35242 Federal Register / Vol. 63, No. 124 / Monday, June 29, 1998 / Notices

for the State AIDS Drug Assistance

Programs that receive assistance under

Title XXVI of the PHS Act.

(C) The State ADAP Section 340B

Rebate Option

In light of the comments and

responses set forth above, the guideline

for the state ADAP 340B rebate option

is as follows: HRSA recognizes rebates

obtained by the State ADAPs or their

components that equal or exceed the

340B discount provided by the statutory

ceiling price as a method of

participating in the 340B program,

subject to compliance with other

requirements for participation. Standard

business practices, such as those

reflected in the Medicaid Rebate

Program and current voluntary

manufacturer rebate programs

(consistent with the requirements of

section 340B and all program guidance

published in the Federal Register) are

appropriate for the development of

rebate contracts and agreements

between State ADAPs and

manufacturers. State ADAPs or their

components and manufacturers wishing

technical assistance in developing a

rebate program and rebate agreements

should contact HRSA’s Office of Drug

Pricing at (301) 594–4353 or (800) 628–

6297.

State ADAPs or their components

determined to be eligible for

participation in the State ADAP 340B

rebate program will be listed on the

Office of Drug Pricing (ODP) Electronic

Data Retrieval System (EDRS) on the

first quarterly update of the EDRS which

occurs 30 days following the effective

date of this Federal Register notice.

State ADAPs or their components listed

on this update may submit rebate claims

to participating manufacturers for

covered drugs that are purchased

starting 30 days after the date of this

final notice publication. State ADAPs or

their components listed on a later EDRS

update may claim rebates only on

purchases made after their effective date

of listing on the EDRS.

Section 340B(a)(5)(A) reflects

Congressional recognition that there is a

potential for a covered drug purchased

by a covered entity at the 340B discount

price to be subject to a Medicaid rebate,

if the drug is reimbursed by the

Medicaid program. All program

guidance regarding the prevention of

such duplicate discounting must be

followed by ADAPs participating in the

rebate program as well as those

participating in the discount program.

Guidance regarding billing State

Medicaid Agencies at actual acquisition

cost plus a dispensing fee (established

by the State Medicaid agency) and the

prevention of duplicate discounting was

published in the Federal Register on

May 7, 1993 (58 FR 27293) entitled

‘‘Duplicate Discounts and Rebates on

Drug Purchases.’’ Further guidance was

published in the Federal Register on

May 13, 1994 (59 FR 25112). State

ADAPs may find it necessary to work

with State Medicaid Agencies to adapt

these guidelines to meet the unique

circumstances of each individual State,

such as provisions permitting

retroactive reimbursement of drug

purchases while Medicaid eligibility

was pending.

The HRSA is sensitive to concerns

about diversion of covered drugs to

individuals who are not patients of the

covered entities. Guidelines have been

issued to minimize this potential, and

manufacturers have available to them

specified remedies if they believe

diversion has occurred. These

guidelines and remedies will apply fully

to drugs purchased under a rebate

option, and we believe that instituting

rebates will not increase the potential

for diversion.

Dated: May 22, 1998.

Claude Earl Fox,

Administrator.

[FR Doc. 98–17142 Filed 6–26–98; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Notice of Establishment of the

Secretary’s Advisory Committee on

Genetic Testing

Pursuant to the Federal Advisory

Committee Act, as amended (5 U.S.C.

Appendix 2), the Director, National

Institutes of Health (NIH), announces

the establishment of the Secretary’s

Advisory Committee on Genetic Testing

(Committee).

This Committee will advise the

Secretary of Health and Human Services

on all aspects of the development and

use of genetic tests, including making

recommendations on policies and

procedures for the safe and effective

incorporation of genetic technologies

into health care; assessing the

effectiveness of existing and future

measures for oversight of genetic tests;

and identifying research needs related

to the Committee’s purview.

Unless renewed by appropriate action

prior to its expiration, the charter for the

Secretary’s Advisory Committee on

Genetic Testing will expire two years

from the date of establishment.

Dated: June 22, 1998.

Harold Varmus,

Director, National Institutes of Health.

[FR Doc. 98–17168 Filed 6–26–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute; Notice of

Closed Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meeting.

The meeting will be closed to the public

in accordance with the provisions set forth in

sections 552b(c)(4) and 552b(c)(6), Title 5

U.S.C., as amended. The grant applications

and the discussions could disclose

confidential trade secrets or commercial

property such as patentable material, and

personal information concerning individuals

associated with the grant applications, the

disclosure of which would constitute a

clearly unwarranted invasion of personal

privacy.

Name of Committee: National Cancer

Institute Initial Review Group Subcommittee

D—Clinical Studies.

Date: August 2–5, 1998.

Time: 7:00 p.m. to 6:00 p.m.

Agenda: To review and evaluate grant

applications.

Place: Holiday Inn—Silver Spring, 8777

Georgia Avenue, Silver Spring, MD 20910.

Contact Person: Martin H. Goldrosen, PhD,

Scientific Review Administrator, Grants

Review Branch, Division of Extramural

Activities, National Cancer Institute, National

Institute of Health, 6130 Executive

Boulevard, Rm. 635F, Rockville, MD 20852–

7405, (301) 496–7930.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.392, Cancer Construction;

93.393, Cancer Cause and Prevention

Research; 93.394, Cancer Detection and

Diagnosis Research; 93.395, Cancer

Treatment Research; 93.396, Cancer Biology

Research; 93.397, Cancer Centers Support;

93.398, Cancer Research Manpower; 93.399,

Cancer Control, National Institutes of Health,

HHS)

Dated: June 23, 1998.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 98–17172 Filed 6–26–98; 8:45 am]

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