HHS Approval of Entities That Certify Medical Review Officers, 31335-31336 [2017-14154]

Download as PDF sradovich on DSK3GMQ082PROD with NOTICES Federal Register / Vol. 82, No. 128 / Thursday, July 6, 2017 / Notices 1014, 2004 (hereafter referred to as ‘‘Science 2004’’). • National Institute on Drug Abuse (NIDA), NIH, grant application R21 DA025703–01. • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH, grant application R21 DK082631– 01. • NIDDK, NIH, grant application R01 DK082675–01. • NIGMS, NIH, grant application R01 GM073776–06A1. • NIGMS, NIH, grant application R01 GM085229–01. • NIGMS, NIH, grant application R01 GM085303–01. • NIGMS, NIH, grant application R01 GM085303–01A1. ORI found by a preponderance of the evidence that the Respondent engaged in research misconduct by intentionally, knowingly, or recklessly falsifying and/ or fabricating images in seven (7) submitted NIH grant application and three (3) published papers by manipulating, reusing, and falsely labeling images. Specifically, the Respondent falsified and/or fabricated images representing controls or experimental results for in vitro interactions between RNA and proteins, co-immunoprecipitation (‘‘co-IP’’) assays, histone methytransferase (‘‘HMT’’) or kinase assays and related stained SDS–PAGE gels, and reverse transcription-polymerase chain reactions (‘‘RT–PCR’’) in the following grant applications and publications. 1. The image in Figure S4, Science 2006, representing the in vitro interactions between RNA and specific proteins, was used in similar assays to represent results with other sets of protein-RNA interactions in Figure 9, R21 DA025703–01, Figure 9, R21 DK082631–01, and Figure 9, R01 DK082675–01, and again in R01 GM085229–01, Figure 11C. 2. The image in Figure 1A, R01 GM085303–01, representing a co-IP assay from the Drosophila cell line S2, was manipulated and used in Figure 1B of the same grant application to represent a different co-IP assay from Drosophila embryonic extracts. 3. The image in Figure 8A, R01 GM085303–01A1, representing an SDS– PAGE gel for an in vitro HMT assay, was used previously in Figure 1d in a manuscript submitted to Nature in 2005 to represent an SDS–PAGE gel from an unrelated experiment for an ubiquitination assay. 4. The image in Figure 1E, R01 GM085303–01 and Figure 1D, R01 GM085303–01A1, representing stained SDS–PAGE for an HMT assay, was used in Figure 1b, Nature 419(6909):857–862, VerDate Sep<11>2014 18:13 Jul 05, 2017 Jkt 241001 2002, to represent an HMT assay with different experimental conditions, and also was used in Figure 1B, Science 2004, to represent stained PAGE for an in vitro kinase assay. 5. The image in Figure 1C, R01 GM085303–01 and Figure 1B, R01 GM085303–01A1, representing an HMT assay, was manipulated and used to represent an HMT assay with different experimental conditions in Figure 1E, R01 GM085303–01 and Figure 1D, R01 GM085303–01A1, and also was used to represent another unrelated HMT assay in Figure 2 (right panel) in R01 GM085303–01. 6. The image in Figure 2 (right panel) in R01 GM085303–01 representing an HMT assay was used in Figure 1B, PLoS One 2010 to represent an HMT assay with different experimental conditions. 7. The image in Figure 6B, R21 DA025703–01, Figure 11B, R01 GM085229–01, Figure 6B, R01 DK082675–01, and Figure 6B, R21 DK082631–01, all representing RT–PCR experiments for transcribed ncRNAs, was used in Figure 13, R21 DK082631– 01 and Figure 13, R21 DA025703–01 to represent RT–PCR experiments for transcription for different ncRNAs. 8. The image in Figure 10C (right half) in R01 GM073776–06A1, representing transcription of endodermal genes from embroid bodies, was manipulated and used in Figure 10C (left half) in the same grant application to represent the transcription of mesodermal and ectodermal genes. Science 311(5764):1118–1123, 2006 was retracted in: Science 344(6187):981, 2014. Science 304(5673):1010–1014, 2004 was retracted in: Science 344(6187):981, 2014. Nature 419(6909):857–862, 2002 was retracted in Nature 521(7550):110, 2015. ORI issued a charge letter enumerating the above findings of research misconduct and proposing HHS administrative actions. Dr. Sauer subsequently requested a hearing before an Administrative Law Judge (ALJ) of the Departmental Appeals Board to dispute these findings. The parties filed cross-motions for summary judgment. On May 22, 2017, the ALJ recommended to the Assistant Secretary for Health that summary judgment be granted in favor of ORI. On June 22, 2017, the ALJ’s recommended decision became the final agency decision. Thus, the research misconduct findings set forth above became effective, and the following administrative actions have been implemented, beginning on June 22, 2017: (1) Dr. Sauer is prohibited from serving in any advisory capacity to PHS including, but not limited to, service on PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 31335 any PHS advisory committee, board, and/or peer review committee, or as a consultant, through July 27, 2020, the end date of his government-wide debarment, which was imposed by NSF; and (2) ORI will send a notice to PLoS requesting retraction or correction of PLoS One 5(5):e10581, 2010 (PMID: 20498723) in accordance with 42 CFR 93.411(b). FOR FURTHER INFORMATION CONTACT: Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453–8200. Kathryn M. Partin, Director, Office of Research Integrity. [FR Doc. 2017–14075 Filed 7–5–17; 8:45 am] BILLING CODE 4150–31–P DEPARTMENT OF HEALTH AND HUMAN SERVICES HHS Approval of Entities That Certify Medical Review Officers Substance Abuse and Mental Health Services Administration, Department of Health and Human Services. ACTION: Notice. AGENCY: The current version of the Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines), effective on October 1, 2010, addresses the role and qualifications of Medical Review Officers (MROs) and HHS approval of entities that certify MROs. As required under Section 13.1(b) of the Mandatory Guidelines, this notice publishes a list of HHS approved MRO certification entities. FOR FURTHER INFORMATION CONTACT: Sean J. Belouin, Pharm.D., CAPT, United States Public Health Service, Senior Pharmacology and Regulatory Policy Advisor, Substance Abuse and Mental Health Services Administration, 5600 Fishers Lane, Room 16N06D, Rockville, Maryland 20857; Telephone: (240) 276–2716; Email: sean.belouin@ samhsa.hhs.gov. SUPPLEMENTARY INFORMATION: Subpart M-Medical Review Officer (MRO), Section 13.1(b) of the Mandatory Guidelines, ‘‘Who may serve as an MRO?’’ states as follows: ‘‘Nationally recognized entities that certify MROs or subspecialty boards for physicians performing a review of Federal employee drug testing results that seek approval by the Secretary must submit their qualifications and a sample examination. Based on an annual SUMMARY: E:\FR\FM\06JYN1.SGM 06JYN1 31336 Federal Register / Vol. 82, No. 128 / Thursday, July 6, 2017 / Notices objective review of the qualifications and content of the examination, the Secretary shall publish a list in the Federal Register of those entities and boards that have been approved.’’ HHS has completed its review of entities that certify MROs, in accordance with requests submitted by such entities to HHS. The HHS Secretary approves the following MRO certifying entities that offer MRO certification through examination: Dated: June 29, 2017. Lawrence A. Tabak, Deputy Director, National Institutes of Health. American Association of Medical Review Officers (AAMRO), P.O. Box 12873, Research Triangle Park, NC 27709, Phone: (800) 489–1839, Fax: (919) 490–1010, Email: bbrandon@ aamro.com, Web site: https:// www.aamro.com/. Medical Review Officer Certification Council (MROCC), 3231 S. Halsted St, #167, Chicago, IL 60608, Phone: (847) 631–0599, Fax: (847) 483–1282, Email: mrocc@mrocc.org, Web site: https://www.mrocc.org/. DATES: HHS approval is effective June 30, 2017. Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, July 20, 2017, 11:00 a.m. to July 20, 2017, 02:00 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the Federal Register on June 28, 2017, 82 FR 29298. The meeting will be held on July 28, 2017 instead of July 20, 2017. The meeting time remains the same. The meeting is closed to the public. Dated: June 30, 2017. Thomas E. Price, Secretary. [FR Doc. 2017–14128 Filed 7–5–17; 8:45 am] [FR Doc. 2017–14154 Filed 6–30–17; 4:15 pm] DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2017–14190 Filed 7–5–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Dated: June 29, 2017. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. BILLING CODE 4140–01–P BILLING CODE 4162–20–P National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES Center for Scientific Review; Notice of Closed Meeting National Institutes of Health sradovich on DSK3GMQ082PROD with NOTICES Extension of Effective Date of NIH Policy on the Use of a Single Institutional Review Board for MultiSite Research The National Institutes of Health (NIH) is extending the effective date of the NIH Policy on the Use of a Single Institutional Review Board for MultiSite Research from September 25, 2017 to January 25, 2018. A copy of the NIH Policy was published in the Federal Register on June 21, 2016 (81 FR 40325). See https://www.gpo.gov/fdsys/pkg/FR2016-06-21/pdf/2016-14513.pdf. Guidance and Frequently Asked Questions to assist in the implementation of the policy are available at https://osp.od.nih.gov/ clinical-research/irb-review/. For further information contact the NIH Office of Science Policy, Telephone: 301–496–9838, Email: SingleIRBPolicy@mail.nih.gov. VerDate Sep<11>2014 18:13 Jul 05, 2017 Jkt 241001 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting 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: Center for Scientific Review Special Emphasis Panel Research Resource for Human Organs and Tissues. Date: July 26, 2017. Time: 1:00 p.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 Contact Person: Yuanna Cheng, MD, PhD., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4138, MSC 7814, Bethesda, MD 20892, (301) 435– 1195, Chengy5@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: June 29, 2017. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–14127 Filed 7–5–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. 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: Center for Scientific Review Special Emphasis Panel PAR17–122: NINDS Exploratory Clinical Trials. Date: July 25, 2017. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Samuel C. Edwards, Ph.D., Chief, Brain Disorders and Clinical Neuroscience, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5210, MSC 7846, Bethesda, MD 20892, (301) 435–1246, edwardss@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel HIV/AIDS Point-of-care Applications. Date: July 25, 2017. Time: 12:00 p.m. to 4:00 p.m. E:\FR\FM\06JYN1.SGM 06JYN1

Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 82, Number 128 (Thursday, July 6, 2017)]
[Notices]
[Pages 31335-31336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14154]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


HHS Approval of Entities That Certify Medical Review Officers

AGENCY: Substance Abuse and Mental Health Services Administration, 
Department of Health and Human Services.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The current version of the Department of Health and Human 
Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing 
Programs (Mandatory Guidelines), effective on October 1, 2010, 
addresses the role and qualifications of Medical Review Officers (MROs) 
and HHS approval of entities that certify MROs. As required under 
Section 13.1(b) of the Mandatory Guidelines, this notice publishes a 
list of HHS approved MRO certification entities.

FOR FURTHER INFORMATION CONTACT: Sean J. Belouin, Pharm.D., CAPT, 
United States Public Health Service, Senior Pharmacology and Regulatory 
Policy Advisor, Substance Abuse and Mental Health Services 
Administration, 5600 Fishers Lane, Room 16N06D, Rockville, Maryland 
20857; Telephone: (240) 276-2716; Email: sean.belouin@samhsa.hhs.gov.

SUPPLEMENTARY INFORMATION: Subpart M-Medical Review Officer (MRO), 
Section 13.1(b) of the Mandatory Guidelines, ``Who may serve as an 
MRO?'' states as follows: ``Nationally recognized entities that certify 
MROs or subspecialty boards for physicians performing a review of 
Federal employee drug testing results that seek approval by the 
Secretary must submit their qualifications and a sample examination. 
Based on an annual

[[Page 31336]]

objective review of the qualifications and content of the examination, 
the Secretary shall publish a list in the Federal Register of those 
entities and boards that have been approved.''
    HHS has completed its review of entities that certify MROs, in 
accordance with requests submitted by such entities to HHS.
    The HHS Secretary approves the following MRO certifying entities 
that offer MRO certification through examination:

American Association of Medical Review Officers (AAMRO), P.O. Box 
12873, Research Triangle Park, NC 27709, Phone: (800) 489-1839, Fax: 
(919) 490-1010, Email: bbrandon@aamro.com, Web site: https://www.aamro.com/.
Medical Review Officer Certification Council (MROCC), 3231 S. Halsted 
St, #167, Chicago, IL 60608, Phone: (847) 631-0599, Fax: (847) 483-
1282, Email: mrocc@mrocc.org, Web site: https://www.mrocc.org/.
DATES: HHS approval is effective June 30, 2017.

    Dated: June 30, 2017.
Thomas E. Price,
Secretary.
[FR Doc. 2017-14154 Filed 6-30-17; 4:15 pm]
 BILLING CODE 4162-20-P

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