80 FR 15018 - Electronic Cigarettes and the Public Health; Public Workshop
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 54 (March 20, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 54 (March 20, 2015)
| Page Range | 15018-15020 | |
| FR Document | 2015-06388 |
[Federal Register Volume 80, Number 54 (Friday, March 20, 2015)] [Notices] [Pages 15018-15020] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-06388] ----------------------------------------------------------------------- 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; extension of comment period. ----------------------------------------------------------------------- The Food and Drug Administration (FDA), Center for Tobacco Products, is announcing a public workshop to obtain information on electronic cigarettes (e-cigarettes) and the public health. This will be the final 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 impacts on the population as a whole, including users and non-users of tobacco products. Dates and Times: The public workshop will be held on June 1 and 2, 2015. Individuals who wish to attend the public workshop must register by May 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, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, 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 May 20, 2015. Please submit electronic requests at https://www.surveymonkey.com/s/CTP-June-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 May 25, 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) at least 7 days in advance of the meeting. 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 [[Page 15019]] 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 April 3, 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 III. 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 May 25, 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 e-cigarettes on population health, including prevalence and patterns of use, impacts of e-cigarettes on tobacco product users and non-users, and knowledge, attitudes, and beliefs about e-cigarette products. A workshop on December 10-11, 2014, focused on e-cigarette product science, product packaging, constituent labeling, and environmental impact; and a workshop on March 9-10, 2015, focused on the impact of e-cigarettes on individual health. On April 25, 2014, FDA published a document to extend its tobacco product authorities to additional products that meet the statutory definition of ``tobacco product'' entitled ``Deeming Tobacco Products to Be Subject to the Federal Food, Drug, and Cosmetic 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 Chapter IX of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 387-387u). 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 III. II. Extension of Comment Period Extension. At the start of the first workshop in this series, FDA announced via a Federal Register document 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.thefederalregister.org/fdsys/pkg/FR-2014-12-02/pdf/2014-28261.pdf). The comment period for submission of written comments was scheduled to end on April 15, 2015. The Agency is extending the comment period to end on July 2, 2015, to allow interested parties time to submit comments concerning the third workshop. General Information About Submitting Comments. Regardless of attendance at the public workshop, interested parties are invited to submit comments, supported by research and data, regarding e-cigarettes and the public health. 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. Interested persons may submit either electronic comments to http://www.regulations.gov or written comments to this docket 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 found in brackets in the heading of this document. 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. Public Availability of Comments. 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. As a matter of Agency practice, FDA generally does not post comments submitted by individuals in their individual capacity on http://www.regulations.gov. This is determined by information indicating that the submission is written by an individual, for example, the comment is identified with the category ``Individual Consumer'' under the field titled ``Category (Required),'' on the ``Your Information'' page on www.regulations.gov. For this docket, however, FDA will not be following this general practice. Instead, FDA will post on http://www.regulations.gov comments to this docket that have been submitted by individuals in their individual capacity. If you wish to submit any information under a claim of confidentiality, please refer to 21 CFR 10.20. Information Identifying the Person Submitting the Comment. Please note that your name, contact information, and other information identifying you will be posted on http://www.regulations.gov if you include that information in the body of your comments. For electronic comments submitted to http://www.regulations.gov, FDA will post the body of your comment on http:// [[Page 15020]] www.regulations.gov along with your state/province and country (if provided), the name of your representative (if any), and the category identifying you (e.g., individual, consumer, academic, industry). For written submissions submitted to the Division of Dockets Management, FDA will post the body of your comments on http://www.regulations.gov, but you can put your name and/or contact information on a separate cover sheet and not in the body of your comments. III. 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 the population as a whole. Topics to be addressed include: (1) Prevalence and patterns of use; (2) impacts on current tobacco product users; (3) impacts on non-users of tobacco products; and (4) knowledge, attitudes, beliefs, and perceptions about e-cigarette products. 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: March 16, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-06388 Filed 3-19-15; 8:45 am] BILLING CODE 4164-01-P
![15018 Federal Register / Vol. 80, No. 54 / Friday, March 20, 2015 / Notices
would constitute a clearly unwarranted National Institutes of Health/NIAID, 5601 Hyattsville, MD 20783. The conference
invasion of personal privacy. Fishers Lane, Room 3F30B, Rockville, MD center’s telephone number is 301–985–
20852, 240–669–5029, battlesja@ 7300.
Name of Committee: National Institute on mail.nih.gov.
Drug Abuse Special Emphasis Panel, Clinical Contact Person: Caryn Cohen, Office
Coordination Center (2243). Name of Committee: National Institute of of Science, Center for Tobacco Products,
Date: April 21, 2015. Allergy and Infectious Diseases Special Food and Drug Administration,
Emphasis Panel; NIAID Clinical Trial
Time: 9:00 a.m. to 5:00 p.m. Document Control Center, 10903 New
Agenda: To review and evaluate contract Planning Grants (R34).
Date: April 16, 2015. Hampshire Ave., Bldg. 71, Rm. G335,
proposals. Silver Spring, MD 20993–0002, 1–877–
Place: National Institutes of Health, Time: 10:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant 287–1373, email: workshop.CTPOS@
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone applications. fda.hhs.gov.
Conference Call). Place: National Institutes of Health, Room Registration to Attend the Workshop:
Contact Person: Lyle Furr, Scientific 2H200B, 5601 Fisher Lane, Rockville, MD If you wish to attend the workshop in
Review Officer, Office of Extramural Affairs, 20892 (Telephone Conference Call). person or by Webcast, you must register
National Institute on Drug Abuse, NIH, Contact Person: Jane K. Battles, Ph.D., by submitting an electronic or written
DHHS, Room 4227, MSC 9550, 6001 Scientific Review Officer, Scientific Review request no later than May 20, 2015.
Executive Boulevard, Bethesda, MD 20892– Program, Division of Extramural Activities,
Please submit electronic requests at
9550, (301) 435–1439, lf33c.nih.gov. National Institutes of Health/NIAID 5601
Fishers Lane, Room 3F30B, Rockville, MD
https://www.surveymonkey.com/s/CTP-
(Catalogue of Federal Domestic Assistance June-Workshop. Persons without
Program No.: 93.279, Drug Abuse and 20852, 240–669–5029, battlesja@
mail.nih.gov. Internet access may send written
Addiction Research Programs, National
Institutes of Health, HHS) (Catalogue of Federal Domestic Assistance requests for registration to Caryn Cohen
Program Nos. 93.855, Allergy, Immunology, (see Contact Person). Requests for
Dated: March 13, 2015. registration must include the
and Transplantation Research; 93.856,
Michelle Trout, Microbiology and Infectious Diseases prospective attendee’s name, title,
Program Analyst, Office of Federal Advisory Research, National Institutes of Health, HHS) affiliation, address, email address if
Committee Policy. available, and telephone number.
Dated: March 13, 2015.
[FR Doc. 2015–06348 Filed 3–19–15; 8:45 am]
David Clary, Registration is free and you may register
BILLING CODE 4140–01–P to attend in-person or view the live
Program Analyst, Office of Federal Advisory
Committee Policy. Webcast. Seating and viewership are
limited, so early registration is
DEPARTMENT OF HEALTH AND [FR Doc. 2015–06347 Filed 3–19–15; 8:45 am]
recommended. FDA may limit the
HUMAN SERVICES BILLING CODE 4140–01–P
number of registrants from a single
organization and the total number of
National Institutes of Health participants if registration reaches full
DEPARTMENT OF HEALTH AND
National Institute of Allergy and HUMAN SERVICES capacity. For registrants with Internet
Infectious Diseases; Notice of Closed access, confirmation of registration will
Meetings Food and Drug Administration be emailed to you no later than May 25,
2015. Onsite registration may be
Pursuant to section 10(d) of the [Docket No. FDA–2014–N–1936] allowed if space is available. If
Federal Advisory Committee Act, as registration reaches maximum capacity,
Electronic Cigarettes and the Public
amended (5 U.S.C. App.), notice is FDA will post a notice closing
Health; Public Workshop
hereby given of the following meetings. registration at http://www.fda.gov/
The meetings will be closed to the AGENCY: Food and Drug Administration, TobaccoProducts/NewsEvents/
public in accordance with the HHS. ucm238308.htm.
provisions set forth in sections ACTION: Notice of public workshop; If you need special accommodations
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., extension of comment period. due to a disability, please contact Caryn
as amended. The grant applications and Cohen (see Contact Person) at least 7
the discussions could disclose The Food and Drug Administration days in advance of the meeting.
confidential trade secrets or commercial (FDA), Center for Tobacco Products, is Presenters and Panelists: FDA is
property such as patentable material, announcing a public workshop to obtain interested in gathering scientific
and personal information concerning information on electronic cigarettes (e- information from individuals with a
individuals associated with the grant cigarettes) and the public health. This broad range of backgrounds on the
applications, the disclosure of which will be the final in a series of three scientific topics to be discussed at the
would constitute a clearly unwarranted workshops. The workshop will include workshop. To be considered as a
invasion of personal privacy. presentations and panel discussions presenter, please provide the following:
Name of Committee: National Institute of about the current state of the science • A brief abstract for each
Allergy and Infectious Diseases Special and will focus on impacts on the presentation. The abstract should
Emphasis Panel; NIH Support for population as a whole, including users identify the specific topic(s) to be
Conferences and Scientific Meeting (R13/ and non-users of tobacco products. addressed and the amount of time
U13). Dates and Times: The public requested.
Date: April 13–15, 2015. workshop will be held on June 1 and 2, • A one-page biosketch that describes
mstockstill on DSK4VPTVN1PROD with NOTICES
Time: 10:00 a.m. to 5:00 p.m. 2015. Individuals who wish to attend and supports the speaker’s scientific
Agenda: To review and evaluate grant the public workshop must register by expertise on the specific topic(s) being
applications.
May 20, 2015. presented, nature of the individual’s
Place: National Institutes of Health, Room
3F30B, 5601 Fishers Lane, Rockville, MD
Location: The public workshop will experience and research in the scientific
20852 (Virtual Meeting). be held at the Marriott Inn and field, positions held, and any program
Contact Person: Jane K. Battles, Ph.D., Conference Center, University of development activities.
Scientific Review Officer, Scientific Review Maryland University College, Potomac Panelists will discuss their scientific
Program, Division of Extramural Activities, Ballroom, 3501 University Blvd. East, knowledge on the questions and
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![15020 Federal Register / Vol. 80, No. 54 / Friday, March 20, 2015 / Notices
www.regulations.gov along with your establish new ERCs, as appropriate, to This Notice of Intent is being
state/province and country (if address the burden of Occupational provided to allow potential applicants
provided), the name of your Safety and Health (OSH) in the United sufficient time to develop meaningful
representative (if any), and the category States by providing state-of-the-art collaborations and responsive projects.
identifying you (e.g., individual, interdisciplinary graduate and research The Funding Opportunity
consumer, academic, industry). For training for the next generation of OSH Announcement (FOA) is expected to be
written submissions submitted to the practitioners and researchers. published in May 2015 with an
Division of Dockets Management, FDA Table of Contents expected application due date in
will post the body of your comments on November 2015.
http://www.regulations.gov, but you can Dates The FOA will utilize the T42 activity
put your name and/or contact For Further Information Contact code. ERCs are located in accredited
Supplementary Information
information on a separate cover sheet Recipient Reporting Requirements
academic institutions across the country
and not in the body of your comments. Award Information and provide graduate degree and
Needs Assessment certificate training in core and allied
III. Topics for Discussion
Regional Presence disciplines of OSH. ERCs also provide
The public workshop will include Budget Limits for Required and Optional interdisciplinary research training to
presentations and panel discussion Components identify, assess, address, and improve
regarding e-cigarettes and the public DATES: OSH. ERCs conduct outreach to help
health, specifically relating to the • Anticipated Publication Date of improve knowledge and awareness of
impact of e-cigarettes on the population Announcement: May 2015 work-related safety and health issues,
as a whole. Topics to be addressed • First Anticipated Application Due and they provide continuing education
include: (1) Prevalence and patterns of Date: November 2015 for OSH professionals. Through
use; (2) impacts on current tobacco • Earliest Anticipated Award Date: June comprehensive, integrated programs,
product users; (3) impacts on non-users 2016 ERCs improve the safety and health of
of tobacco products; and (4) knowledge, • Earliest Anticipated Start Date: July our nation’s workers.
attitudes, beliefs, and perceptions about 2016 Recipient Reporting Requirements:
e-cigarette products. FOR FURTHER INFORMATION CONTACT: Dr. Recipients funded with NIOSH ERC
Additional information related to Elizabeth H. Maples, National Institute appropriations will be required to report
workshop presentations and discussion for Occupational Safety and Health, project status on an annual basis.
topics, including specific questions to Centers for Disease Control, 1600 Clifton Specific reporting requirements will be
be addressed at the workshop, can be Road NE., Mailstop E–74, Atlanta, GA detailed in the Terms and Conditions of
found at http://www.fda.gov/ 30333; Phone (not toll-free numbers): the Notice of Award.
TobaccoProducts/NewsEvents/ (404) 498–2557, Fax: (404) 498–2571, Award Information:
ucm238308.htm. Email: EMaples@cdc.gov. • Approximate Current Fiscal Year
Dated: March 16, 2015. SUPPLEMENTARY INFORMATION: The Funding: $24,000,000.
Leslie Kux, National Institute for Occupational • Approximate Number of Awards:
Associate Commissioner for Policy. Safety and Health (NIOSH), Centers for 15–20.
[FR Doc. 2015–06388 Filed 3–19–15; 8:45 am] Disease Control and Prevention (CDC), • Approximate Average Awards: Up
BILLING CODE 4164–01–P intends to publish a funding to $1,800,000/year.
opportunity announcement for • Fiscal Year Funds: 2016.
Education and Research Centers (ERCs) • Budget Period: 12 months.
DEPARTMENT OF HEALTH AND that are focused on occupational safety • Project Period: Up to 5 years for
HUMAN SERVICES and health graduate training and established ERCs and up to 3 years for
research training. new ERCs.
Centers for Disease Control and NIOSH is mandated to provide an Application Selection Process:
Prevention adequate supply of qualified personnel Applications will be evaluated for
to carry out the purposes of the scientific and technical merit by an
Notice of Intent To Publish a Funding Occupational Safety and Health Act, appropriate peer review group, in
Opportunity Announcement for and the ERCs are one of the principal accordance with CDC peer review
Occupational Safety and Health means for meeting this mandate. ERCs policy and procedure using review
Education and Research Centers are academic institutions that provide criteria that will be stated in the
AGENCY: National Institute for high-quality interdisciplinary graduate Funding Opportunity Announcement
Occupational Safety and Health training, continuing education, and (FOA).
(NIOSH) of the Centers for Disease outreach in the core occupational safety As part of the scientific peer review,
Control and Prevention (CDC), and health disciplines of industrial all applications will:
Department of Health and Human hygiene (IH), occupational health • Undergo a selection process in
Services (HHS). nursing (OHN), occupational medicine which all responsive applications will
ACTION: Notice. residency (OMR), and occupational be discussed and assigned an overall
safety (OS), as well as closely related impact/priority score, and
SUMMARY: This notice provides allied disciplines. Research and • Receive a written critique.
mstockstill on DSK4VPTVN1PROD with NOTICES
information on the Centers for Disease research training are integral Needs Assessment: ERCs must
Control and Prevention (CDC), National components of ERCs, with ERC faculty document that their proposed academic
Institute for Occupational Safety and and NIOSH trainees conducting and research training programs meet
Health (NIOSH) intent to publish a research on issues related to the NIOSH specific regional or national workforce
funding opportunity announcement for National Occupational Research Agenda need and demand.
Education and Research Centers (ERCs). (NORA). The ERCs also serve as regional Regional Presence: ERCs should
The purpose of this program is to resources for industry, labor, demonstrate collaborative efforts by
support existing NIOSH ERCs and government, and the public. working with a diverse and broad range
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Document Created: 2015-12-18 11:34:16
Document Modified: 2015-12-18 11:34:16
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public workshop; extension of comment period. | |
| FR Citation | 80 FR 15018 |
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