This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents.

Rules and Regulations Federal Register

81781 

Vol. 85, No. 243 

Thursday, December 17, 2020 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

2 CFR Part 376 

42 CFR Parts 23, 51c, 52i, 56, 57, 63, 

and 124 

45 CFR Parts 3, 63, and 75 

48 CFR Parts 302 and 326 

[Docket Number HHS–OS–2020–0015] 

RIN 0991–AC19 

Food and Drug Administration 

21 CFR Parts 1, 5, 12, 14, 25, 81, 133, 

172, 178, 184, 201, 310, 369, 501, and 

582 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 411, 412, 422, 423, 426, 

440, 441, 447, 482, and 485 

Office of Inspector General 

42 CFR Parts 1004 and 1008 

Administration for Children and 

Families 

45 CFR Parts 305, 307, 1324, 1325, 

1326, and 1328 

Regulatory Clean Up Initiative; 

Correction 

AGENCY: Office of the Assistant 

Secretary for Administration (ASA), 

HHS. 

ACTION: Final rule; correction. 

SUMMARY: The Department of Health and 

Human Services is correcting a final 

rule that appeared in the Federal 

Register on November 16, 2020. This 

document had incorrectly designated 

footnotes and typographical errors. 

DATES: Effective December 17, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Douglas Cheung, Ph.D., phone: 202– 

690–6704, email: douglas.cheung@

hhs.gov; and RegCleanUp@hhs.gov. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

2020–21774, appearing on page 72899 

in the Federal Register of November 16, 

2020, the following corrections are 

made: 

§ 51c [Corrected] 

■ 1. On page 72901, in the first column, 

in 42 CFR part 51c, ‘‘Correct Reference. 

Section 51c.107(5) . . .’’ is corrected to 

read ‘‘Correct Reference. Section 

51c.107(b)(5) . . .’’ 

§ 56 [Corrected] 

■ 2. On page 72901, in the second 

column, in 42 CFR part 56, a bullet is 

missing and is corrected to read as 

follows: • Correct Reference. Section 56.603(e) 

is amended to remove the phrase ‘‘the 

most recent CSA Income Poverty 

Guidelines (45 CFR 1060.2)’’ and 

replace it with ‘‘the poverty guidelines 

updated periodically in the Federal 

Register by the U.S. Department of 

Health and Human Services under the 

authority of 42 U.S.C. 9902(2)’’. The 

Secretary of HHS is required to update 

the poverty guidelines at least annually, 

adjusting them based on the Consumer 

Price Index for All Urban Consumers. 45 

CFR 1060.2 no longer exists; rather, 

updates are published at least annually 

in the Federal Register. 

§ 422 [Corrected] 

■ 3. On page 72902, in the first column, 

in 42 CFR part 422, the third sentence 

of the last bullet, ‘‘The reference to 

§ 423.858 . . .’’ is corrected to read 

‘‘The reference to § 422.858 . . .’’ 

§ 5.1100 [Corrected] 

■ 4. On page 72906, in the third column, 

instruction 6 is corrected to read as 

follows: 

■ 6. Amend § 5.1100 by: 

a. Redesignating footnotes 2 through 

62 as footnotes 3 through 63. b. Revising the entry for ‘‘Office of the 

Chief Counsel’’ as follows: 

§ 5.1100 Headquarters. 

* * * * * 

Office of the Chief Counsel.2

2The Office of the Chief Counsel (also 

known as the Food and Drug Division, Office 

of the General Counsel, Department of Health 

and Human Services), while administratively 

within the Office of the Commissioner, is 

part of the Office of the General Counsel of 

the Department of Health and Human 

Services. 

* * * * * 

§ 14.7 [Corrected] 

■ 5. On page 72906, in the third column, 

instruction 11 is corrected to read as 

follows: 

■ 11. Amend § 14.7(b) by removing ‘‘45 

CFR 5.34’’ and adding in its place ‘‘45 

CFR 5.61 through 5.64’’. 

§ 56.303 [Corrected] 

■ 6. On page 72908, in the third column, 

instructions 48 and 49 are corrected to 

read as follows: 

■ 48. Amend § 56.303(f) by removing 

the phrase ‘‘the most recent CSA 

Poverty Income Guidelines (45 CFR 

1060.2)’’ and adding in its place ‘‘the 

poverty guidelines updated periodically 

in the Federal Register by the U.S. 

Department of Health and Human 

Services under the authority of 42 

U.S.C. 9902(2)’’. 

49. Amend § 56.603(e) by removing 

the phrase ‘‘the most recent CSA 

Poverty Income Guidelines (45 CFR 

1060.2)’’ and adding in its place ‘‘the 

poverty guidelines updated periodically 

in the Federal Register by the U.S. 

Department of Health and Human 

Services under the authority of 42 

U.S.C. 9902(2)’’.’’ 

§ 3.5 [Corrected] 

■ 7. On page 72910, in the first column, 

instruction 91 is corrected to read as 

follows: 

■ 91. Amend § 3.5 by: 

a. Removing the reference ‘‘41 CFR 

part 101–48’’ and adding in its place 

‘‘41 CFR 102’’. 

b. Removing ‘‘41 CFR 101–45.304 and 

101–48.305’’ and adding in its place ‘‘41 

CFR 102–41’’.’’ 

§ 1324.11 [Corrected] 

■ 8. On page 72911, in the second 

column, instruction 102 is corrected to 

read as follows: 

■ 102. Amend § 1324.11 by: 

a. Removing the reference 

‘‘1327.13(e)’’ and adding in its place 

‘‘1324.13(e)’’. 

b. Removing all references 

‘‘1327.19(b)(5) through (8)’’ and adding 

in their places ‘‘1324.19(b)(5) through 

(8)’’. 

c. Removing the reference ‘‘1327.21’’ 

and adding in its place ‘‘1324.21’’.’’ 

81782 Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Rules and Regulations 

Dated: November 24, 2020. 

Wilma M. Robinson, 

Deputy Executive Secretary, Department of 

Health and Human Services. 

[FR Doc. 2020–26389 Filed 12–16–20; 8:45 am] 

BILLING CODE 4151–17–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 25 

[Docket No. FAA–2019–1054; Special 

Conditions No. 25–777–SC] 

Special Conditions: Boeing 

Commercial Airplanes Model 777–9 

Airplane; Overhead Flightcrew Rest 

Compartment Occupiable During Taxi, 

Takeoff, and Landing 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final special conditions. 

SUMMARY: These special conditions are 

issued for the Boeing Commercial 

Airplanes (Boeing) Model 777–9 

airplane. This airplane will have a novel 

or unusual design feature when 

compared to the state of technology 

envisioned in the airworthiness 

standards for transport-category 

airplanes. This design feature is an 

overhead flightcrew rest (OFCR) 

compartment occupiable during taxi, 

takeoff, and landing (TT&L). The 

applicable airworthiness regulations do 

not contain adequate or appropriate 

safety standards for this design feature. 

These special conditions contain the 

additional safety standards that the 

Administrator considers necessary to 

establish a level of safety equivalent to 

that established by the existing 

airworthiness standards. 

DATES: Effective January 19, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Shannon Lennon, Airframe and Cabin 

Safety Section, AIR–675, Transport 

Standards Branch, Policy and 

Innovation Division, Aircraft 

Certification Service, Federal Aviation 

Administration, 2200 South 216th 

Street, Des Moines, Washington 98198; 

telephone and fax 206–231–3209; email 

shannon.lennon@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

On December 6, 2013, Boeing applied 

for an amendment to Type Certificate 

No. T00001SE to include the new 777– 

9 airplane. The application date was 

extended to March 30, 2016, at Boeing’s 

request. The Boeing Model 777–9 

airplane, which is a derivative of the 

Boeing Model 777 airplane currently 

approved under Type Certificate No. 

T00001SE, is a twin-engine, transportcategory airplane with seating for 495 

passengers, and a maximum takeoff 

weight of 775,000 lbs. 

Type Certification Basis 

Under the provisions of title 14, Code 

of Federal Regulations (14 CFR) 21.101, 

Boeing must show that the 777–9 

airplane, as changed, continues to meet 

the applicable provisions of the 

regulations listed in Type Certificate No. 

T00001SE, or the applicable regulations 

in effect on the date of application for 

the change, except for earlier 

amendments as agreed upon by the 

FAA. 

If the Administrator finds that the 

applicable airworthiness regulations 

(e.g., 14 CFR part 25) do not contain 

adequate or appropriate safety standards 

for the Boeing Model 777–9 airplane 

because of a novel or unusual design 

feature, special conditions are 

prescribed under the provisions of 

§ 21.16. 

Special conditions are initially 

applicable to the model for which they 

are issued. Should the type certificate 

for that model be amended later to 

include any other model that 

incorporates the same novel or unusual 

design feature, or should any other 

model already included on the same 

type certificate be modified to 

incorporate the same novel or unusual 

design feature, these special conditions 

would also apply to the other model 

under § 21.101. 

In addition to the applicable 

airworthiness regulations and special 

conditions, the Boeing Model 777–9 

airplane must comply with the fuel-vent 

and exhaust-emission requirements of 

14 CFR part 34, and the noisecertification requirements of 14 CFR 

part 36. 

The FAA issues special conditions, as 

defined in 14 CFR 11.19, in accordance 

with § 11.38, and they become part of 

the type certification basis under 

§ 21.101. 

Novel or Unusual Design Features 

The Boeing Model 777–9 airplane will 

incorporate the following novel or 

unusual design features: 

An overhead flightcrew rest (OFCR) 

compartment occupiable during taxi, 

takeoff, and landing. 

Discussion 

Crew rest compartments have been 

previously installed and certificated on 

several Boeing airplane models in 

locations such as in the main passenger 

seating area, the overhead space above 

the main passenger-cabin seating area, 

and below the passenger-cabin seating 

area within the cargo compartment. In 

each case, the Administrator determined 

that the applicable regulations (i.e., 14 

CFR part 25) did not provide all of the 

necessary requirements, because each 

installation had unique features by 

virtue of its design, location, and use on 

the airplane. 

For Boeing Model 777 airplanes, the 

FAA issued Special Conditions No. 25– 

260–SC, dated April 14, 2004, for OFCR 

compartments allowed to be occupied 

during TT&L, as well as during flight. 

However, after issuance of Special 

Conditions No. 25–260–SC, the FAA 

issued Special Conditions No. 25–418– 

SC for the Boeing Model 787–8 airplane, 

for the same novel design feature, with 

changes to better address oxygen 

systems and fire suppressors. Those 

special conditions reflected the 

methodology necessary to provide an 

equivalent level of safety for remote 

OFCR compartments. Therefore, new 

special conditions are issued for this 

design feature on Boeing Model 777–9 

airplanes, in lieu of Special Conditions 

No. 25–260–SC. 

For the Boeing Model 777–9 airplane, 

the OFCR compartment is located in the 

overhead space above the main 

passenger-cabin seating area 

immediately aft of the first pair of maindeck emergency exits (Door 1). The 

compartment includes two private 

berths and up to two seats. Occupancy 

of the compartment will be limited to a 

maximum of four trained crewmembers 

during flight, and two trained flightcrew 

members, one in each seat, during 

TT&L. The compartment will be 

accessed from the main deck by stairs 

through a vestibule. In addition, a 

secondary evacuation route, which 

opens directly into the main passenger 

seating area, will be available as an 

alternate route for evacuating occupants 

of the compartment. A smoke-detection 

system and an oxygen system will be 

provided in the compartment. Other 

optional features, such as a sink with 

cold-drink stowage or a lavatory, may be 

provided as well. 

This Boeing Model 777–9 airplane 

OFCR compartment is novel or unusual 

to part 25 due to its design, location, 

and use on the airplane. This 

compartment is particularly novel or 

unusual in that it is located in the 

overhead area of the passenger 

compartment, and will be occupied by 

trained flightcrew during TT&L. Due to 

the novel or unusual features associated 

with the installation of this 

compartment, special conditions are 

considered necessary to provide a level