Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Notices 44977

Government, and State, Local or Tribal

Government; Number of Respondents:

7,000; Total Annual Responses: 7,000;

Total Annual Hours Requested: 1.

It should be noted for the HCFA–R–

142, OMB 0938–0667, that based on

industry input and HCFA analysis, the

applicability and burden associated

with the information collection

requirements (ICR) captured in this

submission have been adjusted to

properly reflect the degree of burden

associated with this collection. In

particular, the ICRs captured in this

submission have been determined to be

either exempt or the burden has been

deemed usual and customary in

accordance with the 1995 PRA. In order

to comply and properly reflect the Act,

HCFA assigned a token one-hour of

burden for this submission.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, E-mail your request,

including your address and phone

number, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the OMB desk officer: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: August 18, 1997.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Information

Technology Investment Management Group,

Division of HCFA Enterprise Standards.

[FR Doc. 97–22451 Filed 8–22–97; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

Periodically, the Health Resources

and Services Administration (HRSA)

publishes abstracts of information

collection requests under review by the

Office of Management and Budget, in

compliance with the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35). To request a copy of the

clearance requests submitted to OMB for

review, call the HRSA Reports

Clearance Office on (301)–443–1129.

The following request has been

submitted to the Office of Management

and Budget for review under the

Paperwork Reduction Act of 1995:

Proposed Project: Drug Pricing

Program Reporting Requirements (OMB

No. 0915–0176)—Extension and

Revision—Section 602 of Public Law

102–585, the Veterans Health Care Act

of 1992, enacted section 340B of the

Public Health Service Act (PHS Act),

Limitation on Prices of Drugs Purchased

by Covered Entities. Section 340B

provides that a manufacturer who sells

covered outpatient drugs to eligible

entities must sign a pharmaceutical

pricing agreement with the Secretary of

Health and Human Services in which

the manufacturer agrees to charge a

price for covered outpatient drugs that

will not exceed an amount determined

under a statutory formula.

Covered entities which choose to

participate in the section 340B drug

discount program must comply with the

requirements of section 340B(a)(5) of the

PHS Act. Section 340B(a)(5)(A)

prohibits a covered entity from

accepting a discount for a drug that

would also generate a Medicaid rebate.

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 Drug Pricing Program

has developed a dispute resolution

process for manufacturers and covered

entities as well as manufacturer

guidelines for audit 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 the

provisions of section 340B. If the

problem cannot be resolved, the

manufacturer must then submit an audit

work plan describing the audit to the

HRSA Office of Drug Pricing Program

for review. The manufacturer will

submit copies of the audit report to the

HRSA Office of Drug Pricing Program

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. As

a result of public comment on the draft

audit guidelines, one of the

requirements has changed. The

manufacturer is no longer required to

submit a request for an audit of a

covered entity to the HRSA Office of

Drug Pricing Program. Instead, the

manufacturer must notify the covered

entity in writing when it believes the

covered entity has violated the

provisions of section 340B.

Dispute resolution guidelines:

Because of the potential for disputes

involving covered entities and

participating drug manufacturers, the

HRSA Office of Drug Pricing Program

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 Office of Drug Pricing

Program, 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 Office of Drug Pricing Program. 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 responsesHours/responseTotal burden hours

Audits:

Audit Notification of Entity 1 ............................................................... 2 1.0 2 4.0 8

Audit Workplan 1 ................................................................................ 1 1.0 1 8.0 8

Audit Report 1 .................................................................................... 1 1.0 1 1.0 1

Entity Response ................................................................................ 0 0.0 0 16.0 0
44978 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Notices

Reporting requirement Number of

respondents

Responses

per respondent

Total responsesHours/responseTotal burden hours

Dispute resolution:

Mediation Request ............................................................................. 5 1.0 5 8 40

Rebuttal ............................................................................................. 2 1.0 2 16 32

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

1Prepared by the manufacturers.

Recordkeeping requirement No. of recordkeepers

Hours of

recordkeeping

Total burden

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

The total burden is 94 hours.

Written comments and

recommendations concerning the

proposed information collection should

be sent within 30 days of this notice to:

Laura Oliven, Human Resources and

Housing Branch, Office of Management

and Budget, New Executive Office

Building, Room 10235, Washington,

D.C. 20503.

Dated: August 19, 1997.

Jane Harrison,

Acting Director, Divison of Policy Review and

Coordination.

[FR Doc. 97–22423 Filed 8–22–97; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Advisory Council; Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), announcement is

made of the following National

Advisory body scheduled to meet

during the month of September 1997:

Name: National Advisory Committee on

Rural Health

Dates and Time: September 15—September

17, 1997

Place: Radisson Barcelo Hotel Washington,

2121 P Street, NW., Washington, DC 20037,

Phone: (202) 293–3100, FAX: (202) 857–

0134.

The meeting is open to the public.

Agenda: The plenary session on Monday

morning September 15, will include a

presentation and discussion of the Child

Health Initiative and a presentation of the

Balanced Budget Amendment, followed by a

panel discussion on its implications for rural

health. Also to be on the agenda is an update

on rural AIDS issues. The latter part of the

afternoon will be spent with the Work

Groups discussing, in concurrent sessions,

what the Balanced Budget Amendment

means for rural health services, education,

and health care financing. Strategies for

addressing the issues will be explored on

Tuesday in concurrent Work Group sessions.

The final plenary session will be convened

on Wednesday, September 17, at 8:30 a.m.

During this session the Work Groups will

report on their activities and information

regarding the next agenda and future meeting

dates and places will be discussed. The

meeting will be adjourned at 12 Noon.

Anyone requiring information regarding

the subject Committee should contact Dena

S. Puskin, Executive Secretary, National

Advisory Committee on Rural Health, Health

Resources and Services Administration,

Room 9–05, Parklawn Building, 5600 Fishers

Lane, Rockville, Maryland 20857, Telephone

(301) 443–0835, FAX (301) 443–2803.

Persons interested in attending any portion

of the meeting should contact Ms. Arlene

Granderson or Lilly Smetana, Office of Rural

Health Policy, Health Resources and Services

Administration, Telephone (301) 443–0835.

Agenda Items are subject to change as

priorities dictate.

Dated: August 20, 1997.

Jane M. Harrison,

Committee Management Office, Health

Resources and Services Administration.

[FR Doc. 97–22552 Filed 8–22–97; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Meeting of the National Advisory

Council for Human Genome Research

Pursuant to Pub. L. 92–463, notice is

hereby given of the meeting of the

National Advisory Council for Human

Genome Research, National Human

Genome Research Institute, September

11–12, 1997, Holiday Inn, 5520

Wisconsin Avenue, Chevy Chase, MD.

This meeting will be open to the

public on Thursday, September 11, 8:30

a.m. to approximately 3 p.m. to discuss

administrative details or other issues

relating to committee activities.

Attendance by the public will be limited

to space available.

In accordance with the provisions set

forth in secs. 552b(c)(4) and 552b(c)(6),

Title 5, U.S.C. and sec. 10(d) of Pub. L.

92–463, the meeting will be closed to

the public on September 11, from 3 p.m.

to recess and on September 12, from

8:30 a.m. to adjournment, for the

review, discussion and evaluation of

individual grant applications. The

applications and the discussions could

reveal confidential trade secrets or

commercial property such as patentable

material, and personal information

concerning individuals associated with

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Dr. Elke Jordan, Deputy Director,

National Human Genome Research

Institute, National Institutes of Health,

Building 31, Room 4B09, Bethesda,

Maryland 20892, (301) 496–0844, will

furnish the meeting agenda, rosters of

Committee members and consultants,

and substantive program information

upon request.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

contact Ms. Jane Ades, (301) 594–0654,

two weeks in advance of the meeting.

This notice is being published less

than 15 days prior to the meeting due

to the urgent need to meet timing

limitations imposed by the review and

funding cycles.

(Catalog of Federal Domestic Assistance

Program No. 93.172, Human Genome

Research)

Dated: August 19, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–22545 Filed 8–22–97; 8:45 am]

BILLING CODE 4140–01–M