[Federal Register Volume 67, Number 82 (Monday, April 29, 2002)]
[Notices]
[Pages 20980-20982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-10429]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Maternal and Child Health Federal Set-Aside Program; Special 
Projects of Regional and National Significance; Sickle Cell Disease and 
Newborn Screening Program

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice of availability of funds.

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SUMMARY: The Health Resources and Services Administration (HRSA) 
announces that approximately $3.6 million in fiscal year (FY) 2002 
funds is available to fund (1) a single cooperative agreement with a 
national sickle cell disease organization for a national coordinating 
center, and (2) up to 15 grants for community-based sickle cell disease 
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. 450(b)). 
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)), or ``SPRANS.'' Funds for these 
awards were appropriated under Public Law 107-116. Up to $750,000 will 
be available for one cooperative agreement; up to $2.87 million will be 
available for community-based grants. Awards are made for a grant 
period of one year.

DATES: Applicants for this program are expected to notify the Maternal 
and Child Health Bureau (MCHB) by May 20, 2002. Notification of intent 
to apply can be made in one of three ways: telephone: 301-443-1080; 
email [email protected]; mail, MCHB, HRSA; Division for Children with 
Special Health Care Needs, Parklawn Building, Room 18A-19; 5600 Fishers 
Lane; Rockville, MD 20857. The deadline for receipt of applications is 
June 29, 2002. 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 1, 
2002.

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 April 29, 2002, 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 93.110A 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].
    This application guidance and the required form for the Sickle Cell 
Disease and Newborn Screening grant program may be downloaded in either 
WordPerfect 6.1 or Adobe Acrobat format (.pdf) from the MCHB HomePage 
at http://www.mchb.hrsa.gov/. Please contact Joni Johns at 301/443-2088 
or [email protected]/, if you need technical assistance in accessing the 
MCHB Home Page via the Internet.
    This announcement will appear on the HRSA Home Page at: http://www.hrsa.gov/. Federal Register notices are found by following 
instructions at: http://www.access.gpo.gov/su_docs/aces/aces140.html.

FOR FURTHER INFORMATION CONTACT: Michele A. Lloyd-Puryear, M.D., Ph.D. 
301-443-1080, e-mail: [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; e-mail, 
[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

[[Page 20981]]

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 
State wide screening programs, the 1987 Consensus Development 
Conference on Newborn Screening for Sickle Cell and Other 
Hemoglobinopathies recommendation for universal screening has not been 
realized.
    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 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.
    Just as important as follow-up in a SCD program is the education 
component. 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 newborns diagnosed with SCD or trait and their 
families, relying on partnerships among the State newborn screening 
programs, community-based SCD organizations, comprehensive SCD 
treatment centers, and health care professionals. Specifically, the 
program will enhance the follow up component of State SCD screening 
programs and support community-based projects that provide SCD related 
education, carrier counseling, and support services.
    Through a cooperative agreement, a national SCD organization will 
partner with families, community based SCD organizations, health care 
professionals, State agencies and MCHB, and assist in the coordination 
and implementation of community-based SCD projects funded by this 
initiative. Further, it will provide an organizational forum for 
interaction between MCHB and the SCD community to identify and 
prioritize issues of importance to the SCD community.
    The funded community-based SCD projects will partner with State 
newborn screening programs, comprehensive sickle cell treatment 
centers, and health care professionals to provide support to infants 
screened positive for SCD and trait and their families; as well as 
working cooperatively with each other and the funded national SCD 
organization to 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 part 51a.3, any 
public or private entity, including an Indian tribe or tribal 
organization (as defined at 25 U.S.C. 450(b)), is eligible to apply for 
grants and cooperative agreements 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.

Funding Levels/Project Periods

    The administrative and funding instrument to be used for the 
national SCD coordinating center will be a cooperative agreement, in 
which substantial MCHB scientific and/or programmatic involvement with 
the awardee is anticipated during the performance of the project. Under 
the terms of this cooperative agreement, in addition to the required 
monitoring and technical assistance, Federal responsibilities will 
include:
    (1) Provision of services of experienced federal personnel as 
participants in the planning and development of all phases of this 
activity.
    (2) Participation, as appropriate, in meetings conducted during the 
period of the cooperative agreement.
    (3) Ongoing review and concurrence with activities and procedures 
to be established and implemented for accomplishing the scope of work.
    (4) Participation in the preparation of project information prior 
to dissemination.
    (5) Participation in the presentation of information on project 
activities.
    (6) Assistance with the establishment of contacts with Federal and 
State agencies, MCHB grant projects, and other contacts that may be 
relevant to the project's mission; and referrals to these agencies.
    Up to $750,000 will be used to fund the national coordinating 
center through a cooperative agreement. Up to $2.87 million will be 
used to fund up to 15 community-based grants within the program. 
Grantees will be expected to work cooperatively with the national 
coordinating center also described in this announcement. All awards 
will be made for one year.

Funding Priorities

    Funding priority for the cooperative agreement will be given to an 
established national SCD organization with clearly demonstrated 
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.
    Funding priority for community-based grants will be given to 
existing local community-based SCD organizations meeting one of 
following two priority factors:
    (1) A collaborative relationship with the State Title V and newborn 
screening program and a partnership with a local comprehensive sickle 
cell treatment center; or
    (2) Participation in a cooperative relationship with the national 
SCD coordinating center and fellow grantees funded by this initiative 
to collect information and standardize the education and counseling to 
be offered by the network of local, community-based projects.
    An applicant meeting one of these priority factors will be given a 
5 point favorable adjustment to the ranking score assigned to that 
application, on a 100 point scale. There is a maximum of 2 awards per 
State.

Review Criteria

    Applications that are complete and responsive to the guidance will 
be

[[Page 20982]]

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 criteria:
    1. Understanding of the problem, solutions, and desired outcome;
    2. Quality of the proposal for the coordination and support to be 
provided to the community-based SCD projects to be funded by MCHB under 
this initiative;
    3. Collaboration between the organization and State newborn 
screening programs and sickle cell treatment centers and health care 
professionals;
    4. Infrastructure, including sound administrative and management 
components, necessary to carry out the proposed activities;
    5. Expertise and experience of the project staff;
    6. Budget request to be commensurate with the proposed activities 
and well justified;
    Applications for community-based grants will be evaluated using the 
following criteria:
    1. Experience in providing outreach, education, and support to 
parents of newborns determined by newborn screening to have SCD or 
sickle cell trait;
    2. Willingness to engage in a collaborative relationship with the 
State newborn screening program and a comprehensive sickle cell 
treatment center;
    3. Willingness to participate in a cooperative relationship with 
the national SCD organization and fellow grantees funded by this 
initiative to collect information and standardize the education and 
counseling to be offered by the grantees;
    4. Quality of plan for collaboration with partners and conduct of 
outreach, education, and counseling activities;
    5. Infrastructure, including sound administrative and management 
components, necessary to carry out the proposed plan;
    6. Budget request to be commensurate with the proposed plan and 
well justified;
    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

    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: April 23, 2002.
Jane M. Harrison,
Director, Division of Policy Review and Coordination.
[FR Doc. 02-10429 Filed 4-26-02; 8:45 am]
BILLING CODE 4165-15-P