83 FR 29124 - Tobacco Products Scientific Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 121 (June 22, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 121 (June 22, 2018)
| Page Range | 29124-29125 | |
| FR Document | 2018-13405 |
[Federal Register Volume 83, Number 121 (Friday, June 22, 2018)] [Notices] [Pages 29124-29125] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-13405] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-2066] Tobacco Products Scientific Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) announces a [[Page 29125]] forthcoming public advisory committee meeting of the Tobacco Products Scientific Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. DATES: The meeting will be held on September 13, 2018, from 8:30 a.m. to 5 p.m. and on September 14, 2018, from 8 a.m. to 3 p.m. ADDRESSES: FDA White Oak Conference Center, 10903 New Hampshire Ave., Bldg. 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: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. FOR FURTHER INFORMATION CONTACT: 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: TPSAC@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 website at https://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. SUPPLEMENTARY INFORMATION: Agenda: On September 13 and 14, 2018, the Committee will discuss modified risk tobacco product applications, submitted by R.J. Reynolds Tobacco Company for six products:MR0000068: Camel Snus Frost MR0000069: Camel Snus Frost Large MR0000070: Camel Snus Mellow MR0000071: Camel Snus Mint MR0000072: Camel Snus Robust MR0000073: Camel Snus Winterchill 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 website 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 website after the meeting. Background material is available at https://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 August 29, 2018. Oral presentations from the public will be scheduled between approximately 8 a.m. and 9 a.m. on September 14, 2018. 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 August 16, 2018. 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 August 17, 2018. 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 disabilities. If you require accommodations due to a disability, please contact Caryn Cohen at least 7 days in advance of the meeting (see, FOR FURTHER INFORMATION CONTACT). FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://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: June 18, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-13405 Filed 6-21-18; 8:45 am] BILLING CODE 4164-01-P
![29124 Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Notices
Notice requests comment on whether and intends to rate studies as either high, empirical basis suggesting that,
how studies should also be rated on the moderate, or low on the extent to which compared to its likely benefits, the
number of null effects on ‘target outcomes’, ‘target outcome’ measures are reliable (i.e., practice constitutes a risk of harm to
and on whether and how ratings should the extent to which a measure produces the
those receiving it’’, ‘‘If multiple outcome
consider the number or magnitude of same results when used repeatedly), valid
unfavorable effects. (i.e., the extent to which a measure captures studies are conducted, the overall
2.5.3 Sustained Favorable Effect. HHS what it is intended to measure), and were weight of evidences supports the
intends for studies with at least one favorable administered consistently and accurately benefits of the practice’’, and ‘‘There is
effect on a ‘target outcome’, as determined by across all those receiving the practice in no case data suggesting a risk of harm
the criteria in 2.5.1 Favorable Effects, to be accordance with FFPSA statutory language that was probably caused by the
rated on whether or not they demonstrate a [section 471(e)(4)(C)] or receiving the treatment and that was severe or
sustained favorable effect. As noted in appropriate comparison practice. This Notice frequent’’.
section 471(e)(4)(C), a ‘supported practice’ requests comment on appropriate thresholds
must have at least one study that for evaluating and assigning a rating to the 3.0 Recommendations of Potential
demonstrates ‘‘a sustained effect (when reliability, validity, and administration of Candidate Programs and Services for
compared to a control group) for at least 6 ‘target outcome’ measures. Review
months beyond the end of treatment’’ and a 2.6 Program or Service Rating Criteria.
‘well-supported practice’ must have at least HHS intends for programs or services to be This Notice requests comment on
one study that demonstrates ‘‘a sustained rated as promising, supported, or well- potential candidate programs and
effect (when compared to a control group) for supported practices if they meet the below services to consider for the systematic
at least 1 year beyond the end of treatment.’’ criteria that collectively assess the strength of evidence review. Comments should
HHS intends to classify studies as not evidence for a practice and build from the identify how recommended programs
demonstrating a sustained favorable effect individual study criteria described in section and services meet the criteria described
(i.e., effects are demonstrated for less than 6 2.5 Study Rating Criteria. These criteria were in section 2.1 Program or Service
months), demonstrating a sustained favorable developed in accordance with FFPSA
Eligibility Criteria. These criteria
effect of 6 months or more (but less than 12 statutory language [section 471(e)(4)(C)].
months), or demonstrating a sustained 2.6.1 Promising Practice: HHS intends to include: Types of Programs and Services
favorable effect of 12 months or more. designate a program or service as a and Book/Manual/Writings Available.
2.5.4 Rigorous Study Design. HHS ‘promising practice’ if the program or service Comments should also identify how
intends to rate studies as either high, has at least one study that demonstrates a recommended programs and services
moderate, or low on the rigor and favorable effect on a target outcome as meet the criteria described in section 2.2
appropriateness of their study design. Study described by criterion 2.5.1 Favorable Effects Program or Service Prioritization
designs that receive the highest rating will be and achieves, at a minimum, moderate Criteria. These criteria include: Types of
either Randomized Controlled Trials (RCTs) ratings on criteria 2.5.4 through 2.5.6.
Programs and Services, Target
or rigorous quasi-experimental designs. HHS 2.6.2 Supported Practice: HHS intends to
designate a program or service as a Population of Interest, Target Outcomes,
defines randomized controlled trials as a
study design in which sample members are ‘supported practice’ if the program or service Number of Impact Studies, In Use/
assigned to the program or service and has at least one study that demonstrates a Active, Implementation and Fidelity
comparison groups by chance. Randomized favorable effect on a target outcome as Support, Trauma-Informed, and
control designs are often considered the described by 2.5.1 Favorable Effects, Delivery Setting for In-Home Parent
‘‘gold standard’’ of research design because demonstrates a sustained favorable effect on Skill-Based Programs and Services. In
personal characteristics (before the program a target outcome of at least 6 months beyond order to leverage new insights from the
or service begins) do not affect whether the end of treatment as described in Section field, HHS may put forth additional
someone is assigned to the program or 2.5.3 Sustained Favorable Effect, and
future Notices requesting
service or control group. HHS defines a achieves the high rating on criteria 2.5.4
through 2.5.6. recommendations of potential candidate
quasi-experimental design as a study design
in which sample members are selected for 2.6.3 Well-Supported Practice: HHS programs and services for review.
the program or service and comparison intends to designate a program or service as 4.0 Submission of Comments
groups in a nonrandom way. Similar to a ‘well-supported practice’ if the practice has
criteria considered in other federal evidence at least two studies with non-overlapping Comments may be submitted until
clearinghouses, rigorous study designs will analytic samples and distinct July 22, 2018 by email to
be those that are appropriately powered, implementations that demonstrate favorable ffclearinghouse@acf.hhs.gov.
include an appropriate control group, effects as described by 2.5.1 Favorable
Effects, demonstrate sustained favorable Naomi Goldstein,
maintain original assignment to study arms,
and are appropriate to combat threats to effects of at least 12 months beyond the end Deputy Assistant Secretary for Planning,
internal validity. This Notice requests of treatment as described in Section 2.5.3 Research, and Evaluation.
comment on threats to internal validity that Sustained Favorable Effect, and achieve the [FR Doc. 2018–13420 Filed 6–21–18; 8:45 am]
should be considered. This Notice requests high rating on criteria 2.5.4 through 2.5.6. BILLING CODE 4184–25–P
comment on appropriate thresholds for HHS does not intend to rate a program
evaluating and assigning a rating to a study
or service as a ‘promising’, ‘supported’,
design. DEPARTMENT OF HEALTH AND
2.5.5 Rigorous Study Analysis. HHS or ‘well-supported practice’ if there is
an empirical basis, as evidenced by HUMAN SERVICES
intends to rate studies as either high,
moderate, or low on the rigor and multiple unfavorable effects on target or
Food and Drug Administration
appropriateness of their analysis. Study non-target outcomes across reviewed
analyses that receive the highest rating may studies, as described in 2.5.2 [Docket No. FDA–2018–N–2066]
be those that tested and established baseline Unfavorable Effects, that suggest the
equivalence, appropriately accounted for overall weight of evidence does not Tobacco Products Scientific Advisory
daltland on DSKBBV9HB2PROD with NOTICES
overall and differential sample attrition, support the benefits of the program or Committee; Notice of Meeting
appropriately accounted for multiple
service. This Notice requests comment AGENCY: Food and Drug Administration,
comparisons, and when necessary accounted
for clustering. This Notice requests comment on approaches for determining that HHS.
on appropriate thresholds for evaluating and promising, supported, and well- ACTION: Notice.
assigning a rating to a study analysis. supported practices do not constitute a
2.5.6 Reliability, Validity, and Systematic risk of harm. As described in FFPSA SUMMARY: The Food and Drug
Administration of Outcome Measures. HHS [section 471(e)(4)(C)], ‘‘There is no Administration (FDA) announces a
VerDate Sep<11>2014 17:16 Jun 21, 2018 Jkt 244001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\22JNN1.SGM 22JNN1](https://thefederalregister.org/doc/83_FR_29245/page/1.svg)
![Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Notices 29125
forthcoming public advisory committee location of the advisory committee DEPARTMENT OF HEALTH AND
meeting of the Tobacco Products meeting, and the background material HUMAN SERVICES
Scientific Advisory Committee. The will be posted on FDA’s website after
general function of the committee is to the meeting. Background material is National Institutes of Health
provide advice and recommendations to available at https://www.fda.gov/
the Agency on FDA’s regulatory issues. AdvisoryCommittees/Calendar/ National Institute on Drug Abuse;
The meeting will be open to the public. default.htm. Scroll down to the Notice of Closed Meetings
DATES: The meeting will be held on appropriate advisory committee meeting
link. Pursuant to section 10(d) of the
September 13, 2018, from 8:30 a.m. to
Procedure: Interested persons may Federal Advisory Committee Act, as
5 p.m. and on September 14, 2018, from
present data, information, or views, amended, notice is hereby given of the
8 a.m. to 3 p.m.
orally or in writing, on issues pending following meetings.
ADDRESSES: FDA White Oak Conference
Center, 10903 New Hampshire Ave., before the committee. Written The meetings will be closed to the
Bldg. 31 Conference Center, the Great submissions may be made to the contact public in accordance with the
Room (Rm. 1503), Silver Spring, MD person on or before August 29, 2018. provisions set forth in sections
20993–0002. Answers to commonly Oral presentations from the public will 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
asked questions including information be scheduled between approximately 8 as amended. The grant applications and
regarding special accommodations due a.m. and 9 a.m. on September 14, 2018. the discussions could disclose
to a disability, visitor parking, and Those individuals interested in making confidential trade secrets or commercial
transportation may be accessed at: formal oral presentations should notify property such as patentable material,
https://www.fda.gov/Advisory the contact person and submit a brief and personal information concerning
Committees/AboutAdvisoryCommittees/ statement of the general nature of the individuals associated with the grant
ucm408555.htm. evidence or arguments they wish to applications, the disclosure of which
present, the names and addresses of would constitute a clearly unwarranted
FOR FURTHER INFORMATION CONTACT: invasion of personal privacy.
proposed participants, and an
Caryn Cohen, Office of Science, Center indication of the approximate time
for Tobacco Products, Food and Drug Name of Committee: National Institute on
requested to make their presentation on Drug Abuse Special Emphasis Panel;
Administration, Document Control or before August 16, 2018. Time allotted Mechanism for Time-Sensitive Drug Abuse
Center, 10903 New Hampshire Ave., for each presentation may be limited. If Research (R21 Clinical Trial Optional).
Bldg. 71, Rm. G335, Silver Spring, MD the number of registrants requesting to Date: June 29, 2018.
20993–0002, 1–877–287–1373, email: speak is greater than can be reasonably Time: 8:00 a.m. to 2:00 p.m.
TPSAC@fda.hhs.gov, or FDA Advisory accommodated during the scheduled Agenda: To review and evaluate grant
Committee Information Line, 1–800– open public hearing session, FDA may applications.
741–8138 (301–443–0572 in the conduct a lottery to determine the Place: National Institutes of Health,
Washington, DC area). A notice in the speakers for the scheduled open public Neuroscience Center, 6001 Executive
Federal Register about last minute hearing session. The contact person will Boulevard, Rockville, MD 20852 (Telephone
modifications that impact a previously notify interested persons regarding their Conference Call).
announced advisory committee meeting request to speak by August 17, 2018.
Contact Person: Hiromi Ono, Ph.D.,
cannot always be published quickly Scientific Review Officer, Office of
Persons attending FDA’s advisory Extramural Policy and Review, National
enough to provide timely notice.
committee meetings are advised that the Institute on Drug Abuse, National Institutes
Therefore, you should always check the
Agency is not responsible for providing of Health, DHHS, 6001 Executive Boulevard,
Agency’s website at https://
access to electrical outlets. Room 4238, MSC 9550, Bethesda, MD 20892,
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the FDA welcomes the attendance of the 301–827–5820, hiromi.ono@nih.gov.
appropriate advisory committee meeting public at its advisory committee This notice is being published less than 15
link, or call the advisory committee meetings and will make every effort to days prior to the meeting due to the timing
information line to learn about possible accommodate persons with disabilities. limitations imposed by the review and
modifications before coming to the If you require accommodations due to a funding cycle.
meeting. disability, please contact Caryn Cohen Name of Committee: National Institute on
at least 7 days in advance of the meeting Drug Abuse Special Emphasis Panel; Multi-
SUPPLEMENTARY INFORMATION: (see, FOR FURTHER INFORMATION site Clinical Trials.
Agenda: On September 13 and 14, CONTACT). Date: July 26–27, 2018.
2018, the Committee will discuss FDA is committed to the orderly Time: 10:00 a.m. to 8:00 p.m.
modified risk tobacco product conduct of its advisory committee Agenda: To review and evaluate grant
applications, submitted by R.J. Reynolds meetings. Please visit our applications.
Tobacco Company for six products: website at https://www.fda.gov/ Place: National Institutes of Health,
• MR0000068: Camel Snus Frost AdvisoryCommittees/AboutAdvisory
Neuroscience Center, 6001 Executive
• MR0000069: Camel Snus Frost Large Committees/ucm111462.htm for
Boulevard, Rockville, MD 20852 (Virtual
• MR0000070: Camel Snus Mellow Meeting).
procedures on public conduct during Contact Person: Susan O. McGuire, Ph.D.,
• MR0000071: Camel Snus Mint advisory committee meetings. Scientific Review Officer, Office of
• MR0000072: Camel Snus Robust Notice of this meeting is given under Extramural Policy and Review, National
• MR0000073: Camel Snus Winterchill
the Federal Advisory Committee Act Institute on Drug Abuse, National Institutes
daltland on DSKBBV9HB2PROD with NOTICES
FDA intends to make background (5 U.S.C. app. 2). of Health, DHHS, 6001 Executive Blvd.,
material available to the public no later Room 4245, Rockville, MD 20852, (301) 827–
Dated: June 18, 2018.
than 2 business days before the meeting. 5817, mcguireso@mail.nih.gov.
If FDA is unable to post the background Leslie Kux,
(Catalogue of Federal Domestic Assistance
material on its website prior to the Associate Commissioner for Policy. Program Nos.: 93.279, Drug Abuse and
meeting, the background material will [FR Doc. 2018–13405 Filed 6–21–18; 8:45 am] Addiction Research Programs, National
be made publicly available at the BILLING CODE 4164–01–P Institutes of Health, HHS)
VerDate Sep<11>2014 17:16 Jun 21, 2018 Jkt 244001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\22JNN1.SGM 22JNN1](https://thefederalregister.org/doc/83_FR_29245/page/2.svg)
Document Created: 2018-11-06 09:50:04
Document Modified: 2018-11-06 09:50:04
| 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. | |
| Dates | The meeting will be held on September 13, 2018, from 8:30 a.m. to 5 p.m. and on September 14, 2018, from 8 a.m. to 3 p.m. | |
| Contact | 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: [email protected], 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 website at https://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. | |
| FR Citation | 83 FR 29124 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR