80828 Federal Register / Vol. 75, No. 246 / Thursday, December 23, 2010 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0575] 

Draft Compliance Policy Guide Sec. 

510.800 Beverages—Serving Size 

Labeling; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of draft ‘‘Compliance Policy 

Guide Sec. 510.800 Beverages—Serving 

Size Labeling’’ (the draft CPG). The draft 

CPG, when finalized, will provide 

guidance for FDA staff on FDA’s 

exercise of enforcement discretion 

related to serving size labeling for 

certain beverages that are packaged in 

containers larger than 20 fluid ounces 

and that display calories per 12 fluid 

ounce serving on the front of the 

container. 

DATES: Although you can comment on 

any CPG at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on the draft 

CPG before it begins work on the final 

version of the CPG, submit either 

electronic or written comments on the 

draft CPG by February 22, 2011. 

ADDRESSES: Submit electronic 

comments on the draft CPG to http:// 

www.regulations.gov. Submit written 

comments on the draft CPG to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Submit written requests for 

single copies of the draft CPG to the 

Division of Compliance Policy (HFC– 

230), Office of Enforcement, Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857. Send two 

self-addressed adhesive labels to assist 

that office in processing your request or 

fax your request to 240–632–6861. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft CPG. 

FOR FURTHER INFORMATION CONTACT: 

Jillonne Kevala, Center for Food Safety 

and Applied Nutrition (HFS–830), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–1450. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The draft CPG is intended to provide 

guidance for FDA staff on the labeling 

of certain beverages. In particular, the 

draft CPG sets forth a policy to typically 

consider not taking an enforcement 

action when a beverage container larger 

than 20 fluid ounces states the calories 

per 12 fluid ounces on the Principal 

Display Panel (PDP) and 

correspondingly provides the number of 

12 fluid ounce servings in the container 

and the nutrition information is based 

on a 12 fluid ounce serving in the 

Nutrition Facts panel. FDA’s labeling 

regulations require that the labeled 

serving size be based on Reference 

Amounts Customarily Consumed 

(RACC) (21 CFR 101.9(b) and § 101.12(b) 

(21 CFR 101.12(b))). The RACC for 

beverages is 240 milliliters (8 fluid 

ounces) (§ 101.12(b)). FDA’s exercise of 

enforcement discretion is limited to the 

following beverages in containers that 

are larger than 20 fluid ounces and that 

display calories on the PDP of the label 

per 12 ounces: (1) Sports drinks (this 

term is used by industry and has not 

been defined by the Agency), (2) bottled 

water and water beverages, (3) soft 

drinks and diet soft drinks, (4) energy 

drinks (this term is used by industry 

and has not been defined by the 

Agency), and (5) ready-to-drink teas. 

The CPG reflects the Agency’s recent 

response to the American Beverage 

Association’s request that FDA exercise 

enforcement discretion for industry to 

label certain beverages based on a 12 

fluid ounce serving size (Refs. 1, 2, and 

3). The draft CPG also contains 

information that may be useful to the 

regulated industry and to the public. 

FDA is issuing the draft CPG as level 1 

draft guidance consistent with FDA’s 

good guidance practices regulation (21 

CFR 10.115). The draft CPG, when 

finalized, will represent FDA’s current 

thinking on the exercise of enforcement 

discretion for serving size labeling for 

the applicable beverages. It does not 

create or confer any rights for or on any 

person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the draft CPG from FDA’s 

Office of Regulatory Affairs history page 

at http://www.fda.gov/ora/ 

compliance_ref/cpg/default.htm. 

IV. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES), 

and may be seen by interested persons 

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

through Friday. 

1. Letter from Stuart M. Pape, Counsel 

to the American Beverage Association, 

May 27, 2010. 

2. Letter from Stuart M. Pape, Counsel 

to the American Beverage Association, 

June 24, 2010. 

3. Letter from Michael R. Taylor, 

Deputy Commissioner for Foods, FDA, 

July 12, 2010. 

Dated: December 13, 2010. 

Dara Corrigan, 

Associate Commissioner for Regulatory 

Affairs. 

[FR Doc. 2010–32249 Filed 12–22–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; The NIH–American 

Association for Retired Persons 

(AARP) interactive Comprehensive 

Lifestyle Interview by Computer Study 

(iCLIC) (NCI) 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Cancer Institute (NCI), the National 

Institutes of Health (NIH), has submitted 

to the Office of Management and Budget 

(OMB) a request to review and approve 

the information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register on October 18, 2010 (75 FR 

63833) and allowed 60-days for public 

comment. There was one public 

comment received on October 18, 2010 

which questioned the use of ‘‘spending 

American tax dollars on this study.’’ A 

response was sent on December 14, 

2010. The purpose of this notice is to 

allow an additional 30 days for public 

comment. The National Institutes of 

Health may not conduct or sponsor, and 

the respondent is not required to 

respond to, an information collection 

that has been extended, revised, or 

implemented on or after October 1, 

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