Solicitation for Applications From Individuals Interested in Being Appointed to the Chronic Fatigue Syndrome Advisory Committee, 72066-72067 [2016-25307]
Download as PDF
<![CDATA[
72066
Federal Register / Vol. 81, No. 202 / Wednesday, October 19, 2016 / Notices
any identified deficiencies and what
information is required to correct those
deficiencies. FDA must also promptly
notify the applicant if FDA identifies
additional deficiencies or of any
additional information required to
complete Agency review.
Recordkeeping
§ 814.82(a)(5) and (a)(6)—
Maintenance of Records. The
recordkeeping burden under this section
requires the maintenance of records,
used to trace patients and the
organization and indexing of records
into identifiable files to ensure the
device’s continued safety and
effectiveness. These records are required
of all applicants who have an approved
PMA.
PMAs have been required since 1976,
and there are 725 active PMAs that
could be subject to these requirements,
based on actual FDA data, and
approximately 30 new PMAs are
approved every year. The aggregate
burden for the estimated 422 PMA
holders of approved original PMAs for
the next few years is estimated to be
7,174 hours.
The applicant determines which
records should be maintained during
product development to document and/
or substantiate the device’s safety and
effectiveness. Records required by the
current good manufacturing practices
for medical devices regulation (21 CFR
part 820) may be relevant to a PMA
review and may be submitted as part of
an application. In individual instances,
records may be required as conditions of
approval to ensure the device’s
continuing safety and effectiveness.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity/21 CFR or FD&C Act section
Research conducted outside the United States (814.15(b))
PMA application (814.20) ....................................................
PMA amendments and resubmitted PMAs (814.37(a)–(c)
and (e)) .............................................................................
PMA supplements (814.39(a)) .............................................
Special PMA supplement—changes being affected
(814.39(d)) ........................................................................
30-day notice (814.39(f)) .....................................................
Postapproval requirements (814.82(a)(9)) ...........................
Periodic reports (814.84(b)) .................................................
Agreement meeting (520(g)(7)) ...........................................
Expedited review request (515(d)(5) of the FD&C Act) ......
Determination Meeting (513(1)(3)(D) of the FD&C Act) ......
Panel meeting (515(c)(3) of the FD&C Act) ........................
Day 100 meeting (515(d)(3) of the FD&C Act) ...................
Total ..............................................................................
1 There
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
Total hours
25
35
1
1
25
35
2
668
50
23,380
1,222
695
1
1
1,222
695
167
60
204,074
41,700
88
1,710
340
695
1
6
1
9
19
1
1
1
1
1
1
1
1
1
88
1,710
340
695
1
6
1
9
19
6
16
135
10
50
10
50
30
10
528
27,360
45,900
6,950
50
60
50
270
190
........................
........................
........................
........................
350,562
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity/21 CFR section
Number of
recordkeepers
Number of
records
per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Maintenance of records (814.82(a)(5) and (a)(6)) ...............
422
1
422
17
7,174
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
ACTION:
Authority: 42 U.S.C. 217a, Section 222 of
the Public Health Service Act, as amended.
The Committee is governed by the provisions
of Public Law 92–463, as amended (5 U.S.C.
App. 2), which sets forth standards for the
formation and use of advisory committees.
[FR Doc. 2016–25232 Filed 10–18–16; 8:45 am]
BILLING CODE 4164–01–P
sradovich on DSK3GMQ082PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health.
VerDate Sep<11>2014
17:39 Oct 18, 2016
Jkt 241001
The Office of the Assistant
Secretary for Health (OASH), within the
Department of Health and Human
Services (HHS), is seeking nominations
of qualified candidates to be considered
for appointment as members of the
Chronic Fatigue Syndrome Advisory
Committee (CFSAC). CFSAC provides
advice and recommendations to the
Secretary of HHS, through the Assistant
SUMMARY:
Solicitation for Applications From
Individuals Interested in Being
Appointed to the Chronic Fatigue
Syndrome Advisory Committee
AGENCY:
Notice.
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
Secretary for Health (ASH), on a broad
range of issues and topics related to
myalgic encephalomyelitis/chronic
fatigue syndrome (ME/CFS). The
appointments of two Committee
members are scheduled to end during
the 2016 calendar year. Nominations of
qualified candidates are being sought to
fill the positions that are scheduled to
be vacated.
DATES: Applications for individuals to
be considered for appointment to the
Committee must be received no later
than 5 p.m. EDT on November 18, 2016
at the address listed below.
ADDRESSES: All nominations should be
mailed or delivered to Commander,
(CDR) Gustavo Seinos, MPH, Designated
E:\FR\FM\19OCN1.SGM
19OCN1
sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 81, No. 202 / Wednesday, October 19, 2016 / Notices
Federal Officer, Chronic Fatigue
Syndrome Advisory Committee, Office
on Women’s Health, Office of the
Assistant Secretary for Health,
Department of Health and Human
Services, 200 Independence Avenue
SW., Room 712E, Washington, DC
20201. Nomination materials, including
attachments, may be submitted
electronically to cfsac@hhs.gov.
FOR FURTHER INFORMATION CONTACT: CDR
Gustavo Seinos, Designated Federal
Officer, Chronic Fatigue Syndrome
Advisory Committee, Office on
Women’s Health, Office of the Assistant
Secretary for Health, Department of
Health and Human Services, 200
Independence Ave. SW., Room 712E,
Washington, DC 20201. Inquiries may
also be made to cfsac@hhs.gov.
SUPPLEMENTARY INFORMATION: CFSAC
was established on September 5, 2002.
The purpose of the CFSAC is to provide
advice and recommendations to the
Secretary of HHS, through the ASH, on
issues related to ME/CFS. The CFSAC
advises and makes recommendations on
a broad range of topics including: (1)
Opportunities to improve knowledge
and research about the epidemiology,
etiologies, biomarkers and risk factors
for ME/CFS; (2) research on the
diagnosis, treatment, and management
of ME/CFS and potential impact of
treatment options; (3) strategies to
inform the public, health care
professionals, and the biomedical
academic and research communities
about ME/CFS advances; (4)
partnerships to improve the quality of
life of ME/CFS patients; and (5)
strategies to insure that input from ME/
CFS patients and caregivers is
incorporated into HHS policy and
research. The CFSAC charter is
available at: https://www.hhs.gov/
advcomcfs/charter/.
Management and support services for
Committee activities are provided by
staff from within the OASH. The ASH
provides direction and guidance for
services performed to support CFSAC
activities and operation.
Nominations: OASH is requesting
nominations to fill CFSAC positions
scheduled to be vacated at the end of
2016. The Committee composition
consists of seven scientists with
demonstrated expertise in biomedical
research applicable to ME/CFS, four
individuals with demonstrated expertise
in health care delivery, private health
care services, insurance, and three
patients/care givers of ME/CFS. The
vacant positions are in the biomedical
research category. Individuals selected
for appointment to the Committee will
serve as voting members and may be
VerDate Sep<11>2014
17:39 Oct 18, 2016
Jkt 241001
invited to serve terms of up to four
years.
CFSAC members are authorized to
receive a stipend for conducting
Committee related business, including
attending Committee meetings.
Committee members also are authorized
to receive per diem and reimbursement
for travel expenses incurred for
conducting Committee related business.
To qualify for consideration of
appointment to the Committee, an
individual must possess demonstrated
experience and knowledge in the
designated fields or disciplines, as well
as expert knowledge of the broad issues
and topics pertinent to ME/CFS.
Nomination materials should be
typewritten. If mailed, please submit
original documents. The nomination
materials should be submitted
(postmarked or received) no later than
5:00 p.m. EDT on the specified date.
The following information must be part
of the nomination package submitted for
each individual being nominated: (1) A
letter of nomination that clearly states
the name and affiliation of the nominee,
the basis for the nomination (i.e.,
specific attributes which qualify the
nominee for service in this capacity),
and a statement that the nominee is
willing to serve as a member of the
Committee; (2) the nominator’s name,
address, and daytime telephone
number; (3) the home and/or work
address, telephone number, and email
address of the individual being
nominated; and (4) a current copy of the
nominee’s curriculum vitae or resume,
which should not exceed 10 pages. An
individual may self-nominate. Federal
employees should not be nominated for
consideration of appointment to this
Committee. Nominations that do not
contain all of the above information will
not be considered.
Electronic submissions: Nomination
materials, including attachments, may
be submitted electronically to cfsac@
hhs.gov.
Regular, Express, or Overnight Mail:
Written documents may be submitted to
the following addressee only: CDR
Gustavo Seinos, MPH, Designated
Federal Officer, CFSAC, Office on
Women’s Health, Office of the Assistant
Secretary for Health, Department of
Health and Human Services, 200
Independence Ave. SW., Room 712E,
Washington, DC 20201.
Telephone and facsimile submissions
cannot be accepted.
Appointment to the Committee is
made by the Secretary of HHS. The
Department makes every effort to ensure
that the membership of federal advisory
committees is fairly balanced in terms of
points of view represented. Every effort
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
72067
is made to ensure that a broad
representation of geographic areas,
females, ethnic and minority groups,
and people with disabilities are given
consideration for membership on
federal advisory committees.
Appointment to this Committee shall be
made without discrimination on the
basis of age, race, ethnicity, gender,
sexual orientation, disability, and
cultural, religious, or socioeconomic
status. Nominations must state that the
nominee is willing to serve as a member
of CFSAC and appears to have no
conflict of interest that would preclude
membership. Candidates who are
selected for appointment to the
Committee are required to provide
detailed information concerning such
matters as financial holdings,
consultancies, and research grants or
contracts for an ethics analysis to be
conducted to identify potential conflicts
of interest.
Dated: October 14, 2016.
Nicole Greene,
Deputy Director, Office on Women’s Health.
[FR Doc. 2016–25307 Filed 10–18–16; 8:45 am]
BILLING CODE 4150–42–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Human Genome Research
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Board
of Scientific Counselors, National
Human Genome Research Institute.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
NATIONAL HUMAN GENOME
RESEARCH INSTITUTE, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors, National Human Genome
Research Institute.
Date: November 1–2, 2016.
Time: November 1, 2016, 6:00 p.m. to 9:30
p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
E:\FR\FM\19OCN1.SGM
19OCN1
]]>Agencies
[Federal Register Volume 81, Number 202 (Wednesday, October 19, 2016)]
[Notices]
[Pages 72066-72067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25307]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Solicitation for Applications From Individuals Interested in
Being Appointed to the Chronic Fatigue Syndrome Advisory Committee
AGENCY: Department of Health and Human Services, Office of the
Secretary, Office of the Assistant Secretary for Health.
ACTION: Notice.
-----------------------------------------------------------------------
Authority: 42 U.S.C. 217a, Section 222 of the Public Health
Service Act, as amended. The Committee is governed by the provisions
of Public Law 92-463, as amended (5 U.S.C. App. 2), which sets forth
standards for the formation and use of advisory committees.
SUMMARY: The Office of the Assistant Secretary for Health (OASH),
within the Department of Health and Human Services (HHS), is seeking
nominations of qualified candidates to be considered for appointment as
members of the Chronic Fatigue Syndrome Advisory Committee (CFSAC).
CFSAC provides advice and recommendations to the Secretary of HHS,
through the Assistant Secretary for Health (ASH), on a broad range of
issues and topics related to myalgic encephalomyelitis/chronic fatigue
syndrome (ME/CFS). The appointments of two Committee members are
scheduled to end during the 2016 calendar year. Nominations of
qualified candidates are being sought to fill the positions that are
scheduled to be vacated.
DATES: Applications for individuals to be considered for appointment to
the Committee must be received no later than 5 p.m. EDT on November 18,
2016 at the address listed below.
ADDRESSES: All nominations should be mailed or delivered to Commander,
(CDR) Gustavo Seinos, MPH, Designated
[[Page 72067]]
Federal Officer, Chronic Fatigue Syndrome Advisory Committee, Office on
Women's Health, Office of the Assistant Secretary for Health,
Department of Health and Human Services, 200 Independence Avenue SW.,
Room 712E, Washington, DC 20201. Nomination materials, including
attachments, may be submitted electronically to cfsac@hhs.gov.
FOR FURTHER INFORMATION CONTACT: CDR Gustavo Seinos, Designated Federal
Officer, Chronic Fatigue Syndrome Advisory Committee, Office on Women's
Health, Office of the Assistant Secretary for Health, Department of
Health and Human Services, 200 Independence Ave. SW., Room 712E,
Washington, DC 20201. Inquiries may also be made to cfsac@hhs.gov.
SUPPLEMENTARY INFORMATION: CFSAC was established on September 5, 2002.
The purpose of the CFSAC is to provide advice and recommendations to
the Secretary of HHS, through the ASH, on issues related to ME/CFS. The
CFSAC advises and makes recommendations on a broad range of topics
including: (1) Opportunities to improve knowledge and research about
the epidemiology, etiologies, biomarkers and risk factors for ME/CFS;
(2) research on the diagnosis, treatment, and management of ME/CFS and
potential impact of treatment options; (3) strategies to inform the
public, health care professionals, and the biomedical academic and
research communities about ME/CFS advances; (4) partnerships to improve
the quality of life of ME/CFS patients; and (5) strategies to insure
that input from ME/CFS patients and caregivers is incorporated into HHS
policy and research. The CFSAC charter is available at: https://www.hhs.gov/advcomcfs/charter/. Management and support
services for Committee activities are provided by staff from within the
OASH. The ASH provides direction and guidance for services performed to
support CFSAC activities and operation.
Nominations: OASH is requesting nominations to fill CFSAC positions
scheduled to be vacated at the end of 2016. The Committee composition
consists of seven scientists with demonstrated expertise in biomedical
research applicable to ME/CFS, four individuals with demonstrated
expertise in health care delivery, private health care services,
insurance, and three patients/care givers of ME/CFS. The vacant
positions are in the biomedical research category. Individuals selected
for appointment to the Committee will serve as voting members and may
be invited to serve terms of up to four years.
CFSAC members are authorized to receive a stipend for conducting
Committee related business, including attending Committee meetings.
Committee members also are authorized to receive per diem and
reimbursement for travel expenses incurred for conducting Committee
related business. To qualify for consideration of appointment to the
Committee, an individual must possess demonstrated experience and
knowledge in the designated fields or disciplines, as well as expert
knowledge of the broad issues and topics pertinent to ME/CFS.
Nomination materials should be typewritten. If mailed, please
submit original documents. The nomination materials should be submitted
(postmarked or received) no later than 5:00 p.m. EDT on the specified
date. The following information must be part of the nomination package
submitted for each individual being nominated: (1) A letter of
nomination that clearly states the name and affiliation of the nominee,
the basis for the nomination (i.e., specific attributes which qualify
the nominee for service in this capacity), and a statement that the
nominee is willing to serve as a member of the Committee; (2) the
nominator's name, address, and daytime telephone number; (3) the home
and/or work address, telephone number, and email address of the
individual being nominated; and (4) a current copy of the nominee's
curriculum vitae or resume, which should not exceed 10 pages. An
individual may self-nominate. Federal employees should not be nominated
for consideration of appointment to this Committee. Nominations that do
not contain all of the above information will not be considered.
Electronic submissions: Nomination materials, including
attachments, may be submitted electronically to cfsac@hhs.gov.
Regular, Express, or Overnight Mail: Written documents may be
submitted to the following addressee only: CDR Gustavo Seinos, MPH,
Designated Federal Officer, CFSAC, Office on Women's Health, Office of
the Assistant Secretary for Health, Department of Health and Human
Services, 200 Independence Ave. SW., Room 712E, Washington, DC 20201.
Telephone and facsimile submissions cannot be accepted.
Appointment to the Committee is made by the Secretary of HHS. The
Department makes every effort to ensure that the membership of federal
advisory committees is fairly balanced in terms of points of view
represented. Every effort is made to ensure that a broad representation
of geographic areas, females, ethnic and minority groups, and people
with disabilities are given consideration for membership on federal
advisory committees. Appointment to this Committee shall be made
without discrimination on the basis of age, race, ethnicity, gender,
sexual orientation, disability, and cultural, religious, or
socioeconomic status. Nominations must state that the nominee is
willing to serve as a member of CFSAC and appears to have no conflict
of interest that would preclude membership. Candidates who are selected
for appointment to the Committee are required to provide detailed
information concerning such matters as financial holdings,
consultancies, and research grants or contracts for an ethics analysis
to be conducted to identify potential conflicts of interest.
Dated: October 14, 2016.
Nicole Greene,
Deputy Director, Office on Women's Health.
[FR Doc. 2016-25307 Filed 10-18-16; 8:45 am]
BILLING CODE 4150-42-P
