Request for Nominations for Individuals and Consumer Organizations for Advisory Committees, 59156-59160 [2015-24835]
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Federal Register / Vol. 80, No. 190 / Thursday, October 1, 2015 / Notices
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–24863 Filed 9–30–15; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Joint Meeting of the Antimicrobial
Drugs Advisory Committee (Formerly
Known as the Anti-Infective Drugs
Advisory Committee) and the Drug
Safety and Risk Management Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committees: Antimicrobial
Drugs Advisory Committee (formerly
known as the Anti-Infective Drugs
Advisory Committee) and the Drug
Safety and Risk Management Advisory
Committee.
General Function of the Committees:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on November 5, 2015, from 8 a.m.
to 6 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm408555.htm.
Contact Person: Jennifer Shepherd,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, FAX:
301–847–8533, email: AMDAC@
fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
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cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://www.fda.
gov/AdvisoryCommittees/default.htm
and scroll down to the appropriate
advisory committee meeting link, or call
the advisory committee information line
to learn about possible modifications
before coming to the meeting.
Agenda: The committees will discuss
the risks and benefits of the systemic
fluoroquinolone antibacterial drugs for
the treatment of acute bacterial sinusitis,
acute bacterial exacerbation of chronic
bronchitis in patients who have chronic
obstructive pulmonary disease, and
uncomplicated urinary tract infections
in the context of available safety
information and the treatment effect of
antibacterial drugs in these clinical
conditions.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committees. Written
submissions may be made to the contact
person on or before October 22, 2015.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2:30 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before October
14, 2015. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by October 15, 2015.
Persons attending FDA’s advisory
committee meetings are advised that the
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Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Jennifer
Shepherd at least 7 days in advance of
the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: September 25, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2015–24836 Filed 9–30–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2015–N–0001]
Request for Nominations for
Individuals and Consumer
Organizations for Advisory
Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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. Nominations will be
accepted for current vacancies and for
those that will or may occur through
December 31, 2015.
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
SUMMARY:
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Federal Register / Vol. 80, No. 190 / Thursday, October 1, 2015 / Notices
committee or panel may send a letter or
email stating that interest to FDA (see
ADDRESSES) by November 2, 2015, for
vacancies listed in this notice.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA (see ADDRESSES) by November 2,
2015.
ADDRESSES: All statements of interest
from consumer organizations interested
in participating in the selection process
and consumer representative
nominations should submit information
electronically to kimberly.hamilton@
fda.hhs.gov, or by mail to Advisory
Committee Oversight and Management
Staff, 10903 New Hampshire Ave., Bldg.
32, Rm. 5103, Silver Spring, MD 20993–
0002, or 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, or by mail to Advisory
Committee Oversight and Management
Staff, 10903 New Hampshire Ave., Bldg.
32, Rm. 5103, Silver Spring, MD 20993–
0002, or FAX: 301–847–8640.
Additional information about
becoming a member on an FDA advisory
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committee can also be obtained by
visiting FDA’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
FOR FURTHER INFORMATION CONTACT:
Kimberly Hamilton, Advisory
Committee Oversight and Management
Staff, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32,
Rm. 5117, Silver Spring, MD 20993–
0002, 301 796–8224, email:
kimberly.hamilton@fda.hhs.gov.
For questions relating to specific
advisory committees or panels, contact
the persons listed in Table 1:
TABLE 1—ADVISORY COMMITTEE CONTACTS
Contact person
Committee/Panel
Shanika Craig, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
1613, Silver Spring, MD 20993–0002, Phone: 301–796–6639, Email:
Shanika.Craig@fda.hhs.gov.
Dimitrus Culbreath, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm.
3530, Silver Spring, MD 20993, Phone: 301–796–6872, Email:
Dimitrus.Culbreath@fda.hhs.gov.
Sara Anderson, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
1544, Silver Spring, MD 20993–0002, Phone: 301–796–1643, Email:
Sara.Anderson@fda.hhs.gov.
Yvette Waples, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm.
2510, Silver Spring, MD 20993–0002, Phone: 301–796–9034, Email:
Yvette.Waples@fda.hhs.gov.
Patricio Garcia, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
1535, Silver Spring, MD 20993–0002, Phone: 301–796–6875, Email:
Patricio.Garcia@fda.hhs.gov.
Natasha Facey, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
1552, Silver Spring, MD 20993–0002, Phone: 301–796–5290, FAX:
301–874–8120, Email: Natasha.Facey@fda.hhs.gov.
Rakesh Raghuwanshi, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4308, Silver
Spring,
MD
20993–0002,
Phone:
301–796–4769,
Email:
Rakesh.Raghuwanshi@fda.hhs.gov.
Donna Mendrick, National Center for Toxicological Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm.
2208, Silver Spring, MD 20993–0002, Phone: 301–796–8892, FAX:
301–847–8600, Email: Donna.Mendrick@fda.hhs.gov.
Sujata Vijh, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
6128, Silver Spring, MD 20993–0002, Phone: 240–402–7107, Email:
Sujata.Vijh@fda.hhs.gov.
FDA is
requesting nominations for voting and/
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SUPPLEMENTARY INFORMATION:
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Anesthesiology and Respiratory Therapy Devices Panel.
Circulatory System Devices Panel; Molecular and Clinical Genetics
Panel.
Dental Products Device Panel; Hematology and Pathology Devices
Panel.
Dermatologic and Ophthalmic Drugs Advisory Committee; Pharmaceutical Science & Clinical Pharmacology Advisory Committee.
General and Plastic Surgery Devices Panel; Neurological Devices
Panel.
General Hospital and Personal Use Devices Panel; Ophthalmic Devices Panel.
Science Advisory Board to the Food and Drug Administration.
Science Advisory Board to National Center for Toxicological Research
(NCTR).
Vaccines and Related Biological Products Advisory Committee.
or nonvoting consumer representatives
for the vacancies listed in table 2:
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Federal Register / Vol. 80, No. 190 / Thursday, October 1, 2015 / Notices
TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE DATE
NEEDED
Type of
vacancy
Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee—Anesthesiologists, pulmonary medicine specialists, or other experts who have specialized
interests in ventilator support, pharmacology, physiology, or the effects and complications of anesthesia.
Circulatory System Devices Panel of the Medical Devices Advisory Committee—Knowledgeable in
the safety and effectiveness of marked and investigational devices for use in the circulatory and
vascular systems.
Dental Products Devices Panel of the Medical Devices Advisory Committee—Dentists, engineers
and scientists who have expertise in the areas of dental implants, dental materials,
periodontology, tissue engineering, and dental anatomy.
Dermatologic and Ophthalmic Drugs Advisory Committee—Knowledgeable in the fields of dermatology, ophthalmology, internal medicine, pathology, immunology, epidemiology or statistics, and
other related professions.
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee—Knowledgeable in the fields of general, plastic, reconstructive, pediatric, thoracic, abdominal, pelvic, and
endoscopic surgery; biomaterials, lasers, wound healing, and quality of life issues.
General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee—Internists, pediatricians, neonatologists, endocrinologists, gerontologists, nurses, biomedical engineers or microbiologists, infection control practitioners or experts.
Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee
—Knowledgeable in the fields of hematology, hematopathology, coagulation and homeostasis,
hematological oncology, and gynecological oncology.
Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee—Experts in
human genetics and in the clinical management of patients with genetic disorders, e.g., pediatricians, obstetricians, neonatologists. The Agency is also interested in considering candidates with
training in inborn errors of metabolism, biochemical and/or molecular genetics, population genetics, epidemiology, and related statistical training. Additionally, individuals with experience in genetic counseling, medical ethics, as well as ancillary fields of study will be considered.
Neurological Devices Panel of the Medical Devices Advisory Committee—Neurosurgeons (cerebrovascular and pediatric), neurologists (stroke, pediatric, pain management, and movement disorders), interventional neuroradiologists, psychiatrists, and biostatisticians.
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee—Knowledgeable in the fields of perinatology, embryology, reproductive endocrinology, pediatric gynecology, gynecological oncology, operative hysteroscopy, pelviscopy, electrosurgery, laser surgery,
assisted reproductive technologies, contraception, postoperative adhesions, and cervical cancer
and colposcopy; obstetrics/gynecology devices; gynecology in the older patient; midwifery; and
labor and delivery nursing.
Ophthalmic Devices Panel of the Medical Devices Advisory Committee—Ophthalmologists with expertise in corneal-external disease, vitreo-retinal surgery, glaucoma, ocular immunology, ocular
pathology; optometrists; vision scientists; and ophthalmic professionals with expertise in clinical
trial design, quality of life assessment, electrophysiology, low vision rehabilitation, and biostatistics.
Pharmaceutical Science and Clinical Pharmacology Advisory Committee—Knowledgeable in the
fields of pharmaceutical manufacturing, clinical pharmacology, pharmacokinetics, bioavailability
and bioequivalence research, the design and evaluation of clinical trials, laboratory analytical
techniques, pharmaceutical chemistry, physiochemistry, biochemistry, biostatistics, and related
biomedical and pharmacological specialties.
Science Board Advisory Committee for the Food and Drug Administration—Knowledgeable in the
fields of food science, safety, and nutrition; chemistry; pharmacology; translational and clinical
medicine and research; toxicology; biostatistics; medical devices; imaging; robotics; cell and tissue based products; regenerative medicine; public health and epidemiology; international health
and regulation; product safety; product manufacturing sciences and quality; and other scientific
areas relevant to FDA regulated products such as systems biology, informatics, nanotechnology,
and combination products.
Science Advisory Board to the NCTR—Knowledgeable in the fields related to toxicological research
Vaccines and Related Biological Products—Knowledgeable in the fields of immunology, molecular
biology, rDNA, virology, bacteriology, epidemiology or biostatistics, allergy, preventive medicine,
infectious diseases, pediatrics, microbiology, and biochemistry.
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Committee/Panel/Areas of expertise needed
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I. Functions and General Description of
the Committee Duties
A. Certain Panels of the Medical Devices
Advisory Committee
The committee reviews and evaluates
data on the safety and effectiveness of
marketed and investigational devices
and makes recommendations for their
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regulation. The panels engage in a
number of activities to fulfill the
functions the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) envisions
for device advisory panels. With the
exception of the Medical Devices
Dispute Resolution Panel, each panel,
according to its specialty area, advises
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Approximate date
needed
the Commissioner of Food and Drugs
(the Commissioner) regarding
recommended classification or
reclassification of devices into one of
three regulatory categories, advises on
any possible risks to health associated
with the use of devices, advises on
formulation of product development
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protocols, reviews premarket approval
applications for medical devices,
reviews guidelines and guidance
documents, recommends exemption of
certain devices from the application of
portions of the FD&C Act, advises on the
necessity to ban a device, and 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 on issues relating to
the design of clinical studies regarding
the safety and effectiveness of marketed
and investigational devices. The Dental
Products Panel also functions at times
as a dental drug panel. The functions of
the dental drug panel are to evaluate
and recommend whether various
prescription drug products should be
changed to over-the-counter status and
to evaluate data and make
recommendations concerning the
approval of new dental drug products
for human use.
B. Dermatologic and Ophthalmic 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 dermatologic and ophthalmic
disorders.
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C. Pharmaceutical Science and Clinical
Pharmacology Advisory Committee
Provide advice on scientific and
technical issues concerning the safety
and effectiveness of human generic drug
products for use in the treatment of a
broad spectrum of human diseases, and
as required, any other product for which
the FDA has regulatory responsibility.
The committee may also review Agency
sponsored intramural and extramural
biomedical research programs in
support of FDA’s generic drug
regulatory responsibilities.
D. Science Board
Provides advice primarily to the
Commissioner of Food and Drugs and
other appropriate officials on specific
complex and technical issues as well as
emerging issues in the scientific
community, industry, and academia.
Additionally, the Board will provide
advice to the Agency on keeping pace
with technical and scientific evolutions
in the fields of regulatory science, on
formulating an appropriate research
agenda, and on upgrading its scientific
and research facilities to keep pace with
these changes. It will also provide the
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means for critical review of Agency
sponsored intramural and extramural
scientific research programs.
E. Science Advisory Board to the
National Center for Toxicological
Research
Reviews and advises the Agency on
the establishment, implementation, and
evaluation of the research programs and
regulatory responsibilities as it relates to
NCTR. The Board will also provide an
extra-Agency review in ensuring that
the research programs at NCTR are
scientifically sound and pertinent.
F. Vaccines and Related Biological
Products Advisory Committee
Reviews and evaluates data
concerning the safety, effectiveness, and
appropriate use of vaccines and related
biological products which are intended
for use in the prevention, treatment, or
diagnosis of human diseases, as well as
considers the quality and relevance of
FDA’s research program which provides
scientific support for the regulation of
these products.
II. Criteria for Members
Persons nominated for membership as
consumer representatives on
committees or panels should meet the
following criteria: (1) Demonstrate ties
to consumer and 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
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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 should include a
cover letter and current curriculum
vitae or resume for each nominee,
including a current business and/or
home address, telephone number, and
email address if available, and a list of
consumer or community-based
organizations for which the candidate
can demonstrate active participation.
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.
Nominations should also specify the
advisory committee(s) or panel(s) for
which the nominee is recommended. In
addition, nominations should include
confirmation 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
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
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Federal Register / Vol. 80, No. 190 / Thursday, October 1, 2015 / Notices
vote in the selection process. Persons
who nominate themselves to serve as
voting or nonvoting consumer
representatives will not participate in
the selection process.
Dated: September 25, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2015–24835 Filed 9–30–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Pharmacy Compounding Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Pharmacy
Compounding Advisory Committee.
General Function of the Committee:
To provide advice on scientific,
technical, and medical issues
concerning drug compounding under
sections 503A and 503B of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act), and, as required, any other product
for which FDA has regulatory
responsibility, and make appropriate
recommendations to the Commissioner
of Food and Drugs.
Date and Time: The meeting will be
held on October 27, 2015, from 8 a.m.
to 5:30 p.m., and on October 28, 2015,
from 8:30 a.m. to 4:45 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
Contact Person: Cindy Hong, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
PCAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
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Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Background: Section 503A of the
FD&C Act (21 U.S.C. 353a) describes the
conditions that must be satisfied for
human drug products compounded by a
licensed pharmacist or licensed
physician to be exempt from the
following three sections of the FD&C
Act: (1) Section 501(a)(2)(B) (21 U.S.C.
351(a)(2)(B)) (concerning current good
manufacturing practice); (2) section
502(f)(1) (21 U.S.C. 352(f)(1))
(concerning the labeling of drugs with
adequate directions for use); and (3)
section 505 (21 U.S.C. 355) (concerning
the approval of human drug products
under new drug applications (NDAs) or
abbreviated new drug applications
(ANDAs)).
The Drug Quality and Security Act
adds a new section, 503B, to the FD&C
Act (21 U.S.C. 353b) that creates a new
category of ‘‘outsourcing facilities.’’
Outsourcing facilities, as defined in
section 503B of the FD&C Act, are
facilities that meet certain conditions
described in section 503B, including
registration with FDA as an outsourcing
facility. If these conditions are satisfied,
a drug product compounded for human
use by or under the direct supervision
of a licensed pharmacist in an
outsourcing facility is exempt from
three sections of the FD&C Act: (1)
Section 502(f)(1), (2) section 505, and (3)
section 582 (21 U.S.C. 360eee–1), but
not section 501(a)(2)(B).
One of the conditions that must be
satisfied to qualify for the exemptions
under both sections 503A and 503B of
the FD&C Act is that the drug that is
compounded does not appear on a list
published by the Secretary of Health
and Human Services (the Secretary) of
drugs that have been withdrawn or
removed from the market because such
drug products or components of such
drug products have been found to be
unsafe or not effective (‘‘withdrawn or
removed list’’) (see sections
503A(b)(1)(C) and 503B(a)(4) of the
FD&C Act).
Another condition that must be
satisfied to qualify for the exemptions
under section 503A of the FD&C Act is
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
that a bulk drug substance (active
pharmaceutical ingredient) used in a
compounded drug must meet one of the
following criteria: (1) Complies with the
standards of an applicable United States
Pharmacopoeia (USP) or National
Formulary monograph, if a monograph
exists, and the USP chapter on
pharmacy compounding; (2) if an
applicable monograph does not exist, is
a component of a drug approved by the
Secretary; or (3) if such a monograph
does not exist and the drug substance is
not a component of a drug approved by
the Secretary, appears on a list (‘‘section
503A bulk drug substances list’’)
developed by the Secretary through
regulations issued by the Secretary (see
section 503A(b)(1)(A)(i) of the FD&C
Act).
FDA will discuss with the committee
drugs proposed for inclusion on the
withdrawn or removed list pursuant to
sections 503A and 503B of the FD&C
Act and on the section 503A bulk drug
substances list.
Agenda: On October 27, 2015, during
the morning session, the committee will
discuss a revision FDA is considering to
the list of drug products that may not be
compounded under the exemptions
provided by the FD&C Act because the
drug product has been withdrawn or
removed from the market because such
drug product or such components of
drug products have been found to be
unsafe or not effective. The list of those
drug products is currently codified at 21
CFR 216.24. FDA now is considering
whether to amend the regulation to add
one more drug to the list: Quinacrine:
All drug products containing quinacrine
for intrauterine administration. As
explained in the Federal Register of July
2, 2014, (79 FR 37687 at 37689 through
37690), the list may specify that a drug
may not be compounded in any form,
or, alternatively, may expressly exclude
a particular formulation, indication,
dosage form, or route of administration
from an entry on the list because an
approved drug containing the same
active ingredient(s) has not been
withdrawn or removed from the market.
Moreover, a drug may be listed only
with regard to certain formulations,
indications, routes of administration, or
dosage forms because it has been found
to be unsafe or not effective in those
particular formulations, indications,
routes of administration, or dosage
forms. FDA plans to seek the
committee’s advice concerning the
inclusion of this drug product.
On October 27, 2015, during the
morning and afternoon sessions, the
committee will discuss six bulk drug
substances nominated for inclusion on
the section 503A bulk drug substances
E:\FR\FM\01OCN1.SGM
01OCN1
]]>Agencies
[Federal Register Volume 80, Number 190 (Thursday, October 1, 2015)]
[Notices]
[Pages 59156-59160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24835]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. FDA-2015-N-0001]
Request for Nominations for Individuals and Consumer
Organizations for Advisory Committees
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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. Nominations will be accepted for current vacancies and
for those that will or may occur through December 31, 2015.
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
[[Page 59157]]
committee or panel may send a letter or email stating that interest to
FDA (see ADDRESSES) by November 2, 2015, for vacancies listed in this
notice. Concurrently, nomination materials for prospective candidates
should be sent to FDA (see ADDRESSES) by November 2, 2015.
ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process and consumer
representative nominations should submit information electronically to
kimberly.hamilton@fda.hhs.gov, or by mail to Advisory Committee
Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm.
5103, Silver Spring, MD 20993-0002, or 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, or by mail to Advisory Committee Oversight and
Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver
Spring, MD 20993-0002, or 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: Kimberly Hamilton, Advisory Committee
Oversight and Management Staff, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5117, Silver Spring, MD 20993-0002, 301
796-8224, email: kimberly.hamilton@fda.hhs.gov.
For questions relating to specific advisory committees or panels,
contact the persons listed in Table 1:
Table 1--Advisory Committee Contacts
------------------------------------------------------------------------
Contact person Committee/Panel
------------------------------------------------------------------------
Shanika Craig, Center for Devices and Anesthesiology and Respiratory
Radiological Health, Food and Drug Therapy Devices Panel.
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1613, Silver
Spring, MD 20993-0002, Phone: 301-796-
6639, Email: Shanika.Craig@fda.hhs.gov.
Dimitrus Culbreath, Center for Devices Circulatory System Devices
and Radiological Health, Food and Drug Panel; Molecular and Clinical
Administration, 10903 New Hampshire Genetics Panel.
Ave., Bldg. 31, Rm. 3530, Silver
Spring, MD 20993, Phone: 301-796-6872,
Email: Dimitrus.Culbreath@fda.hhs.gov.
Sara Anderson, Center for Devices and Dental Products Device Panel;
Radiological Health, Food and Drug Hematology and Pathology
Administration, 10903 New Hampshire Devices Panel.
Ave., Bldg. 66, Rm. 1544, Silver
Spring, MD 20993-0002, Phone: 301-796-
1643, Email: Sara.Anderson@fda.hhs.gov.
Yvette Waples, Center for Drug Dermatologic and Ophthalmic
Evaluation and Research, Food and Drug Drugs Advisory Committee;
Administration, 10903 New Hampshire Pharmaceutical Science &
Ave., Bldg. 31, Rm. 2510, Silver Clinical Pharmacology Advisory
Spring, MD 20993-0002, Phone: 301-796- Committee.
9034, Email: Yvette.Waples@fda.hhs.gov.
Patricio Garcia, Center for Devices and General and Plastic Surgery
Radiological Health, Food and Drug Devices Panel; Neurological
Administration, 10903 New Hampshire Devices Panel.
Ave., Bldg. 66, Rm. 1535, Silver
Spring, MD 20993-0002, Phone: 301-796-
6875, Email:
Patricio.Garcia@fda.hhs.gov.
Natasha Facey, Center for Devices and General Hospital and Personal
Radiological Health, Food and Drug Use Devices Panel; Ophthalmic
Administration, 10903 New Hampshire Devices Panel.
Ave., Bldg. 66, Rm. 1552, Silver
Spring, MD 20993-0002, Phone: 301-796-
5290, FAX: 301-874-8120, Email:
Natasha.Facey@fda.hhs.gov.
Rakesh Raghuwanshi, Office of the Science Advisory Board to the
Commissioner, Food and Drug Food and Drug Administration.
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4308, Silver
Spring, MD 20993-0002, Phone: 301-796-
4769, Email:
Rakesh.Raghuwanshi@fda.hhs.gov.
Donna Mendrick, National Center for Science Advisory Board to
Toxicological Research, Food and Drug National Center for
Administration, 10903 New Hampshire Toxicological Research (NCTR).
Ave., Bldg. 32, Rm. 2208, Silver
Spring, MD 20993-0002, Phone: 301-796-
8892, FAX: 301-847-8600, Email:
Donna.Mendrick@fda.hhs.gov.
Sujata Vijh, Center for Biologics Vaccines and Related Biological
Evaluation and Research, Food and Drug Products Advisory Committee.
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 6128, Silver
Spring, MD 20993-0002, Phone: 240-402-
7107, Email: Sujata.Vijh@fda.hhs.gov.
------------------------------------------------------------------------
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
and/or nonvoting consumer representatives for the vacancies listed in
table 2:
[[Page 59158]]
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
----------------------------------------------------------------------------------------------------------------
Anesthesiology and Respiratory Therapy One Non-Voting..................... Immediately.
Devices Panel of the Medical Devices
Advisory Committee--Anesthesiologists,
pulmonary medicine specialists, or
other experts who have specialized
interests in ventilator support,
pharmacology, physiology, or the
effects and complications of
anesthesia.
Circulatory System Devices Panel of the One Non-Voting..................... Immediately.
Medical Devices Advisory Committee--
Knowledgeable in the safety and
effectiveness of marked and
investigational devices for use in the
circulatory and vascular systems.
Dental Products Devices Panel of the One Non-Voting..................... Immediately.
Medical Devices Advisory Committee--
Dentists, engineers and scientists who
have expertise in the areas of dental
implants, dental materials,
periodontology, tissue engineering,
and dental anatomy.
Dermatologic and Ophthalmic Drugs One Voting......................... Immediately.
Advisory Committee--Knowledgeable in
the fields of dermatology,
ophthalmology, internal medicine,
pathology, immunology, epidemiology or
statistics, and other related
professions.
General and Plastic Surgery Devices One Non-Voting..................... Immediately.
Panel of the Medical Devices Advisory
Committee--Knowledgeable in the fields
of general, plastic, reconstructive,
pediatric, thoracic, abdominal,
pelvic, and endoscopic surgery;
biomaterials, lasers, wound healing,
and quality of life issues.
General Hospital and Personal Use One Non-Voting..................... Immediately.
Devices Panel of the Medical Devices
Advisory Committee--Internists,
pediatricians, neonatologists,
endocrinologists, gerontologists,
nurses, biomedical engineers or
microbiologists, infection control
practitioners or experts.
Hematology and Pathology Devices Panel One Non-Voting..................... Immediately.
of the Medical Devices Advisory
Committee --Knowledgeable in the
fields of hematology, hematopathology,
coagulation and homeostasis,
hematological oncology, and
gynecological oncology.
Molecular and Clinical Genetics Panel One Non-Voting..................... Immediately.
of the Medical Devices Advisory
Committee--Experts in human genetics
and in the clinical management of
patients with genetic disorders, e.g.,
pediatricians, obstetricians,
neonatologists. The Agency is also
interested in considering candidates
with training in inborn errors of
metabolism, biochemical and/or
molecular genetics, population
genetics, epidemiology, and related
statistical training. Additionally,
individuals with experience in genetic
counseling, medical ethics, as well as
ancillary fields of study will be
considered.
Neurological Devices Panel of the One Non-Voting..................... Immediately.
Medical Devices Advisory Committee--
Neurosurgeons (cerebrovascular and
pediatric), neurologists (stroke,
pediatric, pain management, and
movement disorders), interventional
neuroradiologists, psychiatrists, and
biostatisticians.
Obstetrics and Gynecology Devices Panel One Non-Voting..................... Immediately.
of the Medical Devices Advisory
Committee--Knowledgeable in the fields
of perinatology, embryology,
reproductive endocrinology, pediatric
gynecology, gynecological oncology,
operative hysteroscopy, pelviscopy,
electrosurgery, laser surgery,
assisted reproductive technologies,
contraception, postoperative
adhesions, and cervical cancer and
colposcopy; obstetrics/gynecology
devices; gynecology in the older
patient; midwifery; and labor and
delivery nursing.
Ophthalmic Devices Panel of the Medical One Non-Voting..................... Immediately.
Devices Advisory Committee--
Ophthalmologists with expertise in
corneal-external disease, vitreo-
retinal surgery, glaucoma, ocular
immunology, ocular pathology;
optometrists; vision scientists; and
ophthalmic professionals with
expertise in clinical trial design,
quality of life assessment,
electrophysiology, low vision
rehabilitation, and biostatistics.
Pharmaceutical Science and Clinical One Voting......................... Immediately.
Pharmacology Advisory Committee--
Knowledgeable in the fields of
pharmaceutical manufacturing, clinical
pharmacology, pharmacokinetics,
bioavailability and bioequivalence
research, the design and evaluation of
clinical trials, laboratory analytical
techniques, pharmaceutical chemistry,
physiochemistry, biochemistry,
biostatistics, and related biomedical
and pharmacological specialties.
Science Board Advisory Committee for One Voting......................... Immediately.
the Food and Drug Administration--
Knowledgeable in the fields of food
science, safety, and nutrition;
chemistry; pharmacology; translational
and clinical medicine and research;
toxicology; biostatistics; medical
devices; imaging; robotics; cell and
tissue based products; regenerative
medicine; public health and
epidemiology; international health and
regulation; product safety; product
manufacturing sciences and quality;
and other scientific areas relevant to
FDA regulated products such as systems
biology, informatics, nanotechnology,
and combination products.
Science Advisory Board to the NCTR-- One Voting......................... Immediately.
Knowledgeable in the fields related to
toxicological research.
Vaccines and Related Biological One Voting......................... Immediately.
Products--Knowledgeable in the fields
of immunology, molecular biology,
rDNA, virology, bacteriology,
epidemiology or biostatistics,
allergy, preventive medicine,
infectious diseases, pediatrics,
microbiology, and biochemistry.
----------------------------------------------------------------------------------------------------------------
I. Functions and General Description of the Committee Duties
A. Certain Panels of the Medical Devices Advisory Committee
The committee reviews and evaluates data on the safety and
effectiveness of marketed and investigational devices and makes
recommendations for their regulation. The panels engage in a number of
activities to fulfill the functions the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) envisions for device advisory panels. With
the exception of the Medical Devices Dispute Resolution Panel, each
panel, according to its specialty area, advises the Commissioner of
Food and Drugs (the Commissioner) regarding recommended classification
or reclassification of devices into one of three regulatory categories,
advises on any possible risks to health associated with the use of
devices, advises on formulation of product development
[[Page 59159]]
protocols, reviews premarket approval applications for medical devices,
reviews guidelines and guidance documents, recommends exemption of
certain devices from the application of portions of the FD&C Act,
advises on the necessity to ban a device, and 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 on issues relating to the design of
clinical studies regarding the safety and effectiveness of marketed and
investigational devices. The Dental Products Panel also functions at
times as a dental drug panel. The functions of the dental drug panel
are to evaluate and recommend whether various prescription drug
products should be changed to over-the-counter status and to evaluate
data and make recommendations concerning the approval of new dental
drug products for human use.
B. Dermatologic and Ophthalmic 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 dermatologic and ophthalmic disorders.
C. Pharmaceutical Science and Clinical Pharmacology Advisory Committee
Provide advice on scientific and technical issues concerning the
safety and effectiveness of human generic drug products for use in the
treatment of a broad spectrum of human diseases, and as required, any
other product for which the FDA has regulatory responsibility. The
committee may also review Agency sponsored intramural and extramural
biomedical research programs in support of FDA's generic drug
regulatory responsibilities.
D. Science Board
Provides advice primarily to the Commissioner of Food and Drugs and
other appropriate officials on specific complex and technical issues as
well as emerging issues in the scientific community, industry, and
academia. Additionally, the Board will provide advice to the Agency on
keeping pace with technical and scientific evolutions in the fields of
regulatory science, on formulating an appropriate research agenda, and
on upgrading its scientific and research facilities to keep pace with
these changes. It will also provide the means for critical review of
Agency sponsored intramural and extramural scientific research
programs.
E. Science Advisory Board to the National Center for Toxicological
Research
Reviews and advises the Agency on the establishment,
implementation, and evaluation of the research programs and regulatory
responsibilities as it relates to NCTR. The Board will also provide an
extra-Agency review in ensuring that the research programs at NCTR are
scientifically sound and pertinent.
F. Vaccines and Related Biological Products Advisory Committee
Reviews and evaluates data concerning the safety, effectiveness,
and appropriate use of vaccines and related biological products which
are intended for use in the prevention, treatment, or diagnosis of
human diseases, as well as considers the quality and relevance of FDA's
research program which provides scientific support for the regulation
of these products.
II. Criteria for Members
Persons nominated for membership as consumer representatives on
committees or panels should meet the following criteria: (1)
Demonstrate ties to consumer and 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
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 should include a cover letter and current curriculum vitae
or resume for each nominee, including a current business and/or home
address, telephone number, and email address if available, and a list
of consumer or community-based organizations for which the candidate
can demonstrate active participation. 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.
Nominations should also specify the advisory committee(s) or
panel(s) for which the nominee is recommended. In addition, nominations
should include confirmation 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 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
[[Page 59160]]
vote in the selection process. Persons who nominate themselves to serve
as voting or nonvoting consumer representatives will not participate in
the selection process.
Dated: September 25, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-24835 Filed 9-30-15; 8:45 am]
BILLING CODE 4164-01-P
