27582 Federal Register / Vol. 63, No. 96 /Tuesday, May 19, 1998 / Notices

requesting certification. A copy of the

label or labeling to be used for the batch

must accompany the sample. Under

§ 80.39, the person to whom a certificate

is issued must keep complete records

showing the disposal of all the color

additive covered by the certificate. Such

records are to be made available upon

request to any accredited representative

of FDA until at least 2 years after

disposal of all of the color additive.

The request for certification of a batch

of color additive is reviewed by FDA’s

Office of Cosmetics and Colors to verify

that all of the required information has

been included. Since the information

required in the request for certification

is unique to the specific batch of color

additive involved, it must be generated

for each batch. The information

submitted with the request helps FDA to

ensure that only safe color additives

will be used in foods, drugs, cosmetics,

and medical devices sold in the United

States. The batch number assigned by

the manufacturer is a means of

temporary identification until a

certification lot number has been issued

by FDA. After certification, the

manufacturer’s batch number helps

assure that the proper batch of color is

indeed being used under the

certification lot number issued by FDA.

In the case of a batch that has been

refused certification for noncompliance

with the regulations, the manufacturer’s

batch number aids in tracing the

ultimate disposition of that batch of

color additive. The batch weight serves

to account for the disposition of the

entire batch; for example, it might be

used in determining whether uncertified

color has been sold under the lot

number assigned to the batch by FDA

or, in the event of a recall after

certification, to determine whether all

unused color has been recalled. In

addition, the batch weight is the basis

for assessing the certification fee. The

name and address of the manufacturer

of the color additive being submitted for

certification allows FDA to contact the

person responsible for its manufacture

should a question arise concerning

compliance with the regulations.

Information on storage conditions

pending certification is used to evaluate

the possibility that the batch could have

been inadvertently or intentionally

altered in a manner that would make the

sample submitted for certification

analysis no longer representative of the

batch. It is also used when an FDA

investigator is sent to the site; the

veracity of the storage statements is

checked during normal plant

inspections. Information on the uses

which the person seeking certification

proposes that the color be certified for

it is to assure that all of the proposed

uses are within the limits of the listing

regulation. The statement of the fee on

the certification request is for

accounting purposes so that the person

seeking certification can be promptly

notified if any discrepancies appear.

The information requested on the label

of the sample submitted with the

certification request is to identify the

sample. The regulations require an

accompanying copy of the label or

labeling to be used for the batch so that

FDA can verify that the batch will be

labeled appropriately when it enters

commerce.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

80.21 20 152 4,091 0.2 818

80.22 20 152 4,091 0.05 205

Total 1,023

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

80.39 27 152 4,091 .25 1,023

Total 1,023

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

The estimated total annual burden for

this information collection is 2,046

hours. Over the period fiscal year (FY)

1995 to FY 1997, FDA processed an

average of 4,091 requests for

certification of batches of color additive.

Approximately 20 different respondents

submitted requests for certification each

year over the period FY 1995 to FY

1997. The estimates for the length of

time necessary to prepare certification

requests and accompanying samples,

and to comply with recordkeeping

requirements, were obtained from

industry program area personnel.

Dated: May 8, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–13228 Filed 5–18–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Open Meeting for Representatives of

Health Professional Organizations

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of public meeting.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

public meeting with representatives of

health professional organizations. The

meeting will be chaired by Sharon

Smith Holston, Deputy Commissioner

for External Affairs. The agenda will

include presentations and discussions

on the main topic of emerging infectious

diseases. FDA staff will make

presentations on FDA’s involvement in

the President’s Food Safety Initiative,

antimicrobial resistance, and issues in

vaccine development and diagnostics.

There will also be brief updates on
Federal Register / Vol. 63, No. 96 /Tuesday, May 19, 1998 / Notices 27583

tobacco and the FDA Modernization

Act.

DATES: The meeting will be held on

Thursday, May 28, 1998, from 2 p.m. to

4 p.m.

ADDRESSES: The meeting will be held at

the Bethesda Holiday Inn, 8120

Wisconsin Ave., Bethesda, MD.

FOR FURTHER INFORMATION CONTACT:

Peter H. Rheinstein, Office of Health

Affairs (HFY–40), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–6630.

Registration: There is no registration fee,

however, space is limited. Persons will

be registered in the order in which calls

are received. Please call Betty Palsgrove

at 301–827–6618 to register.

Registrations also may be transmitted by

FAX to 1–800–344–3332 or 301–443–

2446. Please include the name and title

of the person attending and the name of

the organization.

SUPPLEMENTARY INFORMATION: The

purpose of the meeting is to provide an

opportunity for representatives of health

professional organizations and other

interested persons to be briefed by

senior FDA staff. It will also provide an

opportunity for informal discussion on

these topics of particular interest to

health professional organizations.

This public meeting is free of charge;

however, space is limited. Registration

for the meeting will be accepted in the

order received and should be sent to the

contact person. Registration should

include the name and title of the person

attending and the name of the

organization being represented, if any.

Dated: May 13, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–13410 Filed 5–15–98; 2:58 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

First Party Audit Program

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of industry exchange

meeting.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

industry exchange meeting to discuss

with the regulated industry a new

initiative being considered by the

agency. The First Party Audit Program

(FPAP) is intended to gather

information from selected human use

pharmaceutical manufacturers regarding

their quality assurance measures. This

information would be submitted to FDA

by those firms and would substitute, in

some measure, for information the

agency would otherwise obtain from its

direct inspectional activities. The

industry exchange meeting is intended

to present the broad concepts of this

initiative, discuss attendant issues, and

obtain feedback from all interested

parties as to the merits of proceeding

with the project. This meeting is

cosponsored by the Center for Drug

Evaluation and Research’s (CDER’s)

Office of Compliance and the Office of

the Commissioner’s Industry Small

Business and Community Affairs Staff.

DATES: The industry exchange meeting

will be held on June 23, 1998, from 9

a.m. to 4 p.m. Registration is required by

June 12, 1998.

ADDRESSES: The industry exchange

meeting will be held at the Hyatt

Regency Bethesda Hotel, One Bethesda

Metro Center, Bethesda, MD.

FOR FURTHER INFORMATION CONTACT: C.

Russ Rutledge, Center for Drug

Evaluation and Research (HFD–325),

Food and Drug Administration, 7500

Standish Pl., Rockville, MD 20855, 301–

594–2455.

Those persons interested in attending

this meeting should FAX or e-mail their

registration to C. Russ Rutledge (FAX

301–594–2202 or e-mail via the Internet

at ‘‘rutledgec@cder.fda.gov’’), including

name of attendee(s), title, affiliation,

mailing address, phone number, fax

number, and e-mail address. There is no

registration fee for this meeting, but

advance registration is required.

Interested parties are encouraged to

register early because space is limited.

SUPPLEMENTARY INFORMATION: FDA relies

in large part on information acquired

during inspections of manufacturing

facilities, conducted by the agency’s

investigators, to ensure that firms are

meeting the minimum levels of product

quality assurance for human drug

products. Although the agency believes

that full inspection by its investigators

is the ideal situation, FDA is evaluating

alternative methods of acquiring

information it would otherwise directly

obtain from traditional onsite

inspections. One approach the agency is

considering is the FPAP. The first party

is the manufacturing firm itself. The

concept is to limit program participation

to those manufacturers FDA recognizes

as having both a quality assurance

program that is effective and a record of

substantial compliance with FDA

requirements. Program participation

would be strictly voluntary. Firms the

agency selects for the program would

supply FDA with information from its

self-audits apart from FDA onsite

inspections. The agency would use this

information along with modified

inspections to document minimum

levels of assurance of manufacturing

quality of the pharmaceuticals produced

in that site.

FDA is holding this industry

exchange meeting to present the core

concepts of FPAP, discuss the relevant

issues, and afford interested parties the

opportunity to pose questions and

provide comments. The agency will

consider this public input in deciding

on whether and how to proceed with

the program, initially on a pilot basis.

The agenda and any other relevant

information will be available

electronically via the Internet at ‘‘http:/

/www.fda.gov/cder/dmpq/fpap.htm’’

beginning Monday, May 18, 1998.

Dated: May 8, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–13163 Filed 5–18–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Advisory Committee for

Pharmaceutical Science; 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). The meeting will be open to the

public.

Name of Committee: Advisory

Committee for Pharmaceutical Science.

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 23, 1998, 8 a.m. to 5 p.m.,

and on June 24, 1998, 8:30 a.m. to 5:30

p.m.

Location: Holiday Inn, The Ballrooms,

Two Montgomery Village Ave.,

Gaithersburg, MD.

Contact Person: Kimberly L. Topper,

Center for Drug Evaluation and Research

(HFD–21), Food and Drug

Administration 5600 Fishers Lane,

Rockville, MD 20857, 301–443–5455,

(For Federal Express Deliveries—

Chapman Bldg., 801 Thompson Ave.,

rm. 200, Rockville, MD 20857) or FDA

Advisory Committee Information Line,