Federal Register / Vol. 62, No. 169 / Tuesday, September 2, 1997 / Notices 46365

determine what and where tests are

available; (3) predicting the impact of

proposed regulatory changes on

laboratory services, the government can

respond to requests for information from

a position of more complete knowledge

and understanding than the partial

information currently available; and (4)

monitoring the changes in laboratory

testing as our health care delivery

systems moves toward managed care.

The total annual burden hours are

1,228.

Respondents Number of respondents

Number of responses/respondentAverage burden/response

(in hrs.)

Contact questionnaire .................................................................................................................. 1,178 1 0.25

Mail survey ................................................................................................................................... 1.178 1 0.50

Telephone follow-up ..................................................................................................................... 1,178 1 0.25

On-site QC ................................................................................................................................... 100 1 0.50

Dated: August 25, 1997.

Wilma G. Johnson,

Acting Associate Director for Policy Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–23183 Filed 8–29–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Advisory Committee Meeting;

Amendment of Notice

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration is announcing an

amendment to the notice of meeting of

the Oncologic Drugs Advisory

Committee which is scheduled for

September 18 and 19, 1997. This

meeting was announced in the Federal

Register of August 14, 1997 (62 FR

43539). The amendment is being made

to: (1) Remove the second agenda item

scheduled on September 19, 1997; (2)

change the starting and ending times of

the meeting on September 19, 1997; and

(3) reschedule the time allotted for oral

presentations from the public on

September 19, 1997. There are no other

changes. This amendment will be

announced at the beginning of the open

portion of the meeting.

FOR FURTHER INFORMATION CONTACT:

Jannette O’Neill-Gonzalez or Robinette

Taylor, Center for Drug Evaluation and

Research (HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–5455, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12542.

SUPPLEMENTARY INFORMATION: In the

Federal Register of August 14, 1997 (62

FR 43539), FDA announced that a

meeting of the Oncologic Drugs

Advisory Committee would be held on

September 18 and 19, 1997. This

amendment is to provide an update to

the information provided earlier

pertaining to the September 19, 1997,

meeting day. There are no changes for

the September 18, 1997, meeting day.

On page 43540, beginning in column 1,

portions of the notice pertaining to the

September 19, 1997, meeting day are

amended to read as follows:

Date and Time: The meeting will be

held on September 19, 1997, from 8:30

a.m. to 12:50 p.m.

Agenda: On September 19, 1997, the

committee will discuss: NDA 20–826,

Paxene (paclitaxel, Baker-Norton

Pharmaceuticals, Inc.), ‘‘indicated after

failure of first line or subsequent

systemic chemotherapy for the

treatment of advanced AIDS-related

Kaposi’s Sarcoma.’’

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 September 4, 1997. Oral

presentations from the public will be

scheduled between approximately 8:35

a.m. and 9:05 a.m. on September 19,

1997. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before September 4, 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: August 25, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–23121 Filed 8–29–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

X-ray Assemblers Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

following workshop: X-ray Assemblers

Workshop. This workshop is being

sponsored by FDA’s Southeast Region

and the radiological health programs

within the Southeast Region (Alabama,

Florida, Georgia, Louisiana, Mississippi,

North Carolina, Puerto Rico, South

Carolina, Tennessee, and the Virgin

Islands). The topics to be discussed are

the update on the x-ray assemblers’

responsibilities under the diagnostic xray performance standard; State rules

and regulations on diagnostic x-ray

standards; completing the form, FDA–

2579 (Report of Assembly of a

Diagnostic X-ray System); and

inspections of x-ray assemblers. The

purpose of the workshop is to provide

x-ray assemblers with an update on

assemblers responsibilities under the

diagnostic x-ray performance standard;

review the various State regulations;

and provide technical training in the

area of assembler inspections and

completion of the form, FDA–2579.

Date and Time: The workshop will be

held on Thursday, September 25, 1997,

8 a.m. to 4:30 p.m.

Location: The workshop will be held

at the Medical Forum Bldg., 950 22d

Street North, Birmingham, AL.

Contact: R. Thomas Trout, Regional

Radiological Health Representative,

Southeast Region, Food and Drug

Administration (HFR–SE19), 60 Eighth

Street NE., Atlanta, GA 30309, 404–347–

4001, ext. 5248, FAX 404–347–4349.

Registration: Send registration

information (name, title, firm name,

address, telephone, and fax number) to

the contact person by September 18,