27894 Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Rules and Regulations 

Administration (NARA). For information on 

the availability of this material at NARA, call 

202–741–6030, or go to: http://

www.archives.gov/federal-register/cfr/ibrlocations.html. 

Issued in Burlington, Massachusetts, on 

June 8, 2018. 

Robert J. Ganley, 

Manager, Engine and Propeller Standards 

Branch, Aircraft Certification Service. 

[FR Doc. 2018–12873 Filed 6–14–18; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 101 

[Docket No. FDA–2018–D–1323] 

The Declaration of Certain Isolated or 

Synthetic Non-Digestible 

Carbohydrates as Dietary Fiber on 

Nutrition and Supplement Facts 

Labels; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the availability of a final 

guidance for industry entitled ‘‘The 

Declaration of Certain Isolated or 

Synthetic Non-Digestible Carbohydrates 

as Dietary Fiber on Nutrition and 

Supplement Facts Labels; Guidance for 

Industry.’’ The guidance identifies eight 

specific, additional isolated or synthetic 

non-digestible carbohydrates that we 

intend to add to our regulatory 

definition of ‘‘dietary fiber’’ through our 

regular rulemaking process. In the 

interim, the guidance also advises 

manufacturers of our policy for when 

one or more of these eight nondigestible carbohydrates, present in a 

food, are included in the declared 

amount of ‘‘dietary fiber,’’ and for the 

use of a caloric value for polydextrose 

of 1 kilocalorie per gram (kcal/g). 

DATES: The announcement of the 

guidance is published in the Federal 

Register on June 15, 2018. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–D–1323 for ‘‘The Declaration of 

Certain Isolated or Synthetic NonDigestible Carbohydrates as Dietary 

Fiber on Nutrition and Supplement 

Facts Labels; Guidance for Industry.’’ 

Received comments will be placed in 

the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ We 

will review this copy, including the 

claimed confidential information, in our 

consideration of comments. The second 

copy, which will have the claimed 

confidential information redacted/ 

blacked out, will be available for public 

viewing and posted on https://

www.regulations.gov. Submit both 

copies to the Dockets Management Staff. 

If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to the Office of 

Nutrition and Food Labeling, Center for 

Food Safety and Applied Nutrition 

(HFS–830), Food and Drug 

Administration, 5100 Campus Dr., 

College Park, MD 20740. Send two selfaddressed adhesive labels to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Paula R. Trumbo, Center for Food Safety 

and Applied Nutrition (HFS–830), Food 

and Drug Administration, 5100 Campus 

Dr., College Park, MD 20740, 240–402– 

2579. 

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the availability of 

a guidance for industry entitled ‘‘The 

Declaration of Certain Isolated or 

Synthetic Non-Digestible Carbohydrates 

as Dietary Fiber on Nutrition and 

Supplement Facts Labels; Guidance for 

Industry.’’ We are issuing this guidance 

consistent with our good guidance 

practices (GGP) regulation (§ 10.115 (21 


sradovich on DSK3GMQ082PROD with RULES
Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Rules and Regulations 27895 

CFR 10.115)). We are implementing this 

guidance without prior public comment 

because we have determined that prior 

public participation is not feasible or 

appropriate (§ 10.115(g)(2)). We made 

this determination because this 

guidance sets out compliance policy 

that reduces burden and is consistent 

with the public health. Although this 

guidance document is immediately in 

effect, it remains subject to comment in 

accordance with FDA’s GGP regulation. 

Before 2016, FDA regulations did not 

define the term ‘‘dietary fiber’’ for 

purposes of the Nutrition Facts and 

Supplement Facts labels. In the Federal 

Register of May 27, 2016 (81 FR 33742), 

we published a final rule amending our 

Nutrition Facts and Supplement Facts 

Labels regulations (hereafter referred to 

as ‘‘the final rule’’). The final rule, 

among other things, defines dietary fiber 

as non-digestible soluble and insoluble 

carbohydrates (with 3 or more 

monomeric units), and lignin that are 

intrinsic and intact in plants; isolated or 

synthetic non-digestible carbohydrates 

(with 3 or more monomeric units) 

determined by FDA to have 

physiological effects that are beneficial 

to human health (§ 101.9(c)(6)(i) (21 

CFR 101.9(c)(6)(i))). The final rule also 

identifies seven isolated or synthetic 

non-digestible carbohydrates, each of 

which has a physiological effect that is 

beneficial to human health and that 

must be declared as dietary fiber on 

Nutrition and Supplement Facts labels 

when present in a food. 

Interested parties can ask us to list 

additional isolated or synthetic nondigestible carbohydrates in the 

definition of dietary fiber in 

§ 101.9(c)(6)(i). For example, a 

manufacturer can request FDA to 

include another added isolated or 

synthetic non-digestible carbohydrate in 

the listing of dietary fibers by 

submitting a citizen petition under 21 

CFR 10.30. FDA would review the 

scientific evidence to determine 

whether the evidence supports the nondigestible carbohydrate as having a 

physiological effect that is beneficial to 

human health. If so, FDA would 

propose a rule to include the nondigestible carbohydrate in the listing of 

dietary fibers. 

Based on our review of citizen 

petitions that FDA has received 

requesting that we identify additional 

isolated or synthetic non-digestible 

carbohydrates in the listing of dietary 

fibers, and comments that we have 

received on a draft guidance entitled 

‘‘Scientific Evaluation of the Evidence 

on the Beneficial Physiological Effects 

of Isolated or Synthetic Non-Digestible 

Carbohydrates Submitted as a Citizen 

Petition (21 CFR 10.30)’’ and an 

accompanying document titled 

‘‘Evaluation of the Beneficial 

Physiological Effects of Isolated or 

Synthetic Non-Digestible 

Carbohydrates,’’ the availability of 

which we announced in the Federal 

Register of November 23, 2016 (81 FR 

84516 and 81 FR 84595), in addition to 

our independent evaluation of the 

available scientific data, we intend to 

add certain isolated or synthetic nondigestible carbohydrates to the dietary 

fiber definition in § 101.9(c)(6)(i) 

through our regular rulemaking process. 

The eight non-digestible carbohydrates 

that we intend to add are: Mixed plant 

cell wall fibers; arabinoxylan; alginate, 

inulin and inulin-type fructans; high 

amylose starch (resistant starch 2); 

galactooligosaccharide; polydextrose; 

and resistant maltodextrin/dextrin. One 

category of non-digestible carbohydrate 

that we intend to add to § 101.9(c)(6)(i) 

through our regular rulemaking 

process—mixed plant cell wall fibers— 

encompasses a number of fiber 

ingredients, such as rice bran fibers, soy 

fibers, and sugar cane fibers. We have 

tentatively determined that each of 

these isolated or synthetic nondigestible carbohydrates has a 

physiological effect that is beneficial to 

human health. Several petitions are still 

pending with FDA and reviewing this 

information is a very high priority for 

FDA. Firms also can submit new citizen 

petitions, and we will review the 

petitions on a rolling basis. Firms whose 

non-digestible carbohydrates do not 

meet our regulatory definition of 

‘‘dietary fiber’’ and are not one of the 

eight non-digestible carbohydrates 

identified in the guidance can still use 

those non-digestible carbohydrates in 

foods. Although those non-digestible 

carbohydrates cannot be listed as 

dietary fiber in the Nutrition Facts label, 

they would still be declared as part of 

the amount of total carbohydrate and 

listed by name in the ingredients on the 

food package. In addition, based on our 

review of the scientific evidence, 

including evidence we received in a 

citizen petition, we intend to establish 

a caloric value for polydextrose at 1 

kcal/g in § 101.9(c)(1)(i)(C). 

Pending completion of the rulemaking 

process, we are announcing a policy for 

the eight identified isolated or synthetic 

non-digestible carbohydrates when one 

or more are present in food and declared 

in the amount of ‘‘dietary fiber’’ on 

Nutrition Facts and Supplement Facts 

labels and when the caloric value of 1 

kcal/g is used to determine the calorie 

contribution of polydextrose. Section 

101.9(g) requires manufacturers to make 

and keep records to verify the amount 

of non-digestible carbohydrates added 

to food that do not meet the definition 

of dietary fiber. Under our policy, when 

a mixture of dietary fiber and one or 

more of these eight added non-digestible 

carbohydrates (that are not currently 

listed as a ‘‘dietary fiber’’ in the 

definition in § 101.9(c)(6)(i)) are present 

in a food, we do not expect 

manufacturers to make and keep records 

in accordance with § 101.9(g)(10) and 

(11) to verify the declared amount of 

one or more of these eight added nondigestible carbohydrates in the label and 

labeling of food. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on this topic. It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. This 

guidance is not subject to Executive 

Order 12866. 

II. Electronic Access 

Persons with access to the internet 

may obtain the document at either 

https://www.fda.gov/FoodGuidances or 

https://www.regulations.gov. Use the 

FDA website listed in the previous 

sentence to find the most current 

version of the guidance. 

Dated: June 8, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12867 Filed 6–14–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 876 

[Docket No. FDA–2018–N–1894] 

Medical Devices; GastroenterologyUrology Devices; Classification of the 

Fluid Jet System for Prostate Tissue 

Removal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the fluid jet system for 

prostate tissue removal into class II 

(special controls). The special controls 

that apply to the device type are 

identified in this order and will be part 

of the codified language for the fluid jet 


sradovich on DSK3GMQ082PROD with RULES