§ 50.303 General rule.

Federal financial participation is not available for the performance of an abortion in programs or projects to which this subpart applies except under circumstances described in §§ 50.304 or 50.306.

[43 FR 4570, Feb. 2, 1978, as amended at 44 FR 61598, Oct. 26, 1979]

§ 50.304 Life of the mother would be endangered.

Federal financial participation is available in expenditures for an abortion when a physician has found, and so certified in writing to the program or project, that on the basis of his/her professional judgment, the life of the mother would be endangered if the fetus were carried to term. The certification must contain the name and address of the patient.

(Sec. 101, Pub. L. 95-205, 91 Stat. 1461, Dec. 9, 1977)

[43 FR 13868, July 21, 1978]

§ 50.305 [Reserved]

§ 50.306 Rape and incest.

Federal financial participation is available in expenditures for medical procedures performed upon a victim of rape or incest if the program or project has received signed documentation from a law enforcement agency or public health service stating:

(a) That the person upon whom the medical procedure was performed was reported to have been the victim of an incident of rape or incest;

(b) The date on which the incident occurred;

(c) The date on which the report was made, which must have been within 60 days of the date on which the incident occurred;

(d) The name and address of the victim and the name and address of the person making the report (if different from the victim); and

(e) That the report included the signature of the person who reported the incident.

Federal financial participation is also available in expenditures for abortions for victims of rape or incest under the circumstances described in

§ 50.304 without regard to the requirements of the preceding sentence.

(Sec. 101, Pub. L. 95-205, 91 Stat. 1461, Dec. 9, 1977)

[43 FR 13868, July 21, 1978, as amended at 44 FR 61598, Oct. 26, 1979]

§ 50.307 Documentation needed by programs or projects.

Federal financial participation is unavailable for the performance of abortions or other medical procedures otherwise provided for under §§ 50.304 and 50.306 if the program or project has paid without first having received the certifications and documentation specified in those sections.

[43 FR 4570, Feb. 2, 1978, as amended at 44 FR 61598, Oct. 26, 1979]

§ 50.308 Drugs and devices and termination of ectopic pregnancies.

Federal financial participation is available with respect to the cost of drugs or devices to prevent implantation of the fertilized ovum, and for medical procedures necessary for the termination of an ectopic pregnancy.

§ 50.309 Recordkeeping requirements.

Programs or projects to which this subpart applies must maintain copies of the certifications and documentation specified in §§ 50.304 and 50.306 for three years pursuant to the retention and custodial requirements for records at 45 CFR 74.20 et seq.

[43 FR 4570, Feb. 2, 1978, as amended at 44 FR 61598, Oct. 26, 1979]

§ 50.310 Confidentiality.

Information in the records or in the possession of programs or projects which is acquired in connection with the requirements of this subpart may not be disclosed in a form which permits the identification of an individual without the individual's consent except as may be necessary for the health of the individual or as may be necessary for the Secretary to monitor the activities of those programs or projects. In any event, any disclosure shall be subject to appropriate safeguards which will minimize the likelihood of disclosures of personal information in identifiable form.

Subpart D—Public Health Service Grant Appeals Procedure

AUTHORITY: Sec. 215, Public Health Service Act, 58 Stat. 690 (42 U.S.C. 216); 45 CFR 16.3(c)).

SOURCE: 39 FR 33782, Sept. 19, 1974, unless otherwise noted.

§ 50.401 Purpose.

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 subpart is applicable to all grant programs which are subject to 45 CFR Part 16 ("Procedures of the Departmental Grant Appeals Board") and which are administered by the Office of the Assistant Secretary for Health, the National Institutes of Health, the Health Resources and Services Administration, the Centers for Disease Control, Alcohol, Drug Abuse and Mental Health Administration, or the Food and Drug Administration, or by the Public Health Service Regional Offices. For the scope of 45 CFR Part 16, see Appendix A to such part.

[49 FR 38109, Sept. 27, 1984]

§ 50.403 Policy.

The Secretary of Health and Human Services 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 DHHS 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 procedure 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.

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 chairman) either on an ad hoc, case-by-case basis, or as regular members of review committees for such terms as may be designated. None of the members of the review committee reviewing any given appeal may be from the office of the responsible official whose determination is being appealed.

(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 statements, and correspondence) and 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 deems appropriate.

it

(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 appeal to the Departmental Grant Appeals Board, pursuant to 45 CFR Part 16.

Subpart E-Maximum Allowable Cost for Drugs

AUTHORITY: Sec. 215, Public Health Service Act, 58 Stat. 690 (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,

As used in this subpart:

(a) "Public Health Service" means the Office of the Assistant Secretary for Health, Health Resources and

Services Administration, National Institutes of Health, Centers 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 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.

(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 non-Federal 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.

[40 FR 34514, Aug. 15, 1975, as amended at 49 FR 38109, Sept. 27, 1984]

§ 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

(1) The maximum 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 cost 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

Subpart E-[Reserved]

Subpart F-Grants for Research, Demonstrations, and Public Information and Education for the Prevention and Control of Venereal Disease

Sec.

51b.601 To which programs does this subpart apply?

51b.602 Who is eligible for a grant under this subpart?

51b.603 What are the confidentiality requirements?

51b.604 What information is required in the application?

51b.605 How will grant applications be evaluated and the grants awarded? 51b.606 How can grant funds be used?

AUTHORITY: Secs. 317 and 318, Public Health Service Act, 92 Stat. 3574 and 3582 (42 U.S.C. 247b, 247c); sec. 1743 Pub. L. 9735, 95 Stat. 763 (31 U.S.C. 1243 note).