Federal Register / Vol. 85, No. 250 / Wednesday, December 30, 2020 / Notices 86569 

vulnerabilities are identified and 

resolved. 

Authority: 44 U.S.C. 3101. 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Seema Verma, having reviewed and 

approved this document, authorizes 

Lynette Wilson, who is the Federal 

Register Liaison, to electronically sign 

this document for purposes of 

publication in the Federal Register. 

Dated: December 22, 2020. 

Lynette Wilson, 

Federal Register, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2020–28795 Filed 12–28–20; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; OPRE Data Collection for 

Supporting Youth To Be Successful in 

Life (SYSIL) (New Collection) 

AGENCY: Office of Planning, Research, 

and Evaluation, Administration for 

Children and Families, HHS. 

ACTION: Request for public comment. 

SUMMARY: The Administration for 

Children and Families (ACF) is 

requesting approval from the Office of 

Management and Budget (OMB) for a 

new data collection. The Supporting 

Youth to be Successful in Life study 

(SYSIL) will build evidence on how to 

end homelessness among youth and 

young adults with experience in the 

child welfare system by continuing 

work with an organization who 

conducted foundational work as part of 

the Youth At-Risk of Homelessness 

project (OMB Control Number: 0970– 

0445). SYSIL will provide important 

information to the field by designing 

and conducting a federally led 

evaluation of a comprehensive service 

model for youth at risk of homelessness. 

DATES: Comments due within 60 days of 

publication. In compliance with the 

requirements of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

ACF is soliciting public comment on the 

specific aspects of the information 

collection described above. 

ADDRESSES: Copies of the proposed 

collection of information can be 

obtained and comments may be 

forwarded by emailing 

OPREinfocollection@acf.hhs.gov. 

Alternatively, copies can also be 

obtained by writing to the 

Administration for Children and 

Families, Office of Planning, Research, 

and Evaluation, 330 C Street SW, 

Washington, DC 20201, Attn: OPRE 

Reports Clearance Officer. All requests, 

emailed or written, should be identified 

by the title of the information collection. 

SUPPLEMENTARY INFORMATION: 

Description: The SYSIL evaluation 

includes an implementation study and 

an impact study, which will use a 

rigorous quasi-experimental design that 

includes a comparison group. This new 

information collection request includes 

the baseline and follow-up survey 

instruments for the impact study (a 

single instrument administered four 

times), and discussion guides for 

interviews and focus groups and the 

Working Alliance Inventory (WAI) for 

the implementation study. The data 

collected from the baseline and followup surveys will be used to describe the 

characteristics of the study sample of 

youth, develop models for estimating 

program impacts, and determine 

program effectiveness by comparing 

outcomes between youth in the 

treatment (youth receiving the Pathways 

program) and control groups. Data from 

the interviews and focus groups will 

provide a detailed understanding of 

program implementation. The study 

will also use administrative data from 

the child welfare system, homelessness 

management information system, and 

program providers. Administrative data 

will be used in its existing format and 

does not impose any new information 

collection or recordkeeping 

requirements on respondents. 

Respondents: The baseline and 

follow-up surveys will be administered 

to youth in the treatment group (youth 

receiving the Pathways program) and 

youth in the control group who consent 

to participate in the study. Interviews 

will be conducted with program 

leadership and staff. Focus groups will 

be conducted with a subset of youth 

who are participating in the study. The 

WAI will be completed by Pathways 

youth and their caseworkers. 

ANNUAL BURDEN ESTIMATES

Instrument 

Number of 

respondents 

(total over 

request 

period) 

Number of 

responses per 

respondent 

(total over 

request 

period) 

Avg. burden 

per response 

(in hours) 

Total burden 

(in hours) 

Annual burden 

(in hours) 

SYSIL Youth Survey—Baseline survey ............................... 700 1 .5 350 117 

SYSIL Youth Survey—Follow-up survey 1 (6 months) ....... 630 1 .5 315 105 

SYSIL Youth Survey—Follow-up survey 2 (12 months) ..... 595 1 .5 298 99 

SYSIL Youth Survey—Follow-up survey 3 (24 months) ..... 372 1 .5 186 62 

Interview guide for Pathways sites (treatment sites) ........... 30 1 1.5 45 15 

Interview guide for comparison sites ................................... 30 1 1.5 45 15 

Focus group discussion guide for Pathways youth (treatment youth) ...................................................................... 50 1 1.5 75 25 

Focus group discussion guide for comparison youth .......... 50 1 1.5 75 25 

Working Alliance Inventory for Pathways youth .................. 400 1 .08 32 11 

Working Alliance Inventory for Pathways case workers ..... 40 10 .08 32 11 

Estimated Total Annual Burden 

Hours: 485. 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

86570 Federal Register / Vol. 85, No. 250 / Wednesday, December 30, 2020 / Notices 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: Section 105(b)(5) of the Child 

Abuse Prevention and Treatment Act 

(CAPTA) of 1978 (42 U.S.C. 5106(b)(5)), as 

amended by the CAPTA Reauthorization Act 

of 2010 (Pub. L. 111–320). 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2020–28886 Filed 12–29–20; 8:45 am] 

BILLING CODE 4184–29–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1804] 

Product Labeling for Laparoscopic 

Power Morcellators; Guidance for 

Industry and Food and Drug 

Administration Staff; 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 entitled ‘‘Product Labeling for 

Laparoscopic Power Morcellators.’’ This 

guidance updates recommended 

‘‘Contraindications’’ and ‘‘Warnings’’ 

information to be included in product 

labeling to reflect the state of the science 

and available technology regarding use 

of laparoscopic power morcellators 

(LPMs). These labeling 

recommendations are intended to 

enhance, but not replace, the physicianpatient discussion of the benefits and 

risks of use of LPMs that uniquely 

pertain to individual patients. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 30, 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– 

2014–D–1804 for ‘‘Product Labeling for 

Laparoscopic Power Morcellators.’’ 

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)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Product Labeling for 

Laparoscopic Power Morcellators’’ to 

the Office of Policy, Guidance and 

Policy Development, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: 

Veronica Price, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2659, Silver Spring, 

MD 20993–0002, 301–796–6538. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Following issuance of the 2014 

guidance document entitled 

‘‘Immediately in Effect Guidance 

Document: Product Labeling for 

Laparoscopic Power Morcellators,’’ FDA 

has continued to consider new scientific 

information and the input of 

stakeholders. Additional scientific 

information is available that stratifies 

the risks of an undetected uterine cancer 

in women with presumed fibroids based 

on age. 

FDA also considered scientific 

information pertaining to the risk of 

spreading benign uterine tissue beyond 

the uterus during gynecologic surgeries