[Federal Register Volume 68, Number 116 (Tuesday, June 17, 2003)]
[Notices]
[Pages 35904-35907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15183]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

[Announcement Number: HRSA-03-098]


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 [email protected]; 
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

[[Page 35905]]

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: [email protected].
    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: [email protected] (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, 
[email protected] (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

[[Page 35906]]

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:

    [sbull] 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

[[Page 35907]]

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.
[FR Doc. 03-15183 Filed 6-16-03; 8:45 am]
BILLING CODE 4165-15-P