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. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

18305 

Vol. 80, No. 65 

Monday, April 6, 2015 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 25 

[Docket No. FAA–2015–0177; Special 

Conditions No. 25–579–SC] 

Special Conditions: Cessna Aircraft 

Company Model 680A Airplane, PilotCompartment View Through 

Hydrophobic Windshield Coatings in 

Lieu of Windshield Wipers 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final special conditions, request 

for comment. 

SUMMARY: These special conditions are 

issued for the Cessna Model 680A 

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 

hydrophobic windshield coatings in 

lieu of windshield wipers. 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 date: This action is 

effective on Cessna Aircraft Company 

on April 6, 2015. We must receive your 

comments by May 21, 2015. 

ADDRESSES: Send comments identified 

by docket number FAA–2015–0177 

using any of the following methods: 

• Federal eRegulations Portal: Go to 

http://www.regulations.gov/ and follow 

the online instructions for sending your 

comments electronically. 

• Mail: Send comments to Docket 

Operations, M–30, U.S. Department of 

Transportation (DOT), 1200 New Jersey 

Avenue SE., Room W12–140, West 

Building Ground Floor, Washington, DC 

20590–0001. 

• Hand Delivery or Courier: Take 

comments to Docket Operations in 

Room W12–140 of the West Building 

Ground Floor at 1200 New Jersey 

Avenue SE., Washington, DC, between 9 

a.m. and 5 p.m., Monday through 

Friday, except Federal holidays. 

• Fax: Fax comments to Docket 

Operations at 202–493–2251. 

Privacy: The FAA will post all 

comments it receives, without change, 

to http://www.regulations.gov/, 

including any personal information the 

commenter provides. Using the search 

function of the docket Web site, anyone 

can find and read the electronic form of 

all comments received into any FAA 

docket, including the name of the 

individual sending the comment (or 

signing the comment for an association, 

business, labor union, etc.). DOT’s 

complete Privacy Act Statement can be 

found in the Federal Register published 

on April 11, 2000 (65 FR 19477–19478), 

as well as at http://DocketsInfo.dot. 

gov/. 

Docket: Background documents or 

comments received may be read at 

http://www.regulations.gov/ at any time. 

Follow the online instructions for 

accessing the docket or go to Docket 

Operations in Room W12–140 of the 

West Building Ground Floor at 1200 

New Jersey Avenue SE., Washington, 

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

through Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: Bob 

Hettman, ANM–112, Transport Airplane 

Directorate, Aircraft Certification 

Service, 1601 Lind Avenue SW., 

Renton, Washington 98057–3356; 

telephone (425) 227–2683; facsimile 

(425) 227–1149. 

SUPPLEMENTARY INFORMATION: 

Background 

On January 25, 2012, Cessna Aircraft 

Company applied for an amended type 

certificate for a new Model 680A 

airplane. 

The Model 680A, a derivative of the 

Cessna Model 680 airplane currently 

approved under type-certificate number 

T00012WI, is intended to be a ninepassenger executive airplane with a 

maximum takeoff weight of 30,300 

pounds and a maximum operating 

altitude of 45,000 feet. The Model 680A 

airplane uses a hydrophobic windshield 

coating, in lieu of windshield wipers, 

for an unobstructed outside view from 

the pilot compartment. 

Type Certification Basis 

Under the provisions of Title 14, Code 

of Federal Regulations (14 CFR) 21.101, 

Cessna Aircraft Company must show 

that the Model 680A airplane meets the 

applicable provisions of the regulations 

listed in type-certificate no. T00012WI, 

or the applicable regulations in effect on 

the date of application for the change 

except for earlier amendments as agreed 

upon by the FAA. The regulations listed 

in the type certificate are commonly 

referred to as the ‘‘original typecertification basis.’’ 

The certification basis includes 

certain special conditions, exemptions, 

or later amended sections of the 

applicable part that are not relevant to 

these special conditions. 

If the Administrator finds that the 

applicable airworthiness regulations 

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

adequate or appropriate safety standards 

for the Model 680A 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 or similar 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 Model 680A airplane 

must comply with the fuel-vent and 

exhaust-emission requirements of part 

34, and the noise-certification 

requirements of 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 Cessna Model 680A airplane will 

incorporate the following novel or 

unusual design features: 


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18306 Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Rules and Regulations 

The airplane flight-deck design 

incorporates a hydrophobic windshield 

coating that, during precipitation, 

provides an adequate outside view from 

the pilot compartment. Sole reliance on 

such a coating, without windshield 

wipers, constitutes a novel or unusual 

design feature for which the applicable 

airworthiness regulations do not contain 

adequate or appropriate safety 

standards. Therefore, special conditions 

are required to provide a level of safety 

equivalent to that established by the 

regulations. 

Discussion 

Section 25.773(b)(1) requires a means 

to maintain a clear portion of the 

windshield for both pilots of a 

transport-category airplane to have a 

sufficiently extensive view along the 

flight path during precipitation 

conditions. The regulations require this 

means to maintain such an area clear 

vision during heavy-rain precipitation at 

airplane speeds up to 1.5 VSR1. 

This requirement has existed in 

principle since 1953 in part 4b of the 

‘‘Civil Air Regulations’’ (CAR). Section 

4b.351(b)(1) of CAR 4b required that 

‘‘Means shall be provided for 

maintaining a sufficient portion of the 

windshield clear so that both pilots are 

afforded a sufficiently extensive view 

along the flight path in all normal flight 

attitudes of the airplane. Such means 

shall be designed to function under the 

following conditions without 

continuous attention on the part of the 

crew: (i) In heavy rain at speeds up to 

1.6 VS1, flaps retracted.’’ 

Effective December 26, 2002, 

Amendment 25–108 changed the speed 

for effectiveness of the means to 

maintain an area of clear vision from up 

to 1.6 VS1 to 1.5 VSR1 to accommodate 

the redefinition of the reference stall 

speed from the minimum speed in the 

stall, VS1, to greater than or equal to the 

1g stall speed, VSR1. As noted in the 

preamble to the final rule for that 

amendment, the reduced factor of 1.5 on 

VSR1 is to maintain approximately the 

same speed as the 1.6 factor on VS1. 

The requirement that the means to 

maintain a clear area of forward vision 

must function at high speeds and high 

precipitation rates is based on the use of 

windshield wipers as the means to 

maintain an adequate area of clear 

vision in precipitation conditions. The 

requirement in 14 CFR 121.313(b) and 

125.213(b) to provide ‘‘a windshield 

wiper or equivalent for each pilot 

station’’ has remained unchanged since 

at least 1953. 

The effectiveness of windshield 

wipers to maintain an area of clear 

vision normally degrades as airspeed 

and precipitation rates increase. It is 

assumed that because high speeds and 

high precipitation rates represent 

limiting conditions for windshield 

wipers, they will also be effective at 

lower speeds and precipitation levels. 

Accordingly, § 25.773(b)(1)(i) does not 

require maintenance of a clear area of 

forward vision at lower speeds or lower 

precipitation rates. 

A forced airflow blown directly over 

the windshield has also been used to 

maintain an area of clear vision in 

precipitation. The limiting conditions 

for this technology are comparable to 

those for windshield wipers. 

Accordingly, introduction of this 

technology did not present a need for 

special conditions to maintain the level 

of safety embodied in the existing 

regulations. 

Hydrophobic windshield coatings 

may depend to some degree on airflow 

to maintain a clear-vision area. The 

heavy rain and high speed conditions 

specified in the current rule do not 

necessarily represent the limiting 

condition for this new technology. For 

example, airflow over the windshield, 

which may be necessary to remove 

moisture from the windshield, may not 

be adequate to maintain a sufficiently 

clear-vision area of the windshield in 

low-speed flight or during surface 

operations. Alternatively, airflow over 

the windshield may be disturbed during 

such critical times as the approach to 

land, where the airplane is at a higherthan-normal pitch attitude. In these 

cases, areas of airflow disturbance or 

separation on the windshield could 

cause failure to maintain a clear-vision 

area on the windshield. 

In addition to potentially depending 

on airflow to function effectively, 

hydrophobic coatings may also be 

dependent on water-droplet size for 

effective precipitation removal. For 

example, precipitation in the form of a 

light mist may not be sufficient for the 

coating’s properties to result in 

maintaining a clear area of vision. 

The current regulations identify speed 

and precipitation rate requirements that 

represent limiting conditions for 

windshield wipers and blowers, but not 

for hydrophobic coatings. Likewise, it is 

necessary to issue special conditions to 

maintain the level of safety represented 

by the current regulations. 

These special conditions provide an 

appropriate safety standard for the 

hydrophobic coating technology as the 

means to maintain a clear area of vision 

by requiring the coating to be effective 

at low speeds and low precipitation 

rates, as well as at the higher speeds and 

precipitation rates identified in the 

current regulation. These are the only 

new or changed requirements relative to 

those in § 25.773(b)(1) at Amendment 

25–108. 

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. 

Applicability 

As discussed above, these special 

conditions are applicable to the Cessna 

Model 680A airplane. Should Cessna 

apply at a later date for a change to the 

type certificate to include another 

model incorporating the same novel or 

unusual design feature, the special 

conditions would apply to that model as 

well. 

Conclusion 

This action affects only certain novel 

or unusual design features on the 

Cessna Model 680A airplane. It is not a 

rule of general applicability. 

The substance of these special 

conditions has been subjected to the 

notice and comment period in several 

prior instances and has been derived 

without substantive change from those 

previously issued. It is unlikely that 

prior public comment would result in a 

significant change from the substance 

contained herein. Therefore, because a 

delay would significantly affect the 

certification of the airplane, which is 

imminent, the FAA has determined that 

prior public notice and comment are 

unnecessary and impracticable, and 

good cause exists for adopting these 

special conditions upon publication in 

the Federal Register. The FAA is 

requesting comments to allow interested 

persons to submit views that may not 

have been submitted in response to the 

prior opportunities for comment 

described above. 

List of Subjects in 14 CFR Part 25 

Aircraft, Aviation safety, Reporting 

and recordkeeping requirements. 

The authority citation for these 

special conditions is as follows: 

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

44702, 44704. 

The Special Conditions 

Accordingly, pursuant to the 

authority delegated to me by the 

Administrator, the following special 

conditions are issued as part of the typecertification basis for Cessna Model 

680A airplanes. 

The airplane must have a means to 

maintain a clear portion of the 

windshield, during precipitation 

conditions, enough for both pilots to 

have a sufficiently extensive view along 


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Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Rules and Regulations 18307 

the ground or flight path in normal taxi 

and flight attitudes of the airplane. This 

means must be designed to function, 

without continuous attention on the 

part of the flightcrew, in conditions 

from light misting precipitation to heavy 

rain, at speeds from fully stopped in 

still air, to 1.5 VSR1 with lift and drag 

devices retracted. 

Issued in Renton, Washington, on March 

27, 2015. 

Michael Kazycki, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. 2015–07713 Filed 4–3–15; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 14 

[Docket No. FDA–2009–N–0443] 

Advisory Committee; Anti-Infective 

Drugs Advisory Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

standing advisory committees’ 

regulations to change the name of the 

Anti-Infective Drugs Advisory 

Committee. This action is being taken to 

change the name of this committee on 

the Agency’s list of standing advisory 

committees. 

DATES: This rule is effective April 6, 

2015. The name change became 

applicable March 4, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Michael Ortwerth, Advisory Committee 

Oversight and Management Staff, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, Rm. 5129, 

Silver Spring, MD 20993–0002, FAX: 

301–847–8640, or Michael.Ortwerth@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The AntiInfective Drugs Advisory Committee 

(the Committee) was established on 

October 7, 1980 (45 FR 79025). The 

Committee reviews and evaluates 

available data concerning the safety and 

effectiveness of marketed and 

investigational human drug products for 

use in the treatment of infectious 

diseases and disorders. 

The Committee name has been 

changed to the following: Antimicrobial 

Drugs Advisory Committee. The Agency 

changed the name to better reflect the 

products and issues that will be brought 

to the committee. The change became 

effective March 4, 2015. 

Therefore, the Agency is amending 21 

CFR 14.100(c) as set forth in the 

regulatory text of this document. 

Under 5 U.S.C. 553(b)(3)(B) and (d) 

and 21 CFR 10.40(d) and (e), the Agency 

finds good cause to dispense with notice 

and public comment procedures and to 

proceed to an immediate effective date 

on this rule. Notice and public comment 

and a delayed effective date are 

unnecessary and are not in the public 

interest as this final rule merely 

removes the name of the Anti-Infective 

Drugs Advisory Committee from the list 

of standing advisory committees in 21 

CFR 14.100 and replaces it with the 

Antimicrobial Drugs Advisory 

Committee. 

List of Subjects in 21 CFR Part 14 

Administrative practice and 

procedure, Advisory committees, Color 

additives, Drugs, Radiation protection. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 14 is 

amended as follows: 

PART 14—PUBLIC HEARING BEFORE 

A PUBLIC ADVISORY COMMITTEE 

■ 1. The authority citation for 21 CFR 

part 14 continues to read as follows: 

Authority: 5 U.S.C. App. 2; 15 U.S.C. 

1451–1461; 21 U.S.C. 41–50, 141–149, 321– 

394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 

U.S.C. 201, 262, 263b, 264; Pub. L. 107–109; 

Pub. L. 108–155; Pub. L. 113–54. 

■ 2. Amend § 14.100 by revising 

paragraph (c)(2) introductory text to 

read as follows: 

§ 14.100 List of standing advisory 

committees. 

* * * * * 

(c) * * * 

(2) Antimicrobial Drugs Advisory 

Committee. 

* * * * * 

Dated: March 27, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07789 Filed 4–3–15; 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–2015–N–0804] 

Medical Devices; GastroenterologyUrology Devices; Classification of the 

Urethral Insert With Pump for Bladder 

Drainage 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

urethral insert with pump for bladder 

drainage into class II (special controls). 

The special controls that will apply to 

the device are identified in this order 

and will be part of the codified language 

for the urethral insert with pump for 

bladder drainage’s classification. The 

Agency is classifying the device into 

class II (special controls) in order to 

provide a reasonable assurance of safety 

and effectiveness of the device. 

DATES: This order is effective April 6, 

2015. The classification was applicable 

on October 14, 2014. 

FOR FURTHER INFORMATION CONTACT: John 

Baxley, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. G210, Silver Spring, 

MD 20993–0002, 301–796–6549. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In accordance with section 513(f)(1) of 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 

360c(f)(1)), devices that were not in 

commercial distribution before May 28, 

1976 (the date of enactment of the 

Medical Device Amendments of 1976), 

generally referred to as postamendments 

devices, are classified automatically by 

statute into class III without any FDA 

rulemaking process. These devices 

remain in class III and require 

premarket approval, unless and until 

the device is classified or reclassified 

into class I or II, or FDA issues an order 

finding the device to be substantially 

equivalent, in accordance with section 

513(i) of the FD&C Act, to a predicate 

device that does not require premarket 

approval. The Agency determines 

whether new devices are substantially 

equivalent to predicate devices by 

means of premarket notification 

procedures in section 510(k) of the 

FD&C Act (21 U.S.C. 360(k)) and part 

807 (21 CFR part 807) of the regulations. 


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