Federal Register / Vol. 62, No. 45 / Friday, March 7, 1997 / Notices 10575

Proposed Project

Drug Pricing Program Reporting

Requirements (OMB No. 0915–0176)—

Extension, No Change—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

and/or audits involving covered entities

and participating drug manufacturers;

the HRSA Office of Drug Pricing

Program has developed an informal

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 submit a request for

an audit of a covered entity to the HRSA

Office of Drug Pricing Program. 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.

Dispute resolution guidelines:

Because of the potential for audit and

other disputes involving covered

entities and participating drug

manufacturers, the HRSA Office of Drug

Pricing Program has developed an

informal 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

responses

Hours/responseTotal burden

hours

Audits:

Audit request 1 ............................................................... 2 1 2 4 8

Audit workplan 1 ............................................................. 1 1 1 8 8

Audit report 1 .................................................................. 1 1 1 1 1

Entity response .............................................................. 1 1 1 16 16

Dispute resolution:

Mediation request .......................................................... 5 1 5 8 40

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

Total ........................................................................ 10 1.2 12 8.75 105

1Prepared by the manufacturer.

Recordkeeping requirement Number of

recordkeepers

Hours of

recordkeeping Total burden

Dispute records ........................................................................................ 8 .5 4

Send comments to Patricia Royston,

HRSA Reports Clearance Officer, Room

14–36, Parklawn Building, 5600 Fishers

Lane, Rockville, MD 20857. Written

comments should be received within 60

days of this notice.

Dated: February 26, 1997.

J. Henry Montes,

Director, Office of Policy and Information

Coordination.

[FR Doc. 97–5560 Filed 3–6–97; 8:45 am]

BILLING CODE 4160–15–P

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:

Customer Survey of Entities Eligible To

Participate in the Drug Pricing

Program—New

Section 602 of the Veterans Health

Care Act of 1992 enacted Section 340B

of the Public Health Service (PHS) Act,

‘‘Limitation of Prices of Drugs

Purchased by Covered Entities.’’ This

section provides that a manufacturer

that sells outpatient drugs to covered
10576 Federal Register / Vol. 62, No. 45 / Friday, March 7, 1997 / Notices

entities must agree to charge a price that

will not exceed the amount determined

under a statutory formula. The covered

entities—certain PHS grantees,

disproportionate share hospitals (DSHs),

and other selected entities, total

approximately 11,000 sites. Most of

these entities serve the economically

disadvantaged or medically uninsured.

The legislative intent of Section 340B is

‘‘to enable * * * certain Federallyfunded clinics to obtain lower prices on

the drugs that they provide to their

patients.’’

Because of the significant savings that

covered entities can realize if they are

able to access Section 602 pricing, it is

imperative to know the degree of

satisfaction with various aspects of the

program service and where

improvements can be made; and to

identify the barriers to access and what

changes can be made to reduce them.

The HRSA Office of Drug Pricing

Program (ODPP)administers the

program and has designed a survey with

questions that relate to the two areas

that they can modify readily: The

availability of information about the

program, and the design of the program.

The survey also includes questions on

the amount of savings realized by

participating entities, how the savings

are used, and factors affecting

satisfaction with savings. Participating

and non-participating entities will be

surveyed, and the results will be used

to guide program changes that will

increase customer satisfaction and

ultimately increase program

participation.

The estimated burden is as follows:

Respondents Number of

Respondents

Responses

per

respondent

Burden per

response

(hours)

Total burden

hours

Covered entities ................................................................................................ 1,508 1 .25 377

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: March 3, 1997.

J. Henry Montes,

Director, Office of Policy and Information

Coordination.

[FR Doc. 97–5559 Filed 3–6–97; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4124–N–28]

Federal Property Suitable as Facilities

To Assist the Homeless

AGENCY: Office of the Assistant

Secretary for Community Planning and

Development, HUD.

ACTION: Notice.

SUMMARY: This Notice identifies

unutilized, underutilized, excess, and

surplus Federal property reviewed by

HUD for suitability for possible use to

assist the homeless.

EFFECTIVE DATE: March 7, 1997.

FOR FURTHER INFORMATION CONTACT:

Mark Johnston, Department of Housing

and Urban Development, Room 7256,

451 Seventh Street SW, Washington, DC

20410; telephone (202) 708–1226; TDD

number for the hearing- and speechimpaired (202) 708–2565, (these

telephone numbers are not toll-free), or

call the toll-free Title V information line

at 1–800–927–7588.

SUPPLEMENTARY INFORMATION: In

accordance with the December 12, 1988

court order in National Coalition for the

Homeless v. Veterans Administration,

No. 88–2503–OG (D.D.C.), HUD

publishes a Notice, on a weekly basis,

identifying unutilized, underutilized,

excess and surplus Federal buildings

and real property that HUD has

reviewed for suitability for use to assist

the homeless. Today’s Notice is for the

purpose of announcing that no

additional properties have been

determined suitable or unsuitable this

week.

Dated: February 27, 1997.

Jacquie M. Lawing,

Deputy Assistant Secretary for Economic

Development.

[FR Doc. 97–5296 Filed 3–6–97; 8:45 am]

BILLING CODE 4210–29–M

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Information Collection Submitted to

the Office of Management and Budget

(OMB) for Extension Approval Under

the Paperwork Reduction Act

SUMMARY: The proposal for the

collection of information listed below

has been submitted to OMB for

extension approval under the provisions

of the Paperwork Reduction Act. Copies

of the proposed information collection

requirement and related forms and

explanatory material may be obtained

by contacting the Service Information

Collection Clearance Officer at the

address listed below.

DATES: Comments must be submitted on

or before April 7, 1997.

ADDRESSES: Comments and suggestions

on the requirement should be sent

directly to the Office of Information and

Regulatory Affairs; Office of

Management and Budget; Attention:

Interior Desk Officer; Washington, DC

20503; and a copy of the comments

should be sent to the Information

Collection Clearance Officer, U.S. Fish

and Wildlife Service, MS 224–ARLSQ;

1849 C Street, NW., Washington, DC

20240.

FOR FURTHER INFORMATION CONTACT:

Phyllis H. Cook, Service Information

Collection Clearance Officer, 703/358–

1943; 703/358–2269 (fax).

SUPPLEMENTARY INFORMATION: Comments

are invited on (1) whether the collection

of information is necessary for the

proper performance of the functions of

the agency, including whether the

information will have practical utility;

(2) the accuracy of the agency’s estimate

of the burden of the collection of

information; (3) ways to enhance the

quality, utility, and clarity of the

information to be collected; and, (4)

ways to minimize the burden of the

collection of information on

respondents.

Title: Federal Subsistence Hunt

Application and Permit and Designated

Hunter Permit Application and Permit.

OMB Approval Number: 1018–0075.

Service Form Number(s): 7–FS 1

(Federal Subsistence Hunt Application

and 7–FS 2 (Federal Subsistence

Application for the Designated Hunter).

Description and Use: The Alaska

National Interest Lands Conservation

Act (ANILCA) and Fish and Wildlife

Service regulations found in 50 CFR

(Code of Federal Regulations) 100,

require that persons engaged in taking

fish and wildlife must comply with

reporting provisions of the Federal

Subsistence Board. The harvest activity

must be reported. In many cases, a

special permit is required for the rural