Federal Register / Vol. 63, No. 13 / Wednesday, January 21, 1998 / Notices 3145

are not necessary to provide reasonable

assurance of the safety and effectiveness

of the device. By February 19, 1998,

FDA will provide guidance on how to

request such an exemption.

Dated: January 15, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–1485 Filed 1–16–98; 12:00 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Immunology Devices Panel of the

Medical Devices 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: Immunology

Devices Panel of the Medical Devices

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 February 2, 1998, 9:30 a.m. to

6:30 p.m.

Location: Parklawn Bldg., conference

rooms D & E, 5600 Fishers Lane,

Rockville, MD.

Contact Person: Peter E. Maxim,

Center for Devices and Radiological

Health (HFZ–440), Food and Drug

Administration, 2098 Gaither Rd.,

Rockville, MD 20850, 301–594–1293, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12516. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: The committee will discuss

proposed prescription home use

labeling for a unitized bladder cancer

tumor marker assay used to aid in the

detection of bladder cancer recurrence.

Also, the committee will discuss, make

recommendations, and vote on a

premarket approval application for a

free PSA (prostate-specific antigen)

assay. The assay is intended to be used

in men over the age of 50 with a

negative digital rectal examination and

a total serum PSA measurement of 4.0

to 10.0 nanograms/milliliter. The free

PSA/total PSA ratio aids in the

differentiation between benign and

malignant prostate disease.

Procedure: On February 2, 1998, from

10 a.m. to 6:30 p.m., the meeting is open

to the public. 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 January 29, 1998. 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 January 29, 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

February 2, 1998, from 9:30 a.m. to 10

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)). FDA staff will

present to the committee confidential

information regarding present or future

issues.

FDA regrets that it was unable to

publish this notice 15 days prior to the

February 2, 1998, Immunology Devices

Panel of the Medical Devices Advisory

Committee meeting. Because the agency

believes there is some urgency to bring

this issue to public discussion and

qualified members of the Immunology

Devices Panel of the Medical Devices

Advisory Committee were available at

this time, the Commissioner concluded

that it was in the public interest to hold

this meeting even if there was not

sufficient time for the customary 15-day

public notice.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: January 15, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–1418 Filed 1–15–98; 3:51 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0007]

Draft ‘‘Guidance for Industry: For the

Submission of Chemistry,

Manufacturing and Controls and

Establishment Description Information

for Human Plasma-Derived Biological

Products or Animal Plasma or SerumDerived Products;’’ Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the draft guidance

document entitled ‘‘Guidance for

Industry: For the Submission of

Chemistry, Manufacturing and Controls

and Establishment Description

Information for Human Plasma-Derived

Biological Products or Animal Plasma or

Serum-Derived Products.’’ The draft

guidance document is intended to assist

applicants in the preparation of the

content and format of the chemistry,

manufacturing, and controls (CMC)

section and the establishment

description section of a biologics license

application (BLA), revised Form FDA

356h for human plasma-derived

biological products, animal plasma, or

serum-derived products. This action is

part of FDA’s continuing effort to

achieve the objectives of the President’s

‘‘Reinventing Government’’ initiatives

and FDA Modernization Act of 1997,

and is intended to reduce unnecessary

burdens for industry without

diminishing public health protection.

DATES: Written comments may be

submitted at any time, however,

comments should be submitted by April

21, 1998, to ensure their adequate

consideration in preparation of the final

document.

ADDRESSES: Submit written requests for

single copies of the draft guidance

entitled ‘‘Guidance for Industry: For the

Submission of Chemistry,

Manufacturing and Controls and

Establishment Description Information

for Human Plasma-Derived Biological

Products or Animal Plasma or SerumDerived Products’’ to the Office of

Communication, Training, and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research, Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send one

self-addressed adhesive label to assist

that office in processing your requests.
3146 Federal Register / Vol. 63, No. 13 / Wednesday, January 21, 1998 / Notices

The document may also be obtained by

mail by calling the CBER Voice

Information System at 1–800–835–4709

or 301–827–1800, or by FAX by calling

the FAX Information System at 1–888–

CBER–FAX or 301–827–3844. Submit

written comments on the document to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Valerie A. Butler, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a draft guidance document entitled

‘‘Guidance for Industry: For the

Submission of Chemistry,

Manufacturing and Controls and

Establishment Description Information

for Human Plasma-Derived Biological

Products or Animal Plasma or SerumDerived Products.’’ The draft guidance

provides general information for the

CMC and establishment description

section of the BLA, Form FDA 356h for

human plasma-derived biological

products, animal plasma, or serumderived products. In the Federal Register of July 8, 1997

(62 FR 36558), FDA announced the

availability of a new harmonized Form

FDA 356h entitled ‘‘Application to

Market a New Drug, Biologic, or an

Antibiotic for Human Use.’’ The new

harmonized form is intended to be used

by applicants for all drug and biological

products. The new harmonized form

when fully implemented will allow

biological product manufacturers to

submit a single application, the BLA,

instead of two separate license

application submissions, a product

license application (PLA) and an

establishment license application (ELA). The draft guidance document

represents the agency’s current thinking

on content and format of the CMC, and

establishment description information

section of a license application for

human plasma-derived biological

products, animal plasma, or serumderived products. 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 statute,

regulations, or both. As with other

guidance documents, FDA does not

intend this document to be all inclusive

and cautions that not all information

may be applicable to all situations. The

document is intended to provide

information and does not set forth

requirements.

II. Comments

The draft guidance document is being

distributed for comment purposes only

and is not intended for implementation

at this time. Interested persons may

submit written comments to the Dockets

Management Branch (address above)

regarding the draft guidance document.

Written comments may be submitted at

any time, however, comments should be

submitted by April 21, 1998, to ensure

their adequate consideration in

preparation of the final document. Two

copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments and

requests for copies should be identified

with the docket number found in the

brackets in the heading of this

document. A copy of the draft guidance

document and received comments are

available for public examination 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 draft guidance document

by using the World Wide Web (WWW).

For WWW access connect to CBER at

‘‘http://www.fda.gov/cber/

guidelines.htm.’’ Received comments will be

considered in determining whether

further revision of the draft guidance

document is warranted.

Dated: January 13, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–1293 Filed 1–20–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0261]

Frequently Asked Questions About the

New FDA Tobacco Regulations: Draft

Guidance; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration is announcing the

availability of a new section to the draft

guidance entitled ‘‘Frequently Asked

Questions About the New FDA Tobacco

Regulations.’’ The draft guidance

addresses the questions most frequently

asked by retailers, consumers and others

about the age and photo identification

requirements of the final rule restricting

the sale of cigarettes and smokeless

tobacco to protect children and

adolescents. The new section on

enforcement procedures addresses

questions raised by retailers and others

concerning the amount of penalties that

FDA intends to seek for third and

subsequent violations of the age and

identification requirements.

DATES: Submit written comments on the

draft guidance by April 21, 1998.

ADDRESSES: The draft guidance entitled

‘‘Frequently Asked Questions About the

New FDA Tobacco Regulations,’’ and

the amendment are available on the

Internet at

http://www.fda.gov/, or a paper copy

may be ordered free of charge by calling

1–888–FDA–4KIDS.

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.

FOR FURTHER INFORMATION CONTACT:

Mary M. Lyda, Office of Policy (HF–11),

Food and Drug Administration, 5600

Fishers Lane, rm. 14–101, Rockville, MD

20857, 301–827–3360.

SUPPLEMENTARY INFORMATION: In the

Federal Register of August 28, 1996 (61

FR 44396), FDA issued a final rule to

restrict the sale and distribution of

cigarettes and smokeless tobacco in

order to protect children and

adolescents (21CFR part 897). The final

rule covers three general classes of

nicotine-containing tobacco products:

Cigarettes, loose cigarette tobacco, and

smokeless tobacco. The final rule

applies to manufacturers, distributors,

retailers and importers who make,

distribute, sell, and import such

products.

Since February 28, 1997, the final rule

has prohibited retailers from selling

cigarettes, loose cigarette tobacco or

smokeless tobacco to persons under the

age of 18, and has required retailers to

verify the age of customers under the

age of 27 by checking an identification

(ID) card which contains the bearer’s

photograph and birth date.

The draft guidance answers questions

most frequently asked by retailers,

consumers, and others concerning these

requirements and the agency’s

enforcement plans. To ensure that

retailers are complying with the

requirements, FDA has commissioned

State officials to conduct compliance

checks, during which adolescents,

accompanied by State officials, attempt

to purchase cigarettes or smokeless

tobacco from retailers. The guidance