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Draft Guidance for Industry on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availability of a draft guidance for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 This draft guidance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submitted on the draft guidance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single copies of the draft guidance for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
Federal Register / Vol. 62, No. 181 / Thursday, September 18, 1997 / Notices 49017

approved collection; Title of

Information Collection: Managed Care

Organization, Incentive Arrangement

Disclosure Form and Supporting

Regulations 42 CFR 417.479, 417.500,

434.44, 434.67, 434.70, 1003.100,

1003.101, 1003.103, 1003.106; Form

No.: HCFA–R–201 (OMB # 0938–0700)

; Use: These forms were created in an

extensive cooperative effort with the

American Association of Health Plans,

State Medicaid Agency representatives,

and the Medicaid Managed Care

Technical Advisory group to monitor

compliance with federal statute and

supporting regulations, governing

physician incentives under Medicare

and Medicaid managed care

organizations. The currently approved

forms and the revised forms being

submitted to OMB for approval are

available for inspection on the HCFA

web site, on the Internet, at http://

www.hcfa.gov; Frequency: Annually;

Affected Public: Business or other for

profit, not for profit institutions, state,

local or tribal government, and federal

government; Number of Respondents:

450; Total Annual Responses: 450; Total

Annual Hours: 45,000.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, or to

obtain the supporting statement and any

related forms, 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 designated at the

following address: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: September 10, 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. 97–24726 Filed 9–17–97; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–685, and HCFA–684 A–J]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

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, 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.

1. Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: End Stage Renal

Disease (ESRD) Network Semi-Annual

Cost Report Forms and Supporting

Regulations 42 CFR 405.2110 and 405.

2112; Form No.: HCFA–685 OMB #

0938–0657; Use: The Semi-annual cost

report enables HCFA to review specific

Network costs, compare costs between

Networks, and project future Network

costs. The reports are also used as an

early warning system to determine if a

Network is in danger of exceeding the

total cost of its contract. Frequency:

Semi-annually; Affected Public: Not-forprofit institutions; Number of

Respondents: 18; Total Annual

Responses: 36; Total Annual Hours:

108.

2. Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: End Stage Renal

Disease Network (ESRD) Business

Proposal Forms and Supporting

Regulations 42 CFR 405.2110 and

405.2112; Form No.: HCFA–684 through

684 A-J OMB # 0938–0658; Use: Current

End Stage Renal Disease (ESRD)

Networks and other bidders are required

to submit contract proposals to

participate as a HCFA sanctioned ESRD

Network. The business proposal forms

are used to satisfy HCFA’s need for

consistent, meaningful, and verifiable

data to evaluate contract proposals.

Frequency: Every three years; Affected

Public: Not-for-profit institutions;

Number of Respondents: 18; Total

Annual Responses: 36; Total Annual

Hours: 1,080.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, or to

obtain the supporting statement and any

related forms, 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 designated at the

following address: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: September 10, 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. 97–24764 Filed 9–17–97; 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: