As used in this subpart:

(a) "Act" means the Public Health Service Act, as amended.

(b) "Applicant” means a public or nonprofit private entity which applies for a grant under this subpart.

(c) "Area of association" means the area outside a project's catchment area in which the project provides services in a program of association with providers of health care pursuant to § 51d.105(c) of this subpart.

(d) "Catchment area" means the area in which a project provides all of its services, except those provided pursuant to § 51d.105(c).

(e) "Center" means a project funded under this subpart.

(f) "Comprehensive care program" means a program detailing the appropriate treatment for an individual suffering from hemophilia which:

(1) Includes:

(i) An assessment of the type and severity of the individual's hemophilia condition;

(ii) Statements of the health care needed, including estimates of the individual's needs for prophylactic or replacement therapy, prophylactic dental care, physical therapy for prevention of secondary joint problems, and orthopedic treatment;

(iii) A statement of the activity (educational, recreational, and occupational) to be limited or avoided by the individual, or recommended for the individual;

(iv) Recommendations for periodic reevaluation (no less frequently than annually);

(v) Recommendations and/or referral for social and vocational counseling;

(vi) Recommendations and/or referral for genetic counseling; and

(vii) Information on 24-hour, 7-daya-week emergency service; and

(2) Is developed by a multidisciplinary team which includes:

(i) Each of the following: a hematologist, a pediatrician or internist as appropriate, a nurse, and a social worker; and

(ii) If medically indicated, any one or more of the following: an orthopedist, a physical therapist, a psychiatrist, a psychologist, an oral surgeon or dentist, or an educational and/or vocational counselor.

(g) "Diagnosis" means the determination of the cause of significant bleeding tendencies.

(h) "Hemophilia" means a genetically transmitted bleeding disorder resulting from a deficiency of a plasma clotting factor.

(1) "Mild hemophilia" means a condition under which an individual:

(i) Generally leads a normal life, and (ii) Has a sufficient amount of the clotting factor for blood to coagulate and bleeding to be controlled (in most cases, a circulating level of clotting factor above 10 percent of normal).

(2) "Moderate hemophilia" means a condition under which an individual:

(i) Rarely hemorrhages spontaneously but may experience significant hemorrhage after minor trauma, and

(ii) Has (in most cases) a circulating level of clotting factor that ranges from 1 to 10 percent of normal.

(3) "Severe hemophilia" means a condition under which an individual:

(i) Throughout his life is subject to spontaneous hemorrhage into soft tissue, bone joints, and muscles as well as bleeding after any type of trauma or minor surgery, and

(ii) Has (in most cases) a circulating level of clotting factor of less than 1 percent of normal.

(i) "Nonprofit" as applied to a private entity means that no part of the net earnings of such entity inures, or may lawfully inure, to the benefit of any private shareholder or individual.

(j) "Secretary" means the Secretary of Health, Education, and Welfare and any other officer or employee of the Department of Health, Education, and Welfare to whom the authority involved has been delegated.

(k) "Social counseling" means counseling provided by persons with appropriate training which includes at least: (1) Genetic counseling;

(2) Counseling about family relationships and interrelationships;

(3) Counseling about sources of referral for appropriate medical treatment; and

(4) Counseling about sources of financial assistance for medical expenses.

(1) "State" means any of the several States, the District of Columbia, Guam, Puerto Rico, the Virgin Islands, American Samoa, and the Trust Territory of the Pacific Islands.

(m) "Vocational counseling" means counseling provided by persons with appropriate training about appropriate education, training and/or employment.

§ 51d.103 Eligibility.

Any public or nonprofit private entity is eligible to apply for a grant under this subpart.

§ 51d.104 Application for a grant.

An application for a grant under this subpart shall be submitted to the Secretary at such time and in such form and manner as the Secretary may prescribe, and shall contain:

(a) A full and adequate description of the project and of the manner in which the applicant intends to conduct the project and carry out the requirements of this subpart.

(b) A budget and justification of the amount of grant funds requested.

(c) Evidence that the applicant is or within a reasonable time will become an approved provider of crippled children's services for hemophiliacs under Title V of the Social Security Act.

(d) A description of the precise boundaries of the catchment area which the applicant proposes to serve, and a description of the largest area outside that catchment area which the applicant cannot conveniently serve directly but can realistically serve through association with other health care providers who are treating individuals with hemophilia in a program of association meeting the requirements of § 51d.105(c) of this subpart.

(e) The estimated number of severe, moderate, and mild hemophiliacs residing in the applicant's proposed catchment area and the estimated number of those hemophiliacs in the proposed area of association.

(f) The estimated number of and a description of the programs for hemophiliacs within the applicant's catchment area and in the area of associ

ation, and the estimated number of hemophiliacs receiving care in each area under the programs.

(g) A statement of the method to be used to identify providers of health care who are treating individuals with hemophilia in the applicant's proposed area of association, and the method to be used to notify such providers of the services which the applicant will make available to them.

(h) An estimate of the average financial burden caused by the disease on a hemophiliac within the applicant's proposed catchment area and within its proposed area of association.

(i) The approximate number of hemophiliacs to be served by the applicant in its proposed area of association.

(j) An assurance satisfactory to the Secretary that the applicant will serve the maximum number of individuals that its available and potential resources will enable it effectively to

serve.

(k) A description of the diagnostic and specialty treatment services to be offered and, in the case of an applicant already providing services to hemophiliacs, a description of all diagnostic, treatment, and other services for hemophiliacs being provided by the applicant.

(1) A description of the applicant's arrangements for access to an appropriate coagulation laboratory and an appropriate blood bank under § 51d.105(a) (1) and (2).

(m) The plans and curricula for training professional and paraprofessional personnel pursuant to § 51d.105(a)(3) of this subpart.

(n) Copies of position descriptions for key personnel to be utilized in carrying out the project, a statement indicating the need for the specific positions, and a description of the qualifications of principal staff members.

(0) A description of the counseling program to be provided pursuant to § 51d.105(b)(2) and of the arrangements to be made to provide social and vocational counseling.

(p) Such other pertinent information as the Secretary may require. (q) Evidence that:

(1) The requirements of Part I of Office of Management and Budget

Circular No. A-95 have been satisfied, and

(2) All applicable requirements for review and approval under title XV of the Act have been met.

(r) The signature of the individual authorized to act for the applicant and to assume on behalf of the applicant the obligations imposed by the Act, the applicable regulations of this subpart, and any additional conditions of the grant award.

§ 51d.105 Project elements.

(a) General requirements. A project funded under this subpart must:

(1) Have a program to diagnose the type, degree, and nature of the bleeding tendency of individuals identified as probably suffering from hemophilia for the purpose of determining appropriate treatment. Such program shall include, at a minimum:

(i) Ready access to a coagulation laboratory which is capable of:

(A) Diagnosing any plasmatic factor deficiency,

(B) Identifying the existence of platelet functional disorders,

(C) Identifying the presence of inhibitors to one or more of the clotting factors, and

(D) Determining the existence of Factor VIII-related antigen, or obtaining access to this test by arrangement with another institution; and

(ii) Performing, at least annually, a test to detect inhibitors to one or more of the clotting factors on each hemophiliac served by the project who is receiving replacement therapy.

(2) Provide a program of comprehensive hemophilia treatment services. as specified in the grant award, of a specialized, multidisciplinary nature generally unavailable in its catchment area or area of association. This program may be carried out directly or on a referral basis, except that each project shall at a minimum

(i) Have access to a blood bank which:

(A) Has expertise in preparing, evaluating, and storing therapeutic blood factors,

(B) Has available a comprehensive variety of blood products, including freeze-dried clotting factor

concen

trates, cryoprecipitates of plasma, and fresh or frozen whole plasma, and

(C) Relies, to the extent practicable, on voluntary donor sources for blood.

(ii) Provide to individuals served by the project prescriptions for blood products and directly provide blood products where the required blood product is not available through prescription in the catchment area or, for individuals served under paragraph (c) of this section, in the catchment area or the area of association; and

(iii) Provide training in home care to all hemophiliacs served by the project in need thereof.

(3) Provide a program of:

(i) Short-term training (not to exceed the equivalent of three months of fulltime training) in standards of hemophilia diagnosis and treatment to professional and paraprofessional personnel of the project and, as resources permit, to personnel concerned with the treatment of hemophiliacs, who work in the project's catchment area and area of association; and

(ii) Training of professional and paraprofessional project personnel in at least one selected area of hemophilia research.

(4) Develop for, in consultation with the individual's primary physician, and provide to each hemophiliac served by the project (unless medically contraindicated) a written comprehensive care program.

(5) Serve as a clearinghouse for information on the availability of other programs of assistance and insurance for hemophiliacs, and assist hemophiliacs served by the project in making any necessary arrangements with those programs.

(6) Establish an outreach program to encourage all hemophiliacs and health care providers in the project's catchment area and area of association to participate in the program sponsored by the project.

(7) Provide for sufficient full- or part-time staff, qualified by training and experience, to carry out its activities.

(i) The staff shall include, at a minimum, a hematologist, internist, pediatrician, orthopedic surgeon, oral surgeon or dentist, physical therapist, nurse, and a social worker, except that

if the hematologist is also an internist or a pediatrician an additional internist or pediatrician is not required to be on the staff.

(i) The project must also insure the availability of a nutritionist, psychiatrist, psychologist, and an educational/vocational or rehabilitation counselor.

(8) Be, or within a reasonable time become, an approved provider of crippled children's services for hemophiliacs under the approved State plan under Title V of the Social Security Act of the State or States in which its catchment area and area of association lie.

(9) Make every reasonable effort to collect payment for services provided by the project in accordance with the applicable schedule of fees and payments for such services of the approved State plan referred to in paragraph (a)(8) of this section. Where a project provides services to residents of more than one State, the project shall provide services to residents of the State in which the project facility is located in accordance with the schedule of the State plan of such State, and shall provide services to residents of any other State served in accordance with an agreement with the State agency which administers the approved title V State plan of such other State concerning such fees and payments.

(10) Establish basic medical data, statistical data, cost accounting, management information and reporting systems which shall enable the project to provide such statistics and other information as the Secretary may reasonably require relating to its costs of operation, patterns of utilization, and the availability, accessibility, acceptability, and effectiveness of its services, and to make these reports to the Secretary in a timely manner with such frequency as the Secretary may reasonably require.

(b) Requirements applicable to the project's catchment area only. In addition to the requirements of paragraph (a) of this section, a project funded under this subpart must provide within its catchment area:

(1) Access to the services of the project for all individuals suffering from

hemophilia who reside in this catchment area and

(2) A program of social and vocational counseling designed to assist hemophiliacs, who reside in the project's catchment area and are served by the center, to lead an independent life. Such counseling may be provided directly or by referral.

(c) Requirements applicable to the area of association only. In addition to the requirements of paragraph (a) of this section, a project funded under this subpart must provide a program of association with providers of health care who are treating individuals suffering from hemophilia residing outside the project's catchment area but within the area which the Secretary has determined (and has specified in the grant award) that the project cannot conveniently serve directly but can realistically serve with such a program. This program shall consist of at least the following:

(1) Implementation of a plan to identify and contact all providers of health services to hemophiliacs in the area of association and notify these providers of the project services available to them; and

(2) Institution of a program to attempt to enter into cooperative arrangements with these providers for the treatment of these hemophiliacs. Such arrangements must provide at a minimum for the following:

(i) Development by the project of individualized, written comprehensive care programs for hemophiliacs being treated by the providers in association with the project, with the participation and agreement of the providers in association.

(ii) Treatment of these hemophiliacs in accordance with the comprehensive care programs,

(iii) Provision for having these hemophiliacs visit the project for an annual re-evaluation of their medical and treatment status, and

(iv) Cooperation of the providers in association in arranging for social and vocational counseling for these hemophiliacs.

§ 51d.106 Fiscal management.

The Health Services Funding regulations, 42 CFR Part 50, Subpart A,

90-164 O 78 16

apply to all grants under this subpart, except to the extent otherwise provided in § 51d.105(a)(9) of this subpart.

§ 51d.107 Grant evaluation and award.

(a) Within the limits of funds available for such purposes, the Secretary may award grants under this subpart to eligible applicants which submit approvable applications therefor, in accordance with the following procedures:

(1) In determining whether an application is approvable, the Secretary shall take into account:

(i) Whether it meets the requirements of this subpart;

(ii) The number of persons to be served by the project in relation to the grant funds requested; and

(iii) The extent to which rapid and effective use of grant funds will be made by the project, considering the following:

(A) The degree to which the project will be operated consistent with the hemophilia services part of the State plan for crippled children's services under Title V of the Social Security Act;

(B) The professional and technical competence of the project in hemophilia diagnosis, treatment, rehabilitation, and research;

(C) The potential integration of the project's services with other health service delivery programs;

(D) The soundness of the project's management; and

(E) The extent of community participation.

(2) The Secretary will give priority to projects which will operate in areas which the Secretary determines have the greatest number of severe and moderate hemophiliacs whose need for the services to be provided by such projects is unmet, as determined on the basis of the information supplied pursuant to § 51c.104.

(b) The amount of any award will be determined by the Secretary on the basis of his estimate of the sum necessary for the proper performance of the project. In determining the grantee's share of project costs, if any, costs borne by Federal funds, or costs used to match other Federal grants,

may not be included except as may be otherwise provided by law.

(c) All grant awards shall be in writing, shall set forth the amount of funds granted, and the period for which support is recommended.

(d) Neither the approval of any project nor any grant award shall commit or obligate the United States in any way to make any additional, supplemental, continuation, or other award with respect to any approved project or portion thereof. For continuation support, grantees must make separate application periodically at such times and in such form as the Secretary may direct.

§ 51d.108 Payment.

The Secretary shall from time to time make payments to a grantee of all or a portion of any grant award either in advance or by way of reimbursement for expenses incurred in the performance of the project, to the extent he determines these payments necessary to promote prompt initiation and advancement of the approved project.

§ 51d.109 Use of project funds.

(a) Any funds granted pursuant to this subpart, as well as other funds to be used in performance of the approved project, may be expended solely for carrying out the approved project in accordance with section 1131 of the Act, the regulations of this subpart, the terms and conditions of the award, and the applicable cost principles prescribed in Subpart Q of 45 CFR Part 74.

(b) Project funds awarded under this subpart may be used, but need not be limited, to pay the costs of the following:

(1) Diagnosis and treatment services; (2) Social, rehabilitative, and other counseling;

(3) Training professionals and paraprofessionals in hemophilia diagnosis, treatment, and research;

(4) Data collection and pooling of medical information;

(5) Transportation of patients, as necessary.

(6) Transportation and per diem for training professionals and paraprofessionals in association with the project;