Federal Register / Vol. 62, No. 181 / Thursday, September 18, 1997 / Notices 49015

Specifically, Mr. Leonhard (1)

fabricated experimental records and

falsely represented them to his

supervisor as being results obtained

from multiple electrophysiological

screening sessions conducted on eight

animals; and (2) fabricated two surgical

records as evidence of experimental

preparations (implantation of

indwelling electrodes) on two animals,

which in fact had not been done. The

experimental records did not appear in

any publications.

Mr. Leonhard has accepted the ORI

finding and has entered into a Voluntary

Exclusion Agreement with ORI in which

he has voluntarily agreed, for the three

(3) year period beginning September 8,

1997:

(1) To exclude himself from serving in

any advisory capacity to the Public

Health Service (PHS), including but not

limited to service on any PHS advisory

committee, board, and/or peer review

committee, or as a consultant; and

(2) That any institution that submits

an application for PHS support for a

research project on which Mr.

Leonhard’s participation is proposed or

which uses him in any capacity on PHS

supported research or that submits a

report of PHS-funded research in which

he is involved must concurrently submit

a plan for supervision of his duties to

the funding agency for approval. The

supervisory plan must be designed to

ensure the scientific integrity of Mr.

Leonhard’s research contribution. The

institution also must submit a copy of

the supervisory plan to ORI.

No scientific publications were

required to be corrected as part of this

Agreement.

FOR FURTHER INFORMATION CONTACT:

Acting Director, Division of Research

Investigations, Office of Research

Integrity, 5515 Security Lane, Suite 700,

Rockville, MD 20852, (301) 443–5330.

Chris B. Pascal,

Acting Director, Office of Research Integrity.

[FR Doc. 97–24808 Filed 9–17–97; 8:45 am]

BILLING CODE 4160–17–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Biological

Response Modifiers Advisory

Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on October 17, 1997, 8 a.m. to 5:30

p.m.

Location: Holiday Inn, Ballroom, Two

Montgomery Village Ave., Gaithersburg,

MD.

Contact Person: Gail M. Dapolito or

Rosanna L. Harvey, Center for Biologics

Evaluation and Research (HFM–21),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852,

301–827–0314, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), code 12388.

Please call the Information Line for upto-date information on this meeting.

Agenda: During the morning session,

the committee will discuss Zenapax,

(dacliximab, a humanized monoclonal

antibody directed against the human

interleukin 2 receptor), Hoffmann-La

Roche. An indication is sought for the

prophylaxis of acute organ rejection as

part of an immunosuppressive regimen

for patients receiving cadaveric kidney

transplants. During the afternoon

session, the committee will discuss

Intron-A, (recombinant human

interferon, interferon alfa–2b), ScheringPlough Corp. An indication is sought for

the treatment of patients with hightumor burden, follicular non-Hodgkin’s

lymphoma, in conjunction with

combination chemotherapy.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by October 10, 1997. Oral

presentations from the public will be

scheduled between approximately 8

a.m. to 8:30 a.m., and 1 p.m. to 1:30

p.m. Time allotted for each presentation

may be limited. Those desiring to make

formal oral presentations should notify

the contact person before October 10,

1997, and submit a brief statement of

the general nature of the evidence or

arguments they wish to present, the

names and addresses of proposed

participants, and an indication of the

approximate time requested to make

their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C., app. 2).

Dated: September 9, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–24849 Filed 9–17–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Cardiovascular

and Renal Drugs Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on October 23, 1997, 8:30 a.m. to

5:30 p.m., and October 24, 1997, 9 a.m.

to 4 p.m.

Location: National Institutes of

Health, Clinical Center, Bldg. 10, Jack

Masur Auditorium, 9000 Rockville Pike,

Bethesda, MD.

Parking in the Clinical Center visitor

area is reserved for Clinical Center

patients and their visitors. If you must

drive, please use an outlying lot such as

Lot 41B. Free shuttle bus service is

provided from Lot 41B to the Clinical

Center every 8 minutes during rush

hour and every 15 minutes at other

times.

Contact Person: Joan C. Standaert,

Center for Drug Evaluation and Research

(HFD–110), 419–259–6211, or Danyiel

D’Antonio (HFD–21), 301–443–5455,

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12533. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On October 23, 1997, the

committee will discuss basic statistical

considerations for the evaluation of

active control clinical trials, and new

drug application (NDA) 20–845, inhaled

nitric oxide (Ohmeda Pharmaceutical

Products Division, Inc.), for treatment of

primary pulmonary hypertension of the

newborn. On October 24, 1997, the

committee will discuss NDA 20–839,

PlavixTM (clopidogrel bisulfate, Sanofi
49016 Federal Register / Vol. 62, No. 181 / Thursday, September 18, 1997 / Notices

Pharmaceuticals, Inc.), for prevention of

vascular ischemic events in patients

with a history of symptomatic

atherosclerotic disease.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by October 9, 1997. Oral

presentations from the public will be

scheduled between approximately 8:30

a.m. and 9:30 a.m. on October 23, 1997.

Time allotted for each presentation may

be limited. Those desiring to make

formal oral presentations should notify

the contact person before October 9,

1997, and submit a brief statement of

the general nature of the evidence or

arguments they wish to present, the

names and addresses of proposed

participants, and an indication of the

approximate time requested to make

their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: September 10, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–24848 Filed 9–17–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food And Drug Administration

[Docket No. 97D–0383]

Draft Guidance for Industry on

Population Pharmacokinetics;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance for

industry entitled ‘‘Population

Pharmacokinetics.’’ This draft guidance

is intended to provide recommendations

regarding the use of population

pharmacokinetics in the drug

development process. It summarizes

scientific and regulatory issues that

should be addressed during the conduct

of population pharmacokinetic studies/

analyses.

DATES: Written comments may be

submitted on the draft guidance

document by November 17, 1997.

General comments on agency guidance

documents are welcome at any time.

ADDRESSES: Submit written requests for

single copies of the draft guidance for

industry entitled ‘‘Population

Pharmacokinetics’’ to the Drug

Information Branch (HFD–210), Center

for Drug Evaluation and Research, Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857. Send two

self-addressed adhesive labels to assist

that office in processing your request.

Submit written comments on the draft

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857. Request

and comments should be identified with

the docket number found in brackets in

the heading of this document. A copy of

the draft guidance and received

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Shiew-Mei Huang, Center for Drug

Evaluation and Research (HFD–850),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–594–5671, FAX 301–594–2503.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a draft

guidance for industry entitled

‘‘Population Pharmacokinetics.’’

Population pharmacokinetics is the

study of the sources and correlates of

variability in plasma drug

concentrations between individuals,

representative of those in whom the

drug will be used clinically when

clinically relevant dosage regimens are

administered. Certain

pathophysiological features of patients

can regularly alter dose-concentration

relationships. For example, renal failure

usually causes steady state drug

concentrations to be greater than those

of patients with normal renal function

receiving the same dosage of a drug

eliminated mostly by the kidney.

Population pharmacokinetics seeks to

discover which measurable

pathophysiologic factors cause changes

in the dose-concentration relationship

and to what degree so that appropriate

dosage can be recommended.

This draft guidance presents a

comprehensive overview of population

methods, including when to perform a

population study/analysis; how to

design and execute population

pharmacokinetic studies; how to handle

and analyze population

pharmacokinetic data; how to perform

internal and external validation of

population pharmacokinetic models;

and how to provide the appropriate

documentation for population

pharmacokinetic reports intended for

submission to the FDA.

This draft guidance represents the

agency’s current thinking on population

pharmacokinetics. It does not create or

confer any rights for or on any person

and does not operate to bind FDA or the

public. An alternative approach may be

used if such approach satisfies the

requirement of the applicable statute,

regulations, or both.

Interested persons may submit written

comments on the draft guidance to the

Dockets Management Branch (address

above). Two copies of any comments are

to be submitted, except that individuals

may submit one copy. Comments are to

be identified with the docket number

found in brackets in the heading of this

document. The draft guidance and

received comments may be seen in the

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

Monday through Friday.

An electronic version of this draft

guidance is available on the Internet at

http://www.fda.gov/cder/guidance/

index.htm.

Dated: September 12, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–24733 Filed 9–12–97; 4:34 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–201]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

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, has submitted to the Office of

Management and Budget (OMB) the

following proposal for the collection of

information. Interested persons are

invited to send comments regarding the

burden estimate or any other aspect of

this collection of information, including

any of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: Revision of a currently