Request for Nominations for Individuals and Consumer Organizations for Advisory Committees, 48098-48102 [2017-22344]
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48098
Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices
sections 514 and 515 of the FD&C Act
(21 U.S.C. 360d and 360e) provided that
the device: (1) Is designed to treat or
diagnose a disease or condition that
affects no more than 8,000 individuals
in the United States; (2) would not be
available to a person with a disease or
condition unless an exemption is
granted and there is no comparable
device other than another HUD
approved under this exemption that is
available to treat or diagnose such
disease or condition; and (3) will not
expose patients to an unreasonable or
significant risk of illness or injury and
the probable benefit to health from the
use of the device outweighs the risk of
injury or illness from its use, taking into
account the probable risks and benefits
of currently available devices or
alternative forms of treatment.
Respondents may submit a
humanitarian device exemption (HDE)
application seeking exemption from the
effectiveness requirements of sections
514 and 515 of the FD&C Act as
authorized by section 520(m)(2). The
information collected will assist FDA in
making determinations on the
following: (1) Whether to grant HUD
designation of a medical device; (2)
whether to exempt an HUD from the
effectiveness requirements under
sections 514 and 515 of the FD&C Act,
provided that the device meets
requirements set forth under section
520(m) of the FD&C Act; and (3)
whether to grant marketing approval(s)
for the HUD. Failure to collect this
information would prevent FDA from
making a determination on the factors
listed previously in this document.
Further, the collected information
would also enable FDA to determine
whether the holder of an HUD is in
compliance with the HUD provisions
under section 520(m) of the FD&C Act.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity/21 CFR section
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Request for HUD designation—814.102 .............................
HDE Application—814.104 ..................................................
HDE Amendments and resubmitted HDEs—814.106 .........
HDE Supplements—814.108 ...............................................
Notification of withdrawal of an HDE—814.116(e)(3) .........
Notification of withdrawal of Institutional Review Board approval—814.124(b) ...........................................................
Periodic reports—814.126(b)(1) ..........................................
19
3
6
110
1
1
1
5
1
1
19
3
30
110
1
40
320
50
80
1
760
960
1,500
8,800
1
1
35
1
1
1
35
2
120
2
4,200
Total ..............................................................................
........................
........................
........................
........................
16,223
1 There
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
recordkeeping
Total annual
records
Average
burden per
recordkeeping
Total hours
HDE Records—814.126(b)(2) ..............................................
247
1
247
2
494
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Activity/21 CFR section
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Notification of emergency use—814.124(a) ........................
22
1
22
1
22
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The number of respondents in tables
1, 2, and 3 of this document are an
average based on data for the previous
3 years, i.e., fiscal years 2014 through
2016. The number of annual reports
submitted under § 814.126(b)(1) in table
1 reflects 35 respondents with approved
HUD applications. Under
§ 814.126(b)(2) in table 2, the estimated
number of recordkeepers is 247.
The number of respondents has been
adjusted to reflect updated respondent
data. This has resulted in an overall
decrease of 2,971 hours to the total
estimated annual reporting burden.
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There have been no program changes
and the estimated Average Burden per
Response has not changed for any of the
information collections since the last
OMB approval.
Dated: October 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–22320 Filed 10–13–17; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2017–N–0001]
Request for Nominations for
Individuals and Consumer
Organizations for Advisory
Committees
AGENCY:
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration,
HHS.
ACTION:
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Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices
The Food and Drug
Administration (FDA) is requesting that
any consumer organizations interested
in participating in the selection of
voting and/or nonvoting consumer
representatives to serve on its advisory
committees or panels notify FDA in
writing. FDA is also requesting
nominations for voting and/or
nonvoting consumer representatives to
serve on advisory committees and/or
panels for which vacancies currently
exist or are expected to occur in the near
future. Nominees recommended to serve
as a voting or nonvoting consumer
representative may be self-nominated or
may be nominated by a consumer
organization.
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and, therefore, encourages
nominations of appropriately qualified
candidates from these groups.
DATES: Any consumer organization
interested in participating in the
selection of an appropriate voting or
SUMMARY:
nonvoting member to represent
consumer interests on an FDA advisory
committee or panel may send a letter or
email stating that interest to FDA (see
ADDRESSES) by November 15, 2017, for
vacancies listed in this notice.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA (see ADDRESSES) by November 15,
2017. Nominations will be accepted for
current vacancies and for those that will
or may occur through November 30,
2017.
ADDRESSES: All statements of interest
from consumer organizations interested
in participating in the selection process
and consumer representative
nominations should be submitted
electronically to ACOMSSubmissions@
fda.hhs.gov; by mail to Advisory
Committee Oversight and Management
Staff, 10903 New Hampshire Ave., Bldg.
32, Rm. 5103, Silver Spring, MD 20993–
0002; or by Fax: 301–847–8640.
Consumer representative nominations
should be submitted electronically by
logging into the FDA Advisory
Committee Membership Nomination
48099
Portal: https://www.accessdata.fda.gov/
scripts/FACTRSPortal/FACTRS/
index.cfm; by mail to Advisory
Committee Oversight and Management
Staff, 10903 New Hampshire Ave., Bldg.
32, Rm. 5103, Silver Spring, MD 20993–
0002; or by Fax: 301–847–8640.
Additional information about becoming
a member on an FDA advisory
committee can also be obtained by
visiting FDA’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
For
questions relating to participation in the
selection process: Kimberly Hamilton,
Advisory Committee Oversight and
Management Staff (ACOMS), Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993–0002, 301–
796–8220 email: kimberly.hamilton@
fda.hhs.gov.
For questions relating to specific
advisory committees or panels, contact
the appropriate Contact Person listed in
table 1.
FOR FURTHER INFORMATION CONTACT:
TABLE 1—ADVISORY COMMITTEE CONTACTS
Contact person
Committee/panel
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Lauren Tesh, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2426, Silver Spring, MD 20993–0002, phone: 301–796–2721, email:
Lauren.Tesh@fda.hhs.gov.
Patricio Garcia, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G610, Silver Spring, MD 20993–0002, phone: 301–796–6875, email:
Patricio.Garcio@fda.hhs.gov.
Evella Washington, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G640, Silver Spring, MD 20993–0002, phone: 301–796–6683, email:
Evella.Washington@fda.hhs.gov.
Pamela Scott, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5572, Silver Spring, MD 20993–0002, phone: 301–796–5433, email:
Pamela.Scott@fda.hhs.gov.
Aden Asefa, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G642, Silver Spring, MD 20993–0002, phone: 301–796–0400, email:
Aden.Asefa@fda.hhs.gov.
LaToya Bonner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2428, Silver Spring, MD 20993–0002, phone: 301–796–2855, email:
LaToya.Bonner@fda.hhs.gov.
Karen Strambler, Center for Food Safety and Nutrition, Food and Drug Administration, FDA College Park,
CPK1, Rm. 1C008, College Park, MD 20740, phone: 240–402–2589, email: Karen.Strambler@
fda.hhs.gov.
Cindy Chee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2430, Silver Spring, MD 20993–0002, phone: 301–796–0889, email:
Cindy.Chee@fda.hhs.gov.
Jennifer Shepherd, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2434, Silver Spring, MD 20993–0002, phone: 301–796–4043, email: Jennifer.Shepherd@fda.hhs.gov.
Moon Hee Choi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2434, Silver Spring, MD 20993–0002, phone: 301–796–2894, email:
MoonHee.Choi@fda.hhs.gov.
Marieann Brill, Office of the Commissioner, Office of Medical Products and Tobacco, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, Silver Spring, MD 20993–0002, phone:
240–402–3838, email: Mariann.Brill@fda.hhs.gov.
FDA is
requesting nominations for voting and/
SUPPLEMENTARY INFORMATION:
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Antimicrobial Advisory Committee.
Clinical Chemistry and Clinical
Toxicology Devices Panel.
Ear, Nose and Throat Devices
Panel,
Immunology
Devices
Panel.
Medical Devices Dispute Resolution.
Neurological Devices Panel.
Endocrinologic
and
Metabolic
Drugs Advisory Committee.
Food Advisory Committee.
Gastrointestinal Drugs Advisory
Committee,
Pulmonary-Allergy
Drugs Advisory Committee.
Medical Imaging Advisory Committee.
Non-Prescription Drugs Advisory
Committee, Peripheral & Central
Nervous Systems Advisory Committee.
Pediatrics Advisory Committee.
or nonvoting consumer representatives
for the vacancies listed in table 2.
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Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices
TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE DATE
NEEDED
Approximate date
needed
Committee/panel/areas of expertise needed
Type of vacancy
Antimicrobial Advisory Committee—Knowledgeable in the fields of infectious disease, internal medicine, microbiology, pediatrics, epidemiology or statistics, and related specialties.
Clinical Chemistry and Clinical Toxicology Devices Panel—Doctors of medicine or philosophy with experience in clinical chemistry (e.g., cardiac markers), clinical toxicology, clinical pathology, clinical laboratory medicine, and endocrinology.
Ear, Nose and Throat Devices Panel—Otologists, neurologists, and audiologists .............
Immunology Devices—Persons with experience in medical, surgical, or clinical oncology,
internal medicine, clinical immunology, allergy, molecular diagnostics, or clinical laboratory medicine.
Medical Devices Dispute Resolution—Experts with broad, cross-cutting scientific, clinical,
analytical, or mediation skills.
Neurological Devices Panel—Neurosurgeons (cerebrovascular and pediatric), neurologists (stroke, pediatric, pain management, and movement disorders), interventional
neuroradiologists, psychiatrists, and biostatisticians.
Endocrinologic and Metabolic Drugs Advisory Committee—Knowledgeable in the fields
of endocrinology, metabolism, epidemiology or statistics, and related specialties.
Food Advisory Committee—Knowledgeable in the fields of physical sciences, biological
and life sciences, food science, risk assessment, nutrition, food technology, molecular
biology, and other relevant scientific and technical disciplines.
Gastrointestinal Drugs Advisory Committee—Knowledgeable in the fields of gastroenterology, endocrinology, surgery, clinical pharmacology, physiology, pathology, liver
function, motility, esophagitis, and statistics.
Pulmonary-Allergy Drugs Advisory Committee—Knowledgeable in the fields of pulmonary medicine, allergy, clinical immunology, and epidemiology or statistics.
Medical Imaging Advisory Committee—Knowledgeable in the fields of nuclear medicine,
radiology, epidemiology, statistics, and related specialties.
Non-Prescription Drugs Advisory Committee—Knowledgeable in the fields of internal
medicine, family practice, clinical toxicology, clinical pharmacology, pharmacy, dentistry, and related specialties.
Peripheral and Central Nervous System Drugs Advisory Committee—Knowledgeable in
the fields of neurology, neuropharmacology, neuropathology, otolaryngology, epidemiology or statistics, and related specialties.
Pediatrics Advisory Committee—Knowledgeable in pediatric research, pediatric subspecialties, statistics, and/or biomedical ethics. The core of voting members shall also
include one representative from a pediatric health organization and one representative
from a relevant patient or patient-family organization and may include one technically
qualified member, selected by the Commissioner or designee, who is identified with
consumer interests and is recommended by either a consortium of consumer-oriented
organizations or other interested persons. In addition to the voting members, the Committee may include one nonvoting member who is identified with industry interests.
1—Voting ..............................
November 30, 2017.
1—Nonvoting ........................
Immediately.
1—Nonvoting ........................
1—Nonvoting ........................
Immediately.
Immediately.
1—Nonvoting ........................
Immediately.
1—Nonvoting ........................
Immediately.
1—Voting ..............................
Immediately.
1—Voting ..............................
Immediately.
1—Voting ..............................
Immediately.
1—Voting ..............................
Immediately.
1—Voting ..............................
Immediately.
1—Voting ..............................
Immediately.
1—Voting ..............................
Immediately.
1—Voting ..............................
Immediately.
I. Functions and General Description of
the Committee Duties
A. Antimicrobial Advisory Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of infectious diseases and disorders.
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B. Certain Panels of the Medical Devices
Advisory Committee
Reviews and evaluates data on the
safety and effectiveness of marketed and
investigational devices and makes
recommendations for their regulation.
With the exception of the Medical
Devices Dispute Resolution Panel, each
panel, according to its specialty area: (1)
Advises on the classification or
reclassification of devices into one of
three regulatory categories; (2) advises
on any possible risks to health
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associated with the use of devices; (3)
advises on formulation of product
development protocols; (4) reviews
premarket approval applications for
medical devices; (5) reviews guidelines
and guidance documents; (6)
recommends exemption of certain
devices from the application of portions
of the Federal Food, Drug, and Cosmetic
Act; (7) advises on the necessity to ban
a device; and (8) responds to requests
from the Agency to review and make
recommendations on specific issues or
problems concerning the safety and
effectiveness of devices. With the
exception of the Medical Devices
Dispute Resolution Panel, each panel,
according to its specialty area, may also
make appropriate recommendations to
the Commissioner of Food and Drugs on
issues relating to the design of clinical
studies regarding the safety and
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effectiveness of marketed and
investigational devices.
The Medical Devices Dispute
Resolution Panel provides advice to the
Commissioner on complex or contested
scientific issues between FDA and
medical device sponsors, applicants, or
manufacturers relating to specific
products, marketing applications,
regulatory decisions and actions by
FDA, and Agency guidance and
policies. The Panel makes
recommendations on issues that are
lacking resolution, are highly complex
in nature, or result from challenges to
regular advisory panel proceedings or
Agency decisions or actions.
C. Endocrinologic and Metabolic Drugs
Advisory Committee
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational human
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drug products for use in the treatment
of endocrine and metabolic disorders.
D. Food Advisory Committee
Make recommendations on emerging
food safety, food science, nutrition, and
other food-related health issues that
FDA considers of primary importance
for its food and cosmetics programs.
Reviewing and evaluating available data
and making recommendations on
matters such as those relating to: (1)
Broad scientific and technical food or
cosmetic related issues; (2) the safety of
new foods and food ingredients; (3)
labeling of foods and cosmetics; (4)
nutrient needs and nutritional
adequacy; and (5) safe exposure limits
for food contaminants. The Committee
may also be asked to provide advice and
make recommendations on ways of
communicating to the public the
potential risks associated with these
issues and on approaches that might be
considered for addressing the issues.
E. Gastrointestinal Drugs Advisory
Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of gastrointestinal diseases.
F. Pulmonary-Allergy Drugs Advisory
Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of pulmonary disease and diseases with
allergic and/or immunologic
mechanisms.
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G. Medical Imaging Drugs Advisory
Committee
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in diagnostic and
therapeutic procedures using
radioactive pharmaceuticals and
contrast media used in diagnostic
radiology.
H. Non-Prescription Drugs Advisory
Committee
Review and evaluate available data
concerning the safety and effectiveness
of over-the-counter (nonprescription)
human drug products, or any other
FDA-regulated product, for use in the
treatment of a broad spectrum of human
symptoms and diseases and advise the
Commissioner either on the
promulgation of monographs
establishing conditions under which
these drugs are generally recognized as
safe and effective and not misbranded or
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on the approval of new drug
applications for such drugs. The
Committee will serve as a forum for the
exchange of views regarding the
prescription and nonprescription status,
including switches from one status to
another, of these various drug products
and combinations thereof. The
Committee may also conduct peer
review of Agency sponsored intramural
and extramural scientific biomedical
programs in support of FDA’s mission
and regulatory responsibilities.
I. Peripheral and Central Nervous
System Advisory Committee
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of neurologic diseases.
J. Pediatrics Advisory Committee
The Committee advises and makes
recommendations to the Commissioner
of Food and Drugs regarding: (1)
Pediatric research; (2) identification of
research priorities related to pediatric
therapeutics and the need for additional
treatments of specific pediatric diseases
or conditions; (3) the ethics, design, and
analysis of clinical trials related to
pediatric therapeutics; (4) pediatric
labeling disputes; (5) pediatric labeling
changes; (6) adverse event reports for
drugs granted pediatric exclusivity and
any safety issues that may occur; (7) any
other pediatric issue or pediatric
labeling dispute involving FDA
regulated products; (8) research
involving children as subjects; and (9)
any other matter involving pediatrics for
which FDA has regulatory
responsibility. The Committee also
advises and makes recommendations to
the Secretary of Health and Human
Services (Secretary) directly or to the
Secretary through the Commissioner on
research involving children as subjects
that is conducted or supported by the
Department of Health and Human
Services.
II. Criteria for Members
Persons nominated for membership as
consumer representatives on
committees or panels should meet the
following criteria: (1) Demonstrate an
affiliation with and/or active
participation in consumer or
community-based organizations, (2) be
able to analyze technical data, (3)
understand research design, (4) discuss
benefits and risks, and (5) evaluate the
safety and efficacy of products under
review. The consumer representative
should be able to represent the
consumer perspective on issues and
actions before the advisory committee;
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48101
serve as a liaison between the
committee and interested consumers,
associations, coalitions, and consumer
organizations; and facilitate dialogue
with the advisory committees on
scientific issues that affect consumers.
III. Selection Procedures
Selection of members representing
consumer interests is conducted
through procedures that include the use
of organizations representing the public
interest and public advocacy groups.
These organizations recommend
nominees for the Agency’s selection.
Representatives from the consumer
health branches of Federal, State, and
local governments also may participate
in the selection process. Any consumer
organization interested in participating
in the selection of an appropriate voting
or nonvoting member to represent
consumer interests should send a letter
stating that interest to FDA (see
ADDRESSES) within 30 days of
publication of this document.
Within the subsequent 30 days, FDA
will compile a list of consumer
organizations that will participate in the
selection process and will forward to
each such organization a ballot listing at
least two qualified nominees selected by
the Agency based on the nominations
received, together with each nominee’s
´
´
current curriculum vitae or resume.
Ballots are to be filled out and returned
to FDA within 30 days. The nominee
receiving the highest number of votes
ordinarily will be selected to serve as
the member representing consumer
interests for that particular advisory
committee or panel.
IV. Nomination Procedures
Any interested person or organization
may nominate one or more qualified
persons to represent consumer interests
on the Agency’s advisory committees or
panels. Self-nominations are also
accepted. Nominations must include a
´
´
current, complete resume or curriculum
vitae for each nominee, a signed copy of
the Acknowledgement and Consent
form available at the FDA Advisory
Nomination Portal (see ADDRESSES), and
a list of consumer or community-based
organizations for which the candidate
can demonstrate active participation.
Nominations must also specify the
advisory committee(s) or panel(s) for
which the nominee is recommended. In
addition, nominations must also
acknowledge that the nominee is aware
of the nomination unless selfnominated. FDA will ask potential
candidates to provide detailed
information concerning such matters as
financial holdings, employment, and
research grants and/or contracts to
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Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices
permit evaluation of possible sources of
conflicts of interest. Members will be
invited to serve for terms up to 4 years.
FDA will review all nominations
received within the specified
timeframes and prepare a ballot
containing the names of qualified
nominees. Names not selected will
remain on a list of eligible nominees
and be reviewed periodically by FDA to
determine continued interest. Upon
selecting qualified nominees for the
ballot, FDA will provide those
consumer organizations that are
participating in the selection process
with the opportunity to vote on the
listed nominees. Only organizations
vote in the selection process. Persons
who nominate themselves to serve as
voting or nonvoting consumer
representatives will not participate in
the selection process.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: October 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–22344 Filed 10–13–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Proposed Standards for the Children’s
Hospitals Graduate Medical Education
Payment Program’s Quality Bonus
System
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Request for public comment.
AGENCY:
This notice seeks public
comment on establishing a quality
bonus system for the Children’s
Hospitals Graduate Medical Education
(CHGME) Payment Program. The
CHGME Support Reauthorization Act of
2013 states that the Secretary may
establish a quality bonus system,
whereby the Secretary distributes bonus
payments to hospitals participating in
the program that meet standards
specified by the Secretary. The goal of
this notice is to seek comment to assist
HRSA in the development of the
standards, payment structure, and
outcome measures for the CHGME
Quality Bonus System.
DATES: Submit written comments no
later than December 15, 2017.
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SUMMARY:
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Written comments should
be submitted to Malena Crawford,
Public Health Analyst, HRSA, by email
(MCrawford@hrsa.gov) or by fax (301–
443–0162).
FOR FURTHER INFORMATION CONTACT:
Malena Crawford, Public Health
Analyst, HRSA, 5600 Fishers Lane,
Rockville, MD, 20852, (301) 443–7334.
SUPPLEMENTARY INFORMATION: The
CHGME Program supports graduate
medical education (GME) in
freestanding children’s hospitals. The
program supports the training of
primary care pediatricians and pediatric
medical and surgical subspecialists. The
CHGME Support Reauthorization Act of
2013 makes up to 25 percent of the total
amount appropriated annually in excess
of $245 million, but not to exceed
$7,000,000, available to provide
payments to newly qualified hospitals,
as defined in section 340E(h) of the
Public Health Service Act. The statute
additionally states that the Secretary
may establish a quality bonus system for
CHGME hospitals using any remaining
funds after payments are made to newly
qualified hospitals. In FY 2017,
Congress appropriated $300 million to
the CHGME Program. Of this,
approximately $4 million in payments
were made to newly qualified hospitals.
If funding levels and mechanisms
remain constant, it is estimated that
approximately $3 million may be
available annually for the CHGME
Quality Bonus System. If the total
amount available for the CHGME
Quality Bonus System in a fiscal year is
less than $2 million, HRSA does not
plan to implement the CHGME Quality
Bonus System in that year to minimize
administrative burden on the hospitals.
In this case, the funds would be
disbursed to all eligible hospitals
(including those newly qualified)
according to the CHGME formula
payment methodology.
HRSA understands the complexities
involved in designing a GME quality
improvement initiative. The CHGME
Quality Bonus System would be the first
of its kind for any federal GME payment
program and responds to changes
occurring in the larger health care arena.
For example, the Accreditation Council
for GME, one of the prevailing GME
accrediting bodies, recently
implemented new GME program
requirements around patient safety and
quality improvement. Many GME
programs and stakeholders are working
towards establishing GME quality
related outcome metrics, but currently
no widely accepted metrics exist that
have the ability to distinguish between
the quality of training provided at
ADDRESSES:
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
different hospitals and training
programs. Additionally, clinical
outcomes alone may not be appropriate
measures for establishing a GME quality
improvement initiative. HRSA would
like to begin to develop approaches to
measure and assess the quality of GME
programs using existing data sources
initially and then develop new and
improved data sources as we learn
which are most informative and useful.
Quality Bonus Payment in FY 2019—
Proposal for Public Comment
HRSA is proposing a multi-step
implementation in recognition of the
changing landscape and the need for
additional data. For FY 2019, HRSA
proposes a quality bonus system that
will initially recognize high-level
engagement of CHGME hospitals in state
and regional health care transformation,
as well as engagement of resident
trainees in these activities. HRSA is
seeking public comment on the
timeline, eligibility, standards,
documentation, and payment structure
as described below. HRSA is also
proposing areas for comment for FY
2020 and beyond.
Timeline: HRSA anticipates
implementing the proposed CHGME
Quality Bonus System standards in FY
2019 payments (project period October
1, 2018, through September 30, 2019).
CHGME Hospital Eligibility: HRSA
proposes to include all eligible CHGME
hospitals, including those newly
qualified, as eligible entities for the
CHGME Quality Bonus System.
Quality Bonus System Standards: The
proposed standards are: (1)
Demonstration of engagement in stateor regional-level initiatives by a
children’s hospital to transform
pediatric health care to improve access,
quality, and cost effectiveness of health
care; and (2) demonstration of resident
trainee engagement in these activities.
HRSA has identified several
initiatives involving CHGME hospitals
that require a significant level of
engagement. These include federally
funded efforts such as: Participation in
a state Medicaid initiative to improve
access, quality, and cost effectiveness of
pediatric health care (e.g., a Centers for
Medicare & Medicaid Services State
Innovation Model Award or other
Health Care Innovation Award with a
state or regional impact); participation
in the HRSA Maternal and Child Health
Bureau’s Health Care Delivery System
Innovations for Children with Medical
Complexity Collaborative Improvement
and Innovation Network (CoIIN); or,
participation in HRSA’s Federal Office
of Rural Health Policy Rural Health
Network Development Grant Program.
E:\FR\FM\16OCN1.SGM
16OCN1
]]>Agencies
[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)]
[Notices]
[Pages 48098-48102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22344]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0001]
Request for Nominations for Individuals and Consumer
Organizations for Advisory Committees
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 48099]]
SUMMARY: The Food and Drug Administration (FDA) is requesting that any
consumer organizations interested in participating in the selection of
voting and/or nonvoting consumer representatives to serve on its
advisory committees or panels notify FDA in writing. FDA is also
requesting nominations for voting and/or nonvoting consumer
representatives to serve on advisory committees and/or panels for which
vacancies currently exist or are expected to occur in the near future.
Nominees recommended to serve as a voting or nonvoting consumer
representative may be self-nominated or may be nominated by a consumer
organization.
FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees and, therefore, encourages nominations of
appropriately qualified candidates from these groups.
DATES: Any consumer organization interested in participating in the
selection of an appropriate voting or nonvoting member to represent
consumer interests on an FDA advisory committee or panel may send a
letter or email stating that interest to FDA (see ADDRESSES) by
November 15, 2017, for vacancies listed in this notice. Concurrently,
nomination materials for prospective candidates should be sent to FDA
(see ADDRESSES) by November 15, 2017. Nominations will be accepted for
current vacancies and for those that will or may occur through November
30, 2017.
ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process and consumer
representative nominations should be submitted electronically to
ACOMSSubmissions@fda.hhs.gov; by mail to Advisory Committee Oversight
and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993-0002; or by Fax: 301-847-8640.
Consumer representative nominations should be submitted
electronically by logging into the FDA Advisory Committee Membership
Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm; by mail to Advisory Committee Oversight and
Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver
Spring, MD 20993-0002; or by Fax: 301-847-8640. Additional information
about becoming a member on an FDA advisory committee can also be
obtained by visiting FDA's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: For questions relating to
participation in the selection process: Kimberly Hamilton, Advisory
Committee Oversight and Management Staff (ACOMS), Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver
Spring, MD 20993-0002, 301-796-8220 email:
kimberly.hamilton@fda.hhs.gov.
For questions relating to specific advisory committees or panels,
contact the appropriate Contact Person listed in table 1.
Table 1--Advisory Committee Contacts
------------------------------------------------------------------------
Contact person Committee/panel
------------------------------------------------------------------------
Lauren Tesh, Center for Drug Evaluation and Antimicrobial Advisory
Research, Food and Drug Administration, Committee.
10903 New Hampshire Ave., Bldg. 31, Rm.
2426, Silver Spring, MD 20993-0002, phone:
301-796-2721, email:
Lauren.Tesh@fda.hhs.gov.
Patricio Garcia, Center for Devices and Clinical Chemistry and
Radiological Health, Food and Drug Clinical Toxicology
Administration, 10903 New Hampshire Ave., Devices Panel.
Bldg. 66, Rm. G610, Silver Spring, MD
20993-0002, phone: 301-796-6875, email:
Patricio.Garcio@fda.hhs.gov.
Evella Washington, Center for Devices and Ear, Nose and Throat
Radiological Health, Food and Drug Devices Panel, Immunology
Administration, 10903 New Hampshire Ave., Devices Panel.
Bldg. 66, Rm. G640, Silver Spring, MD
20993-0002, phone: 301-796-6683, email:
Evella.Washington@fda.hhs.gov.
Pamela Scott, Center for Devices and Medical Devices Dispute
Radiological Health, Food and Drug Resolution.
Administration, 10903 New Hampshire Ave.,
Bldg. 66, Rm. 5572, Silver Spring, MD
20993-0002, phone: 301-796-5433, email:
Pamela.Scott@fda.hhs.gov.
Aden Asefa, Center for Devices and Neurological Devices Panel.
Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave.,
Bldg. 66, Rm. G642, Silver Spring, MD
20993-0002, phone: 301-796-0400, email:
Aden.Asefa@fda.hhs.gov.
LaToya Bonner, Center for Drug Evaluation Endocrinologic and
and Research, Food and Drug Metabolic Drugs Advisory
Administration, 10903 New Hampshire Ave., Committee.
Bldg. 31, Rm. 2428, Silver Spring, MD
20993-0002, phone: 301-796-2855, email:
LaToya.Bonner@fda.hhs.gov.
Karen Strambler, Center for Food Safety and Food Advisory Committee.
Nutrition, Food and Drug Administration,
FDA College Park, CPK1, Rm. 1C008, College
Park, MD 20740, phone: 240-402-2589,
email: Karen.Strambler@fda.hhs.gov.
Cindy Chee, Center for Drug Evaluation and Gastrointestinal Drugs
Research, Food and Drug Administration, Advisory Committee,
10903 New Hampshire Ave., Bldg. 31, Rm. Pulmonary-Allergy Drugs
2430, Silver Spring, MD 20993-0002, phone: Advisory Committee.
301-796-0889, email:
Cindy.Chee@fda.hhs.gov.
Jennifer Shepherd, Center for Drug Medical Imaging Advisory
Evaluation and Research, Food and Drug Committee.
Administration, 10903 New Hampshire Ave.,
Bldg. 31, Rm. 2434, Silver Spring, MD
20993-0002, phone: 301-796-4043, email:
Jennifer.Shepherd@fda.hhs.gov.
Moon Hee Choi, Center for Drug Evaluation Non-Prescription Drugs
and Research, Food and Drug Advisory Committee,
Administration, 10903 New Hampshire Ave., Peripheral & Central
Bldg. 31, Rm. 2434, Silver Spring, MD Nervous Systems Advisory
20993-0002, phone: 301-796-2894, email: Committee.
MoonHee.Choi@fda.hhs.gov.
Marieann Brill, Office of the Commissioner, Pediatrics Advisory
Office of Medical Products and Tobacco, Committee.
Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5154, Silver
Spring, MD 20993-0002, phone: 240-402-
3838, email: Mariann.Brill@fda.hhs.gov.
------------------------------------------------------------------------
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
and/or nonvoting consumer representatives for the vacancies listed in
table 2.
[[Page 48100]]
Table 2--Committee Descriptions, Type of Consumer Representative Vacancy, and Approximate Date Needed
----------------------------------------------------------------------------------------------------------------
Committee/panel/areas of expertise needed Type of vacancy Approximate date needed
----------------------------------------------------------------------------------------------------------------
Antimicrobial Advisory Committee-- 1--Voting.................. November 30, 2017.
Knowledgeable in the fields of infectious
disease, internal medicine, microbiology,
pediatrics, epidemiology or statistics,
and related specialties.
Clinical Chemistry and Clinical Toxicology 1--Nonvoting............... Immediately.
Devices Panel--Doctors of medicine or
philosophy with experience in clinical
chemistry (e.g., cardiac markers),
clinical toxicology, clinical pathology,
clinical laboratory medicine, and
endocrinology.
Ear, Nose and Throat Devices Panel-- 1--Nonvoting............... Immediately.
Otologists, neurologists, and audiologists.
Immunology Devices--Persons with experience 1--Nonvoting............... Immediately.
in medical, surgical, or clinical
oncology, internal medicine, clinical
immunology, allergy, molecular
diagnostics, or clinical laboratory
medicine.
Medical Devices Dispute Resolution--Experts 1--Nonvoting............... Immediately.
with broad, cross-cutting scientific,
clinical, analytical, or mediation skills.
Neurological Devices Panel--Neurosurgeons 1--Nonvoting............... Immediately.
(cerebrovascular and pediatric),
neurologists (stroke, pediatric, pain
management, and movement disorders),
interventional neuroradiologists,
psychiatrists, and biostatisticians.
Endocrinologic and Metabolic Drugs Advisory 1--Voting.................. Immediately.
Committee--Knowledgeable in the fields of
endocrinology, metabolism, epidemiology or
statistics, and related specialties.
Food Advisory Committee--Knowledgeable in 1--Voting.................. Immediately.
the fields of physical sciences,
biological and life sciences, food
science, risk assessment, nutrition, food
technology, molecular biology, and other
relevant scientific and technical
disciplines.
Gastrointestinal Drugs Advisory Committee-- 1--Voting.................. Immediately.
Knowledgeable in the fields of
gastroenterology, endocrinology, surgery,
clinical pharmacology, physiology,
pathology, liver function, motility,
esophagitis, and statistics.
Pulmonary-Allergy Drugs Advisory Committee-- 1--Voting.................. Immediately.
Knowledgeable in the fields of pulmonary
medicine, allergy, clinical immunology,
and epidemiology or statistics.
Medical Imaging Advisory Committee-- 1--Voting.................. Immediately.
Knowledgeable in the fields of nuclear
medicine, radiology, epidemiology,
statistics, and related specialties.
Non-Prescription Drugs Advisory Committee-- 1--Voting.................. Immediately.
Knowledgeable in the fields of internal
medicine, family practice, clinical
toxicology, clinical pharmacology,
pharmacy, dentistry, and related
specialties.
Peripheral and Central Nervous System Drugs 1--Voting.................. Immediately.
Advisory Committee--Knowledgeable in the
fields of neurology, neuropharmacology,
neuropathology, otolaryngology,
epidemiology or statistics, and related
specialties.
Pediatrics Advisory Committee-- 1--Voting.................. Immediately.
Knowledgeable in pediatric research,
pediatric subspecialties, statistics, and/
or biomedical ethics. The core of voting
members shall also include one
representative from a pediatric health
organization and one representative from a
relevant patient or patient-family
organization and may include one
technically qualified member, selected by
the Commissioner or designee, who is
identified with consumer interests and is
recommended by either a consortium of
consumer-oriented organizations or other
interested persons. In addition to the
voting members, the Committee may include
one nonvoting member who is identified
with industry interests.
----------------------------------------------------------------------------------------------------------------
I. Functions and General Description of the Committee Duties
A. Antimicrobial Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of infectious diseases and disorders.
B. Certain Panels of the Medical Devices Advisory Committee
Reviews and evaluates data on the safety and effectiveness of
marketed and investigational devices and makes recommendations for
their regulation. With the exception of the Medical Devices Dispute
Resolution Panel, each panel, according to its specialty area: (1)
Advises on the classification or reclassification of devices into one
of three regulatory categories; (2) advises on any possible risks to
health associated with the use of devices; (3) advises on formulation
of product development protocols; (4) reviews premarket approval
applications for medical devices; (5) reviews guidelines and guidance
documents; (6) recommends exemption of certain devices from the
application of portions of the Federal Food, Drug, and Cosmetic Act;
(7) advises on the necessity to ban a device; and (8) responds to
requests from the Agency to review and make recommendations on specific
issues or problems concerning the safety and effectiveness of devices.
With the exception of the Medical Devices Dispute Resolution Panel,
each panel, according to its specialty area, may also make appropriate
recommendations to the Commissioner of Food and Drugs on issues
relating to the design of clinical studies regarding the safety and
effectiveness of marketed and investigational devices.
The Medical Devices Dispute Resolution Panel provides advice to the
Commissioner on complex or contested scientific issues between FDA and
medical device sponsors, applicants, or manufacturers relating to
specific products, marketing applications, regulatory decisions and
actions by FDA, and Agency guidance and policies. The Panel makes
recommendations on issues that are lacking resolution, are highly
complex in nature, or result from challenges to regular advisory panel
proceedings or Agency decisions or actions.
C. Endocrinologic and Metabolic Drugs Advisory Committee
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human
[[Page 48101]]
drug products for use in the treatment of endocrine and metabolic
disorders.
D. Food Advisory Committee
Make recommendations on emerging food safety, food science,
nutrition, and other food-related health issues that FDA considers of
primary importance for its food and cosmetics programs. Reviewing and
evaluating available data and making recommendations on matters such as
those relating to: (1) Broad scientific and technical food or cosmetic
related issues; (2) the safety of new foods and food ingredients; (3)
labeling of foods and cosmetics; (4) nutrient needs and nutritional
adequacy; and (5) safe exposure limits for food contaminants. The
Committee may also be asked to provide advice and make recommendations
on ways of communicating to the public the potential risks associated
with these issues and on approaches that might be considered for
addressing the issues.
E. Gastrointestinal Drugs Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of gastrointestinal diseases.
F. Pulmonary-Allergy Drugs Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of pulmonary disease and diseases with allergic
and/or immunologic mechanisms.
G. Medical Imaging Drugs Advisory Committee
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in
diagnostic and therapeutic procedures using radioactive pharmaceuticals
and contrast media used in diagnostic radiology.
H. Non-Prescription Drugs Advisory Committee
Review and evaluate available data concerning the safety and
effectiveness of over-the-counter (nonprescription) human drug
products, or any other FDA-regulated product, for use in the treatment
of a broad spectrum of human symptoms and diseases and advise the
Commissioner either on the promulgation of monographs establishing
conditions under which these drugs are generally recognized as safe and
effective and not misbranded or on the approval of new drug
applications for such drugs. The Committee will serve as a forum for
the exchange of views regarding the prescription and nonprescription
status, including switches from one status to another, of these various
drug products and combinations thereof. The Committee may also conduct
peer review of Agency sponsored intramural and extramural scientific
biomedical programs in support of FDA's mission and regulatory
responsibilities.
I. Peripheral and Central Nervous System Advisory Committee
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in the
treatment of neurologic diseases.
J. Pediatrics Advisory Committee
The Committee advises and makes recommendations to the Commissioner
of Food and Drugs regarding: (1) Pediatric research; (2) identification
of research priorities related to pediatric therapeutics and the need
for additional treatments of specific pediatric diseases or conditions;
(3) the ethics, design, and analysis of clinical trials related to
pediatric therapeutics; (4) pediatric labeling disputes; (5) pediatric
labeling changes; (6) adverse event reports for drugs granted pediatric
exclusivity and any safety issues that may occur; (7) any other
pediatric issue or pediatric labeling dispute involving FDA regulated
products; (8) research involving children as subjects; and (9) any
other matter involving pediatrics for which FDA has regulatory
responsibility. The Committee also advises and makes recommendations to
the Secretary of Health and Human Services (Secretary) directly or to
the Secretary through the Commissioner on research involving children
as subjects that is conducted or supported by the Department of Health
and Human Services.
II. Criteria for Members
Persons nominated for membership as consumer representatives on
committees or panels should meet the following criteria: (1)
Demonstrate an affiliation with and/or active participation in consumer
or community-based organizations, (2) be able to analyze technical
data, (3) understand research design, (4) discuss benefits and risks,
and (5) evaluate the safety and efficacy of products under review. The
consumer representative should be able to represent the consumer
perspective on issues and actions before the advisory committee; serve
as a liaison between the committee and interested consumers,
associations, coalitions, and consumer organizations; and facilitate
dialogue with the advisory committees on scientific issues that affect
consumers.
III. Selection Procedures
Selection of members representing consumer interests is conducted
through procedures that include the use of organizations representing
the public interest and public advocacy groups. These organizations
recommend nominees for the Agency's selection. Representatives from the
consumer health branches of Federal, State, and local governments also
may participate in the selection process. Any consumer organization
interested in participating in the selection of an appropriate voting
or nonvoting member to represent consumer interests should send a
letter stating that interest to FDA (see ADDRESSES) within 30 days of
publication of this document.
Within the subsequent 30 days, FDA will compile a list of consumer
organizations that will participate in the selection process and will
forward to each such organization a ballot listing at least two
qualified nominees selected by the Agency based on the nominations
received, together with each nominee's current curriculum vitae or
r[eacute]sum[eacute]. Ballots are to be filled out and returned to FDA
within 30 days. The nominee receiving the highest number of votes
ordinarily will be selected to serve as the member representing
consumer interests for that particular advisory committee or panel.
IV. Nomination Procedures
Any interested person or organization may nominate one or more
qualified persons to represent consumer interests on the Agency's
advisory committees or panels. Self-nominations are also accepted.
Nominations must include a current, complete r[eacute]sum[eacute] or
curriculum vitae for each nominee, a signed copy of the Acknowledgement
and Consent form available at the FDA Advisory Nomination Portal (see
ADDRESSES), and a list of consumer or community-based organizations for
which the candidate can demonstrate active participation.
Nominations must also specify the advisory committee(s) or panel(s)
for which the nominee is recommended. In addition, nominations must
also acknowledge that the nominee is aware of the nomination unless
self-nominated. FDA will ask potential candidates to provide detailed
information concerning such matters as financial holdings, employment,
and research grants and/or contracts to
[[Page 48102]]
permit evaluation of possible sources of conflicts of interest. Members
will be invited to serve for terms up to 4 years.
FDA will review all nominations received within the specified
timeframes and prepare a ballot containing the names of qualified
nominees. Names not selected will remain on a list of eligible nominees
and be reviewed periodically by FDA to determine continued interest.
Upon selecting qualified nominees for the ballot, FDA will provide
those consumer organizations that are participating in the selection
process with the opportunity to vote on the listed nominees. Only
organizations vote in the selection process. Persons who nominate
themselves to serve as voting or nonvoting consumer representatives
will not participate in the selection process.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: October 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22344 Filed 10-13-17; 8:45 am]
BILLING CODE 4164-01-P
