82_FR_44813 82 FR 44629 - National Advisory Council on Migrant Health

82 FR 44629 - National Advisory Council on Migrant Health

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Service Administration

Federal Register Volume 82, Issue 184 (September 25, 2017)

Page Range44629-44630
FR Document2017-20422

In accordance with the Federal Advisory Committee Act, notice is hereby given that a National Advisory Council on Migrant Health (NACMH/Council) meeting has been scheduled. This meeting will be open to the public. The agenda for the NACMH meeting can be obtained by contacting the Designated Federal Officer (DFO) or accessing the Council Web site: https://bphc.hrsa.gov/qualityimprovement/ strategicpartnerships/nacmh/index.html.

Federal Register, Volume 82 Issue 184 (Monday, September 25, 2017)
[Federal Register Volume 82, Number 184 (Monday, September 25, 2017)]
[Notices]
[Pages 44629-44630]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-20422]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Service Administration


National Advisory Council on Migrant Health

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

ACTION: Notice of meeting.

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SUMMARY: In accordance with the Federal Advisory Committee Act, notice 
is hereby given that a National Advisory Council on Migrant Health 
(NACMH/Council) meeting has been scheduled. This meeting will be open 
to the public. The agenda for the NACMH meeting can be obtained by 
contacting the Designated Federal Officer (DFO) or accessing the 
Council Web site: https://bphc.hrsa.gov/qualityimprovement/strategicpartnerships/nacmh/index.html.

DATES: The meeting will be held on November 7, 2017, 8:30 a.m.to 5:00 
p.m.

[[Page 44630]]

ET, and November 8, 2017, 8:30 a.m. to 5:00 p.m. ET.

ADDRESSES: The address for the meeting is Doubletree by Hilton Raleigh 
Brownstone-University, 1707 Hillsborough Street, Raleigh, NC 27605. 
Phone: (919) 828-0811.

FOR FURTHER INFORMATION CONTACT: All requests for information regarding 
the NACMH should be sent to Esther Paul, DFO, NACMH, HRSA, in one of 
three ways: (1) By mail to: Esther Paul, Office of Policy and Program 
Development, Bureau of Primary Health Care, HRSA, 5600 Fishers Lane, 
16N38B, Rockville, Maryland 20857; (2) by phone: (301) 594-4300; or (3) 
by email: [email protected].

SUPPLEMENTARY INFORMATION: The NACMH is a non-discretionary advisory 
body mandated by the Public Health Service (PHS) Act, Title 42 U.S.C. 
218, to advise, consult with, and make recommendations to the Secretary 
of HHS and the Administrator of HRSA regarding the organization, 
operation, selection, and funding of migrant health centers and other 
entities funded under section 330(g) of the PHS Act (42 U.S.C. 254b). 
The NACMH Charter requires that the Council meet at least twice per 
year to discuss services and issues related to the health of migrant 
and seasonal agricultural workers and their families and to formulate 
their recommendations to the HHS Secretary and HRSA Administrator.
    Agenda: The agenda includes an overview of the Council's general 
business activities. The Council will also hear presentations from a 
federal official and experts on issues facing agricultural workers, 
including the status of agricultural worker health at the local and 
national levels. In addition, the Council will hold a public hearing 
where migratory and seasonal agricultural workers will testify 
regarding matters affecting them. This hearing is scheduled for 
Tuesday, November 7, 2017 from 1:30 p.m. to 5:00 p.m. at the Doubletree 
by Hilton Raleigh Brownstone-University. Agenda items are subject to 
change as priorities indicate.
    Public Participation: Members of the public will not be able to 
provide oral comments during the meeting. Please provide any written 
questions or comments for the NACMH to the DFO by October 27, 2017, 
using the address, phone number, or email provided above. Individuals 
who plan to attend the meeting and need special assistance, such as 
sign language interpretation or other reasonable accommodations, should 
notify the DFO at least 10 days prior to the meeting.

Amy McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2017-20422 Filed 9-22-17; 8:45 am]
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                                                                              Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices                                                  44629

                                                    Staff, FDA will post your comment, as                   Tobacco Products, Food and Drug                       II. Significance of Guidance
                                                    well as any attachments, except for                     Administration, Document Control                        This guidance is being issued
                                                    information submitted, marked and                       Center, Bldg. 71, Rm. G335, 10903 New                 consistent with FDA’s good guidance
                                                    identified, as confidential, if submitted               Hampshire Ave., Silver Spring, MD                     practices regulation (21 CFR 10.115).
                                                    as detailed in ‘‘Instructions.’’                        20993–0002. Send one self-addressed                   The guidance represents the current
                                                       Instructions: All submissions received               adhesive label to assist that office in               thinking of FDA on its compliance
                                                    must include the Docket No. FDA–                        processing your request or include a Fax              policy for cigars in small packaging. It
                                                    2017–D–0121 for ‘‘Compliance Policy                     number to which the guidance
                                                    for Required Warning Statements on                                                                            does not establish any rights for any
                                                                                                            document may be sent. See the                         person and is not binding on FDA or the
                                                    Small-Packaged Cigars.’’ Received                       SUPPLEMENTARY INFORMATION section for
                                                    comments will be placed in the docket                                                                         public. You can use an alternative
                                                                                                            information on electronic access to the               approach if it satisfies the requirements
                                                    and, except for those submitted as                      guidance.
                                                    ‘‘Confidential Submissions,’’ publicly                                                                        of the applicable statutes and
                                                                                                            FOR FURTHER INFORMATION CONTACT:                      regulations. This guidance is not subject
                                                    viewable at https://www.regulations.gov
                                                                                                            Deirdre Jurand, Center for Tobacco                    to Executive Order 12866.
                                                    or at the Dockets Management Staff
                                                                                                            Products, Food and Drug
                                                    between 9 a.m. and 4 p.m., Monday                                                                             III. Paperwork Reduction Act of 1995
                                                                                                            Administration, 10903 New Hampshire
                                                    through Friday.
                                                       • Confidential Submissions—To                        Ave., Document Control Center, Bldg.                    This guidance also refers to
                                                    submit a comment with confidential                      71, Rm. G335, Silver Spring, MD 20993–                previously approved collections of
                                                    information that you do not wish to be                  0002, 1–877–287–1373, AskCTP@                         information found in FDA regulations.
                                                    made publicly available, submit your                    fda.hhs.gov.                                          The collections of information in 21
                                                    comments only as a written/paper                                                                              CFR part 1143 have been approved
                                                                                                            SUPPLEMENTARY INFORMATION:
                                                    submission. You should submit two                                                                             under 0910–0768.
                                                    copies total. One copy will include the                 I. Background
                                                                                                                                                                  IV. Electronic Access
                                                    information you claim to be confidential                   FDA is announcing the availability of
                                                    with a heading or cover note that states                                                                        Persons with access to the internet
                                                                                                            a guidance for industry entitled                      may obtain an electronic version of the
                                                    ‘‘THIS DOCUMENT CONTAINS                                ‘‘Compliance Policy for Required
                                                    CONFIDENTIAL INFORMATION’’. The                                                                               guidance at either https://
                                                                                                            Warning Statements on Small-Packaged                  www.regulations.gov or https://
                                                    Agency will review this copy, including                 Cigars.’’
                                                    the claimed confidential information, in                                                                      www.fda.gov/TobaccoProducts/
                                                                                                               On June 22, 2009, the Family                       Labeling/RulesRegulationsGuidance/
                                                    its consideration of comments. The                      Smoking Prevention and Tobacco
                                                    second copy, which will have the                                                                              default.htm.
                                                                                                            Control Act (Tobacco Control Act) (Pub.
                                                    claimed confidential information                        L. 111–31) was signed into law. The                     Dated: September 20, 2017.
                                                    redacted/blacked out, will be available                 Tobacco Control Act granted FDA the                   Anna K. Abram,
                                                    for public viewing and posted on                                                                              Deputy Commissioner for Policy, Planning,
                                                                                                            authority to regulate the manufacture,
                                                    https://www.regulations.gov. Submit                                                                           Legislation, and Analysis.
                                                                                                            marketing, and distribution of cigarettes,
                                                    both copies to the Dockets Management                                                                         [FR Doc. 2017–20426 Filed 9–22–17; 8:45 am]
                                                                                                            cigarette tobacco, roll-your-own tobacco
                                                    Staff. If you do not wish your name and
                                                                                                            (RYO), and smokeless tobacco products                 BILLING CODE 4164–01–P
                                                    contact information to be made publicly
                                                                                                            to protect the public health and to
                                                    available, you can provide this
                                                                                                            reduce tobacco use by minors.
                                                    information on the cover sheet and not                                                                        DEPARTMENT OF HEALTH AND
                                                    in the body of your comments and you                       The Tobacco Control Act also gave
                                                                                                            FDA the authority to issue a regulation               HUMAN SERVICES
                                                    must identify this information as
                                                    ‘‘confidential.’’ Any information marked                deeming other products that meet the                  Health Resources and Service
                                                    as ‘‘confidential’’ will not be disclosed               statutory definition of a tobacco product             Administration
                                                    except in accordance with 21 CFR 10.20                  to be subject to Chapter IX of the FD&C
                                                    and other applicable disclosure law. For                Act (section 901(b) of the FD&C Act). On              National Advisory Council on Migrant
                                                    more information about FDA’s posting                    May 10, 2016, FDA issued that rule,                   Health
                                                    of comments to public dockets, see 80                   extending FDA’s tobacco product
                                                                                                            authority to cigars, among other                      AGENCY: Health Resources and Service
                                                    FR 56469, September 18, 2015, or access                                                                       Administration (HRSA), Department of
                                                    the information at: https://www.gpo.gov/                products (81 FR 28973). Among the
                                                                                                            requirements that now apply to cigars                 Health and Human Services (HHS).
                                                    fdsys/pkg/FR-2015-09-18/pdf/2015-
                                                    23389.pdf.                                              are health warning statements                         ACTION: Notice of meeting.
                                                       Docket: For access to the docket to                  prescribed under section 906(d) of the
                                                                                                            FD&C Act, which permits restrictions on               SUMMARY:   In accordance with the
                                                    read background documents or the                                                                              Federal Advisory Committee Act, notice
                                                    electronic and written/paper comments                   the sale and distribution of tobacco
                                                                                                            products that are ‘‘appropriate for the               is hereby given that a National Advisory
                                                    received, go to https://                                                                                      Council on Migrant Health (NACMH/
                                                    www.regulations.gov and insert the                      protection of the public health.’’ The
                                                                                                            rule specifies the health warning                     Council) meeting has been scheduled.
                                                    docket number, found in brackets in the                                                                       This meeting will be open to the public.
                                                    heading of this document, into the                      statements that must be displayed on
                                                                                                            cigar packaging and where those                       The agenda for the NACMH meeting can
asabaliauskas on DSKBBXCHB2PROD with NOTICES




                                                    ‘‘Search’’ box and follow the prompts                                                                         be obtained by contacting the
                                                    and/or go to the Dockets Management                     statements must be placed, among other
                                                                                                            requirements.                                         Designated Federal Officer (DFO) or
                                                    Staff, 5630 Fishers Lane, Rm. 1061,                                                                           accessing the Council Web site: https://
                                                    Rockville, MD 20852.                                       The guidance discusses FDA’s
                                                                                                            compliance policy for cigars with                     bphc.hrsa.gov/qualityimprovement/
                                                       You may submit comments on any
                                                                                                            packaging too small or otherwise unable               strategicpartnerships/nacmh/
                                                    guidance at any time (see 21 CFR
                                                                                                            to accommodate the warning statements                 index.html.
                                                    10.115(g)(5)).
                                                       Submit written requests for single                   and specifications required under the                      The meeting will be held on
                                                                                                                                                                  DATES:
                                                    copies of this guidance to the Center for               regulation.                                           November 7, 2017, 8:30 a.m.to 5:00 p.m.


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                                                    44630                     Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices

                                                    ET, and November 8, 2017, 8:30 a.m. to                  should notify the DFO at least 10 days                including attachments, to https://
                                                    5:00 p.m. ET.                                           prior to the meeting.                                 www.regulations.gov will be posted to
                                                                                                                                                                  the docket unchanged. Because your
                                                    ADDRESSES:  The address for the meeting                 Amy McNulty,
                                                                                                                                                                  comment will be made public, you are
                                                    is Doubletree by Hilton Raleigh                         Acting Director, Division of the Executive            solely responsible for ensuring that your
                                                    Brownstone-University, 1707                             Secretariat.
                                                                                                                                                                  comment does not include any
                                                    Hillsborough Street, Raleigh, NC 27605.                 [FR Doc. 2017–20422 Filed 9–22–17; 8:45 am]           confidential information that you or a
                                                    Phone: (919) 828–0811.                                  BILLING CODE 4165–15–P                                third party may not wish to be posted,
                                                    FOR FURTHER INFORMATION CONTACT:     All                                                                      such as medical information, your or
                                                    requests for information regarding the                                                                        anyone else’s Social Security number, or
                                                    NACMH should be sent to Esther Paul,                    DEPARTMENT OF HEALTH AND                              confidential business information, such
                                                    DFO, NACMH, HRSA, in one of three                       HUMAN SERVICES                                        as a manufacturing process. Please note
                                                    ways: (1) By mail to: Esther Paul, Office               [Docket No. FDA–2015–D–3638]                          that if you include your name, contact
                                                    of Policy and Program Development,                                                                            information, or other information that
                                                    Bureau of Primary Health Care, HRSA,                    Minutes of Institutional Review Board                 identifies you in the body of your
                                                    5600 Fishers Lane, 16N38B, Rockville,                   Meetings; Guidance for Institutions                   comments, that information will be
                                                    Maryland 20857; (2) by phone: (301)                     and Institutional Review Boards;                      posted on https://www.regulations.gov.
                                                    594–4300; or (3) by email: epaul@                       Availability                                            • If you want to submit a comment
                                                    hrsa.gov.                                                                                                     with confidential information that you
                                                                                                            AGENCY:  The Office for Human Research                do not wish to be made available to the
                                                    SUPPLEMENTARY INFORMATION:      The                     Protections, Office of the Assistant                  public, submit the comment as a
                                                    NACMH is a non-discretionary advisory                   Secretary for Health, Office of the                   written/paper submission and in the
                                                    body mandated by the Public Health                      Secretary, and the Food and Drug                      manner detailed (see ‘‘Written/Paper
                                                    Service (PHS) Act, Title 42 U.S.C. 218,                 Administration, HHS.                                  Submissions’’ and ‘‘Instructions’’).
                                                    to advise, consult with, and make                       ACTION: Notice of availability.
                                                    recommendations to the Secretary of                                                                           Written/Paper Submissions
                                                                                                            SUMMARY:   The Office for Human                          Submit written/paper submissions as
                                                    HHS and the Administrator of HRSA
                                                                                                            Research Protections (OHRP), Office of                follows:
                                                    regarding the organization, operation,
                                                                                                            the Assistant Secretary for Health, and                  • Mail/Hand delivery/Courier (for
                                                    selection, and funding of migrant health
                                                                                                            the Food and Drug Administration                      written/paper submissions): Dockets
                                                    centers and other entities funded under
                                                                                                            (FDA) are announcing the availability of              Management Staff (HFA–305), Food and
                                                    section 330(g) of the PHS Act (42 U.S.C.
                                                                                                            a guidance entitled ‘‘Minutes of                      Drug Administration, 5630 Fishers
                                                    254b). The NACMH Charter requires
                                                                                                            Institutional Review Board Meetings;                  Lane, Rm. 1061, Rockville, MD 20852.
                                                    that the Council meet at least twice per
                                                                                                            Guidance for Institutions and                            • For written/paper comments
                                                    year to discuss services and issues
                                                                                                            Institutional Review Boards.’’ The                    submitted to the Dockets Management
                                                    related to the health of migrant and
                                                                                                            guidance is intended for institutions                 Staff, FDA will post your comment, as
                                                    seasonal agricultural workers and their
                                                                                                            and Institutional Review Boards (IRBs)                well as any attachments, except for
                                                    families and to formulate their
                                                                                                            that are responsible for the review and               information submitted, marked and
                                                    recommendations to the HHS Secretary
                                                                                                            oversight of human subject research                   identified, as confidential, if submitted
                                                    and HRSA Administrator.
                                                                                                            conducted or supported by the U.S.                    as detailed in ‘‘Instructions.’’
                                                       Agenda: The agenda includes an                       Department of Health and Human                           Instructions: All submissions received
                                                    overview of the Council’s general                       Services (HHS) or regulated by FDA.                   must include the Docket No. FDA–
                                                    business activities. The Council will                   The purpose of the guidance is to assist              2015–D–3638 for ‘‘Minutes of
                                                    also hear presentations from a federal                  institutions and IRBs in preparing and                Institutional Review Board Meetings;
                                                    official and experts on issues facing                   maintaining minutes of IRB meetings                   Guidance for Institutions and
                                                    agricultural workers, including the                     (also referred to in the guidance as                  Institutional Review Boards.’’ Received
                                                    status of agricultural worker health at                 minutes) that meet the regulatory                     comments will be placed in the docket
                                                    the local and national levels. In                       requirements for minutes set forth in                 and, except for those submitted as
                                                    addition, the Council will hold a public                FDA and HHS regulations. The                          ‘‘Confidential Submissions,’’ publicly
                                                    hearing where migratory and seasonal                    guidance also provides general                        viewable at https://www.regulations.gov
                                                    agricultural workers will testify                       recommendations on the type and                       or at the office of Dockets Management
                                                    regarding matters affecting them. This                  amount of information to be included in               Staff between 9 a.m. and 4 p.m.,
                                                    hearing is scheduled for Tuesday,                       the minutes. The guidance announced                   Monday through Friday.
                                                    November 7, 2017 from 1:30 p.m. to                      in this notice finalizes the draft                       • Confidential Submissions—To
                                                    5:00 p.m. at the Doubletree by Hilton                   guidance of the same title dated                      submit a comment with confidential
                                                    Raleigh Brownstone-University. Agenda                   November 2015.                                        information that you do not wish to be
                                                    items are subject to change as priorities               DATES: The announcement of the                        made publicly available, submit your
                                                    indicate.                                               guidance is published in the Federal                  comments only as a written/paper
                                                       Public Participation: Members of the                 Register on September 25, 2017.                       submission. You should submit two
                                                    public will not be able to provide oral                 ADDRESSES: You may submit comments                    copies total. One copy will include the
asabaliauskas on DSKBBXCHB2PROD with NOTICES




                                                    comments during the meeting. Please                     as follows:                                           information you claim to be confidential
                                                    provide any written questions or                                                                              with a heading or cover note that states
                                                    comments for the NACMH to the DFO                       Electronic Submissions                                ‘‘THIS DOCUMENT CONTAINS
                                                    by October 27, 2017, using the address,                   Submit electronic comments in the                   CONFIDENTIAL INFORMATION.’’ The
                                                    phone number, or email provided                         following way:                                        Agency will review this copy, including
                                                    above. Individuals who plan to attend                     • Federal eRulemaking Portal:                       the claimed confidential information, in
                                                    the meeting and need special assistance,                https://www.regulations.gov. Follow the               its consideration of comments. The
                                                    such as sign language interpretation or                 instructions for submitting comments.                 second copy, which will have the
                                                    other reasonable accommodations,                        Comments submitted electronically,                    claimed confidential information


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Document Created: 2018-10-24 14:41:21
Document Modified: 2018-10-24 14:41:21
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 November 7, 2017, 8:30 a.m.to 5:00 p.m. ET, and November 8, 2017, 8:30 a.m. to 5:00 p.m. ET.
ContactAll requests for information regarding the NACMH should be sent to Esther Paul, DFO, NACMH, HRSA, in one of three ways: (1) By mail to: Esther Paul, Office of Policy and Program Development, Bureau of Primary Health Care, HRSA, 5600 Fishers Lane, 16N38B, Rockville, Maryland 20857; (2) by phone: (301) 594-4300; or (3) by email: [email protected]
FR Citation82 FR 44629 

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