Federal Register / Vol. 83, No. 133 / Wednesday, July 11, 2018 / Notices 32129 

ANNUAL BURDEN ESTIMATES—Continued 

Total 

number of 

respondents 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hour 

per response 

Annual 

burden hours 

Administrative Data List ....................................................... 30 10 2 5.00 100 

Estimated Total Annual Burden 

Hours: 849. 

Additional Information: Copies of the 

proposed collection may 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 should be identified by the 

title of the information collection. Email 

address: OPREinfocollection@

acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning 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. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Email: OIRA_

SUBMISSION@OMB.EOP.GOV. Attn: 

Desk Officer for the Administration for 

Children and Families. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2018–14792 Filed 7–10–18; 8:45 am] 

BILLING CODE 4184–25–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review: Updates 

to Approved Information Collection 

AGENCY: Office of Planning, Research, 

and Evaluation; ACF; HHS. 

ACTION: Public comment request. 

Title: Evaluation of Employment 

Coaching for TANF and Other LowIncome Populations (0970–0506). 

SUMMARY: The Administration for 

Children and Families (ACF) is 

proposing an increase in the number of 

sites for data collection activities to be 

conducted as part of the Evaluation of 

Employment Coaching for TANF and 

Other Low-Income Populations. The 

Office of Management and Budget 

(OMB) Office of Information and 

Regulatory Affairs approved this 

information collection in March 2018 

(0970–0506). As approved, we planned 

to include three employment programs. 

We have since identified three 

additional employment programs to 

include in the study. This Notice 

provides the opportunity for public 

comment on the addition of three sites. 

This study will provide an 

opportunity to learn more about the 

potential of coaching to help clients 

achieve self-sufficiency and other 

desired employment-related outcomes. 

The programs included in the study 

are Temporary Assistance for Needy 

Families (TANF) agencies and other 

public or private employment programs 

that serve low-income individuals. 

Selected sites include a robust coaching 

component and have the capacity to 

conduct a rigorous impact evaluation, 

among other criteria. This study will 

provide information on whether 

coaching helps people obtain and retain 

jobs, advance in their careers, move 

toward self-sufficiency, and improve 

their overall well-being. To meet these 

objectives, this study includes an 

impact and implementation study. 

The impact study involves 

participants being randomly assigned to 

either a ‘‘program group,’’ who will be 

paired with a coach, or to a ‘‘control 

group,’’ who will not be paired with a 

coach. The effectiveness of the coaching 

will be determined by differences 

between members of the program and 

control groups in outcomes such as 

obtaining and retaining employment, 

earnings, measures of self-sufficiency, 

and measures of self-regulation. 

The implementation study will 

document coaching practices, describe 

lessons learned from implementing 

coaching, and enhance interpretation of 

the impact study findings. 

The proposed information collection 

activities have not changed since OMB/ 

OIRA approval. The only change to this 

information collection is to add three 

additional sites. 

Respondents: Program staff and 

individuals enrolled in the Evaluation 

of Employment Coaching for TANF and 

Other Low-Income Populations. 

Program staff may include coaches, case 

managers, workshop instructors, job 

developers, supervisors, and managers. 

All participants will be able to opt out 

of participating in the data collection 

activities. 

ANNUAL BURDEN ESTIMATES

Instrument 

Original 

request: 

Total number 

of respondents 

Updated 

request: 

Total number 

of respondents 

Updated 

request: 

Annual 

number 

of respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Updated 

request: 

Annual 

burden hours 

Baseline data collection—study participants ..................................................... 6,000 6,000 2,000 1 .33 660 

Baseline data collection—staff ................. 60 60 20 100 .33 660 

First follow-up survey ............................... 2,400 4,800 1,600 1 1 1,600 

Semi-structured staff interviews ............... 66 132 44 1 1.5 66 

Staff survey .............................................. 48 96 32 1 .75 24 

In-depth participant interviews ................. 24 48 16 1 2.5 40 

Staff reports of program service receipt .. 30 60 20 5,200 .03 3,120 

Video recordings of coaching sessions ... 27 54 18 10 .1 18 


daltland on DSKBBV9HB2PROD with NOTICES
32130 Federal Register / Vol. 83, No. 133 / Wednesday, July 11, 2018 / Notices 

Estimated Total Annual Burden 

Hours: 6,188. 

DATES: Comments due within 30 days of 

publication. OMB is required to make a 

decision concerning 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 

directly to the following: 

Office of Management and Budget, 

Paperwork Reduction Project, Email: OIRA_

SUBMISSION@OMB.EOP.GOV, Attn: Desk 

Officer for the Administration for Children 

and Families. 

Copies of the proposed collection may 

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 

should be identified by the title of the 

information collection. Email address: 

OPREinfocollection@acf.hhs.gov. 

(Authority: Section 413 of the Social Security 

Act, as amended by the FY 2017 

Consolidated Appropriations Act, 2017 (Pub. 

L. 115–31) 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2018–14793 Filed 7–10–18; 8:45 am] 

BILLING CODE 4184–09–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2434] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry on Formal Meetings With 

Sponsors and Applicants for 

Prescription Drug User Fee Act 

Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection contained in the guidance for 

industry on formal meetings with 

sponsors and applicants for Prescription 

Drug User Fee Act (PDUFA) products. 

DATES: Submit either electronic or 

written comments on the collection of 

information by September 10, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before September 10, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of September 10, 2018. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

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– 

2018–N–2434 for ‘‘Guidance for 

Industry on Formal Meetings with 

Sponsors and Applicants for PDUFA 

Products.’’ Received comments, those 

filed in a timely manner (see 

ADDRESSES), 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. 

• 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.gpo.gov/ 

fdsys/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. 


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