(Federal Register Notice April 28, 2008)
Part I Overview Information
Department of Health and Human Services
Food and Drug Administration (FDA) http://www.fda.gov
Components of Participating Organizations
Center for Food Safety and Applied Nutrition (CFSAN) (http://www.cfsan.fda.gov) and Center for Veterinary Medicine (CVM) (http://www.fda.gov/cvm)
Title: Cooperative Agreement to Support the World Health Organization (WHO) International Programme on Chemical Safety (IPCS) (U01)
NEW Competitive Continuation - Limited Competition - Sole Source
Request For Applications (RFA) Number: RFA-FD-08-002
Catalog of Federal Domestic Assistance Number(s): 93.103
Key Date: Release Date: April 28, 2008
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
This FOA is soliciting an application from the World Health Organization (WHO) International Programme on Chemical Safety (IPCS), to continue their work in important international risk assessment and standard setting activities for food ingredients, contaminants, and veterinary drug residues in food.
The World Health Organization (WHO) International Programme on Chemical Safety (IPCS) is an umbrella organization that provides for timely international collaboration on multinational cooperative activities. Various programs under the WHO/IPCS, such as the Joint Food and Agriculture (FAO)/WHO Expert Committee on Food Additives (JECFA), significantly contribute to internationally-recognized, science-based risk assessments of food additives, contaminants, and residues of veterinary drugs in foods. The Codex Alimentarius Commission (CAC) relies on JECFA's scientific advice when establishing international standards for foods. The WHO/IPCS also supports FAO/WHO Expert Consultations on risk assessments for emerging or cross-cutting issues (e.g., non-dioxin-like polychlorinated biphenyls (PCBs), allergenicity of foods derived from biotechnology, risk-benefit assessment of the use of active chlorine species in food processing). The evaluations that are produced by these Expert Consultations provide a sound scientific basis for Codex's standard-setting activities that contribute to improved public health and food safety worldwide.
The following activities are to be supported by this cooperative agreement:
- Schedule, plan and conduct appropriate work groups, consultations, and committee meetings, which have emphasis on, but are not limited to, food additives, contaminants, and residues of veterinary drugs in food.
- Identify advisers, and prepare written working papers summarizing the data on substances under consideration.
- Prepare written working papers and technical documents for the JECFA, and for the FAO/WHO Expert Consultations related to food additives, contaminants, and residues of veterinary drugs in food.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information
Mechanism of Support
This funding opportunity will use a cooperative agreement award mechanism. 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 and National Policy Requirements, item # 3, "Reporting".
The length of support will be one year with the possibility of an additional four years of non-competitive support. Continuation beyond the first year will be based upon satisfactory performance during the preceding year and the availability of Federal fiscal year appropriation.
The estimated amount of funds available for support of this cooperative agreement is $120,000 (direct and indirect costs) for fiscal year 2008. It is anticipated than an additional four years of support will be available at $90,000 per year, depending annual appropriations and successful performance.
This award will be funded based on the quality of the application received and is subject to the 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 the FDA.
FDA grants policies as described in the DHHS Policy Statement (http://www.hhs.gov/grantsnet/adminis/gpd/index.htm) apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
The following organizations/institutions are eligible to apply:
Competition is limited to the WHO/IPCS because, as the parent organization of the JECFA, it is solely responsible for providing scientific advice, including risk assessments, to the CAC on matters related to food additives, contaminants, and residues of veterinary drugs in food. Thus, the programs under the IPCS are unique. It is essential that the WHO/IPCS be able to provide science-based risk assessments that are of the highest integrity, as these assessments form the basis of international standards that both protect public health and promote fair trade practices. Awarding this cooperative agreement to the WHO/IPCS will ensure that JECFA's risk assessments are science-based, will enhance the safe use of food additives, will ensure that residues of veterinary drugs in imported foods are safe, and will help to ensure that food sold in the United States is safe.
A. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the 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 FDA support.
Cost Sharing or Matching
This program does not require cost sharing as defined in the current DHHS Policy Statement (http://www.hhs.gov/grantsnet/adminis/gpd/index.htm).
Section IV. Application and Submission Information
Address to 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 Grants Info, Telephone (301) 435-0714, Email: .
Telecommunications for the hearing impaired: TTY 301-451-0088.
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 noted on the face page of the application.
Required Application Components: Non Modular format as follows:
Form Page 1: Face Page; Form Page 2: Description, Performance Sites, Key Personnel, Other Significant Contributors; Form Page 3: Table of Contents; Form Page 4: Detailed Budget for Initial Budget Period: Form Page 5: Budget for Entire Proposed Period of Support: Biographical Sketch Format Page; Resources Format Page; Checklist Form Page: Personal Data Form Page; Other Support Format Page; Personnel Report Format Page.
- Submission Dates and Times
A. Receipt, Review and Anticipated Start Dates
Application Receipt Date: May, 2008
Peer Review Date: May, 2008
Council Review Date: June, 2008
Earliest Anticipated Start Date: July, 2008
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, hard copy original of the application, including the checklist, and three signed photocopies in one package to:
Food and Drug Administration/OAGS/GAAT/Gladys M. Bohler
5630 Fishers Lane, Room 2105, HFA 500
Rockville, MD 20857 (U.S. Postal Service Express or regular mail)
FDA will also accept the application for this program electronically via http://www.grants.gov. The applicant is encouraged to apply electronically by visiting the Web site http://www.grants.gov and following the instructions under "Apply for Grants". The required application, SF 424 (R&R) can be completed and submitted online. The package should be labeled, "Response to RFA FD-08-002. If you experience technical difficulties with your online submission contact Gladys M. Bohler by telephone at 301-827-7168 or by e-mail at .
PHS Research Plan Component Sections via Grants.gov
Items 2-5 of the PHS 398 Research Plan component are limited to 25 pages. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to FDA in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
C. Application Processing
Applications must be received on or before the application receipt date) described above Section IV.3A.. 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 for responsiveness by the CFSAN Project Officer and the Grants Management contact. Incomplete and/or non-responsive applications will not be reviewed.
This initiative is not subject to Intergovernmental Review under the terms of Executive Order 12372.
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 new or 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 new or 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 (refer to preaward costs in the DHHS Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm
Other Submission Requirements and Information
Several additional separate actions are required before an applicant institution/organization can submit an application.
- Organizational DUNS - As of October 1, 2003, applicants are required to have a Dun and Bradstreet Number (DUNS) to apply for a grant or cooperative agreement from the Federal Government. The DUNS number is a 9 digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number applicants should go to http://www.grants.gov/RequestaDUNS
- Central Contractor Registration - Applicants must register with the CCR database. This database is a government wide warehouse of commercial and financial information for all organizations conducting business with the Federal Government. The preferred method for completing a registration is at http://www.ccr.gov. This Web site provides a CCR handbook with detailed information on data you will need prior to beginning the online pre-registration as well as steps to walk you through the registration process. You must have a DUNS NUMBER to begin your registration. For foreign entities the Web site is Correct web address: http://www.grants.gov/RequestaDUNS.
http://www.grants.gov/RequestaDUNS.gov. In order to access grants.gov an applicant will be required to register with the Credential Provider. Information about this is available at https://apply.grants.gov/OrcRegister.
A copy of the complete RFA can also be viewed on FDA's Center for Food Safety and Applied Nutrition Web site at http://www.cfsan.fda.gov/ or call 1-866-705-5711.
- Foreign Applications (Non-domestic (non-U.S.) Entity)
- Indicate how the proposed project has specific relevance to the mission and objectives of FDA and has the potential for significantly advancing sciences in the United States.
- Research grant applications from foreign or international organizations may not be funded unless approved by the NCI National Advisory Board.
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.
Paper applications submitted for due date may voluntarily provide the appendix on five identical CDs; if submitting CDs it is not necessary to include a paper appendix.)
Resource Sharing Plan(s)
Section V. Application Review Information
Program Review Criteria
The application submitted by the WHO/IPCS will first be reviewed by grants management and program staff for responsiveness. The requested budget must not exceed $120,000 (direct and indirect costs). The application will be considered nonresponsive if it is not in compliance with this document. If an application is found to be nonresponsive, it will be returned to the applicant without further consideration.
The staff will consider the application non-responsive for any of the following reasons: (1) the application is received after the specified receipt date, (2) the application is incomplete, (3) the application is illegible, (4) the application is not responsive to the RFA, or (5) the material presented is insufficient to permit an adequate review.
The application submitted by the WHO/IPCS will undergo a competitive dual peer review. The application will be reviewed for scientific and technical merit by an ad hoc panel of experts based on the applicable evaluation criteria. If the application is recommended for approval, it will then be presented to the National Cancer Institute Advisory Board for their concurrence.
Scientific/Technical Review Criteria
The ad hoc expert panel will review the application based on the following scientific and technical merit criteria:
- The application clearly demonstrates an understanding of the purpose and objectives of the cooperative agreement regarding the safety of food ingredients, contaminants, and veterinary drug residues.
- The application clearly describes the steps and a proposed schedule for planning, implementing and accomplishing the activities to be carried out under the cooperative agreement. The application presents a clear plan and schedule of steps to accomplish the goals of the cooperative agreement.
- The application establishes the WHO/IPCS's ability to perform the responsibilities under the cooperative agreement, including the availability of appropriate staff and sufficient funding.
- The application specifies the manner in which interaction with FDA will be maintained throughout the lifetime of the project.
- The application specifies how the WHO/IPCS will monitor progress of the work under the cooperative agreement and how progress will be reported to FDA.
The application shall include a detailed budget that shows: (1) anticipated costs for personnel, travel, communications and postage, equipment, and supplies and other expenses as allocable; and (2) and the sources of funds to meet those needs.
Only the review criteria described below will be considered in the review process.
Review and Selection Process
A responsive application will be reviewed and evaluated for scientific and technical merit by an ad hoc panel of experts in the subject field of the specific application. A responsive application will be subject to a second review by the National Cancer Institute Advisory Board for concurrence with the recommendations made by the first-level reviewers, and funding decisions will be made by the Commissioner of Food and Drugs or his designee.
A score will be assigned based on the scientific and technical review criteria. The ad hoc review panel may advise the program staff about the appropriateness of the proposal to the goals of the CFSAN cooperative agreement program.
A. Additional Review Criteria:
In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:
Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research, e.g. Is the number of person months listed for the effort of the PD/PI's appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods?
Anticipated Announcement and Award Dates
Notification regarding the results of the review is anticipated within two weeks after review of the application. The earliest expected start date for this award is July, 2008.
Section VI. Award Administration Information
After the review of the application is completed, the PD/PI will receive his or her Summary Statement (written critique)via e-mail from the CFSAN Project Officer.
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.
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 Section IV.5., "Funding Restrictions.")
Administrative and National Policy Requirements
All FDA grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see http://www.hhs.gov/grantsnet/adminis/gpd/index.htm
A. 1 Arbitration Process
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the FDA may be brought to arbitration. An Arbitration Panel composed of three members will be convened. This special arbitration procedure in no way affects the awardees' 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.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) three to two months prior to the start of the next budget period and Financial Status Reports as required in the HHS Grants Policy Statement, dated October 1, 2006, http://www.hhs.gov/grantsnet/adminis/gpd/)
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.
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 activities of the project funded by the cooperative agreement. Substantive involvement includes, but is not limited to the following:
- FDA will provide experts to the JECFA. FDA's expertise may include, but is not limited to: food additive specification development; estimation of intake of food additives and contaminants; and risk assessments of food additives, contaminants, and veterinary drug residues in food.
- FDA will participate in FAO/WHO Expert Consultations. These Expert Consultations may include, but are not limited to: development of harmonized risk assessment procedures for food substances (e.g. food additives (including flavors) and contaminants) and for emerging or cross-cutting issues (e.g. non-dioxin-like polychlorinated biphenyls (PCBs), allergenicity of foods derived from biotechnology, risk-benefit assessment of the use of active chlorine species in food processing); and performing risk assessments on substances identified by the Expert Consultation.
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, and financial or grants management issues:
For issues regarding the programmatic aspects of this document, contact Susan E. Carberry at 301-436-1269 or by e-mail: .
Financial or Grants Management Contacts:
For issues regarding the administrative and financial management aspects, contact Gladys Melendez-Bohler at 301-827-7168 or by e-mail: .
Section VIII. Other Information
Access to Research Data through the Freedom of Information Act:
Data included in the application, if restricted with the legend specified below, may be entitled to confidential treatment as trade secret or confidential commercial information within the meaning of the Freedom of Information Act (5 U.S.C 552(b)(4) and FDA's implementing regulations (21 CFR 20.61).
"Unless disclosure is required under the Freedom of Information Act as amended (5 U.S.C. 552) as determined by the freedom of information officials of the Department of Health and Human Services or by a court, data contained in the portions of this application that have been specifically identified by page number, paragraph, etc. by the applicant as containing restricted information, shall not be used or disclosed except for evaluation purposes".
Required Federal Citations
Freedom of Information Act (FOIA)
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.
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).
Standards for Privacy of Individually Identifiable Health Information:
HHS 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 HHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR Web site 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?".
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 FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
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 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 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 DHHS Grants Policy Statement 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.