26978 Federal Register / Vol. 63, No. 94 / Friday, May 15, 1998 /Rules and Regulations

Coyle VORTAC

(lat. 39°49′02′′N., long. 74°25′54′′W.)

Robbinsville VORTAC

(lat. 40°12′08′′N., long. 74°29′43′′W.)

That airspace extending upward from 700

feet above the surface within a 6.4-mile

radius of Lakewood Airport and within a

10.5-mile radius of McGuire AFB and within

a 11.3-mile radius of the Lakehurst (Navy)

TACAN extending clockwise from the

Lakehurst (Navy) Tacan 310° radial to the

148° radial and within 4.4 miles each side of

the Coyle VORTAC 031° radial extending

from the VORTAC to 11.3 miles northeast

and within 2.6 miles southwest and 4.4 miles

northeast of the Lakehurst (Navy) TACAN

148° radial extending from the TACAN to

12.2 miles southeast and within a 6.4-mile

radius of Trenton-Robbinsville Airport and

within 5.7 miles north and 4 miles south of

the Robbinsville VORTAC 278° and 098°

radials extending from 4.8 miles west to 10

miles east of the VORTAC and within a 6.7-

mile radius of Allaire Airport and within 1.8

miles each side of the Colts Neck VOR/DME

167° radial extending from the Allaire

Airport 6.7-mile radius to the VOR/DME and

within 4 miles each side of the 312° bearing

from the Allaire airport extending from the

6.7-mile radius of the airport to 9 miles

northwest of the airport and within 9.5-mile

radius of Flying W Airport and within a 6.5-

mile radius of Robert J. Miller Air Park and

within 1.3 miles each side of the Coyle

VORTAC 044° radial extending from the 6.5-

mile radius of Robert J. Miller Air Park to the

VORTAC, excluding the portions that

coincide with the Berlin, NJ, Princeton, NJ,

Vincentown, NJ, Old Bridge, NJ, Matawan,

NJ, and North Philadelphia, PA Class E

airspace areas.

* * * * *

Issued in Jamacia, New York on May 6,

1998.

Franklin D. Hatfield,

Manager, Air Traffic Division, Eastern Region.

[FR Doc. 98–12984 Filed 5–14–98; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Airspace Docket No. 98–AEA–04]

Amendment to Class E Airspace;

Downingtown, PA

AGENCY: Federal Aviation

Administration (FAA) DOT.

ACTION: Final rule.

SUMMARY: This action removes Class E

airspace at Shannon Memorial Field

Airport, Downingtown, PA. All

instrument procedures for the airport

have been cancelled. The need for Class

E airspace no longer exists for

Instrument Flight Rules (IFR) operations

at the airport. This action will result in

the airspace reverting to Class G

airspace.

EFFECTIVE DATE: 0901 UTC, August 13,

1988.

FOR FURTHER INFORMATION CONTACT:

Mr. Francis Jordan, Airspace Specialist,

Airspace Branch, AEA–520, Air Traffic

Division, Eastern Region, Federal

Aviation Administration, Federal

Building # 111, John F. Kennedy

International Airport, Jamaica, New

York 11430; telephone: (718) 553–4521.

SUPPLEMENTARY INFORMATION:

History

On April 3, 1998, a proposal to amend

Part 71 of the Federal Aviation

Regulations (14 CFR part 71) to remove

the Class E airspace extending upward

from 700 feet above the surface at

Shannon Memorial Field Airport,

Downingtown, PA, was published in the

Federal Register (63 FR 16451).

Interested parties were invited to

participate in this rulemaking

proceeding by submitting written

comments on the proposal to the FAA.

No comments to the proposal were

received. The rule is adopted as

proposed. The coordinates for this airspace

docket are based on North American

Datum 83. Class E airspace areas

designations for airspace extending

upward from 700 feet AGL are

published in paragraph 6005 of FAA

Order 7400.9E, dated September 10,

1997, and effective September 16, 1997,

which is incorporated by reference in 14

CFR 71.1. The Class E airspace

designation listed in this document will

be removed subsequently from the

Order.

The Rule

This amendment to Part 71 of the

Federal Aviation Regulations (14 CFR

Part 71) removes Class E airspace at

Downingtown, PA. The need for

controlled airspace extending from 700

feet AGL at the Shannon Memorial Field

Airport no longer exists. This area will

be removed from the appropriate

aeronautical charts.

The FAA has determined that this

regulation only involves an established

body of technical regulations from

which frequent and routine

amendments are necessary to keep them

operationally current. Therefore, this

regulation—(1) is not a ‘‘significant

regulatory action’’ under Executive

Order 12866; (2) is not a ‘‘significant

rule’’ under DOT Regulatory Policies

and Procedures (44 FR 11034; February

26, 1979); and (3) does not warrant

preparation of a Regulatory Evaluation

as the anticipated impact is so minimal.

Since this is a routine matter that will

only affect air traffic procedures and air

navigation it is certified that this rule

will not have significant economic

impact on a substantial number of small

entities under the criteria of the

Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference,

Navigation (air).

Adoption of the Amendment

In consideration of the foregoing, the

Federal Aviation Administration

amends 14 CFR part 71 as follows:

PART 71—[AMENDED]

1. The authority citation for 14 CFR

part 71 continues to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113,

40120; EO 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p.389.

§ 71.1 [Amended]

The incorporation by reference in 14

CFR 71.1 of Federal Aviation

Administration Order 7400.9E, Airspace

Designations and Reporting Points,

dated September 10, 1997, and effective

September 16, 1997, is amended as

follows:

Paragraph 6005 Class E airspace areas

extending upward from 700 feet or more

above the surface of the earth.

* * * * *

AEA PA E5, Downingtown, PA [Removed]

* * * * *

Issued in Jamaica, New York, on May 6,

1998.

Franklin D. Hatfield,

Manager, Air Traffic Division, Eastern Region.

[FR Doc. 98–12983 Filed 5–14–98; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 98N–0283]

Food Labeling; Nutrient Content

Claims—General Provisions

AGENCY: Food and Drug

Administration, HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending its

regulations for nutrient content claims

by revoking the requirement that the

label or labeling of a food for which a

nutrient content claim is made must

bear a ‘‘referral statement’’ that directs

consumers’ attention to the panel on the

label or labeling that bears nutrition
Federal Register / Vol. 63, No. 94 / Friday, May 15, 1998 /Rules and Regulations 26979

information. FDA is taking this action in

response to section 305 of the Food and

Drug Administration Modernization Act

of 1997 (FDAMA). FDA also is making

some technical conforming amendments

to the regulations.

DATES: The regulation is effective May

15, 1998, except for the amendment to

§ 101.13(q)(3)(ii) (21 CFR

101.13(q)(3)(ii)) that will be effective

March 23, 1999. Written comments by

June 15, 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:

Hilario R. Duncan, Center for Food

Safety and Applied Nutrition (HFS–24),

Food and Drug Administration, 200 C

St. SW., Washington, DC 20204, 202–

205–8281.

SUPPLEMENTARY INFORMATION: On

November 21, 1997, President Clinton

signed into law FDAMA (Pub. L. 105–

115). Section 305 of FDAMA amended

section 403(r)(2)(B) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 343(r)(2)(B)) to eliminate the

requirement that referral statements be

made on food labeling whenever

nutrient content claims are made.

Section 305 of FDAMA retained the

requirement that there be disclosure

statements when FDA determines that

the food for which the nutrient content

claim is to be made contains a nutrient

at a level that increases to persons in the

general population the risk of a disease

or health related condition that is diet

related, although section 305 of FDAMA

changed how the disclosure statement

should be worded. The act as amended

by the Nutrition Labeling and Education

Act of 1990 had previously mandated

referral statements whenever nutrient

content claims were made on the label

or labeling of a food product.

FDA is revising § 101.13 (21 CFR

101.13) to reflect the statutory changes

of FDAMA. The agency is doing so by

removing the introductory text of

§ 101.13(g), which requires referral

statements whenever nutrient content

claims are made; by redesignating and

amending § 103.13(g)(1), (g)(2), and

(g)(3), which specify the size and

placement of referral statements, as

paragraphs (h)(4)(i), (h)(4)(ii), and

(h)(4)(iii), respectively, to specify the

size and placement of disclosure

statements; by revising § 101.13(h)(1) to

make the disclosure statement language

conform to that required by Section 305

of FDAMA; and by making other

conforming revisions.

Under amended section 403(r)(2)(B) of

the act, and the conforming rule set

forth in this document, affected food

products are misbranded unless they

contain the disclosure statement ‘‘See

nutrition information for ll content.’’

This disclosure statement replaces the

disclosure statement currently set forth

in § 101.13(h), which states: ‘‘See

[appropriate panel] for information

about [nutrient requiring disclosure]

and other nutrients.’’ FDA does not

believe that Congress intended that food

producers immediately relabel their

products to include the new disclosure

statement, which would create an

unnecessary economic burden on them,

especially as the old disclosure

statement is not false or misleading.

Accordingly, FDA advises that, with

respect to food products that are subject

to the requirements of § 101.13(h), the

agency intends at this time to exercise

its enforcement discretion by refraining

from taking regulatory action against

them solely because they continue to

use the disclosure statement ‘‘See

[appropriate panel] for information

about [nutrient requiring disclosure]

and other nutrients.’’ FDA encourages

food producers to revise the labeling for

their products that fall under the

requirements of § 101.13(h) to include

the new disclosure statement ‘‘See

nutrition information for ll content’’

as soon as possible but no later than the

next scheduled redesign of the product’s

label or labeling. Finally, FDA advises

that food producers may continue to use

the referral statement previously

required under § 101.13(g). Because that

referral statement is not false or

misleading, such a referral statement

would not be prohibited under the act.

FDA is also taking this opportunity to

correct an error that occurs in the

current issue of the Code of Federal

Regulations (CFR) in § 101.13(g)(1). In

the Federal Register of August 12, 1997

(62 FR 43071), in the document entitled

‘‘Food and Cosmetic Labeling;

Revocation of Certain Regulations,’’

FDA revoked § 101.2(c)(1), (c)(2), and

(c)(3) (21 CFR 101.2(c)(1), (c)(2), and

(c)(3)) and redesignated remaining

paragraphs (c)(4) and (c)(5) as

paragraphs (c)(1) and (c)(2),

respectively. In making this change,

however, FDA inadvertently neglected

to change the citation to § 101.2(c)(5)

that appeared in § 101.13(g)(1). FDA is

correcting that inadvertent omission in

§ 101.13. Additionally, in a document

entitled ‘‘Food Labeling; General

Requirements for Health Claims for

Food’’ (see 58 FR 2478 at 2534, January

6, 1993), FDA inadvertently used the

term ‘‘referral’’ instead of the preferred

term ‘‘disclosure’’, in issuing

§ 101.14(e)(3) (21 CFR 101.14(e)(3)).

FDA is correcting that error in

§ 101.14(e)(3).

The agency has determined under 21

CFR 25.30(k) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

FDA has examined the economic

implications of this final rule under

Executive Order 12866. Executive Order

12866 directs agencies to assess all costs

and benefits of available regulatory

alternatives and, when regulation is

necessary, to select the regulatory

approach that maximizes net benefits

(including potential economic,

environmental, public health and safety

effects; distributive impacts; and

equity). Executive Order 12866

classifies a rule as significant if it meets

any one of a number of specified

conditions, including having an annual

effect on the economy of $100 million

or adversely affecting in a material way

a sector of the economy, competition, or

jobs, or if it raises novel legal or policy

issues. The agency finds that this final

rule is not a significant rule as defined

by Executive Order 12866. No analysis

is required for this rule under the

Regulatory Flexibility Act (5 U.S.C.

601–612) because, as discussed herein,

FDA is issuing it without publishing a

general notice of proposed rulemaking.

Finally, in accordance with the Small

Business Regulatory Enforcement

Fairness Act, the administrator of the

Office of Information and Regulatory

Affairs of the Office of Management and

Budget has determined that this final

rule is not a major rule for the purpose

of congressional review.

FDA concludes that the labeling

requirements in this final rule are not

subject to review by the Office of

Management and Budget because they

do not constitute a ‘‘collection of

information’’ under the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501–

3520). Rather, the labeling statements

are ‘‘public disclosure of information

originally supplied by the Federal

Government to the recipient for the

purpose of disclosure to the public’’ (5

CFR 1320.3(c)(2)).

Because FDA is revoking a

requirement (referral statements for all

nutrient content claims) that was issued

under legal authority that has been

eliminated by Congress in FDAMA,

FDA finds, for good cause, that notice

and public procedure on this rule are

unnecessary and, therefore, are not

required under 5 U.S.C. 553.
26980 Federal Register / Vol. 63, No. 94 / Friday, May 15, 1998 /Rules and Regulations

Nonetheless, under 21 CFR 10.40(e),

FDA is providing an opportunity for

comment on whether the regulations set

forth below should be modified or

revoked.

Interested persons may, on or before

June 15, 1998, submit to the Dockets

Management Branch (address above)

written comments regarding this final

rule. 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. Received comments may be

seen in the office above between 9 a.m.

and 4 p.m., Monday though Friday.

List of Subjects in 21 CFR Part 101

Food labeling, Nutrition, Reporting

and recordkeeping requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 101 is

amended as follows:

PART 101—FOOD LABELING

1. The authority citation for 21 CFR

part 101 continues to read as follows:

Authority: 15 U.S.C. 1453, 1454, 1455; 21

U.S.C. 321, 331, 342, 343, 348, 371.

2. Section 101.13 is amended by

removing the introductory text of

paragraph (g); by redesignating

paragraphs (g)(1), (g)(2), and (g)(3) as

paragraphs (h)(4)(i), (h)(4)(ii), and

(h)(4)(iii), respectively and reserving

paragraph (g); by removing the

introductory text of paragraph (h); by

revising paragraph (h)(1) and newly

redesignated paragraphs (h)(4)(i),

(h)(4)(ii), and (h)(4)(iii); in paragraphs

(j)(2)(ii) and (p)(2) by removing the

phrase ‘‘with paragraph (g)(1)’’ and

adding in its place the phrase ‘‘with

paragraph (h)(4)(i)’’; by revising the

second sentence in paragraph (q)(2) and

the last sentence in paragraph (q)(3)(ii);

in paragraph (q)(5)(i) by removing the

phrase ‘‘in paragraphs (g) and (h)’’ and

adding in its place the phrase ‘‘in

paragraph (h)’’; and in paragraph (q)(6)

by removing the phrase ‘‘of paragraphs

(b), (g), and (h)’’ and adding in its place

the phrase ‘‘of paragraphs (b) and (h)’’

to read as follows:

§ 101.13 Nutrient content claims—general

principles.

* * * * *

(h)(1) If a food, except a meal product

as defined in § 101.13(l), a main dish

product as defined in § 101.13(m), or

food intended specifically for use by

infants and children less than 2 years of

age, contains more than 13.0 g of fat, 4.0

g of saturated fat, 60 milligrams (mg) of

cholesterol, or 480 mg of sodium per

reference amount customarily

consumed, per labeled serving, or, for a

food with a reference amount

customarily consumed of 30 g or less or

2 tablespoons or less, per 50 g (for

dehydrated foods that must be

reconstituted before typical

consumption with water or a diluent

containing an insignificant amount, as

defined in § 101.9(f)(1), of all nutrients

per reference amount customarily

consumed, the per 50 g criterion refers

to the ‘‘as prepared’’ form), then that

food must bear a statement disclosing

that the nutrient exceeding the specified

level is present in the food as follows:

‘‘See nutrition information for ll

content’’ with the blank filled in with

the identity of the nutrient exceeding

the specified level, e.g., ‘‘See nutrition

information for fat content.’’

* * * * *

(4) * * *

(i) The disclosure statement ‘‘See

nutrition information for ll content’’

shall be in easily legible boldface print

or type, in distinct contrast to other

printed or graphic matter, and in a size

no less than that required by

§ 101.105(i) for the net quantity of

contents statement, except where the

size of the claim is less than two times

the required size of the net quantity of

contents statement, in which case the

disclosure statement shall be no less

than one-half the size of the claim but

no smaller than one-sixteenth of an

inch, unless the package complies with

§ 101.2(c)(2), in which case the

disclosure statement may be in type of

not less than one thirty-second of an

inch.

(ii) The disclosure statement shall be

immediately adjacent to the nutrient

content claim and may have no

intervening material other than, if

applicable, other information in the

statement of identity or any other

information that is required to be

presented with the claim under this

section (e.g., see paragraph (j)(2) of this

section) or under a regulation in subpart

D of this part (e.g., see §§ 101.54 and

101.62). If the nutrient content claim

appears on more than one panel of the

label, the disclosure statement shall be

adjacent to the claim on each panel

except for the panel that bears the

nutrition information where it may be

omitted.

(iii) If a single panel of a food label

or labeling contains multiple nutrient

content claims or a single claim

repeated several times, a single

disclosure statement may be made. The

statement shall be adjacent to the claim

that is printed in the largest type on that

panel.

* * * * *

(q) * * *

(2) * * * Such claims are exempt

from the requirements of section

403(r)(2) of the act (e.g., the disclosure

statement also required by § 101.13(h)).

* * *

(3) * * *

(ii) * * * All such claims shall be

accompanied by any disclosure

statement required under paragraph (h)

of this section.

* * * * *

§ 101.14 [Amended]

3. Section 101.14 Health claims:

general requirements is amended in

paragraph (e)(3), in the 15th line by

removing the word ‘‘referral’’ and

adding in its place the word

‘‘disclosure’’.

4. Section 101.54 is amended by

revising paragraph (d)(2) to read as

follows:

§ 101.54 Nutrient content claims for ‘‘good

source,’’ ‘‘high,’’ ‘‘more,’’ and ‘‘potency.’’

* * * * *

(d) * * *

(2) The disclosure shall appear in

immediate proximity to such claim, be

in a type size no less than one-half the

size of the claim and precede any

disclosure statement required under

§ 101.13(h) (e.g., ‘‘contains [x amount]

of total fat per serving. See nutrition

information for fat content’’).

* * * * *

§ 101.62 [Amended]

5. Section 101.62 Nutrient content

claims for fat, fatty acid, and cholesterol

content of foods is amended in

paragraphs (d)(1)(ii)(D), (d)(2)(iii)(C),

(d)(2)(iv)(C), (d)(4)(ii)(C), and

(d)(5)(ii)(C) by removing the phrase ‘‘the

referral statement required in

§ 101.13(g)’’ wherever it appears and by

adding in its place the phrase ‘‘any

disclosure statement required under

§ 101.13(h)’’.

* * * * *

Dated: May 6, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–12833 Filed 5-14-98; 8:45 am]

BILLING CODE 4160–01–F