Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in the Medical Device Fellowship Program, 85579-85580 [2016-28443]
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Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Notices
TABLE 9—SUMMARY OF STATUS OF POSTMARKETING COMMITMENTS ESTABLISHED 1 BETWEEN FY2009 AND FY2015 2—
Continued
[Numbers as of September 30, 2015] 3
PMC Status as of
FY2015
(% of total PMCs in
each establishment
year)
Fiscal year of PMC establishment
2009
2010
2011
2012
2013
2014
2015
Delayed ........................
Terminated ...................
Released ......................
Fulfilled .........................
6 (13%)
1 (2%)
4 (8%)
30 (63%)
12 (13%)
0
7 (7%)
44 (47%)
8 (10%)
0
10 (12%)
35 (43%)
6 (13%)
0
1 (2%)
22 (48%)
4 (9%)
0
1 (2%)
14 (30%)
0
0
0
10 (16%)
0
0
1 (2%)
1 (2%)
Total 4 ....................
48
94
82
46
46
61
54
1 The establishment date is the date of the formal FDA communication to the applicant that included the final FDA required (PMR) or requested
(PMC) postmarketing study or clinical trial.
2 The table shows data for PMCs that were closed (fulfilled or released) as of FY2015. Therefore, data for PMCs that were closed in prior fiscal
years are included.
3 Percentages may not total 100 due to rounding.
4 The total number of PMRs/PMCs established in FY2009 through FY2014 reflects the data in FDA’s databases as of September 30, 2015. As
a result of data corrections, as well as improvements in ascertainment of the PMR/PMC establishment date, some of the total numbers of PMRs/
PMCs established in each fiscal year are different from those reported in the prior fiscal year’s (FY2014) Federal Register report.
Dated: November 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–28442 Filed 11–25–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1064]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Application for
Participation in the Medical Device
Fellowship Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0551. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
ADDRESSES:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by December
28, 2016.
SUMMARY:
Application for Participation in the
Medical Device Fellowship Program—
OMB Control Number 0910–0551—
Extension
Sections 1104, 1302, 3301, 3304,
3320, 3361, 3393, and 3394 of Title 5 of
the United States Code authorize
Federal Agencies to rate applicants for
Federal jobs. Collecting applications for
the Medical Device Fellowship Program
will allow FDA’s Center for Devices and
Radiological Health (CDRH) to easily
and efficiently elicit and review
information from students and health
care professionals who are interested in
becoming involved in CDRH activities.
The process will reduce the time and
cost of submitting written
documentation to the Agency and lessen
the likelihood of applications being
misrouted within the Agency mail
system. It will assist the Agency in
promoting and protecting the public
health by encouraging outside persons
to share their expertise with CDRH.
In the Federal Register of September
6, 2016 (81 FR 61221), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
mstockstill on DSK3G9T082PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
respondents
FDA Form
Application Form (FDA 3608) ..............................................
1 There
Number of
responses per
respondent
250
Total annual
responses
1
250
are no capital costs or operating and maintenance costs associated with this collection of information.
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Average
burden per
response
Total hours
1
250
85580
Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Notices
Dated: November 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Service
Administration
[FR Doc. 2016–28443 Filed 11–25–16; 8:45 am]
BILLING CODE 4164–01–P
Advisory Committee on
Interdisciplinary, Community-Based
Linkages
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Service
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
Food and Drug Administration
[Docket No. FDA–2011–N–0769]
Notice of Listing of Members of the
Food and Drug Administration’s
Performance Review Board
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
names of the members who will serve
on its Performance Review Board (PRB).
The purpose of the PRB is to provide
fair and impartial review of senior
executive service (SES), senior
professional and Title 42 SES
Equivalents performance appraisals,
bonus recommendations, and pay
adjustments.
SUMMARY:
DATES:
Effective November 7, 2016.
Abu
Sesay, Office of Human Resources
Executive and Resources Management
Staff, Food and Drug Administration,
Three White Flint North, 05D04, 11601
Landsdown St., North Bethesda, MD
20852, 240–402–0440, abu.sesay@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
This
action is being taken pursuant to 5
U.S.C. 4314(c)(4), which requires that
members of performance review boards
be appointed in a manner to ensure
consistency, stability, and objectivity in
performance appraisals and requires
that notice of the appointment of an
individual to serve as a member be
published in the Federal Register.
The following persons will serve on
FDA’s Performance Review Board,
which oversees the evaluation of
performance appraisals of FDA’s senior
executives: James Sigg, PRB Chair and
member; Tania Tse, PRB Officiator;
Glenda Barfell; Vincent Bunning; Mary
Beth Clarke; Tracey Forfa; Leslie Kux;
Deanna Murphy; Lynne Rice; and
Richard Turman.
mstockstill on DSK3G9T082PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Dated: November 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–28452 Filed 11–25–16; 8:45 am]
BILLING CODE 4164–01–P
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In accordance with section
10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92–463), notice
is hereby given that a meeting is
scheduled for Advisory Committee on
Interdisciplinary, Community-Based
Linkages (ACICBL). This meeting will
be open to the public. Information about
the ACICBL and the agenda for this
meeting can be obtained by accessing
the following Web site: https://
www.hrsa.gov/advisorycommittees/
bhpradvisory/acicbl/. The
agenda will be available 2 days prior to
the meeting on the HRSA Web site
listed above.
DATES: The meeting will be held on
December 8, 2016 (10:00 a.m.–4:00
p.m.).
SUMMARY:
This meeting will be held
via webinar and teleconference.
Webinar information can be found on
the Web site at: https://
hrsa.connectsolutions.com/acicbl and
below.
• The conference call-in number is 1–
800–619–2521. The passcode is:
9271697.
• The Webinar link is https://
hrsa.connectsolutions.com/acicbl.
FOR FURTHER INFORMATION CONTACT:
Anyone requesting information
regarding the ACICBL should contact
Dr. Joan Weiss, Designated Federal
Official, within the Bureau of Health
Workforce, Health Resources and
Services Administration, in one of three
ways: (1) Send a request to the following
address: Dr. Joan Weiss, Designated
Federal Official, Bureau of Health
Workforce, Health Resources and
Services Administration, 5600 Fishers
Lane, Room 15N39, Rockville, Maryland
20857; (2) call (301) 443–0430; or (3)
send an email to jweiss@hrsa.gov.
SUPPLEMENTARY INFORMATION: The
ACICBL provides advice and
recommendations to the Secretary of
HHS (Secretary) concerning policy,
program development, and other
matters of significance related to
interdisciplinary, community-based
training grant programs authorized
ADDRESSES:
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under sections 750–759, Title VII, Part
D of the Public Health Service (PHS)
Act, as amended by the Affordable Care
Act. The following sections of the PHS
Act are included under Part D: 751—
Area Health Education Centers; 752—
Continuing Educational Support for
Health Professionals Serving in
Underserved Communities; 753—
Geriatrics Workforce Enhancement;
754—Quentin N. Burdick Program for
Rural Interdisciplinary Training; 755—
Allied Health and Other Disciplines;
756—Mental and Behavioral Health
Education and Training, and 759—
Program for Education and Training in
Pain Care.
Per the PHS Act section 757(d)(2), the
Committee is responsible for publishing
an annual report describing ‘‘the
activities of the Committee, including
findings and recommendations made by
the Committee concerning the activities
under this part.’’ The members of the
ACICBL will discuss how they would
like to proceed with and structure the
statutorily mandated 17th report. They
will also finalize the statutorily
mandated 16th Annual Report to the
Secretary and Congress on ‘‘Enhancing
Community-Based Training Sites:
Challenges and Opportunities.’’
Members of the public will have the
opportunity to provide comments. Oral
comments will be honored in the order
they are requested and may be limited
as time allows. Requests to make oral
comments or provide written comments
to the ACICBL should be sent to Dr. Joan
Weiss, Designated Federal Official,
using the address and phone number
above at least 3 days prior to the
meeting.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–28469 Filed 11–25–16; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Decision To Evaluate a Petition To
Designate a Class of Employees From
Metals & Controls Corp. in Attleboro,
Massachusetts, To Be Included in the
Special Exposure Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention, Department of Health
and Human Services.
ACTION: Notice.
AGENCY:
NIOSH gives notice of a
decision to evaluate a petition to
designate a class of employees from
Metals & Controls Corp. in Attleboro,
SUMMARY:
E:\FR\FM\28NON1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 228 (Monday, November 28, 2016)]
[Notices]
[Pages 85579-85580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28443]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1064]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Application for
Participation in the Medical Device Fellowship Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
December 28, 2016.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0551.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North 10A63, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Application for Participation in the Medical Device Fellowship
Program--OMB Control Number 0910-0551--Extension
Sections 1104, 1302, 3301, 3304, 3320, 3361, 3393, and 3394 of
Title 5 of the United States Code authorize Federal Agencies to rate
applicants for Federal jobs. Collecting applications for the Medical
Device Fellowship Program will allow FDA's Center for Devices and
Radiological Health (CDRH) to easily and efficiently elicit and review
information from students and health care professionals who are
interested in becoming involved in CDRH activities. The process will
reduce the time and cost of submitting written documentation to the
Agency and lessen the likelihood of applications being misrouted within
the Agency mail system. It will assist the Agency in promoting and
protecting the public health by encouraging outside persons to share
their expertise with CDRH.
In the Federal Register of September 6, 2016 (81 FR 61221), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden1
----------------------------------------------------------------------------------------------------------------
Number of
FDA Form Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Application Form (FDA 3608)..... 250 1 250 1 250
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 85580]]
Dated: November 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28443 Filed 11-25-16; 8:45 am]
BILLING CODE 4164-01-P
