83 FR 8091 - Findings of Research Misconduct
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary Federal Register Volume 83, Issue 37 (February 23, 2018)
Office of the Secretary
Federal Register Volume 83, Issue 37 (February 23, 2018)
| Page Range | 8091-8093 | |
| FR Document | 2018-03766 |
[Federal Register Volume 83, Number 37 (Friday, February 23, 2018)] [Notices] [Pages 8091-8093] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03766] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of Research Misconduct AGENCY: Office of the Secretary, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: Findings of research misconduct have been made on the part of Colleen T. Skau, Ph.D., former postdoctoral fellow in the Cell Biology and Physiology Center, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH). Dr. Skau engaged in research misconduct in research supported by NHLBI, NIH. The administrative actions, including three (3) years of supervision, were implemented beginning on January 25, 2018, and are detailed below. FOR FURTHER INFORMATION CONTACT: Wanda K. Jones, Ph.D., Interim Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453-8200. SUPPLEMENTARY INFORMATION: Colleen T. Skau, Ph.D., National Institutes of Health: Based on Respondent's admission, an assessment conducted by NIH, and analysis conducted by ORI in its oversight review, ORI found that Dr. Colleen T. Skau, former postdoctoral fellow in the Cell Biology and Physiology Center, NHLBI, NIH, engaged in research misconduct in research supported by NHLBI, NIH. ORI found that Respondent engaged in research misconduct by intentionally, knowingly, or recklessly reporting falsified and/or fabricated data and/or falsifying and/or fabricating data in the following two (2) papers:Cell 167(6):1571-1585, 2016 (hereafter referred to as ``Paper 1'') Proceedings of the National Academy of Sciences 112(19):E2447- E2456, 2015 (hereafter referred to as ``Paper 2'') ORI found that Respondent engaged in research misconduct by intentional, knowing, or reckless falsification and/or fabrication of the research record by selectively reporting by inappropriate inclusion/omission or alteration of data points in ten (10) figures and falsely reporting the statistical significance based on falsified data in ten (10) figures across the two (2) papers and supplementary material. Specifically, ORI found that: In Paper 1, Respondent falsified and/or fabricated the research record in: --Figure 3B, by selectively omitting/including data points in the Rescue condition --Figure 5B, by reporting a significant difference between conditions by performing statistical calculations based on fabricated primary data --Figure 5C (bottom), by selectively omitting images and conditions from the analysis --Figure 6I (bottom left), by reporting data from the same data set as Figure 6B (top) --Figure S5B, by reporting statistical significance despite performing a T test calculation that returned an insignificant p-value --Figure 7F, by reporting that error bars represented standard deviation, when they actually represented standard error of the mean (SEM.) --Figure S4D, by performing different normalizing calculations in the Rescue condition than performed in other conditions and by omitting three data points from the Rescue conditions calculated average In Paper 2, Respondent falsified and/or fabricated the research record in: [[Page 8092]] --Figure 1E, by selectively omitting data points from the analysis --Figure 2A, by selectively omitting data points from the analysis --Figure 2C (left and right), by changing selected raw measurements by multiplying with a fixed value to make the data consistent with data collected in other experiments --Figure 5B, by selectively including and omitting data points from the analysis --Figure 5C, by selectively including and omitting data points from the analysis --Figure 7A (right), by reporting that error bars represented standard deviation, when they actually represented standard error of the mean (SEM.) ORI found that Respondent engaged in research misconduct by intentionally, knowingly, or recklessly falsely claiming in the methods and results to have performed validation of deletion/re-expression of FMNR2 levels in genetically modified B16 cell lines when that genetic modification was not validated for data reported in Figures 7 and 7S of Paper 1. ORI found that Respondent engaged in research misconduct by intentionally, knowingly, or recklessly falsely reporting a larger number of data points than actually were collected in fourteen (14) figures across the two (2) papers and supplementary materials. Specifically: In Paper 1, Respondent falsified and/or fabricated the reported data in: --Figure 2B (top), by reporting ten (10) cells per condition when nine (9) Knock Down (KD) and eight (8) Rescue were included in the analysis --Figure 2B (middle), by reporting ten (10) cells per condition when eight (8) Rescue were included in the analysis --Figure 3B (top), by reporting twenty-five (25) cells per condition when nineteen (19) Control, nineteen (19) KD, and fourteen (14) Rescue were included in the analysis --Figure 3B (bottom), by reporting twenty-five (25) cells per condition when twenty-four (24) Control and twenty-three (23) Rescue were included in the analysis --Figure 5A, by reporting to have examined fifty (50) cells per condition, when only twenty-three (23), twenty-three (23), and twelve (12) for the 2mg/mL conditions (Control, KD, and Rescue, respectively) and twenty-five (25), twenty (20), and nine (9) for the 3mg/mL conditions (Control, KD, and Rescue, respectively) were recorded --Figure 6D, by reporting ten (10) cells per condition when only eight (8) Control were recorded --Figure 7D, by reporting four (4) mice for each of two (2) independent clones (8 total) for each condition when only four (4) Vector+GFP, four (4) WT, and two (2) B16 conditions were examined --Figure S2E (top), by reporting to have measured two hundred fifty (250) Focal Adhesions per condition, when only fifty-six (56) measurements were recorded for the Leading Edge Adhesions (LEA) analysis --Figure S2E (3rd row left and 4th row left), by reporting twenty-five (25) cells per condition when only ten (10) cells were recorded --Figure S4C, by reporting ten (10) cells per condition when only five (5) cells were recorded --Figure S5B, by reporting ten (10) cells per condition when only seven (7) and six (6) cells were recorded for Control and KD respectively --Figure S6E, by reporting twenty-five (25) cells per condition when only twenty-four (24), eighteen (18), and sixteen (16) cells were recorded for Control (48hr), KD (24hr), and KD (48hr) respectively In Paper 2, Respondent falsified and/or fabricated the reported data in: --Figure 1E (top), by reporting six (6) cells per condition when only three (3) were recorded in Tropomyosin (Tpm) analysis --Figure 2C (middle and right), by reporting twenty (20) cells per condition when only sixteen (16), sixteen (16), and five (5) cells were recorded for Control, KD, and Rescue respectively --Figure 3A (right), by reporting the data from one of four analyses in the KD condition as the average of five --Figure 3C (right), by reporting examination of ten (10) stress fibers per condition when only three (3), four (4), and seven (7) cells were recorded for Control, KD, and Rescue respectively --Figure 5B, overstating the number of adhesions examined --Figure 5C, overstating the number of cells examined in all conditions --Figure 7D (right), by reporting examination of ten (10) cells per condition when only five (5), four (4), and five (5) cells were recorded for Control, KD, and Rescue respectively ORI found that Respondent engaged in research misconduct by intentionally, knowingly, or recklessly fabricating results and/or falsely labelling experimental results that arose from alternate experimental conditions/experiments in seven (7) figures across the two (2) papers and supplementary materials. Specifically: In Paper 1, Respondent falsified and/or fabricated the record in: --Figure 5B (top right), by reporting results of 8 and 12 um pore migration, which did not originate from experimental observations --Figure 5B (bottom left), by reporting results for the Rescue condition, which did not originate from experimental observations --Figure 5B (left), by using selected regions from the same original image to represent both the control (top) and rescue conditions (bottom) --Figure 5C (bottom), by reporting data derived from 2.5um channels as originating from 3.5um channels --Figure 6B (top), by reporting results for the ``Glass'' condition (all treatments) and rescue treatment (both conditions) that did not originate from experimental observations --Figure 6B (bottom), by reporting results for the 8um pore condition that did not originate from experimental observations --Figure 6E, by reporting results for the ATRi and ATMi treatments (Control and KD conditions) and DMSO control (Rescue condition) that did not originate from experimental observations and reporting results as originating from DMSO (Control and KD conditions) controls that had originated from a different treatment --Figure 6G, by reporting results for the ``No Drug'' conditions that did not originate from experimental observations --Figure 6I, by reporting results in all conditions that originated in part from the same experimental dataset reported in Figure 6B (top) --Figure S4D, by reporting results that did not originate from experimental observations for the KD condition --Figure S6C (right), by shifting selected data points in the KD condition from their original time points to different time points --Figure S7A, by using bands to represent FMN2 expression in six separate conditions, which originated from different molecular weight regions in three lanes on the original Western blot, and by representing absence of FMN2 expression in two conditions (CRISPR1 and CRISPR2) by reporting absence of bands in lanes in which no protein had been loaded --Figure S7F (rightmost), by selecting single data points from different treatments and reporting them as means and standard deviations for all of the treatments [[Page 8093]] In Paper 2, Respondent falsified and/or fabricated the record in: --Figure 2A (top), by reporting results for the Rescue condition that did not originate from experimental observations --Figure 3C (right), by reporting results for the Rescue condition that did not originate from experimental observations Dr. Skau entered into a Voluntary Settlement Agreement and voluntarily agreed, beginning on January 25, 2018: (1) To have her research supervised for a period of three (3) years; Respondent agreed to ensure that prior to the submission of an application for PHS support for a research project on which Respondent's participation is proposed and prior to Respondent's participation in any capacity on PHS-supported research, the institution employing her must submit a plan for supervision of Respondent's duties to ORI for approval; the plan for supervision must be designed to ensure the scientific integrity of Respondent's research contribution; Respondent agreed that she will not participate in any PHS-supported research until a plan for supervision is submitted and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed upon plan for supervision. (2) that for a period of three (3) years, any institution employing her must submit in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS supported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract; (3) if no supervisory plan is provided to ORI, to provide certification to ORI on annual basis that she has not engaged in, applied for, or had her name included on any application, proposal, or other request for PHS funds without prior notification to ORI; (4) to exclude herself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant for a period of three (3) years; and (5) to the correction or retraction of: Cell 167(6):1571-1585, 2016 Proceedings of the National Academy of Sciences 112(19):E2447- E2456, 2015 Wanda K. Jones, Interim Director, Office of Research Integrity. [FR Doc. 2018-03766 Filed 2-22-18; 8:45 am] BILLING CODE 4150-31-P
![Federal Register / Vol. 83, No. 37 / Friday, February 23, 2018 / Notices 8091
Human Research Protections (SACHRP) Tuesday, March 13, meeting will SUPPLEMENTARY INFORMATION:
will hold a meeting that will be open to adjourn at approximately 5:00 p.m. Colleen T. Skau, Ph.D., National
the public. Information about SACHRP The Wednesday, March 14, meeting Institutes of Health: Based on
and the full meeting agenda will be will begin at 8:30 a.m. The SOH will Respondent’s admission, an assessment
posted on the SACHRP website at: present and discuss recommendations conducted by NIH, and analysis
http://www.dhhs.gov/ohrp/sachrp- on the European Union’s General Data conducted by ORI in its oversight
committee/meetings/index.html. Protection Regulation and its impact on review, ORI found that Dr. Colleen T.
DATES: The meeting will be held on U.S. human subjects research. Skau, former postdoctoral fellow in the
Tuesday, March 13, 2018, from 8:30 Modifications to the previous day’s Cell Biology and Physiology Center,
a.m. until 5:00 p.m., and Wednesday, work will be discussed and finalized. NHLBI, NIH, engaged in research
March 14, 2018, from 8:30 a.m. until The meeting will adjourn at misconduct in research supported by
4:00 p.m. approximately 4:00 p.m. NHLBI, NIH.
ADDRESSES: Fishers Lane Conference
Time for public comment sessions ORI found that Respondent engaged
Center, Terrace Level, 5635 Fishers will be allotted both days. On-site in research misconduct by intentionally,
Lane, Rockville, Maryland 20852. registration is required for participation knowingly, or recklessly reporting
in the live public comment session. falsified and/or fabricated data and/or
FOR FURTHER INFORMATION CONTACT: Julia
Note that public comment must be falsifying and/or fabricating data in the
Gorey, J.D., Executive Director,
relevant to issues currently being following two (2) papers:
SACHRP; U.S. Department of Health
addressed by the SACHRP. Individuals • Cell 167(6):1571–1585, 2016
and Human Services, 1101 Wootton
submitting written statements as public (hereafter referred to as ‘‘Paper 1’’)
Parkway, Suite 200, Rockville,
comment should email or fax their • Proceedings of the National Academy
Maryland 20852; telephone: 240–453–
comments to SACHRP at SACHRP@ of Sciences 112(19):E2447–E2456,
8141; fax: 240–453–6909; email address:
hhs.gov at least five business days prior 2015 (hereafter referred to as ‘‘Paper
SACHRP@hhs.gov.
to the meeting. 2’’)
SUPPLEMENTARY INFORMATION: Under the Public attendance at the meeting is
authority of 42 U.S.C. 217a, Section 222 limited to space available. Individuals ORI found that Respondent engaged
of the Public Health Service Act, as who plan to attend and need special in research misconduct by intentional,
amended, SACHRP was established to assistance, such as sign language knowing, or reckless falsification and/or
provide expert advice and interpretation or other reasonable fabrication of the research record by
recommendations to the Secretary of accommodations, should notify the selectively reporting by inappropriate
Health and Human Services (HHS), designated SACHRP point of contact at inclusion/omission or alteration of data
through the Assistant Secretary for the address/phone number listed above points in ten (10) figures and falsely
Health, on issues and topics pertaining at least one week prior to the meeting. reporting the statistical significance
to or associated with the protection of based on falsified data in ten (10) figures
Dated: February 16, 2018.
human research subjects. across the two (2) papers and
The Subpart A Subcommittee (SAS) Julia G. Gorey, supplementary material. Specifically,
was established by SACHRP in October Executive Director, Secretary’s Advisory ORI found that:
2006 and is charged with developing Committee on Human Research Protections.
• In Paper 1, Respondent falsified
recommendations for consideration by [FR Doc. 2018–03768 Filed 2–22–18; 8:45 am]
and/or fabricated the research record in:
SACHRP regarding the application of BILLING CODE 4150–36–P
—Figure 3B, by selectively omitting/
subpart A of 45 CFR part 46 in the
including data points in the Rescue
current research environment.
The Subcommittee on Harmonization DEPARTMENT OF HEALTH AND condition
(SOH) was established by SACHRP at its HUMAN SERVICES —Figure 5B, by reporting a significant
July 2009 meeting and charged with difference between conditions by
identifying and prioritizing areas in Office of the Secretary performing statistical calculations
which regulations and/or guidelines for based on fabricated primary data
Findings of Research Misconduct —Figure 5C (bottom), by selectively
human subjects research adopted by
various agencies or offices within HHS AGENCY: Office of the Secretary, HHS. omitting images and conditions from
would benefit from harmonization, the analysis
ACTION: Notice.
consistency, clarity, simplification and/ —Figure 6I (bottom left), by reporting
or coordination. SUMMARY: Findings of research data from the same data set as Figure
The SACHRP meeting will open to the misconduct have been made on the part 6B (top)
public at 8:30 a.m., on Tuesday, March of Colleen T. Skau, Ph.D., former —Figure S5B, by reporting statistical
13, 2018, followed by opening remarks postdoctoral fellow in the Cell Biology significance despite performing a T
from Dr. Jerry Menikoff, Director of the and Physiology Center, National Heart, test calculation that returned an
Office for Human Research Protections Lung, and Blood Institute (NHLBI), insignificant p-value
and Dr. Stephen Rosenfeld, SACHRP National Institutes of Health (NIH). Dr. —Figure 7F, by reporting that error bars
Chair. Skau engaged in research misconduct in represented standard deviation, when
The SAS and SOH subcommittees research supported by NHLBI, NIH. The they actually represented standard
will present their recommendations administrative actions, including three error of the mean (SEM.)
regarding the description of ‘‘key (3) years of supervision, were —Figure S4D, by performing different
daltland on DSKBBV9HB2PROD with NOTICES
information,’’ as required by the revised implemented beginning on January 25, normalizing calculations in the
Common Rule’s § 46.116(a)(5)(i). This 2018, and are detailed below. Rescue condition than performed in
will be followed by a discussion of SOH FOR FURTHER INFORMATION CONTACT: other conditions and by omitting
recommendations on the research use of Wanda K. Jones, Ph.D., Interim Director, three data points from the Rescue
repositories and registries under various Office of Research Integrity, 1101 conditions calculated average
consent models, under both the current Wootton Parkway, Suite 750, Rockville, • In Paper 2, Respondent falsified
and the revised Common Rule. The MD 20852, (240) 453–8200. and/or fabricated the research record in:
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![Federal Register / Vol. 83, No. 37 / Friday, February 23, 2018 / Notices 8093
• In Paper 2, Respondent falsified • Proceedings of the National Academy Time: 8:00 a.m. to 6:00 p.m.
and/or fabricated the record in: of Sciences 112(19):E2447–E2456, Agenda: To review and evaluate grant
2015 applications.
—Figure 2A (top), by reporting results Place: Embassy Suites at the Chevy Chase
for the Rescue condition that did not Wanda K. Jones, Pavilion, 4300 Military Road NW,
originate from experimental Interim Director, Office of Research Integrity. Washington, DC 20015.
observations Contact Person: Mark Caprara, Ph.D.,
[FR Doc. 2018–03766 Filed 2–22–18; 8:45 am]
Scientific Review Officer, Center for
—Figure 3C (right), by reporting results BILLING CODE 4150–31–P Scientific Review, National Institutes of
for the Rescue condition that did not Health, 6701 Rockledge Drive, Room 5156,
originate from experimental MSC 7844, Bethesda, MD 20892, 301–435–
observations DEPARTMENT OF HEALTH AND 1042, capraramg@mail.nih.gov.
HUMAN SERVICES Name of Committee: Center for Scientific
Dr. Skau entered into a Voluntary Review Special Emphasis Panel; Topics in
Settlement Agreement and voluntarily National Institutes of Health Bacterial Pathogenesis.
agreed, beginning on January 25, 2018: Date: March 19, 2018.
Center for Scientific Review; Notice of Time: 8:00 a.m. to 6:00 p.m.
(1) To have her research supervised Agenda: To review and evaluate grant
Closed Meetings
for a period of three (3) years; applications.
Respondent agreed to ensure that prior Pursuant to section 10(d) of the Place: Residence Inn Bethesda, 7335
to the submission of an application for Federal Advisory Committee Act, as Wisconsin Avenue, Bethesda, MD 20814.
PHS support for a research project on amended, notice is hereby given of the Contact Person: Richard G Kostriken,
which Respondent’s participation is following meetings. Ph.D., Scientific Review Officer, Center for
proposed and prior to Respondent’s The meetings will be closed to the Scientific Review, National Institutes of
public in accordance with the Health, 6701 Rockledge Drive, Room 3192,
participation in any capacity on PHS- MSC 7808, Bethesda, MD 20892, 240–519–
supported research, the institution provisions set forth in sections 7808, kostrikr@csr.nih.gov.
employing her must submit a plan for 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Name of Committee: Center for Scientific
supervision of Respondent’s duties to as amended. The grant applications and Review Special Emphasis Panel; Small
ORI for approval; the plan for the discussions could disclose Business Hematology.
supervision must be designed to ensure confidential trade secrets or commercial Date: March 19–20, 2018.
the scientific integrity of Respondent’s property such as patentable material, Time: 9:00 a.m. to 5:00 p.m.
research contribution; Respondent and personal information concerning Agenda: To review and evaluate grant
agreed that she will not participate in individuals associated with the grant applications.
any PHS-supported research until a plan applications, the disclosure of which Place: National Institutes of Health, 6701
would constitute a clearly unwarranted Rockledge Drive, Bethesda, MD 20892
for supervision is submitted and (Virtual Meeting).
approved by ORI; Respondent agreed to invasion of personal privacy. Contact Person: Bukhtiar H. Shah, DVM,
maintain responsibility for compliance Name of Committee: Center for Scientific Ph.D., Scientific Review Officer, Center for
with the agreed upon plan for Review Special Emphasis Panel; Small Scientific Review, National Institutes of
supervision. Business: Cancer Drug Development and Health, 6701 Rockledge Drive, Room 4120,
Therapeutics. MSC 7802, Bethesda, MD 20892, 301–806–
(2) that for a period of three (3) years,
Date: March 19–20, 2018. 7314, shahb@csr.nih.gov.
any institution employing her must Time: 8:00 a.m. to 5:00 p.m. (Catalogue of Federal Domestic Assistance
submit in conjunction with each Agenda: To review and evaluate grant Program Nos. 93.306, Comparative Medicine;
application for PHS funds, or report, applications. 93.333, Clinical Research, 93.306, 93.333,
manuscript, or abstract involving PHS Place: Embassy Suites at the Chevy Chase 93.337, 93.393–93.396, 93.837–93.844,
supported research in which Pavilion, 4300 Military Road NW, 93.846–93.878, 93.892, 93.893, National
Respondent is involved, a certification Washington, DC 20015. Institutes of Health, HHS)
to ORI that the data provided by Contact Person: Lilia Topol, Ph.D.,
Respondent are based on actual Scientific Review Officer, Center for
Scientific Review, National Institutes of Dated: February 16, 2018.
experiments or are otherwise Health, 6701 Rockledge Drive, Room 6192, Sylvia L. Neal,
legitimately derived and that the data, MSC 7804, Bethesda, MD 20892 301–451– Program Analyst, Office of Federal Advisory
procedures, and methodology are 0131, ltopol@mail.nih.gov. Committee Policy.
accurately reported in the application, Name of Committee: Center for Scientific [FR Doc. 2018–03702 Filed 2–22–18; 8:45 am]
report, manuscript, or abstract; Review Special Emphasis Panel; Disease BILLING CODE 4140–01–P
(3) if no supervisory plan is provided Prevention and Management, Risk Reduction
to ORI, to provide certification to ORI and Health Behavior Change.
Date: March 19–20, 2018.
on annual basis that she has not engaged DEPARTMENT OF HEALTH AND
Time: 8:00 a.m. to 6:00 p.m.
in, applied for, or had her name Agenda: To review and evaluate grant HUMAN SERVICES
included on any application, proposal, applications.
or other request for PHS funds without Place: Westin Grand, 2350 M Street NW, National Institutes of Health
prior notification to ORI; Washington, DC 20037.
Contact Person: Michael John McQuestion, Center for Scientific Review; Notice of
(4) to exclude herself voluntarily from Meeting
Ph.D., Scientific Review Officer, Center for
serving in any advisory capacity to PHS Scientific Review, National Institutes of
including, but not limited to, service on Pursuant to section 10(a) of the
daltland on DSKBBV9HB2PROD with NOTICES
Health, 6701 Rockledge Drive, Room 3114,
any PHS advisory committee, board, Bethesda, MD 20892, 301–480–1276, Federal Advisory Committee Act, as
and/or peer review committee, or as a mike.mcquestion@nih.gov. amended, notice is hereby given of a
consultant for a period of three (3) years; Name of Committee: Center for Scientific meeting of the Center for Scientific
and Review Special Emphasis Panel; PAR17–316: Review Advisory Council.
Biomedical Technology Research Resource The meeting will be open to the
(5) to the correction or retraction of:
(P41). public, with attendance limited to space
• Cell 167(6):1571–1585, 2016 Date: March 19, 2018. available. Individuals who plan to
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Document Created: 2018-02-23 01:32:20
Document Modified: 2018-02-23 01:32:20
| 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 | Notice. | |
| Contact | Wanda K. Jones, Ph.D., Interim Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453-8200. | |
| FR Citation | 83 FR 8091 |
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