Federal Register / Vol. 63, No. 96 /Tuesday, May 19, 1998 / Notices 27581

Dated: May 13, 1998.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

Appendix A

Sample

Fax to: Henry Falk, M.D., Director, Division

of Environmental Hazards and Health

Effects, National Center for

Environmental Health Centers for

Disease Control and Prevention (CDC),

4770 Buford Highway, NE., Mailstop F–

28, Atlanta, GA 30341–3724, Facsimile

(770) 488–4127

Fax copy to: Chief, Vessel Sanitation

Program, National Center for

Environmental Health Centers for

Disease Control and Prevention (CDC),

4770 Buford Highway, NE., Mailstop F–

16, Atlanta, GA 30341–3724, Facsimile

(770) 488–4127

We request the presence of a PHS

representative for shipyard consultation on

cruise liner (NAME). We tentatively expect to

take delivery of the cruise liner on (DATE).

We would like to schedule the shipyard

consultation for (DATE). We expect the

consultation to take approximately

(NUMBER OF DAYS).

We will pay CDC in accordance with the

inspection fee published in the Federal

Register, and for all expenses in connection

with the shipyard inspection. We will make

all necessary arrangements for lodging and

transportation, which includes airfare and

ground transportation in (CITY, STATE,

COUNTRY). We will provide in-kind for

lodging and transportation expenses. All

remaining expenses, such as en route per

diem and meals and miscellaneous expenses,

including ground transportation to and from

the airport nearest the representatives work

site or residence, should be sent to the

following address:

Company

Attention:

Street Address

City, State, Country

Zip Code

Office Telephone Number

Facsimile Number

If you have questions regarding this

confirmation, please contact:

Signed:

[FR Doc. 98–13212 Filed 5–18–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0194]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995 (the

PRA), Federal agencies are required to

publish notice in the Federal Register

concerning each proposed collection of

information, including each proposed

extension of an existing collection of

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

the information collection provisions of

FDA’s regulations governing batch

certification of color additives

manufactured for use in foods, drugs,

cosmetics or medical devices in the

United States.

DATES: Submit written comments on the

collection of information by July 20,

1998.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. All comments

should be identified with the docket

number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Schlosburg, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: Under the

PRA (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information,

including each proposed extension of an

existing collection of information,

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information listed below.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Color Additive Certification Requests

and Recordkeeping—21 CFR Part 80

(OMB Control Number 0910–0216—

Extension)

Section 721(a) of the Federal Food,

and Drug and Cosmetic Act (the act) (21

U.S.C. 379e(a)) provides that a color

additive shall be deemed unsafe unless

the additive and its use are in

conformity with a regulation that

describes the conditions under which

the additive may be safely used, or

unless the additive and its use conform

to the terms of an exemption for

investigational use. If a regulation

prescribing safe conditions of use has

been issued, the additive must be from

a batch certified by FDA to conform to

the requirements of that regulation and

other applicable regulations, unless the

additive has been exempted from the

certification requirement. Section 721 of

the act instructs the Secretary of Health

and Human Services (through FDA) to

issue regulations providing for batch

certification of color additives for which

she finds such requirement to be

necessary in the interest of protecting

the public health. FDA’s implementing

regulations in part 80 (21 CFR part 80)

specify the information that must

accompany a request for certification of

a batch of color additive and require

certain records to be kept pending and

after certification. FDA requires batch

certification for all color additives listed

in 21 CFR part 74 and for all color

additives provisionally listed in 21 CFR

part 82. Color additives listed in 21 CFR

part 73 are exempt from certification.

Under § 80.21, a request for

certification must include: Name of

color additive, batch number and weight

in pounds, name/address of

manufacturer, storage conditions,

statement of use(s), fee, and signature of

requester. The request for certification

must also include a sample of the batch

of color additive that is the subject of

the request. Under § 80.22, the sample

must be labeled to show: Name of color

additive, batch number and quantity,

and name and address of person
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