29124 Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Notices 

Notice requests comment on whether and 

how studies should also be rated on the 

number of null effects on ‘target outcomes’, 

and on whether and how ratings should 

consider the number or magnitude of 

unfavorable effects. 

2.5.3 Sustained Favorable Effect. HHS 

intends for studies with at least one favorable 

effect on a ‘target outcome’, as determined by 

the criteria in 2.5.1 Favorable Effects, to be 

rated on whether or not they demonstrate a 

sustained favorable effect. As noted in 

section 471(e)(4)(C), a ‘supported practice’ 

must have at least one study that 

demonstrates ‘‘a sustained effect (when 

compared to a control group) for at least 6 

months beyond the end of treatment’’ and a 

‘well-supported practice’ must have at least 

one study that demonstrates ‘‘a sustained 

effect (when compared to a control group) for 

at least 1 year beyond the end of treatment.’’ 

HHS intends to classify studies as not 

demonstrating a sustained favorable effect 

(i.e., effects are demonstrated for less than 6 

months), demonstrating a sustained favorable 

effect of 6 months or more (but less than 12 

months), or demonstrating a sustained 

favorable effect of 12 months or more. 

2.5.4 Rigorous Study Design. HHS 

intends to rate studies as either high, 

moderate, or low on the rigor and 

appropriateness of their study design. Study 

designs that receive the highest rating will be 

either Randomized Controlled Trials (RCTs) 

or rigorous quasi-experimental designs. HHS 

defines randomized controlled trials as a 

study design in which sample members are 

assigned to the program or service and 

comparison groups by chance. Randomized 

control designs are often considered the 

‘‘gold standard’’ of research design because 

personal characteristics (before the program 

or service begins) do not affect whether 

someone is assigned to the program or 

service or control group. HHS defines a 

quasi-experimental design as a study design 

in which sample members are selected for 

the program or service and comparison 

groups in a nonrandom way. Similar to 

criteria considered in other federal evidence 

clearinghouses, rigorous study designs will 

be those that are appropriately powered, 

include an appropriate control group, 

maintain original assignment to study arms, 

and are appropriate to combat threats to 

internal validity. This Notice requests 

comment on threats to internal validity that 

should be considered. This Notice requests 

comment on appropriate thresholds for 

evaluating and assigning a rating to a study 

design. 

2.5.5 Rigorous Study Analysis. HHS 

intends to rate studies as either high, 

moderate, or low on the rigor and 

appropriateness of their analysis. Study 

analyses that receive the highest rating may 

be those that tested and established baseline 

equivalence, appropriately accounted for 

overall and differential sample attrition, 

appropriately accounted for multiple 

comparisons, and when necessary accounted 

for clustering. This Notice requests comment 

on appropriate thresholds for evaluating and 

assigning a rating to a study analysis. 

2.5.6 Reliability, Validity, and Systematic 

Administration of Outcome Measures. HHS 

intends to rate studies as either high, 

moderate, or low on the extent to which 

‘target outcome’ measures are reliable (i.e., 

the extent to which a measure produces the 

same results when used repeatedly), valid 

(i.e., the extent to which a measure captures 

what it is intended to measure), and were 

administered consistently and accurately 

across all those receiving the practice in 

accordance with FFPSA statutory language 

[section 471(e)(4)(C)] or receiving the 

appropriate comparison practice. This Notice 

requests comment on appropriate thresholds 

for evaluating and assigning a rating to the 

reliability, validity, and administration of 

‘target outcome’ measures. 

2.6 Program or Service Rating Criteria. 

HHS intends for programs or services to be 

rated as promising, supported, or wellsupported practices if they meet the below 

criteria that collectively assess the strength of 

evidence for a practice and build from the 

individual study criteria described in section 

2.5 Study Rating Criteria. These criteria were 

developed in accordance with FFPSA 

statutory language [section 471(e)(4)(C)]. 

2.6.1 Promising Practice: HHS intends to 

designate a program or service as a 

‘promising practice’ if the program or service 

has at least one study that demonstrates a 

favorable effect on a target outcome as 

described by criterion 2.5.1 Favorable Effects 

and achieves, at a minimum, moderate 

ratings on criteria 2.5.4 through 2.5.6. 

2.6.2 Supported Practice: HHS intends to 

designate a program or service as a 

‘supported practice’ if the program or service 

has at least one study that demonstrates a 

favorable effect on a target outcome as 

described by 2.5.1 Favorable Effects, 

demonstrates a sustained favorable effect on 

a target outcome of at least 6 months beyond 

the end of treatment as described in Section 

2.5.3 Sustained Favorable Effect, and 

achieves the high rating on criteria 2.5.4 

through 2.5.6. 

2.6.3 Well-Supported Practice: HHS 

intends to designate a program or service as 

a ‘well-supported practice’ if the practice has 

at least two studies with non-overlapping 

analytic samples and distinct 

implementations that demonstrate favorable 

effects as described by 2.5.1 Favorable 

Effects, demonstrate sustained favorable 

effects of at least 12 months beyond the end 

of treatment as described in Section 2.5.3 

Sustained Favorable Effect, and achieve the 

high rating on criteria 2.5.4 through 2.5.6. 

HHS does not intend to rate a program 

or service as a ‘promising’, ‘supported’, 

or ‘well-supported practice’ if there is 

an empirical basis, as evidenced by 

multiple unfavorable effects on target or 

non-target outcomes across reviewed 

studies, as described in 2.5.2 

Unfavorable Effects, that suggest the 

overall weight of evidence does not 

support the benefits of the program or 

service. This Notice requests comment 

on approaches for determining that 

promising, supported, and wellsupported practices do not constitute a 

risk of harm. As described in FFPSA 

[section 471(e)(4)(C)], ‘‘There is no 

empirical basis suggesting that, 

compared to its likely benefits, the 

practice constitutes a risk of harm to 

those receiving it’’, ‘‘If multiple outcome 

studies are conducted, the overall 

weight of evidences supports the 

benefits of the practice’’, and ‘‘There is 

no case data suggesting a risk of harm 

that was probably caused by the 

treatment and that was severe or 

frequent’’. 

3.0 Recommendations of Potential 

Candidate Programs and Services for 

Review 

This Notice requests comment on 

potential candidate programs and 

services to consider for the systematic 

evidence review. Comments should 

identify how recommended programs 

and services meet the criteria described 

in section 2.1 Program or Service 

Eligibility Criteria. These criteria 

include: Types of Programs and Services 

and Book/Manual/Writings Available. 

Comments should also identify how 

recommended programs and services 

meet the criteria described in section 2.2 

Program or Service Prioritization 

Criteria. These criteria include: Types of 

Programs and Services, Target 

Population of Interest, Target Outcomes, 

Number of Impact Studies, In Use/ 

Active, Implementation and Fidelity 

Support, Trauma-Informed, and 

Delivery Setting for In-Home Parent 

Skill-Based Programs and Services. In 

order to leverage new insights from the 

field, HHS may put forth additional 

future Notices requesting 

recommendations of potential candidate 

programs and services for review. 

4.0 Submission of Comments 

Comments may be submitted until 

July 22, 2018 by email to 

ffclearinghouse@acf.hhs.gov. 

Naomi Goldstein, 

Deputy Assistant Secretary for Planning, 

Research, and Evaluation. 

[FR Doc. 2018–13420 Filed 6–21–18; 8:45 am] 

BILLING CODE 4184–25–P 

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 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Notices 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/Advisory

Committees/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/AboutAdvisory

Committees/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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; 

Mechanism for Time-Sensitive Drug Abuse 

Research (R21 Clinical Trial Optional). 

Date: June 29, 2018. 

Time: 8:00 a.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Telephone 

Conference Call). 

Contact Person: Hiromi Ono, Ph.D., 

Scientific Review Officer, Office of 

Extramural Policy and Review, National 

Institute on Drug Abuse, National Institutes 

of Health, DHHS, 6001 Executive Boulevard, 

Room 4238, MSC 9550, Bethesda, MD 20892, 

301–827–5820, hiromi.ono@nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; Multisite Clinical Trials. 

Date: July 26–27, 2018. 

Time: 10:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Virtual 

Meeting). 

Contact Person: Susan O. McGuire, Ph.D., 

Scientific Review Officer, Office of 

Extramural Policy and Review, National 

Institute on Drug Abuse, National Institutes 

of Health, DHHS, 6001 Executive Blvd., 

Room 4245, Rockville, MD 20852, (301) 827– 

5817, mcguireso@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos.: 93.279, Drug Abuse and 

Addiction Research Programs, National 

Institutes of Health, HHS) 


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