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

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–D–6759 for ‘‘Establishing 

Effectiveness for Drugs Intended to 

Treat Male Hypogonadotropic 

Hypogonadism Attributed to NonStructural Disorders.’’ 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 

office 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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft 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 draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Jeannie Roule, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 5332, 

Silver Spring, MD 20993–0002, 301– 

796–3993. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA 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 is intended to assist 

sponsors in designing drug development 

programs to demonstrate effectiveness 

of 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. 

Male hypogonadism is characterized 

by serum testosterone concentrations 

below the lower limit of the normal 

range for young, healthy men with 

associated symptoms (e.g., reduced 

libido) or signs (e.g., loss of muscle mass 

with reduced muscle strength). Some 

men who have had normal puberty and 

sexual development are subsequently 

diagnosed with hypogonadotropic 

hypogonadism associated with obesity 

or other acquired conditions in the 

absence of intrinsic damage to the 

hypothalamus or pituitary. Although 

these men have serum testosterone 

concentrations below the lower limit of 

the normal range for young, healthy 

men, the associated symptoms often 

experienced in this population (e.g., low 

energy, depressed mood) are 

nonspecific and cannot definitively be 

attributed to the low testosterone 

concentrations. In addition, it is unclear 

whether these testosterone 

concentrations—in the absence of 

intrinsic damage to the hypothalamus 

and pituitary gland—are inappropriately 

low and whether increasing testosterone 

concentrations in these men confers 

clinical benefit. 

For these reasons, serum testosterone 

is not a validated surrogate endpoint for 

establishing efficacy in these patients, 

and sponsors would need to show that 

an increase in serum testosterone 

translates into improvement in how 

patients feel, function, or survive. 

This draft guidance addresses the 

following topics in establishing 

effectiveness of drugs for this 

population: 

• Identification of patients for inclusion 

in clinical trials and 

• Efficacy endpoints. 

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. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on establishing effectiveness for drugs 

intended to treat male 

hypogonadotropic hypogonadism 

attributed to non-structural disorders. 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. This guidance is not subject 

to Executive Order 12866. 

II. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, or https://

www.regulations.gov. 

Dated: December 27, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–28337 Filed 1–2–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Findings of Research Misconduct; 

Correction 

AGENCY: Office of the Secretary, HHS. 

ACTION: Correction of notice. 

SUMMARY: This document corrects an 

error that appeared in the notice 

published in the November 27, 2017, 

Federal Register entitled ‘‘Findings of 

Research Misconduct.’’ 

DATES: 

Effective Date: January 3, 2018. 

Applicability Date: The correction 

notice is applicable for the Findings of 


sradovich on DSK3GMQ082PROD with NOTICES