Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Proposed Rules 12133 

10–07 and 31–10–08, both dated November 

25, 2009, of Chapter 31, Indicating/Recording 

Systems in RUAG Aerospace Services GmbH 

Dornier 228 Airplane Maintenance Manual, 

TM–AMM–228–00014–080184, Revision 3, 

October 30, 2012. 

(2) If any chafed or damaged wires are 

found during any inspection required in 

paragraph (f)(1) of this AD, before further 

flight, repair the affected wire(s) and assure 

correct installation of the wiring in the flight 

deck overhead panels by reattaching or 

replacing the wire tie attachment holders and 

securing any loose wires to the wire tie 

attachment holders with plastic wire ties 

following subjects 31–10–07 and 31–10–08, 

both dated November 25, 2009, of Chapter 

31, Indicating/Recording Systems in RUAG 

Aerospace Services GmbH Dornier 228 

Airplane Maintenance Manual, TM–AMM– 

228–00014–080184, Revision 3, October 30, 

2012. 

(3) To comply with the actions of this AD, 

you may insert a copy of this AD or a copy 

of the required actions of this AD into the 

airworthiness limitations section of the FAAapproved maintenance program (e.g., 

maintenance manual). This action may be 

done by an owner/operator (pilot) holding at 

least a private pilot certificate and must be 

entered into the airplane records showing 

compliance with this AD in accordance with 

14 CFR 43.9 (a)(1)(4) and 14 CFR 

91.417(a)(2)(v). The record must be 

maintained as required by 14 CFR 91.173 or 

135.439. 

(g) Other FAA AD Provisions 

The following provisions also apply to this 

AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, Standards Office, 

FAA, has the authority to approve AMOCs 

for this AD, if requested using the procedures 

found in 14 CFR 39.19. Send information to 

ATTN: Karl Schletzbaum, Aerospace 

Engineer, FAA, Small Airplane Directorate, 

901 Locust, Room 301, Kansas City, Missouri 

64106; telephone: (816) 329–4146; fax: (816) 

329–4090; email: karl.schletzbaum@faa.gov. 

Before using any approved AMOC on any 

airplane to which the AMOC applies, notify 

your appropriate principal inspector (PI) in 

the FAA Flight Standards District Office 

(FSDO), or lacking a PI, your local FSDO. 

(2) Airworthy Product: For any requirement 

in this AD to obtain corrective actions from 

a manufacturer or other source, use these 

actions if they are FAA-approved. Corrective 

actions are considered FAA-approved if they 

are approved by the State of Design Authority 

(or their delegated agent). You are required 

to assure the product is airworthy before it 

is returned to service. 

(h) Related Information 

Refer to MCAI European Aviation Safety 

Agency (EASA) AD No.: 2013–0244, dated 

October 4, 2013, for related information. You 

may examine the MCAI on the Internet at 

http://www.regulations.gov by searching for 

and locating it in Docket No. FAA–2013– 

1056. For service information related to this 

AD, contact RUAG Aerospace Services 

GmbH, Dornier 228 Customer Support, P.O. 

Box 1253, 82231 Wessling, Germany; 

telephone: +49 (0) 8153–30 2220; fax: +49 (0) 

8153–30 4258; email: 

custsupport.dornier228@ruag.com; Internet: 

http://www.ruag.com/en/Aviation/Aviation_

Home. You may review copies of the 

referenced service information at the FAA, 

Small Airplane Directorate, 901 Locust, 

Kansas City, Missouri 64106. For information 

on the availability of this material at the 

FAA, call (816) 329–4148. 

Issued in Kansas City, Missouri, on 

February 25, 2014. 

Steven W. Thompson, 

Acting Manager, Small Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2014–04699 Filed 3–3–14; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 175 

[Docket No. FAA–2014–0131] 

Notice of Availability of Proposed 

Advisory Circular for Passenger 

Notification Hazardous Materials 

Regulations 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of availability; request 

for comments. 

SUMMARY: In April 2013, the FAA 

Administrator chartered an Aviation 

Rulemaking Committee to develop 

recommendations that would establish 

an acceptable and effective means for air 

carriers to notify passengers of 

hazardous materials regulations. In 

November 2013, that Aviation 

Rulemaking Committee published a 

report containing its recommendations, 

as well as a proposed Advisory Circular 

with one or more means for air carriers 

to comply with passenger notification 

regulations. The FAA invites public 

comment on the Aviation Rulemaking 

Committee’s recommended guidance. 

DATES: Comments must be received by 

April 3, 2014. 

ADDRESSES: Send comments identified 

by docket number FAA–2014–0131 

using any of the following methods: 

• Federal eRulemaking 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: In accordance with 5 U.S.C. 

553(c), DOT solicits comments from the 

public to better inform its rulemaking 

process. DOT posts these comments, 

without edit, including any personal 

information the commenter provides, to 

www.regulations.gov, as described in 

the system of records notice (DOT/ALL– 

14 FDMS), which can be reviewed at 

www.dot.gov/privacy. 

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 the 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: 

Richard Bornhorst or Kenneth Miller, 

International and Domestic Standards 

Division, Office of Hazardous Materials 

Safety, Federal Aviation 

Administration, 470 L’Enfant Plaza SW., 

Washington, DC 20024; telephone (202) 

385–4906, or (202) 385–4916. 

SUPPLEMENTARY INFORMATION: 

Background 

In April 2013, the FAA Administrator 

chartered an Aviation Rulemaking 

Committee (ARC) to develop 

recommendations that would establish 

an acceptable and effective means for air 

carriers to notify passengers of 

hazardous materials regulations. The 

ARC’s charter can be viewed online at: 

http://www.faa.gov/regulations_

policies/rulemaking/committees/

documents/media/ 

PassengerNotificationof

HazardousMaterials

Regulations.ARC.Cht.04302013.pdf. 

In November 2013, the ARC 

submitted a report containing its 

recommendations, as well as an 

Advisory Circular (AC) proposing one or 

more means for air carriers to comply 

with passenger notification 

requirements under Title 49, Code of 

Federal Regulations (49 CFR) part 175. 

The FAA invites public comment on the 

ARC’s recommended guidance, which 

can be found in the docket. 

Comments Invited 

As noted in the ARC’s report, the ARC 

was comprised of experts representing 

air carriers, pilots, flight attendants, the 

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12134 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Proposed Rules 

1FDA, ‘‘Collection, Analysis, and Availability of 

Demographic Subgroup Data for FDA-Approved 

Medical Products,’’ August 2012, available at http:// 

www.fda.gov/downloads/regulatoryinformation/

legislation/federalfooddrugandcosmeticactfdcact/

significantamendmentstothefdcact/fdasia/

ucm365544.pdf. 

travel industry, as well as the FAA and 

Pipeline and Hazardous Materials Safety 

Administration. The ARC now seeks 

input from the general public and is 

particularly interested in feedback from 

entities subject to passenger notification 

regulations prescribed by U.S. 

Hazardous Materials (49 CFR 175.25). 

We note that operators transporting 

passengers in commerce under 14 CFR 

parts 135 and 91 are subject to the noted 

49 CFR regulation, and it is important 

that a final AC provide a clear, 

acceptable, and effective means for 

these operators to communicate 

hazardous materials regulations to their 

passengers. 

The ARC will review all comments 

received and consider them in its final 

recommendation to the FAA. 

Issued in Washington, DC, on February 26, 

2014. 

Christopher Glasow, 

Director, Office of Hazardous Materials 

Safety. 

[FR Doc. 2014–04739 Filed 3–3–14; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 15 

[Docket No. FDA–2013–N–0745] 

Action Plan for the Collection, 

Analysis, and Availability of 

Demographic Subgroup Data in 

Applications for Approval of Food and 

Drug Administration-Regulated 

Medical Products; Notice of Public 

Hearing; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of public hearing; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public hearing to obtain input on the 

issues and challenges associated with 

the collection, analysis, and availability 

of demographic subgroup data in 

applications for approval of FDAregulated human medical products. 

DATES: The public hearing will be held 

on April 1, 2014, from 9 a.m. to 3 p.m. 

Submit electronic or written requests to 

make oral presentations at the hearing 

by March 21, 2014. Electronic or written 

comments will be accepted after the 

hearing until May 16, 2014. 

ADDRESSES: The public hearing will be 

held at FDA’s White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31, 

Conference Center, the Great Room (Rm. 

1503A), Silver Spring, MD 20993. 

Entrance for the public hearing 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to 

http://www.fda.gov/AboutFDA/

WorkingatFDA/BuildingsandFacilities/

WhiteOakCampusInformation/

ucm241740.htm. 

Submit electronic comments to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

corresponding docket number for the 

public meeting as follows: ‘‘Docket No. 

FDA–2013–N–0745, Action Plan for the 

Collection, Analysis, and Availability of 

Demographic Subgroup Data in 

Applications for Approval of FDARegulated Human Medical Products, 

Public Hearing.’’ 

FOR FURTHER INFORMATION CONTACT: 

Brenda Evelyn, Office of the 

Commissioner, Office of Minority 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 32, 

Rm. 2303, Silver Spring, MD 20993 

240–402–4201, email: FDASIA907@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In section 907 of the Food and Drug 

Administration Safety and Innovation 

Act (FDASIA) (Pub. L. 112–144), the 

U.S. Congress directed FDA to produce 

a report that addressed the extent to 

which clinical trial participation and 

the inclusion of safety and effectiveness 

data by demographic subgroups, 

including sex, age, race, and ethnicity, 

is included in applications submitted to 

FDA. Specifically, Congress asked FDA 

to consider four key topic areas: (1) A 

description of existing tools to ensure 

submission of demographic information 

along with how information about 

differences in safety and effectiveness of 

medical products according to 

demographic subgroup is made 

available to health care providers, 

researchers, and patients; (2) an analysis 

of the extent to which demographic data 

subset analyses are presented in 

applications; (3) an analysis of 

demographic subgroup representation in 

clinical trials submitted to FDA in 

support of product applications; and (4) 

an analysis of the extent to which a 

summary of product safety and 

effectiveness data by demographic 

subgroup is made available to the public 

in product labeling or on FDA’s Web 

site. 

To comply with that request, in 

August 2013, FDA published a report 

‘‘Collection, Analysis, and Availability 

of Demographic Subgroup Data for FDAApproved Medical Products.’’ 1 The 

report describes the Agency’s evaluation 

of 72 applications approved during 2011 

for new molecular entity drug products, 

original biologics, and class III devices 

(premarket approval). 

Regarding collection of data, although 

there was variation by product area, the 

evaluation found FDA’s statutory and 

regulatory requirements, guidances, 

policies, and procedures generally 

informed sponsors about including 

tabulations of the demographic data on 

clinical trial participants and 

demographic subset analyses in their 

medical product applications. 

Similarly, tools (e.g., application 

review templates and FDA standard 

operating policies and procedures) 

guide regulatory review staff in the 

assessment of marketing applications to 

ensure that demographic data and 

subset analyses are included in the 

information FDA uses in its review and 

approval processes. 

However, the extent to which 

demographic subset data were analyzed 

varied across medical product types 

(drugs, biologics, and devices). 

Applications for drugs and biologics 

uniformly addressed subset analyses by 

sex, race, and age—that is, the 

applications mentioned demographic 

subsets in some way. The report noted 

that FDA’s new drug application 

regulations (21 CFR part 314; 

specifically § 314.50) call for 

demographic analysis in all applications 

in the integrated summaries of safety 

and effectiveness. Guidance and 

standard operating procedures for drugs 

and biologics also emphasize the 

importance of such analyses. There are 

no regulations requiring demographic 

analysis for device applications. 

Nonetheless, the majority of the device 

applications contained a subset analysis 

for age and sex, with a lower percentage 

of applications containing a subset 

analysis for race and ethnicity. 

Inclusion did not necessarily mean that 

the data on patient subgroups was 

sufficient for meaningful analysis or to 

detect relevant subgroup effects. 

The report stated that all biologics, 

drugs, and the majority of the medical 

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