Federal Register / Vol. 65, No. 109 / Tuesday, June 6, 2000 / Notices 35949

Further, section 340B(a)(5)(B) prohibits

a covered entity from reselling or

otherwise transferring a discounted drug

to a person who is not a patient of the

entity.

Because of the potential for disputes

involving covered entities and

participating drug manufacturers, the

HRSA Office of Pharmacy Affairs (OPA)

has developed a dispute resolution

process for manufacturers and covered

entities as well as manufacturer

guidelines for audits of covered entities.

Audit guidelines: A manufacturer will

be permitted to conduct an audit only

when there is reasonable cause to

believe a violation of section

340B(a)(5)(A) or (B) has occurred. The

manufacturer must notify the covered

entity in writing when it believes the

covered entity has violated these

provisions of section 340B. If the

problem cannot be resolved, the

manufacturer must then submit an audit

work plan describing the audit and

evidence in support of the reasonable

cause standard to the HRSA OPA for

review. The office will review the

documentation to determine if

reasonable cause exists. Once the audit

is completed, the manufacturer will

submit copies of the audit report to the

HRSA OPA for review and resolution of

the findings, as appropriate. The

manufacturer will also submit an

informational copy of the audit report to

the HHS Office of Inspector General.

Dispute resolution guidelines:

Because of the potential for disputes

involving covered entities and

participating drug manufacturers, the

HRSA OPA has developed a dispute

resolution process which can be used if

an entity or manufacturer is believed to

be in violation of section 340B. Prior to

filing a request for resolution of a

dispute with the HRSA OPA, the parties

must attempt, in good faith, to resolve

the dispute. All parties involved in the

dispute must maintain written

documentation as evidence of a good

faith attempt to resolve the dispute. If

the dispute is not resolved and dispute

resolution is desired, a party must

submit a written request for a review of

the dispute to the HRSA OPA. A

committee appointed to review the

documentation will send a letter to the

party alleged to have committed a

violation. The party will be asked to

provide a response to or a rebuttal of the

allegations.

To date, there have been no requests

for audits, and no disputes have reached

the level where a committee review was

needed. As a result, the estimates of

annualized hour burden for audits and

disputes have been reduced to the level

shown in the table below.

Reporting requirement Number of

respondents

Responses

per

respondent

Total

responses

Hours/

response

Total burden

hours

Audits:

Audit Notification of Entity 1 ................................................. 2 1 2 4 8

Audit Workplan 1 .................................................................. 1 1 1 8 8

Audit Report 1 ....................................................................... 1 1 1 1 1

Entity Response ................................................................... 0 0 0 16 0

Dispute Resolution:

Mediation Request ............................................................... 5 1 5 8 40

Rebuttal ................................................................................ 2 1 2 16 32

Total .............................................................................. 9 1.2 11 8.1 89

1Prepared by the manufacturer

Recordkeeping requirement Number of

recordkeepers

Hours of

recordkeeping Total burden

Dispute records ............................................................................................................................ 10 .5 5

The total burden is 94 hours.

Send comments to Susan G. Queen,

HRSA Reports Clearance Officer, Room

14–33, Parklawn Building, 5600 Fishers

Lane, Rockville, MD 20857. Written

comments should be received within 60

days of this notice.

Dated: June 1, 2000.

James J. Corrigan,

Associate Administrator for Management and

Program Support.

[FR Doc. 00–14215 Filed 6–5–00; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Advisory Commission on Childhood

Vaccines; Request for Nominations for

Voting Members

AGENCY: Health Resources and Services

Administration, HHS.

ACTION: Notice.

SUMMARY: The Health Resources and

Services Administration (HRSA) is

requesting nominations to fill three

vacancies on the Advisory Commission

on Childhood Vaccines (ACCV). The

ACCV was established by Title XXI of

the Public Health Service Act (the Act),

as enacted by Public Law (Pub. L.) 99–

660 and as subsequently amended, and

advises the Secretary of Health and

Human Services (the Secretary) on

issues related to implementation of the

National Vaccine Injury Compensation

Program (VICP).

FOR FURTHER INFORMATION CONTACT: Ms.

Shelia Tibbs, Principal Staff Liaison,

Policy Analysis Branch, Division of

Vaccine Injury Compensation, at (301)

443–4036.

DATES: Nominations are to be submitted

by July 6, 2000.

ADDRESSES: All nominations are to be

submitted to the Director, Division of

Vaccine Injury Compensation, Bureau of

Health Professions, HRSA, Parklawn

Building, Room 8A–46, 5600 Fishers

Lane, Rockville, Maryland 20857.

SUPPLEMENTARY INFORMATION: Under the

authorities that established the ACCV,

viz., the Federal Advisory Committee

Act of October 6, 1972 (Pub. L. 92–463)

and section 2119 of the Act, 42 U.S.C.

300aa–19, as added by Public Law 99–

35950 Federal Register / Vol. 65, No. 109 / Tuesday, June 6, 2000 / Notices

660 and amended, HRSA is requesting

nominations for three voting members

of the ACCV.

The ACCV advises the Secretary on

the implementation of the VICP; on its

own initiative or as the result of the

filing of a petition, recommends changes

in the Vaccine Injury Table; advises the

Secretary in implementing the

Secretary’s responsibilities under

section 2127 regarding the need for

childhood vaccination products that

result in fewer or no significant adverse

reactions; surveys Federal, State, and

local programs and activities relating to

the gathering of information on injuries

associated with the administration of

childhood vaccines, including the

adverse reaction reporting requirements

of section 2125(b); advises the Secretary

on means to obtain, compile, publish,

and use credible data related to the

frequency and severity of adverse

reactions associated with childhood

vaccines; and recommends to the

Director, National Vaccine Program

Office, research related to vaccine

injuries which should be conducted to

carry out the VICP.

The ACCV consists of nine voting

members appointed by the Secretary as

follows: three health professionals, of

whom at least two are pediatricians,

who are not employees of the United

States, who have expertise in the health

care of children, the epidemiology,

etiology and prevention of childhood

diseases, and the adverse reactions

associated with vaccines; three members

from the general public, of whom at

least two are legal representatives

(parents or guardians) of children who

have suffered a vaccine-related injury or

death; and three attorneys, of whom at

least one shall be an attorney whose

specialty includes representation of

persons who have suffered a vaccinerelated injury or death, and one shall be

an attorney whose specialty includes

representation of vaccine

manufacturers. In addition, the Director

of the National Institutes of Health, the

Assistant Secretary for Health, the

Director of the Centers for Disease

Control and Prevention, and the

Commissioner of the Food and Drug

Administration (or the designees of such

officials) serve as nonvoting ex officio

members.

Specifically, HRSA is requesting

nominations for three voting members

of the ACCV representing: (1) a health

professional with special experience in

childhood diseases; (2) an attorney

whose specialty includes representation

of a vaccine manufacturer and (3) a

member from the general public.

Nominees will be invited to serve 3-year

terms beginning January 1, 2001, and

ending December 31, 2003.

Interested persons may nominate one

or more qualified persons for

membership on the ACCV. Nominations

shall state that the nominee is willing to

serve as a member of the ACCV and

appears to have no conflict of interest

that would preclude the ACCV

membership. Potential candidates will

be asked to provide detailed information

concerning such matters as financial

holdings, consultancies, and research

grants or contracts to permit evaluation

of possible sources of conflicts of

interest. A curriculum vitae or resume

should be submitted with the

nomination.

The Department of Health and Human

Services has special interest in assuring

that women, minority groups, and the

physically handicapped are adequately

represented on advisory committees and

therefore extends particular

encouragement to nominations for

appropriately qualified female,

minority, or physically handicapped

candidates.

Dated: May 30, 2000.

Claude Earl Fox,

Administrator, HRSA.

[FR Doc. 00–14041 Filed 6–5–00; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Advisory Commission on Childhood

Vaccines (ACCV); Notice of Meeting;

Cancellation

Federal Register Document 00–11251,

in the issue dated Friday, May 5, 2000,

on the following pages 26219–26220,

the Advisory Commission on Childhood

Vaccines meeting scheduled for June 7,

2000, has been cancelled due to lack of

quorum.

Dated: May 31, 2000.

Jane M. Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 00–14107 Filed 6–5–00; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Availability of Draft Comprehensive

Conservation Plan and Environmental

Assessment for Tewaukon National

Wildlife Refuge Complex, Cayuga, ND.

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Notice of availability.

SUMMARY: Pursuant to the Refuge

Improvement Act of 1997, the U.S. Fish

and Wildlife Service has published the

Tewaukon National Wildlife Refuge

Complex Draft Comprehensive

Conservation Plan and Environmental

Assessment. This Plan describes how

the FWS intends to manage the

Tewaukon NWR and Wetland

Management District for the next 10–15

years.

DATES: Submit written comments by

July 6, 2000. All comments need to be

addressed to Allison Banks, Refuge

Planner, Land Acquisition and Refuge

Planning, U.S. Fish and Wildlife

Service, P.O. Box 25486 DFC, Denver,

Colorado 80225.

ADDRESSES: A copy of the Plan may be

obtained by writing to U.S. Fish and

Wildlife Service, 9754 1431⁄2 Avenue

SE, Cayuga, ND 58013–9764; or

download from http://www.r6.fws.gov/

larp/.

FOR FURTHER INFORMATION CONTACT:

Allison Banks, U.S. fish and Wildlife

Service, P.O. Box 25486 DFC, Denver,

CO 80225, 303/236–8145 extension 626;

fax 303/236–4792.

SUPPLEMENTARY INFORMATION: Tewaukon

NWR Complex is located in southeast

North Dakota. Implementation of the

Plan will focus on adaptive resource

management of glaciated prairie

wetlands, tall and mixed grass prairie

grasslands, riparian woodlands, and

opportunities for compatible wildlifedependent recreation. Habitat

monitoring and evaluation will be

emphasized as the Plan is implemented.

Opportunities for compatible wildlifedependent recreation will continue to

be provided.

Dated: May 31, 2000.

Ralph O. Morgenweck,

Regional Director, Denver, Colorado.

[FR Doc. 00–14100 Filed 6–5–00; 8:45 am]

BILLING CODE 4310–55–M