Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Proposed Rules 2393 

§ 10.75 Internal agency review of 

decisions. 

* * * * * 

(e) Each request by an interested 

person for review of a decision within 

the Center for Devices and Radiological 

Health shall also comply with § 800.75 

of this chapter. 

PART 800—GENERAL 

■ 3. The authority citation for part 800 

is revised to read as follows: 

Authority: 5 U.S.C. 551–559; 21 U.S.C. 

301–399f. 

■ 4. In part 800, add § 800.75 to subpart 

C to read as follows: 

§ 800.75 Requests for supervisory review 

of certain decisions made by the Center for 

Devices and Radiological Health. 

(a) The following definitions shall 

apply to this section: 

(1) FDA means the Food and Drug 

Administration. 

(2) 517A decision means a significant 

decision made by the Center for Devices 

and Radiological Health, as set forth in 

section 517A of the Federal Food, Drug, 

and Cosmetic Act, and includes one of 

the following decisions: 

(i) A substantially equivalent order 

under § 807.100(a)(1) of this chapter, or 

a not substantially equivalent order 

under § 807.100(a)(2) of this chapter; 

(ii) An approval order under 

§ 814.44(d) of this chapter, an 

approvable letter under § 814.44(e) of 

this chapter, a not approvable letter 

under § 814.44(f) of this chapter, or an 

order denying approval under § 814.45 

of this chapter; 

(iii) An approval order under 

§ 814.116(b) of this chapter, an 

approvable letter under § 814.116(c) of 

this chapter, a not approvable letter 

under § 814.116(d) of this chapter, or an 

order denying approval under § 814.118 

of this chapter; 

(iv) A grant or denial of a request for 

breakthrough device designation under 

section 515C of the Federal Food, Drug, 

and Cosmetic Act; 

(v) An approval order under 

§ 812.30(a) of this chapter or a 

disapproval order under § 812.30(c) of 

this chapter; 

(vi) A failure to reach agreement letter 

under section 520(g)(7) of the Federal 

Food, Drug, and Cosmetic Act; or 

(vii) A clinical hold determination 

under section 520(g)(8) of the Federal 

Food, Drug, and Cosmetic Act. 

(3) CDRH means the Center for 

Devices and Radiological Health. 

(b) Submission of request. 

(1) Review of 517A decisions. 

(i) An initial or sequential request for 

supervisory review within CDRH of a 

517A decision under § 10.75 of this 

chapter must be addressed to the next 

organizational level or higher above the 

individual who made the decision; 

submitted in electronic format in 

accordance with section 745A(b) of the 

Federal Food, Drug, and Cosmetic Act; 

marked ‘‘Appeal: Request for 

Supervisory Review;’’ and received by 

CDRH no later than 30 days after the 

date of the decision involved. Any such 

request for supervisory review not 

received by CDRH within 30 days after 

the date of the decision involved is not 

eligible for review. Except as provided 

in paragraph (b)(1)(ii) or (iii) of this 

section, FDA will render a decision 

within 45 days of the request for 

supervisory review. 

(ii) A person requesting supervisory 

review under paragraph (b)(1)(i) may 

request an in-person meeting or 

teleconference with the supervisor 

reviewing the request for supervisory 

review. Except as provided in paragraph 

(b)(1)(iii) of this section, if a request for 

in-person meeting or teleconference is 

included in the request for supervisory 

review to CDRH, CDRH will schedule 

the meeting or teleconference to occur 

within 30 days of receipt of the request. 

Except as provided in paragraph 

(b)(1)(iii) of this section, a decision will 

be rendered within 30 days of such 

meeting or teleconference. 

(iii) The timeframes for CDRH to 

render a decision provided in (b)(1)(i) 

and (ii), and the timeframe to schedule 

an in-person meeting or teleconference 

review in (b)(1)(ii) of this section do not 

apply, if a matter related to the 517A 

decision under review is referred by 

CDRH to external experts, such as an 

advisory committee, as provided in 

§ 10.75(b) of this chapter. 

(2) An initial or sequential request for 

supervisory review within CDRH under 

§ 10.75 of this chapter of a decision 

other than a 517A decision that is not 

received by CDRH within 60 days after 

the date of the decision involved will be 

denied as untimely, unless CDRH, for 

good cause, permits the request to be 

filed after 60 days. An initial or 

sequential request for supervisory 

review within CDRH of a decision other 

than a 517A decision must be addressed 

to the next organizational level or higher 

above the individual who made the 

decision; submitted in electronic format 

in accordance with section 745A(b) of 

the Federal Food, Drug, and Cosmetic 

Act, when applicable; marked, ‘‘Appeal: 

Request for Supervisory Review’’ in the 

subject line of the electronic request; 

and sent to the CDRH Ombudsman at 

CDRHOmbudsman@fda.hhs.gov. 

Dated: January 10, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00646 Filed 1–16–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 101 

[Docket No. FDA–2017–N–0763] 

RIN 0910–AH43 

Food Labeling: Health Claims; Soy 

Protein and Coronary Heart Disease; 

Extension of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule; extension of 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

extending the comment period for the 

proposed rule that appeared in the 

Federal Register of October 31, 2017. 

We are taking this action in response to 

requests for an extension to allow 

interested persons additional time to 

submit comments. 

DATES: FDA is extending the comment 

period on the proposed rule published 

on October 31, 2017 (82 FR 50324). 

Submit either electronic or written 

comments by March 19, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before March 19, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of March 19, 2018. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

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 


ethrower on DSK3G9T082PROD with PROPOSALS
2394 Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Proposed Rules 

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– 

2017–N–0763 for ‘‘Food Labeling: 

Health Claims; Soy Protein and 

Coronary Heart Disease.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), 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. 

FOR FURTHER INFORMATION CONTACT: 

Crystal Rivers, Center for Food Safety 

and Applied Nutrition (HFS–830), Food 

and Drug Administration, 5001 Campus 

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

1444. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of October 31, 2017, 

FDA published a proposed rule to 

revoke our regulation authorizing the 

use of health claims on the relationship 

between soy protein and coronary heart 

disease on the label or in the labeling of 

foods. We proposed this action based on 

our review of the totality of publicly 

available scientific evidence currently 

available and our tentative conclusion 

that such evidence does not support our 

previous determination that there is 

significant scientific agreement among 

qualified experts for a health claim 

regarding the relationship between soy 

protein and reduced risk of coronary 

heart disease. We provided a 75-day 

comment period for the proposed rule. 

We have received requests for a 60- 

day extension of the comment period for 

the proposed rule. Each request 

conveyed concern that the current 

comment period does not allow 

sufficient time to develop a meaningful 

or thoughtful response to the proposed 

rule. 

FDA has considered the requests and 

is extending the comment period for the 

proposed rule until March 19, 2018. We 

believe that this extension allows 

adequate time for interested persons to 

submit comments without significantly 

delaying rulemaking on these important 

issues. 

Dated: January 11, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00683 Filed 1–12–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2017–1058] 

RIN 1625–AA00 

Safety Zone; Lower Mississippi River, 

New Orleans, LA 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Coast Guard proposes to 

establish two temporary safety zones for 

multiple locations and dates within the 

Captain of the Port Sector New Orleans 

Zone. These safety zones are necessary 

to protect persons and vessels from 

potential safety hazards associated with 

fireworks displays on or over navigable 

waterways. Entry into these zones is 

prohibited unless specifically 

authorized by the Captain of the Port 

Sector New Orleans (COTP) or a 

designated representative. We invite 

your comments on this proposed 

rulemaking. 

DATES: Comments and related material 

must be received by the Coast Guard on 

or before March 19, 2018. 

ADDRESSES: You may submit comments 

identified by docket number USCG– 

2017–1058 using the Federal 

eRulemaking Portal at http://

www.regulations.gov. See the ‘‘Public 

Participation and Request for 

Comments’’ portion of the 

SUPPLEMENTARY INFORMATION section for 

further instructions on submitting 

comments. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this proposed 

rulemaking, call or email Lieutenant 

Commander (LCDR) Howard Vacco, 

Sector New Orleans, US Coast Guard; 

telephone 504–365–2281, email 

Howard.K.Vacco@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

COTP Captain of the Port Sector New 

Orleans 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of proposed rulemaking 

§ Section 


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