(b) Requirements for acquisition grants. In addition to the requirements of paragraph (a) of this section, a grantee which has received a grant under section 330 of the Act for a project which includes the acquisition of an existing building must:

(1) Bona-fide sale. Acquire or, in the case of a grant solely for amortization of principal and payment of interest on an existing loan, have acquired the existing building pursuant to a bonafide sale involving an actual cost to the applicant and resulting in additional or improved facilities for the purposes of the project.

(2) Standards of construction and equipment. Except in the case of a grant solely for amortization of principal and payment of interest on an existing loan, obtain a determination by the Secretary that the facility conforms (or upon completion of any necessary alteration and renovation or modernization will conform) to the standards set forth in § 51c.503(a)(7)(iii) of this subpart before entering into a final or unconditional contract for the acquisition. Where the Secretary finds that exceptions to or modifications of any such standards would be consistent with the purposes of the Act and of the program, he may authorize such exceptions or modifications.

(3) Financing. Where the grantee will obtain a loan secured by the building in order to acquire the building, obtain such financing at the lowest current rate prevailing in the area for comparable loans on comparable facilities.

(c) Requirements for modernization grants. In addition to the requirements of paragraph (a) of this section, a grantee which has received a grant under section 330 of the Act for a project which includes the modernization of an existing building must:

(1) Costs in excess of approved costs. Finance all costs in excess of the estimated costs approved in the application and submit to the Secretary for prior approval any changes that substantially alter the scope of the function, utilities, or safety of the facility.

(2) Competitive bids. (i) Obtain the approval of the Secretary before the project is advertised or placed on the

market for bidding; such approval must include a determination by the Secretary that the final plans and specifications conform to the standards set forth in § 51c.503(a)(7)(iii) of these regulations.

(ii) Except as otherwise provided by State or local law, contract for construction (including the purchase and installation of built-in equipment) on a lump sum fixed-price basis, and award contracts on the basis of competitive bidding obtained by public advertising with award of the contracts to the lowest responsive and responsible bidders. The provision for exceptions based on State and local law shall not be invoked to give local contractors or suppliers a percentage preference over non-local contractors bidding for the same contract. Such practices are precluded by this paragraph.

(3) Construction contracts. (i) InIclude the following conditions and provisions in all construction contracts for the modernization project:

(A) The provisions set forth in “DHHS Requirements for Federally Assisted Construction Contracts Regarding Labor Standards and Equal Employment Opportunities," Form DHHS 514 (rev. 7/76) (issued by the Office of Grants Administration Policy, U.S. Department of Health and Human Services) pertaining to the Davis-Bacon Act, the Contract Work Hours Standards Act, and the Copeland Act (Anti-Kickback) Regulations, except in the case of contracts in the amount of $2,000 or less; and pertaining to Executive Order 11246, 30 FR 12319 (September 24, 1965), as amended, relating to nondiscrimination in construction contract employment, except in the case of contracts in the amount of $10,000 or less;

(B) That the contractor shall furnish performance and payment bonds each of which shall be in the full 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 pay

ment 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]

§ 51c.505 Determination of cost.

The cost of acquisition and/or modernization of existing buildings for which funds may be granted under this part will be determined by the Secretary, utilizing such documentation 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]

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 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.

(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.

(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 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 per