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
Federal Register / Vol. 83, No. 2 / Wednesday, January 3, 2018 / Notices 385 

Research Misconduct notice published 

on November 27, 2017. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Karen Gorirossi at 240–453–8800. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In FR Doc. 2017–25549 of November 

27, 2017 (82 FR 56042–56043), there 

was a referencing error involving 

incorrect citation of a paper in the 

notice. The error is identified and 

corrected in the Correction of Errors 

section below. 

II. Correction of Errors 

In FR Doc. 2017–25549 of November 

27, 2017 (82 FR 56042–56043), make the 

following corrections: 

1. On page 56042, third column, in FR 

Doc. 2017–25549, last paragraph, lines 

16–26, and page 56043, first paragraph, 

lines 1–5, delete ‘‘Respondent engaged 

in research misconduct at ESOM and 

falsified RT–PCR data on Excel 

spreadsheets in the research record and 

in a figure generated from the false data 

included in a manuscript submitted to 

and withdrawn from Scientific Reports 

(‘‘Immipramine Blue Sensitively and 

Selectively Targets FLT3–ITD Positive 

Acute Myeloid Leukemia Cells.’’ 

Scientific Reports 7(1):4447, 2017 June 

30; doi:10.1038/s41598–017–04796–1. 

PMID: 28667329. Submitted to 

Scientific Reports [withdrawn]; 

hereafter referred to as the ‘‘Scientific 

Reports manuscript’’)’’ and replace with 

the following text: ‘‘Respondent engaged 

in research misconduct at ESOM and 

falsified RT–PCR data on Excel 

spreadsheets in the research record and 

in a figure generated from the false data 

included in an unpublished manuscript 

submitted to and withdrawn from 

Scientific Reports [withdrawn]; 

hereafter referred to as the ‘‘Scientific 

Reports manuscript.’’ ’’ 

2. On page 56043, first column, in FR 

Doc. 2017–25549, fourth paragraph 

(second bullet), lines 6–7, insert 

‘‘unpublished’’ before ‘‘Scientific 

Reports’’ so that the text reads: 

‘‘included false data in the unpublished 

Scientific Reports manuscript.’’ 

Dated: December 20, 2017. 

Wanda K. Jones, 

Interim Director, Office of Research Integrity. 

[FR Doc. 2017–28409 Filed 1–2–18; 8:45 am] 

BILLING CODE 4150–31–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of 

meetings of the National Diabetes and 

Digestive and Kidney Diseases Advisory 

Council. 

The meetings will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Diabetes and 

Digestive and Kidney Diseases Advisory 

Council. 

Date: January 24, 2018. 

Open: 8:30 a.m. to 12:00 p.m. 

Agenda: To present the Director’s Report 

and other scientific presentations. 

Place: National Institutes of Health, 

Natcher Building (Natcher Conference 

Center), Conference Room E1/E2, 45 Center 

Drive, Bethesda, MD 20892. 

Closed: 1:00 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Natcher Building (Natcher Conference 

Center), Conference Room E1/E2, 45 Center 

Drive, Bethesda, MD 20892. 

Contact Person: Karl F. Malik, Ph.D., 

Acting Director, Division of Extramural 

Activities, National Institutes of Diabetes and 

Digestive, and Kidney Diseases, 6707 

Democracy Blvd., Room 7329, MSC 5452, 

Bethesda, MD 20892, (301) 594–4757, 

malikk@niddk.nih.gov. 

Name of Committee: National Diabetes and 

Digestive and Kidney Diseases Advisory 

Council, Kidney, Urologic and Hematologic 

Diseases. 

Date: January 24, 2018. 

Open: 1:00 p.m. to 3:30 p.m. 

Agenda: To review the Division’s scientific 

and planning activities. 

Place: National Institutes of Health, 

Natcher Building (Natcher Conference 

Center), Conference Room F1/F2, 45 Center 

Drive, Bethesda, MD 20892. 

Closed: 3:30 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Natcher Building (Natcher Conference 

Center), Conference Room F1/F2, 45 Center 

Drive, Bethesda, MD 20892. 

Contact Person: Karl F. Malik, Ph.D., 

Acting Director, Division of Extramural 

Activities, National Institutes of Diabetes and 

Digestive and Kidney Diseases, 6707 

Democracy Blvd., Room 7329, MSC 5452, 

Bethesda, MD 20892, (301) 594–4757, 

malikk@niddk.nih.gov. 

Name of Committee: National Diabetes and 

Digestive and Kidney Diseases Advisory 

Council; Diabetes, Endocrinology and 

Metabolic Diseases. 

Date: January 24, 2018. 

Open: 1:00 p.m. to 2:00 p.m. 

Agenda: To review and evaluate to review 

the Division’s scientific and planning 

activities. 

Place: National Institutes of Health, 

Natcher Building (Natcher Conference 

Center), Conference Room E1/E2, 45 Center 

Drive, Bethesda, MD 20892. 

Closed: 2:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Natcher Building (Natcher Conference 

Center), Conference Room E1/E2, 45 Center 

Drive, Bethesda, MD 20892. 

Contact Person: Karl F. Malik, Ph.D., 

Acting Director, Division of Extramural 

Activities, National Institutes of Diabetes and 

Digestive, and Kidney Diseases, 6707 

Democracy Blvd., Room, 7329, MSC 5452, 

Bethesda, MD 20892, (301) 594–4757, 

malikk@niddk.nih.gov. 

Name of Committee: National Diabetes and 

Digestive and Kidney Diseases Advisory 

Council; Digestive Diseases and Nutrition. 

Date: January 24, 2018. 

Open: 1:00 p.m. to 2:30 p.m. 

Agenda: To review the Division’s scientific 

and planning activities. 

Place: National Institutes of Health, 

Natcher Building (Natcher Conference 

Center), Conference Room D, 45 Center Drive, 

Bethesda, MD 20892. 

Closed: 2:30 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place:National Institutes of Health, Natcher 

Building (Natcher Conference Center), 

Conference Room D, 45 Center Drive, 

Bethesda, MD 20892. 

Contact Person: Karl F. Malik, Ph.D., 

Acting Director, Division of Extramural 

Activities, National Institutes of Diabetes and 

Digestive, and Kidney Diseases, 6707 

Democracy Blvd. Room 7329, MSC 5452, 

Bethesda, MD 20892, (301) 594–4757, 

malikk@niddk.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 


sradovich on DSK3GMQ082PROD with NOTICES