This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

67513

Vol. 69, No. 222

Thursday, November 18, 2004

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket Nos. 1994P–0390 and 1995P–0241]

Food Labeling: Nutrient Content 

Claims, General Principles; Health 

Claims, General Requirements and 

Other Specific Requirements for 

Individual Health Claims; Reopening of 

the Comment Period

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Proposed rule; reopening of the 

comment period.

SUMMARY: The Food and Drug 

Administration (FDA) is reopening for 

60 days the comment period for the 

proposed rule entitled ‘‘Food Labeling: 

Nutrient Content Claims, General 

Principles; Health Claims, General 

Requirements and Other Specific 

Requirements for Individual Health 

Claims’’ (60 FR 66206, December 21, 

1995) (the 1995 proposal). In that 

document, FDA proposed to amend its 

existing nutrient content claims and 

health claims regulations to provide 

additional flexibility in the use of these 

claims on food products. FDA reopened 

the comment period for the 1995 

proposal to seek comment on the 

proposed amendments to permit 

unqualified health claims on certain 

foods that do not contain 10 percent or 

more of one of certain required 

nutrients, the proposed amendments to 

provide criteria that FDA would 

consider in determining whether to 

grant an exemption from disqualifying 

nutrient levels related to unqualified 

health claims of certain nutrients, and 

the proposed amendments to retain the 

word ‘‘may’’ or ‘‘might’’ in unqualified 

health claims. In addition, FDA sought 

comment on the proposed use of 

unlisted synonyms and abbreviated 

health claims. The comment period for 

the 1995 proposal closed on July 6, 

2004. FDA is reopening the comment 

period again in response to four requests 

for additional time to submit comments 

to FDA.

DATES: Submit written or electronic 

comments by January 18, 2005.

ADDRESSES: You may submit comments, 

identified by Docket Nos. 1994P–0390 

and 1995P–0241, by any of the 

following methods:

• Federal eRulemaking Portal: http://

www.regulations.gov. Follow the 

instructions for submitting comments.

• Agency Web site: http://

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments on the agency Web site.

• E-mail: fdadockets@oc.fda.gov. 

Include Docket Nos. 1994P–0390 and 

1995P–0241 in the subject line of your 

e-mail message.

• FAX: 301–827–6870.

• Mail/Hand delivery/Courier [For 

paper, disk, or CD-ROM submissions]: 

Division of Dockets Management, 5630 

Fishers Lane, rm. 1061, Rockville, MD 

20852.

Instructions: All submissions received 

must include the agency name and 

Docket No(s). or Regulatory Information 

Number (RIN) for this rulemaking. All 

comments received will be posted 

without change to http://www.fda.gov/

ohrms/dockets/default.htm, including 

any personal information provided. For 

detailed instructions on submitting 

comments and additional information 

on the rulemaking process, see the 

‘‘Comments’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document.

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

www.fda.gov/ohrms/dockets/

default.htm and insert the docket 

numbers, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ritu 

Nalubola, Center for Food Safety and 

Applied Nutrition (HFS–820), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 301–

436–2371.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of December 

21, 1995, FDA proposed to amend its 

existing regulations on nutrient content 

claims and health claims to provide 

additional flexibility in the use of these 

claims on food products. Specifically, 

FDA proposed the following: (1) To 

allow additional synonyms for nutrient 

content claims without specific 

preclearance by the agency (i.e., 

unlisted synonyms), (2) to permit health 

claims on certain foods that do not 

currently qualify to bear a claim because 

they do not contain 10 percent of one 

or more of certain required nutrients, (3) 

to permit the use of shortened versions 

of authorized health claims (i.e., 

abbreviated health claims) under certain 

circumstances, (4) to eliminate and/or 

make optional some of the specific 

health claim elements required by 

regulation, and (5) to provide criteria 

that FDA would consider in 

determining whether to grant an 

exemption from disqualifying nutrient 

levels to permit some foods to bear an 

unqualified health claim even though 

they contain high levels of one or more 

of certain nutrients. FDA proposed these 

amendments in response to petitions 

submitted by the National Food 

Processors Association (NFPA) (Docket 

No. 1994P–0390) and the American 

Bakers Association (ABA) (Docket No. 

1995P–0241). FDA requested comments 

on the 1995 proposal by March 20, 

1996, which was later extended to July 

18, 1996 (61 FR 11793, March 22, 1996). 

The comment period was reopened in 

1997 to obtain comment on an FDA 

study and two consumer research 

studies submitted by industry (62 FR 

3635, January 24, 1997), and then 

extended to allow interested persons 

more time to review the studies and 

submit comments (62 FR 11129, March 

11, 1997).

In the Federal Register of May 4, 2004 

(69 FR 24541), FDA reopened for 60 

days the comment period for the 1995 

proposal. In the May 4, 2004, notice 

reopening the comment period, FDA 

noted that since the publication of the 

1995 proposal, FDA established a task 

force for the Consumer Health 

Information for Better Nutrition 

Initiative (the task force). The purpose 

of the initiative is to make available 

more and better information about 

conventional foods and dietary 

supplements to help American 

67514 Federal Register / Vol. 69, No. 222 / Thursday, November 18, 2004 / Proposed Rules 

1See Proposed Rulemaking Concerning 

Amendment to the Rules of Practice and Procedure, 

PRC Order No. 1389, January 16, 2004.

consumers improve their health and 

decrease their risk of contracting 

diseases by making sound dietary 

choices. The task force issued a final 

report on July 10, 2003 (68 FR 41387, 

July 11, 2003), which recommended that 

FDA seek public comment on several 

topics related to qualified health claims 

(i.e., claims that do not meet the 

significant scientific agreement (SSA) 

standard of evidence required by the 

Federal Food, Drug, and Cosmetic Act 

and FDA regulations to evaluate the 

scientific validity of health claims) and 

unqualified health claims (i.e., health 

claims that are supported by SSA and 

authorized by FDA by regulation). Some 

of the topics identified in the task force 

report were specifically addressed in the 

1995 proposal. FDA reopened the 

comment period on the 1995 proposal to 

seek comment on these topics, which 

include the following: (1) The proposed 

amendments to permit unqualified 

health claims on certain foods that do 

not contain 10 percent or more of one 

of certain required nutrients; (2) the 

proposed amendments to provide 

criteria that FDA would consider in 

determining whether to grant an 

exemption from disqualifying nutrient 

levels related to unqualified health 

claims of certain nutrients; and (3) the 

proposed amendments to retain the 

word ‘‘may’’ or ‘‘might’’ in unqualified 

health claims to describe the 

relationship between a substance and a 

disease or health-related condition. In 

addition, FDA sought comment on the 

proposed use of unlisted synonyms and 

abbreviated health claims. Specifically, 

for unlisted synonyms (i.e., terms not 

defined by regulation), FDA repeated its 

request for data or other information 

demonstrating that unlisted synonyms 

that are anchored to defined terms in 

nutrient content claims are reasonably 

understood by consumers to be 

synonyms of the defined terms. FDA 

also sought comments on the petition 

process in 21 CFR 101.69(n) for 

synonyms and examples of synonyms 

that industry may be seeking to use. For 

abbreviated health claims, FDA sought 

comments and requested data or other 

information regarding whether 

abbreviated health claims would 

mislead consumers.

Following publication of the May 4, 

2004, notice reopening the comment 

period, FDA received four requests for 

an extension of the comment period to 

allow interested persons additional time 

to comment. Two of the requests were 

submitted by NFPA and ABA, the 

petitioners. The requesters asserted that 

more time is needed, given the 

complexity of the issues, to thoroughly 

review the specific elements of the 1995 

proposal. Some requesters further 

supported their requests for additional 

time by noting that more than 7 years 

have passed since the 1995 proposal 

was last considered in comments and 

FDA’s May 4, 2004, notice reopening 

the comment period. NFPA and ABA, 

which are trade associations, 

specifically stated that, over the 

intervening years, many of their member 

companies’ representatives who were 

responsible for consideration of the 

technical aspects of the 1995 proposal 

have left their companies and have been 

replaced by staff that are less familiar 

with the 1995 proposal, subsequent 

comments, and underlying petitions. In 

addition, NFPA and ABA asserted that 

because the character of their 

membership has changed and current 

members may advocate different views 

of the issues raised in the 1995 proposal 

and in comments on the 1995 proposal 

received through 1997, additional time 

is needed to ensure that all members’

concerns are addressed to accurately 

comment and respond to FDA. Another 

requester, also a trade association, also 

requested more time to ensure that all 

of its members’ concerns are addressed 

to accurately comment and respond to 

FDA.

FDA has considered the requests for 

additional time to submit comments 

and, because the comment period for 

the 1995 proposal closed on July 6, 

2004, FDA is again reopening the 

comment period on the 1995 proposal 

for an additional 60 days to provide 

interested persons an opportunity to 

comment on the issues identified herein 

and in FDA’s May 4, 2004, notice 

reopening the comment period for the 

1995 proposal.

II. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments in response to FDA’s request 

for comments and available data or 

other information identified in FDA’s 

May 4, 2004, notice reopening the 

comment period on the 1995 proposal. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Identify comments with the docket 

numbers found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.

Dated: November 8, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–25529 Filed 11–17–04; 8:45 am]

BILLING CODE 4160–01–S

POSTAL RATE COMMISSION

39 CFR Part 3001 

[Docket No. RM2004–1; Order No. 1424] 

Definition of Postal Service

AGENCY: Postal Rate Commission.

ACTION: Proposed rule.

SUMMARY: This document addresses a 

proposal to add a definition of the term 

‘‘postal service’’ to the rules of practice. 

This proposal is prompted by the Postal 

Service’s action with respect to 

nonpostal initiatives. There is often 

controversy and uncertainty regarding 

the postal character of the services 

provided under those initiatives. The 

proposed definition is intended to 

provide guidance to the Postal Service 

and the general public concerning 

services that are subject to sections 3622 

and 3623 of the Postal Reorganization 

Act.

DATES: 1. Deadline for filing initial 

comments: December 15, 2004. 

2. Deadline for filing reply comments: 

January 12, 2004.

ADDRESSES: File all documents referred 

to in this order electronically via the 

Commission’s Filing Online system at 

http://www.prc.gov.

FOR FURTHER INFORMATION CONTACT:

Stephen L. Sharfman, (202) 789–6818.

SUPPLEMENTARY INFORMATION: 

Regulatory History 

69 FR 3288, January 23, 2004. 

69 FR 11353, March 10, 2004. 

I. Introduction and Summary 

In Order No. 1389, the Commission 

proposed to amend its rules of practice 

and procedure to include a definition of 

the term ‘‘postal service.’’ 1 The postal 

character of a spate of relatively new 

services initiated unilaterally by the 

Postal Service is uncertain and the issue 

whether a service is postal or nonpostal 

has become increasingly controversial. 

Consequently, the Commission 

proposed to codify a definition of the 

term ‘‘postal service’’ in its rules to 

provide guidance to the Postal Service 

and the public for evaluating what falls 

within the scope of sections 3622 and