Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Rules and Regulations 27891 

of ADs is normally a function of the 

Compliance and Airworthiness 

Division, but during this transition 

period, the Executive Director has 

delegated the authority to issue ADs 

applicable to engines, propellers, and 

associated appliances to the Manager, 

Engine and Propeller Standards Branch, 

Policy and Innovation Division. 

Regulatory Findings 

This AD will not have federalism 

implications under Executive Order 

13132. This AD will not have a 

substantial direct effect on the States, on 

the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. 

For the reasons discussed above, I 

certify that this AD: 

(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), 

(3) Will not affect intrastate aviation 

in Alaska and 

(4) Will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

Adoption of the Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA amends 14 CFR part 39 as 

follows: 

PART 39—AIRWORTHINESS 

DIRECTIVES 

■ 1. The authority citation for part 39 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

■ 2. The FAA amends § 39.13 by adding 

the following new airworthiness 

directive (AD): 

2018–13–02 Pratt & Whitney Division: 

Amendment 39–19314; Docket No. 

FAA–2017–0817; Product Identifier 

2017–NE–30–AD. 

(a) Effective Date 

This AD is effective July 20, 2018. 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to all Pratt & Whitney 

Division (PW) PW4052, PW4056, PW4060, 

PW4062, PW4062A, PW4152, PW4156A, 

PW4158, PW4460, and PW4462 turbofan 

engine models, including engines identified 

with suffixes –1C, –1E, –3, –3A, or –3B, with 

4th stage low-pressure turbine (LPT) air seal, 

part number (P/N) 50N346, installed. 

(d) Subject 

Joint Aircraft System Component (JASC) 

Code 7240, Turbine Engine Combustion 

Section. 

(e) Unsafe Condition 

This AD was prompted by the discovery of 

multiple cracked air seals. We are issuing 

this AD to prevent failure of the 4th stage 

LPT air seal. This unsafe condition, if not 

addressed, could result in uncontained 

release of the air seal, damage to the engine, 

and damage to the airplane. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Required Actions 

The next time the 4th stage LPT vanes are 

removed from the LPT module, remove 4th 

stage air seal, P/N 50N346, from service and 

replace with a part eligible for installation. 

(h) Installation Prohibition 

After the effective date of this AD, do not 

install any 4th stage LPT air seal, P/N 

50N346, into any LPT module. 

(i) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, ECO Branch, FAA, has 

the authority to approve AMOCs for this AD, 

if requested using the procedures found in 14 

CFR 39.19. In accordance with 14 CFR 39.19, 

send your request to your principal inspector 

or local flight standards district office, as 

appropriate. If sending information directly 

to the manager of the certification office, 

send it to the attention of the person 

identified in paragraph (j) of this AD. You 

may email your request to: ANE-AD-AMOC@

faa.gov. 

(2) Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the local flight standards district office/ 

certificate holding district office. 

(j) Related Information 

For more information about this AD, 

contact Jo-Ann Theriault, Aerospace 

Engineer, ECO Branch, FAA, 1200 District 

Avenue, Burlington, MA 01803; phone: 781– 

238–7105; fax: 781–238–7199; email: joann.theriault@faa.gov. 

(k) Material Incorporated by Reference 

None. 

Issued in Burlington, Massachusetts, on 

June 11, 2018. 

Robert J. Ganley, 

Manager, Engine and Propeller Standards 

Branch, Aircraft Certification Service. 

[FR Doc. 2018–12830 Filed 6–14–18; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2018–0501; Product 

Identifier 2018–NE–19–AD; Amendment 39– 

19304; AD 2018–11–16] 

RIN 2120–AA64 

Airworthiness Directives; Engine 

Alliance Turbofan Engines 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule; request for 

comments. 

SUMMARY: We are adopting a new 

airworthiness directive (AD) for certain 

Engine Alliance (EA) GP7270, GP7272, 

and GP7277 turbofan engines. This AD 

requires a one-time eddy current 

inspection (ECI) of the engine fan hub 

blade slot bottom and blade slot front 

edge for cracks, a visual inspection of 

the engine fan hub for damage, and 

removal of parts if damage or defects are 

found that are outside serviceable 

limits. This AD was prompted by an 

uncontained failure of the engine fan 

hub. We are issuing this AD to address 

the unsafe condition on these products. 

DATES: This AD is effective July 2, 2018. 

The Director of the Federal Register 

approved the incorporation by reference 

of a certain publication listed in this AD 

as of July 2, 2018. 

We must receive comments on this 

AD by July 30, 2018. 

ADDRESSES: You may send comments, 

using the procedures found in 14 CFR 

11.43 and 11.45, by any of the following 

methods: 

• Federal eRulemaking Portal: Go to 

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

instructions for submitting comments. 

• Fax: 202–493–2251. 

• Mail: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE, 

Washington, DC 20590. 

• Hand Delivery: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE, 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. 

For service information identified in 

this final rule, contact Engine Alliance, 

411 Silver Lane, East Hartford, CT 

06118; phone: 800–565–0140; email: 

help24@pw.utc.com; website: 

www.engineallianceportal.com. You 

may view this service information at the 

FAA, Engine and Propeller Standards 


sradovich on DSK3GMQ082PROD with RULES
27892 Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Rules and Regulations 

Branch, 1200 District Avenue, 

Burlington, MA. For information on the 

availability of this material at the FAA, 

call 781–238–7759. It is also available 

on the internet at http://

www.regulations.gov by searching for 

and locating Docket No. FAA–2018– 

0501. 

Examining the AD Docket 

You may examine the AD docket on 

the internet at http://

www.regulations.gov by searching for 

and locating Docket No. FAA–2018– 

0501; or in person at Docket Operations 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

The AD docket contains this final rule, 

the regulatory evaluation, any 

comments received, and other 

information. The street address for the 

Docket Operations (phone: 800–647– 

5527) is listed above. Comments will be 

available in the AD docket shortly after 

receipt. 

FOR FURTHER INFORMATION CONTACT: 

David Bethka, Aerospace Engineer, ECO 

Branch, FAA, 1200 District Avenue, 

Burlington, MA 01803; phone: 781– 

238–7129; fax: 781–238–7199; email: 

david.bethka@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Discussion 

We received information concerning 

an uncontained engine fan hub failure 

that occurred on an EA GP7200-series 

turbofan engine. AD 2017–23–03 (82 FR 

51979, November 9, 2017), requires 

visual inspections of all engine fan hubs 

for damage. This AD requires additional 

visual inspections of the EA GP7200- 

series engine fan hub beyond those 

required by AD 2017–23–03. This AD 

also requires an ECI that was not 

required by AD 2017–23–03. This 

condition, if not addressed, could result 

in an uncontained failure of the engine 

fan hub, damage to the engine, and 

damage to the airplane. We are issuing 

this AD to address the unsafe condition 

on these products. 

Related Service Information Under 1 

CFR Part 51 

We reviewed EA Alert Service 

Bulletin (ASB) EAGP7–A72–389, 

Revision No. 2, dated April 17, 2018. 

The ASB describes procedures for ECI 

and visual inspection of the GP7270, 

GP7272, and GP7277 engine fan hub. 

This service information is reasonably 

available because the interested parties 

have access to it through their normal 

course of business or by the means 

identified in the ADDRESSES section. 

FAA’s Determination 

We are issuing this AD because we 

evaluated all the relevant information 

and determined the unsafe condition 

described previously is likely to exist or 

develop in other products of the same 

type design. 

AD Requirements 

This AD requires a one-time ECI of 

the GP7270, GP7272, and GP7277 

engine fan hub blade slot bottom and 

blade slot front edge for cracks, a visual 

inspection of the engine fan hub for 

damage, and removal of the engine fan 

hub if damage or defects are found that 

are outside of serviceable limits. 

Interim Action 

We consider this AD interim action. 

An investigation to determine the cause 

of the failure is on-going and we may 

consider additional rulemaking if final 

action is identified. 

FAA’s Justification and Determination 

of the Effective Date 

An unsafe condition exists that 

requires the immediate adoption of this 

AD without providing an opportunity 

for public comments prior to adoption. 

The FAA has found that the risk to the 

flying public justifies waiving notice 

and comment prior to the adoption of 

this rule because the compliance time 

for the required action is shorter than 

the time necessary for the public to 

comment and for us to publish the final 

rule. Therefore, we find good cause that 

notice and opportunity for prior public 

comment are impracticable. In addition, 

for the reason stated above, we find that 

good cause exists for making this 

amendment effective in less than 30 

days. 

Comments Invited 

This AD is a final rule that involves 

requirements affecting flight safety and 

was not preceded by notice and an 

opportunity for public comment. 

However, we invite you to send any 

written data, views, or arguments about 

this final rule. Send your comments to 

an address listed under the ADDRESSES

section. Include the docket number 

FAA–2018–0501 and Product Identifier 

2018–NE–19–AD at the beginning of 

your comments. We specifically invite 

comments on the overall regulatory, 

economic, environmental, and energy 

aspects of this final rule. We will 

consider all comments received by the 

closing date and may amend this final 

rule because of those comments. 

We will post all comments we 

receive, without change, to http://

www.regulations.gov, including any 

personal information you provide. We 

will also post a report summarizing each 

substantive verbal contact we receive 

about this final rule. 

Costs of Compliance 

We estimate that this AD affects 0 

engines installed on airplanes of U.S. 

registry. 

We estimate the following costs to 

comply with this AD: 

ESTIMATED COSTS

Action Labor cost Parts cost Cost per 

product 

Cost on U.S. 

operators 

ECI and visual inspection ............................... 14 work-hours × $85 per hour = $1190 ......... $0 $1190 $0 

Authority for This Rulemaking 

Title 49 of the United States Code 

specifies the FAA’s authority to issue 

rules on aviation safety. Subtitle I, 

section 106, describes the authority of 

the FAA Administrator. ‘‘Subtitle VII: 

Aviation Programs’’ describes in more 

detail the scope of the Agency’s 

authority. 

We are issuing this rulemaking under 

the authority described in Subtitle VII, 

Part A, Subpart III, Section 44701: 

‘‘General requirements.’’ Under that 

section, Congress charges the FAA with 

promoting safe flight of civil aircraft in 

air commerce by prescribing regulations 

for practices, methods, and procedures 

the Administrator finds necessary for 

safety in air commerce. This regulation 

is within the scope of that authority 

because it addresses an unsafe condition 

that is likely to exist or develop on 

products identified in this rulemaking 

action. 

This AD is issued in accordance with 

authority delegated by the Executive 

Director, Aircraft Certification Service, 

as authorized by FAA Order 8000.51C. 

In accordance with that order, issuance 

of ADs is normally a function of the 

Compliance and Airworthiness 


sradovich on DSK3GMQ082PROD with RULES
Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Rules and Regulations 27893 

Division, but during this transition 

period, the Executive Director has 

delegated the authority to issue ADs 

applicable to engines, propellers, and 

associated appliances to the Manager, 

Engine and Propeller Standards Branch, 

Policy and Innovation Division. 

Regulatory Findings 

This AD will not have federalism 

implications under Executive Order 

13132. This AD will not have a 

substantial direct effect on the States, on 

the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. 

For the reasons discussed above, I 

certify that this AD: 

(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), 

(3) Will not affect intrastate aviation 

in Alaska, and 

(4) Will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

Adoption of the Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA amends 14 CFR part 39 as 

follows: 

PART 39—AIRWORTHINESS 

DIRECTIVES 

■ 1. The authority citation for part 39 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

■ 2. The FAA amends § 39.13 by adding 

the following new airworthiness 

directive (AD): 

2018–11–16 Engine Alliance: Amendment 

39–19304 ; Docket No. FAA–2018–0501; 

Product Identifier 2018–NE–19–AD. 

(a) Effective Date 

This AD is effective July 2, 2018. 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to Engine Alliance (EA) 

GP7270, GP7272, and GP7277 model 

turbofan engines with serial numbers (S/Ns) 

identified in Table 3 in Planning Information 

of Engine Alliance (EA) Alert Service 

Bulletin (ASB) EAGP7–A72–389, Revision 

No. 2, dated April 17, 2018. 

(d) Subject 

Joint Aircraft System Component (JASC) 

Code 7230, Turbine Engine Compressor 

Section. 

(e) Unsafe Condition 

This AD was prompted by an uncontained 

failure of the engine fan hub. We are issuing 

this AD to detect defects, damage, and cracks 

that could result in an uncontained failure of 

the engine fan hub. The unsafe condition, if 

not addressed, could result in uncontained 

failure of the engine fan hub, damage to the 

engine, and damage to the airplane. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Required Actions 

Within 120 days after the effective date of 

this AD: 

(1) For engine fan hubs at the low-pressure 

compressor (LPC) module assembly level: 

(i) Perform a visual inspection of the 

engine fan hub, in accordance with the 

Accomplishment Instructions, For Fan Hubs 

at LPC Module Assembly Level, paragraphs 

1.A.(1), 1.A.(4), and 1.A.(6)(a), of EA ASB 

EAGP7–A72–389, Revision No. 2, dated 

April 17, 2018. 

(ii) Perform an eddy current inspection 

(ECI) of the engine fan hub blade slot bottoms 

and front edges, in accordance with the 

Accomplishment Instructions, For Fan Hubs 

at LPC Module Assembly Level, paragraphs 

2.A and 2.B, of EA ASB EAGP7–A72–389, 

Revision No. 2, dated April 17, 2018. 

(2) For engine fan hubs at the piece part 

level: 

(i) Perform a visual inspection of the 

engine fan hub, in accordance with the 

Accomplishment Instructions, For Fan Hubs 

at Piece Part Level, paragraphs 1.A.(1) and 

1.A.(3), of EA ASB EAGP7–A72–389, 

Revision No. 2, dated April 17, 2018. 

(ii) Perform an ECI of the engine fan hub 

blade slot bottoms and front edges, in 

accordance with the Accomplishment 

Instructions, For Fan Hubs at Piece Part 

Level, paragraphs 2.A and 2.B, of EA ASB 

EAGP7–A72–389, Revision No. 2, dated 

April 17, 2018. 

(3) For engine fan hubs installed in an 

engine (on-wing or off-wing): 

(i) Perform a visual inspection of the 

engine fan hub, in accordance with the 

Accomplishment Instructions, For Fan Hubs 

Installed in an Engine, paragraphs 1.C.(1), 

1.C.(5), and 1.C.(7)(a), of EA ASB EAGP7– 

A72–389, Revision No. 2, dated April 17, 

2018. 

(ii) Perform an ECI of the engine fan hub 

blade slot bottoms and front edges, in 

accordance with the Accomplishment 

Instructions, For Fan Hubs Installed in an 

Engine, paragraphs 1.D.(1) and 1.D.(2), of EA 

ASB EAGP7–A72–389, Revision No. 2, dated 

April 17, 2018. 

(4) If the engine fan hub visual inspection 

reveals defects or damage to the engine fan 

hub that are found outside the serviceable 

limits specified in Table 4 in the 

Accomplishment Instructions of EA ASB 

EAGP7–A72–389, Revision No. 2, dated 

April 17, 2018, remove the engine fan hub 

from service and replace with a part that is 

eligible for installation, prior to further flight. 

(5) If the fan hub ECI results in a rejectable 

indication, per the Appendix, Added Data, of 

EA ASB EAGP7–A72–389, Revision No. 2, 

dated April 17, 2018, remove the hub from 

service and replace with a part that is eligible 

for installation, prior to further flight. 

(h) Credit for Previous Actions 

You may take credit for the inspection 

required by paragraph (g) of this AD if you 

performed the inspection before the effective 

date of this AD, using EA ASB EAGP7–A72– 

389, dated December 19, 2017, or EA ASB 

EAGP7–A72–389, Revision No. 1, dated 

January 19, 2018. 

(i) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, ECO Branch, FAA, has 

the authority to approve AMOCs for this AD, 

if requested using the procedures found in 14 

CFR 39.19. In accordance with 14 CFR 39.19, 

send your request to your principal inspector 

or local Flight Standards District Office, as 

appropriate. If sending information directly 

to the manager of the certification office, 

send it to the attention of the person 

identified in paragraph (j) of this AD. You 

may email your request to: ANE-AD-AMOC@

faa.gov. 

(2) Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the local flight standards district office/ 

certificate holding district office. 

(j) Related Information 

For more information about this AD, 

contact David Bethka, Aerospace Engineer, 

ECO Branch, FAA, 1200 District Avenue, 

Burlington, MA 01803; phone: 781–238– 

7129; fax: 781–238–7199; email: 

david.bethka@faa.gov. 

(k) Material Incorporated by Reference 

(1) The Director of the Federal Register 

approved the incorporation by reference 

(IBR) of the service information listed in this 

paragraph under 5 U.S.C. 552(a) and 1 CFR 

part 51. 

(2) You must use this service information 

as applicable to do the actions required by 

this AD, unless the AD specifies otherwise. 

(i) Engine Alliance Alert Service Bulletin 

EAGP7–A72–389, Revision No. 2, dated 

April 17, 2018. 

(ii) Reserved. 

(3) For Engine Alliance service information 

identified in this AD, contact Engine 

Alliance, 411 Silver Lane, East Hartford, CT 

06118; phone: 800–565–0140; email: help24@

pw.utc.com; website: 

www.engineallianceportal.com. 

(4) You may view this service information 

at FAA, Engine and Propeller Standards 

Branch, 1200 District Avenue, Burlington, 

MA. For information on the availability of 

this material at the FAA, call 781–238–7759. 

(5) You may view this service information 

that is incorporated by reference at the 

National Archives and Records 


sradovich on DSK3GMQ082PROD with RULES
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