Federal Register / Vol. 63, No. 106 /Wednesday, June 3, 1998 / Notices 30241

Form No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

CBER:

Form FDA 3500 804 1 804 0.5 402

Form FDA 3500A 63 158.5 9,988 1.0 9,988

CDER:

Form FDA 3500 14,875 1 14,875 0.5 7,438

Form FDA 3500A 500 375 187,522 1.0 187,522

CDRH:

Form FDA 3500 2,807 1 2,807 0.5 1,404

Form FDA 3500A 39,889 2.05 81,928 1.0 81,928

CFSAN:

Form FDA 3500 646 1 646 0.5 323

Form FDA 3500A 0 0 0 1.0 0

Total Hours 289,005

Form FDA 3500 9,567

Form FDA 3500A 279,438

1There are no capital costs or operating and maintenance costs associated with this collection of information.

Note: CBER = Center for Biologics Evaluation and Research; CDER = Center for Drug Evaluation and Research; CDRH = Center for Devices

and Radiological Health; CFSAN = Center for Food Safety and Applied Nutrition. Form FDA 3500 is for voluntary reporting; Form FDA 3500A is

for mandatory reporting.

As more medical products are

approved by FDA and marketed, FDA

expects that more reports will be

submitted. The figures in the table are

based on the average number of reports

received in FY 1996, adjusted for the

anticipated annual increase in reports.

The anticipated annual increase

in reports is based on the average

annual increase from 1993 to 1996.

There are zeroes in the CFSAN row for

Form FDA 3500A because mandatory

reporting using Form FDA 3500A is not

applicable to foods.

Dated: May 28, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–14721 Filed 6–2–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Blood Products 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). At least one portion of the

meeting will be closed to the public.

Name of Committee: Blood Products

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 June 18, 1998, 8 a.m. to 5:30

p.m., and on June 19, 1998, 8 a.m. to 3

p.m.

Location: Doubletree Hotel, Plazas I

and II, 1750 Rockville Pike, Rockville,

MD.

Contact Person: Linda A. Smallwood,

Center for Biologics Evaluation and

Research (HFM–350), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–827–

3514, or FDA Advisory Committee

Information Line, 1–800–741–8138

(301–443–0572 in the Washington, DC

area), code 19516. Please call the

Information Line for up-to-date

information on this meeting.

Agenda: On June 18, 1998, the

committee will: (1) Hear updates on

hepatitis C recipient notification and

partner deferral of xenotransplantation

recipients; (2) discuss information

provided on the Blood Action Plan,

Immune Globulin Intravenous supply

issues, and Plasma Inventory Hold; and

(3) discuss and make recommendations

on standard testing for human

immunodeficiency virus (HIV) variants.

On June 19, 1998, the committee will:

(1) Discuss and make recommendations

on the review of clinical trial design for

Alpha-1-Proteinase Inhibitor; and (2)

review and discuss the draft report on

the intramural site visit of the

Laboratories of Hemostasis and Cellular

Hematology, Division of Hematology,

and the Laboratories of Hepatitis and

Molecular Virology, Division of

Transfusion Transmitted Diseases.

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 June 9, 1998. Oral

presentations from the public will be

scheduled between approximately 2

p.m. and 3 p.m. on June 18, 1998, and

between 10:45 a.m. and 11:15 a.m. on

June 19, 1998. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before June 9, 1998, 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.

Closed Committee Deliberations: On

June 18, 1998, from 3 p.m. to 3:30 p.m.,

and on June 19, 1998, from 10:15 a.m.

to 10:45 a.m., the meeting will be closed

to permit discussion and review of trade

secret and/or confidential information

(5 U.S.C. 552b(c)(4)). These portions of

the meeting will be closed to discuss

increased sensitivity of manufacturers’

tests for HIV variants and review of

clinical trial design for Alpha-1-

Proteinase Inhibitor. On June 19, 1998,

from 2 p.m. to 3 p.m., the meeting will

be closed to permit discussion where

disclosure would constitute a clearly

unwarranted invasion of personal

privacy (5 U.S.C. 552b(c)(6)). This

portion of the meeting will be closed to

discuss the draft report of the intramural

site visit.
30242 Federal Register / Vol. 63, No. 106 /Wednesday, June 3, 1998 / Notices

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: May 28, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–14760 Filed 6–2–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0359]

Program Priorities in the Center for

Food Safety and Applied Nutrition;

Public Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

public meeting to solicit input on

program priorities in the Center for

Food Safety and Applied Nutrition

(CFSAN). CFSAN is currently

conducting a comprehensive review of

its programs to set priorities and

establish work product expectations.

This meeting is intended to give the

public an opportunity to provide input

into the priority-setting process.

Date and Time: The meeting will be

held on June 24 and 25, 1998, 10 a.m.

to 5 p.m.

Location: The meeting will be held in

the auditorium at the Cohen Bldg., 330

Independence Ave. SW., Washington,

DC.

Contact: Tracy S. Summers, Center for

Food Safety and Applied Nutrition

(HFS–1), Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–4850,

FAX 202–205–5025, e-mail

tsummers@bangate.fda.gov.

Registration and Requests for Oral

Presentations: Send registration

information (name, title, firm name,

address, telephone, and fax number)

and requests to make oral presentations

to the contact person by June 15, 1998.

Written comments should be identified

with the docket number found in

brackets in the heading of this

document and should be submitted by

July 15, 1998, to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

SUPPLEMENTARY INFORMATION: FDA’s

CFSAN is conducting a comprehensive

review of all its programs to set

priorities and establish reasonable work

product expectations. Although

implementation of the President’s Food

Safety Initiative (FSI) is clearly CFSAN’s

top priority, CFSAN has responsibility

for many other important programs as

well. (The Presidential initiative is

aimed at reducing foodborne microbial

illness by strengthening food safety

practices and policies.) This meeting is

intended to provide the public with an

opportunity to provide input into the

priority-setting process. This meeting

will also serve as one of many activities

undertaken by the agency to solicit

input in accordance with section 406(b)

of the Food and Drug Administration

Modernization Act (FDAMA) of 1997

(Pub. L. 105–115) (codified at 21 U.S.C.

393(f)). Section 406 of FDAMA requires

that FDA, after consultation with

appropriate scientific and academic

experts, health care professionals,

representatives of patient and consumer

advocacy groups, and the regulated

industry, develop and publish in the

Federal Register a plan for meeting all

statutory obligations of the Federal

Food, Drug, and Cosmetic Act.

By way of example, in CFSAN’s

regulations program, work priorities are

being assigned as follows: (1) The

highest priority will be those regulations

that enhance consumer safety, such as

those issued to carry out the President’s

FSI; (2) those regulations that are

mandated by statute; (3) health-related

product labeling regulations; (4)

regulations that will improve efficiency

of operations; and (5) those additional

regulations that have a major positive

impact. The agency is interested in

comments regarding the use of these

criteria for setting priorities in CFSAN’s

other program areas. To facilitate

comments on this issue, the appendix to

this notice contains a list of major

activities undertaken by FDA to ensure

that foods are safe, wholesome, sanitary,

and properly labeled, and that cosmetics

are safe and properly labeled. Specific

activities are listed in one of six general

categories: Application review, injury

reporting, product safety assurance,

research, outreach, and enforcement.

The agency is most interested at this

time in receiving comments regarding

program priorities outside of FSI, as

other venues are available for interested

persons to provide input regarding

implementation of FSI across the

Federal Government. (Information

regarding public meetings on the

implementation of FSI can be obtained

by contacting Camille E. Brewer at 202–

260–1784.) Moreover, because many

FSI-related activities require that FDA

collaborate with one or more of the

other Federal agencies that have

primary responsibility for food safety

(e.g., the Centers for Disease Control and

Prevention in the Department of Health

and Human Services; the Food Safety

and Inspection Service, the Agricultural

Research Service and the Cooperative

State Research, Education, and

Extension Service in the Department of

Agriculture; and the Environmental

Protection Agency), comments on

priorities in the FSI program at the

meeting should be limited to those

activities for which FDA has sole

responsibility.

To help focus comments, FDA

requests that oral and/or written input

regarding CFSAN program priorities

address the following questions:

1. With respect to products under the

jurisdiction of CFSAN, do you believe

there are issues that directly affect

consumer safety that are not being

adequately addressed?

2. Beyond implementation of FSI,

which program areas and/or activities

do you believe should be top priorities

for CFSAN, and why?

3. The criteria being used to set

priorities for CFSAN’s regulations are

described above. Should these same

criteria be used to set priorities for work

in CFSAN’s other program areas? If not,

what criteria should be used?

4. FDA needs to ensure that its

research programs provide the scientific

information upon which regulatory

decisions are made. In CFSAN, what do

you believe should be the highest

priority areas for conducting research?

5. Because so much of our nation’s

food supply is either imported or

exported, international activities, such

as Codex, appear to be growing in

importance. What level of priority do

you believe should be given in CFSAN

to international activities? Please

identify specific activities in your

answer.

6. Finally, while not a public health

issue, economic fraud affects both the

industry and consumers. What level of

priority do you believe should be given

to addressing issues of economic fraud

in the food supply?

Transcripts of the meeting may be

requested in writing from the Freedom

of Information Office (HFI–35), Food

and Drug Administration, 5600 Fishers

Lane, rm. 12A–16, Rockville, MD 20857,

approximately 15 working days after

each meeting at a cost of 10 cents per

page. The transcript of the meeting will

be available for public examination at

the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

Persons requiring a sign language

interpreter or other special