Federal Register / Vol. 85, No. 251 / Thursday, December 31, 2020 / Notices 86937 

Estimated Total Annual Burden 

Hours: 9,900. 

Authority: 5 U.S.C. 301; 42 U.S.C. 470, 620 

et seq., 622(b), 629b(a), 652(b), 654A, 670 et 

seq., 671(a), 1302, and 1396a(a). 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2020–28925 Filed 12–30–20; 8:45 am] 

BILLING CODE 4184–25–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–N–0124 (Formerly 

Docket No. FDA–1975–N–0012)] 

Consumer Antiseptic Rub Final Rule; 

Finding of Ineligibility for Inclusion in 

Final Monograph Questions and 

Answers; Guidance for Industry; Small 

Entity Compliance Guide; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled 

‘‘Consumer Antiseptic Rub Final Rule 

Questions and Answers.’’ We are 

issuing this guidance in accordance 

with the Small Business Regulatory 

Enforcement Fairness Act to help small 

businesses understand and comply with 

the Consumer Antiseptic Rub Final 

Rule; Finding of Ineligibility for 

Inclusion in Final Monograph 

(Consumer Antiseptic Rub FR). In the 

Consumer Antiseptic Rub FR, FDA 

established that 28 active ingredients 

used in nonprescription (also known as 

over-the-counter (OTC)) consumer 

antiseptic products intended for use 

without water (consumer antiseptic 

rubs) are not eligible for evaluation 

under FDA’s OTC Drug Review, which 

was used to evaluate the safety and 

effectiveness of OTC drug products 

marketed in the United States on or 

before May 1972. The Consumer 

Antiseptic Rub FR 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 

eligible ingredients to allow for the 

development and submission of new 

safety and effectiveness data. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 31, 2020. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2016–N–0124 for ‘‘Consumer Antiseptic 

Rub Final Rule Questions and 

Answers.’’ Received comments will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Anita Kumar, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 5445, 

Silver Spring, MD 20993–0002, 301– 

796–1032. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Consumer Antiseptic Rub Final Rule 


khammond on DSKJM1Z7X2PROD with NOTICES
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