Federal Register / Vol. 87, No. 96 / Wednesday, May 18, 2022 / Notices 30225 

available for public comment for a 

period of 4 weeks. If you would like to 

be notified when the draft is posted, 

please sign up for the email list at: 

https://www.effectivehealthcare.

ahrq.gov/email-updates. 

The systematic review will answer the 

questions below. This information is 

provided as background and AHRQ is 

not requesting that the public provide 

answers to these questions. 

Key Questions (KQ) 

KQ 1a: Which medications are 

efficacious for improving consumption 

outcomes for adults with alcohol-use 

disorders in outpatient settings? 

KQ 1b: How do medications for adults 

with alcohol-use disorders compare for 

improving consumption outcomes in 

outpatient settings? 

KQ 2a: Which medications are 

efficacious for improving health 

outcomes (including functioning and 

quality-of-life outcomes) for adults with 

alcohol-use disorders in outpatient 

settings? 

KQ 2b: How do medications for adults 

with alcohol-use disorders compare for 

improving health outcomes (including 

functioning and quality-of-life 

outcomes) in outpatient settings? 

KQ 3a: What adverse effects are 

associated with medications for adults 

with alcohol-use disorders in outpatient 

settings? 

KQ 3b: How do medications for adults 

with alcohol-use disorders compare for 

adverse effects in outpatient settings? 

KQ 4: Are medications for treating 

adults with alcohol-use disorders 

effective in primary care settings? 

KQ 5: Are any of the medications 

more or less effective than other 

medications for older adults, younger 

adults, smokers, or those with cooccurring disorders? 

PICOTS (Populations, Interventions, 

Comparators, Outcomes, Timing, and 

Setting) 

• Population(s) 

Æ Adults (age 18 years or older) with 

alcohol-use disorders. 

• Interventions 

Æ Pharmacotherapy for relapse 

prevention. This includes: 

D Medications approved by FDA for 

treating alcohol dependence: 

• Acamprosate 

• disulfiram 

• naltrexone (oral or injectable) 

D Certain medications in use off label 

that are available in the United States: 

• Baclofen 

• gabapentin 

• ondansetron 

• topiramate 

• prazosin 

• varenicline 

Æ Studies evaluating 

pharmacotherapy that used cointerventions with other treatments for 

AUDs (e.g., behavioral counseling, 

cognitive behavioral therapy, 

motivational enhancement therapy, 

psychosocial treatments, or self-help 

such as 12-step programs [e.g., 

Alcoholics Anonymous]) will be eligible 

for inclusion, as long as they meet other 

inclusion/exclusion criteria. 

Æ This review will not include 

pharmacotherapy for alcohol 

withdrawal. 

• Comparators 

Æ Studies must compare one of the 

medications listed above with placebo 

or another eligible medication. 

• Outcomes 

Æ Consumption outcomes: 

D Abstinence/any drinking 

—rates of continuous abstinence 

—percentage of days abstinent 

—time to first drink/lapse 

—time to heavy drinking/relapse 

D reduction in alcohol consumption 

—number of heavy drinking days 

—percentage of subjects with no 

heavy drinking days 

—number of drinking days 

—drinks per drinking day 

—drinks per week 

Æ Health outcomes: 

D Accidents 

D injuries 

D quality of life 

D function 

D mortality 

Æ Adverse effects of intervention(s): 

D Withdrawals due to adverse events 

D nausea/vomiting 

D diarrhea 

D anorexia 

D alpitations 

D headache 

D dizziness 

D cognitive dysfunction 

D taste abnormalities 

D paresthesias (numbness, tingling) 

D metabolic acidosis 

D glaucoma 

D vision changes 

D suicidal ideation 

D insomnia 

D anxiety 

D rash 

D tiredness 

D weakness 

D constipation 

• Timing 

Æ Studies with at least 12 weeks of 

planned pharmacologic treatment and 

followup from the time of medication 

initiation. 

• Setting 

Æ Outpatient healthcare settings; KQ 

4 applies to primary care settings only 

(i.e., internal medicine, family 

medicine, obstetrics/gynecology, or 

college and university health clinics). 

Dated: May 12, 2022. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2022–10614 Filed 5–17–22; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; Plan for 

Foster Care and Adoption 

Assistance—Title IV–E (OMB #0970– 

0433) 

AGENCY: Children’s Bureau, 

Administration for Children and 

Families, HHS. 

ACTION: Request for public comment. 

SUMMARY: The Children’s Bureau (CB), 

Administration for Children and 

Families (ACF), U.S. Department of 

Health and Human Services (HHS), is 

requesting a 3-year extension of the Plan 

for Foster Care and Adoption 

Assistance—Title IV–E, (OMB#: 0970– 

0433, expiration 11/30/2022). This plan 

also incorporates the plan requirements 

for the optional Guardianship 

Assistance program, the Title IV–E 

Prevention Services plan and the Title 

IV–E Kinship Navigator program. There 

are no changes requested to the form. 

DATES: Comments due within 30 days of 

publication. OMB must make a decision 

about the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. You can also obtain 

copies of the proposed collection of 

information by emailing infocollection@

acf.hhs.gov. Identify all emailed 


lotter on DSK11XQN23PROD with NOTICES1
30226 Federal Register / Vol. 87, No. 96 / Wednesday, May 18, 2022 / Notices 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: A title IV–E plan is 

required by section 471, part IV–E of the 

Social Security Act (the Act) for each 

public child welfare agency requesting 

federal funding for foster care, adoption 

assistance, and guardianship assistance 

under the Act. Section 479B of the Act 

provides for an Indian tribe, tribal 

organization, or tribal consortium (tribe) 

to operate a title IV–E program in the 

same manner as a state with minimal 

exceptions. The tribe must have an 

approved Title IV–E Plan. The Title IV– 

E Plan provides assurances the 

programs will be administered in 

conformity with the specific 

requirements stipulated in Title IV–E. 

The plan must include all applicable 

state or tribal statutory, regulatory, or 

policy references and citations for each 

requirement as well as supporting 

documentation. A title IV–E agency may 

use the pre-print format prepared by CB, 

or a different format, on the condition 

that the format used includes all of the 

Title IV–E Plan requirements. 

Title IV–E of the Act was amended by 

Public Law 115–123, which included 

the Family First Prevention Services Act 

(FFPSA). FFPSA authorized new 

optional Title IV–E funding for timelimited (1 year) prevention services for 

mental health/substance abuse and inhome parent skill-based programs for (1) 

a child who is a candidate for foster care 

(as defined in section 475(13) of the 

Act), (2) pregnant/parenting foster 

youth, and (3) the parents/kin caregivers 

of those children and youth (sections 

471(e), 474(a)(6), and 475(13) of the 

Act). Title IV–E prevention services 

must be rated as promising, supported, 

or well supported in accordance with 

HHS criteria and be approved by HHS 

(section 471(e)(4)(C) of the Act) as part 

of the Title IV–E Prevention Services 

Clearinghouse (section 476(d)(2) of the 

Act). A state or tribal Title IV–E agency 

electing to participate in the program 

must submit a 5-year Title IV–E 

Prevention Program Plan that meets the 

statutory requirements. (See Program 

Instructions ACYF–CB–PI–18–09 and 

ACYF–CB–PI–18–10 for more 

information.) 

FFPSA also amended section 

474(a)(7) of the Act to reimburse state 

and tribal Title IV–E agencies for a 

portion of the costs of operating kinship 

navigator programs that meet certain 

criteria. To qualify for funding under 

the Title IV–E Kinship Navigator 

Program, the program must meet the 

requirements of a kinship navigator 

program described in section 427(a)(1) 

of the Act. The Kinship Navigator 

Program must meet practice criteria of 

promising, supported, or well-supported 

in accordance with HHS criteria and be 

approved by HHS (section 471(e)(4)(C) 

of the Act). To begin participation in the 

Title IV–E Kinship Navigator Program, a 

Title IV–E agency must submit an 

attachment to its Title IV–E plan that 

specifies the kinship navigator model it 

has chosen to implement and the date 

on which the provision of program 

services began or will begin, and 

provide an assurance that the model 

meets the requirements of section 

427(a)(1) of the Act, as well as a brief 

narrative describing how the program 

will be operated. (Please see Program 

Instruction ACYF–CB–PI–18–11 for 

additional information: https://www.acf.

hhs.gov/cb/policy-guidance/pi-18-11.) 

Respondents: State and tribal title IV– 

E agencies. 

ANNUAL BURDEN ESTIMATES

Instrument 

Annual 

number of 

respondents 

Annual 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual burden 

hours 

Title IV–E Plan ................................................................................................. 17 1 16 272 

Title IV–E prevention services plan ................................................................. 12 1 5 60 

Attachment to Title IV–E plan for Kinship Navigator Program ........................ 15 1 1 15 

Estimated Total Annual Burden 

Hours: 347. 

Authority: Title IV–E of the Social 

Security Act as amended by Public Law 

115– 123 enacted February 9, 2018. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–10652 Filed 5–17–22; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0001] 

Science Board to the Food and Drug 

Administration Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 

announces a forthcoming public 

advisory committee meeting of the 

Science Board to the Food and Drug 

Administration. The Science Board 

provides advice to the Commissioner of 

Food and Drugs and other appropriate 

officials on specific, complex scientific 

and technical issues important to 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, and 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. The meeting will be 

open to the public. 

DATES: The meeting will be held 

virtually on June 14, 2022, from 9 a.m. 

to 4 p.m. Eastern Time. 

ADDRESSES: Please note that due to the 

impact of this COVID–19 pandemic, all 

meeting participants will be joining this 

advisory committee meeting via an 

online teleconferencing platform. 

Answers to commonly asked questions 

about FDA advisory committee meetings 

may be accessed at: https://

www.fda.gov/AdvisoryCommittees/ 

AboutAdvisoryCommittees/ucm408555.

htm. 

FOR FURTHER INFORMATION CONTACT: 

Rakesh Raghuwanshi, Office of the 

Chief Scientist, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 3309, Silver Spring, 

MD 20993, 301–796–4769, 

Rakesh.Raghuwanshi@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 


lotter on DSK11XQN23PROD with NOTICES1