30224 Federal Register / Vol. 87, No. 96 / Wednesday, May 18, 2022 / Notices 

The public portions of the 

applications listed below, as well as 

other related filings required by the 

Board, if any, are available for 

immediate inspection at the Federal 

Reserve Bank(s) indicated below and at 

the offices of the Board of Governors. 

This information may also be obtained 

on an expedited basis, upon request, by 

contacting the appropriate Federal 

Reserve Bank and from the Board’s 

Freedom of Information Office at 

https://www.federalreserve.gov/foia/ 

request.htm. Interested persons may 

express their views in writing on the 

standards enumerated in paragraph 7 of 

the Act. 

Comments regarding each of these 

applications must be received at the 

Reserve Bank indicated or the offices of 

the Board of Governors, Ann E. 

Misback, Secretary of the Board, 20th 

Street and Constitution Avenue NW, 

Washington DC 20551–0001, not later 

than June 2, 2022. 

A. Federal Reserve Bank of Chicago 

(Colette A. Fried, Assistant Vice 

President) 230 South LaSalle Street, 

Chicago, Illinois 60690–1414: 

1. The David C. Neuhaus Bank Stock 

Revocable Trust, Fairfax, Iowa; Laurie 

Neuhaus, as trustee, Amana, Iowa; 

Patrick Slater, Lois E. Slater, John C. 

Slater, John E. Neuhaus and Carla A. 

Neuhaus, all of Cedar Rapids, Iowa; the 

John D. Lefebure 2010 Revocable Trust, 

John D. Lefebure, as trustee, both of 

Fairfax, Iowa; James Neuhaus, Amana, 

Iowa; and David J. Slater, Lakewood, 

Colorado; to become members of the 

Neuhaus Family Control Group, a group 

acting in concert, to retain voting shares 

of Vanderbilt Holding Company, Inc., 

and thereby indirectly retain voting 

shares of Fairfax State Savings Bank, 

both of Fairfax, Iowa. Additionally, 

Patrick Slater to acquire additional 

voting shares of Vanderbilt Holding 

Company, Inc., and thereby indirectly 

acquire voting shares of Fairfax State 

Savings Bank. 

Board of Governors of the Federal Reserve 

System. 

Margaret M. Shanks, 

Deputy Secretary of the Board. 

[FR Doc. 2022–10710 Filed 5–17–22; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Supplemental Evidence and Data 

Request on Pharmacotherapy for 

Adults With Alcohol-Use Disorders in 

Outpatient Settings: Systematic 

Review Update 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Request for supplemental 

evidence and data submissions. 

SUMMARY: The Agency for Healthcare 

Research and Quality (AHRQ) is seeking 

scientific information submissions from 

the public. Scientific information is 

being solicited to inform our review on 

Pharmacotherapy for Adults with 

Alcohol-Use Disorders in Outpatient 

Settings: Systematic Review Update, 

which is currently being conducted by 

the AHRQ’s Evidence-based Practice 

Centers (EPC) Program. Access to 

published and unpublished pertinent 

scientific information will improve the 

quality of this review. 

DATES: Submission Deadline on or 

before June 17, 2022. 

ADDRESSES:

Email submissions: epc@

ahrq.hhs.gov. 

Print submissions: 

Mailing Address: Center for Evidence 

and Practice Improvement, Agency for 

Healthcare Research and Quality, 

ATTN: EPC SEADs Coordinator, 5600 

Fishers Lane, Mail Stop 06E53A, 

Rockville, MD 20857 

Shipping Address (FedEx, UPS, etc.): 

Center for Evidence and Practice 

Improvement, Agency for Healthcare 

Research and Quality, ATTN: EPC 

SEADs Coordinator, 5600 Fishers 

Lane, Mail Stop 06E77D, Rockville, 

MD 20857 

FOR FURTHER INFORMATION CONTACT: 

Jenae Benns, Telephone: 301–427–1496 

or Email: epc@ahrq.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Agency for Healthcare Research and 

Quality has commissioned the 

Evidence-based Practice Centers (EPC) 

Program to complete a review of the 

evidence for Pharmacotherapy for 

Adults with Alcohol-Use Disorders in 

Outpatient Settings: Systematic Review 

Update. AHRQ is conducting this 

systematic review pursuant to Section 

902 of the Public Health Service Act, 42 

U.S.C. 299a. 

The EPC Program is dedicated to 

identifying as many studies as possible 

that are relevant to the questions for 

each of its reviews. In order to do so, we 

are supplementing the usual manual 

and electronic database searches of the 

literature by requesting information 

from the public (e.g., details of studies 

conducted). We are looking for studies 

that report on Pharmacotherapy for 

Adults with Alcohol-Use Disorders in 

Outpatient Settings: Systematic Review 

Update, including those that describe 

adverse events. The entire research 

protocol is available online at: https://

effectivehealthcare.ahrq.gov/products/ 

alcohol-misuse-drug-therapy/protocol. 

This is to notify the public that the 

EPC Program would find the following 

information on Pharmacotherapy for 

Adults with Alcohol-Use Disorders in 

Outpatient Settings: Systematic Review 

Update helpful: 

D A list of completed studies that 

your organization has sponsored for this 

indication. In the list, please indicate 

whether results are available on 

ClinicalTrials.gov along with the 

ClinicalTrials.gov trial number. 

D For completed studies that do not 

have results on ClinicalTrials.gov, a 

summary, including the following 

elements: Study number, study period, 

design, methodology, indication and 

diagnosis, proper use instructions, 

inclusion and exclusion criteria, 

primary and secondary outcomes, 

baseline characteristics, number of 

patients screened/eligible/enrolled/lost 

to follow-up/withdrawn/analyzed, 

effectiveness/efficacy, and safety results. 

D A list of ongoing studies that your 

organization has sponsored for this 

indication. In the list, please provide the 

ClinicalTrials.gov trial number or, if the 

trial is not registered, the protocol for 

the study including a study number, the 

study period, design, methodology, 

indication and diagnosis, proper use 

instructions, inclusion and exclusion 

criteria, and primary and secondary 

outcomes. 

D Description of whether the above 

studies constitute ALL Phase II and 

above clinical trials sponsored by your 

organization for this indication and an 

index outlining the relevant information 

in each submitted file. 

Your contribution is very beneficial to 

the Program. Materials submitted must 

be publicly available or able to be made 

public. Materials that are considered 

confidential; marketing materials; study 

types not included in the review; or 

information on indications not included 

in the review cannot be used by the EPC 

Program. This is a voluntary request for 

information, and all costs for complying 

with this request must be borne by the 

submitter. 

The draft of this review will be posted 

on AHRQ’s EPC Program website and 


lotter on DSK11XQN23PROD with NOTICES1
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