Federal Register / Vol. 70, No. 201 / Wednesday, October 19, 2005 / Proposed Rules 60749 

for providing oral and/or written 

comments at the meeting. 

We will ask for public comments on 

our proposed rules after a presentation 

of an overview of SSA’s Comprehensive 

Work Opportunity Initiative. This 

discussion will be followed by a brief 

overview of the Ticket NPRM followed 

by an opportunity to offer comment on 

the following areas: (1) State 

participation and beneficiary choice; (2) 

employment network payment systems; 

(3) ticket eligibility for beneficiaries 

whose conditions may improve; (4) 

eligibility for more than one ticket per 

period of eligibility; (5) the definition of 

‘‘using a ticket’’ and timely progress; (6) 

the evidence requirements for 

employment network payment; and (7) 

availability of phase 1 milestone 

payments in conjunction with 

vocational rehabilitation 

reimbursement. 

The third and final phase of the 

meeting will start with an overview of 

SSA’s Demonstration Projects and will 

be followed by an opportunity to 

comment on any of the Demonstration 

Projects or SSA Work Incentives. 

For each issue and as time allows, we 

will give each individual the 

opportunity to provide oral comments 

within a specified amount of time (e.g., 

approximately two minutes). 

Microphones will be stationed at 

convenient points in the meeting room. 

We will ask individuals wanting to 

provide comments to us to form a line 

behind each microphone and approach 

the microphone in turn. We will ask 

that each speaker, before delivering his 

or her remarks, identify themselves by 

full name, address, and telephone 

number. For those individuals 

representing organizations, we will 

request that they identify themselves by 

full name, state the name of the 

organization and the capacity in which 

they represent the organization, and 

give the organization’s address and 

telephone number. Each individual will 

then state his/her comments regarding 

the area/issue open for comment. Each 

individual’s remarks will be recorded 

and later transcribed and entered into 

the rulemaking record as written 

comments. 

We anticipate allotting a period of 

time to receive oral comments on each 

area/issue, with a short break between 

each such period. At times announced 

during the meeting, and at the end of 

each meeting, we will accept written 

comments from individuals wishing to 

give us comments in writing. 

What Will SSA Do With the Comments 

It Receives on the NPRM? 

The transcript of the oral comments 

on the NPRM given to us at the town 

hall meetings and any written 

comments we receive at the meetings, 

together with the written comments that 

we receive in the manner prescribed in 

the NPRM during the 90-day comment 

period, will become a part of the 

rulemaking record for making changes 

to the regulations for the Ticket to Work 

program. The 90-day comment period 

ends on December 29, 2005. We will 

consider all of these comments in 

developing the final rules for the Ticket 

to Work program. We will summarize 

the public comments we received on the 

NPRM and respond to the major 

comments in the preamble to our final 

regulations. 

We will post the written comments 

we receive during the 90-day comment 

period, including the transcript of the 

oral comments presented at the town 

hall meetings, on our Internet site at 

http://policy.ssa.gov/pnpublic.nsf/ 

LawsRegs. You may also make 

arrangements to inspect the comments 

as explained in the ‘‘How do I provide 

comments on the NPRM if I do not go 

to a town hall meeting?’’ section of this 

notice. 

What Are the Tentative Sites and Dates 

for Other Town Hall Meetings? 

The tentative sites and approximate 

dates for additional town hall meetings 

are as follows: 

Miami, Florida: November 16, 2005 

from 9 a.m.–12 p.m. 

Hartford, Connecticut: December 6, 

2005 from 9 a.m.–12 p.m. 

Des Moines, Iowa: December 14, 2005 

from 9 a.m.–12 p.m. 

When we have more information 

about these additional town hall 

meetings, we will publish that 

information in a notice(s) in the Federal 

Register at a time nearer to the event(s). 

Seating may be limited at these 

meetings. 

How Do I Provide Comments on the 

NPRM if I Do Not Go to a Town Hall 

Meeting? 

You may give us your written 

comments by: using our Internet site 

facility (i.e., Social Security Online) at 

http://policy.ssa.gov/pnpublic.nsf/ 

LawsRegs or the Federal eRulemaking 

Portal at http://www.regulations.gov; email to regulations@ssa.gov; telefax to 

(410) 966–2830; or letter to the 

Commissioner of Social Security, P.O. 

Box 17703, Baltimore, MD 21235–7703. 

You may also deliver them to the Office 

of Regulations, Social Security 

Administration, 107 Altmeyer Building, 

6401 Security Boulevard, Baltimore, MD 

21235–6401, between the hours of 8 

a.m. and 4:30 p.m. on regular business 

days. To be sure your comments are 

considered, we must receive them by 

December 29, 2005. 

We post the comments on our Internet 

site at http://policy.ssa.gov/ 

pnpublic.nsf/LawsRegs. You may also 

inspect the comments on regular 

business days by making arrangements 

with the following contact person: Greg 

Zwitch, SSA Regulations Officer, Social 

Security Administration, 107 Altmeyer 

Building, 6401 Security Boulevard, 

Baltimore, MD 21235–6401, e-mail 

regulations@ssa.gov, or telephone (410) 

965–1887 or TTY (410) 966–5609. 

Authority: Sec. 1148 of the Social Security 

Act (42 U.S.C. 1320b–19); sec. 101(e), Pub. L. 

106–170, 113 Stat. 1860, 1877 (42 U.S.C. 

1320b–19 note). 

Dated: October 14, 2005. 

Martin H. Gerry, 

Deputy Commissioner for Disability and 

Income Security Programs. 

[FR Doc. 05–20972 Filed 10–18–05; 8:45 am] 

BILLING CODE 4191–02–U 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 101 

[Docket No. 2005N–0413] 

Assessing Consumer Perceptions of 

Health Claims; Public Meeting; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting entitled ‘‘Assessing 

Consumer Perceptions of Health 

Claims.’’ The meeting will present 

research assessing consumers’ reactions 

to health claims and will address the 

implications of these studies for future 

research designed to evaluate consumer 

understanding of health claims and the 

effect of health claims on consumer 

perceptions and behaviors. 

DATES: The public meeting will be held 

on Thursday, November 17, 2005, from 

9 a.m. to 4:30 p.m. All of those 

attending the meeting must register by 

November 10, 2005. See section III of 

this document for details on how to 

register. Submit written or electronic 

comments, including all relevant data 

60750 Federal Register / Vol. 70, No. 201 / Wednesday, October 19, 2005 / Proposed Rules 

and information, related to the focus of 

the public meeting by January 17, 2006. 

ADDRESSES: The public meeting will be 

held at the Food and Drug 

Administration, Center for Food Safety 

and Applied Nutrition, Harley W. Wiley 

Auditorium, 5100 Paint Branch Pkwy., 

College Park, MD 20740. 

You may submit comments, identified 

by Docket No. 2005N–0413, by any of 

the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following ways: 

• 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. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD–ROM submissions]: 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal or the 

agency Web site, as described in the 

Electronic Submissions portion of this 

paragraph. 

Instructions: All submissions received 

must include the agency name and 

Docket No(s). and Regulatory 

Information Number (RIN) (if a RIN 

number has been assigned) for this 

rulemaking. All comments received may 

be posted without change to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm, including any personal 

information provided. For detailed 

instructions on submitting comments, 

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 

number(s), 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: 

For general questions about the 

meeting, to register, to request 

permission to speak at the meeting, 

or to request onsite parking: Marion 

V. Allen, Center for Food Safety and 

Applied Nutrition (HFS–32), Food 

and Drug Administration, 5100 

Paint Branch Pkwy., College Park, 

MD 20740, 301–436–1584, FAX: 

301–436–2371, e-mail: 

marion.allen@fda.hhs.gov. 

For technical questions: Steven L. 

Bradbard, Center for Food Safety 

and Applied Nutrition (HFS–727), 

Food and Drug Administration, 

5100 Paint Branch Pkwy., College 

Park, MD 20740, 301–436–1826, 

FAX: 301–436–1826, e-mail: 

steve.bradbard@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Health claims are statements used on 

food labels or in food labeling that 

describe a relationship between a food 

or component of food and reduction in 

the risk of a disease or health-related 

condition (21 U.S.C. 343(r)(1)(B); 

§ 101.14(a)(1) and (a)(2) (21 CFR 

101.14(a)(1) and (a)(2)). The 1993 

regulations for health claims (§ 101.14) 

adopted the congressionally mandated 

standard of significant scientific 

agreement (SSA) in the Nutrition 

Labeling and Education Act of 1990 

(Public Law 101–538). This standard 

limits authorized health claims in food 

labeling to those dietary substance/ 

disease relationships where, based on 

the totality of publicly available 

scientific evidence, there is significant 

scientific agreement among qualified 

experts that the claim is supported by 

such evidence. However, the approach 

of deciding whether a claim was 

misleading or not based on FDA’s 

evaluation of whether the scientific 

evidence met the significant scientific 

agreement standard was overturned in 

court on first amendment grounds (see 

Pearson v. Shalala, 164 F.3d 650 (D.C. 

Cir. 1999) (Pearson decision)). 

The Pearson decision rejected FDA’s 

approach in part because the agency did 

not meet its burden under the First 

Amendment of justifying a restriction 

on health claims that do not meet the 

SSA standard. The court criticized 

FDA’s approach for not considering the 

possibility that disclaimers about the 

quality of science underlying claims 

that did not meet the SSA standard 

(‘‘qualified health claims’’) could 

remedy any potential harm. Following 

the Pearson decision and subsequent 

related cases, including Whitaker v. 

Thompson, 248 F. Supp. 2d 1 (D.D.C. 

2002) (finding a ‘‘credible evidence’’

standard as the appropriate standard for 

FDA to apply in evaluating qualified 

health claims), FDA revised its process 

for reviewing qualified health claim 

petitions. FDA considers the use of 

qualified health claims when such 

claims are supported by credible 

scientific evidence and accurately 

communicate the level of scientific 

support for the claim. FDA instituted an 

interim system for communicating 

qualified health claims in food and 

dietary supplement labeling based on a 

four level system to classify health 

claim petitions in terms of the strength 

of science supporting the claim 

(‘‘Guidance for Industry and FDA: 

Interim Evidence-Based Ranking System 

for Scientific Data’’ (68 FR 41387, July 

11, 2003); ‘‘Guidance for Industry and 

FDA: Interim Procedures for Qualified 

Health Claims in the Labeling of 

Conventional Human Food and Human 

Dietary Supplements’’ (68 FR 41387)). 

At the same time it instituted this 

interim system, FDA developed a 

consumer studies research agenda 

designed to identify the most effective 

ways to best present scientifically based, 

truthful and nonmisleading information 

to consumers and to identify the kinds 

of information known to be misleading 

to consumers. See ‘‘Consumer Studies 

Research Agenda—Improving Consumer 

Understanding and Product 

Competition on the Health 

Consequences of Dietary Choices,’’

Attachment D to the Report of the FDA 

Task Force on Consumer Health 

Information for Better Nutrition (July 10, 

2003), available at http:// 

www.cfsan.fda.gov/~dms/ 

nuttftoc.html#memo (last accessed 

September 30, 2005). 

FDA (Ref. 1) and others (Refs. 2 and 

3) have conducted research to assess 

consumers’ responses to health claims. 

Some of this research has studied 

consumers’ reactions to qualifying 

language that is similar to that found in 

FDA’s interim system for 

communicating the level of scientific 

support for health claims. This research 

provides important information about 

consumers’ judgments about the level of 

scientific support for health claims, and 

reports the effects of health claims on 

consumers’ perceptions of the 

substance-disease relationship, product 

healthfulness, product quality and 

safety, and purchase intent. 

II. Purpose and Scope of the Meeting 

FDA is holding this public meeting to 

discuss the findings from its own and 

other research that examines consumers’

reactions to health claims, including 

those claims supported by SSA and 

those that are qualified, on conventional 

foods and dietary supplements. The 

Federal Register / Vol. 70, No. 201 / Wednesday, October 19, 2005 / Proposed Rules 60751 

meeting also will allow attendees an 

opportunity to provide comments to 

FDA about the implications of the 

available research for further consumer 

studies that may be needed or that are 

already underway by other parties to 

assess consumer understanding of 

health claims and the effect of health 

claims on consumer perceptions and 

behaviors. FDA is also interested in 

hearing from commenters their views 

regarding schemes or signals, other than 

those already studied, that may, 

consistent with the first amendment, 

effectively communicate to consumers 

the level of scientific support for health 

claims, without leading consumers to 

make erroneous inferences about the 

claimed substance-disease relationship 

and/or other product characteristics. 

FDA anticipates that this meeting will 

also include comments from attendees 

about alternative research methods to 

empirically assess consumer 

understanding of health claims and the 

effect of health claims on consumer 

perceptions and behaviors. FDA intends 

to consider all pertinent information 

from this public meeting in any 

rulemaking related to alternatives for 

regulating qualified health claims in the 

labeling of conventional human foods 

and dietary supplements (see 68 FR 

66040, November 25, 2003). 

III. Registration 

Please submit your registration 

information (including name, title, firm 

name (if applicable), address, telephone, 

FAX (if available), by November 10, 

2005. We encourage you to register 

online at http://www.cfsan.fda.gov/ 

~comm/register.html or by FAX to 

Marion V. Allen at 301–436–2605. 

Space is limited and registration will be 

closed when maximum seating capacity 

is reached. Please also specify whether 

you need onsite parking when you 

register. We also will accept 

registrations onsite, if space is available. 

If you need special accommodations 

due to a disability, please contact 

Marion V. Allen (see FOR FURTHER

INFORMATION CONTACT) no later than 

November 10, 2005. 

If you wish to make a presentation, 

indicate your request when registering 

and submit the following information by 

November 10, 2005: (1) A brief written 

statement about the general nature of 

the views you wish to present and (2) 

the names of any copresenters who must 

also register to attend. The amount of 

time allowed for each oral presentation 

at the public meeting will be limited 

(e.g., 5 minutes each), and will depend 

in part upon the number of persons who 

request to speak. Individuals and 

organizations that do not preregister to 

make a presentation may be given an 

opportunity to speak if time permits. 

Persons preregistered or wishing to 

register onsite should check in between 

7:30 and 8:30 a.m. Because the meeting 

will be held in a Federal building, 

meeting participants must present photo 

identification and plan adequate time to 

pass through the security system. 

IV. Comments 

In addition to attending or presenting 

oral comments at the meeting, interested 

persons may submit to the Division of 

Dockets Management (see ADDRESSES) 

written or electronic comments related 

to the focus of this public meeting. All 

relevant data and information should be 

submitted with the written comments. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper 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 Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

V. Meeting Transcript 

A transcript will be made of the 

meeting’s proceedings. You may request 

a copy in writing from FDA’s Freedom 

of Information Office (HFI–35), Food 

and Drug Administration, 5600 Fishers 

Lane, rm. 12A–16, Rockville, MD 20857, 

approximately 30 working days after the 

public meeting at a cost of 10 cents per 

page. The transcript of public meeting 

and all comments submitted will be 

available for public examination at the 

Division of Dockets Management (see 

ADDRESSES) between 9 a.m. and 4 p.m., 

Monday through Friday, as well as on 

the FDA Web site at http://www.fda.gov/ 

ohrms/dockets/default.htm. 

VI. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSESS) 

and may be viewed between 9 a.m. and 

4 p.m., Monday through Friday. (FDA 

has verified the Web site address, but 

we are not responsible for subsequent 

changes to the Web site after this 

document publishes in the Federal 

Register.) 

1. Derby, B.M. and A.S. Levy, ‘‘Working 

Paper: Effects of Strength of Science 

Disclaimers on the Communication Impact of 

Health Claims,’’ Working Paper No. 1, FDA, 

Center for Food Safety and Applied Nutrition 

(http://www.fda.gov/OHRMS/dockets/ 

dockets/03N0496/03N–0496–rpt0001.pdf), 

September 2005. 

2. France, K.R. and P.F. Bone, ‘‘Policy 

Maker’s Paradigms and Evidence from 

Consumer Interpretations of Dietary 

Supplement Labels,’’ Journal of Consumer 

Affairs, Volume 39, No. 1, Copyright 2005 by 

the American Council on Consumer Interests, 

2005. 

3. Qualified Health Claims Consumer 

Research Project Executive Summary, 

International Food Information Council 

Foundation (http://www.ific.org/research/ 

qualhealthclaimsres.cfm), March 2005. 

Dated: October 14, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–20969 Filed 10–17–05; 10:49 

am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 133 

[Docket No. 2000P–0586 (formerly Docket 

No. 00P–0586)] 

Cheeses and Related Cheese 

Products; Proposal to Permit the Use 

of Ultrafiltered Milk 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

amend its regulations to provide for the 

use of fluid ultrafiltered milk (UF) in the 

manufacture of standardized cheeses 

and related cheese products. This action 

responds principally to two citizen 

petitions: One submitted by the 

American Dairy Products Institute 

(ADPI) and another submitted jointly by 

the National Cheese Institute (NCI), the 

Grocery Manufacturers of America, Inc. 

(GMA), and the National Food 

Processors Association (NFPA). FDA 

tentatively concludes that this action 

will promote honesty and fair dealing in 

the interest of consumers and, to the 

extent practicable, will achieve 

consistency with existing international 

standards of identity for cheeses and 

related cheese products. 

DATES: Submit comments by January 17, 

2006. 

ADDRESSES: You may submit comments, 

identified by Docket No. 2000P–0586, 

by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following ways: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Agency Web site: http:// 

www.fda.gov/dockets/ecomments.