policy statement: http://www.hhs.gov/grantsnet/adminis/gpd/index.htm
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 is the authorizing document. Once all administrative and programmatic issues have been resolved, the Notice of Award will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Award will be mailed to the business official.
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. 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 following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.
2.A. Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and FDA 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 FDA programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the FDA purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the FDA as defined below.
2. A.1. Principal Investigator Rights and Responsibilities
The Principal Investigator will have the primary responsibility for and dominant role in planning, directing, and executing the proposed project, with the FDA staff being substantially involved as a partner with the PI.
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and FDA policies.
2. A.2. FDA Responsibilities
An FDA Project Officer will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The program project officer will monitor the grantee periodically. The monitoring may be in the form of telephone conversations, emails, or written correspondence between the project officer/grants management officer and the Principal Investigator. Periodic site visits with officials of the grantee organization may also occur. The results of these monitoring activities will be recorded in the official grant file and will be available to the grantee upon request, consistent with applicable disclosure statutes and with FDA disclosure regulations. Also, the grantee organization must comply with all special terms and conditions of the grant, including those that state that future funding will depend on recommendations from the project officer. In addition,
- FDA will have prior approval of the appointment of all key administrative and scientific personnel proposed by the grantee.
- FDA will be directly involved in the guidance and development of the program.
FDA scientists will participate, with the grantee, in determining and carrying out scientific and technical activities. Collaboration will also include data analysis, interpretation of findings and, where appropriate, co-authorship of publications
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
A final progress report, final invention statement, and a final Financial Status Report are required when a recipient changes institutions and an award is relinquished, or when an award is terminated.
Section VII. Agency Contacts
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, or administrative and financial grants management issues:
1. Scientific/Research Contacts:
Project Officer, Division of Seafood Science and Technology
FDA, CFSAN, Office of Food Safety
Gulf Coast Seafood Laboratory
1 Iberville Drive, Dauphin Island, AL 36528
Tel: 251-694-4479; FAX: 251-694-4477
2. Financial or Grants Management Contacts:
Division of Acquisition Support and Grants
Food and Drug Administration; HFA 500
5630 Fishers Lane, Rm. 2139
Rockville, MD 20857
Telephone: (301) 827-7175
Section VIII. Other Information
Required Federal Citations
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.
Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. Guidance provided by the NIH is in the following link: http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in FDA Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.
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 PA 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.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement in the following link: http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.