73034 Federal Register / Vol. 88, No. 204 / Tuesday, October 24, 2023 / Notices 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued 

Recommended disclosure activity; guidance section Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total 

annual 

disclosures 

Average 

burden per 

disclosure 

Total 

hours 

The publication date of any referenced or included 

publication(s) (if not specified in the publication or citation); Q2.

1,008 3 3,024 0.1 (6 minutes) .... 302.4 

When firms share an SIUU communication in the form 

of an unabridged CPG or reference text in its entirety that discusses a wide range of medical products and that discussion is not primarily focused on 

one or more of a firm’s medical products, the firm 

should include, in lieu of some of the specific disclosures listed above, a more general statement in the 

SIUU communication, such as ‘‘This [CPG/reference 

text] describes some uses of medical products that 

are not approved by the FDA and the safety and effectiveness of any unapproved use(s) have not been 

established.’’; Q4.

1,008 3 3,024 0.1 (6 minutes) .... 302.4 

When firms share an SIUU communication in the form 

of a firm-generated presentation of scientific information from an accompanying reprint that SIUU communication should clearly disclose what portions of 

the communication are firm-generated; Q4.

1,008 10 10,080 0.1 (6 minutes) .... 1,008 

Total ........................................................................ ........................ ........................ 174,384 ............................. 75,902.4 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on a current listing of firms 

promoting approved/cleared human and 

animal drug products (747), combined 

with an estimated number of device 

firms marketing products (261), we 

assume 1,008 firms (‘‘number of 

respondents’’ in table (1) may each 

choose to publicly share 30 SIUU 

communications annually. Our estimate 

of the burden per disclosure (2.5 hours) 

reflects what we believe is the average 

burden based on the number and 

content and complexity of disclosures 

as recommended in the guidance. 

III. Request for Comment on Other 

Issues for Consideration 

FDA is interested in additional 

matters related to communications by 

firms about scientific information on 

unapproved use(s) of approved/cleared 

medical products. This revised draft 

guidance pertains to these 

communications by firms to HCPs 

engaged in making clinical practice 

decisions for the care of an individual 

patient. FDA is specifically seeking 

input on the following: 

1. What considerations, if any, exist 

that are unique to communications of 

scientific information about unapproved 

use(s) of approved/cleared medical 

products by firms to researchers 

(including HCPs working in their 

capacity as researchers)? 

2. What other factors should firms 

consider when sharing firm-generated 

presentations (as described in the draft 

guidance) to ensure that presentations 

are truthful, non-misleading, factual and 

unbiased and provide all information 

necessary for HCPs to interpret the 

strengths and weaknesses and validity 

and utility of the presented information? 

IV. Electronic Access 

Persons with access to the internet 

may obtain an electronic version of the 

draft guidance at https://www.fda.gov/ 

Drugs/GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https:// 

www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm, 

https://www.fda.gov/animal-veterinary/ 

guidance-regulations/guidanceindustry, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https:// 

www.regulations.gov. 

Dated: October 18, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–23372 Filed 10–23–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Notice of Request for Public Comment 

on Proposed Update to the Bright 

Futures Periodicity Schedule as Part of 

the HRSA-Supported Preventive 

Services Guidelines for Infants, 

Children, and Adolescents 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: This notice seeks public 

comment on a proposed update to the 

Periodicity Schedule of the Bright 

Futures Recommendations for Pediatric 

Preventive Health Care (‘‘Bright Futures 

Periodicity Schedule’’), as part of the 

HRSA-supported preventive services 

guidelines for infants, children, and 

adolescents. 

DATES: Members of the public are 

invited to provide written comments on 

the proposed update no later than 

November 24, 2023. All comments 

received on or before this date will be 

reviewed and considered by the Bright 

Futures Periodicity Schedule Working 

Group and provided for further 

consideration by HRSA in determining 

the recommended updates that it will 

support. 


ddrumheller on DSK120RN23PROD with NOTICES1
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