03-15183. Maternal and Child Health Federal Set-Aside Program; Special Projects of Regional and National Significance; Sickle Cell Disease and Newborn Screening Programs (CFDA #93.110)

AGENCY:

Health Resources and Services Administration, HHS.

ACTION:

Notice of availability of funds.

SUMMARY:

The Health Resources and Services Administration (HRSA) announces that approximately $3.71 million in fiscal year (FY) 2003 funds is available to fund (1) one cooperative agreement with an established sickle cell disease (SCD) organization with a national scope to institute a project coordinating center, and (2) up to 16 grants for community-based SCD projects to enhance the Sickle Cell Disease and Newborn Screening program through provision of outreach and counseling efforts. Eligibility is open to any public or private entity, including an Indian tribe or tribal organization (as defined at 25 U.S.C. 450b). Awards will be made under the program authority of section 501(a)(2) of the Social Security Act, the Maternal and Child Health (MCH) Federal Set-Aside Program (42 U.S.C. 701(a)(2)), i.e., Special Projects of Regional and National Significance (SPRANS). Funds for these awards were appropriated under Public Law 108-7, the “Consolidated Appropriation Resolution, 2003.” Up to $750,000 in FY 2003 funds is available for one cooperative agreement and up to $2.96 million in FY 2003 funds is available for 16 or less community-based grants. Estimated amount for each community-based grant award is $185,000. The project period for the awards will be for two years. Funding beyond the first year is dependent upon the availability of appropriated funds for the sickle cell newborn screening program in FY 2004 and grantee satisfactory performance.

DATES:

Applicants for this program are requested to notify the Maternal and Child Health Bureau (MCHB) of their intent to apply by June 25, 2003. Please note that “notice of intent to submit an application” will be used as a mechanism to deliver technical assistance and to assist in the planning of the objective review; it is not a requirement of the application process. Notification can be made in one of three ways: telephone: Carrie Diener at 301-443-1080; email [e-mail]; mail, MCHB, HRSA; Division for Children with Special Health Care Needs, Parklawn Building, Room 18-20; 5600 Fishers Lane; Rockville, MD 20857. The deadline for receipt of applications is July 21, 2003. Applications will be considered “on time” if they are either received on or before the deadline date or postmarked on or before the deadline date. The projected award date is September 30, 2003.

ADDRESSES:

To receive a complete application kit, applicants may telephone the HRSA Grants Application Center at 1-877-477-2123 (1-877-HRSA-123) beginning June 16, 2003, or register on-line at: http://www.hrsa.gov/​,, or by accessing http://www.hrsa.gov/​g_​order3.htm directly. This program uses the standard Form PHS 5161-1 (rev. 7/00) for applications (approved under OMB No. 0920-0428). Applicants must use the appropriate Catalog of Federal Domestic Assistance (CFDA) number 93.110 and the title, “Sickle Cell Disease and Newborn Screening Program,” when requesting application materials. The CFDA is a Government-wide compendium of enumerated Federal programs, projects, services, and activities that provide assistance. All applications should be mailed or delivered to: Grants Management Officer (MCHB), HRSA Grants Application Center, 901 Russell Avenue, Suite 450, Gaithersburg MD; Telephone: 1-877-HRSA-123 (477-2123); E-mail: [e-mail].

HRSA expects to begin accepting grant applications on-line on July 14, 2003. The automated application process should be faster, easier and better for applicants and for HRSA. We encourage you to take advantage of this new option. Check http://www.hrsa.gov/​grants to see which HRSA programs are accepting on-line applications.

FOR FURTHER INFORMATION CONTACT:

Michele A. Lloyd-Puryear, M.D., Ph.D., 301-443-1080, email: [e-mail] (for questions specific to project activities of the program, program objectives, or the Letter of Intent described above); and Jacquelyn Whitaker, 301-443-1440; email, [e-mail] (for grants policy, budgetary, and business questions).

SUPPLEMENTARY INFORMATION:

Program Background and Objectives

Sickle cell disease (SCD) is an inherited red blood cell condition characterized primarily by chronic anemia and periodic episodes of pain. In affected individuals, the abnormal red blood cells break easily and clog blood vessels to block blood flow to organs and tissues. This process results in anemia, periodic pain episodes, and ultimately can damage tissues and vital organs and lead to increased infections and early death. In the United States, most cases of SCD occur among people of African ancestries. People of Mediterranean, Middle Eastern, and Indian background are also affected. It is estimated that more than 2 million Americans have the sickle cell trait and over 70,000 have the disease. Annually, approximately 1,000 newborns are identified with the disease through state newborn screening programs.

Early diagnosis of SCD is critical so that children who have the condition can receive proper interventions. Newborn screening for SCD followed by parental health education, enrollment in comprehensive care, initiation of penicillin prophylaxis and anti-pneumococcal vaccination within the first two months of life can prevent death from severe infections.

The Federal MCHB has long recognized the significance of SCD. In the mid 1960s, MCHB developed and disseminated SCD educational materials nationally. Following passage of the National Sickle Cell Anemia Control Act in 1972, MCHB, with initial funding from the National Institutes of Health (NIH), provided support for community-based sickle cell clinics to conduct testing, counseling, and education. In the mid 1980s, the Federal MCHB supported the development and implementation of State newborn screening programs for SCD. By 1990, 30 States and jurisdictions had implemented programs with direct Federal support. Although most States and jurisdictions currently have Statewide screening programs, a 1987 Consensus Development Conference on Newborn Screening for Sickle Cell and Other Hemoglobinopathies recommendation for universal screening has not been realized.

In FY 2002, MCHB funded 15 community-based grants and one cooperative agreement through its Sickle Cell Disease and Newborn Screening Program. These one-year community-based awards were established to enhance follow-up services for infants who screen positive for SCD or sickle cell trait and support community-based efforts to provide SCD-related education and counseling. For FY 2003, similar awards will be made for this purpose.

All State SCD screening programs include a follow-up component. Some, however, fall short of the guidelines recommended by the Council of Regional Networks for Genetic Services (CORN). There are infants with SCD who do not enter into appropriate programs of comprehensive care and do not receive the requisite interventions. Further, follow-up of infants with sickle cell trait or who are carriers is sub-optimal. While the benefit of carrier notification leads to increased knowledge for the affected infant's family, problems of misunderstanding (infant with the trait perceived as defective), stigmatization, and issues of paternity can also result from carrier notification. It is thus imperative that trait notification and counseling be undertaken with sensitivity and accuracy. In many State SCD programs, parents are notified of the carrier infant's abnormal test results but are left on their own to seek education, genetic counseling, and testing. Many parents do not receive counseling and testing. The educational component of the SCD program is just as important as the follow-up. Patients and families need to remain well informed and be empowered as active participants in service delivery. State SCD programs need to enlist partners in this effort, including primary care providers, subspecialists, and community-based support organizations. In some communities, the staff of the community-based organization can make the initial contact with the affected family and maintain subsequent contact and provide support and education.

Authorization

Section 501(a)(2) of the Social Security Act (42 U.S.C. 701(a)(2)).

Purpose

The purpose of the Sickle Cell Disease and Newborn Screening Program is to support the comprehensive care for newborns diagnosed with SCD or trait and their families, relying on partnerships among the State Title V and newborn screening programs, community-based SCD organizations, comprehensive SCD treatment centers, and community-based primary care professionals. Specifically, the program will enhance the follow-up component of State SCD screening programs and support community-based efforts that provide hemoglobinopathy counseling, SCD-related education, and support services.

Project 1—Through a cooperative agreement, a national SCD organization will partner with families, community-based SCD organizations, health care professionals, State agencies including State Title V and newborn screening programs, and MCHB and its National Newborn Screening and Genetics Resource Center (NNSGRC.) It will serve as a national SCD coordinating center, to coordinate the implementation of the community-based SCD projects funded by this initiative and provide a community forum to identify and prioritize issues of importance to the SCD community.

Project 2 “ The grant funded community-based SCD projects will rely on partnerships between the community-based SCD organizations, State Title V and newborn screening programs, comprehensive sickle cell treatment centers, and community-based primary care professionals to provide support including counseling and education to infants screened positive for SCD and trait and their families; as well as participate in a cooperative relationship with the national coordinating center and fellow grantees funded by this initiative as a collaborative effort to collect and share information and to standardize SCD education and counseling activities, and implement a model program of SCD carrier follow-up to include notification, extended family testing, counseling and education of affected individuals and families.

Eligibility

Under SPRANS project grant regulations at 42 CFR 51a.3, any public or private entity, including an Indian tribe or tribal organization (as defined at 25 U.S.C. 450b), is eligible to apply for grants and the cooperative agreement covered by this announcement. Under the President's initiative, community-based and faith-based organizations that are otherwise eligible and believe they can contribute to HRSA's program objectives are urged to consider this initiative.

Project 1: National Coordinating Center

Funding Level/Project Period

Up to $750,000 in FY 2003 will be used to fund the national coordinating center through a cooperative agreement. The project period for the award will be for two years. Funding beyond the first year is dependent upon the availability of appropriated funds for the sickle cell newborn screening program in FY 2004 and grantee satisfactory performance.

The Federal Role

The funding for the national SCD coordinating center will be in the form of a cooperative agreement, in which substantial participation on the project of MCHB staff is anticipated during the performance period. Under the terms of this cooperative agreement, in addition to the required monitoring and technical assistance, Federal responsibilities will include:

(1) Participation in meetings conducted during the period of the cooperative agreement;

(2) Ongoing review of activities and procedures to be established and implemented for accomplishing the scope of work;

(3) Review of project information prior to dissemination;

(4) Review of information presented on project activities;

(5) Assistance with the establishment of contacts with Federal and State agencies, MCHB grant projects, including the NNSGRC, and other contacts that may be relevant to the project's mission, and referral, as necessary, to these entities.

(6) Provision of information resources.

Funding Priority and Preference

Funding priority for the cooperative agreement will be given to applicants meeting the following:

• The applicant is an established SCD organization with a national scope that clearly demonstrates expertise and national capacity for addressing issues relevant to SCD patients and their families and in which community-based programs play an integral role in its mission.

The applicant will be given a 5-point favorable adjustment to the ranking score assigned to that application if the funding priority is met (score is based on a 100 point scale with a maximum adjustment of 5 points).

Funding preference will be applied to FY 2002 funded grantees in the Sickle Cell Newborn Screening Program. Preference will only be given to those applicants who rank above the 20th percentile of applications recommended for approval by the Objective Review Group.

Review Criteria

Applications that are complete and responsive to the guidance will be evaluated by an objective review panel specifically convened for this solicitation and in accordance with HRSA grants management policies and procedures.

Cooperative agreement applications will be reviewed using the following HRSA criteria:

1. The proposed activities, if well executed, are capable of attaining project objectives.

2. The project objectives are capable of achieving the specific program objectives defined in the program announcement and the proposed results are measurable.

3. The method for evaluating proposed results includes criteria for determining the extent to which the program has achieved its stated objectives and the extent to which the accomplishment of objectives can be attributed to the program.

4. In so far as practical, the proposed activities, when accomplished, are replicable, national in scope and include plans for broad dissemination.

5. The estimated costs to the government of the project are reasonable considering the level and complexity of activity and the anticipated results.

6. The project personnel are well qualified by training and/or experience for the support sought, and the applicant organization has adequate facilities and manpower.

Additional criteria may be used to review and rank applications for this competition. Any such criteria will be identified in the program guidance included in the application kit. Applicants should pay strict attention to addressing these criteria, in addition to those referenced above. Also, to the extent that regulatory review criteria generally applicable to all Title V programs (at 42 CFR part 51a) are relevant to this specific project, such factors will be taken into account.

Project 2: Community-based SCD Organizations

Funding Level/Project Period

Up to $ 2.96 million in FY 2003 will be used to fund up to 16 community-based grants within the program. Estimated amount for each community-based grant award is $185,000. The project period for the awards will be for two years. Funding beyond the first year is dependent upon the availability of appropriated funds for the sickle cell newborn screening program in FY 2004 and grantee satisfactory performance. Grantees will be expected to work cooperatively with the national coordinating center described in this announcement.

Funding Priorities and Preference

Funding priority for community-based grants will be given to applicants meeting the following:

(1) A collaborative relationship with the State Title V and newborn screening program, a local comprehensive SCD treatment center, and a community-based SCD organization;

(2) The applicant is a local, community-based SCD organization with no less than 10 cumulative years experience in providing outreach services to persons and families affected by SCD; and in addition, in providing education and counseling to parents of infants determined by the newborn screening program to have SCD or be carriers of sickle cell or other abnormal hemoglobins.

(3) The applicant can document experience within the past year that:

a. Provides outreach services, education and counseling to parents of infants determined by the newborn screening program to have SCD or be carriers of sickle cell or other abnormal hemoglobins; and

b. Partners with the State Title V and newborn screening program(s), and a local comprehensive sickle cell treatment center or a local community-based SCD organization.

An applicant will be given a 5-point favorable adjustment to the ranking score assigned to that application for each funding priority that is met (score is based on a 100 point scale with a maximum adjustment of 15 points). In order to assure equitable distribution of awards in terms of geography, there is a maximum of 2 awards per State.

Funding preference will be applied to FY 2002 funded grantees in the Sickle Cell Newborn Screening Program. Preference will only be given to those applicants who rank above the 20th percentile of applications recommended for approval by the Objective Review Group.

Review Criteria

Applications that are complete and responsive to the guidance will be evaluated by an objective review panel specifically convened for this solicitation and in accordance with HRSA grants management policies and procedures.

Applications for community-based grants will be evaluated using the following criteria:

1. The proposed activities, if well executed, are capable of attaining project objectives.

2. The project objectives are capable of achieving the specific program objectives defined in the program announcement and the proposed results are measurable.

3. The method for evaluating proposed results includes criteria for determining the extent to which the program has achieved its stated objectives and the extent to which the accomplishment of objectives can be attributed to the program.

4. The estimated costs to the government of the project are reasonable considering the level and complexity of activity and the anticipated results.

5. The project personnel are well qualified by training and/or experience for the support sought, and the applicant organization has adequate facilities and manpower.

Additional criteria may be used to review and rank applications for this competition. Any such criteria will be identified in the program guidance included in the application kit. Applicants should pay strict attention to addressing these criteria, in addition to those referenced above. Also, to the extent that regulatory review criteria generally applicable to all Title V programs (at 42 CFR part 51a) are relevant to this specific project, such factors will be taken into account.

Paperwork Reduction Act

OMB approval for any data collection in connection with this cooperative agreement will be sought, as required under the Paperwork Reduction Act of 1995.

Public Health System Reporting Requirements

The second component (Community-based Sickle Cell Disease organizations—Project 2) of this program is subject to the Public Health System Reporting Requirements (approved under OMB No. 0937-0195). Under these requirements, the community-based nongovernmental applicant must prepare and submit a Public Health System Impact Statement (PHSIS). The PHSIS is intended to provide information to State and local health officials to keep them apprised of proposed health services grant applications submitted by community-based nongovernmental organizations within their jurisdictions.

Community-based nongovernmental applicants are required to submit the following information to the head of the appropriate State and local health agencies in the area(s) to be impacted no later than the Federal application receipt due date:

(a) A copy of the face page of the application (SF 424).

(b) A summary of the project (PHSIS), not to exceed one page, which provides:

(1) A description of the population to be served.

(2) A summary of the services to be provided.

(3) A description of the coordination planned with the appropriate State and local health agencies.

Executive Order 12372

The MCH Federal Set-Aside program has been determined to be a program which is not subject to the provisions of Executive Order 12372 concerning intergovernmental review of Federal programs.

Dated: May 22, 2003.

Stephen R. Smith,

Executive Assistant to the Administrator.