RFA-DK-01-032: NEW APPROACHES TO PREVENT HYPOGLYCEMIA IN PATIENTS WITH DIABETES

Department of Health
and Human Services (HHS)

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NEW APPROACHES TO PREVENT HYPOGLYCEMIA IN PATIENTS WITH DIABETES Release Date: July 27, 2001 RFA: RFA-DK-01-032 National Institute of Diabetes and Digestive and Kidney Diseases (http://www.niddk.nih.gov) National Institute Of Neurological Disorders and Stroke (http://www.ninds.nih.gov) National Institute of Child Health and Human Development (http://www.nichd.nih.gov) National Institute of Nursing Research (http://www.ninr.nih.gov) Juvenile Diabetes Research Foundation International (http://www.jdrf.org) Letter of Intent Receipt Date: October 17, 2001 Application Receipt Date: November 21, 2001 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING LESS THAN $250,000 PER YEAR IN ALL YEARS. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Child Health and Human Development (NICHD), the National Institute of Nursing Research (NINR) and the Juvenile Diabetes Research Foundation International (JDRF) solicit applications for clinical studies designed to enhance understanding and prevention of hypoglycemia in patients with diabetes. Large clinical trials have demonstrated the efficacy of intensified glucose control in the prevention of the long-term complications of diabetes. However, episodes of severe hypoglycemia may complicate intensified treatment and are often a major obstacle to the achievement of euglycemia in many patients. This RFA solicits clinical studies to 1) define and characterize hypoglycemia in diabetic individuals and 2) develop new approaches to prevent the development of hypoglycemia or to ameliorate its effects in individuals with diabetes. A separate RFA (DK 01-031) solicits basic and clinical research specifically addressing the problem of hypoglycemia unawareness. An additional related RFA (NS-02-008) solicits basic research on the effects of hypoglycemia on cerebral metabolism and neural cell function and survival. 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 Request for Applications (RFA), New Approaches to Prevent Hypoglycemia in Patients with Diabetes, is related to the priority area of diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and nonprofit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01) and the Exploratory/Development Research Grant (R21) award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an R01 application submitted in response to this RFA may not exceed 5 years. The R21 awards are to demonstrate feasibility and to obtain preliminary data testing innovative ideas that represent clear departure from ongoing research interests. These grants are intended to 1) provide initial support for new investigators, 2) allow exploration of possible innovative new directions for established investigators, and 3) stimulate investigators from other areas to lend their expertise to research within the scope of this solicitation. Applicants for the R21 must limit their requests to $125,000 direct costs per year and are limited to two years. These R21 grants will not be renewable, continuation of projects developed under this program will be through the regular research grant (R01) program. Applicants from institutions which have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. In such a case, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The anticipated award date is July 2002. FUNDS AVAILABLE The NIDDK, the NINDS, the NICHD and the NINR intend to commit approximately $3.25 million in FY 2002 to fund 4 to 8 grants in response to this RFA. The JDRF intends to commit up to $500,000 in additional funds to co-fund research project grants that are both scientifically meritorious and fit within the mission and research emphasis areas of the JDRF (see http://www.jdrf.org), for more information). All awards will be issued by the NIDDK, the NINDS, the NICHD and the NINR. An R01 applicant may request a project period of up to 5 years. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the NIDDK, the NINDS, the NICHD, the NINR and the JDRF 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 applications of outstanding scientific and technical merit. RESEARCH OBJECTIVES Background The Diabetes Control and Complications Trial (DCCT), for type 1 diabetes, and the United Kingdom Prospective Diabetes Study (UKPDS), for type 2 diabetes, established the importance of intensified diabetes control in dramatically reducing the devastating complications that result from poorly controlled diabetes. However, with current treatment modalities, tight control remains an unattainable goal for many people with diabetes. For example, in the DCCT, fewer than 5% of individuals receiving intensified treatment maintained normal hemoglobin A1c levels. To achieve glycemic control, many patients must walk a tightrope, balancing euglycemia against the danger of low blood glucose. Indeed, for many individuals with diabetes, episodes of severe hypoglycemia are the major obstacle to the achievement of euglycemia and the prevention of long-term complications. Hypoglycemia is frightening to patients and their families. In fact, for some individuals or their families, fear of hypoglycemia may outweigh concern over long-term complications of diabetes, leading to inadequate glycemic control. Fear of hypoglycemia is well-founded, as low blood glucose levels impart significant morbidity and mortality. Two to 4 per cent of deaths among individuals with type 1 diabetes have been attributed to hypoglycemia. Acutely, diminished brain function during a hypoglycemic episode poses potential physical danger to the patient. In addition, recurrent hypoglycemia may impose long-lasting damaging effects on the brain, resulting in impairment of memory or other cognitive functions. This is especially a concern in the early childhood years when the nervous system is still developing. Recurrent hypoglycemia may also impair the body’s defense mechanisms against hypoglycemia, creating a vicious cycle for the patient. A major problem in many individuals with diabetes is a progressive decay in the counterregulatory response over time, resulting in hypoglycemia unawareness. The individual fails to become aware of hypoglycemia and does not initiate appropriate responses. This can result in prolonged hypoglycemia, with consequent brain injury, seizure or loss of consciousness. Children and the elderly may be particularly vulnerable to the development of hypoglycemia and to its deleterious effects. Young children cannot reliably report or interpret symptoms of hypoglycemia. In older individuals, decline of beta adrenergic function with age, coupled with other medical problems (e.g., mild renal impairment which could alter drug metabolism), may predispose to the risk of hypoglycemia and hypoglycemia unawareness. Unrecognized hypoglycemia could contribute to subtle declines in mental function that might simply be attributed to dementia. Hypoglycemia occurs because of a mismatch between insulin dose, food intake and energy expenditure. Despite vigilant blood sugar monitoring and adherence to treatment regimens, euglycemia often cannot be achieved safely (i.e., without the occurrence of hypoglycemia), because current treatment modalities do not mimic normal, physiologically regulated insulin secretion. To address this critical problem in diabetes, the Juvenile Diabetes Research Foundation International, the American Diabetes Association (ADA), the NIDDK, the NINDS, the NICHD and NASA cosponsored a workshop on Hypoglycemia and the Brain on Sept. 7-8, 2000. Participants in the workshop identified a number of knowledge gaps requiring future research (http://www.jdrf.org/research/workshop090800.pdf). Basic research is needed to enhance understanding of the hypothalamic and peripheral control mechanisms that counteract hypoglycemia, and the pathogenic mechanisms involved in loss of counterregulatory control. In addition, clinical studies are needed to better define the scope of the problem and develop new prevention and treatment approaches. As a first step toward addressing the problem of hypoglycemia in diabetes, the NIDDK, the NINDS, the NICHD, the NINR and the JDRF have issued this RFA. Scope and Objectives This RFA solicits clinical studies to 1) define the scope and nature of hypoglycemia in individuals with diabetes, and 2) develop and test strategies to prevent the development of hypoglycemia in patients with diabetes, or to ameliorate its effects. Recent scientific advances, including the availability of continuous glucose monitoring, potentially open up new avenues of exploration. The NINR is particularly interested in applications from qualified nurse investigators that focus on reduction of hypoglycemia through the use of advanced technologies, such as the use of insulin pumps in children and adolescents. While this RFA focuses on clinical studies of hypoglycemia, a separate RFA (DK 01-031) solicits basic and clinical research specifically addressing the problem of hypoglycemia unawareness. An additional related RFA (NS-02-008) solicits basic research on the effects of hypoglycemia on cerebral metabolism and neural cell function and survival. Appropriate topics for investigation under this RFA would include but are not limited to: o Studies to determine the prevalence of hypoglycemia in patients with diabetes, with a focus on delineating differences among various age groups (e.g., children, adults, the elderly), o Studies to delineate the role of age, gender, race/ethnicity, socioeconomic status and other factors in the risk of hypoglycemia, o Studies to identify factors, including method of treatment, exercise, nutrition, or duration of diabetes, which affect risk of hypoglycemia, o Studies to establish normative data for blood glucose levels, particularly in children, throughout a 24-hour period, o Studies to determine whether there are changes in counterregulatory mechanisms with age, o Studies to determine whether intensive glucose control during pregnancy has adverse effects on the developing fetus, o Studies to determine whether alternative fuels (e.g., ketones) can provide a buffer against hypoglycemia, o Studies to assess the reliability and utility of continuous glucose sensors in detecting falling blood glucose levels and in preventing severe hypoglycemia, o Studies to determine whether the occurrence of hypoglycemia can be minimized by altering the timing of drug delivery or by drugs with altered kinetics, o Studies to determine whether different treatment regimens for diabetes affect counterregulatory mechanisms, o Studies to evaluate whether there are differences in counterregulation between individuals with type 1 and type 2 diabetes, o Studies to develop and test strategies for minimizing the risk of hypoglycemia with intensive glucose management. SPECIAL REQUIREMENTS Letter of Authorization Applicants should submit a brief letter to the NIDDK indicating whether or not they wish their application to be considered for funding by the JDRF. While applicants may request that their applications be considered only by the NIH and not by the JDRF, it is necessary that the record indicate the applicant"s consideration of this opportunity. For those applicants who wish to have the JDRF consider their application, all materials relating to the application will be promptly forwarded to that organization and the summary statements for such applications will be shared with the JDRF when available. This separate letter of authorization may be submitted with the Letter of Intent (see below). INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS 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 biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS. It is the policy of NIH 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. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators may also obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. 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. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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 (PA) 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. LETTER OF INTENT Prospective applicants are asked to submit, by 10/17/01, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. 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 NIDDK staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities, NIDDK 6707 Democracy Boulevard, Rm. 752 MSC 5452 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) Telephone: (301) 594-8885 FAX: (301) 480-3505 APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) available at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable PDF format. Although applicants are strongly encouraged to begin using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to accept applications prepared using the 4/1998 revision until January 9, 2002. Beginning January 10, 2002, however, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and NIH staff. The research grant application form PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. Applicants are permitted, however, to use the 4/1998 revision of the PHS 398 for scheduled application receipt dates until January 9, 2002. If you are preparing an application using the 4/1998 version, please refer to the step-by-step instructions for Modular Grants available at http://grants.nih.gov/grants/funding/modular/modular.htm. Additional information about Modular Grants is also available on this site. The RFA label available in the PHS 398 (rev. 5/2001) 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/label-bk.pdf. Submit a signed, typewritten original of the application, including the Checklist, and five signed, photocopies, 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) Applications must be received by the application receipt date listed in the heading of the RFA. If an application is received after that date, it will be returned to the applicant without review. Supplemental documents containing significant revision or additions will not be accepted, unless applicants are notified by the Scientific Review Administrator. 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. This does not preclude the submission of substantial revisions of applications previously reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDDK. If the application is not responsive to the RFA, NIDDK or CSR staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in the competition with unsolicited applications at the next review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and 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, assigned a priority score, and receive a second level review by the NIDDK, the NINDS, the NICHD and the NINR Advisory Councils. 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 discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator 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 (if any)? (5) Environment: Does the scientific 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? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o Adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration to the proposed research. o The adequacy of the proposed protection of humans, animals, or the environment, to the extent that they may be adversely affected by the project proposed in the application. o Availability of special opportunities for furthering research programs through the use of unusual talent resources, populations, or environmental conditions in other countries which are not readily available in the United States or which provide augmentation of existing U.S. resources. Schedule Letter of Intent Receipt Date: October 17, 2001 Application Receipt Date: November 21, 2001 Peer Review Date: March 2002 Council Review: May 2002 Earliest Anticipated Start Date: July 1, 2002 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit as determined by peer review, o Availability of funds, o Programmatic priorities. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Barbara Linder, M.D, Ph.D. Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 699 MSC 5460 Bethesda, MD 20892-5460 Telephone: (301) 594-0021 FAX: (301) 480-3503 E-mail: bl99n@nih.gov Toby Behar, Ph.D. Neural Environment National Institute of Neurological Disorders and Stroke 6001 Executive Blvd., Rm. 2114A Bethesda, MD 20892-9521 Telephone: (301) 496-1431 FAX: (301) 480-2424 E-mail: tb72z@nih.gov Gilman D. Grave, M.D. Chief, Endocrinology, Nutrition, and Growth Branch National Institute of Child Health and Human Development 6100 Executive Blvd., Room 4B11A, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5593 FAX: (301) 480-9791 E-mail: gg37v@nih.gov Nell Armstrong, Ph.D., R.N. National Institute of Nursing Research Building 45, Room 3AN12 Bethesda, MD 20892 6300 Telephone, (301) 594-5973 FAX: (301) 480-8260 E-mail: na21f@nih.gov Direct inquiries regarding fiscal matters to: Charlette Kenley Division of Extramural Activities Grants Management Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 640 MSC 5456 Bethesda, MD 20892-5456 Telephone: (301) 594-8847 FAX: (301) 480-3504 E-mail: ck128k@nih.gov Mary Graham Grants Management Branch National Institute of Neurological Disorders and Stroke 6001 Executive Blvd., Rm. 3290 Bethesda, MD 20892 Telephone: (301) 496-9231 FAX: (301) 402-0219 E-mail: mg50p@nih.gov Mary Daley Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17E, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1305 FAX: (301) 402-0915 E-mail: md74u@nih.gov Robert L. Tarwater Office of Grants and Contracts Management National Institute of Nursing Research Building 45, Room 3AN12 Bethesda, MD 20892-6300 Telephone: (301) 594-2807 FAX: (310) 480-8260 E-mail: tarwater@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847, 93.853, 93.865 and 93.361. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and promote the non-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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