(12) Establish a formal referral system which will provide timely and necessary arrangements for eligibility, transfer of records, and a written referral for hemophiliacs who move to another treatment center's catchment area or area of association.

(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 the catchment area and

(2) A program of 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 Accord with health planning.

A grant may be made under this part only if the applicable requirements of Title XV of the Act relating to review and approval by the appropriate health planning agencies have been met.

§ 51d.107

Grant evaluation and award.

(a) Within the limits of funds available, the Secretary may award grants to applicants which will, in his judgment, best promote the purposes of Title V of the Social Security Act, as amended by Pub. L. 97-35, and which submit approvable applications.

(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 that 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.

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

§ 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) Counseling services;

(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; (7) Public information;

(8) Delivering project services to hemophiliacs within the project's catchment area and area of association, within the following limitations: grant funds may be used to pay the portion of the reasonable cost of services provided in accordance with the schedule of fees and payments used pursuant to § 51d.105(a)(9) which, under such schedule, is uncompensated.

(c) Project funds awarded under this subpart shall not be used to pay the cost of:

(1) Inpatient hospital care;

(2) Provision of blood products except when the blood products are infused by and at the project as part of the course of treatment provided at the project.

(d) Grant funds shall not be used in lieu of other area funding sources to pay to support the program.

§ 51d.110 Civil rights.

(a) Attention is called to the requirements of Title VI of the Civil Rights Act of 1964 (78 Stat. 252 (42 U.S.C. 2000d et seq.)) and in particular section 601 of such Act which provides that no person in the United States shall on the grounds of race, color, or national origin be excluded from participation, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance. A regulation implementing such Title VI, which applies to grants made under this part, has been issued by the Secretary with

the approval of the President (45 CFR Part 80). In addition, no person shall be denied employment in or by such program or activity on the grounds of age, sex, creed, or marital status.

(b) Attention is also called to the requirements of section 504 of the Rehabilitation Act of 1973, as amended, which provides that no otherwise qualified handicapped individual in the United States shall, solely by reason of his handicap, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance. § 51d.111 Confidentiality.

All information as to personal facts and circumstances obtained by the project staff in connection with the provision of services under the project shall be treated as privileged communication, shall be held confidential, and shall not be divulged to any party including the provider in association without the individual's consent except as may be otherwise required by applicable law (including this subpart) or necessary to provide services to the individual. Such information may be disclosed in summary, statistical, or other form which does not identify particular individuals.

§ 51d.112 Publications and copyright.

Except as may be provided under the terms and conditions of the award, the Department of Health and Human Services copyright requirement set forth in 45 CFR 74.140, shall apply to any book or otherwise copyrightable material developed or resulting from the activity supported by a grant under this part.

§ 51d.113 Grantee accountability.

(a) Accounting for grant award payments. The grantee shall record all payments made by the Secretary in accounting records separate from the records of all other grant funds, including funds derived from other grant awards. With respect to each approved project, the grantee shall account for the sum total of all amounts paid by by presenting or otherwise making available evidence satisfactory to the Secretary of expenditures for

direct and indirect costs meeting the requirement of this subpart. Provided, however, that when the amount awarded for indirect costs was based on a predetermined fixed percentage of estimated direct costs, the amount allowed for indirect costs shall be computed on the basis of such predetermined fixed percentage rates applied to the total, or a selected element thereof, of the reimbursement direct costs incurred.

(b) Grant closeout. (1) Date of final accounting. A grantee shall render, with respect to each approved project, a full account as provided herein, as of the date of the termination of grant support. The Secretary may require other special and periodic accounting.

(2) Final settlement. There shall be payable to the Federal Government as final settlement with respect to each approved project the total sum of:

(i) Any amount not accounted for pursuant to paragraph (b) of this section.

(ii) Any credits for earned interest pursuant to paragraph (b) of this section.

(iii) Any other amounts due pursuant to Subparts F, M, and O of 45 CFR Part 74.

(iv) Such total sum shall constitute a debt owed by the grantee to the Federal Government and shall be recovered from the grantee or its successors or assignees by setoff or other action as provided by law.

51f.103 Who is eligible to apply for a genet

ic diseases testing and counseling grant? 51f.104 How is application made for a genetic diseases testing and counseling grant?

51f.105 What health planning requirements must be met?

51f.106 What requirements must be met by a genetic diseases testing and counseling project?

51f.107 What requirements must be met by a previously funded sickle cell project? 51f.108 What criteria will HHS use to decide which genetic diseases testing and counseling projects to fund? 51f.109 For what purposes may grant funds be used? 51f.110 What additional information

should an applicant or grantee have about a genetic diseases testing and counseling grant?

AUTHORITY: Sec. 215, Public Health Service Act (42 U.S.C. 216); sec. 1101(a)(1), Public Health Service Act (42 U.S.C. 300b), as amended by Title II of Pub. L. 95-626, 92 Stat. 3570-3590; sec. 502(a) of the Social Se

curity Act, as amended, 95 Stat. 819-20 (42 U.S.C. 702(a)).

SOURCE: 44 FR 23841, Apr. 23, 1979, unless otherwise noted.

§ 51f.101 To whom do these regulations apply?

The regulations of this part apply to grants for projects to plan, establish, and operate voluntary genetic diseases testing and counseling programs. 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 Pub. L. 97-35), the grants are awarded under section 1101(c) of the Public Health Service Act (42 U.S.C. 300b(a)(1)) as in effect before the enactment of Pub. L. 97-35. For entities in other States, the grants are awarded under section 502(a) of the Social Security Act (as amended by Pub. L. 97-35).

[47 FR 27825, June 25, 1982]

For the purposes of this part:

Except for references to the Social Security Act and except as set forth in § 51f.101, "Act" means the Public Health Service Act as in effect before the enactment of Pub. L. 97-35.

"Carrier" means a person who has a gene or chromosome which may cause a deleterious effect in his or her offspring.

"Genetic diseases" means inherited disorders caused by the transmission of certain aberrant genes from one generation to another.

"Nonprofit," as applied to any private agency, institution, or organization, means that no part of the entity's net earnings benefits, or may lawfully benefit, any private shareholder or individual.

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

"Service area" means the area served by a project funded under Section 1101(a)(1) of the Act.

"State" means one of the 50 States, the District of Columbia, the Com

monwealth of Puerto Rico, the Northern Mariana Islands, the Virgin Islands, Guam, American Samoa, or the Trust Territory of the Pacific Islands.

[44 FR 23841, Apr. 23, 1979, as amended at 47 FR 27825, June 25, 1982]

§ 51f.103 Who is eligible to apply for a genetic diseases testing and counseling grant?

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

§ 51f.104 How is application made for a genetic diseases testing and counseling grant?

An application for a grant under this part must be submitted to the Secretary at the time, and contain the information and assurances, required by the Secretary. The application must include a budget and narrative plan of the manner in which the project has met, or plans to meet, each of the requirements contained in § 51f.106(a), relating to genetic diseases testing and counseling projects, or § 51f.107, relating to previously funded sickle cell projects. The plan must describe the project in sufficient detail to identify clearly the nature, need, and specific objectives of, and methodology for carrying out, the project.

§ 51f.105 What health planning requirements must be met?

A grant may be made under this part only if the applicable requirements of section 1513(e) of the Act relating to review and approval by the appropriate health systems agency have been met.

through written agreements with providers, all of the following essential services:

(i) Individual testing, including those available and appropriate laboratory and clinical evaluation procedures which assure accurate diagnoses of carriers and persons who may have any of the genetic diseases proposed to be covered by the project; and all laboratory facilities used by the project must meet the standards set forth in 42 CFR Part 405, Conditions of Coverage of Services of Independent Laboratories, and must participate in the Center for Disease Control proficiency testing program;

(ii) Community-wide testing where appropriate, taking into consideration widely prevalent genetic diseases and certain high-risk population groups in which a genetic disease occurs with high incidence, and directed especially to persons who are entering their child-producing years;

(iii) Genetic counseling, to the extent of current knowledge in that field, for all persons concerned about having, or being carriers of, any genetic diseases;

(iv) A system for referral of persons to appropriate medical and supportive services, including the exchange of the patient's pertinent clinical records where necessary to provide services to the patient, consistent with the confidentiality requirements in § 51f.110(b), and followup procedures; and

as

(v) Facilitating services, such transportation of patients to project facilities and interpreter services, where appropriate to ease access to project services.

(2) Provide, or have the capability to provide, directly or through written agreements with providers, the services described in paragraph (a)(1) of this section so that they are available and accessible promptly, including the provision of services in local facilities, as appropriate, to all of the residents of the service area, in a manner which will assure continuity of services. The service area may be no smaller than a State unless the Secretary waives this requirement for good cause shown.

(3) To the extent feasible, coordinate and integrate project activities with the activities of other federally