32102 Federal Register / Vol. 63, No. 112 /Thursday, June 11, 1998 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0389]

Guidance for Industry: Notification of a

Health Claim or Nutrient Content Claim

Based on an Authoritative Statement

of a Scientific Body; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance entitled

‘‘Guidance for Industry: Notification of

a Health Claim or Nutrient Content

Claim Based on an Authoritative

Statement of a Scientific Body.’’ The

guidance is intended to provide

information regarding the submission of

notifications of health claims or nutrient

content claims based on authoritative

statements of scientific bodies. This

action is in response to provisions of the

FDA Modernization Act of 1997

(FDAMA).

DATES: Written comments on agency

guidance documents may be submitted

at any time.

ADDRESSES: Submit written requests for

single copies of the guidance entitled

‘‘Guidance for Industry: Notification of

a Health Claim or Nutrient Content

Claim Based on an Authoritative

Statement of a Scientific Body’’ to the

Office of Food Labeling (HFS–150),

Center for Food Safety and Applied

Nutrition, Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204. Send one selfaddressed adhesive label to assist that

office in processing your request or

include a fax number to which the

guidance may be sent. Alternatively,

you may fax your request to 202–205–

5494. See the SUPPLEMENTARY

INFORMATION section for electronic

access to the guidance. Submit written

comments on this 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:

Constance B. Henry, Center for Food

Safety and Applied Nutrition (HFS–

158), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–205–5099.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a

guidance entitled ‘‘Guidance for

Industry: Notification of a Health Claim

or Nutrient Content Claim Based on an

Authoritative Statement of a Scientific

Body.’’

The agency has adopted good

guidance practices (GGP’s), which set

forth the agency’s policies and

procedures for the development,

issuance, and use of guidance

documents (62 FR 8961, February 27,

1997). The guidance entitled ‘‘Guidance

for Industry: Notification of a Health

Claim or Nutrient Content Claim Based

on an Authoritative Statement of a

Scientific Body’’ is issued as a level 1

guidance consistent with GGP’s. It may

be utilized upon issuance because it is

needed to help effect the

implementation of the new statutory

provisions of FDAMA.

This guidance document represents

the agency’s current thinking on the

submission of notifications under

sections 303 and 304 of FDAMA (new

section 403(r)(3)(C) and (r)(2)(G) of the

Federal Food, Drug, and Cosmetic Act).

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.

Interested persons may, at any time,

submit written comments on the

guidance to the Dockets Management

Branch (address above). Two copies of

any comments are to be submitted,

except that individuals may submit one

copy. Comments are to be identified

with the docket number found in

brackets in the heading of this

document. The guidance and received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday.

This guidance document contains a

collection of information that requires

clearance by the Office of Management

and Budget under the Paperwork

Reduction Act of 1995. In a notice

published elsewhere in this issue of the

Federal Register, FDA is announcing

that this collection of information has

been submitted to OMB for emergency

processing. The notice also solicits

comments on the collection of

information.

An electronic version of the guidance

entitled ‘‘Guidance for Industry:

Notification of a Health Claim or

Nutrient Content Claim Based on an

Authoritative Statement of a Scientific

Body’’ is also available on the Internet

at ‘‘http://www.cfsan.fda.gov/∼dms/

guidance.html’’.

Dated: June 5, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–15483 Filed 6–10–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0320]

Agency Emergency Processing

Request Under OMB Review

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a proposed collection of

information has been submitted to the

Office of Management and Budget

(OMB) for emergency processing under

the Paperwork Reduction Act of 1995

(the PRA). The proposed collection of

information concerns the submission of

notifications of health claims or nutrient

content claims based on authoritative

statements of scientific bodies. This

action is in response to provisions of the

FDA Modernization Act of 1997

(FDAMA).

DATES: Submit written comments on the

collection of information by June 22,

1998.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Desk

Officer for FDA. 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:

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
Federal Register / Vol. 63, No. 112 /Thursday, June 11, 1998 / Notices 32103

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.

Notification of a Health Claim or a

Nutrient Content Claim Based on an

Authoritative Statement

Section 403(r)(2)(G) and (r)(3)(C) of

the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 343(r)(2)(G) and

(r)(3)(C)), as amended by FDAMA,

provides that a food producer may

market a food product whose label bears

a nutrient claim or a health claim that

is based on an authoritative statement of

a scientific body of the Federal

Government or the National Academy of

Sciences. Under these sections of the

act, a food producer that intends to use

such a claim must submit a notification

of its intention to use the claim 120 days

before it begins marketing.

Elsewhere in this issue of the Federal

Register, FDA is announcing the

availability of a guidance entitled

‘‘Guidance for Industry: Notification of

a Health Claim or Nutrient Content

Claim Based on an Authoritative

Statement of a Scientific Body.’’ The

guidance provides the agency’s

interpretation of terms central to the

submission of a notification and the

agency’s views on the information that

should be included in a notification. In

addition to the information specifically

required by the act to be in such

notifications, the guidance states that

the notifications should also contain

information on analytical methodology

for the nutrient that is the subject of a

claim based on an authoritative

statement.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of

Respondents

No. of Responses per

Respondent

Total Annual

Responses

Hours per

Response

Total Annual

Hours

Guidance for Notifications 12 5 60 1 60

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

The agency believes that this

guidance will enable food producers to

meet the criteria for notifications that

are established in sections 403(r)(2)(G)

and 403(r)(3)(C) of the act during the

interim period while the agency is

initiating notice-and-comment

rulemaking in this matter. FDA intends

to review the notifications it receives to

ensure that they comply with the

criteria established for them by the act.

These estimates are based on FDA’s

experience with health claims and

nutrient content claims and with other

similar notification procedures that fall

under its jurisdiction. Because the

claims are based on authoritative

statements of certain scientific bodies of

the Federal Government or the National

Academy of Sciences or one of its

subdivisions, FDA believes that the

information submitted with a

notification will be either provided as

part of the authoritative statement or

readily available to firms wishing to

make claims.

The hour burden estimates contained

in Table 1 of this document are for the

information collection requests in the

guidance only and do not include

statutory requirements specifically

mandated by the act.

FDA has requested emergency

processing of this proposed collection of

information under section 3507(j) of the

PRA and 5 CFR 1320.13. The

information is needed immediately to

implement FDAMA, and it is essential

to the agency’s mission of protecting

and promoting the public health. The

use of normal clearance procedures

would be likely to result in the

prevention or disruption of this

collection of information.

Dated: June 3, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–15484 Filed 6–10–98; 8:45 am]

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