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June 30, 2008
(Federal Register Notice June 30, 2008)
Food and Drug Administration, HHS
http://www.fda.gov
Center for Food Safety and Applied Nutrition (CFSAN) (http://www.cfsan.fda.gov)
Title: Cooperative Agreement to Establish and Support the Western Center for Food Safety (U01)
New Competing Sole Source
Request for Applications (RFA) Number: RFA-FD-08-004
Catalog of Federal Domestic Assistance Number(s): 93.103
Opening Date: Applications are due within 30 days after the publication of the funding opportunity in the Federal Register
NOTE: On-time submission requires that applications be successfully submitted to Food and Drug Administration Grants Management Specialist Contact no later than 5:00 p.m local time (of the applicant's institution/organization).
Expiration/Closing Date: 30 after the publication of the funding opportunity in the Federal Register.
See http://www.whitehouse.gov/omb/grants/spoc.html
FDA intends to establish a cooperative agreement to create the WCFS to address these issues through the development of approaches and data critical to understanding the risks associated with the interface between production agriculture and food protection. Such knowledge is critical to the development of scientifically validated "best practices" for mitigating those risks at the production (versus processing) level. In establishing this cooperative agreement, the FDA recognizes the importance of agricultural practices in the western states, an increasingly important food producing region for fruits, vegetables, specialty crops, and dairy products; and a key point of entry for imported foods. The development of an integrated collaborative food protection research/education/outreach program in this region will benefit both consumers and producers nationwide.
The FDA recognizes that food production and processing technology is rapidly changing, that globalization of the food supply is increasing, and that the number and nature of the hazards associated with foods is rapidly evolving. This presents a particularly difficult challenge for food protection issues related to primary production. FDA intends to establish a cooperative agreement to create the Western Center for Food Safety (WCFS) to address these issues through the development of approaches and data critical to understanding the risks associated with the interface between production agriculture and food protection. Such knowledge is critical to the development of scientifically validated "best practices" for mitigating those risks at the production (versus processing) level. In establishing this cooperative agreement, the FDA recognizes the importance of agricultural practices in the western states, an increasingly important food producing region for fruits, vegetables, specialty crops, and dairy products; and a key point of entry for imported foods. The development of an integrated collaborative food protection research/education/outreach program in this region will benefit both consumers and producers nationwide.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
This Funding Opportunity Announcement (FOA) will use the cooperative agreement award mechanism (U01). Support will be in the form of a cooperative agreement. Accordingly, FDA will have substantial involvement in the program activities of the project. FDA will support the collaboration covered by this notice under the authority of Section 301 of the Public Health Service (PHS) Act (42 U.S.C. 241).
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.A, Administrative and National Policy Requirements, "Cooperative Agreement Terms and Conditions of Award."
This FOA uses "Just-in-Time" information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
The estimated amount of support in FY08 will be for up to $1.5 million (direct plus indirect costs), with the possibility of four additional years of support for up to $2.6 million, subject to the availability of funds. Future year amounts will depend on annual appropriations and successful performance.
The award will provide one year of support and include future recommended support for four additional years, contingent upon satisfactory performance in the achievement of project and program reporting objectives during the preceding year and the availability of Federal fiscal year appropriations.
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. This cooperative agreement program requires that the applicant substantially share in the project costs if an award is made.
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.
The following organizations/institutions are eligible to apply: The University of California
Competition is limited to the University of California. FDA believes that establishing the WCFS at WIFSS is appropriate because WIFSS is uniquely qualified to fulfill the objectives of the proposed cooperative agreement. It is an established partnership between academia, state and federal agencies, and private industry focused on enhancing food protection using a variety of approaches that include basic and applied research, communication and connectivity with public and private partners, outreach programs that extend from farm to fork, and modern information management. WIFSS's location at the University of California, Davis facilitates interaction with numerous Centers and Departments within the School of Veterinary Medicine, School of Medicine, College of Agricultural and Environmental Sciences, and College of Engineering. The existing administrative structure at WIFSS can be readily leveraged for developing new food protection programs and for fostering new partnerships. Existing collaborations with agricultural producers will promote the conduct of on-farm, pre- and post-harvest food protection research. Such field-scale research is critical both for understanding how agricultural practice impacts food safety and for ensuring that new technologies are practical and effective.
Collaboration between the public and the private sectors has proven to be an efficient means for both FDA and academia to remain current with scientific and technical advances associated with FDA regulated products (e.g., foods, animal drugs and feed additives). The degree to which FDA nurtures, develops and builds on these collaborations directly affects FDA's ability to enhance public health. The information and expertise that will be obtained through this partnership between FDA and WIFSS can be leveraged by all segments of the food protection and nutrition community, as well as by public health organizations, other Federal agencies, and academic institutions in the performance of their roles.
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 always encouraged to apply for FDA programs.
This cooperative agreement program requires that the applicant substantially share in the project costs if an award is made, including, but not limited to, partial salary support for administrative staff and in-kind support (e.g., faculty salaries and facilities costs).
Applicants are not permitted to submit a resubmission application in response to this FOA.
Renewal applications are not permitted in response to this FOA.
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 GrantsInfo, Telephone (301) 435-0714, Email: .
Telecommunications for the hearing impaired: TTY 301-451-0088.
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. Additional information is available in the PHS 398 grant application instructions.
FDA faces an increasing number of critical and complex food protection and public health challenges. FDA believes that these challenges can be addressed most efficiently by expanding the available science base through collaborative partnerships. Collaborative partnerships stimulate the integration of applied research, education, and outreach programs to enhance food protection and public health and address new and emerging issues. Collaborative partnerships provide opportunities to leverage resources and to stimulate interest among academics in solving pressing national food protection challenges. Accordingly, access to scientists and facilities associated with agriculture within the western United States increases FDA's understanding of the unique challenges and practices that must be considered when developing risk management measures that are pertinent to agricultural production in this region.
The collaborative partnership with WCFS will focus on the interface between food protection and the agricultural production of commodities such as produce and dairy foods. This will include studies in areas such as pre- and post-harvest practices and environmental contamination (both from point sources and from distributed sources, e.g., perchlorate in ground water) for both domestic and imported commodities. WCFS will address "real-world" problems (such as the development of technologies and practices for food safety-related sampling of fresh produce or the impact of field practices on subsequent processing) and develop knowledge leading to practical solutions and approaches that are both feasible and protective of public health. WCFS will also generate and analyze data needed to provide a scientific basis for optimizing the interactions between potentially competing national concerns, e.g., safety of food production environments versus the protection of wildlife habitats in agricultural communities. The education and outreach components of the partnership will ensure that this knowledge is available for, and useful to, all stakeholders.
A proposal is being solicited to establish and operate a collaborative center that is designed to meet the objectives of the request for application (RFA). The proposal should include information on both the structure and administration of the center and the approaches that will be used to establish robust and sustainable regional, national, and international research and outreach collaborations (including collaborations with the Agency's other Centers of Excellence, with other Centers at UC Davis, such as the Center for Produce Safety, and with other components of the University of California system), as well as strategies for cultivating additional base support for the center.
The applicant has the option of omitting from the application specific salary rates or amounts for individuals specified in the application budget. However, this information will be requested and required prior to award.
Data and information included in the application will generally not be publicly available prior to the funding of the application. After funding has been awarded, data and information included in the application will be given confidential treatment to the extent permitted by the Freedom of Information Act (5 U.S.C. 552(b)) and FDA's implementing regulations (including 21 CFR Part 20.61, and 20.105, and 20.106). By accepting funding, the applicant agrees to allow FDA to publish specific information about the cooperative agreement.
Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.
Opening Date: The application is due within 30 days after publication of the Funding Opportunity Announcement in the Federal Register.
NOTE: On-time submission requires that the application be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization
Expiration/Closing Date: 30 days after the publication of the funding opportunity in the Federal Register.
Application Receipt Date(s): Within 30 days from the publication of this FOA in the Federal Register
Council Review Date(s): September 5, 2008
Earliest Anticipated Start Date(s): September 2008
A letter of intent is not required for the funding opportunity.
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 paper application, including the checklist, three signed photocopies, and appendix material in one package to:
Staff Contact Name: Gladys M. Bohler
Division of Acquisition Support and Grants
Food and Drug Administration
5630 Fishers Lane, Rm. 2105; HFA 500
Rockville, MD 20857
Telephone: (301) 827-7168
FAX: 301-827-7101
Email:
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 and responsiveness by the Program and Grants Management Staff. Incomplete and non-responsive applications will be returned to the applicant without further consideration.
This initiative is not subject to intergovernmental review (http://www.whitehouse.gov/omb/grants/spoc.html).
All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS 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 new 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 new 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 HHS Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm).
In addition, additional Terms and Conditions of award will be determined prior to award of the cooperative agreement.
The cooperative research, education, and outreach programs developed through the WCFS will address scientific issues related to the interface between food protection and agriculture for commodities such as produce, dairy foods, and seafood. These programs will include partnerships with academia, industry, non-governmental organizations, and international organizations. These partnerships will also promote and sustain collaborative domestic and international outreach and education.
The objectives of this cooperative agreement are to:
Consent forms, assent forms, and any other information given to a subject are part of the grant application and must be provided, even if in a draft form. The applicant is referred to DHHS regulations at 45 CFR 46.116 and 21 CFR 50.25 for details.
Awardee(s) must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A.
Appendix Materials
All paper PHS 398 applications submitted must provide appendix material on CD only and include five identical CDs in the same package with the application. If submitting CDs, it is not necessary to include a paper appendix.
Resource/Data Sharing Plan(s)
FDA considers the sharing of unique research resources developed through FDA sponsored research an important means to enhance the value of and advance research. When resources have been developed with FDA funds and the associated research findings have been published or provided to FDA, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.
Investigators should seek guidance from their institutions, on issues related to institutional policies and local Institutional Review Board (IRB) rules, as well as local, state and Federal laws and regulations, including the Privacy Rule (see Section VIII).
General Information
The applicant is strongly encouraged to contact FDA to resolve any questions about criteria before submitting the 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.
FDA grants management and program staff will review applications sent in response to this notice. To be responsive, an application must be submitted in accordance with the requirements of this notice. The staff will consider an application non-responsive if it does not contain the information set forth in this section. If an application is found to be non-responsive, it will be returned to the applicant without further consideration.
First, the grants management and program staff will review applications submitted in response to this request for application (RFA) for responsiveness. To be responsive, an application must: (1) be received by the specified due date, (2) be submitted in accordance with section IV., "Application and Submission Information," of this document, (3) not exceed the recommended funding amount stated within section II, "Award Information," of this document, (4) address the specific program goals and objectives as detailed in section IV.2.B. "Project Emphasis," and (5) bear the original signatures of both the Principal Investigator and the University's authorized official. The staff will also consider an application non-responsive for any of the following reasons: (1) the applicant organization is ineligible, (2) it is received after the specified receipt date, (3) it is incomplete, (4) it is illegible, (5) it is not responsive to the RFA, or (6) the material presented is insufficient to permit an adequate review.
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 FDA, CFSAN, and in accordance with FDA peer review procedures, using the review criteria stated below. As part of the scientific peer review, all applications will:
The following will be considered in making funding decisions:
In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of the goals of the FOA. Each of these criteria will be addressed and considered in assigning the overall score, weighting them 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 meritorious priority score.
Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
Innovation: Is the project original and innovative? For example, does the project challenge existing paradigms or clinical practice or address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigators: Are the investigators appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?
Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment or subject populations or employ useful collaborative arrangements? Is there evidence of institutional support?
A responsive application will undergo a dual peer review. A responsive application will be reviewed first for scientific and technical merit by an ad hoc panel of experts in areas associated with, but not limited to, food protection and human health. The review panel may advise the program staff about the appropriateness of the proposal to the goals of the CFSAN cooperative agreement program. A score will be assigned based on the scientific/technical review criteria.
The application will then be presented to the National Institute of Health, National Cancer Institute National Cancer Advisory Board for its concurrence with the recommendations made by the first-level reviewers, and funding decisions will be made by the Commissioner of the Food and Drug Administration or his designee.
In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific and technical merit and the priority score. The ad hoc panel of experts will evaluate the application based on the extent to which it demonstrates or advances the following scientific and technical criteria:
In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating:
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan section on Human Subjects in the PHS 398 instructions.
Inclusion of Women, Minorities, and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children, as appropriate for the scientific goals of the research, will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan section on Human Subjects in the PHS 398 instructions).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Research Plan section on Vertebrate Animals in the PHS 398 instructions.
Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, the adequacy of proposed protection will be assessed.
Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research will be assessed. The priority score should not be affected by the evaluation of the budget.
Reviewers will consider the resource/data sharing plan but will not factor the plan into the determination of the scientific and technical merit or the priority score.
Notification regarding the results of the review is anticipated within two weeks after review of an application. The expected start date for this award will be no later than September 30, 2008.
After the peer review of an application is completed, the PD/PI will receive a copy of the Summary Statement (written critique) electronically via e-mail.
If an application is under consideration for funding, FDA will request "just-in-time" information from the applicant. For details, applicants may refer to the HHS Grants Policy Statement at http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.
The FDA Grants Management Office will notify the applicant if they have been selected for an award.
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 NoA 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 NoA 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."
Applicants must adhere to the requirements of this Notice. Special Terms and Conditions regarding FDA regulatory requirements and adequate progress of the study may be part of the awards notice.
All FDA 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: http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.
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.
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 NIH 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.
The Principal Investigator (PI) retains 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.
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. The grantee must file a final program progress report, Financial Status Report (FSR) (see Section VI.3), and invention statement within 90 days after the end date of the project period as noted on the notice of grant award.
Delineation of Substantive Involvement
Substantive involvement by the awarding agency is inherent in the cooperative agreement award. Accordingly, FDA will have substantial involvement in the program funded by the cooperative agreement. Substantive involvement includes, but is not limited to, the following:
This agreement will be subject to all policies and requirements that govern the research grant programs of the PHS, including provisions of 42 CFR Part 52 and 45 CFR Parts 74 and 92, and all grants are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement (GPS), dated January, 2007, which supersedes in its entirety the PHS GPS, dated April 1, 1994, and addendum dated January 24, 1995.
An award is subject to the requirements of the HHS GPS that are applicable based on the recipient type and the purpose of this award. This includes any requirements in Parts I and II of the HHS GPS (available at http://www.hhs.gov/grantsnet/adminis/gpd/index.htm) that apply to an award.
Although consistent with the HHS GPS, any applicable statutory or regulatory requirements, including 45 CFR parts 74 or 92, directly apply to this award apart from any coverage in the HHS GPS.
Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the HHS GPS.
The original and two copies of the annual Financial Status Report (FSR) (SF-269) must be sent to FDA's Grants Management Specialist within 90 days of each budget period end date.
A final program progress report and financial status report will be due 90 days after expiration of the project period of the cooperative agreement as noted on the notice of grant award.
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.
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and peer review, and financial or grants management issues:
Steven Gendel
Center for Food Safety and Applied Nutrition (HFS-006)
5100 Paint Branch Parkway
College Park, MD 20740
Telephone: (301) 436-2290
Email:
Gladys M. Bohler
Division of Acquisition Support and Grants
5630 Fishers Lane, Rm. 2105, HFA 500
Rockville, MD 20857
Telephone: (301) 827-7168
FAX: 301-827-7101
Email:
Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.
Human Subjects Protection:
Federal regulations (45 CFR 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).
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the FDA that women, children, and members of minority groups and their sub-populations must be included in all FDA-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research.
Investigators must provide a description of education completed in the protection of human subjects for each individual identified as "key personnel" in the proposed research. Key personnel include all individuals responsible for the design and conduct of the study. The description of education will be submitted in a cover letter that accompanies the description of Other Support, IRB approval, and other information, in accordance with Just-in-Time procedures.
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.
Sharing Research Resources/Data:
FDA considers the sharing of unique research resources developed through FDA sponsored research an important means to enhance the value of and advance research. When resources have been developed with FDA funds and the associated research findings have been published or provided to FDA, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. 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. NIH has provided guidance at 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.
The Freedom of Information Act, 5 U.S.C. 552, provides individuals with a right to access certain records in the possession of the Federal government. The government may withhold information pursuant to the exemptions and exclusions contained in the act. The exact language of the exemptions can be found in the act. Additional guidance on the exemptions and how they apply to certain documents can be found in the HHS regulations implementing the FOIA (45 CFR Part 5). Also see the HHS Web site http://www.hhs.gov/foia/.
Data included in the application may be considered trade secret or confidential commercial information within the meaning of the Freedom of Information Act (5 U.S.C. 552) and FDA's statute and implementing regulations. FDA will protect trade secret or confidential commercial information to the extent allowed under applicable law.
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. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 U.S.C. 241 and 284) and under Federal regulations 42 CFR Part 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. The HHS Grants Policy Statement can be found at http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.
Smoke-Free Workplace:
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.
________________________________________ ________________
Associate Commissioner for Policy Dated
________________________________________ ________________
Director, Office of Acquisitions And Grants Services Dated
