Federal Register / Vol. 60, No. 102 / Friday, May 26, 1995 / Notices 27983

health care practitioners as a result of

medical malpractice actions or claims;

and (2) certain adverse actions taken

regarding the licenses and clinical

privileges of physicians and dentists.

Section 60.3 of these regulations should

be consulted for the definition of terms

used in this announcement.

Section 427(b)(4) of the Act authorizes

the establishment of fees for the costs of

processing requests for disclosure and of

providing such information. A final rule

published elsewhere in this issue of the

Federal Register amends the existing

Data Bank regulations (45 CFR part 60)

to remove regulatory restrictions on

allowable methods of payment to permit

the Secretary to announce alternate

payment methods through periodic

notice in the Federal Register. Section

60.12(c)(3) of the regulations states that

the Secretary shall announce the

method of payment of fees payable to

the Data Bank through periodic

announcement in the Federal Register.

In determining the method, the

Secretary shall consider efficiency,

effectiveness, and convenience for the

Data Bank users and the Department.

An assessment of the full operating

costs related to processing requests for

disclosure of Data Bank information as

required by the DHHS Appropriations

Act of 1994 (title II of Pub. L. 103–112,

dated October 21, 1993), as well as the

comparative costs of the various

methods for filing and paying for

queries has resulted in a decision to

expand the options for methods of

payment of Data Bank fees available to

users.

Effective upon publication, the

following methods of fee payment will

all be accepted by the Data Bank: credit

card, electronic funds transfer, check or

money order.

Allowable methods of fee payment

will be reviewed periodically and

revised as necessary, based upon

experience. Any changes in the methods

of fee payment accepted, and the

effective date of the change, will be

announced in the Federal Register.

Dated: March 14, 1995.

Ciro V. Sumaya,

Administrator.

[FR Doc. 95–12908 Filed 5–25–95; 8:45 am]

BILLING CODE 4160–15–P

Public Health Service

RIN 0905–ZA91

Notice Regarding Section 602 of the

Veterans Health Care Act of 1992 New

Drug Pricing

AGENCY: Public Health Service, HHS.

ACTION: Notice.

SUMMARY: 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.

The purpose of this notice is to inform

interested parties of the following

proposed guidelines relative to new

drug pricing. Public comment is invited.

DATES: The public is invited to submit

comments on the proposed guidelines

by June 26, 1995. After consideration of

the comments submitted, the Secretary

will issue the final guidelines.

FOR FURTHER INFORMATION CONTACT:

Marsha Alvarez, R. Ph., Director, Drug

Pricing Program, Bureau of Primary

Health Care, Health Resources and

Services Administration, 4350 East West

Highway, 10th Floor, Bethesda, MD

20814, Phone (301) 594–4353, FAX

(301) 594–4982.

SUPPLEMENTARY INFORMATION: The Office

of Drug Pricing has developed the

following guidelines to facilitate

program implementation:

New Drug Pricing

Calculation of the current quarter PHS

ceiling price for each covered outpatient

drug, as provided in section 340B(a)(1)

of the PHS Act, is based upon data

supplied to the Medicaid Drug Rebate

Program (i.e., average manufacturer

price, ‘‘AMP,’’ and Best Price, ‘‘BP’’).

The manufacturer calculates pricing

information for all of its covered

outpatient drugs and sends this pricing

data to the Health Care Financing

Administration (HCFA) within 30 days

after the end of the quarter. HCFA

provides PHS with the data necessary

for PHS to determine the ceiling price.

PHS determines the ceiling price based

on the rebate required under the

Medicaid drug rebate program. For

calendar year 1995, the Medicaid basic

rebate for single source and innovator

multiple source drugs is the greater of

15.2 percent of the AMP or the AMP

minus best price. In calendar year 1996

and thereafter, the rebate percentage

decreases to 15.1 percent. An additional

rebate must also be paid for single

source and innovator multiple source

drugs in the amount by which the

increase in the AMP exceeds the

increase in the Consumer Price Index—

Urban (CPI–U). The PHS ceiling price is

computed based on the combined basic

and additional rebate amounts under

the Medicaid program. For noninnovator multiple source drugs, the

rebate percentage is 11 percent of the

AMP.

For PHS pricing purposes, the

timeframe for reporting the pricing data

is a problem with respect to new drugs

because there is a two quarter lag for

new drug pricing information. For new

drugs, AMP is not available until after

the end of the first full quarter after the

day on which the drug was first sold.

For example, if a new drug was first

sold on January 15, the AMP for the first

full quarter would not be available until

after June 30. Manufacturers would

report the baseline AMP for this new

drug to HCFA by July 31.

This time lag is not a problem for the

State Medicaid agencies because they

bill manufacturers for a rebate after the

covered outpatient drugs are dispensed

to Medicaid beneficiaries. However, to

comply with the requirements of section

340B of the PHS Act, the PHS ceiling

price must be determined before the

covered outpatient drug is sold to the

covered entity.

Because there is no sales data for a

new drug from which to determine the

PHS ceiling price, the Office of Drug

Pricing is proposing to utilize a ceiling

price estimated by the manufacturer

until sufficient data is available to

calculate the AMP and BP of the new

drug. Any adjustments necessary to

reconcile differences between the

estimated and the actual ceiling price

will be in the form of a retroactive

charge back or rebate after the actual

ceiling price is established.

Because the manufacturer calculates

the PHS ceiling price using a two

quarter data lag, the manufacturer could

estimate the new drug ceiling price for

three quarters. For example, a new drug

that comes on the market in February

(January–March quarter) will have an

estimated PHS ceiling price for that

quarter. AMP and BP data will be

collected during the second quarter

(April–June) and submitted to HCFA

within 30 days after the third quarter

(July–September) for calculation of the

rebate percentage. Because pricing

needs to be transmitted to wholesalers

two weeks before the beginning of the

quarter, an accurate PHS ceiling price

for the third quarter will not be

available at that time. The manufacturer

must continue to estimate the PHS

ceiling price for the second and third

quarters, and will be able to calculate an

accurate PHS ceiling price for the fourth
27984 Federal Register / Vol. 60, No. 102 / Friday, May 26, 1995 / Notices

quarter (October–December). All

retroactive charge back or rebate

adjustments necessary to reconcile the

estimated ceiling price with the actual

ceiling price must be completed by the

end of the next quarter (i.e., March 31

of the next year).

Dated: May 10, 1995.

Ciro V. Sumaya,

Administrator, Health Resources and Services

Administration.

[FR Doc. 95–13031 Filed 5–25–95; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

Office of the Assistant Secretary for

Housing-Federal Housing

Commissioner

[Docket No. N–95–3762; FR–3613–N–03]

Announcement of Funding Awards for

Preservation Support Grants and

Partial Cancellation

AGENCY: Office of the Assistant

Secretary for Housing, HUD.

ACTION: Announcement of funding

awards and notice of partial

cancellation.

SUMMARY: The Notice of Funding

Availability (NOFA) published in the

Federal Register on June 14, 1994 (59

FR 30640), announced the availability of

up to $6 million in funding for

Preservation Support Grants. Eligible

applicants could apply in one of two

categories. First, Outreach and Training;

and second, Preservation Activity

Grants. This announcement notifies the

public of the cancellation of the

Preservation Activity Grant, in part,

because the language of the NOFA did

not allow HUD to select the types of

activities it wished to fund. The

Department would have been required

to fully fund applicants in rank order,

even if part or all of a high ranking

application contained activities that the

Department did not find appropriate for

the current needs of the Preservation

program.

In accordance with section

102(a)(4)(C) of the Department of

Housing and Urban Development

Reform Act of 1989, this announcement

notifies the public of funding decisions

made by the Department under the

Preservation Support Grants NOFA.

This announcement contains the names

and addresses of the award winners and

the amounts of the awards for the

Outreach and Training Grants.

FOR FURTHER INFORMATION CONTACT:

Kerry J. Mulholland, Acting Director,

Preservation Division, Department of

Housing and Urban Development, 451

Seventh Street, SW, Washington, DC

20410, telephone (202) 708–2300,

extension 2649. The TDD number for

the hearing impaired is (202) 708–9300.

(These are not toll-free numbers.)

SUPPLEMENTARY INFORMATION: The

Outreach and Training grant funds were

made available to resident-controlled or

community-based nonprofit

organizations with experience in

resident education and organizing to

conduct community-, city-, or countywide outreach to identify, organize and

deliver training to residents of eligible

low-income housing.

The 1995 awards announced in this

Notice were selected for funding based

on applications submitted pursuant to

the NOFA published in the Federal

Register on June 14, 1994 (59 FR 30640).

Applications were reviewed and

selected for funding on the basis of

selection criteria contained in that

Notice.

A total of $3.4 million was awarded

to 10 grantees who will aid residents in

organizing and in possibly pursuing the

purchase of developments where

affordable status is threatened. In

accordance with section 102(a)(4)(C) of

the Department of Housing and Urban

Development Reform Act of 1989 (Pub.

L. 101–235, approved December 15,

1989), the Department is publishing the

names, addresses, and amounts of those

awards as follows:

LOW INCOME HOUSING: PRESERVATION SUPPORT GRANTS FOR OUTREACH AND TRAINING

Tides Foundation/Coalition for Low Income Housing, 1388 Sutter Street, San Francisco, CA ................................................................. $358,500

Boston Affordable Coalition, 353 Columbus Avenue, Boston, MA ............................................................................................................. 450,000

Antidisplacement Project, 57 School Street, Springfield, MA ..................................................................................................................... 395,257

Metropolitan Tenants Organization, 2125 W. North Avenue, Chicago, IL .................................................................................................. 288,000

L. A. Center for Affordable Tenant Housing, 1296 N. Fairfax Avenue, Los Angeles, CA .......................................................................... 450,000

Ironbound Community Corporation, 95 Fleming Avenue, Newark, NJ ....................................................................................................... 144,000

Reston Interfaith Housing, 2329 Hunter Woods Plaza, Reston, VA ........................................................................................................... 216,000

Texas Tenants Union, 5405 East Grand Avenue, Dallas, TX .................................................................................................................... 297,000

Metropolitan Tenants Organization, 2125 West North Avenue, Chicago, IL .............................................................................................. 288,000

California Coalition for Rural Housing, 926 J Street, Suite 422, Sacramento, CA ..................................................................................... 450,000

New York State Tenant & Neighborhood Information Service, 248 Hudson Avenue, Albany, NY ............................................................ 450,000

Dated: May 17, 1995.

Nicolas Retsinas,

Assistant Secretary for Housing, Federal

Housing Commissioner.

[FR Doc. 95–12920 Filed 5–25–95; 8:45 am]

BILLING CODE 4210–27–M

Office of the Assistant Secretary for

Community Planning and

Development

[Docket No. N–95–1917; FR–3778–N–38]

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: May 26, 1995.

ADDRESSES: For further information,

contact David Pollack, Department of

Housing and Urban Development, Room

7254, 451 Seventh Street SW.,

Washington, DC 20410; telephone (202)

708–1234; TDD number for the hearingand speech-impaired (202) 708–2565,

(these telephone numbers are not tollfree), 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