86938 Federal Register / Vol. 85, No. 251 / Thursday, December 31, 2020 / Notices 

1 5 U.S.C. 601 (note). 

Questions and Answers.’’ We are 

issuing this guidance in accordance 

with section 212 of the Small Business 

Regulatory Enforcement Fairness Act 

(Pub. L. 104–121, as amended by Pub. 

L. 110–28) 1 to help small businesses

understand and comply with the

Consumer Antiseptic Rub FR (84 FR

14847, April 12, 2019), which

established that 28 active ingredients

are not eligible for evaluation under

FDA’s OTC Drug Review for use in

consumer antiseptic rubs. Drug products

containing these ineligible active

ingredients will require approval under

a new drug application or abbreviated

new drug application before they can be

marketed. In this final action, FDA also

established that three active ingredients

used in consumer antiseptic rubs are

eligible for evaluation under the OTC

Drug Review and granted requests to

temporarily defer further rulemaking on

these three ingredients to allow

interested parties to complete the

studies necessary to fill the safety and

effectiveness data gaps identified for

these three ingredients.

This guidance reviews the content 

and effect of the final action, including 

identifying which active ingredients 

were found eligible and which were 

found not eligible for evaluation under 

the OTC Drug Review for use in 

consumer antiseptic rubs. In addition, 

this guidance explains when and how 

manufacturers must comply with the 

final action. 

This Level 2 guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on how small 

businesses can better understand and 

comply with the Consumer Antiseptic 

Rub FR. It does not establish any rights 

for any person and is not binding on 

FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995

This guidance contains no collection

of information. Therefore, clearance by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 is not required. 

III. Electronic Access

Persons with access to the internet

may obtain the guidance at either 

https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs or https://

www.regulations.gov. 

Dated: December 23, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–28929 Filed 12–30–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Service 

Administration 

Updates to the Bright Futures 

Periodicity Schedule 

AGENCY: Health Resources and Service 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: Effective December 28, 2020, 

HRSA accepted a recommended update 

to the Bright Futures Periodicity 

Schedule, a HRSA-supported guideline 

for infants, children and adolescents, for 

purposes of health insurance coverage 

without cost sharing under the Public 

Health Service (PHS) Act. The update 

includes screening for Hepatitis C Virus 

Infection for individuals ages 18 to 21. 

Please see https://mchb.hrsa.gov/ 

maternal-child-health-topics/childhealth/bright-futures.html for additional 

information. 

FOR FURTHER INFORMATION CONTACT: 

Bethany D. Miller, MSW, M.Ed., HRSA/ 

Maternal and Child Health Bureau by 

calling (301) 495–5156 or by emailing at 

BMiller@hrsa.gov. 

SUPPLEMENTARY INFORMATION: The Bright 

Futures program has been funded by 

HRSA since 1990. A primary focus of 

this program is for the funding recipient 

to maintain and update the Bright 

Futures Guidelines for Health 

Supervision of Infants, Children and 

Adolescents, a set of materials and tools 

that provide theory-based and evidencedriven guidance for all preventive care 

screenings and well-child visits. One 

component of these tools is the Bright 

Futures Periodicity Schedule, a chart 

that identifies the recommended 

screenings, assessments, physical 

examinations, and procedures to be 

delivered within preventive checkups at 

each age milestone. Over the program’s 

existence, the Bright Futures Periodicity 

Schedule has become the accepted 

schedule within the United States for 

preventive health services through the 

course of a child’s development. 

Section 2713 of the PHS Act requires 

that non-grandfathered group health 

plans and health insurance issuers 

offering group or individual health 

insurance coverage provide coverage 

without cost sharing for certain 

preventive health services in four 

identified areas. Section 2713(a)(3) 

describes such services for infants, 

children, and adolescents as ‘‘evidenceinformed preventive care and screenings 

provided for in the comprehensive 

guidelines supported by the Health 

Resources and Services 

Administration.’’ HHS, along with the 

Departments of Treasury and Labor, 

issued an Interim Final Rule on July 19, 

2010, (75 FR 41726–41760) that 

identified two specific resources as the 

comprehensive guidelines supported by 

HRSA for infants, children, and 

adolescents to be covered by insurance 

without cost sharing by nongrandfathered group health plans and 

health insurance issuers: (1) The Bright 

Futures Periodicity Schedule and (2) the 

Recommended Uniform Screening Panel 

of the Advisory Committee on Heritable 

Disorders in Newborns and Children. 

The Interim Final Rule provided that a 

future change to these comprehensive 

guidelines is considered to be issued for 

purposes of Section 2713 on the date on 

which it is accepted by the HRSA 

Administrator or, if applicable, adopted 

by the Secretary of HHS. 

On December 28, 2020, the HRSA 

Administrator accepted the 

recommended update to the Bright 

Futures Periodicity Schedule. The 

Bright Futures recommendation 

included both a recommended clinical 

practice update and revisions to the 

footnotes on the Bright Futures 

Periodicity Schedule. The update 

includes screening for Hepatitis C Virus 

Infection for individuals age 18 to 21. 

The footnote revisions are applied to 

footnote 11 (Developmental Screening); 

footnote 12 (Autism Spectrum Disorder 

Screening) to update the title of the 

relevant revised policy statements and 

the electronic hyperlinks; and a new 

footnote referring to the supporting 

evidence for the recommendation for 

screening for hepatitis C virus infection. 

Therefore, all non-grandfathered group 

health plans and health insurance 

issuers offering group or individual 

health insurance coverage must cover 

without cost-sharing the services and 

screenings listed on the updated Bright 

Futures Periodicity Schedule for plan 

years (in the individual market, policy 

years) beginning on or after December 

28, 2021. 

The updated Bright Futures 

Periodicity schedule can be accessed at 

the following link: https:// 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 85, No. 251 / Thursday, December 31, 2020 / Notices 86939 

mchb.hrsa.gov/maternal-child-healthtopics/child-health/bright-futures.html. 

Thomas J. Engels, 

Administrator. 

[FR Doc. 2020–28971 Filed 12–30–20; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the Advisory Committee on 

Training in Primary Care Medicine and 

Dentistry 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the Advisory 

Committee on Training in Primary Care 

Medicine and Dentistry (ACTPCMD) 

will hold public meetings for the 2021 

calendar year (CY). Information about 

ACTPCMD, agendas, and materials for 

these meetings can be found on the 

ACTPCMD website at https://

www.hrsa.gov/advisory-committees/ 

primarycare-dentist/index.html. 

DATES: ACTPCMD meetings will be held 

on 

• March 2, 2021, 10:00 a.m.–5:00 p.m. 

Eastern Time (ET) and March 3, 2021, 

10:00 a.m.–2:00 p.m. ET; 

• November 2, 2021, 8:30 a.m.–5:00 

p.m. ET and November 3, 2021, 8:30 

a.m.–2:00 p.m. ET. 

ADDRESSES: Meetings may be held inperson, by teleconference, and/or Adobe 

Connect webinar. For updates on how 

the meeting will be held, visit the 

ACTPCMD website 30 business days 

before the date of the meeting, where 

instructions for joining meetings either 

in-person or remotely will also be 

posted. In-person ACTPCMD meetings 

will be held at 5600 Fishers Lane, 

Rockville, Maryland 20857. For meeting 

information updates, go to the 

ACTPCMD website meeting page at 

https://www.hrsa.gov/advisorycommittees/interdisciplinarycommunity-linkages/meetings/ 

index.html. 

FOR FURTHER INFORMATION CONTACT: 

Shane Rogers, Designated Federal 

Official, Division of Medicine and 

Dentistry, Bureau of Health Workforce, 

HRSA, 5600 Fishers Lane, Room 

15N142, Rockville, Maryland 20857; 

301–443–5260; or SRogers@hrsa.gov. 

SUPPLEMENTARY INFORMATION: The 

ACTPCMD provides advice and 

recommendations to the Secretary of 

HHS (Secretary) on policy, program 

development, and other matters of 

significance concerning the activities 

under Section 747 of Title VII of the 

Public Health Service (PHS) Act, as it 

existed upon the enactment of Section 

749 of the PHS Act in 1998. The 

ACTPCMD prepares an annual report 

describing the activities of the 

committee, including findings and 

recommendations made by the 

committee concerning the activities 

under Section 747, as well as training 

programs in oral health and dentistry. 

The annual report is submitted to the 

Secretary as well as the Chairman and 

ranking members of the Senate 

Committee on Health, Education, Labor 

and Pensions and the House of 

Representatives Committee on Energy 

and Commerce. The ACTPCMD 

develops, publishes, and implements 

performance measures and guidelines 

for longitudinal evaluations of programs 

authorized under Title VII, Part C of the 

PHS Act, and recommends 

appropriation levels for programs under 

this Part. Since priorities dictate 

meeting times, be advised that start 

times, end times, and agenda items are 

subject to change. For CY 2021 

meetings, agenda items may include, 

but are not limited to inter-professional 

team-based education, practice, and 

retention in underserved rural 

communities, as well as matters 

pertaining to policy, program 

development, and other matters of 

significance concerning medicine and 

dentistry activities authorized under 

Title VII of the PHS Act. Refer to the 

ACTPCMD website listed above for all 

current and updated information 

concerning the CY 2021 ACTPCMD 

meetings, including draft agendas and 

meeting materials that will be posted 30 

calendar days before the meeting. 

Members of the public will have the 

opportunity to provide comments. 

Public participants may submit written 

statements in advance of the scheduled 

meeting(s). Oral comments will be 

honored in the order they are requested 

and may be limited as time allows. 

Requests to submit a written statement 

or make oral comments to the 

ACTPCMD should be sent to Shane 

Rogers using the contact information 

above at least 5 business days before the 

meeting date(s). 

Individuals who need special 

assistance or another reasonable 

accommodation should notify Shane 

Rogers using the contact information 

listed above at least 10 business days 

before the meeting(s) they wish to 

attend. 

If a meeting is held in-person, it will 

occur in a federal government building 

and attendees must go through a 

security check to enter. Non-U.S. citizen 

attendees must notify HRSA of their 

planned attendance at an in-person 

meeting at least 20 business days prior 

to the meeting in order to facilitate their 

entry into the building. All attendees are 

required to present government-issued 

identification prior to entry. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2020–28919 Filed 12–30–20; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the National Advisory 

Council on Nurse Education and 

Practice 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the National 

Advisory Council on Nurse Education 

and Practice (NACNEP) will hold public 

meetings for the 2021 calendar year 

(CY). Information about NACNEP, 

agendas, and materials for these 

meetings can be found on the NACNEP 

website at https://www.hrsa.gov/ 

advisory-committees/nursing/ 

index.html. 

DATES: NACNEP meetings will be held 

on 

• March 9, 2021, 8:30 a.m.–5:00 p.m. 

Eastern Time (ET) and March 10, 

2021, 8:30 a.m.–2:00 p.m. ET; 

• July 13, 2021, 8:30 a.m.–5:00 p.m. ET 

and July 14, 2021, 8:30 a.m.–5:00 p.m. 

ET; 

• December 7, 2021, 8:30 a.m.–5:00 

p.m. ET and December 8, 2021, 8:30 

a.m.–5:00 p.m. ET. 

ADDRESSES: Meetings may be held inperson, by teleconference, and/or Adobe 

Connect webinar. For updates on how 

the meeting will be held, visit the 

NACNEP website 30 business days 

before the date of the meeting, where 

instructions for joining meetings either 

in-person or remotely will also be 

posted. In-person NACNEP meetings 

will be held at 5600 Fishers Lane, 

Rockville, Maryland 20857. For meeting 


khammond on DSKJM1Z7X2PROD with NOTICES