RFA-AT-05-005: IMPROVING MEASUREMENT TOOLS FOR STERNAL SKIN CONDUCTANCE AND HOT FLASHES: PHASE I SBIR

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IMPROVING MEASUREMENT TOOLS FOR STERNAL SKIN CONDUCTANCE AND HOT FLASHES: PHASE I SBIR RELEASE DATE: September 29, 2004 (See NOT-AT-05-001) RFA Number: RFA-AT-05-005 EXPIRATION DATE: January 21, 2005 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov/) COMPONENTS OF PARTICIPATING ORGANIZATION: National Center for Complementary and Alternative Medicine (NCCAM) (http://nccam.nih.gov/) National Institute of Aging (NIA) (http://www.nia.nih.gov) National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib1.nih.gov/) Office of Research on Women’s Health (ORWH) (http://www4.od.nih.gov/orwh/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.213, 93.287, 93.866 LETTER OF INTENT RECEIPT DATE: December 20, 2004 APPLICATION RECEIPT DATE: January 25, 2005 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Project Period and Amount of Award o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations NOTICE: This Request for Application (RFA) must be read in conjunction with the current OMNIBUS SOLICITATION OF THE NATIONAL INSTITUTES OF HEALTH, CENTERS FOR DISEASE CONTROL AND PREVENTION, and FOOD AND DRUG ADMINISTRATION FOR SMALL BUSINESS INNOVATION RESEARCH (SBIR) AND SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) GRANT APPLICATIONS. The solicitation (see http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf [PDF] or http://grants.nih.gov/grants/funding/sbirsttr1/index.doc [MS Word] contains information about the SBIR and STTR programs, regulations governing the programs, and instructional information for submission. All of the instructions within the SBIR/STTR Omnibus Solicitation apply with the following exceptions: o Special receipt date o Amount of award o Initial review convened by the NCCAM Division of Scientific Review PURPOSE OF THIS RFA The National Center for Complementary and Alternative Medicine (NCCAM), the National Institute on Aging (NIA), the National Institute of Biomedical Imaging and Bioengineering (NIBIB), and the Office of Research on Women’s Health (ORWH) invite Phase 1 small business grant applications to conduct research to improve measurement tools or devices for sternal skin conductance. Sternal skin conductance devices have been used to monitor hot flashes, but existing tools are limited in the amount of data that they can collect and their utility under ambulatory conditions. Improved measurement tools that are reliable, user-friendly, reasonably priced, and can collect data for extended periods of time are needed to evaluate the efficacy of various therapies, including complementary and alternative medicine (CAM) modalities, to reduce hot flashes under unsupervised, ambulatory conditions in clinical studies. Such tools and devices could improve the efficiency and economy of future clinical trials, but research in the area of hot flash measurement has been very limited. Applicants are strongly encouraged to include appropriate bioengineering and clinical collaborations to achieve clinically relevant tools or devices. Personnel with appropriate expertise should be involved in all phases of the proposed effort, including the development of initial concepts and approaches, design of the tool or device, and preliminary validation of the clinical measurement tools or devices to monitor sternal skin conductance. RESEARCH OBJECTIVES Background Vasomotor symptoms, including hot flashes and night sweats, are symptoms frequently reported by menopausal women as well as breast cancer survivors and men undergoing androgen deprivation therapy. Until recently, estrogen and other forms of hormone therapy were used to treat vasomotor symptoms among menopausal women. However, recent findings from the Women’s Health Initiative (WHI) indicate that the benefits of hormone-based therapies for hot flashes are outweighed by risks, such as coronary heart disease, stroke, and pulmonary embolism. Hormone therapy is not an appropriate treatment for hot flashes among individuals with a history of hormone-dependent tumors. People are now turning to other means to manage hot flashes, including complementary and alternative medicine (CAM) therapies. There is a long history of use of CAM therapies for hot flashes, but the empirical base to assess safety and efficacy is neither extensive nor very strong. The FDA now recommends that hormones for the treatment of hot flashes be used at the lowest dosage and for the shortest period of time. However, little is known about risks and benefits for smaller doses, shorter treatment times, and different routes of administration. Thus, it is likely that research will be conducted on a range of treatments to reduce hot flashes. In January 2004, NCCAM and several other NIH Institutes and Centers convened a meeting to assess current measurements for hot flashes. A summary of that meeting is available online. (See http://nccam.nih.gov/health/hotflashes/hotflash_summ.htm) Sternal skin conductance monitors have been used in a limited number of studies conducted in research laboratories and ambulatory settings. While the correlation between sternal skin conductance measures and self-reported hot flashes is high under laboratory conditions, the correlation between these measures is lower in ambulatory studies due to underreporting of subjective hot flashes. Unfortunately, current monitors have limitations that prohibit long-term use in ambulatory settings. Some are too bulky or weigh too much and thus interfere with daily activities and sleep. Electrodes placed on the sternum can be problematic for a number of reasons. They can become unattached with excessive sweating and bathing. Placement and attachment of electrodes requires training, requiring the subject to return to the study site for reattachment. And some units cannot collect and store data for sufficiently long periods of time. It is likely that further clinical trials of interventions for hot flashes will be conducted. Some treatments are likely to be relatively weak when compared with estrogen, but some women may find incomplete relief to be adequate if the benefits of treatment outweigh risks. Given large placebo effects, which have been reported in many studies, unstable self-reported measures of hot flashes, and modest treatment effects, important choices in the conduct of future trials must be made. Investigators can either conduct very large studies to accommodate the limitations of subjective self-reported measures, or they can develop more sensitive and reliable objective measures for use in smaller studies, which would afford important economies in terms of time and resources. Thus, the scientists assessing existing measures of hot flashes at the January meeting called for improved sternal skin conductance monitors to capture data on the frequency of hot flashes. This initiative addresses the need for improved tools and devices for clinicians and researchers to collect meaningful measures of hot flashes under ambulatory conditions. Scope and Objectives SBIR applications responsive to this initiative may include, but are not limited to, research projects to improve the performance characteristics of existing sternal skin conductance devices or research projects to develop new sternal skin conductance monitoring tools or devices. Potential products should be capable of reliable and accurate detection, measurement, and data collection of sternal skin conductance under ambulatory conditions. These tools are needed to evaluate treatments seeking to manage vasomotor symptoms, including hot flashes and night sweats. An important objective is for the proposed device to be affordable, user friendly, and designed for use in an unsupervised environment. It should be able to collect data under conditions of daily life, during waking and sleeping hours, without interfering with daily activities. The proposed tool may be developed to interface with an existing piece of equipment or may be modifications of an existing system, but it should be designed specifically to collect data on hot flashes and night sweats. The applicant’s proposed objectives must be feasible within the time frame and amount of award stated in this RFA. Applications with multidisciplinary projects should demonstrate the potential for integrative collaboration/consultation among a team of investigators such as bioengineer(s) and clinician(s) with an understanding of the complex systems related to vasomotor symptoms. An informed justification of why and how the proposed tool or device could be beneficial for assessing hot flashes is expected. Essential to Phase I feasibility applications are adequate descriptions and rationale for the objectives of the proposal and clearly defined Phase I milestones, noting how they would lead to prospective Phase II goals, which would not be supported through this initiative. Responsive applications will include thorough and detailed descriptions and justifications for the chosen approaches, assessment criteria, evaluation procedures, and outcome measures for the tool or device. When human subjects research is proposed, the application must thoroughly and completely address all of the pertinent issues described in Part I of the SBIR/STTR Omnibus Solicitation instructions. An adequately focused project will have an expected scope and completion time that will be compatible with the time frame and amount of award stated in this RFA. Specifically, the objectives of this RFA are to: o Identify characteristics of existing sternal skin conductance monitors that hinder use under ambulatory conditions and for long term data collection; o Identify and develop modifications or new systems that would improve characteristics that currently limit data collection of hot flashes under ambulatory conditions; o Develop a prototype device; o Conduct pilot tests of that device in the laboratory in individuals experiencing hot flashes, noting correlation between self reported hot flashes and those identified by the tool or device; o Conduct a pilot test of that device under ambulatory conditions, noting correlation between self reported data on hot flashes and those identified by the tool or device. o Determine subsequent steps needed to refine or improve this device for use in larger scale studies; o Estimate cost of producing larger numbers of devices (e.g., 50 to 100 units). MECHANISM OF SUPPORT This RFA uses the SBIR mechanism, which is a set-aside program. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Future unsolicited, competing continuation applications based on this project will compete with all SBIR applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 1, 2005. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW applications using the standard receipt dates for NEW applications described in the current SBIR/STTR Omnibus Solicitation. This RFA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats. Specifically, if you are submitting an application budget of $100,000 total costs (direct, F&A and fee) or less, use the modular budget format. For applications requesting more than $100,000, use the non-modular budget format. Instructions for both are described in the current SBIR/STTR Omnibus Solicitation. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm. Except as otherwise stated in this RFA, awards will be administered under NIH grants policy as stated in the NIH Grants Policy Statement, December 2003, available at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm. Applications may be submitted for support only as Phase I SBIR (R43) grants. This RFA does NOT support STTR nor SBIR or STTR Phase II applications. It also does NOT include the SBIR/STTR Fast-Track option as described in the SBIR/STTR Omnibus Solicitation. Upon successful completion of Phase I research funded by this RFA, the Phase II application must be a logical extension of the Phase I research and will be submitted using the standard receipt dates for new and competing continuation applications described in the current SBIR/STTR Omnibus Solicitation http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf [PDF] or http://grants.nih.gov/grants/funding/sbirsttr1/index.doc [MS Word. PROJECT PERIOD AND AMOUNT OF AWARD The SBIR/STTR Omnibus Solicitation indicates the statutory guidelines of funding support and project duration periods for SBIR and STTR Phase I awards. For this RFA, Phase I budgets up to $250,000 total costs per year and time periods up to one year for Phase I may be requested. Total costs include direct costs, F & A, and fee/profit. FUNDS AVAILABLE NCCAM, NIBIB, and NIA intend to commit approximately $ 1,500,000 in FY 2005 to support four to six new Phase I applications under the SBIR set-aside funding mechanism. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. Although the financial plans of the ICs provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not known if competing renewal applications will be accepted and/or if this RFA will be reissued. ELIGIBLE INSTITUTIONS Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation. Only small business concerns are eligible to submit SBIR/STTR applications. A small business concern is one that, on the date of award for both Phase I and Phase II agreements, meets ALL of the criteria as described in the current SBIR/STTR Omnibus Solicitation. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. On an SBIR application, the principal investigator must have his/her primary employment (more than 50 percent) with the small business at the time of award and for the duration of the project. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA 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: o Direct your questions about scientific/research issues to: Heather Miller, Ph.D., M.F.S. Senior Advisor for Women’s Health National Center for Complementary and Alternative Medicine 31 Center Drive, Room 2B11, MSC 2182 Bethesda, MD 20892-2182 Telephone: (301) 451-3453 FAX: (301) 480-2762 Email: hmiller@mail.nih.gov Sherry Sherman, Ph.D. Director, Clinical Aging and Reproductive Hormone Research National Institute on Aging, NIH Gateway Building Suite 3C-307 7201 Wisconsin Ave. Bethesda, MD 10892-9205 (Courier/Express Mail ZIP is 20814) Telephone: (301) 435-3048 FAX: (301) 402-1784 Email: shermans@mail.nih.gov Peter Moy, Ph.D. Program Director National Institute of Biomedical Imaging and Bioengineering 6707 Democracy Boulevard Suite 200 MSC 5469 Bethesda, MD 20892-5469 Telephone: (301) 451-4778 FAX: (301) 480-4973 moype@mail.nih.gov o Direct your questions about peer review issues to: Dr. Martin Goldrosen Director, Office of Scientific Review National Center for Complementary and Alternative Medicine Democracy 2, Suite 401 6707 Democracy Blvd. Bethesda, MD 20892-5475 Telephone: (301) 594-2014 FAX: (301) 480-2419 Email: goldrosm@mail.nih.gov o Direct your questions about financial or grants management matters to: George Tucker Grants Management Officer National Center for Complementary and Alternative Medicine Democracy 2, Suite 401 6707 Democracy Blvd. Bethesda, MD 20892-5475 Telephone: (301) 594-9102 FAX: (301) 480-1552 Email: gt35v@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Heather Miller, Ph.D., M.F.S. Senior Advisor for Women’s Health Division Extramural Research and Training National Center for Complementary and Alternative Medicine 31 Center Drive, Room 2B11, MSC 2182 Bethesda, MD 20892-2182 Telephone: (301) 451-3453 FAX: (301) 480-2762 Email: hmiller@mail.nih.gov SUBMITTING AN APPLICATION The PHS 398 research grant application must be used for all SBIR/STTR Phase I, Phase II and Fast-Track applications (new and revised.) Effective October 1, 2003, applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 on the face page of the PHS 398 form. The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html. Prepare you application in accordance with the SBIR/STTR Omnibus Solicitation and the PHS 398. Helpful information for advice and preparation of the application can be obtained at: http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf. The NIH will return applications that are not submitted on the 5/2001 version of the PHS 398. For further assistance, contact GrantsInfo, Telephone: (301) 710-0267, Email: GrantsInfo@nih.gov. USING THE RFA LABEL: The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.doc or http://grants.nih.gov/grants/funding/phs398/labels.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist and appendices, and three signed, photocopies (including appendices), in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) To expedite the review process, at the time of submission, send two additional copies of the application to: Dr. Martin Goldrosen Director, Office of Scientific Review National Center for Complementary and Alternative Medicine Democracy 2, Suite 401 6707 Democracy Blvd. Bethesda, MD 20892-5475 Telephone: (301) 594-2014 FAX: (301) 480-2419 Email: goldrosm@mail.nih.gov RECEIPT OF APPLICATIONS: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA 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 unfounded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NCCAM. Incomplete and/or nonresponsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCCAM in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the NCCAM or NIA or NIBIB National Advisory Council. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals within the context of the SBIR/STTR Program. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score: o Significance o Approach o Innovation o Investigator o Environment (1)Significance: Does the proposed project have commercial potential to lead to a marketable product or process? Does this study address an important problem? What may be the anticipated commercial and research benefits of the proposed activity? If the aims of the application are achieved, how will scientific knowledge be advanced? Does the proposal lead to enabling technologies (e.g., instrumentation, software) for further discoveries? Will the technology have a competitive advantage over existing/alternative technologies that can meet the market needs? (2)Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Is the proposed plan a sound approach for establishing technical and commercial feasibility? Does the applicant acknowledge potential problem areas and consider alternative strategies? Are the milestones and evaluation procedures appropriate? (3)Innovation: Does the project challenge existing paradigms or employ novel technologies, approaches, or methodologies? Are the aims original and innovative? (4)Investigators: Is the Principal Investigator capable of coordinating and managing the proposed SBIT/STTR? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers, including consultants and subcontractors (if any)? Are the relationships of the key personnel to the small business and to other institutions appropriate for the work proposed? (5)Environment: Is there sufficient access to resources (e.g., equipment, facilities)? Does the scientific and technological environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: o If the application includes a multidisciplinary team of investigators, does it demonstrate the potential for integrative collaboration/consultation among these investigators and an understanding of vasomotor symptoms? o Is there appropriate and informed justification of why and how the proposed tool or device could be beneficial for assessing frequency of hot flashes? 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 additional information and criteria included in the section on Federal Citations, below.) 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. Plans for the recruitment and retention of subjects will also be evaluated. (See additional information and Inclusion Criteria in the sections on Federal Citations, below). Human Subjects: 1. Protection of Human Subjects from Research Risks for all studies involving human subjects. See instructions and Guidance for Preparing the Human Subjects Research Section. If an exemption is claimed, is it appropriate for the work proposed? If no exemption is claimed, are the applicant’s responses to the six required points appropriate? Are human subjects placed at risk by the proposed study? If so, are the risks reasonable in relation to the anticipated benefits to the subjects and others? Are the risks reasonable in relation to the importance of the knowledge that reasonably may be expected to be gained? Are the plans proposed for the protection of human subjects adequate? 2. Inclusion of Women Plan for clinical research only. Does the applicant propose a plan for the inclusion of both genders that will provide their appropriate representation? Does the applicant provide appropriate justification when representation is limited or absent? Does the applicant propose appropriate and acceptable plans for recruitment/outreach and retention of study participants? 3. Inclusion of Minorities Plan for clinical research only. Does the applicant propose a plan for the inclusion of minorities that will provide their appropriate representation? Does the applicant provide appropriate justification when representation is limited or absent? Does the applicant propose appropriate and acceptable plans for recruitment/outreach and retention of study participants? 4. Inclusion of Children Plan for all studies involving human subjects. Does the applicant describe an acceptable plan in which the representation of children of all ages (under the age of 21) is scientifically appropriate and recruitment/retention is addressed realistically? If not, does the applicant provide an appropriate justification for their exclusion? 5. Data and Safety Monitoring Plan for clinical trials only. Does the applicant describe a Data and Safety Monitoring Plan that defines the general structure of the monitoring entity and mechanisms for reporting Adverse Events to the NIH and the IRB? CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the required five items described under Vertebrate Animals (section f of the Research Plan instructions) will be assessed. BIOHAZARDS: Is the use of materials or procedures that are potentially hazardous to research personnel and/or the environment proposed? Is the proposed protection adequate? ADDITIONAL REVIEW CONSIDERATIONS: The following items may also be considered by reviewers but will not be included in the determination of scientific merit. BUDGET: The reasonableness of the proposed budget may be considered. For all applications, is the percent effort listed for the PI appropriate for the work proposed? Is the overall budget realistic and justified in terms of the aims and methods proposed? PERIOD OF SUPPORT: The appropriateness of the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: December 20, 2004 Application Receipt Date: January 25, 2005 Peer Review Date: June, 2005 Council Review: September, 2005 Earliest Anticipated Start Date: September 1, 2005 AWARD CRITERIA The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS ANIMAL WELFARE PROTECTION: 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 (45CFR46) 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 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). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub- populations must be included in all NIH-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. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_20 01.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov/) It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC 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 RFA 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 research 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 NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to 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 RFA 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 NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm The ODS was mandated by Congress in 1994 and established with the Office of the Director, NIH. The Dietary Supplement Health and Education Act (SHEA) [Public Law 103-417, Section 3.a] amended the Federal Food, Drug, and Cosmetic Act to establish standards with respect to dietary supplements. This law authorized the establishment of the ODS. 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.

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