83 FR 3173 - Office of the Secretary; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 15 (January 23, 2018)

Page Range		3173-3174
FR Document		2018-01082

Federal Register, Volume 83 Issue 15 (Tuesday, January 23, 2018)

[Federal Register Volume 83, Number 15 (Tuesday, January 23, 2018)]
[Notices]
[Pages 3173-3174]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-01082]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Office of the Secretary; Notice of Meeting

    Pursuant to section 10(a) of the Federal Advisory Committee Act, as 
amended, notice is hereby given of meetings of the Task Force on 
Research Specific to Pregnant Women and Lactating Women.
    The meetings will be open to the public, with attendance limited to 
space available. Individuals who plan to attend and need special 
assistance, such as sign language interpretation or other reasonable 
accommodations, should notify the Contact Person listed below in 
advance of the meeting.

    Name of Committee: Task Force on Research Specific to Pregnant 
Women and Lactating Women.
    Date: February 26-27, 2018.
    Time: February 26, 2018, 8:30 a.m. to 5:00 p.m.; February 27, 2018, 
8:00 a.m. to 3:00 p.m.
    Agenda: The Task Force is charged with providing advice and 
guidance to the Secretary of HHS, regarding Federal activities related 
to identifying and addressing gaps in knowledge and research regarding 
safe and effective therapies for pregnant women and lactating women, 
including the development of such therapies and the collaboration on 
and coordination of such activities.

February 26th, 2018--Day 1

8:30 a.m.--Welcome and Opening Remarks
8:40 a.m.--Introductions
8:45 a.m.--Summary and Discussion of work products from meetings 1 and 
2
10:45 a.m.--Follow-up on Task Force Request regarding Lessons learned 
from Pediatrics
1:15 p.m.--Effective communication strategies with health care 
providers and the public on information relevant to pregnant women and 
lactating women
1:50 p.m.--Panel: Effective communication strategies with health care 
providers on information relevant to pregnant women and lactating women
3:30 p.m.--Panel: Effective communication strategies with the public on 
information relevant to pregnant women and lactating women.
4:10 p.m.--Discussion
5:00 p.m.--End of Day 1

February 27th, 2018--Day 2

8:00 a.m.--Recap from Day 1, Outline & Goals of Day 2
8:15 a.m.--Panel and open discussion to cover specific questions on the 
options for a plan or plans to identify and address gaps in knowledge 
and research regarding safe and effective therapies for pregnant women 
and lactating women, including the development of such therapies.
12:45 p.m.--Discussion of Key Points related to topic: Effective 
communication strategies with health care providers and the public on 
information relevant to pregnant women and lactating women
1:30 p.m.--Discussion of Key Points related to topic: A plan to 
identify and address gaps in knowledge and research regarding safe and 
effective therapies for pregnant women and lactating women, including 
the development of such therapies
2:15 p.m.--Review of Recommendations from TF1-3
2:45 p.m.--Action Items, Charge to Group
3:00 p.m.--Adjournment

    Place: 6710B Rockledge Drive, Room 1425/1427 (1st Floor), Bethesda, 
MD 20817.
    Contact Person: Ms. Lisa Kaeser, Executive Secretary, Eunice 
Kennedy Shriver National Institute of Child Health and Human 
Development, 31 Center Drive, Room 2A03, MSC 2425, Bethesda, MD 20892, 
(301) 496-0536, [email protected].
    Public comments are welcome either by filing written comments and/
or providing oral comments at the meeting. Oral comments from the 
public will be scheduled on February 26, 2018, from approximately 10:00 
a.m.-10:45 a.m. Any member of the public interested in presenting oral 
comments on February 26, 2018, should submit a letter of intent, a 
brief description of the organization represented, and the oral 
presentation to Ms. Lisa Kaeser ([email protected]) by 5:00 p.m. on 
Monday, February 19, 2018. Written

[[Page 3174]]

comments to be included at the meeting should also be sent to Lisa 
Kaeser by 5:00 p.m. on Monday, February 19, 2018.
    The submitted presentations and any written comments will be 
formatted to be posted on the PRGLAC website for the record. Only one 
representative of an organization may be allowed to present oral 
comments. Presentations will be limited to three to five minutes per 
speaker depending on the number of speakers to be accommodated within 
the allotted time. Speakers will be assigned a time to speak in the 
order of the date and time when their request to speak is received. 
Both printed and electronic copies are requested for the record.
    Details and additional information about these meetings can be 
found at the NICHD website for the Task Force on Research Specific to 
Pregnant Women and Lactating Women (PRGLAC) https://www.nichd.nih.gov/about/advisory/PRGLAC/Pages/index.aspx.

    Dated: January 17, 2018.
Michelle Trout,
Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-01082 Filed 1-22-18; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices 3173

SUPPLEMENTARY INFORMATION: Pursuant pages in length. Individuals submitting 1:50 p.m.—Panel: Effective
to Section 2101 of the Public Health written comments should email their communication strategies with
Service Act (42 U.S.C. 300aa–1), the comments to the National Vaccine health care providers on
Secretary of Health and Human Services Program Office (nvpo@hhs.gov) at least information relevant to pregnant
was mandated to establish the National five business days prior to the meeting. women and lactating women
Vaccine Program to achieve optimal Dated: January 17, 2018. 3:30 p.m.—Panel: Effective
prevention of human infectious diseases communication strategies with the
Roula Sweis,
through immunization and to achieve public on information relevant to
Deputy Director, National Vaccine Program
optimal prevention against adverse pregnant women and lactating
Office.
reactions to vaccines. The NVAC was women.
[FR Doc. 2018–01142 Filed 1–22–18; 8:45 am]
established to provide advice and make 4:10 p.m.—Discussion
recommendations to the Director of the BILLING CODE 4150–44–P 5:00 p.m.—End of Day 1
National Vaccine Program on matters February 27th, 2018—Day 2
related to the Program’s responsibilities.
The Assistant Secretary for Health DEPARTMENT OF HEALTH AND 8:00 a.m.—Recap from Day 1, Outline &
serves as Director of the National HUMAN SERVICES Goals of Day 2
Vaccine Program. During the February 8:15 a.m.—Panel and open discussion to
National Institutes of Health cover specific questions on the
2018 NVAC meeting, sessions will
consist of presentations on vaccine options for a plan or plans to
Office of the Secretary; Notice of
innovation, including the current status identify and address gaps in
Meeting
of adjuvants in vaccines, universal knowledge and research regarding
influenza, and an overview on the Pursuant to section 10(a) of the safe and effective therapies for
Secretary of the Department of Health Federal Advisory Committee Act, as pregnant women and lactating
and Human Services’ Report to Congress amended, notice is hereby given of women, including the development
on Vaccine Innovation in response to meetings of the Task Force on Research of such therapies.
the 21st Century Cures Act; a report out Specific to Pregnant Women and 12:45 p.m.—Discussion of Key Points
on the recently approved Presidential Lactating Women. related to topic: Effective
Advisory Council on Combatting The meetings will be open to the communication strategies with
Antibiotic-Resistant Bacteria Report, public, with attendance limited to space health care providers and the
‘‘Incentivizing the Development of available. Individuals who plan to public on information relevant to
Vaccines, Therapeutics, and Diagnostics attend and need special assistance, such pregnant women and lactating
to Combat Antibiotic Resistant as sign language interpretation or other women
Bacteria’’; disparities in adult reasonable accommodations, should 1:30 p.m.—Discussion of Key Points
immunizations; and an update on notify the Contact Person listed below related to topic: A plan to identify
strategies to support improving coverage in advance of the meeting. and address gaps in knowledge and
for human papillomavirus vaccine. Name of Committee: Task Force on research regarding safe and
Please note that agenda items will be Research Specific to Pregnant Women effective therapies for pregnant
related to the charge of the Committee and Lactating Women. women and lactating women,
and are subject to change as priorities Date: February 26–27, 2018. including the development of such
dictate. Information on the final meeting Time: February 26, 2018, 8:30 a.m. to therapies
agenda will be posted prior to the 5:00 p.m.; February 27, 2018, 8:00 a.m. 2:15 p.m.—Review of Recommendations
meeting on the NVAC website: http:// to 3:00 p.m. from TF1–3
www.hhs.gov/nvpo/nvac/index.html. Agenda: The Task Force is charged 2:45 p.m.—Action Items, Charge to
Public attendance at the meeting is with providing advice and guidance to Group
limited to the available space. the Secretary of HHS, regarding Federal 3:00 p.m.—Adjournment
Individuals who plan to attend in activities related to identifying and Place: 6710B Rockledge Drive, Room
person and need special assistance, addressing gaps in knowledge and 1425/1427 (1st Floor), Bethesda, MD
such as sign language interpretation or research regarding safe and effective 20817.
other reasonable accommodations, therapies for pregnant women and Contact Person: Ms. Lisa Kaeser,
should notify the National Vaccine lactating women, including the Executive Secretary, Eunice Kennedy
Program Office at the address/phone development of such therapies and the Shriver National Institute of Child
number listed above at least one week collaboration on and coordination of Health and Human Development, 31
prior to the meeting. For those unable to such activities. Center Drive, Room 2A03, MSC 2425,
attend in person, a live webcast will be Bethesda, MD 20892, (301) 496–0536,
available. More information on February 26th, 2018—Day 1 kaeserl@mail.nih.gov.
registration and accessing the webcast 8:30 a.m.—Welcome and Opening Public comments are welcome either
can be found at http://www.hhs.gov/ Remarks by filing written comments and/or
nvpo/nvac/meetings/index.html. 8:40 a.m.—Introductions providing oral comments at the meeting.
Members of the public will have the 8:45 a.m.—Summary and Discussion of Oral comments from the public will be
opportunity to provide comments at the work products from meetings 1 and scheduled on February 26, 2018, from
NVAC meeting during the public 2 approximately 10:00 a.m.–10:45 a.m.
Any member of the public interested in
sradovich on DSK3GMQ082PROD with NOTICES

comment periods designated on the 10:45 a.m.—Follow-up on Task Force
agenda. Public comments made during Request regarding Lessons learned presenting oral comments on February
the meeting will be limited to three from Pediatrics 26, 2018, should submit a letter of
minutes per person to ensure time is 1:15 p.m.—Effective communication intent, a brief description of the
allotted for all those wishing to speak. strategies with health care providers organization represented, and the oral
Individuals are also welcome to submit and the public on information presentation to Ms. Lisa Kaeser
their written comments. Written relevant to pregnant women and (Kaeserl@mail.nih.gov) by 5:00 p.m. on
comments should not exceed three lactating women Monday, February 19, 2018. Written

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3174 Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices

comments to be included at the meeting Contact Person: Suzan Nadi, Ph.D., Time: 10:00 a.m. to 3:15 p.m.
should also be sent to Lisa Kaeser by Scientific Review Officer, Center for Agenda: To review and evaluate grant
5:00 p.m. on Monday, February 19, Scientific Review, National Institutes of applications.
Health, 6701 Rockledge Drive, Room 5217B, Place: National Institutes of Health, 6701
2018.
MSC 7846, Bethesda, MD 20892, 301–435– Rockledge Drive, Bethesda, MD 20892.
The submitted presentations and any 1259, nadis@csr.nih.gov. Contact Person: Marie-Jose Belanger, Ph.D.,
written comments will be formatted to This notice is being published less than 15 Scientific Review Officer, Center for
be posted on the PRGLAC website for days prior to the meeting due to the timing Scientific Review, National Institutes of
the record. Only one representative of limitations imposed by the review and Health, 6701 Rockledge Drive, Rm 6188 MSC
an organization may be allowed to funding cycle. 7804, Bethesda, MD 20892, 301–435–1267,
present oral comments. Presentations (Catalogue of Federal Domestic Assistance belangerm@csr.nih.gov.
will be limited to three to five minutes Program Nos. 93.306, Comparative Medicine; Name of Committee: Genes, Genomes, and
per speaker depending on the number of 93.333, Clinical Research; 93.306, 93.333, Genetics Integrated Review Group;
speakers to be accommodated within 93.337, 93.393–93.396, 93.837–93.844, Therapeutic Approaches to Genetic Diseases
93.846–93.878, 93.892, 93.893, National Study Section.
the allotted time. Speakers will be Institutes of Health, HHS) Date: February 15, 2018.
assigned a time to speak in the order of Time: 10:00 a.m. to 7:00 p.m.
the date and time when their request to Dated: January 17, 2018.
Agenda: To review and evaluate grant
speak is received. Both printed and David Clary, applications.
electronic copies are requested for the Program Analyst, Office of Federal Advisory Place: National Institutes of Health, 6701
record. Committee Policy. Rockledge Drive, Bethesda, MD 20892
Details and additional information [FR Doc. 2018–01077 Filed 1–22–18; 8:45 am] (Virtual Meeting).
about these meetings can be found at the BILLING CODE 4140–01–P Contact Person: Methode Bacanamwo,
NICHD website for the Task Force on Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Research Specific to Pregnant Women Health, 6701 Rockledge Drive, Room 2200,
and Lactating Women (PRGLAC) DEPARTMENT OF HEALTH AND
Bethesda, MD 20892, 301–827–7088,
https://www.nichd.nih.gov/about/ HUMAN SERVICES methode.bacanamwo@nih.gov.
advisory/PRGLAC/Pages/index.aspx. Name of Committee: Center for Scientific
National Institutes of Health
Dated: January 17, 2018. Review Special Emphasis Panel; RFA–RM–
Michelle Trout, Center for Scientific Review; Notice of 17–029: Innovative Adaptations to Simplify
Closed Meetings Existing Technologies for Manipulation and
Analyst, Office of Federal Advisory
Analysis of Glycans.
Committee Policy.
Pursuant to section 10(d) of the Date: February 15, 2018.
[FR Doc. 2018–01082 Filed 1–22–18; 8:45 am] Time: 3:00 p.m. to 6:00 p.m.
Federal Advisory Committee Act, as
BILLING CODE 4140–01–P amended, notice is hereby given of the Agenda: To review and evaluate grant
following meetings. applications.
Place: National Institutes of Health, 6701
The meetings will be closed to the
DEPARTMENT OF HEALTH AND Rockledge Drive, Bethesda, MD 20892.
public in accordance with the Contact Person: Marie-Jose Belanger, Ph.D.,
HUMAN SERVICES provisions set forth in sections Scientific Review Officer, Center for
National Institutes of Health 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Scientific Review, National Institutes of
as amended. The grant applications and Health, 6701 Rockledge Drive, Rm 6188 MSC
Center for Scientific Review; Notice of the discussions could disclose 7804, Bethesda, MD 20892, 301–435–1267,
Closed Meeting confidential trade secrets or commercial belangerm@csr.nih.gov.
property such as patentable material, Name of Committee: Center for Scientific
Pursuant to section 10(d) of the and personal information concerning Review Special Emphasis Panel; PAR Panel:
Federal Advisory Committee Act, as individuals associated with the grant Screenable Disorders: Therapeutics, Tools
amended, notice is hereby given of the applications, the disclosure of which and Natural History.
following meeting. Date: February 16, 2018.
would constitute a clearly unwarranted
Time: 10:00 a.m. to 7:00 p.m.
The meeting will be closed to the invasion of personal privacy. Agenda: To review and evaluate grant
public in accordance with the Name of Committee: Oncology 2— applications.
provisions set forth in sections Translational Clinical Integrated Review Place: National Institutes of Health, 6701
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Group; Radiation Therapeutics and Biology Rockledge Drive, Bethesda, MD 20892
as amended. The grant applications and Study Section. (Virtual Meeting).
the discussions could disclose Date: February 12–13, 2018. Contact Person: Methode Bacanamwo,
confidential trade secrets or commercial Time: 8:00 a.m. to 5:00 p.m. Ph.D., Scientific Review Officer, Center for
property such as patentable material, Agenda: To review and evaluate grant Scientific Review, National Institutes of
and personal information concerning applications. Health, 6701 Rockledge Drive, Room 2200,
Place: Embassy Suites at the Chevy Chase Bethesda, MD 20892, 301–827–7088,
individuals associated with the grant
Pavilion, 4300 Military Road NW, methode.bacanamwo@nih.gov.
applications, the disclosure of which Washington, DC 20015. Name of Committee: Center for Scientific
would constitute a clearly unwarranted Contact Person: Bo Hong, Ph.D., Scientific Review Special Emphasis Panel;
invasion of personal privacy. Review Officer, Center for Scientific Review, Cardiovascular Disorders.
Name of Committee: Center for Scientific National Institutes of Health, 6701 Rockledge Date: February 21, 2018.
Review Special Emphasis Panel; Epilepsy: Drive, Room 6194, MSC 7804, Bethesda, MD Time: 10:00 a.m. to 7:00 p.m.
sradovich on DSK3GMQ082PROD with NOTICES

Molecular Mechanisms. 20892, 301–996–6208, hongb@csr.nih.gov. Agenda: To review and evaluate grant
Date: January 24, 2018. Name of Committee: Center for Scientific applications.
Time: 3:00 p.m. to 6:00 p.m. Review Special Emphasis Panel; RFA–RM– Place: National Institutes of Health, 6701
Agenda: To review and evaluate grant 17–030: Novel and Innovative Tools to Rockledge Drive, Bethesda, MD 20892
applications. Facilitate Identification, Tracking, (Virtual Meeting).
Place: National Institutes of Health, 6701 Manipulation, and Analysis of Glycans and Contact Person: Luis Espinoza, Ph.D.,
Rockledge Drive, Bethesda, MD 20892 their Functions. Scientific Review Officer, Center for
(Telephone Conference Call). Date: February 15, 2018. Scientific Review, National Institutes of

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Document Created: 2018-01-23 01:08:28
Document Modified: 2018-01-23 01:08:28

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Dates		February 26-27, 2018.
FR Citation		83 FR 3173

83 FR 3173 - Office of the Secretary; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 15 (January 23, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health