Meeting of the National Advisory Council on Migrant Health, 5453 [2019-02927]
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Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
information to investigators will take 1
hour per disclosure. FDA estimates that
disclosing information to any committee
or group formally designated to oversee
research involving human subjects will
average 10 minutes per disclosure.
The revised draft guidance also
references examples of disclosing
information to study subjects such as
informed consent. On average, two
disclosures per respondent will be
provided to study subjects. FDA
estimates this will take 30 minutes per
disclosure.
The total burden for the collection of
information under this revised draft
guidance is estimated to be
approximately 2,158 hours.
The revised draft guidance also refers
to previously approved collections of
information. The revised draft guidance
includes a recommendation that persons
who intend to study tobacco products
meet with FDA to discuss research
plans. Additional information about
how to request meetings with FDA’s
CTP can be found in FDA’s guidance
‘‘Meetings with Industry and
Investigators on the Research and
Development of Tobacco Products’’
(https://www.fda.gov/downloads/
TobaccoProducts/Labeling/Rules
RegulationsGuidance/UCM305282.pdf).
The collections of information in the
guidance referenced have been
approved under OMB control number
0910–0731. The collections of
information in section 801(e) of the
FD&C Act and 21 CFR 1.101(b) have
been approved under OMB control
number 0910–0482; the collections of
information for the Safety Reporting
Portal have been approved under OMB
control number 0910–0645; the
collections of information in section
905(j) of the FD&C Act have been
approved under OMB control number
0910–0673.
IV. Electronic Access
amozie on DSK3GDR082PROD with NOTICES1
Persons with access to the internet
may obtain an electronic version of the
revised draft guidance at either https://
www.regulations.gov or https://
www.fda.gov/TobaccoProducts/
Labeling/RulesRegulationsGuidance/
default.htm.
Dated: February 15, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–02971 Filed 2–20–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the National Advisory
Council on Migrant Health
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Secretary’s National
Advisory Council on Migrant Health
(NACMH) has scheduled a public
meeting. Information about NACMH
and the agenda for this meeting can be
found on the NACMH website at https://
bphc.hrsa.gov/qualityimprovement/
strategicpartnerships/nacmh/
index.html.
DATES: May 22, 2019, 9:00 a.m. to 5:00
p.m. Eastern Time (ET), and May 23,
2019, 9:00 a.m. to 5:00 p.m. ET.
ADDRESSES: The meeting will be held inperson. The address for the meeting is
The College at Brockport, State
University of New York (SUNY), Cooper
Hall, 350 New Campus Drive,
Brockport, New York 14420.
FOR FURTHER INFORMATION CONTACT:
Esther Paul, Designated Federal Official,
(DFO), Office of Policy and Program
Development, Bureau of Primary Health
Care, HRSA, 5600 Fishers Lane,
16N38B, Rockville, Maryland 20857;
(301) 594–4300; or epaul@hrsa.gov.
SUPPLEMENTARY INFORMATION: NACMH
provides advice and recommendations
to the Secretary of HHS (Secretary) on
policy, program development, and other
matters of significance concerning the
activities under section 217 of Title 42
U.S.C. 218 of the Public Health Service
(PHS) Act.
During the May 22–23, 2019, meeting,
NACMH will hear presentations from a
federal official and experts, and discuss
issues facing migrant and seasonal
agricultural workers, including the
status of agricultural worker health at
the local and national levels. Topics
addressed at this meeting include health
care for aging farmworkers, oral health,
and sexual harassment in the
agricultural industry. In addition,
during the first day of the meeting, on
May 22, 2019, the council will hear
public comments from migratory and
seasonal agricultural workers regarding
matters affecting their health. Agenda
items are subject to change as priorities
dictate. Refer to the NACMH website for
any updated information concerning the
meeting at https://bphc.hrsa.gov/quality
improvement/strategicpartnerships/
nacmh/.
SUMMARY:
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5453
Members of the public will have the
opportunity to provide comments.
Public participants may submit written
statements in advance of the scheduled
meeting. Oral comments will be
honored in the order they are requested
and may be limited as time allows.
Requests to submit a written statement
or make oral comments to NACMH
should be sent to Esther Paul, DFO,
using the contact information above at
least three business days prior to the
meeting.
Individuals who plan to attend and
need special assistance or another
reasonable accommodation should
notify Esther Paul at the address and
phone number listed above at least 10
business days prior to the meeting.
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2019–02927 Filed 2–20–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
HRSA is publishing this
notice of petitions received under the
National Vaccine Injury Compensation
Program (the Program), as required by
the Public Health Service (PHS) Act, as
amended. While the Secretary of HHS is
named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the Program in
general, contact Lisa L. Reyes, Clerk of
Court, United States Court of Federal
Claims, 717 Madison Place NW,
Washington, DC 20005, (202) 357–6400.
For information on HRSA’s role in the
Program, contact the Director, National
Vaccine Injury Compensation Program,
5600 Fishers Lane, Room 08N146B,
Rockville, MD 20857; (301) 443–6593,
or visit our website at: https://www.hrsa.
gov/vaccinecompensation/.
SUPPLEMENTARY INFORMATION: The
Program provides a system of no-fault
SUMMARY:
E:\FR\FM\21FEN1.SGM
21FEN1
Agencies
[Federal Register Volume 84, Number 35 (Thursday, February 21, 2019)]
[Notices]
[Page 5453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02927]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Meeting of the National Advisory Council on Migrant Health
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Secretary's National Advisory Council on Migrant Health
(NACMH) has scheduled a public meeting. Information about NACMH and the
agenda for this meeting can be found on the NACMH website at https://bphc.hrsa.gov/qualityimprovement/strategicpartnerships/nacmh/.
DATES: May 22, 2019, 9:00 a.m. to 5:00 p.m. Eastern Time (ET), and May
23, 2019, 9:00 a.m. to 5:00 p.m. ET.
ADDRESSES: The meeting will be held in-person. The address for the
meeting is The College at Brockport, State University of New York
(SUNY), Cooper Hall, 350 New Campus Drive, Brockport, New York 14420.
FOR FURTHER INFORMATION CONTACT: Esther Paul, Designated Federal
Official, (DFO), Office of Policy and Program Development, Bureau of
Primary Health Care, HRSA, 5600 Fishers Lane, 16N38B, Rockville,
Maryland 20857; (301) 594-4300; or epaul@hrsa.gov.
SUPPLEMENTARY INFORMATION: NACMH provides advice and recommendations to
the Secretary of HHS (Secretary) on policy, program development, and
other matters of significance concerning the activities under section
217 of Title 42 U.S.C. 218 of the Public Health Service (PHS) Act.
During the May 22-23, 2019, meeting, NACMH will hear presentations
from a federal official and experts, and discuss issues facing migrant
and seasonal agricultural workers, including the status of agricultural
worker health at the local and national levels. Topics addressed at
this meeting include health care for aging farmworkers, oral health,
and sexual harassment in the agricultural industry. In addition, during
the first day of the meeting, on May 22, 2019, the council will hear
public comments from migratory and seasonal agricultural workers
regarding matters affecting their health. Agenda items are subject to
change as priorities dictate. Refer to the NACMH website for any
updated information concerning the meeting at https://bphc.hrsa.gov/qualityimprovement/strategicpartnerships/nacmh/.
Members of the public will have the opportunity to provide
comments. Public participants may submit written statements in advance
of the scheduled meeting. Oral comments will be honored in the order
they are requested and may be limited as time allows. Requests to
submit a written statement or make oral comments to NACMH should be
sent to Esther Paul, DFO, using the contact information above at least
three business days prior to the meeting.
Individuals who plan to attend and need special assistance or
another reasonable accommodation should notify Esther Paul at the
address and phone number listed above at least 10 business days prior
to the meeting.
Amy P. McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2019-02927 Filed 2-20-19; 8:45 am]
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