78450 Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices 

General Function of the Committee: 

The Science Board provides advice 

primarily to the Commissioner of Food 

and Drugs and other appropriate 

officials on specific complex scientific 

and technical issues important to the 

FDA and its mission, including 

emerging issues within the scientific 

community. Additionally, the Science 

Board provides advice to the Agency on 

keeping pace with technical and 

scientific developments including in 

regulatory science, input into the 

Agency’s research agenda, on upgrading 

its scientific and research facilities, and 

training opportunities. It will also 

provide, where requested, expert review 

of Agency-sponsored intramural and 

extramural scientific research programs. 

Date and Time: The meeting will be 

held on March 4, 2015, from 8:30 a.m. 

to 4 p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(Rm. 1503 B and C) Silver Spring, MD 

20993–0002. For those unable to attend 

in person, the meeting will also be 

Webcast. The link for the Webcast is 

available at https://

collaboration.fda.gov/sb315/. 

Information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

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

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You,’’ click 

on ‘‘Public Meetings at the FDA White 

Oak Campus.’’ Please note that visitors 

to the White Oak Campus must enter 

through Building 1. 

Contact Person: Martha Monser, 

Office of the Commissioner, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 1, Rm. 3309, 

Silver Spring, MD 20993–0002, 301– 

796–4627, martha.monser@fda.hhs.gov, 

or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area). 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: The Science Board will be 

provided with a progress report or a 

final draft report the Commissioner’s 

Fellowship Program Evaluation 

subcommittee and will hear a progress 

report from Science Moving Forward 

subcommittee. The Science Board will 

be asked to provide feedback on FDA’s 

public access policy. FDA will seek the 

Science Board’s input regarding 

approaches to regulatory science 

training coordination. The Science 

Board will be provided with a follow up 

on FDA’s activities regarding the reintroduction of bovine heparin and will 

hear an overview of science-related 

activities from one of the centers. A 

recipient of one of the Fiscal Year 2014 

Scientific Achievement Awards 

(selected by the Science Board) will 

provide an overview of the activities for 

which the award was given. 

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 

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: 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 February 25, 2015. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 1:30 p.m. 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 February 

17, 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 February 18, 2015. 

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 Ms. Martha 

Monser 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: December 23, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30516 Filed 12–29–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1936] 

Electronic Cigarettes and the Public 

Health; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA), Center for Tobacco Products, is 

announcing a public workshop to obtain 

information on electronic cigarettes and 

the public health. This will be the 

second in a series of three workshops. 

The workshop will include 

presentations and panel discussions 

about the current state of the science 

and will focus on individual health 

impacts. FDA intends to follow this 

workshop with an electronic cigarette 

workshop on population health effects. 

DATES AND TIMES: The public workshop 

will be held on March 9, 2015, from 8 

a.m. to 5 p.m. and on March 10, 2015, 

from 8 a.m. to 5 p.m. Individuals who 

wish to attend the public workshop 

must register by February 20, 2015. 

LOCATION: The public workshop will be 

held at the Marriott Inn and Conference 

Center, University of Maryland 

University College, Potomac Ballroom, 

3501 University Blvd. East, Hyattsville, 

MD 20783. The conference center’s 

telephone number is 301–985–7300. 

CONTACT PERSON: Caryn Cohen, Office of 

Science, Center for Tobacco Products, 

Food and Drug Administration, 

Document Control Center, Bldg. 71, Rm. 

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Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices 78451 

G335, 10903 New Hampshire Ave., 

Silver Spring, MD 20993–0002, 1–877– 

287–1373, email: workshop.CTPOS@

fda.hhs.gov. 

Registration to Attend the Workshop: 

If you wish to attend the workshop in 

person or by Webcast, you must register 

by submitting an electronic or written 

request no later than February 20, 2015. 

Please submit electronic requests at 

https://www.surveymonkey.com/s/CTPMarch-Workshop. Persons without 

Internet access may send written 

requests for registration to Caryn Cohen 

(see Contact Person). Requests for 

registration must include the 

prospective attendee’s name, title, 

affiliation, address, email address if 

available, and telephone number. 

Registration is free and you may register 

to attend in person or view the live 

Webcast. Seating and viewership are 

limited, so early registration is 

recommended. FDA may limit the 

number of registrants from a single 

organization and the total number of 

participants if registration reaches full 

capacity. For registrants with Internet 

access, confirmation of registration will 

be emailed to you no later than February 

23, 2015. Onsite registration may be 

allowed if space is available. If 

registration reaches maximum capacity, 

FDA will post a notice closing 

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

TobaccoProducts/NewsEvents/

ucm238308.htm. If you need special 

accommodations due to a disability, 

please contact Caryn Cohen (see Contact 

Person) no later than March 2, 2015. 

Presenters and Panelists: FDA is 

interested in gathering scientific 

information from individuals with a 

broad range of backgrounds on the 

scientific topics to be discussed at the 

workshop. To be considered as a 

presenter, please provide the following: 

• A brief abstract for each 

presentation. The abstract should 

identify the specific topic(s) to be 

addressed and the amount of time 

requested. 

• A one page biosketch that describes 

and supports the speaker’s scientific 

expertise on the specific topic(s) being 

presented, nature of the individual’s 

experience and research in the scientific 

field, positions held, and any program 

development activities. 

Panelists will discuss their scientific 

knowledge on the questions and 

presentations in each session. To be 

considered to serve as a panelist, please 

provide the following: 

• A one page biosketch that describes 

and supports the speaker’s scientific 

expertise on the specific topic(s) being 

presented, nature of the individual’s 

experience and research in the scientific 

field, positions held, and any program 

development activities. 

If you are interested in serving as a 

presenter or panelist, please submit the 

requested information, along with the 

topic on which you would like to speak, 

to workshop.CTPOS@fda.hhs.gov by 

January 22, 2015. 

Oral Presentations by Members of the 

Public: This workshop includes a public 

comment session. Persons wishing to 

present during the public comment 

session must make this request at the 

time of registration and should identify 

the topic they wish to address from 

among those topics under consideration 

that are identified in section II. FDA 

will do its best to accommodate requests 

to present. FDA urges individuals and 

organizations with common interests to 

consolidate or coordinate their 

comments, and request a single time for 

a joint presentation. For those requesters 

with Internet access, Caryn Cohen (see 

Contact Person) will email you 

regarding your request to speak during 

the public comment period by February 

23, 2015. 

Transcripts: A transcript of the 

proceedings will be available after the 

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

TobaccoProducts/NewsEvents/

ucm238308.htm as soon as the official 

transcript is finalized. It will also be 

posted to the docket at http://

www.regulations.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing a public 

workshop to gather scientific 

information and stimulate discussion 

among scientists about electronic 

cigarettes (e-cigarettes). The focus of this 

workshop will be the impact of ecigarettes on individual health, 

including user exposure, topography, 

abuse liability, dependence, and short 

and long-term health effects. A 

workshop focusing on product science, 

product packaging, constituent labeling, 

and environmental impact was held in 

December 2014. FDA intends to follow 

this workshop with an additional 

workshop that will address the impact 

of e-cigarettes on the population, 

including discussions of product appeal 

(e.g., impact of advertising, marketing, 

flavorings, consumer perceptions) and 

product safety labeling. 

On April 25, 2014, FDA published a 

proposed rule to extend its tobacco 

product authorities to additional 

products that meet the statutory 

definition of ‘‘tobacco product’’ 

‘‘Deeming Tobacco Products to Be 

Subject to the Federal Food, Drug, and 

Cosmetic Act (FD&C Act), as Amended 

by the Family Smoking Prevention and 

Tobacco Control Act; Regulations on the 

Sale and Distribution of Tobacco 

Products and Required Warning 

Statements for Tobacco Products’’ (79 

FR 23141, April 25, 2014, Docket No. 

FDA–2014–N–0189) (proposed deeming 

rule). If the proposed deeming rule is 

finalized as proposed, e-cigarettes that 

are tobacco products would be subject 

to FDA regulation under the FD&C Act. 

As stated in the proposed deeming rule, 

FDA ‘‘is aware of the recent significant 

increase in the prevalence in e-cigarette 

use’’ (79 FR 23141 at 23152), and there 

is much to be learned about these 

relatively new entrants to the market. 

These workshops are intended to 

better inform FDA about these products. 

Should the Agency move forward as 

proposed to regulate e-cigarettes, 

additional information about the 

products would assist the Agency in 

carrying out its responsibilities under 

the law. This would be true regardless 

of the details of any such final rule. 

Accordingly, FDA is working to obtain 

such information now rather than 

waiting for the conclusion of the 

deeming rulemaking. 

Participants should note that this 

workshop is not intended to inform the 

Agency’s deeming rulemaking. All 

comments regarding the proposed 

deeming rule were to be submitted to 

the Agency by August 8, 2014 (Docket 

No. FDA–2014–N–0189). As such, the 

scope of this workshop is limited to the 

topics presented in Section II. 

At the start of the first workshop in 

this series, FDA announced via a 

Federal Register notice the opening of 

a docket for submission of written 

comments regarding all three workshops 

(see Establishment of a Public Docket; 

Electronic Cigarettes and the Public 

Health Workshop, Docket No. FDA– 

2014–N–1936, http://www.gpo.gov/

fdsys/pkg/FR-2014-12-02/pdf/2014- 

28261.pdf). Regardless of attendance at 

the public workshops, interested 

persons are invited to submit comments 

to the docket. Comments submitted to 

the docket will not be added to other 

dockets, such as the docket for the 

proposed rule deeming additional 

tobacco products subject to the FD&C 

Act. 

II. Topics for Discussion 

The public workshop will include 

presentations and panel discussion 

regarding e-cigarettes and the public 

health, specifically relating to the 

impact of e-cigarettes on individual 

health. Topics to be addressed include, 

for example: (1) Topography; (2) 

exposures and toxicological 

considerations; (3) pharmacokinetics 

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78452 Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices 

and pharmacodynamics of nicotine 

exposure in users; (4) abuse liability and 

dependence; (5) short and long-term 

health effects in users; (6) 

considerations for high risk or 

vulnerable populations; and (7) human 

factors. Additional information related 

to workshop presentations and 

discussion topics, including specific 

questions to be addressed at the 

workshop, can be found at http://

www.fda.gov/TobaccoProducts/

NewsEvents/ucm238308.htm. 

Dated: December 22, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30450 Filed 12–29–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60-Day Comment 

Request; Responsibility of Applicants 

for Promoting Objectivity in Research 

for Which Public Health Service (PHS) 

Funding Is Sought 42 CFR Part 50 

Subpart F and Responsible 

Prospective Contractors 45 CFR Part 

94 (OD) 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

Office of the Director (OD), National 

Institutes of Health (NIH), will publish 

periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Written comments and/or suggestions 

from the public and affected agencies 

are invited on one or more of the 

following points: (1) Whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) The accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; (3) 

Ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Ways to minimize the 

burden of the collection of information 

on those who are to respond, including 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

To submit comments and for further 

information: To obtain a copy of the 

data collection plans and instruments, 

submit comments in writing, or request 

more information on the proposed 

project, contact: Ms. Kathy Hancock, 

Assistant Grants Compliance Officer, 

Division of Grants Compliance and 

Oversight, Office of Policy for 

Extramural Research Administration 

(OPERA), 6705 Rockledge Drive, Room 

3523, Bethesda, MD 20892, or call nontoll-free number (301) 435–1962, or 

Email your request, including your 

address to: FCOICompliance@

mail.nih.gov. Formal requests for 

additional plans and instruments must 

be requested in writing. 

DATES: Comment Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Proposed Collection: Title: 

Responsibility of Applicants for 

Promoting Objectivity in Research for 

which Public Health Service (PHS) 

Funding is Sought 42 CFR part 50 

Subpart F and Responsible Prospective 

Contractors 45 CFR part 94 OMB# 0925– 

0417, Expiration Date: 02/2015, 

EXTENSION, National Institutes of 

Health (NIH), Office of the Director 

(OD). 

Need and Use of Information 

Collection: This is a request for OMB 

Approval for an extension of the 

information collection and 

recordkeeping requirements contained 

in the final rule 42 CFR part 50, subpart 

F and 45 CFR part 94. The purpose of 

these regulations is to promote 

objectivity in research by requiring 

institutions to establish standards that 

provide a reasonable expectation that 

the design, conduct, and reporting of 

research funded under PHS grants, 

cooperative agreements and contracts 

will be free from bias resulting from 

Investigator financial conflicts of 

interest. 

OMB approval is requested for an 

extension of 3 years. There are operating 

costs and/or maintenance costs per 

response. The total estimated 

annualized burden hours are 676,130. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent based on applicable section of regulation Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total annual 

burden hour 

Reporting 

Initial Reports under 42 CFR 50.605(b)(1) and (b)(3) or 45 CFR 94.5(b)(1) 

and (b)(3) from Awardee Institutions ........................................................... 950 1 2 1,900 

Subsequent Reports under 42 CFR 50.605(a)(3)(iii) and (b)(2) or 45 CFR 

94.5(a)(iii) and (b)(2) from Awardee Institutions .......................................... 50 1 2 100 

Mitigation Reports under 45 CFR 94.5(a)(3)(iii) and (b)(2) from Awardee Institutions ....................................................................................................... 5 1 2 10 

Annual Report under 42 CFR 50.605(b)(4) or 45 CFR 94.5(b)(4) from 

Awardee Institution ....................................................................................... 950 1 1 950 

Subsequent Reports under 42 CFR 60.606(a) or 45 CFR 94.6(a) from 

Awardee Institution ....................................................................................... 20 1 10 200 

Record Keeping 

Under 42 CFR 50.604(i) or 45 CFR 94.4(i) from Awardee Institutions .......... 2,000 1 4 8,000 

Disclosure 

Under 42 CFR 50.604(a) or 45 CFR 94.4(a) for Investigators ....................... 3,000 1 81 243,000 

Under 42 CFR 50.604(b) or 45 CFR 94.4(b) for Investigators ....................... 38,000 1 30/60 19,000 

Under 42 CFR 50.604(b) or 45 CFR 94.4(b) for Institutions .......................... 2,000 1 6 12,000 

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