Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meetings, 10863-10864 [2018-04961]
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Federal Register / Vol. 83, No. 49 / Tuesday, March 13, 2018 / Notices
Because listing outside of the annual
requirement is voluntary, FDA estimates
that annually 78 percent of 510(k)s will
continue to be listed outside of the
annual requirement. FDA estimates that
4,080 510(k)s may be listed outside of
the annual registration cycle. FDA
estimates that it will take approximately
15 minutes for each listing, for a total
reporting burden of 1,020 hours.
FDA estimates it will have 2,033
instances of more than one party
claiming to be a 510(k) holder for a
specific device as part of annual
registration and listing. FDA reached
this estimate by identifying the number
of unique 510(k) device listings entered
in FURLS between fiscal years 2009 and
2014 that conflict with a listing already
entered by another party (5,304),
dividing that number by the number of
years (6), and multiplying by the
average number of parties claiming to be
the 510(k) holder when there is a
conflict in the current FURLS database
(2.3). The draft guidance identifies
potential documentation a party could
submit to FDA to establish the transfer
of a 510(k) clearance. FDA estimates it
will take a party approximately 4 hours
to locate and submit information to
establish the transfer of the 510(k)
clearance, resulting in 8,132 burden
hours for those 2,033 parties claiming to
be 510(k) holders. FDA reached this
estimate based on its expectation of the
amount of time it will take a party to
locate the information, copy it, and
submit a copy to FDA.
The burden estimate does not include
the maintenance of records used to
document transferring a premarket
notification (510(k)) clearance. Based on
available information, FDA believes that
the maintenance of these records is a
usual and customary part of normal
business activities. For example, in the
ordinary course of business, supporting
documents should be kept to verify
asset information for calculating the
annual depreciation or calculating gain
or loss on sale of an asset on a
businesses’ tax return. Therefore, this
recordkeeping requirement creates no
additional paperwork burden.
The draft guidance also refers to
previously approved collections of
information found in FDA regulations.
The collections of information in 21
CFR part 807 (registration and listing)
are approved under OMB control
number 0910–0625; the collections of
information in 21 CFR part 807 subpart
E (premarket notification submission)
have been approved under OMB control
number 0910–0120, and collections of
information in 42 CFR 493.17 have been
approved under OMB control number
0910–0607.
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Dated: March 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–04995 Filed 3–12–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Advisory Committee on
Research on Women’s Health.
The meeting will be open to the
public as indicated below, 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.
A portion of the meeting 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
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Advisory Committee
on Research on Women’s Health.
Closed: April 17, 2018, 2:30 p.m. to 4:45
p.m.
Agenda: To evaluate the Sex/Gender
Administrative Supplements program
proposed for ORWH’s Strategic Plan.
Open: April 18, 2018, 9:00 a.m. to 1:30
p.m.
Agenda: Opening Remarks, Director’s
Report, NIH Legislative Update, Strategic
Plan Update, and Scientific Presentations.
Place: National Institutes of Health,
Building 31, 6th Floor, Conference Room 10,
31 Center Drive, Bethesda, MD 20892.
Contact Person: Elizabeth Spencer, R.N.,
Deputy Director, Office of Research on
Women’s Health, Executive Secretary,
ACRWH, National Institutes of Health, 6707
Democracy Blvd., Room 7W444, Bethesda,
MD 20817, 301–402–1770 elizabeth.spencer@
nih.gov.
Any member of the public interested in
presenting oral comments to the committee
may notify the Contact Person listed on this
notice at least 10 days in advance of the
meeting. Interested individuals and
representatives of organizations may submit
a letter of intent, a brief description of the
organization represented, and a short
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10863
description of the oral presentation. Only one
representative of an organization may be
allowed to present oral comments and if
accepted by the committee, presentations
may be limited to five minutes. Both printed
and electronic copies are requested for the
record. In addition, any interested person
may file written comments with the
committee by forwarding their statement to
the Contact Person listed on this notice. The
statement should include the name, address,
telephone number and when applicable, the
business or professional affiliation of the
interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page:
www4.od.nih.gov/orwh/, where an agenda
and any additional information for the
meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.14, Intramural Research
Training Award; 93.22, Clinical Research
Loan Repayment Program for Individuals
from Disadvantaged Backgrounds; 93.232,
Loan Repayment Program for Research
Generally; 93.39, Academic Research
Enhancement Award; 93.936, NIH Acquired
Immunodeficiency Syndrome Research Loan
Repayment Program; 93.187, Undergraduate
Scholarship Program for Individuals from
Disadvantaged Backgrounds, National
Institutes of Health, HHS)
Dated: March 6, 2018.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–04954 Filed 3–12–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; 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
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10864
Federal Register / Vol. 83, No. 49 / Tuesday, March 13, 2018 / Notices
amozie on DSK30RV082PROD with NOTICES
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel—R41 applications.
Date: April 4, 2018.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6710B
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Sathasiva B. Kandasamy,
Ph.D., Scientific Review Administrator,
Division of Scientific Review, National
Institute of Child Health and Human
Development, National Institutes of Health,
6710B Rockledge Drive, Bethesda, MD 20892,
(301) 435–6680, skandasa@mail.nih.gov.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel.
Date: April 9, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda Downtown,
7335 Wisconsin Ave, Bethesda, MD 20814.
Contact Person: Kimberly Lynette Houston,
MD, Scientific Review Officer, Division of
Scientific Review, OD, Eunice Kennedy
Shriver National Institute of Child Health
and Human Development, NIH, DHHS,
National Institutes of Health, 6710B
Rockledge Drive, Bethesda, MD 20892,
301.827.4902, kimberly.houston@nih.gov.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel.
Date: April 10, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda Downtown,
7335 Wisconsin Ave, Bethesda, MD 20814.
Contact Person: Kimberly Lynette Houston,
MD, Scientific Review Officer, Division of
Scientific Review, OD, Eunice Kennedy
Shriver National Institute of Child Health
and Human Development, NIH, DHHS,
National Institutes of Health, 6710B
Rockledge Drive, Bethesda, MD 20892,
301.827.4902, kimberly.houston@nih.gov.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel.
Date: April 10, 2018.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6710B
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Sathasiva B. Kandasamy,
Ph.D., Scientific Review Administrator,
Division of Scientific Review, National
Institute of Child Health and Human
Development, 6710B Rockledge Drive,
Bethesda, MD 20892, (301) 435–6680,
skandasa@mail.nih.gov.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel.
VerDate Sep<11>2014
17:47 Mar 12, 2018
Jkt 244001
Date: April 13, 2018.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Peter Zelazowski, Ph.D.,
Scientific Review Officer, Division of
Scientific Review, Eunice Kennedy Shriver
National Institute of Child Health and
Human Development, NIH, 6710B Rockledge
Drive, Bethesda, MD 20892–7510, 301–435–
6902, peter.zelazowski@nih.gov.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel.
Date: April 16–17, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Dennis E. Leszczynski,
Ph.D., Scientific Review Administrator,
Division of Scientific Review, National
Institute of Child Health and Human
Development, NIH, 6710B Rockledge Drive,
Bethesda, MD 20892, (301) 435–6884,
leszczyd@mail.nih.gov.
(Research for Mothers and Children; 93.929,
Center for Medical Rehabilitation Research;
93.209, Contraception and Infertility Loan
Repayment Program, National Institutes of
Health, HHS)
Dated: March 7, 2018.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–04961 Filed 3–12–18; 8:45 am]
with Title 5 U.S.C § 552b(c)(4) and (6)
and Title 5 U.S.C. App. 2, 10(d).
Meeting information and a roster of
Council members may be obtained by
accessing the SAMHSA Committee
website at https://www.samhsa.gov/
about-us/advisory-councils/csatnational-advisory-council or by
contacting the CSAT National Advisory
Council Designated Federal Officer;
Tracy Goss (see contact information
below).
Council Name: SAMHSA’s Center for
Substance Abuse Treatment National
Advisory Council.
Date/Time/Type: March 26, 2018,
2:00 p.m.–3:00 p.m. EDT, Closed.
Place: SAMHSA, 5600 Fishers Lane,
Rockville, Maryland 20857.
Contact: Tracy Goss, Designated
Federal Officer, CSAT National
Advisory Council, 5600 Fishers Lane,
Rockville, Maryland 20857 (mail),
Telephone: (240) 276–0759, Fax: (240)
276–2252, Email: tracy.goss@
samhsa.hhs.gov.
Carlos Castillo,
Committee Management Officer, SAMHSA.
[FR Doc. 2018–04975 Filed 3–12–18; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
BILLING CODE 4140–01–P
[Docket ID: FEMA–2018–0018; OMB No.
1660–0131]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Center for Substance Abuse
Treatment; Notice of Meeting
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Federal Emergency
Management Agency, DHS.
ACTION: Notice and request for
comments.
AGENCY:
Pursuant to Public Law 92–463,
notice is hereby given that the
Substance Abuse and Mental Health
Services Administration’s (SAMHSA’s)
Center for Substance Abuse Treatment
(CSAT) National Advisory Council will
meet on March 26, 2018, 2:00 p.m.–3:00
p.m. (EDT) in a closed teleconference
meeting.
The meeting will include discussions
and evaluations of grant applications
reviewed by SAMHSA’s Initial Review
Groups, and involve an examination of
confidential financial and business
information as well as personal
information concerning the applicants.
Therefore, the meeting will be closed to
the public as determined by the
SAMHSA Assistant Secretary for Mental
Health and Substance Use in accordance
PO 00000
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Threat and Hazard
Identification and Risk Assessment
(THIRA)—Stakeholder Preparedness
Review (SPR) Reporting Tool
The Federal Emergency
Management Agency (FEMA), as part of
its continuing effort to reduce
paperwork and respondent burden,
invites the general public to take this
opportunity to comment on a revision of
a currently approved information
collection. In accordance with the
Paperwork Reduction Act of 1995, this
notice seeks comments concerning this
annual requirement for the U.S.
Department of Homeland Security
(DHS), FEMA to identify current
capability levels for all States,
Territories, urban areas, and Tribes
receiving non-disaster preparedness
grant funds administered by DHS.
SUMMARY:
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[Federal Register Volume 83, Number 49 (Tuesday, March 13, 2018)]
[Notices]
[Pages 10863-10864]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04961]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and
Human Development; 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
[[Page 10864]]
individuals associated with the grant applications, the disclosure of
which would constitute a clearly unwarranted invasion of personal
privacy.
Name of Committee: National Institute of Child Health and Human
Development Special Emphasis Panel--R41 applications.
Date: April 4, 2018.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6710B Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Sathasiva B. Kandasamy, Ph.D., Scientific Review
Administrator, Division of Scientific Review, National Institute of
Child Health and Human Development, National Institutes of Health,
6710B Rockledge Drive, Bethesda, MD 20892, (301) 435-6680,
[email protected].
Name of Committee: National Institute of Child Health and Human
Development Special Emphasis Panel.
Date: April 9, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Residence Inn Bethesda Downtown, 7335 Wisconsin Ave,
Bethesda, MD 20814.
Contact Person: Kimberly Lynette Houston, MD, Scientific Review
Officer, Division of Scientific Review, OD, Eunice Kennedy Shriver
National Institute of Child Health and Human Development, NIH, DHHS,
National Institutes of Health, 6710B Rockledge Drive, Bethesda, MD
20892, 301.827.4902, [email protected].
Name of Committee: National Institute of Child Health and Human
Development Special Emphasis Panel.
Date: April 10, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Residence Inn Bethesda Downtown, 7335 Wisconsin Ave,
Bethesda, MD 20814.
Contact Person: Kimberly Lynette Houston, MD, Scientific Review
Officer, Division of Scientific Review, OD, Eunice Kennedy Shriver
National Institute of Child Health and Human Development, NIH, DHHS,
National Institutes of Health, 6710B Rockledge Drive, Bethesda, MD
20892, 301.827.4902, [email protected].
Name of Committee: National Institute of Child Health and Human
Development Special Emphasis Panel.
Date: April 10, 2018.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate contract proposals.
Place: National Institutes of Health, 6710B Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Sathasiva B. Kandasamy, Ph.D., Scientific Review
Administrator, Division of Scientific Review, National Institute of
Child Health and Human Development, 6710B Rockledge Drive, Bethesda,
MD 20892, (301) 435-6680, [email protected].
Name of Committee: National Institute of Child Health and Human
Development Special Emphasis Panel.
Date: April 13, 2018.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda,
MD 20814.
Contact Person: Peter Zelazowski, Ph.D., Scientific Review
Officer, Division of Scientific Review, Eunice Kennedy Shriver
National Institute of Child Health and Human Development, NIH, 6710B
Rockledge Drive, Bethesda, MD 20892-7510, 301-435-6902,
[email protected].
Name of Committee: National Institute of Child Health and Human
Development Special Emphasis Panel.
Date: April 16-17, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda,
MD 20814.
Contact Person: Dennis E. Leszczynski, Ph.D., Scientific Review
Administrator, Division of Scientific Review, National Institute of
Child Health and Human Development, NIH, 6710B Rockledge Drive,
Bethesda, MD 20892, (301) 435-6884, [email protected].
(Research for Mothers and Children; 93.929, Center for Medical
Rehabilitation Research; 93.209, Contraception and Infertility Loan
Repayment Program, National Institutes of Health, HHS)
Dated: March 7, 2018.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-04961 Filed 3-12-18; 8:45 am]
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