83_FR_39594 83 FR 39440 - Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH)

83 FR 39440 - Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 83, Issue 154 (August 9, 2018)

Page Range39440-39441
FR Document2018-17042

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH). This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 33 people. The meeting is also open to the public via webcast. If you wish to attend in person or by webcast, please see the NIOSH website to register (http://www.cdc.gov/niosh/bsc/) or call (404-498-2539) at least five business days in advance of the meeting. Teleconference is available toll-free; please dial (888) 397-9578, Participant Pass Code 63257516. Adobe Connect webcast will be available at https:// odniosh.adobeconnect.com/nioshbsc/ for participants wanting to connect remotely. This meeting is open to the public, limited only by the space available. The public is welcome to participate during the public comment period, 12:30 p.m. to 12:45 p.m., EDT, September 27, 2018. Please note that the public comment period ends at the time indicated above. Each commenter will be provided up to five minutes for comment. A limited number of time slots are available and will be assigned on a first come-first served basis. Written comments will also be accepted from those unable to attend the public session via an on-line form at the following website: http://www.cdc.gov/niosh/bsc/contact.html.

Federal Register, Volume 83 Issue 154 (Thursday, August 9, 2018)
[Federal Register Volume 83, Number 154 (Thursday, August 9, 2018)]
[Notices]
[Pages 39440-39441]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-17042]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket Number: NIOSH 278]


Board of Scientific Counselors, National Institute for 
Occupational Safety and Health (BSC, NIOSH)

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice of meeting.

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

SUMMARY: In accordance with the Federal Advisory Committee Act, the CDC 
announces the following meeting of the Board of Scientific Counselors, 
National Institute for Occupational Safety and Health (BSC, NIOSH). 
This meeting is open to the public, limited only by the space 
available. The meeting room accommodates approximately 33 people. The 
meeting is also open to the public via webcast. If you wish to attend 
in person or by webcast, please see the NIOSH website to register 
(http://www.cdc.gov/niosh/bsc/) or call (404-498-2539) at least five 
business days in advance of the meeting. Teleconference is available 
toll-free; please dial (888) 397-9578, Participant Pass Code 63257516. 
Adobe Connect webcast will be available at https://odniosh.adobeconnect.com/nioshbsc/ for participants wanting to connect 
remotely. This meeting is open to the public, limited only by the space 
available. The public is welcome to participate during the public 
comment period, 12:30 p.m. to 12:45 p.m., EDT, September 27, 2018. 
Please note that the public comment period ends at the time indicated 
above. Each commenter will be provided up to five minutes for comment. 
A limited number of time slots are available and will be assigned on a 
first come-first served basis. Written comments will also be accepted 
from those unable to attend the public session via an on-line form at 
the following website: http://www.cdc.gov/niosh/bsc/contact.html.

DATES: The meeting will be held on September 27, 2018, 8:30 a.m.-2:30 
p.m., EDT.

ADDRESSES: Patriots Plaza I, 395 E Street SW, Room 9000, Washington, DC 
20201.

FOR FURTHER INFORMATION CONTACT: Alberto Garcia, M.S., Executive 
Secretary, BSC, NIOSH, CDC, 1090 Tusculum Avenue, MS-R5, Cincinnati, OH 
45226, telephone (513) 841-4596, fax (513) 841-4506, email: 
[email protected].

SUPPLEMENTARY INFORMATION: 
    Purpose: The Secretary, the Assistant Secretary for Health, and by 
delegation the Director, Centers for Disease Control and Prevention, 
are authorized under Sections 301 and 308 of the Public Health Service 
Act to conduct directly or by grants or contracts, research, 
experiments, and demonstrations relating to occupational safety and 
health and to mine health. The Board of Scientific Counselors provides 
guidance to the Director, National Institute for Occupational Safety 
and Health on research and prevention programs. Specifically, the Board 
provides guidance on the Institute's research activities related to 
developing and evaluating hypotheses, systematically documenting 
findings and disseminating results. The Board evaluates the degree to 
which the activities of the National Institute for Occupational Safety 
and Health: (1) Conform to appropriate scientific standards, (2) 
address current, relevant needs, and (3) produce intended results.
    Matters to be Considered: The agenda for the meeting addresses 
occupational safety and health issues related to: NIOSH confronts the 
Opioid Crisis; 21st Century Surveillance Report; and Enhancing the 
Transparency of NIOSH Science. An agenda is also posted on the NIOSH 
website (http://www.cdc.gov/niosh/bsc/). Members of the public who wish 
to address the NIOSH BSC are requested to contact the Executive 
Secretary for scheduling purposes (see contact information below). 
Alternatively, written comments to the BSC may be submitted via an on-
line form at the following website: http://www.cdc.gov/niosh/bsc/contact.html. Agenda items are subject to change as priorities dictate.
    The Director, Management Analysis and Services Office, has been 
delegated the authority to sign Federal Register notices pertaining to 
announcements of

[[Page 39441]]

meetings and other committee management activities, for both the 
Centers for Disease Control and Prevention and the Agency for Toxic 
Substances and Disease Registry.

Sherri A. Berger,
Chief Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2018-17042 Filed 8-8-18; 8:45 am]
 BILLING CODE 4163-18-P



                                                39440                        Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices

                                                  B. Federal Reserve Bank of Kansas                     10045–0001. Comments can also be sent                 on a first come-first served basis.
                                                City (Dennis Denney, Assistant Vice                     electronically to                                     Written comments will also be accepted
                                                President), 1 Memorial Drive, Kansas                    Comments.applications@ny.frb.org:                     from those unable to attend the public
                                                City, Missouri 64198–0001:                                1. Standard Chartered Bank, London,                 session via an on-line form at the
                                                  1. Kevin Page, Trustee of the Kevin                   England; through its subsidiary,                      following website: http://www.cdc.gov/
                                                Page Trust, Fort Worth, Texas, Dana                     Standard Chartered Holdings, Inc., New                niosh/bsc/contact.html.
                                                Page, Co-Trustee of the Dana Page                       York, New York, to engage through a                   DATES: The meeting will be held on
                                                Trust, Austin, Texas, Meghan Anderson                   newly formed entity, The Consortium,                  September 27, 2018, 8:30 a.m.–2:30
                                                Smith, Co-Trustee of the Meghan                         LLC, in data processing activities,                   p.m., EDT.
                                                Anderson Smith Trust, Fremont,                          pursuant to section 225.28(b)(14) of                  ADDRESSES: Patriots Plaza I, 395 E Street
                                                Nebraska, Whitney Anderson, Co-                         Regulation Y.                                         SW, Room 9000, Washington, DC 20201.
                                                Trustee of the Whitney Anderson Trust,
                                                                                                          Board of Governors of the Federal Reserve           FOR FURTHER INFORMATION CONTACT:
                                                Coppell, Texas, Eric Jones, Trustee of                  System, August 3, 2018.                               Alberto Garcia, M.S., Executive
                                                the Eric Jones Trust, Blue Lake,                                                                              Secretary, BSC, NIOSH, CDC, 1090
                                                                                                        Ann Misback,
                                                California, and Christopher Marious                                                                           Tusculum Avenue, MS–R5, Cincinnati,
                                                                                                        Secretary of the Board.
                                                Jones, Co-Trustee of the Christopher                                                                          OH 45226, telephone (513) 841–4596,
                                                Marious Jones Trust, Los Angeles,                       [FR Doc. 2018–17010 Filed 8–8–18; 8:45 am]
                                                                                                        BILLING CODE 6210–01–P
                                                                                                                                                              fax (513) 841–4506, email: agarcia1@
                                                California; to retain shares of Page                                                                          cdc.gov.
                                                Bancshares, Inc., Liberty, Missouri, and
                                                thereby retain shares of Pony Express                                                                         SUPPLEMENTARY INFORMATION:
                                                Bank, Braymer, Missouri.                                DEPARTMENT OF HEALTH AND                                Purpose: The Secretary, the Assistant
                                                                                                        HUMAN SERVICES                                        Secretary for Health, and by delegation
                                                  Board of Governors of the Federal Reserve                                                                   the Director, Centers for Disease Control
                                                System, August 6, 2018.
                                                                                                        Centers for Disease Control and                       and Prevention, are authorized under
                                                Yao-Chin Chao,                                          Prevention                                            Sections 301 and 308 of the Public
                                                Assistant Secretary of the Board.                                                                             Health Service Act to conduct directly
                                                [FR Doc. 2018–17094 Filed 8–8–18; 8:45 am]              [Docket Number: NIOSH 278]
                                                                                                                                                              or by grants or contracts, research,
                                                BILLING CODE P
                                                                                                        Board of Scientific Counselors,                       experiments, and demonstrations
                                                                                                        National Institute for Occupational                   relating to occupational safety and
                                                                                                        Safety and Health (BSC, NIOSH)                        health and to mine health. The Board of
                                                FEDERAL RESERVE SYSTEM                                                                                        Scientific Counselors provides guidance
                                                                                                        AGENCY: Centers for Disease Control and               to the Director, National Institute for
                                                Notice of Proposals To Engage in or                     Prevention (CDC), Department of Health                Occupational Safety and Health on
                                                To Acquire Companies Engaged in                         and Human Services (HHS).                             research and prevention programs.
                                                Permissible Nonbanking Activities                                                                             Specifically, the Board provides
                                                                                                        ACTION: Notice of meeting.
                                                   The companies listed in this notice                                                                        guidance on the Institute’s research
                                                have given notice under section 4 of the                SUMMARY:   In accordance with the                     activities related to developing and
                                                Bank Holding Company Act (12 U.S.C.                     Federal Advisory Committee Act, the                   evaluating hypotheses, systematically
                                                1843) (BHC Act) and Regulation Y, (12                   CDC announces the following meeting                   documenting findings and
                                                CFR part 225) to engage de novo, or to                  of the Board of Scientific Counselors,                disseminating results. The Board
                                                acquire or control voting securities or                 National Institute for Occupational                   evaluates the degree to which the
                                                assets of a company, including the                      Safety and Health (BSC, NIOSH). This                  activities of the National Institute for
                                                companies listed below, that engages                    meeting is open to the public, limited                Occupational Safety and Health: (1)
                                                either directly or through a subsidiary or              only by the space available. The meeting              Conform to appropriate scientific
                                                other company, in a nonbanking activity                 room accommodates approximately 33                    standards, (2) address current, relevant
                                                that is listed in § 225.28 of Regulation Y              people. The meeting is also open to the               needs, and (3) produce intended results.
                                                (12 CFR 225.28) or that the Board has                   public via webcast. If you wish to attend               Matters to be Considered: The agenda
                                                determined by Order to be closely                       in person or by webcast, please see the               for the meeting addresses occupational
                                                related to banking and permissible for                  NIOSH website to register (http://                    safety and health issues related to:
                                                bank holding companies. Unless                          www.cdc.gov/niosh/bsc/) or call (404–                 NIOSH confronts the Opioid Crisis; 21st
                                                otherwise noted, these activities will be               498–2539) at least five business days in              Century Surveillance Report; and
                                                conducted throughout the United States.                 advance of the meeting. Teleconference                Enhancing the Transparency of NIOSH
                                                   Each notice is available for inspection              is available toll-free; please dial (888)             Science. An agenda is also posted on the
                                                at the Federal Reserve Bank indicated.                  397–9578, Participant Pass Code                       NIOSH website (http://www.cdc.gov/
                                                The notice also will be available for                   63257516. Adobe Connect webcast will                  niosh/bsc/). Members of the public who
                                                inspection at the offices of the Board of               be available at https://                              wish to address the NIOSH BSC are
                                                Governors. Interested persons may                       odniosh.adobeconnect.com/nioshbsc/                    requested to contact the Executive
                                                express their views in writing on the                   for participants wanting to connect                   Secretary for scheduling purposes (see
                                                question whether the proposal complies                  remotely. This meeting is open to the                 contact information below).
                                                with the standards of section 4 of the                  public, limited only by the space                     Alternatively, written comments to the
                                                BHC Act.                                                available. The public is welcome to                   BSC may be submitted via an on-line
                                                                                                        participate during the public comment
sradovich on DSK3GMQ082PROD with NOTICES




                                                   Unless otherwise noted, comments                                                                           form at the following website: http://
                                                regarding the applications must be                      period, 12:30 p.m. to 12:45 p.m., EDT,                www.cdc.gov/niosh/bsc/contact.html.
                                                received at the Reserve Bank indicated                  September 27, 2018. Please note that the              Agenda items are subject to change as
                                                or the offices of the Board of Governors                public comment period ends at the time                priorities dictate.
                                                not later than August 23, 2018.                         indicated above. Each commenter will                    The Director, Management Analysis
                                                   A. Federal Reserve Bank of New York                  be provided up to five minutes for                    and Services Office, has been delegated
                                                (Ivan Hurwitz, Vice President) 33                       comment. A limited number of time                     the authority to sign Federal Register
                                                Liberty Street, New York, New York                      slots are available and will be assigned              notices pertaining to announcements of


                                           VerDate Sep<11>2014   18:11 Aug 08, 2018   Jkt 244001   PO 00000   Frm 00039   Fmt 4703   Sfmt 4703   E:\FR\FM\09AUN1.SGM   09AUN1


                                                                             Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices                                                   39441

                                                meetings and other committee                            DEPARTMENT OF HEALTH AND                              FDA to conduct research relating to
                                                management activities, for both the                     HUMAN SERVICES                                        drugs and other FDA regulated products
                                                Centers for Disease Control and                                                                               in carrying out the provisions of the
                                                Prevention and the Agency for Toxic                     Food and Drug Administration                          FD&C Act.
                                                Substances and Disease Registry.                                                                                 FDA regulates prescription drug
                                                                                                        [Docket No. FDA–2017–N–0558]
                                                                                                                                                              advertising and promotional labeling
                                                Sherri A. Berger,                                                                                             directed to healthcare professionals
                                                                                                        Agency Information Collection
                                                Chief Operating Officer, Centers for Disease                                                                  (HCPs) and consumers (section 502(a)
                                                Control and Prevention.                                 Activities; Submission for Office of
                                                                                                        Management and Budget Review;                         and (n), respectively, of the FD&C Act
                                                [FR Doc. 2018–17042 Filed 8–8–18; 8:45 am]                                                                    (21 U.S.C. 352(a) and (n))). In the course
                                                                                                        Comment Request; Disclosures in
                                                BILLING CODE 4163–18–P
                                                                                                        Professional and Consumer                             of promoting their products,
                                                                                                        Prescription Drug Promotion                           pharmaceutical sponsors (sponsors) may
                                                                                                                                                              present a variety of information
                                                DEPARTMENT OF HEALTH AND                                AGENCY:    Food and Drug Administration,              including the indication, details about
                                                HUMAN SERVICES                                          HHS.                                                  the administration of the product,
                                                                                                        ACTION:   Notice.                                     efficacy information, and clinical trial
                                                Centers for Disease Control and                                                                               data. To present often complicated
                                                Prevention                                              SUMMARY:    The Food and Drug                         information concisely, sponsors may not
                                                                                                        Administration (FDA) is announcing                    include relevant information in the
                                                Notice of Closed Meeting                                that a proposed collection of                         body of the text or visual display of the
                                                                                                        information has been submitted to the                 claim. Additionally, sponsors may not
                                                  In accordance with Section 10(a)(2) of
                                                                                                        Office of Management and Budget                       always present limitations to the claim
                                                the Federal Advisory Committee Act
                                                                                                        (OMB) for review and clearance under                  in the main body of the text or display.
                                                (Pub. L. 92–463), the Centers for Disease
                                                                                                        the Paperwork Reduction Act of 1995                   In these cases, sponsors typically
                                                Control and Prevention (CDC)
                                                                                                        (PRA).                                                include disclosures of information
                                                announces the following meeting.
                                                  The meeting will be closed to the                     DATES: Fax written comments on the                    somewhere in the promotional piece.
                                                                                                        collection of information by September                   There is limited published research
                                                public in accordance with provisions set
                                                                                                        10, 2018.                                             on disclosures in prescription drug
                                                forth in Section 552b(c) (4) and (6), Title
                                                                                                        ADDRESSES: To ensure that comments on                 promotion, either directed to consumers
                                                5 U.S.C., and the Determination of the                                                                        or to HCPs. The use of disclosures is one
                                                Director, Management Analysis and                       the information collection are received,
                                                                                                        OMB recommends that written                           method of communicating information
                                                Services Office, CDC, pursuant to Public                                                                      to HCPs and consumers about scientific
                                                Law 92–463.                                             comments be faxed to the Office of
                                                                                                        Information and Regulatory Affairs,                   and clinical data, the limitations of that
                                                  Name of Committee: Safety and                                                                               data, and practical utility of that
                                                Occupational Health Study Section                       OMB, Attn: FDA Desk Officer, Fax: 202–
                                                                                                        395–7285, or emailed to oira_                         information. These disclosures may
                                                (SOHSS), National Institute for                                                                               influence HCP and consumer
                                                Occupational Safety and Health                          submission@omb.eop.gov. All
                                                                                                        comments should be identified with the                comprehension and decision making,
                                                (NIOSH).                                                                                                      and may affect how and what treatment
                                                                                                        OMB control number 0910–NEW and
                                                  Dates: October 16–October 18, 2018.                   title ‘‘Disclosures in Professional and               HCPs prescribe for their patients.
                                                  Time: 8:00 a.m.–5:00 p.m., EDT.                       Consumer Prescription Drug                            Previous research on the effectiveness of
                                                                                                        Promotion.’’ Also include the FDA                     disclosures has been conducted
                                                  Place: Embassy Suites, 1900 Diagonal
                                                                                                                                                              primarily in the dietary supplement
                                                Road, Alexandria, VA 22314.                             docket number found in brackets in the
                                                                                                                                                              arena (Refs. 1–4). Thus, the proposed
                                                  Agenda: The meeting will convene to                   heading of this document.
                                                                                                                                                              research will examine the effectiveness
                                                address matters related to the conduct of               FOR FURTHER INFORMATION CONTACT: Ila
                                                                                                                                                              of clear and conspicuous disclosures in
                                                Study Section business and for the                      S. Mizrachi, Office of Operations, Food               prescription drug promotion directed to
                                                study section to consider safety and                    and Drug Administration, Three White                  both populations. The purpose of our
                                                occupational health-related grant                       Flint North, 10A–12M, 11601                           study is to determine how useful
                                                applications.                                           Landsdown St., North Bethesda, MD                     disclosures regarding prescription drug
                                                  For Further Information Contact: Nina                 20852, 301–796–7726, PRAStaff@                        information are when presented
                                                Turner, Ph.D., Scientific Review Officer,               fda.hhs.gov.                                          prominently and adjacent to claims.1
                                                NIOSH, 1095 Willowdale Road,                            SUPPLEMENTARY INFORMATION: In                         Specifically, are HCPs and consumers
                                                Morgantown, WV 26506, (304) 285–                        compliance with 44 U.S.C. 3507, FDA                   able to use disclosures to effectively
                                                5976; nturner@cdc.gov.                                  has submitted the following proposed                  frame information in efficacy claims in
                                                  The Director, Management Analysis                     collection of information to OMB for                  prescription drug promotion?
                                                and Services Office, has been delegated                 review and clearance.                                    To address this research question, we
                                                the authority to sign Federal Register                                                                        have designed a set of studies that cover
                                                                                                        Disclosures in Professional and                       both consumers and HCPs, as well as
                                                notices pertaining to announcements of                  Consumer Prescription Drug Promotion
                                                meetings and other committee                                                                                  three presentations addressing different
                                                management activities, for both the                     OMB Control Number 0910–NEW
                                                                                                                                                                1 The Federal Trade Commission (FTC), which
                                                Centers for Disease Control and                         I. Background                                         regulates the advertising of non-prescription drug
sradovich on DSK3GMQ082PROD with NOTICES




                                                Prevention and the Agency for Toxic                                                                           products as well as other non-FDA regulated
                                                Substances and Disease Registry.                           Section 1701(a)(4) of the Public                   products (e.g., package goods, cars, etc.) issued a
                                                                                                        Health Service Act (42 U.S.C.                         specific position on disclosures (Ref. 5) for the
                                                Sherri Berger,                                          300u(a)(4)) authorizes FDA to conduct                 advertising it regulates. Specifically, FTC explains
                                                Chief Operating Officer, Centers for Disease            research relating to health information.              that disclosures must be ‘‘clear and conspicuous’’;
                                                Control and Prevention.                                                                                       in other words, in understandable language, located
                                                                                                        Section 1003(d)(2)(C) of the Federal                  near the claim to be further clarified, and not
                                                [FR Doc. 2018–17043 Filed 8–8–18; 8:45 am]              Food, Drug, and Cosmetic Act (FD&C                    hidden or minimized by small font or other
                                                BILLING CODE 4163–18–P                                  Act) (21 U.S.C. 393(d)(2)(C)) authorizes              distractions.



                                           VerDate Sep<11>2014   18:11 Aug 08, 2018   Jkt 244001   PO 00000   Frm 00040   Fmt 4703   Sfmt 4703   E:\FR\FM\09AUN1.SGM   09AUN1



Document Created: 2018-08-09 01:10:52
Document Modified: 2018-08-09 01:10:52
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 of meeting.
DatesThe meeting will be held on September 27, 2018, 8:30 a.m.-2:30 p.m., EDT.
ContactAlberto Garcia, M.S., Executive Secretary, BSC, NIOSH, CDC, 1090 Tusculum Avenue, MS-R5, Cincinnati, OH 45226, telephone (513) 841-4596, fax (513) 841-4506, email: [email protected]
FR Citation83 FR 39440 

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR