382 Federal Register / Vol. 83, No. 2 / Wednesday, January 3, 2018 / Notices 

ANNUAL BURDEN ESTIMATES

Total 

number of 

respondents 

Annual 

number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden hour 

per 

response 

Annual 

burden 

hours 

Guide for Recruitment with PHA and PCWA Administrators .................................................................................... 20 7 1 1.00 7 

Guide to Develop an Evaluation Plan for PCWA FUP 

Management ..................................................................... 10 4 1 1.00 4 

Guide to Develop an Evaluation Plan for PHA FUP Management ............................................................................ 10 4 1 1.00 4 

Guide for Implementation Study for PCWA Management .. 10 4 1 1.00 4 

Guide for Implementation Study for PHA Management ...... 10 4 1 1.00 4 

Guide for Implementation Study for Referral Provider Administrators ....................................................................... 4 2 1 1.00 2 

Guide for Implementation Study with PCWA FUP Management (First) ....................................................................... 10 4 1 1.00 4 

Guide for Implementation Study for PHA FUP Management .................................................................................. 10 4 1 1.00 4 

Guide for Implementation Study Focus Groups with Frontline Workers ..................................................................... 320 107 1 1.50 161 

Guide for Implementation Study Focus Groups with PHA 

Frontline Workers ............................................................. 30 10 1 1.50 15 

Guide for Implementation Study for PCWA FUP Management (Follow Up) .............................................................. 10 4 1 1.00 4 

Guide for Implementation Study for Service Provider Management ............................................................................ 8 3 1 1.00 3 

Referral Form ....................................................................... 200 67 6 0.17 68 

Randomization Tool ............................................................. 10 4 106 0.02 8 

Housing Assistance Questionnaire ...................................... 200 67 3 0.09 18 

Ongoing Services Questionnaire ......................................... 200 67 3 0.09 18 

Dashboard ............................................................................ 20 7 27 0.17 32 

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

Estimated Total Annual Burden 

Hours: 460. 

In compliance with the requirements 

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

Paperwork Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 330 C St SW, 

Washington, DC 20201, Attn: OPRE 

Reports Clearance Officer. Email 

address: OPREinfocollection@

acf.hhs.gov. All requests should be 

identified by the title of the information 

collection. 

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 technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Mary Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2017–28374 Filed 1–2–18; 8:45 am] 

BILLING CODE 4184–25–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Title: Study of We Grow Together: 

The Q–CCIIT Professional Development 

System. 

OMB No.: New Collection 

Description: The Administration for 

Children and Families (ACF) at the U.S. 

Department of Health and Human 

Services (HHS) seeks approval to 

conduct a field test of We Grow 

Together, a system of professional 

development supports including webbased resources and exercises to be used 

by caregivers/teachers, with the help of 

professional development providers, to 

improve the quality of infant and 

toddler care. The study team has 

developed We Grow Together: The Q– 

CCIIT Professional Development System 

based on the research literature to 

support caregiver-child interactions in 

care settings serving infants and 

toddlers. This field test is designed to 

(1) examine changes associated with use 

of the We Grow Together system and (2) 

examine implementation and 

participant experiences with the We 

Grow Together system. As a secondary 

goal, ACF will also further evaluate the 

properties of the Q–CCIIT observational 

measure. Ultimately, findings from the 

field test will provide information about 

the experiences of professional 

development providers (PD providers) 

and caregivers with the We Grow 

Together system so that ACF can 

improve the system to make the 

resources as accessible as possible for 

infant-toddler caregivers. 

Prior to using the We Grow Together 

system, PD providers will complete a 

web-based training survey and all 

participants will complete a web-based 

background survey. Periodically during 

the field test, website users will be 

asked at log-on to respond to a series of 

web-based questions. After system 

implementation, participants will 

complete a web-based feedback survey. 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 2 / Wednesday, January 3, 2018 / Notices 383 

The study team will also collect 

classroom rosters from caregivers before 

and after the field test. 

Respondents: Early care and 

education (ECE) setting representatives 

(e.g., directors or owners), caregivers (in 

center-based and family child care 

settings), and professional development 

providers (e.g., coaches). 

ANNUAL BURDEN ESTIMATES

Instrument 

Total/annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual burden 

hours 

ECE setting eligibility screener ........................................................................ 745 1 .25 186 

Caregiver background survey .......................................................................... 300 1 .75 225 

PD provider background survey ...................................................................... 175 1 .50 88 

Caregiver We Grow Together website user data pop-up questions ............... 300 6 .17 306 

PD provider We Grow Together website user pop-up questions ................... 175 5 .10 88 

Caregiver feedback survey .............................................................................. 300 1 1.0 300 

PD provider feedback survey .......................................................................... 175 1 .75 131 

Classroom roster ............................................................................................. 300 2 .08 48 

PD provider training survey ............................................................................. 175 1 .17 30 

Estimated Total Annual Burden 

Hours: 1,402. 

In compliance with the requirements 

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

Paperwork Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded 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. Email 

address: OPREinfocollection@

acf.hhs.gov. All requests should be 

identified by the title of the information 

collection. 

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 technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Mary Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2017–28375 Filed 1–2–18; 8:45 am] 

BILLING CODE 4184–22–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–6759] 

Establishing Effectiveness for Drugs 

Intended To Treat Male 

Hypogonadotropic Hypogonadism 

Attributed to Non-Structural Disorders; 

Draft Guidance for Industry; 

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 draft 

guidance for industry entitled 

‘‘Establishing Effectiveness for Drugs 

Intended to Treat Male 

Hypogonadotropic Hypogonadism 

Attributed to Non-Structural Disorders.’’ 

This draft guidance provides key design 

considerations, including 

recommendations for patient enrollment 

criteria and efficacy endpoints, for 

clinical trials to establish effectiveness 

for drugs intended to treat male 

hypogonadotropic hypogonadism 

associated with obesity and other 

conditions that do not cause intrinsic 

damage to the hypothalamus or 

pituitary gland. This draft guidance is 

consistent with recommendations FDA 

received at the December 2014 advisory 

committee meeting on the appropriate 

indicated population for testosterone 

replacement therapy, and the December 

2016 advisory committee meeting on 

hypogonadotropic hypogonadism. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by March 5, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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 


sradovich on DSK3GMQ082PROD with NOTICES