Federal Register / Vol. 62, No. 51 / Monday, March 17, 1997 / Proposed Rules 12579

Availability of NPRM’s

Any person may obtain a copy of the

Notice of Proposed Rulemaking (NPRM)

by submitting a request to the Federal

Aviation Administration, Office of

Public Affairs, Attention: Public Inquiry

Center, APA–230, 800 Independence

Avenue, SW., Washington, DC 20591, or

by calling (202) 267–3484.

Communications must identify the

notice number of this NPRM. Persons

interested in being placed on a mailing

list for future NPRM’s should also

request a copy of Advisory Circular No.

11–2A, which describes the application

procedure.

The Proposal

The FAA is considering an

amendment to part 71 of the Federal

Aviation Regulations (14 CFR part 71) to

modify Class E airspace at Manitowish,

WI; this proposal would provide

adequate Class E airspace for operators

executing the GPS Runway 32 SIAP at

Manitowish Waters Airport. Controlled

airspace extending upward from 700 to

1200 feet AGL is needed to contain

aircraft executing the approach. The

intended affect of this action is to

provide segregation of aircraft using

instrument approach procedures in

instrument conditions from other

aircraft operating in visual weather

conditions. The area would be depicted

on appropriate aeronautical charts

thereby enabling pilots to

circumnavigate the area or otherwise

comply with IFR procedures. Class E

airspace designations for airspace areas

extending upward from 700 feet or more

above the surface of the earth are

published in paragraph 6005 of FAA

Order 7400.9D dated September 4, 1996,

and effective September 16, 1996, which

is incorporated by reference in 14 CFR

71.1. The Class E airspace designation

listed in this document would be

published subsequently in the Order.

The FAA has determined that this

proposed regulation only involves an

established body of technical

regulations for which frequent and

routine amendments are necessary to

keep them operationally current.

Therefore this, proposed 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 proposed rule will

not have a 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).

The Proposed Amendment

Accordingly, pursuant to the

authority delegated to me, the Federal

Aviation Administration proposes to

amend part 71 of the Federal Aviation

Regulations (14 CFR part 71) as follows:

PART 71—[AMENDED]

1. The authority citation for part 71

continues to read as follows:

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

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389; 14 CFR 11.69.

§ 71.1 [Amended]

2. The incorporation by reference in

14 CFR 71.1 of the Federal Aviation

Administration Order 7400.9D, Airspace

Designations and Reporting Points,

dated September 4, 1996, and effective

September 16, 1996, is amended as

follows:

Paragraph 6005 Class E airspace areas

extending upward from 700 feet or more

above the surface of the earth.

* * * * *

AGL WI E5 Manitowish, WI [Revised]

Manitowish Waters Airport

(Lat. 46°07′19′′ N, long. 89°52′56′′ W)

That airspace extending upward from 700

feet above the surface within a 7-mile radius

of the Manitowish Waters Airport and within

4 miles each side of the 141° bearing from the

airport extending from the 7-mile radius to 9

miles southeast of the airport, excluding that

airspace within the Minocqua-Woodruff

Class E airspace.

* * * * *

Issued in Des Plaines, Illinois on February

27, 1997.

Maureen Woods,

Manager, Air Traffic Division.

[FR Doc. 97–6619 Filed 3–14–97; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 97N–0075]

Food Labeling; Timeframe for Final

Rules Authorizing Use of Health

Claims

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend its regulations to provide a

timeframe in which it will issue final

rules in rulemakings on health claims

announcing whether it will authorize

the use of the claim at issue. FDA is also

providing for extensions of that

timeframe for cause. The agency is

issuing this proposal in response to a

recent judicial decision.

DATES: Written comments by April 16,

1997. The agency is proposing that any

final rule that may issue based on this

proposal become effective 30 days after

the date of its publication.

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

Section 403(r) of the Food, Drug, and

Cosmetic Act (the act) (21 U.S.C. 343(r)),

which was added by the Nutrition

Labeling and Education Act of 1990 (the

1990 amendments), provides for claims

on the label and in the labeling of food

that characterize the relationship of

nutrients to a disease or health-related

condition. In providing for these claims,

called ‘‘health claims,’’ the act treats

conventional foods differently than

dietary supplements. For conventional

foods, the act sets out the procedure and

standard that FDA is to use in deciding

whether to authorize health claims. For

dietary supplements, the act states that

health claims for these products are to

be subject to a procedure and standard

established by regulation of the

Secretary of Health and Human Services

(the Secretary), and by delegation FDA

(section 403(r)(5)(D) of the act).

In January 1994, FDA completed a

rulemaking to implement the health

claim provisions of the act for dietary

supplements. FDA decided to adopt the

procedure and standard established in

the act for health claims for

conventional foods as the procedure and

standard for dietary supplements (59 FR

395 at 405, January 4, 1994). Thus,

health claims can be made for dietary

supplements if FDA determines that the

relationship between the substance and

disease that are the subjects of the claim

is scientifically valid, as well as truthful

and not misleading. The standard that
12580 Federal Register / Vol. 62, No. 51 / Monday, March 17, 1997 / Proposed Rules

FDA uses in determining scientific

validity is set out in 21 CFR 101.14(c)

of the agency’s regulations, as well as in

section 403(r)(3)(B)(i) of the act. It

requires that the agency determine,

based on the totality of publicly

available scientific evidence (including

evidence from well-designed studies

conducted in a manner which is

consistent with generally recognized

scientific procedures and principles),

that there is significant scientific

agreement, among experts qualified by

scientific training and experience to

evaluate such claims, that the claim is

supported by such evidence.

People interested in having the

agency authorize health claims about a

particular nutrient-disease relationship

may petition the agency to do so (see

§ 101.70 (21 CFR 101.70)). Under the

procedure adopted by FDA, which

parallels that in section 403(r)(4)(A)(i) of

the act and, thus, applies to both

conventional foods and dietary

supplements, within 100 days of the

date that it receives the petition, the

agency will notify the petitioner by

letter that the petition has either been

filed for comprehensive review or

denied. If the agency files the petition,

within 90 days of filing, FDA will either

deny it or advise the petitioner that a

proposal to authorize the use of health

claims about the subject substance/

disease relationship will be published

in the Federal Register. However,

consistent with section 403(r)(4)(A)(i) of

the act, FDA made no mention in its

regulations of when a final rule on the

health claim would be issued, even

though it was asked to do so by a

number of comments (59 FR 395 at 420).

In the wake of its adoption of the

regulations on health claims for dietary

supplements, FDA was sued several

times by dietary supplement trade

associations, manufacturers, retailers,

and individuals, on the grounds that the

agency regulations violate the First

Amendment to the United States

Constitution. One of these cases,

Nutritional Health Alliance v. Shalala,

95 Civ. 4950 (RO) (S.D.N.Y.), was

recently decided by Judge Richard

Owen. In its decision, the District Court

reviewed FDA’s regulations under the

four prong test, established in Central

Hudson Gas & Electric Corp. v. Public

Service Commission of New York, 447

U.S. 557 (1980) (Central Hudson test),

for determining whether a particular

regulation of commercial speech

survives scrutiny under the First

Amendment.

After finding that not all potential

health claims are inherently misleading,

and thus that such claims are entitled to

some First Amendment protection (slip

op. at 7), the court concluded that FDA’s

regulations were supported by a

substantial governmental interest:

‘‘preventing the spread of

unsubstantiated health claims on labels

so that consumers may not be deceived

and follow unsound health practices;

ensuring the reliability of scientific

information disseminated in connection

with the sale of dietary supplements;

and protecting consumers from being

induced to purchase products by

misleading information on labels.’’ (Slip

op. at 8.) The court also found that

FDA’s regulation directly and materially

advanced the substantial governmental

interest. Thus, the court found no

problem for FDA’s regulations under the

first three parts of the Central Hudson

test.

However, under the fourth part of the

test, that the regulation be narrowly

tailored to advance the governmental

interest, the court found a vulnerability.

While the District Court found that the

regulations did not cover more speech

than necessary (slip op. at 8–9), it found

that, once the agency had proposed to

allow a particular health claim, the

absence of a timeframe for the issuance

of a final rule on whether a health claim

would be authorized failed to meet

Central Hudson’s fourth prong and,

thus, violated the First Amendment

(slip op. at 9).

Accordingly, the court ordered FDA

to establish a reasonable time limit for

the issuance of a final rule for a health

claim on dietary supplement labels. The

court directed the agency to, within 90

days of the date of its order (January 31,

1997), submit such a regulation to the

court for review of its reasonableness

and for the entry of such further orders

as may be appropriate (slip op. at 12).

While FDA does not agree with

aspects of the court’s opinion, it has

decided that, on balance, given the

general affirmance of the agency’s

regulations in the court’s opinion, the

most efficient course is to proceed to

develop the regulation required by the

court, to submit it to the court for

review, and not to appeal at this time.

Moreover, given the parallel procedures

for dietary supplements and

conventional foods, FDA has decided to

propose to establish a timeframe for

final rules on health claims for

conventional foods as well as for dietary

supplements.

II. The Proposal

A. Time for Review

FDA has carefully considered how

much time to provide for itself between

the issuance of a proposal to authorize

a particular health claim and the

issuance of a final rule. On the one

hand, it is important that the agency

establish a timeframe that it can

reasonably expect to meet on a regular

basis. On the other hand, the agency

should not provide itself with so much

time that authorization of a health claim

will be unreasonably delayed.

In 1994, in rejecting comments that

requested the establishment of such a

timeframe, FDA expressed concern

about various factors, including work

priorities, the availability of personnel,

and limitations on agency resources. It

is significant to note that each of these

factors has been a problem in the health

claim rulemakings that FDA has

completed since 1994. Thus, each of the

above concerns continues to cause the

agency to question its ability to set a

timeframe to which it can reasonably

expect, and can reasonably be expected,

to adhere. This is particularly the case

because FDA has no control over the

number of petitions that are filed, and

it is obligated to review and act on the

petitions that it receives. Nonetheless,

based on its experience since 1994 in

issuing final rules on folic acid and

neural tube defects, sugar alcohols and

dental caries, and soluble fiber from

whole oat products and coronary heart

disease, FDA finds that it can delineate

the steps involved in the production of

a final rule and provide a reasonable

estimate of how long each step is likely

to take.

The steps in the production of a final

rule include:

1. A comment period—FDA generally

provides 75 days for comments on

proposals. Because of the broad interest

in health claims, however, FDA

provided 90 days or more for comments

in the sugar alcohols and oat bran and

oatmeal rulemakings. To ensure that a

final rule is issued as quickly as

practicable, FDA intends to adhere to a

75-day limit on comment periods in

future health claim rulemakings and to

not consider comments that are received

after the close of the comment period.

2. Reviewing and responding to

comments and developing a draft final

rule—The number of letters that FDA

has received on health claim proposals

issued in response to petitions has

ranged from as high as approximately

1,500 letters, in response to the proposal

on oatmeal and oat bran and the risk of

coronary heart disease, to as few as 20

letters in response to the proposal on

sugar alcohols and the risk of dental

caries. The number of letters, however,

understates the agency’s task in

developing a final rule because many

letters comment on more than one issue.

Thus, it is necessary for FDA to review

the letters, catalogue all the comments,
Federal Register / Vol. 62, No. 51 / Monday, March 17, 1997 / Proposed Rules 12581

group related comments together, and

then formulate a response to each issue

raised. This would seem to be a fairly

straightforward process, given that FDA

has already made a tentative

determination to authorize the claim. In

practice, however, this process has

proven not to be a simple one.

In the oat proceeding, FDA received a

large number of comments that

requested that the agency authorize the

claim for a substance not covered by its

tentative determination, whole oat flour.

In deciding how to respond to these

requests, FDA had to balance the

interest in a prompt decision against the

value to the public health of taking the

time to decide whether the important

health information provided by the

health claim could appropriately appear

on a broader range of foods. To make

this choice, development of the

document had to be delayed while the

agency evaluated the scientific evidence

supporting the request and the import of

that evidence. FDA ultimately chose to

authorize the health claim on a broader

range of foods, but the time involved in

choosing this course added months to

the time that it took FDA to develop the

final rule.

In addition, limitations on the

agency’s resources and the competing

priorities to which the agency is often

subject can combine to cause

interruptions in the development of a

final rule. For example, the

development of the final rule on sugar

alcohols was interrupted on two

occasions because of the filing of new

health claim petitions and the agency’s

desire to conform to the statute’s

requirement that action be taken on

petitions within 190 days. The same

people who were charged with drafting

the final rule also were responsible for

drafting the responses to the new

petitions. Thus, the development of the

final rule on sugar alcohols was

significantly delayed.

Moreover, in the development of final

rules, FDA considers it important to

obtain input from other parts of the

Department of Health and Human

Services (the Department) (such as from

the National Institutes of Health or from

the Centers for Disease Control and

Prevention) and from other parts of the

Federal Government (e.g. the U.S.

Department of Agriculture) that have

relevant expertise. There is a

widespread expectation among the

public, including the regulated industry,

that FDA will solicit this input, and

given the public health significance of

the issues in a health claim proceeding,

FDA considers it important that it do so.

Yet, obtaining the input of the experts

involved can add at least weeks to the

process of developing a final rule

because the scientists that are consulted

have their own work, and FDA’s request

for review is in competition with that

work. Moreover, there sometimes are

disagreements among the scientists

consulted, and these disagreements

must be resolved before a final rule can

issue.

For all these reasons, drafting a final

rule involves much more than reading

comments, summarizing them, and

preparing answers. FDA tentatively

concludes that, given the problems

associated with this task, it is reasonable

to provide 5 months (150 days) between

the close of the comment period and the

completion of a draft final rule that can

be forwarded to the Commissioner of

Food and Drugs (the Commissioner) for

his or her signature.

3. Review and endorsement by the

Commissioner—FDA tentatively finds

that it is appropriate to allow 1 month

(30 days) for clearance of the final rule

for publication. Although the

Commissioner has generally been

delegated sign off authority under the

act by the Secretary (21 CFR 5.10 of

FDA’s regulations), other factors, such

as final legal and policy review, require

that 30 days be provided for this aspect

of the process.

For example, given the public health

significance of health claims and the

involvement of various parts of the

Department in the development of

health claim documents, there is

continuing interest from the Office of

the Secretary in health claim matters.

Thus, time must be reserved to

accommodate the Secretary, should he

or she desire to review the final rule. In

addition, under Executive Order 12866,

the Office of Management and Budget

(OMB) may choose to review a health

claim final rule although it has generally

not done so. Given the potential

involvement of these other entities, FDA

tentatively concludes that it is

appropriate to reserve 1 month for the

review and endorsement of any draft

health claim final rule.

Taken together, these estimated

timeframes total approximately 255

days. Based on these estimates, and the

fact it is reasonable to allow 15 days for

the inevitable slippage that occurs in the

rulemaking process, FDA is proposing

to adopt § 101.70(j)(4)(i), which states

that within 270 days of the publication

of the proposal, FDA will publish a final

rule either authorizing the use of a

health claim or explaining why it has

decided not to authorize one.

FDA notes that the 270 days that it is

proposing for production of a final rule

is approximately 90 days less than the

time that it took from proposal to final

rule in both the whole oat products and

sugar alcohols rulemakings. It is also 90

days less than the agency was granted

by the 1990 amendments between the

proposals and final rules on the 10

health claim topics that it was required

to address. Nonetheless, FDA is

committed, as it told the court (slip op.

at 10), to issue final regulations as

quickly as possible. Therefore, it is

proposing to abide by a 9-month

timeframe.

B. Extension of Time

In its opinion, the District Court

recognized that FDA may receive

information during the comment period

that could require that the agency

rethink whether to authorize a health

claim. The court stated that such

circumstances could be handled by an

extension, founded on a showing of

cause (slip op. at 10 n. 14).

Consistent with the court’s statement,

FDA is providing in proposed

§ 101.70(j)(4)(ii) that it could grant itself

an extension beyond 270 days if cause

exists to justify such an extension. For

example, there may be circumstances in

which the comments are of such volume

(e.g., the soluble fiber from whole oats

rulemaking) or the controversy

surrounding an aspect of the health

claim is so great (e.g., the folic acid

rulemaking) that the agency simply

finds that it cannot meet the 270 day

deadline. In such cases, under proposed

§ 101.70(j)(4)(ii), FDA will publish

notice of the extension in the Federal

Register. The notice will explain the

basis for the extension, the length of the

extension, and the date by which the

final rule will be published. The

extension would be for no longer than

necessary, and FDA would have to

explain the length of the extension. FDA

expects to grant itself such extensions

only on rare occasions.

III. Analysis of Impacts

A. Economic Impact

FDA has examined the impacts of the

proposed rule under Executive Order

12866 and the Regulatory Flexibility

Act. Executive Order 12866 directs

agencies to assess all costs and benefits

of available regulatory alternatives and,

when regulation is necessary, to select

regulatory approaches that maximize

net benefits (including potential

economic, environmental, public health

and safety, and other advantages;

distributive impacts; and equity). The

agency believes that this proposed rule

is consistent with the regulatory

philosophy and principles identified in

the Executive Order. In addition, the

proposed rule is not a significant
12582 Federal Register / Vol. 62, No. 51 / Monday, March 17, 1997 / Proposed Rules

regulatory action as defined by the

Executive Order and so is not subject to

review under the Executive Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. The agency is proposing only to

provide firms with a timeframe in

which they can expect health claim

final rules to issue. Thus, in accordance

with the Regulatory Flexibility Act, the

agency certifies that this proposed rule

will not have a significant economic

impact on a substantial number of small

entities. Therefore, under the Regulatory

Flexibility Act, no further analysis is

required.

B. Environmental Impact

The agency has determined under 21

CFR 25.24(a)(8) 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.

IV. Paperwork Reduction Act

FDA tentatively concludes that this

proposed rule contains no reporting

recordkeeping, labeling, or other third

party disclosure requirements. Thus

there are no ‘‘information collection’’

requirements necessitating clearance by

OMB. However, to ensure the accuracy

of this tentative conclusion, FDA is

seeking comment on whether this

proposed rule imposes any paperwork

burden.

V. Effective Date

FDA is proposing to make the

amendment to § 101.70, contained

herein, effective 30 days after the

publication of a final rule that may issue

based on this proposal.

VI. Comments

Interested persons may, on or before

April 16, 1997, submit to the Docket

Management Branch (address above)

written comments regarding this

proposal. FDA is limiting the comment

period to 30 days because it is necessary

to do so if the agency is to comply with

the District Court’s order of January 31,

1997, that it establish a timeframe for

issuance of final rules on health claims

within 90 days of that order. FDA could

not publish a final rule within that

timeframe if it permitted the normal 75-

day comment period.

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 my be

seen in the Dockets Management Branch

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

through 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, it is proposed that

21 CFR part 101 be amended as follows:

PART 101—FOOD LABELING

1. The authority citation for 21 CFR

part 101 continues to read as follows:

Authority: Secs. 4, 5, 6 of the Fair

Packaging and Labeling Act (15 U.S.C. 1453,

1454, 1455); secs. 201, 301, 402, 403, 409,

501, 502, 505, 701 of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 321, 331, 342,

343, 348, 351, 352, 355, 371).

2. Section 101.70 is amended by

adding new paragraph (j)(4) to read as

follows:

§ 101.70 Petitions for health claims.

* * * * *

(j) * * *

(4)(i) Within 270 days of the date of

publication of the proposal, FDA will

publish a final rule that either

authorizes use of the health claim or

explains why the agency has decided

not to authorize one.

(ii) For cause, FDA may extend the

period in which it will publish a final

rule. FDA will publish notice of the

extension in the Federal Register. The

document will explain the basis for the

extension, the length of the extension,

and the date by which the final rule will

be published.

Dated: March 4, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–6710 Filed 3–13–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Parts 1 and 301

[REG–208172–91]

RIN 1545–AU71

Basis Reduction Due to Discharge of

Indebtedness; Hearing

AGENCY: Internal Revenue Service,

Treasury.

ACTION: Proposed rule; change of date

and location of public hearing.

SUMMARY: This document changes the

date and location of the public hearing

on the notice of proposed rulemaking

relating to basis reduction due to

discharge of indebtedness under

sections 108 and 1017 of the Internal

Revenue Code of 1986.

DATES: The public hearing is being held

on Thursday, May 29, 1997, beginning

at 10 a.m. Requests to speak and

outlines of oral comments must be

received by April 3, 1997.

ADDRESSES: The public hearing

originally scheduled in the IRS

Auditorium, Internal Revenue Building,

1111 Constitution Avenue, NW.,

Washington, DC is changed to the

Commissioner’s Conference Room, room

3313, Internal Revenue Building, 1111

Constitution Avenue, NW., Washington,

DC.

FOR FURTHER INFORMATION CONTACT:

Evangelista Lee of the Regulations Unit,

Assistant Chief Counsel (Corporate),

(202) 622–7180 (not a toll-free number).

SUPPLEMENTARY INFORMATION: A notice

of proposed rulemaking and notice of

public hearing appearing in the Federal

Register on Tuesday, January 7, 1997,

(62 FR 955) announced that a public

hearing on proposed regulations relating

to the basis reduction due to discharge

of indebtedness under sections 108 and

1017 would be held on Thursday, April

24, 1997, beginning at 10 a.m. in the IRS

Auditorium, Internal Revenue Building,

1111 Constitution Avenue, NW.,

Washington, DC and that requests to

speak and outlines of oral comments

should be received by Thursday, April

3, 1997.

The date and location of the public

hearing has changed. The hearing is

scheduled for Thursday, May 29, 1997,

beginning at 10 a.m. in the

Commissioner’s Conference Room, room

3313, Internal Revenue Building, 1111

Constitution Avenue, NW., Washington,

DC. We must receive requests to speak

and outlines of oral comments by

Thursday, April 3, 1997. Because of the

controlled access restrictions, attenders

are not admitted beyond the lobby of the

Internal Revenue Building until 9:45

a.m.

The Service will prepare an agenda

showing the scheduling of the speakers

after the outlines are received from the

persons testifying and make copies

available free of charge at the hearing.

Cynthia E. Grigsby,

Chief, Regulations Unit, Assistant Chief

Counsel (Corporate).

[FR Doc. 97–6674 Filed 3–14–97; 8:45 am]

BILLING CODE 4830–01–U