86936 Federal Register / Vol. 85, No. 251 / Thursday, December 31, 2020 / Notices 

Services as the Privacy Act permits, 

including in accordance with the 

routine uses published for this system 

in the Federal Register, and as 

authorized by law. Such lawful 

purposes may include but are not 

limited to sharing identifiable 

information with state and local public 

health departments, and other 

cooperating authorities. CDC and 

cooperating authorities will retain, use, 

delete, or otherwise destroy the 

designated information in accordance 

with federal law and the System of 

Records Notice (SORN) set forth above. 

You may contact the system manager at 

dgmqpolicyoffice@cdc.gov; Division of 

Global Migration and Quarantine, 

Centers for Disease Control and 

Prevention, 1600 Clifton Road NE, MS 

H16–4, Atlanta, GA 30329, if you have 

questions about CDC’s use of your data. 

Authority 

The authority for these orders is 

Sections 361 and 365 of the Public 

Health Service Act (42 U.S.C. 264) and 

42 CFR 71.20 & 71.31(b). 

Nina B. Witkofsky, 

Acting Chief of Staff, Centers for Disease 

Control and Prevention. 

[FR Doc. 2020–28981 Filed 12–28–20; 4:15 pm] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; Generic 

Clearance for the Comprehensive 

Child Welfare Information System 

(CCWIS) Review and Technical 

Assistance Process (New Collection) 

AGENCY: Children’s Bureau, 

Administration for Children and 

Families, HHS. 

ACTION: Request for public comment. 

SUMMARY: The Children’s Bureau (CB), 

Administration for Children and 

Families (ACF), U.S. Department of 

Health and Human Services (HHS), is 

proposing to establish a generic 

clearance to collect information to 

assess regulatory requirements of title 

IV–E agencies’ Comprehensive Child 

Welfare Information System (CCWIS) 

and ensure that the CCWIS is utilized 

for purposes consistent with the 

efficient, economical, and effective 

administration of the title IV–B and IV– 

E plans. The information collected is 

intended to be used for review and 

technical assistance processes. 

DATES: Comments due within 30 days of 

publication. OMB must make a decision 

about the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

SUPPLEMENTARY INFORMATION: 

Description: This initial request is to 

establish an overarching generic for 

CCWIS Review and Technical 

Assistance (TA) information collections 

and includes six initial TA tools for title 

IV–E agencies to self-assess their 

conformity to CCWIS project and design 

requirements at 45 CFR 1355.52–3. The 

initial six TA tools include intake, 

investigation, case management, 

adoption, foster care and service 

provider management, and 

administration. 

In the future, ACF will submit under 

this generic clearance mechanism 

additional TA tools for title IV–E 

agencies to self-assess design, data 

quality, usability, reporting, data 

exchanges, external systems, eligibility, 

finance, Child Welfare Contributing 

Agencies, and other tools, as needed, to 

assess new child welfare programs and 

modern system architecture. 

The CCWIS requirements at 45 CFR 

1355.55 require the review, assessment, 

and inspection of the planning, design, 

development, installation, operation, 

and maintenance of each CCWIS project 

on a continuing basis. The Advance 

Planning Document regulations at 45 

CFR 95.621 require periodic reviews of 

state and local agency methods and 

practices to insure that information 

systems, including CCWIS, are utilized 

for purposes consistent with proper and 

efficient administration. 

Respondents: Title IV–E agencies 

under the Social Security Act. 

ANNUAL BURDEN ESTIMATES

Instrument 

Total 

number of 

respondents 

Total 

number of 

responses per 

respondent 

Average 

burden 

hours per 

response 

Total burden 

hours 

CCWIS Self-Assessment—Intake .................................................................... 55 1 10 550 

CCWIS Self-Assessment—Investigation ......................................................... 55 1 10 550 

CCWIS Self-Assessment—Case Management ............................................... 55 1 10 550 

CCWIS Self-Assessment—Adoption ............................................................... 55 1 10 550 

CCWIS Self-Assessment—Foster Care and Service Provider Management 55 1 10 550 

CCWIS Self-Assessment—Administration ....................................................... 55 1 10 550 

Future Tools to be Developed ......................................................................... 55 10 12 6,600 


khammond on DSKJM1Z7X2PROD with NOTICES
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 


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