Federal Register / Vol. 62, No. 147 / Thursday, July 31, 1997 / Notices 41063

means to address problems associated

with the categories, including possible

alternatives to the categories for

communicating information on

reproductive and developmental

toxicity. The agency is specifically

seeking comment and data on the

following:

(1) The extent to which the category

designations are relied upon in making

decisions about drug therapy in

pregnant women and women of

childbearing potential and decisions

about inadvertent fetal exposure, the

extent to which such reliance may be

misplaced, and the extent to which such

reliance may have untoward public

health consequences;

(2) The extent to which current

pregnancy labeling (category

designation and accompanying narrative

text) is effective in communicating risk

of reproductive and developmental

toxicity;

(3) The extent to which current

pregnancy labeling may not adequately

address the range of issues that may

bear on decisions about drug therapy in

pregnant women and women of

childbearing potential and decisions

about inadvertent fetal exposure (e.g.,

indication-specific concerns, pregnancy

status, magnitude of exposure,

incidental exposure, chronic exposure,

timing of exposure);

(4) Additional information (data or

interpretation of data) that could be

included in pregnancy labeling to better

address the range of issues that bear on

decisions about drug therapy in

pregnant women and women of

childbearing potential and decisions

about inadvertent fetal exposure; and

(5) Options to improve

communication of reproductive and

developmental risk in labeling, which

could include alternatives to the

categories (both content and format

options) or efforts to make the current

category scheme and accompanying

narrative text more consistent and

informative.

The agency encourages individuals,

industry, consumer groups, health care

professionals, and researchers with

particular expertise in this area, as well

as other interested persons, to respond

to this notice. The agency strongly

encourages persons who cannot attend

the hearing to send information relevant

to the topics and questions listed above

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr., rm

1–23, Rockville, MD 20857. Two copies

of any comments are to be submitted,

except that individuals may submit one

copy. Comments are to be identified

with Docket No. 97N–0289. Received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday.

IV. Notice Of Hearing Under Part 15

The Commissioner of Food and Drugs

(the Commissioner) is announcing that

the public hearing will be held in

accordance with part 15. The presiding

officer will be the Commissioner or his

designee. The presiding officer will be

accompanied by a panel of Public

Health Service employees with relevant

expertise.

Persons who wish to participate in the

part 15 hearing must file a written or

facsimile notice of participation with

the Advisors and Consultants Staff by

August 28, 1997. To ensure timely

handling, the outer envelope or

facsimile cover sheet should be clearly

marked with Docket No. 97N–0289 and

the statement ‘‘Pregnancy Labeling

Hearing.’’ Groups should submit two

copies. The notice of participation

should contain the speaker’s name,

address, telephone number, FAX

number, title, business affiliation, if any,

a brief summary of the presentation, and

approximate amount of time requested

for the presentation.

The agency requests that persons or

groups having similar interests

consolidate their presentations and

present them through a single

representative. FDA will allocate the

time available for the hearing among the

persons who properly file notices of

participation. If time permits, FDA may

allow participation at the conclusion of

the hearing from interested persons

attending the hearing who did not

submit a written notice of participation.

After reviewing the notices of

participation and accompanying

information, FDA will schedule each

appearance and notify each participant

by mail, telephone, or FAX, of the time

allotted to the person and the

approximate time the person’s

presentation is scheduled to begin. The

hearing schedule will be available at the

hearing. After the hearing the schedule

will be placed on file in the Dockets

Management Branch (address above)

under Docket Number 97N–0289.

Under § 15.30(f), the hearing is

informal and the rules of evidence do

not apply. The presiding officer and any

panel members may question any

person during or at the conclusion of

their presentation. No other person

attending the hearing may question a

person making a presentation or

interrupt the presentation of a

participant.

Public hearings under part 15 are

subject to FDA’s guideline (part 10,

subpart C (21 CFR part 10, subpart C))

concerning the policy and procedures

for electronic media coverage of FDA’s

public administrative proceedings.

Under § 10.205, representatives of the

electronic media may be permitted,

subject, to certain limitations, to

videotape, film, or otherwise record

FDA’s public administrative

proceedings, including presentations by

participants. Representatives of the

electronic media are urged to provide

advance notice of their planned

attendance, to the identified contact

person for the hearing, so that their

needs for space and technical assistance

can be anticipated and accommodated.

The hearing will be transcribed as

required in § 15.30(b). Orders for copies

of the transcript can be placed through

the Dockets Management Branch

(address above).

Any disabled persons requiring

special accommodations in order to

attend the hearing should direct those

needs to the contact person listed above.

To the extent that the conditions for

the hearing, as described in this notice,

conflict with any provisions set out in

part 15, this notice acts as a waiver of

those provisions as specified in

§ 15.30(h).

To permit time for all interested

persons to submit data, information, or

views on this subject, the administrative

record will remain open following the

hearing until November 12, 1997.

Dated: July 23, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–20247 Filed 7-30-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Form #HCFA–R–200]

Emergency Clearance: Public

Information Collection Requirements

Submitted to the Office of Management

and Budget (OMB)

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services (DHHS), has submitted

to the Office of Management and Budget

(OMB) the following request for

Emergency review. We are requesting an

emergency review because the

collection of this information is needed

prior to the expiration of the normal

time limits under OMB’s regulations at
41064 Federal Register / Vol. 62, No. 147 / Thursday, July 31, 1997 / Notices

5 CFR Part 1320. The collection of

HEDIS 3.0 performance measures,

including the Health of Seniors and

Consumer Assessment of Health Plans

Study surveys is necessary for HCFA to

obtain the information necessary for the

proper oversight and administration of

the Medicare Managed Care Program.

The Agency cannot reasonably comply

with the normal clearance procedures

because public harm is likely to result

due to the delay in reporting of health

care quality measures. If emergency

clearance is not provided HCFA will be

forced to postpone the collection of this

data due to the timing of contracts and

their respective cycles.

HCFA is requesting OMB review and

approval of this collection by 08/15/97,

with a 180-day approval period. During

this 180-day period HCFA will publish

a separate Federal Register notice

announcing the initiation of an

extensive 60-day agency review and

public comment period on these

requirements. Then HCFA will submit

the requirements for OMB review and

an extension of this emergency

approval.

Type of Information Request: Revision

of a currently approved collection; Title

of Information Collection: HEDIS 3.0

(Health Plan Data and Information Set),

including the Health of Seniors and

Consumer Assessment of Health Plans

Study (CAHPS) surveys and supporting

regulations 42 CFR 417.470, and 42 CFR

417.126; Form Number: HCFA-R–200

(OMB #0938–0701); Use: HEDIS and

CAHPS will be used for 3 purposes: (1)

to provide summary comparative data to

the Medicare beneficiary to assist them

in choosing among health plans; (2) to

provide information to health plans for

internal quality improvement activity;

and (3) to provide HCFA, as purchaser,

information useful for monitoring

quality of and access to care provided

by the plans; Frequency: Annually;

Affected Public: Individuals or

Households, non-profit and for profit

HMOs which contract with HCFA to

provide managed health care to

Medicare beneficiaries; Number of

Respondents: 293,834; Total Annual

Responses: 293,834, Total Annual

Hours Requested: 181,520. To request

copies of the proposed paperwork

collections referenced above, call the

Reports Clearance Office on (410) 786–

1324. Written comments and

recommendations for the proposed

information collections should be sent

by 08/11/97 directly to the OMB Desk

Officer designated at the following

address: OMB Human Resources and

Housing Branch, Attention: Allison

Eydt, New Executive Office Building,

Room 10235, Washington, DC 20503.

Dated: July 23, 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. 97–20089 Filed 7–30–97; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of Inspector General

Program Exclusions: June 1997

AGENCY: Office of Inspector General,

HHS.

ACTION: Notice of program exclusions.

During the month of June 1997, the

HHS Office of Inspector General

imposed exclusions in the cases set

forth below. When an exclusion is

imposed, no program payment is made

to anyone for any items or services

(other than an emergency item or

service not provided in a hospital

emergency room) furnished, ordered or

prescribed by an excluded party under

the Medicare, Medicaid, Maternal and

Child Health Services Block Grant and

Block Grants to States for Social

Services programs. In addition, no

program payment is made to any

business or facility, e.g., a hospital, that

submits bills for payment for items or

services provided by an excluded party.

Program beneficiaries remain free to

decide for themselves whether they will

continue to use the services of an

excluded party even though no program

payments will be made for items and

services provided by that excluded

party. The exclusions have national

effect and also apply to all Executive

Branch procurement and nonprocurement programs and activities.

Subject, city, state Effective

date

Program-Related Convictions

ABRAMS, GARY, LA MIRADA, CA ......................................................................................................................................................... 07/07/97

ALCARE RESPIRATORY SERVICES, TAPPAN, NY ............................................................................................................................. 07/08/97

AMICO, MICHAEL A, STATEN ISLAND, NY .......................................................................................................................................... 07/08/97

ARNDT, SOU KWEI, GREENSBURG, PA .............................................................................................................................................. 07/10/97

BAILEY, ROBYN KAMILYAH, MAGNOLIA, AR ...................................................................................................................................... 07/06/97

BATES, ROBERT E, SILVER SPRING, MD ........................................................................................................................................... 07/07/97

BIXBY, ANGELA M, DOUGLASVILLE, GA ............................................................................................................................................. 07/10/97

BIXBY, HOWARD A, DOUGLASVILLE, GA ........................................................................................................................................... 07/10/97

CAMPBELL, JAMES A, VALLEY, AL ...................................................................................................................................................... 07/03/97

CARTER, STEPHEN, DALLAS, TX ........................................................................................................................................................ 07/06/97

CHATMAN, SABRINA D, LITHONIA, GA ............................................................................................................................................... 07/07/97

CHERRY-HAMMOND, CAPPRECCIA Y, ATLANTA, GA ....................................................................................................................... 07/02/97

COLLINS, STACEY BERNARD, TEXARKANA, TX ................................................................................................................................ 07/02/97

DAHDAH, CHARLES J, MIAMI, FL ......................................................................................................................................................... 07/02/97

DECIUTIIS, CHARLES E, BRONX, NY .................................................................................................................................................. 07/10/97

DIAZ, GEORGE, MIAMI, FL .................................................................................................................................................................... 07/01/97

DISMOND, MICHAEL L, ALBUQUERQUE, NM ..................................................................................................................................... 06/25/97

DODD, JUDY L, DAINGERFIELD, TX .................................................................................................................................................... 07/03/97

DOMINY, HERBERT K, JESUP, GA ....................................................................................................................................................... 07/10/97

DUHON, LESHIA A, LAFAYETTE, LA .................................................................................................................................................... 07/07/97

ELIKWU, PATRICK NGOZI, AUSTELL, GA ........................................................................................................................................... 07/01/97

ETIENNE, JEAN JOSEPH, RIVIERA BEACH, FL .................................................................................................................................. 07/10/97

FALEK, ALEXIS BROWN, PITTSBURGH, PA ........................................................................................................................................ 07/10/97

FRANKEL, STUART M, N MIAMI BEACH, FL ....................................................................................................................................... 07/10/97

GALES, BERNARD, ATLANTA, GA ........................................................................................................................................................ 07/10/97

GELIN, GUERRIER, LANTANA, FL ........................................................................................................................................................ 07/08/97

GENE KUTSCH, D.M.D., P.C., ALBANY, OR ........................................................................................................................................ 06/26/97