Federal Register / Vol. 88, No. 204 / Tuesday, October 24, 2023 / Notices 73035 

ADDRESSES: Members of the public 

interested in providing comments can 

do so by accessing the public comment 

web page at: www.aap.org/en/forms/ 

bright-futures-american-academy-ofpediatrics-recommendations-preventivehealth-care/. 

FOR FURTHER INFORMATION CONTACT: 

Savannah Kidd, M.S., M.F.T.; Senior 

Public Health Analyst; Division of 

Child, Adolescent, and Family Health; 

Maternal and Child Health Bureau; 

HRSA; email: SKidd@hrsa.gov, 

telephone: 301–287–2601. 

SUPPLEMENTARY INFORMATION: The Bright 

Futures Periodicity Schedule is 

maintained through a cooperative 

agreement, the Infant, Child, and 

Adolescent Preventive Services 

Program, for which the American 

Academy of Pediatrics (AAP) is the 

current recipient. When its preventive 

care and screening recommendations 

have been accepted by HRSA, the Bright 

Futures Periodicity Schedule is part of 

the HRSA-supported preventive services 

guidelines for infants, children, and 

adolescents. Under section 2713 of the 

Public Health Service Act (42 U.S.C. 

300gg–13) and pertinent regulations, 

non-grandfathered group health plans 

and health insurance issuers must 

provide coverage, without cost sharing, 

for certain preventive services for plan 

years (in the individual market, policy 

years) that begin on or after the date that 

is 1 year after the date the 

recommendation or guideline is issued. 

These include HRSA-supported 

preventive health services provided for 

in the Bright Futures Periodicity 

Schedule as part of the HRSA-supported 

preventive services guidelines for 

infants, children, and adolescents under 

42 U.S.C. 300gg–13(a)(3). 

Through the Infant, Child, and 

Adolescent Preventive Services 

cooperative agreement, the AAP is 

required to administer a process for 

developing and regularly 

recommending, as needed, updates to 

the Bright Futures Periodicity Schedule 

through a comprehensive, objective, and 

transparent review of available evidence 

that incorporates opportunity for public 

comment. Accordingly, AAP reviews 

the evidence to determine whether 

updates are needed, develops 

recommended updates, seeks and 

considers public comments, and makes 

recommendations to HRSA. The 

proposed update to the Bright Futures 

Periodicity Schedule includes additions 

to existing footnotes, which provide upto-date information and 

recommendations to providers but will 

not change the clinical 

recommendations and associated 

requirement for coverage without costsharing under section 2713 of the Public 

Health Service Act. The footnotes that 

AAP proposes to be revised are as 

follows: 

1. Footnote 4, relating to the first 

week well-child visit, also called the 3– 

5 Day Visit, will be revised with an 

updated reference that aligns with the 

Bright Futures recommendation 

regarding providers helping families 

that choose to breastfeed. 

2. Footnote 5, relating to Body Mass 

Index, is the Clinical Practice Guideline 

for the Evaluation and Treatment of 

Children and Adolescents with Obesity 

(https://doi.org/10.1542/peds.2022- 

060640) published in the January 2023 

issue of Pediatrics. This updated 

reference aligns with the Bright Futures 

recommendation regarding measuring 

body mass index starting at the 24- 

month visit through the 21-year visit 

and provides non-stigmatizing 

recommendations for evaluating and 

treating children who are experiencing 

weight gains. 

3. Footnote 14, relating to Behavioral/ 

Social/Emotional Screening, is the U.S. 

Preventive Services Task Force 

Recommendation Statement, Screening 

for Anxiety in Children and Adolescents 

(https://www.uspreventiveservicestask

force.org/uspstf/recommendation/ 

screening-anxiety-children-adolescents) 

published in the October 2022 issue of 

the Journal of the American Medical 

Association. This additional reference 

aligns with the Bright Futures 

recommendation to use screening 

instruments to better identify children 

experiencing anxiety, followed by a 

confirmatory diagnostic assessment and 

follow-up. 

4. Footnote 15, relating to Tobacco, 

Alcohol, or Drug Use Assessment, is the 

Centers for Disease Control and 

Prevention’s Evidence-Based Strategies 

for Preventing Opioid Overdose: What’s 

Working in the United States (https://

www.cdc.gov/drugoverdose/pdf/pubs/ 

2018-evidence-based-strategies.pdf) and 

the National Institute on Drug Abuse’s 

policy brief, Naloxone for Opioid 

Overdose: Life-Saving Science (https://

nida.nih.gov/publications/naloxoneopioid-overdose-life-saving-science). 

The proposed footnote aligns with the 

Bright Futures recommendation to 

assess patients for substance use with a 

validated screening tool. These 

additional references also describe the 

utility of prescribing Naloxone if there 

is concern for substance or opioid use. 

5. Footnote 21, relating to Newborn 

Bilirubin Screening, is Management of 

Hyperbilirubinemia in the Newborn 

Infant 35 or More Weeks of Gestation 

(https://doi.org/10.1542/peds.2022- 

058859), published in the August 2022 

issue of Pediatrics. This reference aligns 

with the Bright Futures 

recommendation for universal bilirubin 

screening for all newborn infants 

between 24 and 28 hours after birth. 

6. Footnote 35, relating to Oral Health, 

is Maintaining and Improving the Oral 

Health of Young Children (https://

doi.org/10.1542/peds.2022-060417), 

published in the December 2022 issue of 

Pediatrics. This reference aligns with 

the Bright Futures recommendation that 

every child has a dental home by 1 year 

of age. Additionally, the updated 

reference encourages providers to screen 

for social determinants of health, as well 

as access to medical and dental care, as 

they influence oral health status and 

oral health inequities. 

With respect to Footnote 15, HRSA 

welcomes comment on the evidence 

regarding the effect of prescribing 

Naloxone in the setting of a primary 

care preventive visit on preventing or 

reducing opioid overdoses and opioid 

overdose deaths. 

Authority: Section 2713(a)(3) of the 

Public Health Service Act, 42 U.S.C. 

300gg–13(a)(3). 

Carole Johnson, 

Administrator. 

[FR Doc. 2023–23396 Filed 10–23–23; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Findings of Research Misconduct 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: Findings of research 

misconduct have been made against 

Lara S. Hwa, Ph.D. (Respondent), who is 

an Assistant Professor, Department of 

Psychology and Neuroscience, Baylor 

University (BU), and formerly was a 

Postdoctoral Fellow, School of 

Medicine, University of North Carolina 

at Chapel Hill (UNC–CH). Respondent 

engaged in research misconduct in 

research supported by U.S. Public 

Health Service (PHS) funds, specifically 

National Institute on Alcohol Abuse and 

Alcoholism (NIAAA), National 

Institutes of Health (NIH), grants K99/ 

R00 AA027576, T32 AA007573, F31 

AA027129, F32 AA026485, R01 

AA019454, U01 AA020911, R01 

AA025582, and P60 AA011605 and 

included in two grant applications 

submitted for PHS funds, specifically 

K99 AA027576 submitted to NIAAA, 

NIH, and R01 DK136486 submitted to 


ddrumheller on DSK120RN23PROD with NOTICES1
73036 Federal Register / Vol. 88, No. 204 / Tuesday, October 24, 2023 / Notices 

the National Institute of Diabetes and 

Digestive and Kidney Diseases (NIDDK), 

NIH. The administrative actions, 

including supervision for a period of 

four (4) years, were implemented 

beginning on August 24, 2023, and are 

detailed below. 

FOR FURTHER INFORMATION CONTACT: 

Sheila Garrity, JD, MPH, MBA, Director, 

Office of Research Integrity, 1101 

Wootton Parkway, Suite 240, Rockville, 

MD 20852, (240) 453–8200. 

SUPPLEMENTARY INFORMATION: Notice is 

hereby given that the Office of Research 

Integrity (ORI) has taken final action in 

the following case: 

Lara S. Hwa, Ph.D., Baylor University 

and University of North Carolina at 

Chapel Hill: Based on the report of an 

investigation conducted by BU and 

UNC–CH and additional analysis 

conducted by ORI in its oversight 

review, ORI found that Lara S. Hwa, 

Ph.D., who is an Assistant Professor, 

Department of Psychology and 

Neuroscience, BU, and formerly was a 

Postdoctoral Fellow, School of 

Medicine, UNC–CH, engaged in 

research misconduct in research 

supported by PHS funds, specifically 

NIAAA, NIH, grants K99/R00 

AA027576, T32 AA007573, F31 

AA027129, F32 AA026485, R01 

AA019454, U01 AA020911, R01 

AA025582, and P60 AA011605 and 

included in two grant applications 

submitted for PHS funds, specifically 

K99 AA027576 submitted to NIAAA, 

NIH, and R01 DK136486 submitted to 

NIDDK, NIH. 

ORI found that Respondent engaged 

in research misconduct by knowingly or 

recklessly falsifying and/or fabricating 

data, methods, results, and conclusions 

in animal models of alcohol use 

disorders. Specifically, Respondent 

falsified and/or fabricated experimental 

timelines, group conditions, sex of 

animal subjects, mouse strains, and 

behavioral response data in the 

following two (2) published papers and 

two (2) PHS grant applications: 

• Alcohol Drinking Alters Stress 

Response to Predator Odor via BNST 

Kappa Opioid Receptor Signaling in 

Male Mice. Elife. 2020 Jul 21;9:e59709. 

doi: 10.7554/eLife.59709 (hereafter 

referred to as ‘‘Elife 2020’’). Retraction 

in: Elife. 2021 Nov 2;10:e74986. doi: 

10.7554/eLife.74986. 

• Predator Odor Increases Avoidance 

and Glutamatergic Synaptic 

Transmission in the Prelimbic Cortex 

via Corticotropin-releasing Factor 

Receptor 1 Signaling. 

Neuropyschopharmacology. 2019 

Mar;44(4):766–775. doi: 10.1038/ 

s41386–018–0279–2 (hereafter referred 

to as ‘‘Neuropyschopharmacology 

2019’’). 

• K99/R00 AA027576, ‘‘Long-term 

Alcohol Drinking Alters Stress 

Engagement of BNST Circuit Elements,’’ 

submitted to NIAAA, NIH, Funding 

Period: September 20, 2019–August 31, 

2024. 

• R01 DK136486, ‘‘Neuropeptide 

Characterization of Limited Access 

Sugar Drinking in Mice,’’ submitted to 

NIDDK, NIH, administratively 

withdrawn on December 9, 2022. 

Specifically, ORI finds that 

Respondent knowingly or recklessly: 

• Falsified blood ethanol (alcohol) 

concentration results by using 

female dynorphin mice from an 

unrelated study to represent ethanol 

concentrations in male wildtype 

mice in Figure 1D of Elife 2020 

• Falsified ethanol drinking ranges by 

including mice that drank outside 

of the range reported in Figures 2C, 

4, and 6 of Elife 2020 and Figure 4 

of K99 AA027576 

• Falsified ethanol withdrawal times by 

including mice undergoing a broad 

range of withdrawal durations but 

reporting different withdrawal 

parameters in Figures 2C, 4, 6, and 

Figure 6–figure supplement 1 of 

Elife 2020 and Figure 4 of K99 

AA027576 

• Falsified and/or fabricated mouse 

behavioral data by selectively 

switching, omitting, or altering raw 

data by: 

—Switching mouse location data from 

tracking software for water and 

ethanol treatment groups in Figures 

1F, 1G, and 1H of Elife 2020 

—Reporting unrelated heatmap 

images of mouse spatial location 

from a separate previous study to 

falsely demonstrate representative 

heatmap images for experimental 

conditions reported in Figure 1F of 

Elife 2020 

—Falsifying or fabricating mouse 

location data for 2,4,5, trimethyl-3- 

thiazoline (TMT) (i.e., predator 

odorant) contact values in Figures 

1G, 3E, and 5I of Elife 2020 

• Falsified immunolabeling results for 

c-Fos positive nuclei values by 

selectively switching or omitting 

raw data reported in mouse 

prelimbic and infralimbic 

subregions in mice previously 

exposed to H2O (control), vanilla 

(novel odorant), or TMT in Figures 

2b, 2c, and 2d of 

Neuropsychopharmacology 2019 

• Falsified sample size by duplicating 

four (4) data points to falsely report 

spontaneous excitatory postsynaptic current (sEPSC) frequency 

datapoints of electrophysiological 

recordings of eight (8) animal 

subjects in the water and NBI27914 

treatment group in Figure 5f of 

Neuropyschopharmacology 2019 

and Figure 6 of R01 DK136486 

Respondent entered into a Voluntary 

Settlement Agreement (Agreement) and 

voluntarily agreed to the following: 

(1) Respondent will have her research 

supervised for a period of four (4) years 

beginning on August 24, 2023 (the 

‘‘Supervision Period’’). Prior to the 

submission of an application for PHS 

support for a research project on which 

Respondent’s participation is proposed 

and prior to Respondent’s participation 

in any capacity in PHS-supported 

research, Respondent will submit a plan 

for supervision of Respondent’s duties 

to ORI for approval. The supervision 

plan must be designed to ensure the 

integrity of Respondent’s research. 

Respondent will not participate in any 

PHS-supported research until such a 

supervision plan is approved by ORI. 

Respondent will comply with the 

agreed-upon supervision plan. 

(2) The requirements for Respondent’s 

supervision plan are as follows: 

i. A committee of 2–3 senior faculty 

members at the institution who are 

familiar with Respondent’s field of 

research, but not including 

Respondent’s supervisor or 

collaborators, will provide oversight and 

guidance for a period of four (4) years 

from the effective date of the 

Agreement. The committee will review 

primary data from Respondent’s 

laboratory on a quarterly basis and 

submit a report to ORI at six (6) month 

intervals setting forth the committee 

meeting dates and Respondent’s 

compliance with appropriate research 

standards and confirming the integrity 

of Respondent’s research. 

ii. The committee will conduct an 

advance review of each application for 

PHS funds, or report, manuscript, or 

abstract involving PHS-supported 

research in which Respondent is 

involved. The review will include a 

discussion with Respondent of the 

primary data represented in those 

documents and will include a 

certification to ORI that the data 

presented in the proposed application, 

report, manuscript, or abstract are 

supported by the research record. 

(3) During the Supervision Period, 

Respondent will ensure that any 

institution employing her submits, in 

conjunction with each application for 

PHS funds, or report, manuscript, or 

abstract involving PHS-supported 

research in which Respondent is 

involved, a certification to ORI that the 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 204 / Tuesday, October 24, 2023 / Notices 73037 

data provided by Respondent are based 

on actual experiments or are otherwise 

legitimately derived and that the data, 

procedures, and methodology are 

accurately reported and not plagiarized 

in the application, report, manuscript, 

or abstract. 

(4) If no supervision plan is provided 

to ORI, Respondent will provide 

certification to ORI at the conclusion of 

the Supervision Period that her 

participation was not proposed on a 

research project for which an 

application for PHS support was 

submitted and that she has not 

participated in any capacity in PHSsupported research. 

(5) During the Supervision Period, 

Respondent will exclude herself 

voluntarily from serving in any advisory 

or consultant capacity to PHS including, 

but not limited to, service on any PHS 

advisory committee, board, and/or peer 

review committee. 

(6) Respondent will request that the 

following paper be corrected or 

retracted: 

• Neuropyschopharmacology. 2019 

Mar;44(4):766–775. doi: 10.1038/ 

s41386–018–0279–2. Respondent will 

copy ORI and the Research Integrity 

Officer at UNC–CH on the 

correspondence with the journal. 

Dated: October 19, 2023. 

Sheila Garrity, 

Director, Office of Research Integrity, Office 

of the Assistant Secretary for Health. 

[FR Doc. 2023–23464 Filed 10–23–23; 8:45 am] 

BILLING CODE 4150–31–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center For Scientific Review; Notice of 

Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting 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: Center for Scientific 

Review Special Emphasis Panel; Special 

Topics in Biomaterials, Instrumentation, 

Gene and Drug Delivery. 

Date: December 8, 2023. 

Time: 10:00 a.m. to 8:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Joseph D. Mosca, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5158, 

MSC 7808, Bethesda, MD 20892, (301) 408– 

9465, moscajos@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: October 19, 2023. 

Victoria E. Townsend, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–23422 Filed 10–23–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting 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: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Respiratory Sciences. 

Date: December 14, 2023. 

Time: 10:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Ghenima Dirami, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4122, 

MSC 7814, Bethesda, MD 20892, 240–498– 

7546, diramig@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: October 19, 2023. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–23424 Filed 10–23–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Human Genome Research 

Institute; Amended Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the National Human 

Genome Research Institute, Center for 

Inherited Disease Research Access 

Committee, November 3, 2023, 11:30 

a.m. to 12:30 p.m., National Institutes of 

Health, National Human Genome 

Research Institute, 6700B Rockledge 

Drive, Room 3172, Bethesda, MD 20892, 

which was published in the Federal 

Register on September 28, 2023, FR 

DOC 2023–21148, 88 FR 66863. 

The National Human Genome 

Research Institute, Center for Inherited 

Disease Research Access Committee 

meeting is being rescheduled due to 

panel member availability. The meeting 

date and time has been changed to 

November 9, 2023, from 2:00 p.m. to 

3:00 p.m. This meeting will be closed to 

the public. 

Dated: October 19, 2023. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–23423 Filed 10–23–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting 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, 


ddrumheller on DSK120RN23PROD with NOTICES1