67770 Federal Register / Vol. 62, No. 249 / Tuesday, December 30, 1997 / Proposed Rules

conviction, or other legal process, the

port director must have probable cause

to believe the proscribed acts occurred;

(3) The carrier-participant or a

designated driver allows an

unauthorized person or entity to use its

LBCIP certificate or other approved form

of identification;

(4) The carrier-participant or a

designated driver misuses authorized

conveyances;

(5) The carrier-participant or a

designated driver refuses or otherwise

fails to follow any proper order of a

Customs officer or any Customs order,

rule, or regulation relative to continued

participation in the LBCIP;

(6) The carrier-participant or a

designated driver fails to operate in

accordance with the terms of the written

agreement; or

(7) Continuation of LBCIP privileges

would endanger the revenue or security

of the Customs area in the judgment of

the port director.

(b) Notice. When a decision revoking

participation has been made, the port

director shall notify the carrierparticipant, and, where appropriate, the

individual designated driver(s), of the

decision in writing. The notice of

revocation shall clearly state the

reason(s) for revocation and recite the

applicant’s/driver’s appeal rights under

paragraph (c) of this section.

(c) Appeal. An LBCIP participant who

receives a notice of revocation and who

wishes to appeal the decision shall file

a written appeal with the Assistant

Commissioner, Office of Field

Operations, U.S. Customs Service,

Washington, D.C. 20229, within 10

calendar days of receipt of the notice.

The appeal shall be filed in duplicate

and shall set forth the participant’s

responses to the grounds specified by

the port director in the notice. Within

30 working days of receipt of the appeal,

the Assistant Commissioner, or his

designee, shall make a determination

regarding the appeal and notify the

applicant in writing.

PART 142—ENTRY PROCESS

1. The authority citation for part 142

continues to read as follows:

Authority: 19 U.S.C. 66, 1448, 1484, 1624.

2. Section 142.41 is amended by

adding a sentence at the end to read as

follows:

§ 142.41 Line release.

* * * * *

At certain high-risk locations along

the land borders of the United States

(the locations to be published in the

Federal Register), which are approved

by Customs for handling Line Release,

the use of Line Release may be denied

by Customs unless the imported

merchandise is transported by carriers

and drivers that participate in the Land

Border Carrier Initiative Program (see,

subpart H of part 123 of this chapter).

§ 142.47 [Amended]

3. In § 142.47, the first sentence of

paragraph (b) is amended by removing

the words ‘‘because of an examination’’

and adding, in their place, the words

‘‘for the following reasons: because of an

examination, because a carrier

transporting the Line Release

merchandise is not a participant in the

Land Border Carrier Initiative Program

(LBCIP), or because a driver or

conveyance is not authorized in

accordance with the LBCIP’’.

Samuel H. Banks,

Acting Commissioner of Customs.

Approved: August 7, 1997.

Dennis M. O’Connell,

Acting Deputy Assistant Secretary of the

Treasury.

[FR Doc. 97–33854 Filed 12–29–97; 8:45 am]

BILLING CODE 4820–02–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201, 330, and 358

[Docket No. 96N–0420]

Over-The-Counter Human Drugs;

Proposed Labeling Requirements;

Notice of Availability of Study Data and

Reopening of Comment Period

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule; reopening of

comment period on specific data.

SUMMARY: The Food and Drug

Administration (FDA) is reopening to

February 13, 1998 the comment period

on specific data related to the February

27, 1997, proposed rule to establish a

standardized format for the labeling of

over-the-counter (OTC) drug products

(62 FR 9024). As part of that rulemaking

proceeding, the agency collected data

under a study entitled ‘‘Over-theCounter (OTC) Label Format Preference,

Study B.’’ (Study B). This document

announces the availability of the data

and frequency tabulations that

summarize the Study B data and

reopens the comment period for the

OTC rulemaking proceeding to allow an

opportunity for comment on Study B.

DATES: Submit written comments on

Study B by February 13, 1998.

ADDRESSES: Submit written comments

on the information collected in Study B

to the Dockets Management Branch

(HFA–305), ATTN: Study B, OTC Drug

Labeling Data Collection, Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Kathryn J. Aikin, Food and Drug

Administration, Division of Drug

Marketing, Advertising, and

Communications (HFD–40), 5600

Fishers Lane, Rockville, MD, 20857,

301–827–2828, Aikink@cder.fda.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of February 27, 1997

(62 FR 9024), FDA published a

proposed rule intended to enable

consumers to read and understand OTC

drug product labeling and to more

effectively apply the information in the

labeling to the safe and effective use of

such products. An important element of

FDA’s proposed rule is a standardized

labeling format for OTC drug products.

After issuing the proposed rule, FDA

published in the Federal Register a

notice under the Paperwork Reduction

Act of 1995 announcing the agency’s

intention to conduct four studies

relating to OTC drug products (62 FR

28482, May 23, 1997). The agency

intends at this time to use two of the

studies (‘‘Evaluation of Proposed Overthe-Counter (OTC) Label Formats, Study

A,’’ and ‘‘Over-the-Counter (OTC) Label

Format Preference, Study B’’ ) in

deliberations on developing a

standardized, easy to read and easy to

understand, labeling format for OTC

drug products (see 62 FR 9024). The

data and frequency tabulations for one

of these studies, Study B, are now

available.

In Study B, consumers were invited to

view examples and variations of current

OTC label designs. Respondents were

asked to indicate their preference for

various designs and to evaluate labeling

terminology and graphics to help the

agency understand how consumers

interpret various ways of

communicating drug safety and drug

effectiveness information. The agency is

now seeking comments on the data

developed under Study B, including the

opinions of the respondents on the

various labeling format elements used in

the Study. The comments on Study B

will be included in the agency’s

deliberations on developing a final,

standardized OTC labeling format

regulation.

After the results for Study A are

tabulated, the agency will publish a

notice in the Federal Register

announcing when the data and

tabulations are available for viewing.
Federal Register / Vol. 62, No. 249 / Tuesday, December 30, 1997 / Proposed Rules 67771

Interested persons may, on or before

February 13, 1998, submit written

comments on the data developed under

Study B 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 and labeled ‘‘ATTN: Study B,

OTC Drug Labeling Data Collection.’’

The data, frequency tabulations, and

received comments may be seen in the

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

Monday through Friday. An electronic

format of the data are available on the

internet at: www.fda.gov/CDER/ or can

be obtained in electronic form from the

Dockets Management Branch at the

address listed above.

Dated: December 19, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–33803 Filed 12–29–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket Nos. 91N–384H and 96P–0500]

RIN 0910–AA19

Food Labeling: Nutrient Content

Claims, Definition of Term: Healthy

AGENCY: Food and Drug Administration,

HHS.

ACTION: Advance notice of proposed

rulemaking.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that it is considering whether to

institute rulemaking to reevaluate and

possibly amend certain provisions of the

nutrient content claims regulations

pertaining to the use of the term

‘‘healthy.’’ This action is in response to

a citizen petition from ConAgra, Inc., to

amend the definition of this term. The

petitioner has raised important issues

regarding both the technological

feasibility of reductions in sodium

levels in foods that currently meet

FDA’s definition for the term ‘‘healthy’’

and the safety of at least some of these

foods if there are reductions in their

sodium levels. The agency is requesting

that data be submitted relative to these

issues. In addition, FDA is responding

to comments that it received in response

to a stay of certain provisions pertaining

to the use of the term ‘‘healthy.’’

DATES: Written comments by March 16,

1998.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Joyce J. Saltsman, Center for Food Safety

and Applied Nutrition (HFS–165), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–5483.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of May 10,

1994 (59 FR 24232), FDA published a

final rule to establish a definition of the

term ‘‘healthy’’ under section 403(r) of

the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 343(r)). In that

final rule, FDA stated that the

fundamental purpose of a ‘‘healthy’’

claim is to highlight those foods that,

based on their nutrient levels, are

particularly useful in constructing a diet

that conforms to current dietary

guidelines (59 FR 24232 at 24233). In its

consideration of comments relative to

the proposed qualifying level of sodium

to be incorporated into the definition of

the term ‘‘healthy,’’ the agency rejected

comments that suggested that the food

should meet the requirements for ‘‘low

sodium’’ (59 FR 24232 at 24239). The

agency stated that such a definition was

too restrictive, and that many foods that

would otherwise meet the definition of

‘‘healthy’’ would be disqualified by a

‘‘low sodium’’ requirement. The agency

stated that for the claim to be useful,

foods that are able to bear the term

should be of a sufficient number and

variety to help consumers achieve a

total diet that is consistent with current

dietary recommendations (59 FR 24232

at 24239).

The agency explained that sodium

plays an important role in consumer

acceptance of a product, and that many

products that qualify to bear a claim for

‘‘healthy’’ may lose their appeal to

consumers because of an unacceptable

flavor profile if, in addition to being low

in fat and saturated fat, the foods were

low in sodium. FDA stated that, if

consumers abandon products or add salt

to taste at the table, foods bearing the

term would lose their usefulness in

assisting consumers to achieve dietary

recommendations with respect to

sodium intake (59 FR 24232 at 24239).

Based on the comments to the

proposed rule for ‘‘healthy’’ relative to

specific sodium levels, the agency

adopted qualifying criteria of 360

milligrams (mg) of sodium per reference

amount customarily consumed (RACC)

in individual foods and 480 mg sodium

per RACC in main dish and meal

products (59 FR 24232 at 24240). In

addition, the agency established a

transition period to allow time for

industry to reformulate products to meet

the new qualifying sodium levels. The

agency determined that levels of 480 mg

of sodium in individual foods, single

ingredient seafood, and game meat, and

of 600 mg of sodium in main dishes and

meal products, were appropriate levels

during the transition period, but that

after January 1, 1998 (essentially 3-1/2

years from the date of publication of the

final rule), these foods would have to

meet the lower sodium qualifying levels

to bear the claim ‘‘healthy’’ (59 FR

24232 at 24241 and 24245 and see

§ 101.65(d)(2)(ii), (d)(3)(ii), and (d)(4)(ii)

(21 CFR 101.65(d)(2)(ii), (d)(3)(ii), and

(d)(4)(ii))).

On December 13, 1996, FDA received

a petition from ConAgra, Inc. (the

petitioner), 888 17th St. NW., suite 300,

Washington, DC 20006, requesting that

§ 101.65(d) be amended to ‘‘eliminate

the sliding scale sodium requirement for

foods labeled ‘healthy’ by eliminating

the entire second tier levels of 360 mg

sodium for individual foods and 480 mg

sodium for meals and main dishes’’

(Docket 96P–0500, CP–1, p. 1).

Alternatively, the petitioner requested

that the effective date of January 1,

1998, in § 101.65(d)(2) through (d)(4) be

delayed until such time as food

technology catches up with FDA’s goals

to reduce the sodium content of foods,

and until there is a better understanding

of the relationship between sodium and

hypertension.

The agency was persuaded by the

petition that it is in the public interest

to stay the effect of the lower standards

for sodium in the definition of

‘‘healthy’’ in § 101.65 while the agency

endeavors to resolve the issues raised by

the petition. Therefore, in the Federal

Register of April 1, 1997 (62 FR 15390),

FDA published a final rule that stayed,

until January 1, 2000, the effective date

of January 1, 1998, in § 101.65(d)(2)(ii)

and (d)(4)(ii) for when foods must

achieve the lower sodium levels (the

‘‘second tier levels’’) to qualify to bear

the term ‘‘healthy.’’ The agency said that

it was issuing the stay to allow itself

time to reevaluate the standard, and to

evaluate the data contained in the

petition and any additional data that it

may receive; to conduct any subsequent

notice-and-comment rulemaking that it

finds is necessary; and to allow ample

time for implementation of the rule or

of any changes in the rule that may

result from the agency’s reevaluation.