(a) "Public Health Service" means the Health Services Administration, Health Resources Administration, National Institutes of Health, Center for Disease Control, Alcohol, Drug Abuse and Mental Health Administration, Food and Drug Administration and all of their constituent agencies.

(b) "Nontherapeutic

sterilization"

means any procedure or operation, the purpose of which is to render an individual permanently incapable of reproducing and which is not either (1) a necessary part of the treatment of an existing illness or injury, or (2) medically indicated as an accompaniment of an operation on the female genitourinary tract. For purposes of this paragraph mental incapacity is not considered an illness or injury.

(c) "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.

(d) "Informed consent" means the voluntary, knowing assent from the individual on whom any sterilization is to be performed after he has been given (as evidenced by a document executed by such individual):

(1) A fair explanation of the procedures to be followed;

(2) A description of the attendant discomforts and risks;

(3) A description of the benefits to be expected;

(4) An explanation concerning appropriate alternative methods of family planning and the effect and impact of the proposed sterilization including the fact that it must be considered to be an irreversible procedure;

(5) An offer to answer any inquiries concerning the procedures; and

(6) An instruction that the individual is free to withhold or withdraw his or her consent to the procedure at any time prior to the sterilization without prejudicing his or her future care and without loss of other project or program benefits to which the patient might otherwise be entitled.

(7) The documentation referred to in this section shall be provided by one of the following methods:

(i) Provision of a written consent document detailing all of the basic elements of informed consent (paragraphs (d) (1) through (d) (6) of this section).

(ii) Provision of a short form written consent document indicating that the basic elements of informed consent have been presented orally to the patient. The short form document must be supplemented by a written summary of the oral presentation. The short form document must be signed by the patient and by an auditor-witness to the oral presentation. The written summary shall be signed by the person obtaining the consent and by the auditor-witness. The auditor-witness shall be designated by the patient.

(iii) Each consent document shall display the following legend printed prominently at the top:

NOTICE: Your decision at any time not to be sterilized will not result in the withdrawal or withholding of any benefits provided by programs or projects.

§ 50.203 General Policies.

(a) In addition to any other requirement of this subpart, programs or projects to which this subpart applies shall not perform nor arrange for the performance of any nonemergency sterilization unless: (1) Such sterilization is performed pursuant to a voluntary request for such services made by the person on whom the sterilization is to be performed; and (2) such person is advised at the outset and prior to the solicitation or receipt of his or her consent to such sterilization, that no benefits provided by programs or projects may be withdrawn or withheld by reason of his or her decision not to be sterilized.

(b) A program or project to which this subpart applies shall not perform nor arrange for the performance of any nonemergency sterilization unless such program or project has obtained legally effective informed consent from the individual on whom the sterilization is to be performed.

(c) Programs or projects to which this subpart applies shall not perform nor arrange for the performance of a nontherapeutic sterilization sooner than 72 hours following the giving of informed consent.

This subpart establishes an informal procedure for resolution of post-award grant disputes prior to their submission to the Departmental Grant Appeals Board established in 45 CFR Part 16 (38 FR 9906, April 20, 1973).

§ 50.402 Applicability.

This policy is applicable to all grant programs listed in Appendix A and Appendix B, which are administered by the National Institutes of Health, the Health Services Administration, the Health Resources Administration, the Center for Disease Control, the Alcohol, Drug Abuse, and Mental Health Administration, or the Food and Drug Administration, or by the Public Health Service Regional Offices.

The Secretary of Health, Education, and Welfare has established a Departmental Grant Appeals Board for the purpose of reviewing and providing hearings upon post-award disputes which may arise in the administration of certain grant programs by constituent agencies of the Department. Section 16.5(b) (2) of the Charter (45 CFR Part 16) which establishes such Board authorizes DHEW agencies to establish informal appeal procedures which must be exhausted before a formal appeal to the Departmental Board will be allowed. Pursuant to § 16.5(b) (2) of that Charter, this document provides an informal preliminary procedure for resolution of such disputes within the Public Health Service, in order to preclude submission of cases to the Departmental Appeals Board before the Public Health Service has had an opportunity to review decisions of its officials and to settle disputes with grantees.

§ 50.404 Scope.

(a) Adverse determinations to which this procedule is applicable are as follows:

(1) Termination, in whole or in part, of a grant for failure of the grantee to carry out its approved project in accordance with the applicable law and the terms and conditions of such assistance or for failure of the grantee otherwise to comply with any law, regulation, assurance, term, or condition applicable to the grant.

(2) A determination that an expenditure not allowable under the grant has been charged to the grant or that the grantee has otherwise failed to discharge its obligation to account for grant funds.

(3) The disapproval of a grantee's written request for permission to incur an expenditure during the term of a grant.

(4) A determination that a grant is void.

(b) A determination described in paragraph (a) of this section may not be reviewed by the review committee described in § 50.405 unless an officer or employee of the agency or the Regional Office has notified the grantee in writing of such determination. Such notification shall set forth the reasons for the determination in sufficient detail to enable the grantee to respond and shall inform the grantee of his opportunity for review under this subpart. In the case of a determination under paragraph (a) (3) of this section, the failure of an agency or a Regional Office to approve a grantee's request within a reasonable time, which shall be no longer than 30 days after the postmark date of the grantee's request shall be deemed by the review committee a notification for purposes of this paragraph.

(c) Prior to submission to the Departmental Grant Appeals Board of an issue covered by paragraph (a) of this section, the grantee must exhaust the procedure set forth in § 50.406 of this subpart. § 50.405 Review committees.

The head of each agency or his designee shall appoint review committees for reviewing appeals of adverse determinations made by Headquarters officials in his agency. For adverse determinations made by Regional Offices the Assistant Secretary for Health or his designee shall appoint review committees. A minimum of three employees shall be appointed (one of whom shall be designated as

(a) A grantee with respect to whom an adverse determination described in § 50.404(a) above has been made and who desires a review of such determination must submit a request for such review to the head of the appropriate agency or his designee (or in the case of Regional Office determinations to the Assistant Secretary for Health or his designee) no later than thirty (30) days after the written notification of such determination is received: Provided, That (1) an extension of time may be granted for good cause shown, and (2) where the determination is one described in § 50.404 (a) (3), the grantee's request for review must be postmarked no later than 90 days after the postmark date of the grantee's request for permission to incur an expenditure.

(b) Although the request for review need not follow any prescribed form, it shall contain a full statement of the grantee's position with respect to the determination being appealed and the pertinent facts and reasons in support of such position. Except in the case of a determination described in the last sentence of § 50.404(b), the grantee shall attach to this submission a copy of the notice of adverse determination.

(c) When a request for review has been filed under this subpart with respect to a determination, no action may be taken by the awarding agency or Regional Office pursuant to such determination until such request has been disposed of, except that the filing of the request shall not affect the authority which the agency or Regional Office may have to suspend assistance or otherwise to withhold or defer payments under the grant during proceedings under this subpart.

(d) Upon receipt of such a request, the head of the agency or his designee (or, if the adverse determination was made in a Regional Office, the Assistant Secretary for Health or his designee) will immediately notify the office responsible for the adverse determination.

(e) The agency or Regional Office involved will provide the review committee appointed pursuant to § 50.405 with copies of all background materials (including application, award, summary and statements, and correspondence) any additional information available.

(f) The review committee may, at its discretion, invite the grantee, the agency or Regional Office staff, or both to discuss with the review committee pertinent issues, and to submit such additional information as it deems appropriate.

(g) Based on its review, the review committee will prepare a written response to be signed by the chairman. This written response shall be sent to the grantee, with a copy to the official responsible for the adverse determination. If such response is adverse to the grantee's position, the correspondence shall state the grantee's right to apeal to the Departmental Grant Appeals Board, pursuant to 45 CFR Part 16.

Subpart E-Maximum Allowable Cost for

Drugs

AUTHORITY: Secs. 215, 58 Stat. 690, as amended (42 U.S.C. 216).

SOURCE: 40 FR 34514, Aug. 15, 1975, unless otherwise noted.

§ 50.501 Applicability.

This subpart is applicable to programs or projects for health services which are supported in whole or in part by Federal financial assistance, whether by grant or contract, administered by the Public Health Service. It applies to Federal funds and to non-Federal funds which are required to be expended as a condition to receiving Federal funds under such programs or projects.

§ 50.502 Definitions.

As used in this subpart:

(a) "Public Health Service" means the Office of the Assistant Secretary for Health, Health Services Administration, Health Resources Administration, National Institutes of Health, Center for Disease Control, Alcohol, Drug Abuse and Mental Health Administration, Food and Drug Administration, and all of their constituent agencies.

(b) "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.

(c) "Program funds" means (1) Federal funds provided through grant or contract to support a program or project covered by § 50.501, and (2) any nonFederal funds that are required as a condition of such grant or contract to be expended to carry out such program or project.

(d) "Provider" means one who furnishes medical or pharmaceutical services or supplies for which program funds may be expended under any of the programs or projects described in § 50.501.

(e) "Acquisition cost” means the price generally and currently paid by providers for a drug marketed or sold by a particular formulator or labeler in the package size of drug most frequently purchased by providers, as determined by the Secretary on the basis of drug price information furnished by the Department. § 50.503 Policy.

It is the policy of the Secretary that program funds which are utilized for the acquisition of drugs be expended in the most economical manner feasible. In furtherance of this policy, the Secretary has established, in 45 CFR Part 19, a procedure for determining the Maximum Allowable Cost for drugs which are purchased with program funds.

§ 50.504 Allowable cost of drugs.

(a) The maximum amount which may be expended from program funds for the acquisition of any drug shall be the lowest of

maximum

(1) the allowable cost (MAC) of the drug, if any, established in accordance with 45 CFR Part 19, plus a dispensing fee determined by the Secretary in accordance with paragraph (b) of this section, to be reasonable;

(2) the acquisition cost of the drug plus a dispensing fee determined by the Secretary, in accordance with paragraph (b) of this section, to be reasonable; or

(3) the provider's usual and customary charge to the public for the drug; Provided, That the MAC established for any drug shall not apply to a brand of that drug prescribed for a patient which the prescriber has certified, in accordance with paragraph (c) of this section, is medically necessary for that patient; And Provided further, That where compensation for drug dispensing is included in other costs allowable under the applicable program statute and regulations, the terms and conditions of the grant or contract, and the applicable

66-019-76-11

cast principles prescribed in 45 CFR Part 74, no separate dispensing fee will be recognized.

(b) In determining whether a dispensing fee is reasonable, the Secretary will take into account (1) cost components such as overhead, professional services, and profits, (2) payment practices of third-party payment organizations, including other Federal programs such as titles XVIII and XIX of the Social Security Act; and (3) any surveys by States, universities or others of costs of pharmacy operations and the fees charged in the particular area.

(c) a certification by a prescriber, pursuant to paragraph (a) of this section, that a brand of drug is medically necessary for a particular patient shall be in the prescriber's own handwriting, in such form and manner as the Secretary may prescribe. An example of an acceptable certification is the notation "brand necessary". A procedure for checking a box on a form will not constitute an acceptable certification.

APPENDIX A-PUBLIC HEALTH PROGRAMS (1) Section 225 of the Public Health Service Act (42 U.S.C. 2428).

(2) Section 301 of the Public Health Service Act (42 U.S.C. 241).

(3) Section 303 of the Public Health Service Act (42 U.S.C. 242a).

(4) Section 304 of the Public Health Service Act (42 U.S.C. 242b).

(5) Section 306 of the Public Health Service Act (42 U.S.C. 242d).

(6) Section 308 of the Public Health Service Act (42 U.S.C. 2421).

(7) Section 309 of the Public Health Service Act (42 U.S.C. 242g).

(8) Section 310 of the Public Health Service Act (42 U.S.C. 242h).

(9) Section 314 (b), (c), and (e) of the Public Health Service Act (42 U.S.C. 246 (b), (c), and (e)).

(10) Section 317 of the Public Health Service Act (42 U.S.C. 247b).

(11) Section 318 of the Public Health Service Act (42 U.S.C. 247c).

(12) Section 393 of the Public Health Service Act (42 U.S.C. 280b-3).

(13) Section 394 of the Public Health Service Act (42 U.S.C. 280b-4).

(14) Section 395 of the Public Health Service Act (42 U.S.C. 280b-5, 6).

(15) Section 396 of the Public Health Service Act (42 U.S.C. 280b-7).

(18) Section 397 of the Public Health Service Act (42 U.S.C. 280b-8).

(17) Section 398 of the Public Health Service Act (42 U.S.C. 280b-9).

(18) Section 402 of the Public Health Service Act (42 U.S.C. 280b-9).

(19) Section 407 of the Public Health Service Act (402 U.S.C. 286a).

(23) Section 431 of the Public Health Service Act (42 U.S.C. 289a).

(24) Section 433 of the Public Health Service Act (42 U.S.C. 289c).

(25) Section 484 of the Public Health Service Act (42 U.S.C. 2890-1).

(26) Section 444 of the Public Health Service Act (42 U.S.C. 289g).

(27) Section 453 of the Public Health Service Act (42 U.S.C. 289k).

(28) Section 704 of the Public Health Service Act (42 U.S.C. 292c).

(29) Section 720 of the Public Health Service Act (42 U.S.C. 293).

(30) Section 767 of the Public Health Service Act (42 U.S.C. 295e-1).

(31) Section 768 of the Public Health Service Act (42 U.S.C. 295e-2).

(82) Section 769 of the Public Health Service Act (42 U.S.C. 295e-3).

(83) Section 769A of the Public Health Service Act (42 U.S.C. 295e-4).

(34) Section 771 of the Public Health Service Act (42 U.S.C. 2951-1).

(85) Section 772 of the Public Health Service Act (42 U.S.C. 2951-2).

(86) Section 773 of the Public Health Service Act (42 U.S.C. 2951-3).

(87) Section 774 of the Public Health Service Act (42 U.S.C. 2951-4).

(88) Section 784 of the Public Health Service Act (§ 106(c) Public Law 92–157). (89) Section 791 of the Public Health Service Act (4 U.S.C. 295h).

(40) Section 792 of the Public Health Service Act (42 U.S.C. 295h-1).

(41) Section 793 of the Public Health Service Act (42 U.S.C. 295h-2).

(42) Section 794A of the Public Health Service Act (42 U.S.C. 295h-3a).

(43) Section 794B of the Public Health Service Act (42 U.S.C. 295h-3b).

(44) Section 794C of the Public Health Service Act (42 U.S.C. 295h-3c).

(45) Section 802 of the Public Health Service Act (42 U.S.C. 296a).

(46) Section 805 of the Public Health Service Act (42 U.S.C. 296d).

(47) Section 810 of the Public Health Service Act (42 U.S.C. 2961).

(48) Section 821 of the Public Health Service Act (42 U.S.C. 297).

(49) Section 868 of the Public Health Service Act (42 U.S.C. 298c-7).

(50) Section 903 of the Public Health Service Act (42 U.S.C. 299c).

(51) Section 904 of the Public Health Service Act (42 U.S.C. 299d).

(52) Section 1001 of the Public Health Service Act (42 U.S.C. 300).

(53) Section 1003 of the Public Health Service Act (42 TT.S.C. 300a-1).

(54) Sections 1004 and 1005 of the Public Health Service Act (42 U.S.C. 300a-2, 800a-8).

(55) Section 1101 of the Public Health Service Act (42 U.S.C. 300b).

(56) Section 1102 of the Public Health Service Act (42 U.S.C. 300b-1).

(57) Section 1111(a)(1) of the Public Health Service Act (42 U.S.C. 300c(a) (1)).

(58) Section 1111(a)(2) of the Public Health Service Act (42 U.S.C. 300c (a) (2)).

(59) Section 220 of the Community Mental Health Centers Act (42 U.S.C. 2688).

(60) Section 241 of the Community Mental Health Centers Act (42 U.S.C. 26881).

(61) Section 242 of the Community Mental Health Centers Act (42 U.S.C. 2688g).

(62) Section 243 of the Community Mental Health Centers Act (42 U.S.C. 2688h).

(63) Section 246 of the Community Mental Health Centers Act (42 U.S.C. 26881-1).

(64) Section 247 of the Community Mental Health Centers Act (42 U.S.C. 26881-2).

(65) Section 251 of the Community Mental Heath Centers Act (42 U.S.C. 2688k).

(66) Section 252 of the Community Mental Health Centers Act (42 U.S.C. 26881).

(67) Section 253 of the Community Mental Health Centers Act (42 U.S.C. 26881-1).

(68) Section 256 of the Community Mental Health Centers Act (42 U.S.C. 2688n-1).

(69) Section 264 of the Community Mental Health Centers Act (42 U.S.C. 2688r).

(70) Section 271 of the Community Mental Health Centers Act (42 U.S.C. 2688u).

(71) Section 272 of the Community Mental Health Centers Act (42 U.S.C. 2688v).

(72) Section 410 of Public Law 92-255The Drug Abuse Office and Treatment Act of 1972 (21 U.S.C. 1177).

(73) Section 501 of the Coal Mine Health and Safety Act (30 U.S.C. 951).

(74) Section 20 of the Occupational Health and Safety Act (29 U.S.C.669).

(75) Section 21 of the Occupational Health and Safety Act (29 U.S.C. 670).

(76) Section 101 of the Lead Based Paint Poisoning Prevention Act (42 U.S.C. 4801). (77) Section 201 of the Lead Based Paint Poisoning Prevention Act (42 U.S.C. 4811). (78) Section 776 of the Public Health Service Act (42 U.S.C. 2951-6).

(79) Section 1202 of the Public Health Service Act (42 U.S.C. 300d-1).

(80) Section 1203 of the Public Health Service Act (42 U.S.C. 300d-2).

(81) Section 1204 of the Public Health Service Act (42 U.S.C. 300d-3).

(82) Section 1205 of the Public Health Service Act (42 U.S.C. 300d-4).

(83) Section 1303 of the Public Health Service Act (42 U.S.C. 300e-2).

(84) Section 1304 of the Public Health Service Act (42 U.S.C. 800e-3).

(85) Section 503 (2) of the Social Security Act (42 U.S.C. 703 (2)).

(86) Section 504 (2) of the Social Security Act (42 U.S.C. 704(2)).

(87) Section 511 of the Social Security Act (42 U.S.C. 711).

(88) Section 512 of the Social Security Act (42 U.S.C. 712).