amount of the contract price, and shall maintain, during the life of the contract, adequate fire, workmen's compensation, public liability, and property damage insurance: Provided, however, That in the case of a State or local unit of government which enters into a construction contract of less than $100,000, State or local provisions with respect to performance and payment bonds shall be deemed to meet the requirements of this paragraph; and

(C) That the Secretary shall have access at all reasonable times to work wherever it is in preparation or progress, and the contractor shall provide proper facilities for such access and inspection.

(ii) Executive Order 11246. Comply with the applicable requirements of Executive Order 11246, 30 FR 12319 (September 24, 1965) as amended, relating to nondiscrimination in construction contract employment, and the applicable rules, regulations, and procedures prescribed pursuant thereto.

(4) Modernization supervision. Provide and maintain competent and adequate architectural or engineering supervision and inspection at the modernization site to insure that the completed work conforms with the plans and specifications.

(5) Completion responsibility. Complete the modernization in accordance with the grant application and the approved plans and specifications.

(6) Progress reports. Furnish progress reports and such other information concerning the modernization as the Secretary may require.

(d) The Secretary may at any time approve exceptions to the provisions of this section where he finds that such exceptions are not inconsistent with section 330 of the Act, other requirements of law, or the purposes of the program.

[41 FR 57000, Dec. 30, 1976, as amended at 43 FR 5352, Feb. 7, 1978]

tion submitted by the applicant as the Secretary may prescribe (including the reports of such real estate appraisers as the Secretary may approve) and other relevant factors, taking into consideration only that portion of the existing building necessary for the operation of the approved project.

[41 FR 5700, Dec. 30, 1976]

§ 51c.506 Use of grant funds.

Grant funds may be used to amortize the principal of or pay interest on a loan or mortgage on an existing building acquired under this part, including a building purchased by a grantee prior to the promulgation of this part, but only if the building is being used for the purposes of section 330 and complies with the applicable provisions of this subpart and only to the extent the Secretary finds such principal amounts and interest rates to be reasonable.

[41 FR 5700, Dec. 30, 1976]

§ 51c.507 Facility which has previously received Federal grant.

No grant for the acquisition of a facility which has previously received a Federal grant for construction, acquisition, or equipment shall serve either to reduce or restrict the liability of the applicant or any other transferor or transferee from any obligation of accountability imposed by the Federal Government by reason of such prior grant.

[41 FR 5700, Dec. 30, 1976]

Sec.

51d.111 Confidentiality.

51d.112 Publications and copyright. 51d.113 Grantee accountability.

51d.114 Performance and financial reports. 51d.115 Applicability of 45 CFR Part 74. 51d.116 Additional conditions.

AUTHORITY: Secs. 215, 1131, Public Health Service Act, (42 U.S.C. 216, 300c-21); sec. 502(a), Social Security Act, as amended, 95 Stat. 819-20 (42 U.S.C. 702(a)).

SOURCE: 42 FR 56248, Oct. 21, 1977, unless otherwise noted.

Subpart A-Grants for Hemophilia Treatment Centers

§ 51d.101 Applicability.

The regulations of this subpart apply to grants to public and nonprofit private entities for projects for the establishment of comprehensive hemophilia diagnostic and treatment centers. For grants to entities in States that do not participate in the Maternal and Child Health Block Grant, as authorized by Title V of the Social Security Act (as amended by Public Law 97-35), the grants are awarded under section 1131 of the Public Health Service Act (42 U.S.C. 300c-21) as in effect before the enactment of Public Law 97-35. For entities in other States, the grants are awarded under section 502(a) of the Social Security Act (as amended by Public Law 97-35).

[47 FR 27825, June 25, 1982]

As used in this subpart:

(a) Except for references to the Social Security Act and except as set forth in § 51d.101, "Act" means the Public Health Service Act as in effect before the enactment of Public Law 97-35.

(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) "Counseling" means consultation and advice provided by persons appropriately trained in their respective fields, and includes:

(1) Social counseling (counseling which is directed toward enhancing the social functioning of patients and their families through counseling about family relationships and interrelationships and helping to obtain tangible services, sources of referral for appropriate medical treatment, and

sources of financial assistance for medical expenses);

(2) Vocational counseling (counseling concerning education, training, and employment suitable for hemophiliacs); and

(3) Genetic counseling.

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

(i) "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,

(ii) Has a circulating level of clotting factor that is usually less than 1 percent of normal.

(j) "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.

(k) "Secretary" means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom the authority involved has been delegated.

(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.

[42 FR 56248, Oct. 21, 1977, as amended at 47 FR 27825, June 25, 1982]

§ 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 applicant for a grant under this subpart shall submit an application to the Secretary at such time and in such form and manner as the Secretary may prescribe, the application must contain:

(a) A full 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) Evidence that the applicant consulted with appropriate community groups and hemophiliacs within the catchment area in developing its project.

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

(d) 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.

(e) 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.

(f) 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.

(g) The estimated number of and a description of the programs for hemophiliacs within the applicant's catchment area and in the area of association, and the estimated number of hemophiliacs receiving care in each area under the programs.

(h) A statement of the method to be used to identify providers of health care who are treating individuals with hemophilia in the applicant's pro

posed area of association, and the method to be used to notify such providers of the services which the applicant will make available to them.

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

(o) 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 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.

[42 FR 56248, Oct. 21, 1977, as amended at 49 FR 38110, Sept. 27, 1984]

§ 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 that meets the standards set forth in 20 CFR Part 405, "Conditions of Coverage of Services of Independent Laboratories;" participates in the proficiency testing program of the Center for Disease Control; and 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 concentrates, 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 only when infused at and by the project; and

(iii) Provide training in home care to all hemophiliacs served by the project in need thereof and to the parents or guardians of such hemophiliacs who are minors.

(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 or area of association; and

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

(4) Develop, 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, registered 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.

(ii) 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 for 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 that 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 will 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.

(11) Provide for community participation, through establishment of an advisory council, if feasible, to advise with respect to the overall management of the project including services to be provided, the manner of their provision, and appointment of personnel. The membership of the advisory council must be representative of the population in the area served by the center, and include at least one hemophiliac receiving services from the center and at least two persons from separate family groups who are parents or guardians of hemophiliacs who are minors.