83 FR 384 - Findings of Research Misconduct; Correction
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary Federal Register Volume 83, Issue 2 (January 3, 2018)
Office of the Secretary
Federal Register Volume 83, Issue 2 (January 3, 2018)
| Page Range | 384-385 | |
| FR Document | 2017-28409 |
[Federal Register Volume 83, Number 2 (Wednesday, January 3, 2018)] [Notices] [Pages 384-385] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-28409] ----------------------------------------------------------------------- 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 [[Page 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in the research record and in a figure generated from the false data included in a manuscript submitted to and withdrawn from Scientific Reports (``Immipramine Blue Sensitively and Selectively Targets FLT3-ITD Positive Acute Myeloid Leukemia Cells.''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 Submitted to Scientific Reports [withdrawn]; hereafter referred to as the ``Scientific Reports manuscript'')'' and replace with the following text: ``Respondent engaged in research misconduct at ESOM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
![384 Federal Register / Vol. 83, No. 2 / Wednesday, January 3, 2018 / Notices
identified, as confidential, if submitted Drug Evaluation and Research, Food an increase in serum testosterone
as detailed in ‘‘Instructions.’’ and Drug Administration, 10001 New translates into improvement in how
Instructions: All submissions received Hampshire Ave., Hillandale Building, patients feel, function, or survive.
must include the Docket No. FDA– 4th Floor, Silver Spring, MD 20993– This draft guidance addresses the
2017–D–6759 for ‘‘Establishing 0002. Send one self-addressed adhesive following topics in establishing
Effectiveness for Drugs Intended to label to assist that office in processing effectiveness of drugs for this
Treat Male Hypogonadotropic your requests. See the SUPPLEMENTARY population:
Hypogonadism Attributed to Non- INFORMATION section for electronic • Identification of patients for inclusion
Structural Disorders.’’ Received access to the draft guidance document. in clinical trials and
comments will be placed in the docket FOR FURTHER INFORMATION CONTACT: • Efficacy endpoints.
and, except for those submitted as Jeannie Roule, Center for Drug This draft guidance is consistent with
‘‘Confidential Submissions,’’ publicly Evaluation and Research, Food and recommendations FDA received at the
viewable at https://www.regulations.gov Drug Administration, 10903 New December 2014 advisory committee
or at the Dockets Management Staff Hampshire Ave., Bldg. 22, Rm. 5332, meeting on the appropriate indicated
office between 9 a.m. and 4 p.m., Silver Spring, MD 20993–0002, 301– population for testosterone replacement
Monday through Friday. 796–3993. therapy, and the December 2016
• Confidential Submissions—To advisory committee meeting on
submit a comment with confidential SUPPLEMENTARY INFORMATION:
hypogonadotropic hypogonadism.
information that you do not wish to be I. Background This draft guidance is being issued
made publicly available, submit your consistent with FDA’s good guidance
comments only as a written/paper FDA is announcing the availability of
a draft guidance for industry entitled practices regulation (21 CFR 10.115).
submission. You should submit two The draft guidance, when finalized, will
copies total. One copy will include the ‘‘Establishing Effectiveness for Drugs
Intended to Treat Male represent the current thinking of FDA
information you claim to be confidential on establishing effectiveness for drugs
with a heading or cover note that states Hypogonadotropic Hypogonadism
Attributed to Non-Structural Disorders.’’ intended to treat male
‘‘THIS DOCUMENT CONTAINS hypogonadotropic hypogonadism
CONFIDENTIAL INFORMATION.’’ The This draft guidance is intended to assist
sponsors in designing drug development attributed to non-structural disorders. It
Agency will review this copy, including does not establish any rights for any
the claimed confidential information, in programs to demonstrate effectiveness
of drugs intended to treat male person and is not binding on FDA or the
its consideration of comments. The public. You can use an alternative
second copy, which will have the hypogonadotropic hypogonadism
associated with obesity and other approach if it satisfies the requirements
claimed confidential information of the applicable statutes and
redacted/blacked out, will be available conditions that do not cause intrinsic
damage to the hypothalamus or regulations. This guidance is not subject
for public viewing and posted on
pituitary gland. to Executive Order 12866.
https://www.regulations.gov. Submit
both copies to the Dockets Management Male hypogonadism is characterized II. Electronic Access
Staff. If you do not wish your name and by serum testosterone concentrations
below the lower limit of the normal Persons with access to the internet
contact information to be made publicly may obtain the draft guidance at either
available, you can provide this range for young, healthy men with
associated symptoms (e.g., reduced https://www.fda.gov/Drugs/Guidance
information on the cover sheet and not ComplianceRegulatoryInformation/
in the body of your comments and you libido) or signs (e.g., loss of muscle mass
with reduced muscle strength). Some Guidances/default.htm, or https://
must identify this information as www.regulations.gov.
‘‘confidential.’’ Any information marked men who have had normal puberty and
as ‘‘confidential’’ will not be disclosed sexual development are subsequently Dated: December 27, 2017.
except in accordance with 21 CFR 10.20 diagnosed with hypogonadotropic Leslie Kux,
and other applicable disclosure law. For hypogonadism associated with obesity Associate Commissioner for Policy.
more information about FDA’s posting or other acquired conditions in the [FR Doc. 2017–28337 Filed 1–2–18; 8:45 am]
of comments to public dockets, see 80 absence of intrinsic damage to the BILLING CODE 4164–01–P
FR 56469, September 18, 2015, or access hypothalamus or pituitary. Although
the information at: https://www.gpo.gov/ these men have serum testosterone
fdsys/pkg/FR-2015-09-18/pdf/2015- concentrations below the lower limit of DEPARTMENT OF HEALTH AND
23389.pdf. the normal range for young, healthy HUMAN SERVICES
Docket: For access to the docket to men, the associated symptoms often
read background documents or the experienced in this population (e.g., low Office of the Secretary
electronic and written/paper comments energy, depressed mood) are
received, go to https:// nonspecific and cannot definitively be Findings of Research Misconduct;
www.regulations.gov and insert the attributed to the low testosterone Correction
docket number, found in brackets in the concentrations. In addition, it is unclear AGENCY: Office of the Secretary, HHS.
heading of this document, into the whether these testosterone ACTION: Correction of notice.
‘‘Search’’ box and follow the prompts concentrations—in the absence of
and/or go to the Dockets Management intrinsic damage to the hypothalamus SUMMARY: This document corrects an
and pituitary gland—are inappropriately
sradovich on DSK3GMQ082PROD with NOTICES
Staff, 5630 Fishers Lane, Rm. 1061, error that appeared in the notice
Rockville, MD 20852. low and whether increasing testosterone published in the November 27, 2017,
You may submit comments on any concentrations in these men confers Federal Register entitled ‘‘Findings of
guidance at any time (see 21 CFR clinical benefit. Research Misconduct.’’
10.115(g)(5)). For these reasons, serum testosterone DATES:
Submit written requests for single is not a validated surrogate endpoint for Effective Date: January 3, 2018.
copies of the draft guidance to the establishing efficacy in these patients, Applicability Date: The correction
Division of Drug Information, Center for and sponsors would need to show that notice is applicable for the Findings of
VerDate Sep<11>2014 16:13 Jan 02, 2018 Jkt 244001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\03JAN1.SGM 03JAN1](https://thefederalregister.org/doc/83_FR_386/page/1.svg)
![Federal Register / Vol. 83, No. 2 / Wednesday, January 3, 2018 / Notices 385
Research Misconduct notice published DEPARTMENT OF HEALTH AND Center), Conference Room F1/F2, 45 Center
on November 27, 2017. HUMAN SERVICES Drive, Bethesda, MD 20892.
Closed: 3:30 p.m. to 4:00 p.m.
FOR FURTHER INFORMATION CONTACT: Ms. National Institutes of Health Agenda: To review and evaluate grant
Karen Gorirossi at 240–453–8800. applications.
National Institute of Diabetes and Place: National Institutes of Health,
SUPPLEMENTARY INFORMATION: Natcher Building (Natcher Conference
Digestive and Kidney Diseases; Notice
Center), Conference Room F1/F2, 45 Center
I. Background of Meetings
Drive, Bethesda, MD 20892.
In FR Doc. 2017–25549 of November Pursuant to section 10(d) of the Contact Person: Karl F. Malik, Ph.D.,
Federal Advisory Committee Act, as Acting Director, Division of Extramural
27, 2017 (82 FR 56042–56043), there Activities, National Institutes of Diabetes and
was a referencing error involving amended, notice is hereby given of
Digestive and Kidney Diseases, 6707
incorrect citation of a paper in the meetings of the National Diabetes and
Democracy Blvd., Room 7329, MSC 5452,
notice. The error is identified and Digestive and Kidney Diseases Advisory Bethesda, MD 20892, (301) 594–4757,
corrected in the Correction of Errors Council. malikk@niddk.nih.gov.
The meetings will be open to the
section below. Name of Committee: National Diabetes and
public as indicated below, with Digestive and Kidney Diseases Advisory
II. Correction of Errors attendance limited to space available. Council; Diabetes, Endocrinology and
Individuals who plan to attend and Metabolic Diseases.
In FR Doc. 2017–25549 of November need special assistance, such as sign Date: January 24, 2018.
27, 2017 (82 FR 56042–56043), make the language interpretation or other Open: 1:00 p.m. to 2:00 p.m.
following corrections: reasonable accommodations, should Agenda: To review and evaluate to review
notify the Contact Person listed below the Division’s scientific and planning
1. On page 56042, third column, in FR activities.
Doc. 2017–25549, last paragraph, lines in advance of the meeting.
Place: National Institutes of Health,
16–26, and page 56043, first paragraph, The meetings will be closed to the
Natcher Building (Natcher Conference
lines 1–5, delete ‘‘Respondent engaged public in accordance with the Center), Conference Room E1/E2, 45 Center
in research misconduct at ESOM and provisions set forth in sections Drive, Bethesda, MD 20892.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Closed: 2:00 p.m. to 4:00 p.m.
falsified RT–PCR data on Excel
as amended. The grant applications and Agenda: To review and evaluate grant
spreadsheets in the research record and
the discussions could disclose applications.
in a figure generated from the false data Place: National Institutes of Health,
confidential trade secrets or commercial
included in a manuscript submitted to property such as patentable material, Natcher Building (Natcher Conference
and withdrawn from Scientific Reports and personal information concerning Center), Conference Room E1/E2, 45 Center
(‘‘Immipramine Blue Sensitively and individuals associated with the grant Drive, Bethesda, MD 20892.
Selectively Targets FLT3–ITD Positive Contact Person: Karl F. Malik, Ph.D.,
applications, the disclosure of which Acting Director, Division of Extramural
Acute Myeloid Leukemia Cells.’’ would constitute a clearly unwarranted Activities, National Institutes of Diabetes and
Scientific Reports 7(1):4447, 2017 June invasion of personal privacy. Digestive, and Kidney Diseases, 6707
30; doi:10.1038/s41598–017–04796–1. Democracy Blvd., Room, 7329, MSC 5452,
Name of Committee: National Diabetes and
PMID: 28667329. Submitted to Digestive and Kidney Diseases Advisory Bethesda, MD 20892, (301) 594–4757,
Scientific Reports [withdrawn]; Council. malikk@niddk.nih.gov.
hereafter referred to as the ‘‘Scientific Date: January 24, 2018. Name of Committee: National Diabetes and
Reports manuscript’’)’’ and replace with Open: 8:30 a.m. to 12:00 p.m. Digestive and Kidney Diseases Advisory
the following text: ‘‘Respondent engaged Agenda: To present the Director’s Report Council; Digestive Diseases and Nutrition.
in research misconduct at ESOM and and other scientific presentations. Date: January 24, 2018.
Place: National Institutes of Health, Open: 1:00 p.m. to 2:30 p.m.
falsified RT–PCR data on Excel Natcher Building (Natcher Conference Agenda: To review the Division’s scientific
spreadsheets in the research record and Center), Conference Room E1/E2, 45 Center and planning activities.
in a figure generated from the false data Drive, Bethesda, MD 20892. Place: National Institutes of Health,
included in an unpublished manuscript Closed: 1:00 p.m. to 4:30 p.m. Natcher Building (Natcher Conference
submitted to and withdrawn from Agenda: To review and evaluate grant Center), Conference Room D, 45 Center Drive,
Scientific Reports [withdrawn]; applications. Bethesda, MD 20892.
Place: National Institutes of Health, Closed: 2:30 p.m. to 4:00 p.m.
hereafter referred to as the ‘‘Scientific Natcher Building (Natcher Conference Agenda: To review and evaluate grant
Reports manuscript.’’ ’’ Center), Conference Room E1/E2, 45 Center applications.
2. On page 56043, first column, in FR Drive, Bethesda, MD 20892. Place:National Institutes of Health, Natcher
Doc. 2017–25549, fourth paragraph Contact Person: Karl F. Malik, Ph.D., Building (Natcher Conference Center),
Acting Director, Division of Extramural Conference Room D, 45 Center Drive,
(second bullet), lines 6–7, insert
Activities, National Institutes of Diabetes and Bethesda, MD 20892.
‘‘unpublished’’ before ‘‘Scientific Digestive, and Kidney Diseases, 6707 Contact Person: Karl F. Malik, Ph.D.,
Reports’’ so that the text reads: Democracy Blvd., Room 7329, MSC 5452, Acting Director, Division of Extramural
‘‘included false data in the unpublished Bethesda, MD 20892, (301) 594–4757, Activities, National Institutes of Diabetes and
Scientific Reports manuscript.’’ malikk@niddk.nih.gov. Digestive, and Kidney Diseases, 6707
Name of Committee: National Diabetes and Democracy Blvd. Room 7329, MSC 5452,
Dated: December 20, 2017. Bethesda, MD 20892, (301) 594–4757,
Digestive and Kidney Diseases Advisory
sradovich on DSK3GMQ082PROD with NOTICES
Wanda K. Jones, Council, Kidney, Urologic and Hematologic malikk@niddk.nih.gov.
Interim Director, Office of Research Integrity. Diseases. Any interested person may file written
[FR Doc. 2017–28409 Filed 1–2–18; 8:45 am] Date: January 24, 2018. comments with the committee by forwarding
Open: 1:00 p.m. to 3:30 p.m. the statement to the Contact Person listed on
BILLING CODE 4150–31–P
Agenda: To review the Division’s scientific this notice. The statement should include the
and planning activities. name, address, telephone number and when
Place: National Institutes of Health, applicable, the business or professional
Natcher Building (Natcher Conference affiliation of the interested person.
VerDate Sep<11>2014 16:13 Jan 02, 2018 Jkt 244001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\03JAN1.SGM 03JAN1](https://thefederalregister.org/doc/83_FR_386/page/2.svg)
Document Created: 2018-10-26 09:27:44
Document Modified: 2018-10-26 09:27:44
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Correction of notice. | |
| Dates | Effective Date: January 3, 2018. | |
| Contact | Ms. Karen Gorirossi at 240-453-8800. | |
| FR Citation | 83 FR 384 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR