National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings, 28431-28432 [2018-13138]
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Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Notices
28431
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB
control No.
Title of collection
Infant Formula Requirements ..................................................................................................................................
Premarket Notification for a New Dietary Ingredient ...............................................................................................
Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring ..............................................
Guidance for Industry: Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical
Current Good Manufacturing Practice .................................................................................................................
Requests for Inspection by an Accredited Person Under the Inspection for Accredited Persons Program ..........
Substances Prohibited from Use in Animal Food or Feed .....................................................................................
Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under
21 CFR 884.5300 .................................................................................................................................................
Guidance for Industry: Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements
During an Influenza Pandemic .............................................................................................................................
Guidance on Consultation Procedures: Foods Derived From New Plant Varieties ...............................................
Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices ......................
Food Labeling; Calorie Labeling of Articles of Food in Vending Machines and Nutrition Labeling of Standard
Menu Items in Restaurants and Similar Retail Food Establishments .................................................................
Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings with
the Office of Orphan Products Development .......................................................................................................
Food Allergen Labeling and Reporting ....................................................................................................................
Transfer of a Premarket Notification Clearance ......................................................................................................
Dated: June 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–13098 Filed 6–18–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Ryan White HIV/AIDS Program Parts A
and B Integrated HIV Planning
Implementation Cooperative
Agreement to John Snow, Inc. (JSI),
U69HA30144
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice of non-competitive FY
2018 supplemental award.
AGENCY:
This noncompetitive
supplement award to JSI will support
and strengthen current Ryan White HIV/
AIDS Program (RWHAP) Part A and Part
B priority setting and resource
allocation processes to ensure people
living with HIV are linked to care,
remain engaged in care, and achieve
viral suppression.
FOR FURTHER INFORMATION CONTACT: Dr.
Rene Sterling, Acting Director, Division
of State HIV/AIDS Programs, HIV/AIDS
Bureau, HRSA; 5600 Fishers Lane,
Room 09W50, Rockville, MD 20857;
Phone: (301) 443–9017, Email:
rsterling@hrsa.gov.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award: JSI
(U69HA30144).
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SUMMARY:
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Amount of Non-Competitive Award:
$300,000 in FY 2018.
Period of Funding: July 1, 2018,
through June 30, 2019.
CFDA Number: No. 93.145.
Authority: Sections 2606 and 2654(b)
of the Public Health Service Act, as
amended by the Ryan White HIV/AIDS
Treatment Extension Act of 2009 (Pub.
L. 111–87).
Justification: In 2016, JSI was awarded
a 3-year cooperative agreement under
HRSA–16–082 RWHAP Integrated HIV
Planning Implementation (CFDA
93.145), authorized by Sections 2606
and 2654(b) of the Public Health Service
Act, as amended by the Ryan White
HIV/AIDS Treatment Extension Act of
2009 (Pub. L. 111–87). The cooperative
agreement was established to provide
technical assistance to RWHAP Parts A
and B recipients and their planning
bodies regarding: (1) The integration of
HIV planning across prevention, care,
and treatment service delivery systems;
and (2) the development,
implementation, monitoring, and
evaluation of Integrated HIV Prevention
and Care Plans. RWHAP Parts A and B
recipients and planning bodies use
Integrated Plans to better inform and
coordinate HIV prevention and care
program planning, resource allocation,
and continuous quality improvement
efforts to meet the HIV service delivery
needs within their jurisdictions.
The proposed supplemental funding
will provide RWHAP Parts A and B
recipients with additional technical
assistance (TA) specifically focused on
resource allocation planning and
implementation. These additional TA
activities will build upon data elements
identified in the Integrated Plan and
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Date
approval
expires
0910–0256
0910–0330
0910–0409
5/31/2021
5/31/2021
5/31/2021
0910–0563
0910–0569
0910–0627
5/31/2021
5/31/2021
5/31/2021
0910–0633
5/31/2021
0910–0701
0910–0704
0910–0741
5/31/2021
5/31/2021
5/31/2021
0910–0782
5/31/2021
0910–0787
0910–0792
0910–0852
5/31/2021
5/31/2021
5/31/2021
provide jurisdictions with strategies,
tools, and resources to effectively
allocate annual available resources to
prioritize HIV unmet needs. The TA
activities will be directed at addressing
more efficient and proactive methods in
the Priority Setting and Resource
Allocation (PSRA) process to increase
the ability of health care providers and
systems to ensure people living with
HIV are linked to care, remain engaged
in care, and achieve HIV viral
suppression.
Dated: June 12, 2018.
George Sigounas,
Administrator.
[FR Doc. 2018–13121 Filed 6–18–18; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
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28432
Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Notices
would constitute a clearly unwarranted
invasion of personal privacy.
daltland on DSKBBV9HB2PROD with NOTICES
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Immunity in the Elderly
(R01).
Date: July 9–10, 2018.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health LD30,
5601 Fishers Lane, Rockville, MD 20892.
Contact Person: Julio Aliberti, Ph.D.,
Scientific Review Officer, Scientific Review
Program, DEA/NIAID/NIH/DHHS, 5601
Fishers Lane, MSC–9823, Rockville, MD
20852, 301–761–7322, alibertijc@
niaid.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Maintaining Immunity after
Immunization (U01).
Date: July 11–12, 2018.
Time: 8:30 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892.
Contact Person: Geetanjali Bansal, Ph.D.,
Scientific Reviewer Officer, Scientific Review
Program, Division of Extramural Activities,
Room 3G49, National Institutes of Health/
NIAID, 5601 Fishers Lane, MSC 9834,
Bethesda, MD 20892–9834, (240) 669–5073,
geetanjali.bansal@nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID INVESTIGATOR
INITIATED PROGRAM PROJECT (P01).
Date: July 11, 2018.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892,
(Telephone Conference Call).
Contact Person: Raymond R. Schleef,
Ph.D., Senior Scientific Review Officer,
Scientific Review Program, Division of
Extramural Activities, Room 3E61, National
Institutes of Health/NIAID, 5601 Fishers
Lane, MSC 9823, Bethesda, MD 20892–9823,
(240) 669–5019, schleefrr@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: June 13, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–13138 Filed 6–18–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HOMELAND
SECURITY
Substance Abuse and Mental Health
Services Administration
Federal Emergency Management
Agency
Notice of Meeting
[Docket ID FEMA–2018–0002; Internal
Agency Docket No. FEMA–B–1830]
Pursuant to Public Law 92–463,
notice is hereby given that the
Substance Abuse and Mental Health
Services Administration’s (SAMHSA)
Center for Substance Abuse Prevention’s
(CSAP) Drug Testing Advisory Board
(DTAB) will convene via web
conference on August 8, 2018, from 9:00
a.m. EDT to 5:00 p.m. EDT.
The board will meet in closed-session
via web conference on August 8, 2018,
from 9:00 a.m. EDT to 5:00 p.m. EDT to
discuss the proposed Mandatory
Guidelines for Federal Workplace Drug
Testing Programs (hair specimens).
Therefore, the meeting is closed to the
public as determined by the Assistant
Secretary for Mental Health and
Substance Use, SAMHSA, in accordance
with 5 U.S.C. 552b(c)(4) and (9)(B), and
5 U.S.C. App. 2, Section 10(d).
Meeting registration information can
be completed at https://snacregister.
samhsa.gov/MeetingList.aspx. Web
conference and call information will be
sent after completing registration.
Meeting information and a roster of
DTAB members may be obtained by
accessing the SAMHSA Advisory
Committees website, https://
www.samhsa.gov/about-us/advisorycouncils/drug-testing-advisory-boarddtab or by contacting the Designated
Federal Officer, CAPT Sean J. Belouin,
USPHS.
Committee Name: Substance Abuse
and Mental Health Services
Administration’s Drug Testing Advisory
Board.
Dates/Time/Type: August 8, 2018,
from 9:00 a.m. to 5:00 p.m. EDT:
CLOSED.
Place: Web Conference.
Contact: CAPT Sean J. Belouin,
USPHS, Senior Pharmacology and
Regulatory Policy Advisor, Division of
Workplace Programs, 5600 Fishers Lane,
Room 16N06D, Rockville, Maryland
20857, Telephone: (240) 276–2600,
Email: sean.belouin@samhsa.hhs.gov.
Carlos Castillo,
Committee Management Officer, SAMHSA.
[FR Doc. 2018–13116 Filed 6–18–18; 8:45 am]
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Proposed Flood Hazard
Determinations
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:
Comments are requested on
proposed flood hazard determinations,
which may include additions or
modifications of any Base Flood
Elevation (BFE), base flood depth,
Special Flood Hazard Area (SFHA)
boundary or zone designation, or
regulatory floodway on the Flood
Insurance Rate Maps (FIRMs), and
where applicable, in the supporting
Flood Insurance Study (FIS) reports for
the communities listed in the table
below. The purpose of this notice is to
seek general information and comment
regarding the preliminary FIRM, and
where applicable, the FIS report that the
Federal Emergency Management Agency
(FEMA) has provided to the affected
communities. The FIRM and FIS report
are the basis of the floodplain
management measures that the
community is required either to adopt
or to show evidence of having in effect
in order to qualify or remain qualified
for participation in the National Flood
Insurance Program (NFIP). In addition,
the FIRM and FIS report, once effective,
will be used by insurance agents and
others to calculate appropriate flood
insurance premium rates for new
buildings and the contents of those
buildings.
SUMMARY:
Comments are to be submitted
on or before September 17, 2018.
ADDRESSES: The Preliminary FIRM, and
where applicable, the FIS report for
each community are available for
inspection at both the online location
https://www.fema.gov/preliminaryflood
hazarddata and the respective
Community Map Repository address
listed in the tables below. Additionally,
the current effective FIRM and FIS
report for each community are
accessible online through the FEMA
Map Service Center at https://
msc.fema.gov for comparison.
You may submit comments, identified
by Docket No. FEMA–B–1830, to Rick
Sacbibit, Chief, Engineering Services
Branch, Federal Insurance and
Mitigation Administration, FEMA, 400
C Street SW, Washington, DC 20472,
DATES:
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]]>Agencies
[Federal Register Volume 83, Number 118 (Tuesday, June 19, 2018)]
[Notices]
[Pages 28431-28432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13138]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of
Closed Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which
[[Page 28432]]
would constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute of Allergy and Infectious
Diseases Special Emphasis Panel; Immunity in the Elderly (R01).
Date: July 9-10, 2018.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health LD30, 5601 Fishers Lane,
Rockville, MD 20892.
Contact Person: Julio Aliberti, Ph.D., Scientific Review
Officer, Scientific Review Program, DEA/NIAID/NIH/DHHS, 5601 Fishers
Lane, MSC-9823, Rockville, MD 20852, 301-761-7322,
[email protected].
Name of Committee: National Institute of Allergy and Infectious
Diseases Special Emphasis Panel; Maintaining Immunity after
Immunization (U01).
Date: July 11-12, 2018.
Time: 8:30 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 5601 Fishers Lane,
Rockville, MD 20892.
Contact Person: Geetanjali Bansal, Ph.D., Scientific Reviewer
Officer, Scientific Review Program, Division of Extramural
Activities, Room 3G49, National Institutes of Health/NIAID, 5601
Fishers Lane, MSC 9834, Bethesda, MD 20892-9834, (240) 669-5073,
[email protected].
Name of Committee: National Institute of Allergy and Infectious
Diseases Special Emphasis Panel; NIAID INVESTIGATOR INITIATED
PROGRAM PROJECT (P01).
Date: July 11, 2018.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 5601 Fishers Lane,
Rockville, MD 20892, (Telephone Conference Call).
Contact Person: Raymond R. Schleef, Ph.D., Senior Scientific
Review Officer, Scientific Review Program, Division of Extramural
Activities, Room 3E61, National Institutes of Health/NIAID, 5601
Fishers Lane, MSC 9823, Bethesda, MD 20892-9823, (240) 669-5019,
[email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.855,
Allergy, Immunology, and Transplantation Research; 93.856,
Microbiology and Infectious Diseases Research, National Institutes
of Health, HHS)
Dated: June 13, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-13138 Filed 6-18-18; 8:45 am]
BILLING CODE 4140-01-P
