83_FR_39918 83 FR 39763 - HHS Approval of Entities That Certify Medical Review Officers

83 FR 39763 - HHS Approval of Entities That Certify Medical Review Officers

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration

Federal Register Volume 83, Issue 155 (August 10, 2018)

Page Range39763-39763
FR Document2018-17184

This notice publishes a list of the Department of Health and Human Services (HHS) approved Medical Review Officers certification entities. The HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines), applicable on October 1, 2017, addresses the role and qualifications of Medical Review Officers (MROs) and HHS approval of entities that certify MROs.

Federal Register, Volume 83 Issue 155 (Friday, August 10, 2018)
[Federal Register Volume 83, Number 155 (Friday, August 10, 2018)]
[Notices]
[Page 39763]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-17184]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


HHS Approval of Entities That Certify Medical Review Officers

AGENCY: Substance Abuse and Mental Health Services Administration, HHS.

ACTION: Notice.

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SUMMARY: This notice publishes a list of the Department of Health and 
Human Services (HHS) approved Medical Review Officers certification 
entities. The HHS Mandatory Guidelines for Federal Workplace Drug 
Testing Programs (Mandatory Guidelines), applicable on October 1, 2017, 
addresses the role and qualifications of Medical Review Officers (MROs) 
and HHS approval of entities that certify MROs.

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 13.2 of the Mandatory Guidelines, ``How are nationally 
recognized entities or subspecialty boards that certify MROs 
approved?'' states as follows: ``All nationally recognized entities or 
subspecialty boards which seek approval by the Secretary to certify 
physicians as MROs for federal workplace drug testing programs must 
submit their qualifications, a sample examination, and other necessary 
supporting examination materials (e.g., answers, previous examination 
statistics or other background examination information, if requested) 
(OMB Control No.: 0930-0158). Approval will be based on an objective 
review of qualifications that include a copy of the MRO applicant 
application form, documentation that the continuing education courses 
are accredited by a professional organization, and the delivery method 
and content of the examination. Each approved MRO certification entity 
must resubmit their qualifications for approval every two years. The 
Secretary shall publish at least every two years a notice in the 
Federal Register listing those entities and subspecialty boards that 
have been approved. This notice is also available on the internet at 
http://www.samhsa.gov/workplace/drug-testing.''
    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: (919) 489-5407, Fax: 
(919) 490-1010, Email: [email protected], website: 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], website: http://www.mrocc.org/.

DATES: HHS approval is effective July 31, 2018.

Alex M. Azar II,
Secretary.
[FR Doc. 2018-17184 Filed 8-9-18; 8:45 am]
 BILLING CODE 4162-20-P



                                                                             Federal Register / Vol. 83, No. 155 / Friday, August 10, 2018 / Notices                                                 39763

                                               Washington, Center for Drug Evaluation                    Dated: August 6, 2018.                              resubmit their qualifications for
                                               and Research, Food and Drug                             Leslie Kux,                                           approval every two years. The Secretary
                                               Administration, 10903 New Hampshire                     Associate Commissioner for Policy.                    shall publish at least every two years a
                                               Ave., Silver Spring, MD 20993–0002,                     [FR Doc. 2018–17130 Filed 8–9–18; 8:45 am]            notice in the Federal Register listing
                                               301–796–1019, tisha.washington@                         BILLING CODE 4164–01–P                                those entities and subspecialty boards
                                               fda.hhs.gov no later than September 4,                                                                        that have been approved. This notice is
                                               2018.                                                                                                         also available on the internet at http://
                                                                                                       DEPARTMENT OF HEALTH AND                              www.samhsa.gov/workplace/drug-
                                                  Requests for Oral Presentations:                                                                           testing.’’
                                                                                                       HUMAN SERVICES
                                               During online registration you may                                                                              HHS has completed its review of
                                               indicate if you wish to present at the                  Substance Abuse and Mental Health                     entities that certify MROs, in
                                               public comment session, and which                       Services Administration                               accordance with requests submitted by
                                               topic(s) you wish to address. We will do                                                                      such entities to HHS.
                                               our best to accommodate requests to                     HHS Approval of Entities That Certify                   The HHS Secretary approves the
                                               make public comments. Individuals and                   Medical Review Officers                               following MRO certifying entities that
                                               organizations with common interests are                 AGENCY: Substance Abuse and Mental                    offer MRO certification through
                                               urged to consolidate or coordinate their                Health Services Administration, HHS.                  examination:
                                               presentations, and request time for a                                                                         American Association of Medical
                                                                                                       ACTION: Notice.
                                               joint presentation. Following the close                                                                         Review Officers (AAMRO), P.O. Box
                                               of registration, we will determine the                  SUMMARY:    This notice publishes a list of             12873, Research Triangle Park, NC
                                               amount of time allotted to each                         the Department of Health and Human                      27709, Phone: (919) 489–5407, Fax:
                                               presenter and the approximate time                      Services (HHS) approved Medical                         (919) 490–1010, Email: bbrandon@
                                               each oral presentation is to begin, and                 Review Officers certification entities.                 aamro.com, website: http://
                                                                                                       The HHS Mandatory Guidelines for                        www.aamro.com/.
                                               will select and notify participants by                                                                        Medical Review Officer Certification
                                               September 5, 2018. All requests to make                 Federal Workplace Drug Testing
                                                                                                       Programs (Mandatory Guidelines),                        Council (MROCC), 3231 S. Halsted St,
                                               oral presentations must be received by                                                                          #167, Chicago, IL 60608, Phone: (847)
                                                                                                       applicable on October 1, 2017,
                                               the close of registration on September 4,                                                                       631–0599, Fax: (847) 483–1282,
                                                                                                       addresses the role and qualifications of
                                               2018. If selected for presentation, any                 Medical Review Officers (MROs) and                      Email: mrocc@mrocc.org, website:
                                               presentation materials must be emailed                  HHS approval of entities that certify                   http://www.mrocc.org/.
                                               to Tisha Washington (see FOR FURTHER                    MROs.                                                 DATES: HHS approval is effective July
                                               INFORMATION CONTACT) no later than                                                                            31, 2018.
                                                                                                       FOR FURTHER INFORMATION CONTACT:
                                               close of business, September 6, 2018. No
                                                                                                       Sean J. Belouin, Pharm.D., CAPT,                      Alex M. Azar II,
                                               commercial or promotional material
                                                                                                       United States Public Health Service,                  Secretary.
                                               will be permitted to be presented or
                                                                                                       Senior Pharmacology and Regulatory                    [FR Doc. 2018–17184 Filed 8–9–18; 8:45 am]
                                               distributed at the public workshop.                     Policy Advisor, Substance Abuse and
                                                                                                                                                             BILLING CODE 4162–20–P
                                                  Streaming Webcast of the Public                      Mental Health Services Administration,
                                               Workshop: This public workshop will                     5600 Fishers Lane, Room 16N06D,
                                               also be webcast. The webcast link will                  Rockville, Maryland 20857; Telephone:                 DEPARTMENT OF HEALTH AND
                                               be available on the following web page                  (240) 276–2716; Email: sean.belouin@                  HUMAN SERVICES
                                               5 days before the workshop at: https://                 samhsa.hhs.gov.
                                               www.fda.gov/Drugs/NewsEvents/                           SUPPLEMENTARY INFORMATION: Subpart                    National Institutes of Health
                                               ucm611203.htm.                                          M—Medical Review Officer (MRO),
                                                                                                       Section 13.2 of the Mandatory                         National Institute on Alcohol Abuse
                                                  If you have never attended a Connect                                                                       and Alcoholism; Notice of Meeting
                                               Pro event before, test your connection at               Guidelines, ‘‘How are nationally
                                               https://collaboration.fda.gov/common/                   recognized entities or subspecialty                      Pursuant to section 10(d) of the
                                               help/en/support/meeting_test.htm. To                    boards that certify MROs approved?’’                  Federal Advisory Committee Act, as
                                               get a quick overview of the Connect Pro                 states as follows: ‘‘All nationally                   amended, notice is hereby given of a
                                                                                                       recognized entities or subspecialty                   meeting of the National Advisory
                                               program, visit https://www.adobe.com/
                                                                                                       boards which seek approval by the                     Council on Alcohol Abuse and
                                               go/connectpro_overview. FDA has
                                                                                                       Secretary to certify physicians as MROs               Alcoholism.
                                               verified the website addresses in this                  for federal workplace drug testing                       The meeting will be open to the
                                               document, as of the date this document                  programs must submit their                            public as indicated below, with
                                               publishes in the Federal Register, but                  qualifications, a sample examination,                 attendance limited to space available.
                                               websites are subject to change over time.               and other necessary supporting                        Individuals who plan to attend and
                                                  Transcripts: Please be advised that as               examination materials (e.g., answers,                 need special assistance, such as sign
                                               soon as a transcript of the public                      previous examination statistics or other              language interpretation or other
                                               workshop is available, it will be                       background examination information, if                reasonable accommodations, should
                                               accessible at https://                                  requested) (OMB Control No.: 0930–                    notify the Contact Person listed below
                                               www.regulations.gov. It may be viewed                   0158). Approval will be based on an                   in advance of the meeting.
                                               at the Dockets Management Staff (HFA–                   objective review of qualifications that                  The meeting will be closed to the
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                                               305), Food and Drug Administration,                     include a copy of the MRO applicant                   public in accordance with the
                                               5630 Fishers Lane, Rm. 1061, Rockville,                 application form, documentation that                  provisions set forth in sections
                                               MD 20852. A link to the transcript will                 the continuing education courses are                  552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                               also be available on the internet at                    accredited by a professional                          as amended. The grant applications and
                                               https://www.fda.gov/Drugs/NewsEvents/                   organization, and the delivery method                 the discussions could disclose
                                                                                                       and content of the examination. Each                  confidential trade secrets or commercial
                                               ucm611203.htm.
                                                                                                       approved MRO certification entity must                property such as patentable material,


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Document Created: 2018-08-10 01:56:42
Document Modified: 2018-08-10 01:56:42
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesHHS approval is effective July 31, 2018.
ContactSean 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 Citation83 FR 39763 

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