Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Proposed Rules 8577 

(i) Related Information 

(1) Refer to Mandatory Continuing 

Airworthiness Information (MCAI) EASA 

Airworthiness Directive 2014–0191, dated 

August 29, 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–2015–0086. 

(2) For service information identified in 

this AD, contact Airbus SAS, Airworthiness 

Office—EAW, 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 January 

30, 2015. 

Jeffrey E. Duven, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2015–02683 Filed 2–17–15; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 314 and 601 

[Docket No. FDA–2013–N–0500] 

Supplemental Applications Proposing 

Labeling Changes for Approved Drugs 

and Biological Products; Public 

Meeting; Request for Comments; 

Reopening of the Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments; reopening of the 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

1-day public meeting entitled 

‘‘Supplemental Applications Proposing 

Labeling Changes for Approved Drugs 

and Biological Products.’’ The purpose 

of the meeting is to provide a public 

forum for FDA to listen to comments on 

the proposed rule on ‘‘changes being 

effected’’ supplements that was 

published in the Federal Register of 

November 13, 2013, and alternatives 

offered to this proposed rule. FDA is 

also reopening the comment period for 

the proposed rule to receive 

submissions of additional written 

comments on the proposed rule as well 

as alternative proposals presented 

during the public meeting. 

DATES: Meeting. The public meeting will 

be held on March 27, 2015, from 8 a.m. 

to 5 p.m. Registration to attend the 

meeting must be received by March 20, 

2015. See the SUPPLEMENTARY

INFORMATION section for information on 

how to register for the meeting. 

Comments. The comment period for 

the proposed rule publilshed November 

13, 2013 (78 FR 67985), is reopened. 

Submit either electronic or written 

comments regarding proposed 

alternatives to the proposed rule by 

April 27, 2015. 

ADDRESSES: The public meeting will be 

held at the FDA White Oak Campus, 

10903 New Hampshire Ave, Building 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

Entrance for the public meeting 

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. 

You may submit comments by any of 

the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• Mail/Hand delivery/Courier (for 

paper submissions): Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Instructions: All submissions received 

must include the Docket No. FDA– 

2013–N–0500 for the proposed rule. All 

comments received may be posted 

without change to http://

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ 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 and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Ellen Molinaro, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, Bldg. 51, Rm. 

6218, 10903 New Hampshire Ave., 

Silver Spring, MD 20993–0002, 301– 

796–3601, FAX: 301–847–8440. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of November 

13, 2013 (78 FR 67985), FDA proposed 

regulations to revise and clarify 

procedures for application holders of an 

approved drug or biological product to 

change the product labeling to reflect 

certain types of newly acquired safetyrelated information in advance of FDA’s 

review of the change by submitting a 

changes being effected (CBE–0) 

supplement to FDA. The need to 

promptly communicate certain safetyrelated labeling changes based on newly 

acquired information is the basis for the 

‘‘changes being effected’’ exception to 

the general requirement for FDA 

approval of revised labeling prior to 

distribution. The proposed rule, if 

finalized, would enable abbreviated new 

drug application (ANDA) holders for 

generic drugs to update product labeling 

promptly to reflect certain types of 

newly acquired safety-related 

information, irrespective of whether the 

revised labeling differs from that of the 

corresponding reference listed drug 

(RLD or brand drug) upon submission of 

a CBE–0 supplement to FDA. FDA’s 

proposed revisions to its regulations to 

allow generic drug manufacturers to 

update product labeling through CBE–0 

supplements in the same manner as 

brand drug manufacturers are intended 

to improve communication of 

important, newly acquired drug safety 

information to health care professionals 

and the public. For further information 

about this and other proposed 

regulatory changes described in the 

proposed rule, see 78 FR 67985. 

FDA received numerous comments on 

the proposed rule from a diverse group 

of stakeholders, including comments 

proposing alternative approaches to 

communicating newly acquired safetyrelated information in a multisource 

environment. In November 2014, FDA 

received a request from two trade 

associations for a listening meeting with 

FDA to present an alternative to the 

proposed regulatory changes described 

in the proposed rule that they described 

as intended to meet shared public 

health goals regarding multisource 

drugs (see Ref. 1). In December 2014, an 

explanatory statement accompanying 

the Consolidated and Further 

Continuing Appropriations Act, 2015 

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8578 Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Proposed Rules 

(Pub. L. 113–235), supported a listening 

meeting between FDA and the regulated 

industries to consider alternative 

solutions to the proposed rule on safety 

labeling that will meet all public health 

goals relating to multisource drugs (see 

https://www.congress.gov/

congressional-record/2014/12/11/housesection/article/H9307-1) (FDA has 

verified the Web site address, but FDA 

is not responsible for any subsequent 

changes to the Web site after this 

document publishes in the Federal 

Register). 

In view of these requests and to 

promote transparency, FDA will hold a 

public meeting at which any 

stakeholders may present or comment 

on the proposed rule or any alternative 

proposals intended to improve 

communication of important newly 

acquired drug safety information to 

health care professionals and the public. 

In addition, FDA is reopening the 

comment period for the proposed rule 

(78 FR 67985) until April 27, 2015, to 

receive submissions of additional 

written comments on the proposed rule 

as well as alternative proposals 

presented during the public meeting. 

II. Registration and Requests for Oral 

Presentations 

If you would like to attend the public 

meeting, please register for the meeting 

by email to 

CBESupplements.PublicMeeting@

fda.hhs.gov by March 20, 2015. The 

email should contain complete contact 

information for each attendee (including 

name, title, firm name or affiliation, 

address, email, telephone and fax 

numbers). Those without email access 

can register by contacting Ellen 

Molinaro (see FOR FURTHER INFORMATION

CONTACT) by March 20, 2015. There is 

no fee to register for the meeting, and 

registration will be on a first-come, firstserved basis. Early registration is 

recommended because seating is 

limited. Onsite registration on the day of 

the meeting also will be permitted on a 

space-available basis beginning at 7:30 

a.m. 

Individuals who wish to present at 

the public meeting must register on or 

before March 16, 2015, and provide 

complete contact information, including 

name, title, firm name or affiliation, 

address, email, telephone and fax 

numbers. You should provide a brief 

description of your presentation, and 

indicate the approximate desired length 

of your presentation, so that FDA can 

consider these in organizing the 

presentations. FDA will do its best to 

accommodate requests to speak and will 

determine the amount of time allotted to 

each presenter and the approximate 

time that each oral presentation is 

scheduled to begin. After reviewing the 

presentation requests, FDA will notify 

each participant before the meeting of 

the amount of time available and the 

approximate time their presentation is 

scheduled to begin. If time permits, 

individuals or organizations that did not 

register in advance may be granted the 

opportunity to make a presentation. An 

agenda will be posted on the FDA Web 

site at http://www.fda.gov/Drugs/

NewsEvents/ucm431265.htm prior to 

the meeting. Presenters are encouraged 

to submit a copy of their presentation 

and related written material to the 

docket (see ‘‘Comments’’) in advance of 

the public meeting. 

If you need special accommodations 

because of a disability, please contact 

Ellen Molinaro (see FOR FURTHER

INFORMATION CONTACT) at least 7 days in 

advance. 

III. Streaming Webcast of the Public 

Meeting 

This public meeting will also be 

Webcast. Information about how to view 

the live Webcast of this meeting will be 

posted on the FDA Web site at http://

www.fda.gov/Drugs/NewsEvents/

ucm431265.htm prior to the meeting. 

IV. Comments 

Interested persons may submit either 

electronic comments regarding 

proposed alternatives to the proposed 

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

written comments to the Division of 

Dockets Management (see ADDRESSES). 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. 

Electronic or written comments will 

be accepted after the public meeting 

until April 27, 2015. 

V. Transcripts 

Please be advised that as soon as 

possible after a transcript of the public 

meeting is available, it will be accessible 

at http://www.regulations.gov. It may be 

viewed at the Division of Dockets 

Management (see ADDRESSES). A 

transcript will also be available in either 

hardcopy or on CD–ROM, after 

submission of a Freedom of Information 

request. Written requests are to be sent 

to the Division of Freedom of 

Information (ELEM–1029), Food and 

Drug Administration, 12420 Parklawn 

Dr., Element Bldg., Rockville, MD 

20857. 

VI. Reference 

The following reference has been 

placed on display in the Division of 

Dockets Management (see ADDRESSES), 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

1. Letter dated November 14, 2014, 

from Mr. Neas (GPhA) and Mr. 

Castellani (PhRMA) to Dr. Hamburg 

(FDA) regarding request for listening 

meeting on Expedited Agency Review 

proposal. 

Dated: February 11, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03211 Filed 2–17–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[REG–102648–15] 

RIN 1545–BM66 

Request for Information on 

Suspensions of Benefits Under the 

Multiemployer Pension Reform Act of 

2014 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Request for information. 

SUMMARY: The Department of the 

Treasury invites public comments with 

regard to future guidance required to 

implement provisions of the 

Multiemployer Pension Reform Act of 

2014, Division O of the Consolidated 

and Further Continuing Appropriations 

Act, 2015, Public Law 113–235 (MPRA). 

MPRA generally permits a sponsor of a 

multiemployer defined benefit plan that 

is in critical and declining status to 

suspend certain benefits following the 

provision of specified notice, 

consideration of public comments, 

approval of an application for 

suspension, and satisfaction of other 

specified conditions (including a 

participant vote). 

DATES: Comments must be received by 

April 6, 2015. 

ADDRESSES: Send submissions to: 

CC:PA:LPD:PR (REG–102648–15), Room 

5205, Internal Revenue Service, PO Box 

7604, Ben Franklin Station, Washington, 

DC 20044. Submissions may be handdelivered Monday through Friday 

between the hours of 8 a.m. and 4 p.m. 

to: CC:PA:LPD:PR (REG–102648–15), 

Courier’s Desk, Internal Revenue 

Service, 1111 Constitution Avenue NW., 

mstockstill on DSK4VPTVN1PROD with PROPOSALS