86937 Federal Register / Vol. 85, No. 251 / Thursday, December 31, 2020 / Notices 
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 
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15 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)
1to help small businesses
understand and comply with theConsumer Antiseptic Rub FR (84 FR14847, April 12, 2019), whichestablished that 28 active ingredientsare not eligible for evaluation underFDA’s OTC Drug Review for use inconsumer antiseptic rubs. Drug productscontaining these ineligible activeingredients will require approval undera new drug application or abbreviatednew drug application before they can bemarketed. In this final action, FDA alsoestablished that three active ingredientsused in consumer antiseptic rubs areeligible for evaluation under the OTCDrug Review and granted requests totemporarily defer further rulemaking onthese three ingredients to allowinterested parties to complete thestudies necessary to fill the safety andeffectiveness data gaps identified forthese 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/guidance- compliance-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/child- health/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 evidence- driven 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 ‘‘evidence- informed 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 non- grandfathered 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:// 
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