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. 


Rmajette on DSK2VPTVN1PROD with RULES