82 FR 31335 - HHS Approval of Entities That Certify Medical Review Officers

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 82, Issue 128 (July 6, 2017)

Page Range		31335-31336
FR Document		2017-14154

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.

Federal Register, Volume 82 Issue 128 (Thursday, July 6, 2017)

[Federal Register Volume 82, Number 128 (Thursday, July 6, 2017)]
[Notices]
[Pages 31335-31336]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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: [email protected].

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: [email protected], Web site: http://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: [email protected], Web site: http://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

Federal Register / Vol. 82, No. 128 / Thursday, July 6, 2017 / Notices 31335

1014, 2004 (hereafter referred to as 2002, to represent an HMT assay with any PHS advisory committee, board,
‘‘Science 2004’’). different experimental conditions, and and/or peer review committee, or as a
• National Institute on Drug Abuse also was used in Figure 1B, Science consultant, through July 27, 2020, the
(NIDA), NIH, grant application R21 2004, to represent stained PAGE for an end date of his government-wide
DA025703–01. in vitro kinase assay. debarment, which was imposed by NSF;
• National Institute of Diabetes and 5. The image in Figure 1C, R01 and
Digestive and Kidney Diseases (NIDDK), GM085303–01 and Figure 1B, R01 (2) ORI will send a notice to PLoS
NIH, grant application R21 DK082631– GM085303–01A1, representing an HMT requesting retraction or correction of
01. assay, was manipulated and used to PLoS One 5(5):e10581, 2010 (PMID:
• NIDDK, NIH, grant application R01 represent an HMT assay with different 20498723) in accordance with 42 CFR
DK082675–01. experimental conditions in Figure 1E, 93.411(b).
• NIGMS, NIH, grant application R01 R01 GM085303–01 and Figure 1D, R01 FOR FURTHER INFORMATION CONTACT:
GM073776–06A1. GM085303–01A1, and also was used to Director, Office of Research Integrity,
• NIGMS, NIH, grant application R01 represent another unrelated HMT assay 1101 Wootton Parkway, Suite 750,
GM085229–01. in Figure 2 (right panel) in R01
• NIGMS, NIH, grant application R01 Rockville, MD 20852, (240) 453–8200.
GM085303–01.
GM085303–01. 6. The image in Figure 2 (right panel) Kathryn M. Partin,
• NIGMS, NIH, grant application R01 in R01 GM085303–01 representing an Director, Office of Research Integrity.
GM085303–01A1. HMT assay was used in Figure 1B, PLoS [FR Doc. 2017–14075 Filed 7–5–17; 8:45 am]
ORI found by a preponderance of the One 2010 to represent an HMT assay BILLING CODE 4150–31–P
evidence that the Respondent engaged with different experimental conditions.
in research misconduct by intentionally, 7. The image in Figure 6B, R21
knowingly, or recklessly falsifying and/ DA025703–01, Figure 11B, R01 DEPARTMENT OF HEALTH AND
or fabricating images in seven (7) GM085229–01, Figure 6B, R01 HUMAN SERVICES
submitted NIH grant application and DK082675–01, and Figure 6B, R21
three (3) published papers by DK082631–01, all representing RT–PCR HHS Approval of Entities That Certify
manipulating, reusing, and falsely experiments for transcribed ncRNAs, Medical Review Officers
labeling images. Specifically, the was used in Figure 13, R21 DK082631–
Respondent falsified and/or fabricated AGENCY: Substance Abuse and Mental
01 and Figure 13, R21 DA025703–01 to
images representing controls or Health Services Administration,
represent RT–PCR experiments for
experimental results for in vitro Department of Health and Human
transcription for different ncRNAs.
interactions between RNA and proteins, 8. The image in Figure 10C (right half) Services.
co-immunoprecipitation (‘‘co-IP’’) in R01 GM073776–06A1, representing ACTION: Notice.
assays, histone methytransferase transcription of endodermal genes from SUMMARY: The current version of the
(‘‘HMT’’) or kinase assays and related embroid bodies, was manipulated and Department of Health and Human
stained SDS–PAGE gels, and reverse used in Figure 10C (left half) in the Services (HHS) Mandatory Guidelines
transcription-polymerase chain same grant application to represent the for Federal Workplace Drug Testing
reactions (‘‘RT–PCR’’) in the following transcription of mesodermal and Programs (Mandatory Guidelines),
grant applications and publications. ectodermal genes. effective on October 1, 2010, addresses
1. The image in Figure S4, Science Science 311(5764):1118–1123, 2006 the role and qualifications of Medical
2006, representing the in vitro was retracted in: Science 344(6187):981, Review Officers (MROs) and HHS
interactions between RNA and specific 2014. Science 304(5673):1010–1014, approval of entities that certify MROs.
proteins, was used in similar assays to 2004 was retracted in: Science As required under Section 13.1(b) of the
represent results with other sets of 344(6187):981, 2014. Nature Mandatory Guidelines, this notice
protein-RNA interactions in Figure 9, 419(6909):857–862, 2002 was retracted publishes a list of HHS approved MRO
R21 DA025703–01, Figure 9, R21 in Nature 521(7550):110, 2015. certification entities.
DK082631–01, and Figure 9, R01 ORI issued a charge letter
FOR FURTHER INFORMATION CONTACT:
DK082675–01, and again in R01 enumerating the above findings of
research misconduct and proposing Sean J. Belouin, Pharm.D., CAPT,
GM085229–01, Figure 11C.
2. The image in Figure 1A, R01 HHS administrative actions. Dr. Sauer United States Public Health Service,
GM085303–01, representing a co-IP subsequently requested a hearing before Senior Pharmacology and Regulatory
assay from the Drosophila cell line S2, an Administrative Law Judge (ALJ) of Policy Advisor, Substance Abuse and
was manipulated and used in Figure 1B the Departmental Appeals Board to Mental Health Services Administration,
of the same grant application to dispute these findings. The parties filed 5600 Fishers Lane, Room 16N06D,
represent a different co-IP assay from cross-motions for summary judgment. Rockville, Maryland 20857; Telephone:
Drosophila embryonic extracts. On May 22, 2017, the ALJ recommended (240) 276–2716; Email: sean.belouin@
3. The image in Figure 8A, R01 to the Assistant Secretary for Health that samhsa.hhs.gov.
GM085303–01A1, representing an SDS– summary judgment be granted in favor SUPPLEMENTARY INFORMATION: Subpart
PAGE gel for an in vitro HMT assay, was of ORI. On June 22, 2017, the ALJ’s M-Medical Review Officer (MRO),
used previously in Figure 1d in a recommended decision became the final Section 13.1(b) of the Mandatory
manuscript submitted to Nature in 2005 agency decision. Thus, the research Guidelines, ‘‘Who may serve as an
MRO?’’ states as follows: ‘‘Nationally
sradovich on DSK3GMQ082PROD with NOTICES

to represent an SDS–PAGE gel from an misconduct findings set forth above
unrelated experiment for an became effective, and the following recognized entities that certify MROs or
ubiquitination assay. administrative actions have been subspecialty boards for physicians
4. The image in Figure 1E, R01 implemented, beginning on June 22, performing a review of Federal
GM085303–01 and Figure 1D, R01 2017: employee drug testing results that seek
GM085303–01A1, representing stained (1) Dr. Sauer is prohibited from approval by the Secretary must submit
SDS–PAGE for an HMT assay, was used serving in any advisory capacity to PHS their qualifications and a sample
in Figure 1b, Nature 419(6909):857–862, including, but not limited to, service on examination. Based on an annual

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31336 Federal Register / Vol. 82, No. 128 / Thursday, July 6, 2017 / Notices

objective review of the qualifications Dated: June 29, 2017. Contact Person: Yuanna Cheng, MD, PhD.,
and content of the examination, the Lawrence A. Tabak, Scientific Review Officer, Center for
Secretary shall publish a list in the Scientific Review, National Institutes of
Deputy Director, National Institutes of Health.
Health, 6701 Rockledge Drive, Room 4138,
Federal Register of those entities and [FR Doc. 2017–14190 Filed 7–5–17; 8:45 am] MSC 7814, Bethesda, MD 20892, (301) 435–
boards that have been approved.’’ BILLING CODE 4140–01–P 1195, Chengy5@csr.nih.gov.
HHS has completed its review of (Catalogue of Federal Domestic Assistance
entities that certify MROs, in Program Nos. 93.306, Comparative Medicine;
accordance with requests submitted by DEPARTMENT OF HEALTH AND 93.333, Clinical Research, 93.306, 93.333,
HUMAN SERVICES 93.337, 93.393–93.396, 93.837–93.844,
such entities to HHS.
93.846–93.878, 93.892, 93.893, National
The HHS Secretary approves the National Institutes of Health Institutes of Health, HHS)
following MRO certifying entities that
offer MRO certification through Center for Scientific Review; Amended Dated: June 29, 2017.
examination: Notice of Meeting Melanie J. Pantoja,
Notice is hereby given of a change in Program Analyst, Office of Federal Advisory
American Association of Medical Committee Policy.
Review Officers (AAMRO), P.O. Box the meeting of the Center for Scientific
[FR Doc. 2017–14127 Filed 7–5–17; 8:45 am]
12873, Research Triangle Park, NC Review Special Emphasis Panel, July 20,
2017, 11:00 a.m. to July 20, 2017, 02:00 BILLING CODE 4140–01–P
27709, Phone: (800) 489–1839, Fax:
(919) 490–1010, Email: bbrandon@ p.m., National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
aamro.com, Web site: http:// DEPARTMENT OF HEALTH AND
which was published in the Federal
www.aamro.com/. HUMAN SERVICES
Register on June 28, 2017, 82 FR 29298.
Medical Review Officer Certification The meeting will be held on July 28, National Institutes of Health
Council (MROCC), 3231 S. Halsted St, 2017 instead of July 20, 2017. The
#167, Chicago, IL 60608, Phone: (847) meeting time remains the same. The Center for Scientific Review; Notice of
631–0599, Fax: (847) 483–1282, meeting is closed to the public. Closed Meetings
Email: mrocc@mrocc.org, Web site: Dated: June 29, 2017.
http://www.mrocc.org/. Pursuant to section 10(d) of the
Melanie J. Pantoja, Federal Advisory Committee Act, as
DATES: HHS approval is effective June Program Analyst, Office of Federal Advisory amended (5 U.S.C. App.), notice is
30, 2017. Committee Policy. hereby given of the following meetings.
Dated: June 30, 2017. [FR Doc. 2017–14128 Filed 7–5–17; 8:45 am] The meetings will be closed to the
Thomas E. Price, BILLING CODE 4140–01–P public in accordance with the
Secretary. provisions set forth in sections
[FR Doc. 2017–14154 Filed 6–30–17; 4:15 pm]
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
DEPARTMENT OF HEALTH AND as amended. The grant applications and
BILLING CODE 4162–20–P HUMAN SERVICES the discussions could disclose
National Institutes of Health confidential trade secrets or commercial
property such as patentable material,
DEPARTMENT OF HEALTH AND
Center for Scientific Review; Notice of and personal information concerning
HUMAN SERVICES
Closed Meeting individuals associated with the grant
National Institutes of Health applications, the disclosure of which
Pursuant to section 10(d) of the would constitute a clearly unwarranted
Federal Advisory Committee Act, as invasion of personal privacy.
Extension of Effective Date of NIH
amended (5 U.S.C. App.), notice is Name of Committee: Center for
Policy on the Use of a Single hereby given of the following meeting.
Institutional Review Board for Multi- Scientific Review Special Emphasis
The meeting will be closed to the Panel PAR17–122: NINDS Exploratory
Site Research public in accordance with the Clinical Trials.
provisions set forth in sections Date: July 25, 2017.
The National Institutes of Health 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
(NIH) is extending the effective date of Time: 1:00 p.m. to 5:00 p.m.
as amended. The grant applications and Agenda: To review and evaluate grant
the NIH Policy on the Use of a Single the discussions could disclose
Institutional Review Board for Multi- applications.
confidential trade secrets or commercial Place: National Institutes of Health,
Site Research from September 25, 2017 property such as patentable material,
to January 25, 2018. A copy of the NIH 6701 Rockledge Drive, Bethesda, MD
and personal information concerning 20892, (Virtual Meeting).
Policy was published in the Federal individuals associated with the grant
Register on June 21, 2016 (81 FR 40325). Contact Person: Samuel C. Edwards,
applications, the disclosure of which Ph.D., Chief, Brain Disorders and
See https://www.gpo.gov/fdsys/pkg/FR- would constitute a clearly unwarranted Clinical Neuroscience, Center for
2016-06-21/pdf/2016-14513.pdf. invasion of personal privacy. Scientific Review, National Institutes of
Guidance and Frequently Asked Name of Committee: Center for Scientific Health, 6701 Rockledge Drive, Room
Questions to assist in the Review Special Emphasis Panel Research 5210, MSC 7846, Bethesda, MD 20892,
sradovich on DSK3GMQ082PROD with NOTICES

implementation of the policy are Resource for Human Organs and Tissues. (301) 435–1246, edwardss@csr.nih.gov.
available at https://osp.od.nih.gov/ Date: July 26, 2017. Name of Committee: Center for
clinical-research/irb-review/. Time: 1:00 p.m. to 2:30 p.m.
Agenda: To review and evaluate grant
Scientific Review Special Emphasis
For further information contact the applications. Panel HIV/AIDS Point-of-care
NIH Office of Science Policy, Place: National Institutes of Health, 6701 Applications.
Telephone: 301–496–9838, Email: Rockledge Drive, Bethesda, MD 20892 Date: July 25, 2017.
SingleIRBPolicy@mail.nih.gov. (Telephone Conference Call). Time: 12:00 p.m. to 4:00 p.m.

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Document Created: 2017-07-06 01:04:30
Document Modified: 2017-07-06 01:04:30

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.
Dates		HHS approval is effective June 30, 2017.
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: [email protected]
FR Citation		82 FR 31335