65322 Federal Register / Vol. 83, No. 244 / Thursday, December 20, 2018 / Proposed Rules 

§ 61.155 Aeronautical knowledge. 

* * * * * 

(c) * * * 

(14) For an airplane category 

multiengine class rating, the content of 

the airline transport pilot certification 

training program in § 61.156. 

■ 6. Amend § 61.156 by revising the 

heading and introductory text to read as 

follows: 

§ 61.156 Training requirements: Airplane 

category—multiengine class or multiengine 

airplane type rating concurrently with an 

airline transport pilot certificate. 

A person who applies for the 

knowledge test for an airline transport 

pilot certificate with an airplane 

category multiengine class rating must 

present a graduation certificate from an 

authorized training provider under part 

121, 135, 141, or 142 of this chapter 

certifying the applicant has completed 

the following training in a course 

approved by the Administrator. 

* * * * * 

■ 7. Amend § 61.160 by revising the 

introductory text of paragraph (a), the 

introductory text of paragraph (b), the 

introductory text of paragraph (c), and 

paragraph (d) to read as follows: 

§ 61.160 Aeronautical experience— 

airplane category restricted privileges. 

(a) Except for a person who has been 

removed from flying status for lack of 

proficiency or because of a disciplinary 

action involving aircraft operations, a 

U.S. military pilot or former U.S. 

military pilot may apply for an airline 

transport pilot certificate with an 

airplane category multiengine class 

rating or an airline transport pilot 

certificate concurrently with a 

multiengine airplane type rating with a 

minimum of 750 hours of total time as 

a pilot if the pilot presents: 

* * * * * 

(b) A person may apply for an airline 

transport pilot certificate with an 

airplane category multiengine class 

rating or an airline transport pilot 

certificate concurrently with a 

multiengine airplane type rating with a 

minimum of 1,000 hours of total time as 

a pilot if the person: 

* * * * * 

(c) A person may apply for an airline 

transport pilot certificate with an 

airplane category multiengine class 

rating or an airline transport pilot 

certificate concurrently with a 

multiengine airplane type rating with a 

minimum of 1,250 hours of total time as 

a pilot if the person: 

* * * * * 

(d) A graduate of an institution of 

higher education who completes fewer 

than 60 semester credit hours but at 

least 30 credit hours and otherwise 

satisfies the requirements of paragraph 

(b) may apply for airline transport pilot 

certificate with an airplane category 

multiengine class rating or an airline 

transport pilot certificate concurrently 

with a multiengine airplane type rating 

with a minimum of 1,250 hours of total 

time as a pilot. 

* * * * * 

■ 8. Amend § 61.165 by revising 

paragraph (c)(2), the introductory text of 

paragraph (f), and paragraph (f)(2) to 

read as follows: 

§ 61.165 Additional aircraft category and 

class ratings. 

* * * * * 

(c) * * * 

(2) Successfully complete the airline 

transport pilot certification training 

program specified in § 61.156; 

* * * * * 

(f) Adding a multiengine class rating 

to an airline transport pilot certificate 

with a single engine class rating. A 

person applying to add a multiengine 

class rating, or a multiengine class 

rating concurrently with a multiengine 

airplane type rating, to an airline 

transport pilot certificate with an 

airplane category single engine class 

rating must— 

* * * 

(2) Pass a required knowledge test on 

the aeronautical knowledge areas of 

§ 61.155(c), as applicable to multiengine 

airplanes; 

* * * * * 

Issued under authority provided by 49 

U.S.C. 106(f), 44701(a)(5), and 44703(a) in 

Washington, DC, on December 13, 2018. 

Rick Domingo, 

Executive Director, Flight Standards Service. 

[FR Doc. 2018–27402 Filed 12–19–18; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 50, 312, and 812 

[Docket No. FDA–2018–N–2727] 

RIN 0910–AH52 

Institutional Review Board Waiver or 

Alteration of Informed Consent for 

Minimal Risk Clinical Investigations; 

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 the Agency) is 

extending the comment period for the 

proposed rule that appeared in the 

Federal Register of November 15, 2018. 

The Agency is taking this action in 

response to a request for an extension to 

allow interested persons additional time 

to submit comments. 

DATES: FDA is extending the comment 

period on the proposed rule published 

November 15, 2018 (83 FR 57378). 

Submit either electronic or written 

comments by February 13, 2019. 

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 February 13, 

2019. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of February 13, 2019. 

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 

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 


khammond on DSK30JT082PROD with PROPOSAL
Federal Register / Vol. 83, No. 244 / Thursday, December 20, 2018 / Proposed Rules 65323 

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–N–2727 for ‘‘Institutional Review 

Board Waiver or Alteration of Informed 

Consent for Minimal Risk Clinical 

Investigations.’’ 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.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its 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: 

Janet Norden, Office of Good Clinical 

Practice, Food and Drug Administration, 

10903 New Hampshire Ave., Silver 

Spring, MD 20993–0002, 301–796–1127. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of November 15, 2018, 

FDA published a proposed rule with a 

60-day comment period to implement 

the statutory changes made to the 

Federal Food, Drug, and Cosmetic Act 

by section 3024 of the 21st Century 

Cures Act (Pub. L. 114–255) to allow for 

a waiver or alteration of informed 

consent when a clinical investigation 

poses no more than minimal risk to the 

human subject and includes appropriate 

safeguards to protect the rights, safety, 

and welfare of human subjects. The 

proposed rule, if finalized, would 

permit an institutional review board 

(IRB) to waive or alter certain informed 

consent elements or to waive the 

requirement to obtain informed consent, 

under limited conditions, for certain 

minimal risk clinical investigations. 

Comments on the proposed rule will 

inform FDA’s rulemaking to establish 

regulations for IRB waiver or alteration 

of informed consent for certain minimal 

risk clinical investigations. 

The Agency has received a request for 

a 60-day extension of the comment 

period for the proposed rule. This 

request conveyed concern that the 

current 60-day comment period does 

not allow sufficient time to develop a 

meaningful or thoughtful response to 

the proposed rule. 

FDA has considered the request and 

is extending the comment period for the 

proposed rule for 30 days, until 

February 13, 2019. The Agency believes 

that a 30-day extension allows adequate 

time for interested persons to submit 

comments without significantly 

delaying rulemaking on these important 

issues. 

Dated: December 14, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–27519 Filed 12–19–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 199 

[DOD–2018–HA–0028] 

RIN 0720–AB72 

TRICARE; Addition of Physical 

Therapy Assistants and Occupational 

Therapy Assistants as TRICAREAuthorized Providers 

AGENCY: Office of the Secretary, 

Department of Defense (DoD). 

ACTION: Proposed rule. 

SUMMARY: The Department of Defense is 

publishing this proposed rule to add 

certified or licensed physical therapy 

assistants (PTAs) and occupational 

therapy assistants (OTAs) as TRICAREauthorized providers to engage in 

physical therapy or occupational 

therapy under the supervision of a 

TRICARE-authorized physical therapist 

or occupational therapist in accordance 

with Medicare’s rules for supervision 

and qualification when billed by under 

the supervising therapist’s national 

provider identification number. This 

rule will align TRICARE with 

Medicare’s policy, which permits PTAs 

or OTAs to provide physical or 

occupational therapy when supervised 

by and billed under a licensed or 

certified physical therapist or 

occupational therapist. 

DATES: Written comments received at 

the address indicated in the ADDRESSES

section by February 19, 2019 will be 

accepted. 

ADDRESSES: You may submit comments, 

identified by docket number and/or 

Regulatory Information Number (RIN) 

number and title, by either of the 

following methods: 

• Federal Rulemaking Portal: http://

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Department of Defense, Office 

of the Chief Management Officer, 

Directorate for Oversight and 

Compliance, Regulatory and Advisory 

Committee Division, 4800 Mark Center 

Drive, Mailbox #24, Suite 08D09, 

Alexandria, VA 22350–1700. 

Instructions: All submissions received 

must include the agency name and 

docket number or RIN for this Federal 

Register document. The general policy 

for comments and other submissions 

from members of the public is to make 

these submissions available for public 

viewing on the internet at http://

www.regulations.gov as they are 

received without change, including any 


khammond on DSK30JT082PROD with PROPOSAL