Office of the Director, National Institutes of Health; Notice of Meeting, 10863 [2018-04954]
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amozie on DSK30RV082PROD with NOTICES
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 The draft guidance identifies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The draft guidance also refers to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.
VerDate Sep<11>2014
17:47 Mar 12, 2018
Jkt 244001
Dated: March 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–04995 Filed 3–12–18; 8:45 am]
BILLING CODE 4164–01–P
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]
BILLING CODE 4140–01–P
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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[Federal Register Volume 83, Number 49 (Tuesday, March 13, 2018)]
[Notices]
[Page 10863]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04954]
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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 [email protected].
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
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]
BILLING CODE 4140-01-P
