Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices 8093 

related to the approval process for these 

products that can be accomplished 

under the Agency’s existing statutory 

authority. FDA will consider comments 

received at this meeting as it moves 

forward with this process. 

FDA has already opened public 

docket FDA Docket No. FDA–2014–N– 

1050 to receive comments on the issue 

(79 FR 53431, September 9, 2014). 

Although you can comment on this 

document at any time, to ensure that the 

Agency considers your comment before 

finalizing work on the exploration 

process described in this document, 

submit either electronic or written 

comments by March 31, 2016. 

II. Participation in a Public Meeting 

While oral presentations from specific 

individuals and organizations may be 

limited due to time constraints during 

the public meeting, stakeholders may 

submit electronic or written comments 

discussing any issues of concern to the 

administration record (the docket). All 

relevant data and documentation should 

be submitted with the comments to 

Docket No. FDA–2014–N–1050. 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. It is only 

necessary to send one set of comments. 

Identify comments with the docket 

number FDA–2014–N–1050. 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. 

III. Comments, Transcripts, and 

Recorded Video 

Information and data submitted 

voluntarily to FDA during the public 

meeting will become part of the 

administrative record and will be 

accessible to the public at http:// 

www.regulations.gov. The transcript of 

the proceedings from the public meeting 

will become part of the administrative 

record. Please be advised that as soon as 

a transcript is available, it will be 

accessible at http:// 

www.regulations.gov, Docket No. FDA– 

2014–N–1050, and at FDA’s CVM Web 

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

UserFees/ 

AnimalDrugUserFeeActADUFA/ 

ucm042891.htm. It may also be viewed 

at the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 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. Additionally, 

FDA will be recording the meeting via 

Adobe Connect on March 16, 2015. 

Once the recording has been made 508 

compliant, it will be accessible at FDA’s 

CVM Web site at http://www.fda.gov/ 

ForIndustry/UserFees/ 

AnimalDrugUserFeeActADUFA/ 

ucm042891.htm. 

Dated: February 10, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03002 Filed 2–12–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

The Tobacco Products Scientific 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). At least one portion of the 

meeting will be closed to the public. 

Name of Committee: The Tobacco 

Products Scientific Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on April 9, 2015, from 8:30 a.m. to 

5 p.m. and April 10, 2015, from 8 a.m. 

to 5 p.m. 

Location: FDA White Oak, 10903 New 

Hampshire Ave., Building 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

Answers to commonly asked questions 

including information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

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

AdvisoryCommittees/

AboutAdvisoryCommittees/

ucm408555.htm. 

Contact Person: Caryn Cohen, Office 

of Science, Center for Tobacco Products, 

Food and Drug Administration, 

Document Control Center, Bldg. 71, Rm. 

G335, 10903 New Hampshire Ave., 

Silver Spring, MD 20993–0002, 1–877– 

287–1373, email: TPSAC@fda.hhs.gov. 

A notice in the Federal Register about 

last minute modifications that impact a 

previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide 

timely notice. Therefore, you should 

always check the Agency’s Web site at 

http://www.fda.gov/

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before coming to the meeting. 

Agenda: On April 9 and 10, 2015, the 

Committee will discuss modified risk 

tobacco product applications submitted 

by Swedish Match North America Inc. 

for 10 tobacco products: 

• MR0000020: General Loose, 

smokeless tobacco, loose snus, 1.59 oz 

(45g), cardboard can (SKU 4852); 

• MR0000021: General Dry Mint 

Portion Original Mini, smokeless 

tobacco, snus portions, 0.21 oz (6g), 20 

0.3g portions, plastic can (SKU 4800); 

• MR0000022: General Portion 

Original Large, smokeless tobacco, snus 

portions, 0.9 oz (24g), 24 1g portions, 

plastic can (SKU 4880); 

• MR0000023: General Classic Blend 

Portion White Large, smokeless tobacco, 

snus portions, 0.48 oz (13.5g), 15 0.9g 

portions, plastic can (SKU 4877); 

• MR0000024: General Classic Blend 

Portion White Large, smokeless tobacco, 

snus portions, 0.38 oz (10.8g), 12 0.9g 

portions, plastic can (SKU 4878); 

• MR0000025: General Mint Portion 

White Large, smokeless tobacco, snus 

portions, 0.9 oz (24g), 24 1g portions, 

plastic can (SKU 4352); 

• MR0000026: General Nordic Mint 

Portion White Large, smokeless tobacco, 

snus portions, 0.48 oz (13.5g), 15 0.9g 

portions, plastic can (SKU 4876); 

• MR0000027: General Nordic Mint 

Portion White Large, smokeless tobacco, 

snus portions, 0.38 oz (10.8g), 12 0.9g 

portions, plastic can (SKU 4875); 

• MR0000028: General Portion White 

Large, smokeless tobacco, snus portions, 

0.9 oz (24g), 24 1g portions, plastic can 

(SKU 4881); and 

• MR0000029: General Wintergreen 

Portion White Large, smokeless tobacco, 

snus portions, 0.9 oz (24g), 24 1g 

portions, plastic can (SKU 4882). 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 


tkelley on DSK3SPTVN1PROD with NOTICES
8094 Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices 

the meeting. Background material is 

available at http://www.fda.gov/

AdvisoryCommittees/Calendar/

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: On April 9, 2015, from 

8:30 a.m. to 4 p.m. and on April 10, 

2015, from 8 a.m. to 5 p.m., the meeting 

is open to the public. Interested persons 

may present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before March 20, 2015. 

Oral presentations from the public will 

be scheduled between approximately 11 

a.m. and 12 p.m. on April 10, 2015. 

Those individuals interested in making 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before March 12, 2015. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by March 13, 2015. 

Closed Committee Deliberations: On 

April 9, 2015, between 4 p.m. and 5 

p.m., the meeting will be closed to 

permit discussion and review of trade 

secret and/or confidential commercial 

information (see 5 U.S.C. 552b(c)(3) and 

(c)(4)). This portion of the meeting will 

be closed because the Committee will be 

discussing trade secret and/or 

confidential data provided by Swedish 

Match North America Inc. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Caryn Cohen 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/

AdvisoryCommittees/

AboutAdvisoryCommittees/

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: February 9, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03000 Filed 2–12–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Bethesda Campus Master Plan Record 

of Decision 

SUMMARY: The Department of Health and 

Human Services, the National Institutes 

of Health (NIH), has decided, after 

completion of a Final Environmental 

Impact Statement (FEIS) and a thorough 

consideration of the public comments 

on the Draft EIS, to implement the 

Proposed Action, referred to as the 

Proposed Action in the Final EIS. This 

action is for a long-range physical 

Master Plan for National Institutes of 

Health Bethesda Campus (NIH) located 

in Bethesda, Maryland. This alternative 

accounts for potential growth in NIH 

personnel, new construction, additions, 

renovations, demolitions, and upgrades 

in site utilities. 

Responsible Official: Daniel G. 

Wheeland, Director, Office of Research 

Facilities (ORF) Development and 

Operations, NIH. 

FOR FURTHER INFORMATION CONTACT: 

Valerie Nottingham, Deputy Director, 

DEP, ORF, NIH, Building 13, Room 

2S11, 9000 Rockville Pike, Bethesda, 

MD 20892, Phone 301–496–7775, 

nihnepa@mail.nih.gov. 

SUPPLEMENTARY INFORMATION: 

Decision 

After careful review of the 

environmental consequences in the 

Final Environmental Impact Statement 

for the Master Plan, National Institutes 

of Health Bethesda Campus, and 

consideration of public comment 

throughout the NEPA process, the NIH 

has decided to implement the Proposed 

Action described below as the Selected 

Alternative. 

Selected Alternative 

The Selected Alternative is intended 

to be a strategic tool for the efficient 

allocation of campus resources, the 

orderly accommodation of future 

growth, and the creation of an 

environment that is both functionally 

and aesthetically conducive to 

accomplishing the NIH mission. The 

Selected Alternative will provide a 

guide for the reasoned and orderly 

development of the NIH campus, one 

that values and builds on existing 

resources, corrects current deficiencies 

and meets changing needs through new 

construction or renovation. The plan 

sets forth implementation priorities and 

a logical sequencing of planned 

development. 

The Selected Alternative is for a longrange physical Master Plan for NIH. 

This alternative covers a 20-year 

planning period, with reviews every 5 

years to ensure that the plan continues 

to address issues affecting the campus. 

The alternative addresses the future 

development of the NIH site, including 

placement of future construction; 

vehicular and pedestrian circulation on 

and off-campus; parking within the 

property boundaries; open space in and 

around the campus; required setbacks; 

historic properties; natural and scenic 

resources; noise; and lighting. This 

alternative accounts for potential growth 

in NIH personnel, and consequent 

construction of space over the planning 

period. Future construction on the site 

could include such facilities as new 

animal holding, research laboratories, 

and support facilities. 

NIH will continue to develop the 

Bethesda campus to accommodate NIH’s 

research needs and required 

programmatic needs consistent with the 

commitment to maintain the ‘‘campus’’ 

character of the site. The Selected 

Alternative advances this objective by 

programming and locating future NIH 

growth so that new development would 

tie into the existing utility services and 

utilities are available to support growth, 

and establishing development 

guidelines for future changes to the site 

that ensure that as the campus grows 

new development would be responsive 

to the context of adjacent neighborhoods 

or developments. Under the Selected 

Alternative, the total NIH population on 

the campus is anticipated to grow in the 

next twenty years to a total of 

approximately 23,594, which is an 

increase of approximately 3,000 

employees. The primary growth at the 

campus would be in intramural research 

personnel and the administrative and 

facility staff to support them. The 

majority, if not all, of the employees 

would be coming from off-site facilities 

and are already employees, or 

contractors, of NIH. 

Alternatives Considered 

The Proposed Action Alternative, the 

Redevelopment Alternative and No 

Action Alternative were the three 

alternatives analyzed in the Final EIS. 


tkelley on DSK3SPTVN1PROD with NOTICES