Office of Women's Health Update on Strategic Priorities and Initiatives for Nurses, 63234 [2015-26433]
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63234
Federal Register / Vol. 80, No. 201 / Monday, October 19, 2015 / Notices
U.S.C. 360f) to ban devices that present
substantial deception or an
unreasonable and substantial risk of
illness or injury. Section 895.21 (21 CFR
895.21), on banned devices, contains
certain reporting requirements. Section
895.21(d) describes the procedures for
banning a device when the
Commissioner of Food and Drugs (the
Commissioner) decides to initiate such
a proceeding. Under 21 CFR 895.22, a
manufacturer, distributor, or importer of
a device may be required to submit to
FDA all relevant and available data and
information to enable the Commissioner
to determine whether the device
presents substantial deception,
unreasonable and substantial risk of
illness or injury, or unreasonable, direct,
and substantial danger to the health of
individuals.
During the past several years, there
has been an average of less than one
new administrative detention action per
year. Each administrative detention will
have varying amounts of data and
information that must be maintained.
FDA’s estimate of the burden under the
administrative detention provision is
based on FDA’s discussion with one of
the firms whose devices had been
detained.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
800.55(g) ..............................................................................
895.21(d)(8) and 895.22(a) ..................................................
1
26
1
1
1
26
25
16
25
416
Total ..............................................................................
........................
........................
........................
........................
441
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
800.55(k) ..............................................................................
1
1
1
20
20
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Georgia Ave., Suite 400, Silver Spring,
MD 20910–3492.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2015–26440 Filed 10–16–15; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Office of Women’s Health Update on
Strategic Priorities and Initiatives for
Nurses
Food and Drug Administration,
HHS.
Notice of meeting.
The Food and Drug
Administration (FDA) is announcing the
following meeting: Office of Women’s
Health Update on Strategic Priorities
and Initiatives. FDA staff will provide
updates on strategic priorities,
educational outreach, and research
initiatives of interest to national
organizations for nursing professionals
and students.
DATES: The meeting will be held on
November 18, 2015, 1 p.m. to 3 p.m.
ADDRESSES: The meeting will be held at
the American Nurses Association, 8515
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:52 Oct 16, 2015
Jkt 238001
There is
no fee, but pre-registration is required.
Send registration information (including
name, title, organization name, address,
telephone, and fax number) to Deborah
Kallgren. Seating is limited to 35
participants (1 person per organization).
If you need special accommodations
due to a disability, please contact
Deborah Kallgren (see FOR FURTHER
INFORMATION CONTACT) at least 7 days in
advance.
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2015–N–0001]
ACTION:
Health Resources and Services
Administration
Deborah Kallgren, Office of Women’s
Health, Food and Drug Administration,
10903 New Hampshire Ave., Silver
Spring, MD 20993–0002, 301–796–9440,
FAX: 301–847–8604, deborah.kallgren@
fda.hhs.gov.
BILLING CODE 4164–01–P
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: October 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–26433 Filed 10–16–15; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00042
Fmt 4703
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Advisory Commission on Childhood
Vaccines; Request for Nominations for
Voting Members
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
The Health Resources and
Services Administration (HRSA) is
requesting nominations to fill six
vacancies on the Advisory Commission
on Childhood Vaccines (ACCV). The
ACCV was established by Title XXI of
the Public Health Service Act (the Act),
as enacted by Public Law (Pub. L.) 99–
660 and as subsequently amended, and
advises the Secretary of Health and
Human Services (the Secretary) on
issues related to implementation of the
National Vaccine Injury Compensation
Program (VICP).
DATES: The agency will receive
nominations on or before December 18,
2015.
ADDRESSES: All nominations are to be
submitted to the Director, Division of
Injury Compensation Programs,
Healthcare Systems Bureau (HSB),
SUMMARY:
E:\FR\FM\19OCN1.SGM
19OCN1
]]>Agencies
[Federal Register Volume 80, Number 201 (Monday, October 19, 2015)]
[Notices]
[Page 63234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26433]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Office of Women's Health Update on Strategic Priorities and
Initiatives for Nurses
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
following meeting: Office of Women's Health Update on Strategic
Priorities and Initiatives. FDA staff will provide updates on strategic
priorities, educational outreach, and research initiatives of interest
to national organizations for nursing professionals and students.
DATES: The meeting will be held on November 18, 2015, 1 p.m. to 3 p.m.
ADDRESSES: The meeting will be held at the American Nurses Association,
8515 Georgia Ave., Suite 400, Silver Spring, MD 20910-3492.
FOR FURTHER INFORMATION CONTACT: Deborah Kallgren, Office of Women's
Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002, 301-796-9440, FAX: 301-847-8604,
deborah.kallgren@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: There is no fee, but pre-registration is
required. Send registration information (including name, title,
organization name, address, telephone, and fax number) to Deborah
Kallgren. Seating is limited to 35 participants (1 person per
organization).
If you need special accommodations due to a disability, please
contact Deborah Kallgren (see FOR FURTHER INFORMATION CONTACT) at least
7 days in advance.
Dated: October 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-26433 Filed 10-16-15; 8:45 am]
BILLING CODE 4164-01-P
