83_FR_10541 83 FR 10494 - Advisory Committee on Interdisciplinary, Community-Based Linkages

83 FR 10494 - Advisory Committee on Interdisciplinary, Community-Based Linkages

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Service Administration

Federal Register Volume 83, Issue 47 (March 9, 2018)

Page Range10494-10494
FR Document2018-04815

In accordance with the Federal Advisory Committee Act, notice is hereby given that two orientation meetings are scheduled for the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL). These meetings will be open to the public. Information about the ACICBL and the agenda for these meetings can be obtained by accessing the ACICBL website at: https://www.hrsa.gov/advisory- committees/interdisciplinary-community-linkages/meetings/index.html.

Federal Register, Volume 83 Issue 47 (Friday, March 9, 2018)
[Federal Register Volume 83, Number 47 (Friday, March 9, 2018)]
[Notices]
[Page 10494]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-04815]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Service Administration


Advisory Committee on Interdisciplinary, Community-Based Linkages

AGENCY: Health Resources and Service Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice of meetings.

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

SUMMARY: In accordance with the Federal Advisory Committee Act, notice 
is hereby given that two orientation meetings are scheduled for the 
Advisory Committee on Interdisciplinary, Community-Based Linkages 
(ACICBL). These meetings will be open to the public. Information about 
the ACICBL and the agenda for these meetings can be obtained by 
accessing the ACICBL website at: https://www.hrsa.gov/advisory-committees/interdisciplinary-community-linkages/meetings/index.html.

DATES: In order to accommodate the schedules of the ACICBL members, two 
orientation meetings will be held. The first meeting will be on March 
15, 2018 from 11:00 a.m.-4:00 p.m., ET and the second meeting will be 
on March 27, 2018 from 12:00 p.m.-5:00 p.m., ET.

ADDRESSES: These meetings will be held via conference call/webinar.
     The teleconference call-in number is 1-800-619-2521, 
passcode: 9271697.
     The webinar link is https://hrsa.connectsolutions.com/acicbl.

FOR FURTHER INFORMATION CONTACT: Anyone requesting information 
regarding the ACICBL should contact Joan Weiss, Ph.D., RN, CRNP, FAAN, 
HRSA, in one of three ways: (1) Send a request to the following 
address: Joan Weiss, Ph.D., RN, CRNP, FAAN, Senior Advisor and 
Designated Federal Officer, Division of Medicine and Dentistry, HRSA, 
5600 Fishers Lane, Room 15N39, Rockville, Maryland 20857; (2) call 
(301) 443-0430; or (3) send an email to [email protected].

SUPPLEMENTARY INFORMATION: The ACICBL provides advice and 
recommendations on a broad range of issues relating to grant programs 
authorized by sections 750-760, Title VII, Part D of the Public Health 
Service Act. During the March 15, 2018 and March 27, 2018 meetings. 
ACICBL members will be oriented to the work of the Committee and 
identify potential topics to work on for 2018.
    The ACICBL's reports are submitted to the Secretary of HHS; the 
Committee on Health, Education, Labor, and Pensions of the U.S. Senate; 
and the Committee on Energy and Commerce of the U.S. House of 
Representatives.
    Members of the public will have the opportunity to provide 
comments. Oral comments will be honored in the order they are requested 
and may be limited as time allows. Requests to make oral comments or 
provide written comments to the ACICBL should be sent by March 13, 2018 
for the March 15, 2018 meeting and by March 25, 2018 for the March 27, 
2018 meeting.

Amy McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2018-04815 Filed 3-8-18; 8:45 am]
 BILLING CODE 4165-15-P



                                             10494                           Federal Register / Vol. 83, No. 47 / Friday, March 9, 2018 / Notices

                                             purposes of §§ 314.161 and 314.162,                     DEPARTMENT OF HEALTH AND                              on Health, Education, Labor, and
                                             never marketing an approved drug                        HUMAN SERVICES                                        Pensions of the U.S. Senate; and the
                                             product is equivalent to withdrawing                                                                          Committee on Energy and Commerce of
                                             the drug from sale.                                     Health Resources and Service                          the U.S. House of Representatives.
                                                                                                     Administration                                          Members of the public will have the
                                                Goodwin Procter LLP submitted a
                                             citizen petition dated September 26,                                                                          opportunity to provide comments. Oral
                                                                                                     Advisory Committee on                                 comments will be honored in the order
                                             2017 (Docket No. FDA–2017–P–5946),                      Interdisciplinary, Community-Based                    they are requested and may be limited
                                             under 21 CFR 10.30, requesting that the                 Linkages                                              as time allows. Requests to make oral
                                             Agency determine whether DORYX
                                                                                                     AGENCY: Health Resources and Service                  comments or provide written comments
                                             MPC (doxycycline hyclate), delayed-                                                                           to the ACICBL should be sent by March
                                             release tablets, 60 mg, were withdrawn                  Administration (HRSA), Department of
                                                                                                     Health and Human Services (HHS).                      13, 2018 for the March 15, 2018 meeting
                                             from sale for reasons of safety or                                                                            and by March 25, 2018 for the March 27,
                                             effectiveness.                                          ACTION: Notice of meetings.
                                                                                                                                                           2018 meeting.
                                                After considering the citizen petition               SUMMARY:   In accordance with the                     Amy McNulty,
                                             and reviewing Agency records and                        Federal Advisory Committee Act, notice
                                                                                                                                                           Acting Director, Division of the Executive
                                             based on the information we have at this                is hereby given that two orientation                  Secretariat.
                                             time, FDA has determined under                          meetings are scheduled for the Advisory
                                                                                                                                                           [FR Doc. 2018–04815 Filed 3–8–18; 8:45 am]
                                             § 314.161 that DORYX MPC                                Committee on Interdisciplinary,
                                                                                                                                                           BILLING CODE 4165–15–P
                                             (doxycycline hyclate), delayed-release                  Community-Based Linkages (ACICBL).
                                             tablets, 60 mg, were not withdrawn for                  These meetings will be open to the
                                             reasons of safety or effectiveness. The                 public. Information about the ACICBL                  DEPARTMENT OF HEALTH AND
                                             petitioner has identified no data or other              and the agenda for these meetings can                 HUMAN SERVICES
                                             information suggesting that this drug                   be obtained by accessing the ACICBL
                                             product was withdrawn for reasons of                    website at: https://www.hrsa.gov/                     National Institutes of Health
                                             safety or effectiveness. We have                        advisory-committees/interdisciplinary-
                                             carefully reviewed our files for records                community-linkages/meetings/                          National Cancer Institute; Notice of
                                             concerning the withdrawal of DORYX                      index.html.                                           Closed Meetings
                                             MPC (doxycycline hyclate), delayed-                     DATES:  In order to accommodate the                     Pursuant to section 10(d) of the
                                             release tablets, 60 mg, from sale. We                   schedules of the ACICBL members, two                  Federal Advisory Committee Act, as
                                             have found no information that would                    orientation meetings will be held. The                amended, notice is hereby given of the
                                             indicate that this drug product was                     first meeting will be on March 15, 2018               following meetings.
                                             withdrawn from sale for reasons of                      from 11:00 a.m.–4:00 p.m., ET and the                   The meetings will be closed to the
                                             safety or effectiveness.                                second meeting will be on March 27,                   public in accordance with the
                                                                                                     2018 from 12:00 p.m.–5:00 p.m., ET.                   provisions set forth in sections
                                                Accordingly, the Agency will
                                                                                                     ADDRESSES: These meetings will be held                552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                             continue to list DORYX MPC
                                             (doxycycline hyclate), delayed-release                  via conference call/webinar.                          as amended. The grant applications and
                                                                                                        • The teleconference call-in number                the discussions could disclose
                                             tablets, 60 mg, in the ‘‘Discontinued
                                                                                                     is 1–800–619–2521, passcode: 9271697.                 confidential trade secrets or commercial
                                             Drug Product List’’ section of the Orange
                                                                                                        • The webinar link is https://                     property such as patentable material,
                                             Book. The ‘‘Discontinued Drug Product                   hrsa.connectsolutions.com/acicbl.
                                             List’’ delineates, among other items,                                                                         and personal information concerning
                                             drug products that have been                            FOR FURTHER INFORMATION CONTACT:                      individuals associated with the grant
                                                                                                     Anyone requesting information                         applications, the disclosure of which
                                             discontinued from marketing for reasons
                                                                                                     regarding the ACICBL should contact                   would constitute a clearly unwarranted
                                             other than safety or effectiveness.
                                                                                                     Joan Weiss, Ph.D., RN, CRNP, FAAN,                    invasion of personal privacy.
                                             ANDAs that refer to this drug product                   HRSA, in one of three ways: (1) Send a
                                             may be approved by the Agency as long                                                                           Name of Committee: National Cancer
                                                                                                     request to the following address: Joan                Institute Special Emphasis Panel; NCI
                                             as they meet all other legal and                        Weiss, Ph.D., RN, CRNP, FAAN, Senior                  Pediatric Early Phase Clinical Trials Network
                                             regulatory requirements for the approval                Advisor and Designated Federal Officer,               (PEP–CTN).
                                             of ANDAs. If FDA determines that                        Division of Medicine and Dentistry,                     Date: March 27, 2018.
                                             labeling for this drug product should be                HRSA, 5600 Fishers Lane, Room 15N39,                    Time: 11:00 a.m. to 2:00 p.m.
                                             revised to meet current standards, the                  Rockville, Maryland 20857; (2) call                     Agenda: To review and evaluate grant
                                             Agency will advise ANDA applicants to                   (301) 443–0430; or (3) send an email to               applications.
                                             submit such labeling.                                                                                           Place: National Cancer Institute, Shady
                                                                                                     jweiss@hrsa.gov.                                      Grove, 9609 Medical Center Drive, Room
                                               Dated: March 5, 2018.                                 SUPPLEMENTARY INFORMATION: The                        7W538, Rockville, MD 20850, (Telephone
                                             Leslie Kux,                                             ACICBL provides advice and                            Conference Call).
                                                                                                     recommendations on a broad range of                     Contact Person: Shamala K. Srinivas,
                                             Associate Commissioner for Policy.                                                                            Ph.D., Scientific Review Officer, Office of
                                                                                                     issues relating to grant programs
                                             [FR Doc. 2018–04726 Filed 3–8–18; 8:45 am]                                                                    Referral, Review, and Program Coordination,
                                                                                                     authorized by sections 750–760, Title
                                             BILLING CODE 4164–01–P                                  VII, Part D of the Public Health Service              Division of Extramural Activities, National
                                                                                                                                                           Cancer Institute, NIH, 9609 Medical Center
amozie on DSK30RV082PROD with NOTICES




                                                                                                     Act. During the March 15, 2018 and                    Drive, Room 7W530, Bethesda, MD 20892–
                                                                                                     March 27, 2018 meetings. ACICBL                       9750, 240–276–6430, ss537t@nih.gov.
                                                                                                     members will be oriented to the work of                 Name of Committee: National Cancer
                                                                                                     the Committee and identify potential                  Institute Special Emphasis Panel; U01 SEP:
                                                                                                     topics to work on for 2018.                           Liquid Biopsy & Early Cancer Assessment.
                                                                                                        The ACICBL’s reports are submitted                   Date: May 1, 2018.
                                                                                                     to the Secretary of HHS; the Committee                  Time: 10:00 a.m. to 5:00 p.m.



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Document Created: 2018-03-09 03:48:33
Document Modified: 2018-03-09 03:48:33
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 meetings.
DatesIn order to accommodate the schedules of the ACICBL members, two orientation meetings will be held. The first meeting will be on March 15, 2018 from 11:00 a.m.-4:00 p.m., ET and the second meeting will be on March 27, 2018 from 12:00 p.m.-5:00 p.m., ET.
ContactAnyone requesting information regarding the ACICBL should contact Joan Weiss, Ph.D., RN, CRNP, FAAN, HRSA, in one of three ways: (1) Send a request to the following
FR Citation83 FR 10494 

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