11966 Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Proposed Rules 

paragraphs (g)(1) through (g)(5) of this AD, or 

within 30 days after the effective date of this 

AD, whichever occurs later. Accomplishing 

this revision terminates the life limit required 

by paragraph (n)(1) of AD 2014–23–15, 

Amendment 39–18031 (80 FR 3871, January 

26, 2015), for the MLG upper cardan P/N 

201163620 for that airplane only. 

(1) For Airbus Model A319 series 

airplanes, pre-Airbus Modification 26644, 

excluding corporate jets post-Airbus 

Modification 28238, 28162, and 28342: The 

life limit is 50,590 total flight cycles. 

(2) For Airbus Model A319 series 

airplanes, post-Airbus Modification 26644, 

excluding corporate jets post-Airbus 

Modification 28238, 28162, and 28342: The 

life limit is 56,480 total flight cycles. 

(3) For Airbus Model A320 series airplanes 

pre-Airbus Modification 26644 having weight 

variant (WV) WV011, WV012, WV016, or 

WV018: The life limit is 50,590 total flight 

cycles. 

(4) For Airbus Model A320 series airplanes 

post-Airbus Modification 26644, having 

WV011, WV012, WV016, or WV018: The life 

limit is 56,480 total flight cycles. 

(5) For Airbus Model A320 series airplanes 

post-Airbus Modification 26644, having 

WV015 or WV017: The life limit is 42,140 

total flight cycles. 

(h) Additional Life Limit Clarifications 

(1) The life limits specified in paragraphs 

(g)(1) through (g)(5) of this AD are total flight 

cycles accumulated by the MLG since first 

installation on an airplane. 

(2) The life limits specified in paragraphs 

(g)(1) through (g)(5) of this AD are applicable 

only for the airplane model, configuration 

and WV specified in those paragraphs. 

(3) If a part is transferred between airplanes 

having a different life limit for the MLG unit, 

adjust the life limit using the method 

specified in Airbus A318/A319/A320/A321 

ALS Part 1—Safe Life Airworthiness 

Limitation Items, Revision 02, dated May 13, 

2011, which is incorporated by reference in 

AD 2014–23–15, Amendment 39–18031 (80 

FR 3871, January 26, 2015). 

(4) An MLG unit on which Airbus 

Modification 26644 is installed is also known 

as ‘‘enhanced’’ landing gear and is identified 

as P/N 201582xxx Leg and Dressing Series. 

An MLG unit that does not have Airbus 

Modification 26644 installed is identified as 

P/N 201375xxx Leg and Dressing Series. (The 

xxx designation is a placeholder for 

numbers). 

(5) For airplanes with configurations not 

specified in paragraphs (g)(1) through (g)(5) 

of this AD, the life limit for the MLG unit is 

specified in Airbus A318/A319/A320/A321 

ALS Part 1—Safe Life Airworthiness 

Limitation Items, Revision 02, dated May 13, 

2011, which is incorporated by reference in 

AD 2014–23–15, Amendment 39–18031 (80 

FR 3871, January 26, 2015). 

(i) No Alternative Actions and Intervals 

After the maintenance or inspection 

program, as applicable, has been revised as 

required by paragraph (g) of this AD, no 

alternative actions (e.g., inspections) or 

intervals may be used unless the actions or 

intervals are approved as an alternative 

method of compliance (AMOC) in 

accordance with the procedures specified in 

paragraph (k)(1) of this AD. 

(j) Parts Installation Limitation 

As of the effective date of this AD, a MLG 

upper cardan having P/N 201163620 may be 

installed on an airplane, provided the part 

life has not exceeded the applicable life limit 

specified in paragraphs (g)(1) through (g)(5) 

of this AD, and is replaced with a serviceable 

part prior to exceeding the applicable life 

limit specified in paragraphs (g)(1) through 

(g)(5) of this AD. 

(k) Other FAA AD Provisions 

The following provisions also apply to this 

AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, International 

Branch, ANM–116, Transport Airplane 

Directorate, FAA, has the authority to 

approve AMOCs for this AD, if requested 

using the procedures found in 14 CFR 39.19. 

In accordance with 14 CFR 39.19, send your 

request to your principal inspector or local 

Flight Standards District Office, as 

appropriate. If sending information directly 

to the International Branch, send it to ATTN: 

Sanjay Ralhan, Aerospace Engineer, 

International Branch, ANM–116, Transport 

Airplane Directorate, FAA, 1601 Lind 

Avenue SW., Renton, WA 98057–3356; 

telephone 425–227–1405; fax 425–227–1149. 

Information may be emailed to: 9-ANM-116- 

AMOC-REQUESTS@faa.gov. Before using 

any approved AMOC, notify your appropriate 

principal inspector, or lacking a principal 

inspector, the manager of the local flight 

standards district office/certificate holding 

district office. The AMOC approval letter 

must specifically reference this AD. 

(2) Contacting the Manufacturer: For any 

requirement in this AD to obtain corrective 

actions from a manufacturer, the action must 

be accomplished using a method approved 

by the Manager, International Branch, ANM– 

116, Transport Airplane Directorate, FAA; or 

the European Aviation Safety Agency 

(EASA); or Airbus’s EASA Design 

Organization Approval (DOA). If approved by 

the DOA, the approval must include the 

DOA-authorized signature. 

(l) Related Information 

(1) Refer to Mandatory Continuing 

Airworthiness Information (MCAI) European 

Aviation Safety Agency Airworthiness 

Directive 2014–0141, dated June 4, 2014, for 

related information. This MCAI may be 

found in the AD docket on the Internet at 

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

and locating Docket No. FAA–2015–0244. 

(2) For service information identified in 

this AD, contact Airbus, Airworthiness 

Office—EIAS, 1 Rond Point Maurice 

Bellonte, 31707 Blagnac Cedex, France; 

telephone +33 5 61 93 36 96; fax +33 5 61 

93 44 51; email account.airworth-eas@

airbus.com; Internet http://www.airbus.com. 

You may view this service information at the 

FAA, Transport Airplane Directorate, 1601 

Lind Avenue SW., Renton, WA. For 

information on the availability of this 

material at the FAA, call 425–227–1221. 

Issued in Renton, Washington, on February 

3, 2015. 

Dionne Palermo, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. 2015–02923 Filed 3–5–15; 4:15 pm] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 15 

[Docket No. FDA–2014–N–1168] 

Generic Drug User Fee Amendments of 

2012; Regulatory Science Initiatives; 

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 that will provide an 

overview of the current status of 

regulatory science initiatives for generic 

drugs and an opportunity for public 

input on research priorities in this area. 

FDA is seeking this input from a variety 

of stakeholders—industry, academia, 

patient advocates, professional societies, 

and other interested parties—as it 

fulfills its commitment under the 

Generic Drug User Fee Amendments of 

2012 (GDUFA) to develop an annual list 

of regulatory science initiatives specific 

to generic drugs. FDA will take the 

information it obtains from the public 

hearing into account in developing the 

fiscal year (FY) 2016 Regulatory Science 

Plan. 

DATES: The public hearing will be held 

on June 5, 2015, from 9 a.m. to 5 p.m. 

The public hearing may be extended or 

may end early depending on the level of 

public participation. 

ADDRESSES: The public hearing will be 

held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

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/WhiteOak

CampusInformation/ucm241740.htm. 

Registration and Requests for Oral 

Presentations: The FDA Conference 

Center at the White Oak location is a 

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Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Proposed Rules 11967 

Federal facility with security procedures 

and limited seating. Attendance will be 

free and on a first-come, first-served 

basis. If you wish to attend (either in 

person or by Webcast (see Streaming 

Webcast of the Public Hearing)) and/or 

present at the hearing, please register for 

the hearing and/or make a request for 

oral presentations or comments by email 

to GDUFARegulatoryScience@

fda.hhs.gov by May 15, 2015. The email 

should contain complete contact 

information for each attendee (i.e., 

name, title, affiliation, address, email 

address, telephone number, and priority 

number(s)). Those without email access 

can register by contacting Thushi Amini 

by May 15, 2015 (see FOR FURTHER

INFORMATION CONTACT). 

FDA will try to accommodate all 

persons who wish to make a 

presentation. Individuals wishing to 

present should identify the number of 

the topic, or topics, they wish to address 

(see section V under Supplementary 

Information). This will help FDA 

organize the presentations. FDA will 

notify registered presenters of their 

scheduled presentation times. The time 

allotted for each presentation will 

depend on the number of individuals 

who wish to speak. Once FDA notifies 

registered presenters of their scheduled 

times, they are encouraged to submit an 

electronic copy of their presentation to 

GDUFARegulatoryScience@fda.hhs.gov 

on or before May 22, 2015. Persons 

registered to make an oral presentation 

are encouraged to arrive at the hearing 

room early and check in at the onsite 

registration table to confirm their 

designated presentation time. An 

agenda for the hearing and other 

background materials will be made 

available 5 days before the hearing at 

http://www.fda.gov/GDUFARegScience. 

If you need special accommodations 

because of a disability, please contact 

Thushi Amini (see FOR FURTHER

INFORMATION CONTACT) at least 7 days 

before the hearing. 

Streaming Webcast of the Public 

Hearing: For those unable to attend in 

person, FDA will provide a live Webcast 

of the hearing. To join the hearing via 

the Webcast, please go to https://

collaboration.fda.gov/gdufa2012/. 

Comments: Regardless of attendance 

at the public hearing, interested persons 

may submit either electronic comments 

to http://www.regulations.gov or written 

comments to the Division of Dockets 

Management (HFA–305), 5600 Fishers 

Lane, Rm. 1061, Rockville, MD 20857. 

The deadline for submitting comments 

to the docket is June 26, 2015. It is only 

necessary to send one set of comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

Transcripts: Please be advised that as 

soon as a transcript is available, it will 

be accessible at http://www.

regulations.gov or http://www.fda.gov/

GDUFARegScience. It may be viewed at 

the Division of Dockets Management 

(see Comments). A transcript will also 

be available in either hardcopy or on 

CD–ROM, after submission of a 

Freedom of Information request. Send 

written requests to the Division of 

Freedom of Information (ELEM–1029), 

Food and Drug Administration, 12420 

Parklawn Dr., Element Bldg., Rockville, 

MD 20857. 

FOR FURTHER INFORMATION CONTACT: 

Thushi Amini, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 4728, 

Silver Spring, MD 20993; 240–402– 

7958, email: Thushi.Amini@fda.hhs.gov; 

or Robert Lionberger, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 4722, 

Silver Spring, MD 20993, 240–402– 

7957, email: Robert.Lionberger@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In July 2012, Congress passed GDUFA 

(Title III of the Food and Drug 

Administration Safety and Innovation 

Act (Pub. L. 112–144)). GDUFA is 

designed to enhance public access to 

safe, high-quality generic drugs and 

reduce costs to industry. To support this 

goal, FDA agreed in the GDUFA 

commitment letter to work with 

industry and interested stakeholders on 

identifying regulatory science research 

priorities specific to generic drugs for 

each fiscal year covered by GDUFA. The 

commitment letter outlines FDA’s 

performance goals and procedures 

under the GDUFA program for the years 

2012–2017. The commitment letter can 

be found at http://www.fda.gov/

downloads/ForIndustry/UserFees/

GenericDrugUserFees/UCM282505.pdf. 

II. FY 2013 Regulatory Science 

Priorities 

The FY 2013 regulatory science 

research priorities list was developed by 

FDA and industry and included in the 

GDUFA commitment letter. To 

implement the FY 2013 priorities list, 

the Office of Generic Drugs awarded $17 

million in external contracts and grants 

to initiate new research studies during 

FY 2013. Four million dollars were 

allocated to support internal research 

related to generic drugs. This includes 

rapid response capabilities through 

equipment for FDA labs and support for 

laboratory research fellows at FDA, as 

well as research fellows to work on data 

analysis and coordination of internal 

activities with external grants and 

contracts. 

III. FY 2014 Regulatory Science 

Priorities 

On June 21, 2013, the Office of 

Generic Drugs held a public hearing to 

gain input in developing the FY 2014 

regulatory science priorities list. This 

list was prepared based on internal 

Center for Drug Evaluation and Research 

discussions, comments received from 

this public hearing, and comments 

submitted to the public docket. The FY 

2014 priorities list can be found at 

http://www.fda.gov/GDUFARegScience. 

To implement the FY 2014 priorities 

list, the Office of Generic Drugs awarded 

$17 million in external contracts and 

grants to initiate new research studies 

during FY 2014. A list of FY 2014 

awarded studies can be found at http:// 

www.fda.gov/GDUFARegScience. 

IV. FY 2015 Regulatory Science 

Priorities 

On May 16, 2014, the Office of 

Generic Drugs held a public meeting to 

allow public input in developing the FY 

2015 regulatory science priorities list. 

The FY 2015 Regulatory Science 

Priorities are as follows: 

1. Postmarket Evaluation of Generic 

Drugs 

2. Equivalence of Complex Products 

3. Equivalence of Locally Acting 

Products 

4. Therapeutic Equivalence Evaluation 

and Standards 

5. Computational and Analytical Tools 

For more information on these topic 

areas, please visit www.fda.gov/

GDUFARegScience. The Office of 

Generic Drugs is currently developing 

research studies to support the FY 2015 

priorities list. Funding opportunities for 

collaborations will be posted in March 

2015 at www.fda.gov/

GDUFARegScience. 

V. Purpose and Scope of the June 5, 

2015, Public Hearing 

The purpose of the June public 

hearing is to obtain input from industry 

and other interested stakeholders on the 

identification of regulatory science 

priorities for FY 2016. To help fulfill 

FDA’s mission, FDA is particularly 

interested in receiving input on the 

following topics: 

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11968 Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Proposed Rules 

1. Opportunities for scientific or 

technical advancements that would help 

to overcome specific barriers for 

industry that currently limit the 

availability of generic drug products. 

2. Innovative approaches to 

preapproval development of generic 

drugs, including new methodologies for 

design and conduct of in vitro, ex vivo, 

and clinical studies and identification of 

scientifically robust strategies for 

demonstration of bioequivalence for 

various product classes. 

3. Innovations in scientific 

approaches to evaluating the therapeutic 

equivalence of generic drug products 

through later stages of their lifecycle 

following initial approval. 

4. Identification of high-impact public 

health issues involving generic drugs 

that can be addressed by the prioritized 

allocation of FY 2016 funding for 

regulatory science research. 

5. Identification of specific issues 

related to generic drug products where 

scientific recommendations and/or 

clarifications are needed in developing 

and/or revising FDA’s guidance for 

industry. 

6. Strategies for enhancing quality and 

equivalence risk management during 

generic drug product development, 

during regulatory review, and/or 

throughout the drug product’s lifecycle 

following initial approval. 

FDA will consider all comments made 

at this hearing or received through the 

docket (see Comments under 

ADDRESSES) as it develops its FY 2016 

GDUFA Regulatory Science Plan. 

Additional information concerning 

GDUFA, including the text of the law 

and the commitment letter, can be 

found at http://www.fda.gov/gdufa. 

VI. Notice of Hearing Under 21 CFR 

Part 15 

The Commissioner of Food and Drugs 

is announcing that the public hearing 

will be held in accordance with 21 CFR 

part 15. The hearing will be conducted 

by a presiding officer, who will be 

accompanied by FDA senior 

management from the Office of the 

Commissioner and the Center for Drug 

Evaluation and Research. Under 

§ 15.30(f) (21 CFR 15.30), the hearing is 

informal and the rules of evidence do 

not apply. No participant may interrupt 

the presentation of another participant. 

Only the presiding officer and panel 

members may pose questions; they may 

question any person during or at the 

conclusion of each presentation. Public 

hearings under part 15 are subject to 

FDA’s policy and procedures for 

electronic media coverage of FDA’s 

public administrative proceedings (21 

CFR part 10, subpart C). Under § 10.205 

(21 CFR 10.205), representatives of the 

media may be permitted, subject to 

certain limitations, to videotape, film, or 

otherwise record FDA’s public 

administrative proceedings, including 

presentations by participants. The 

hearing will be transcribed as stipulated 

in § 15.30(b) (see Transcripts under 

ADDRESSES). To the extent that the 

conditions for the hearing, as described 

in this document, conflict with any 

provisions set out in part 15, this 

document acts as a waiver of those 

provisions as specified in § 15.30(h). 

Dated: February 23, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–05018 Filed 3–4–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE INTERIOR 

National Park Service 

36 CFR Part 7 

[NPS–LAMR–17097; PPWONRADE2, 

PMP00EI05.YP0000] 

RIN 1024–AD86 

Special Regulations; Areas of the 

National Park System, Lake Meredith 

National Recreation Area, Off-Road 

Motor Vehicles 

AGENCY: National Park Service, Interior. 

ACTION: Proposed rule. 

SUMMARY: The National Park Service 

proposes to amend its special 

regulations for Lake Meredith National 

Recreation Area to require permits to 

operate motor vehicles off roads, 

designate areas and routes where motor 

vehicles may be used off roads, create 

management zones that would further 

manage this activity, and establish 

camping, operational, and vehicle 

requirements. These changes would 

allow off-road vehicle use for recreation 

while reducing associated impacts to 

resources. Unless authorized by special 

regulation, operating a motor vehicle off 

roads within areas of the National Park 

System is prohibited. 

DATES: Comments must be received by 

May 4, 2015. 

ADDRESSES: You may submit comments, 

identified by the Regulation Identifier 

Number (RIN) 1024–AD86, by any of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Superintendent, Lake 

Meredith National Recreation Area, P.O. 

Box 1460, Fritch, TX 79036. 

• Hand Deliver to: Superintendent, 

Lake Meredith National Recreation 

Area, 419 E. Broadway, Fritch, TX 

79036. 

Instructions: All submissions received 

must include the agency name and RIN 

for this rulemaking. Comments received 

will be posted without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information, see the ‘‘Public 

Participation’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Robert Maguire, Superintendent, Lake 

Meredith National Recreation Area, 

Alibates Flint Quarries National 

Monument, P.O. Box 1460, Fritch, Texas 

79036–1460, by phone at 806–857– 

3151, or by email at Robert_Maguire@

nps.gov. 

SUPPLEMENTARY INFORMATION: 

Purpose and Significance of Lake 

Meredith National Recreation Area 

Congress established Lake Meredith 

National Recreation Area (LAMR or 

recreation area) in 1990 ‘‘to provide for 

public outdoor recreation use and 

enjoyment of the lands and waters 

associated with Lake Meredith in the 

State of Texas, and to protect the scenic, 

scientific, cultural, and other values 

contributing to the public enjoyment of 

such lands and waters. . . .’’ 16 U.S.C 

460eee. 

Situated approximately 35 miles 

north of Amarillo, Texas within Potter, 

Moore, Hutchinson, and Carson 

counties, LAMR is approximately 

45,000 acres in size and is the largest 

public landmass in the Texas 

Panhandle. LAMR includes a variety of 

habitats that are uncommon in the 

region, including aquatic, wetland, and 

riparian areas, and one of the few areas 

in the region with trees. The natural and 

geologic resources of the area have 

enabled a continuum of human 

presence in the area for more than 

13,000 years. The exposed geologic 

features on the walls of the Canadian 

River valley (i.e., the ‘‘breaks’’) reveal 

active geologic processes that are easily 

visible to an extent not present 

elsewhere in the region. The recreation 

area is also home to the Arkansas River 

shiner (Notropis girardi), a fish species 

that is federally listed as threatened. 

Authority To Promulgate Regulations 

The National Park Service (NPS) 

manages LAMR under statute 

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