Federal Register / Vol. 66, No. 93 / Monday, May 14, 2001 / Notices 24391

After consideration of the comments

received and revisions to the guidance,

a final draft of the guidance was

submitted to the ICH Steering

Committee and endorsed by the three

participating regulatory agencies in July

2000.

This guidance sets forth general

principles that are relevant to all

controlled trials and are especially

pertinent to the major clinical trials

intended to demonstrate drug (including

biological drug) efficacy. The guidance

includes a description of the five

principal types of controls, a discussion

of two important purposes of clinical

trials, and an exploration of the critical

issue of assay sensitivity, i.e., whether a

trial could have detected a difference

between treatments when there was a

difference, a particularly important

issue in noninferiority/equivalence

trials. In addition, the guidance presents

a detailed description of each type of

control and considers, for each: (1) Its

ability to minimize bias; (2) ethical and

practical issues associated with its use;

(3) its usefulness and the quality of

inference in particular situations; (4)

modifications of study design or

combinations with other controls that

can resolve ethical, practical, or

inferential concerns; and (5) its overall

advantages and disadvantages.

This guidance represents the agency’s

current thinking on the choice of control

group in clinical trials. 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

requirements of the applicable statutes

and regulations.

II. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the

guidance at any time. 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 guidance

and received comments may be seen in

the Dockets Management Branch

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

through Friday.

III. Electronic Access

Persons with access to the Internet

may obtain the document at http://

www.fda.gov/cder/guidance/index.htm

or http://www.fda.gov/cber/

publications.htm.

Dated: May 4, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–12026 Filed 5–11–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Peripheral and Central Nervous

System Drugs Advisory Committee;

Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: 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: Peripheral and

Central Nervous System Drugs Advisory

Committee.

General Function of the Committee: To

provide advice and recommendations to the

agency on FDA’s regulatory issues.

Date and Time: The meeting will be held

on June 6, 2001, 8 a.m. to 5 p.m..

Location: Holiday Inn, 8120 Wisconsin

Ave., Bethesda, MD.

Contact: Sandra Titus, Food and Drug

Administration, Center for Drug Evaluation

and Research, (HFD–21), 5600 Fishers Lane,

Rockville MD 20857, 301–827–7001, e-mail:

Tituss@ cder.fda.gov. FAX 301–827–6801, or

FDA Advisory Committee Information Line

at 1–800–741–8138 (301–443–0572 in the

Washington, DC area) code 12543. Please call

the Information Line for up-to-date

information on this meeting.

Agenda: On June 6, 2001, the committee

will consider the safety and efficacy of new

drug application (NDA) 21–196, Xyrem

(sodium oxybate, Orphan Medical, Inc.)

proposed to reduce the incidence of

cataplexy and to improve the symptom of

daytime sleepiness for persons with

narcolepsy. A main focus of the deliberations

will be on risk management issues.

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 May 29, 2001.

Oral presentations from the public will be

scheduled between approximately 1 p.m. and

2 p.m. Time allotted for each presentation

may be limited. Those desiring to make

formal oral presentations should notify the

contact person before May 29, 2001, 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.

Background material from the sponsor and

FDA will be posted 24 hours before the

meeting at the Peripheral and Central

Nervous System Drugs Advisory Committee

docket site at http://www.fda.gov/ohrms/

dockets/ac/acmenu.htm. (Click on the year

2001 and scroll down to the Peripheral and

Central Nervous Systems Drugs meetings.)

This is the same Web site where you can find

the minutes, transcript, and slides from the

meeting. This material is generally posted

about 3 weeks after the meeting.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: May 8, 2001.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 01–12085 Filed 5–10–01; 10:28 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–267]

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.

Type of Information Collection

Request: Reinstatement, with change, of

a previously approved collection for

which approval has expired; Title of

Information Collection: Medicare Plus

Choice Program Requirements

Referenced in 42 CFR 422.000–422.700;

Form No.: HCFA–R–0267 (OMB# 0938–

0753); Use: Section 4001 of the

Balanced Budget Act of 1997 added

sections 1851 through 1859 to the Social

Security Act to establish a new Part C

of the Medicare Program, known as the

Medicare+Choice program. Under this

program, every individual entitled to

Medicare Part A and enrolled under Part

24392 Federal Register / Vol. 66, No. 93 / Monday, May 14, 2001 / Notices

B may elect to receive benefits through

either the existing Medicare fee-forservice program or a Part C M+C plan.

The regulations implementing these

sections was published on June 26,

1998. The regulations revising these

sections was published on February 17,

1999 and June 29, 2000.; Frequency:

Other: as needed; Affected Public:

Business or other for-profit, Individuals

or Households, Not-for-profit

institutions, Federal Government, and

State, Local, or Tribal Government;

Number of Respondents: 2,450; Total

Annual Responses: 7,657,534; Total

Annual Hours: 2,120,006.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, access

HCFA’s WEB SITE ADDRESS at http://

www.hcfa.gov/regs/prdact95.htm, or Email 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, DC 20503.

Dated: April 24, 2001.

John P. Burke, III,

HCFA Reports Clearance Officer, HCFA,

Office of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 01–11967 Filed 5–11–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF THE INTERIOR

National Park Service

Record of Decision: Final

Environmental Impact Statement; Lake

McDonald/Park Headquarters

Wastewater Treatment System

Rehabilitation, Glacier National Park, A

Unit of Waterton-Glacier International

Peace Park Flathead and Glacier

Counties, MT

The Department of Interior, National

Park Service (NPS) has prepared this

Record of Decision on the Final

Environmental Impact Statement on the

Lake McDonald/Park Headquarters

Wastewater Treatment System

Rehabilitation for Glacier National Park,

Montana. This Record of Decision is a

statement of the decisions made as a

result of environmental and

socioeconomic analysis and

consideration of public input. It

describes the following: project

background, the preferred alternative,

other alternatives considered, the

National Park Service decision and the

basis for the decision, the

environmentally preferable alternative,

mitigation measures and the

involvement of public, agencies and

other nations.

Project Background

Glacier National Park (Park) attracts

about 1.7 million visitors annually.

Approximately 60 percent of these

visitors enter the Park through the west

entrance. The existing Lake McDonald

wastewater treatment facility serves

developed areas at Lake McDonald

Lodge, Apgar Village, Sprague Creek,

Apgar and Fish Creek Campgrounds,

and Park Headquarters, park

maintenance area, seasonal park and

concession staff and year-round park

employee residences.

In 1996, the Park determined that

improvements and upgrades to the

wastewater facility and collection

system were needed to restore the

original treatment capacity and protect

resources from potential damage due to

accidental wastewater discharges. Since

1997, the Park has upgraded lift stations

at Lake McDonald Lodge and Sprague

Creek Campground and has replaced the

sewage collection system and made

other improvements as necessary. The

purpose of the proposed project is to

rehabilitate and improve the existing

wastewater treatment facility because it

is no longer meeting its original

treatment objectives or operating at the

capacity it was originally designed for.

In addition, the existing spray field used

as part of the treatment process, is

within the 100-year floodplain of

McDonald Creek and the Middle Fork of

the Flathead River and is only able to

operate seasonally due to snow cover

and or a high water table. The existing

sewage storage lagoon is inadequate to

store all the winter flow and

precipitation during wet years, until the

spray field is operational in the summer.

Decision (Selected Action)

The National Park Service will

implement Alternative 3 as described in

the Final Environmental Impact

Statement on the Lake McDonald/park

Headquarters Wastewater Treatment

System Rehabilitation, with some minor

clarifications and changes as indicated

below to replace the existing wastewater

treatment system with an advanced

tertiary treatment wastewater facility

that achieves the highest level of

nutrient and pathogen removal of all the

alternatives considered. The proposed

wastewater treatment plant (WWTP)

will incorporate sequencing batch

reactors for nitrogen and phosphorus

removal combined with chemicals that

will remove additional phosphorus and

suspended solids. In addition, UV

disinfection will be used to kill

pathogens prior to discharge. The

proposed facility will require

enlargement of the existing WWTP

building to 60 feet × 100 feet. This

method will insure that nutrients will

be removed in accordance with

treatment levels established by EPA and

regulated by Montana DEQ.

In response to public comment

received on the FEIS, the method for

discharging the effluent has been

changed from what was described in the

FEIS. During the late spring, summer

and early fall, when the plant will be

treating up to 250,000 gallons of waste

per day, the effluent will be treated to

meet Montana DEQ standards for

surface water discharge and will be

disposed of by spray irrigation.

Approximately 30 acres of the existing

58 acre spray field will be refurbished

with new heads, pumps and controls

and will cost approximately $150,000.

Since the effluent will be treated to

surface water discharge standards,

irrigating the meadow by using the

spray field is not part of the treatment

process. However, it will provide a

polishing effect. Any remaining nitrogen

and phosphorus allowed by the

discharge permit will be taken up by the

plants and not enter the groundwater.

During the winter, when the plant

will treat up to 12,000 gallons of waste

per day, the effluent will be treated to

a higher level to meet EPA underground

injection control standards. To meet

these higher standards, the effluent will

be disinfected with ozone prior to

filtration and then UV prior to discharge

into an exfiltration gallery. The gallery

(also known as a groundwater injection

system) will be located southwest of the

horse barn, within the vicinity of the

existing spray field. The new plant’s

biological nutrient removal, filtration

and disinfection process will achieve

treatment standards set by EPA and

regulated by DEQ. Chlorine and the

disinfection by-products produced by

chlorine will not be used or generated.

Treated effluent discharges will meet

Montana DEQ non-degradation water

quality requirements in addition to

EPA’s underground injection control

requirements.

The new site for the exfiltration

gallery is within the area analyzed as

part of the affected environment in the

DEIS and FEIS. This site was not

surveyed for the velvetleaf blueberry,

although according to the park’s