Request for Nominations for Voting Members on Public Advisory Panels or Committees, 59793-59797 [E6-16679]
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Federal Register / Vol. 71, No. 196 / Wednesday, October 11, 2006 / Notices
Dated: October 4, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E6–16746 Filed 10–10–06; 8:45 am]
BILLING CODE 4163–18–P
Dated: October 4, 2006.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E6–16739 Filed 10–10–06; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Centers for Disease Control and
Prevention
CDC/HRSA Advisory Committee on
HIV and STD Prevention and Treatment
(CHACHSPT)
National Institute for Occupational
Safety and Health (NIOSH); Advisory
Board on Radiation and Worker Health
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC) and the
Health Resources and Services
Administration (HRSA) announce the
following committee meeting.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention announces the
following committee meeting:
Name: CDC/HRSA Advisory Committee on
HIV and STD Prevention and Treatment.
Times and Dates: 8 a.m.–5 p.m., November
13, 2006. 8 a.m.–12:15 p.m., November 14,
2006.
Place: Hotel Washington, 15th Street and
Pennsylvania Avenue, NW., Washington, DC
20004, Telephone: 202–638–5900 or Fax
202–638–1594.
Status: Open to the public, limited only by
the space available. The meeting room will
accommodate approximately 100 people.
Purpose: This Committee is charged with
advising the Secretary, the Director, CDC and
the Administrator, HRSA, regarding activities
related to prevention and control of HIV/
AIDS and other STDs, the support of health
care services to persons living with HIV/
AIDS, and education of health professionals
and the public about HIV/AIDS and other
STDs.
Matters To Be Discussed: Agenda items
include issues pertaining to (1) HIV issues
related to stigma, racism and discrimination
and (2) Comprehensive adolescent sexual
health and other HIV related issues. Agenda
items are subject to change as priorities
dictate.
For Further Information Contact: Margie
Scott-Cseh, Committee Management
Specialist, National Center for HIV, STD, and
TB Prevention, 1600 Clifton Road, NE.,
Mailstop E–07, Atlanta, Georgia 30333.
Telephone: 404–639–8317, or Fax 404–639–
3125, e-mail zkr7@cdc.gov.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
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Name: Advisory Board on Radiation and
Worker Health, National Institute for
Occupational Safety and Health.
Time and Date: 10 a.m.–4 p.m., October 18,
2006.
Place: Via Teleconference. For toll-free
access, please dial 866–643–6504. Participant
Pass Code 9448550.
Status: Open to the public, but without a
public comment period.
Background: The Advisory Board was
established under the Energy Employees
Occupational Illness Compensation Program
Act of 2000 to advise the President on a
variety of policy and technical functions
required to implement and effectively
manage the new compensation program. Key
functions of the Advisory Board include
providing advice on the development of
probability of causation guidelines that have
been promulgated by the Department of
Health and Human Services (HHS) as a final
rule, advice on methods of dose
reconstruction which have also been
promulgated by HHS as a final rule, advice
on the scientific validity and quality of dose
estimation and reconstruction efforts being
performed for purposes of the compensation
program, and advice on petitions to add
classes of workers to the Special Exposure
Cohort.
In December 2000, the President delegated
responsibility for funding, staffing, and
operating the Advisory Board to HHS, which
subsequently delegated this authority to CDC.
NIOSH implements this responsibility for
CDC. The charter was issued on August 3,
2001, renewed at appropriate intervals, and
will expire on August 3, 2007.
Purpose: The Advisory Board is charged
with (a) Providing advice to the Secretary,
HHS, on the development of guidelines
under Executive Order 13179; (b) providing
advice to the Secretary, HHS, on the
scientific validity and quality of dose
reconstruction efforts performed for this
program; and (c) upon request by the
Secretary, HHS, advise the Secretary on
whether there is a class of employees at any
Department of Energy facility who were
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exposed to radiation but for whom it is not
feasible to estimate their radiation dose, and
on whether there is reasonable likelihood
that such radiation doses may have
endangered the health of members of this
class.
Matters To Be Discussed: The agenda for
the Advisory Board meeting includes
Updates on Conflict of Interest Issues;
Working Group Updates; Selection of Board
Members for Individual Dose Reconstruction
Reviews; Planning for Board Future Meetings
and Activities; and Discussion of Past Public
Comments and Possible Board Actions.
The agenda is subject to change as
priorities dictate. In the event an individual
cannot attend, written comments may be
submitted. Any written comments received
will be provided at the meeting and should
be submitted to the contact person below
well in advance of the meeting.
Due to programmatic matters, this Federal
Register Notice is being published on less
than 15 calendar days notice to the public (41
CFR 102–3.150(b)).
Contact Person for More Information: Dr.
Lewis V. Wade, Executive Secretary, NIOSH,
CDC, 4676 Columbia Parkway, Cincinnati,
Ohio 45226, telephone 513–533–6825, fax
513–533–6826.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: October 4, 2006.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention (CDC).
[FR Doc. E6–16747 Filed 10–10–06; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Request for Nominations for Voting
Members on Public Advisory Panels or
Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is requesting
nominations for voting members to
serve on the Device Good
Manufacturing Practice Advisory
Committee, certain device panels of the
Medical Devices Advisory Committee,
the National Mammography Quality
Assurance Advisory Committee, and the
Technical Electronic Products Radiation
Safety Standards Committee in the
Center for Devices and Radiological
Health. Nominations will be accepted
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Federal Register / Vol. 71, No. 196 / Wednesday, October 11, 2006 / Notices
for current vacancies and those that will
or may occur through August 31, 2007.
FDA has a special interest in ensuring
that women, minority groups, and
individuals with disabilities are
adequately represented on advisory
committees and, therefore, encourages
nominations of qualified candidates
from these groups.
DATES: Because scheduled vacancies
occur on various dates throughout each
year, no cutoff date is established for the
receipt of nominations. However, when
possible, nominations should be
received at least 6 months before the
date of scheduled vacancies for each
year, as indicated in this notice.
Send all nominations and
curricula vitae to the following contact
persons in table 1 of this document:
ADDRESSES:
TABLE 1.
Contact Person
Committee/Panel
Geretta P. Wood, Center for Devices and Radiological Health (HFZ–
400), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301–594–2022, e-mail: geretta.wood@fda.hhs.gov
Certain Device Panels of the Medical Devices Advisory Committee
Nancy M. Wynne, Center for Devices and Radiological Health (HFZ–
240), Food and Drug Administration, 1350 Piccard Dr., Rockville,
MD 20850, e-mail: nancy.wynne@fda.hhs.gov
National Mammography Quality Assurance Advisory Committee
Collin L. Figueroa, Center for Devices and Radiological Health (HFZ–
342), Food and Drug Administration, 2094 Gaither Rd., Rockville,
MD 20850, e-mail: collin.figueroa@fda.hhs.gov
Device Good Manufacturing Practice Advisory Committee
Richard V. Kaczmarek, Center for Devices and Radiological Health
(HFZ–240), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, e-mail: richard.kaczmarek@fda.hhs.gov
Technical Electronic Product Radiation Safety Standards Committee
FOR FURTHER INFORMATION CONTACT:
Kathleen L. Walker, Center for Devices
and Radiological Health (HFZ–17), Food
and Drug Administration, 7520 Standish
Pl., Rockville, MD 20855, 301–827–
7293, e-mail:
kathleen.walker@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Vacancies
FDA is requesting nominations of
voting members for vacancies listed as
follows:
TABLE 2.
Current and
Upcoming Vacancies
Approximate
Date Needed
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
2
2
Immediately
December 1,
2006
Circulatory System Devices Panel of the Medical Devices Advisory Committee—interventional cardiologists, electrophysiologists, invasive (vascular) radiologists, vascular and cardiothoracic surgeons, and cardiologists with special interest in congestive heart failure
4
July 1, 2007
Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee—doctors of medicine or philosophy with experience in clinical
chemistry (e.g., cardiac markers), clinical toxicology, clinical pathology, clinical laboratory medicine, and endocrinology
2
March 1, 2007
Dental Products 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
2
November 1,
2006
Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee—
otologists, neurotologists, and audiologists
1
November 1,
2006
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee—gastroenterologists, urologists, and nephrologists
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Committee/Panel Expertise Needed
2
January 1, 2007
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee—surgeons (general, plastic, reconstructive, pediatric, thoracic, abdominal,
pelvic, and endoscopic); dermatologists; experts in biomaterials, lasers, wound
healing, and quality of life; and biostatisticians
2
2
Immediately
September 1,
2007
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TABLE 2.—Continued
Committee/Panel Expertise Needed
Current and
Upcoming Vacancies
Approximate
Date Needed
Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee—hematologists (benign and/or malignant hematology), hematopathologists
(general and special hematology, coagulation and homeostasis, and hematological
oncology), gynecologists with special interests in gynecological oncology,
cytopathologists, and molecular pathologists with special interests in development
of predictive and prognostic biomarkers
3
Immediately
Immunology Devices Panel of the Medical Devices Advisory Committee—persons
with experience in medical, surgical, or clinical oncology, internal medicine, clinical
immunology, allergy, molecular diagnostics, or clinical laboratory medicine
2
March 1, 2007
Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee—experts with broad, cross-cutting scientific, clinical, analytical, or mediation
skills
1
Immediately
Microbiology Devices Panel of the Medical Devices Advisory Committee—infectious
disease clinicians (e.g., pulmonary disease specialists, sexually transmitted disease
specialists, pediatric infectious disease specialists, experts in tropical medicine and
emerging infectious diseases, and mycologists); clinical microbiologists and virologists; clinical virology and microbiology laboratory directors, with expertise in clinical diagnosis and in vitro diagnostic assays (e.g., hepatologists and molecular biologists)
3
2
Immediately
March 1, 2007
Molecular and Clinical Genetics Devices 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, and neonatologists); individuals
with training in inborn errors of metabolism, biochemical and/or molecular genetics,
population genetics, epidemiology, and related statistical training; individuals with
experience in genetic counseling or medical ethics; ancillary fields of study will be
considered as well
1
3
Immediately
June 1, 2007
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee—experts in 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; biostatisticians and
engineers with experience in obstetrics/gynecology devices; urogynecologists; experts in breast care; experts in gynecology in the older patient; experts in diagnostic (optical) spectroscopy; experts in midwifery; labor and delivery nursing
2
February 1, 2007
Radiological Devices Panel of the Medical Devices Advisory Committee—physicians
with experience in general radiology, mammography, ultrasound, magnetic resonance, computed tomography, other radiological subspecialties, and radiation oncology; scientists with experience in diagnostic devices, radiation physics, statistical
analysis, digital imaging, and image analysis
1
February 1, 2007
National Mammography Quality Assurance Advisory Committee—physician, practitioner, or other health professional whose clinical practice, research specialization,
or professional expertise includes a significant focus on mammography
1
February 1, 2007
Device Good Manufacturing Practice Advisory Committee—Nine vacancies occurring
immediately; three government representatives, two industry representatives, two
public representatives, and two health professionals
9
Immediately
Technical Electronic Product Radiation Safety Standards Committee—10 vacancies
occurring immediately, 4 government representatives, 2 industry representatives,
and 4 general public representatives; 5 vacancies occurring January 1, 2007, 3 industry representatives, 1 government representative, and 1 general public representative
10
5
Immediately
January 1, 2007
II. Functions
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A. 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
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number of activities to fulfill the
functions the Federal Food, Drug, and
Cosmetic Act (the act) envisions for
device advisory panels. With the
exception of the Medical Devices
Dispute Resolution Panel, each panel,
according to its specialty area, performs
the following duties: (1) Advises the
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Commissioner of Food and Drugs (the
Commissioner) regarding recommended
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)
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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 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
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-thecounter status and to evaluate data and
make recommendations concerning the
approval of new dental drug products
for human use.
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.
B. National Mammography Quality
Assurance Advisory Committee
The functions of the committee are to
advise FDA on the following topics: (1)
Developing appropriate quality
standards and regulations for
mammography facilities, (2) developing
appropriate standards and regulations
for bodies accrediting mammography
facilities under this program, (3)
developing regulations with respect to
sanctions, (4) developing procedures for
monitoring compliance with standards,
(5) establishing a mechanism to
investigate consumer complaints, (6)
reporting new developments concerning
breast imaging which should be
considered in the oversight of
mammography facilities, (7)
determining whether there exists a
shortage of mammography facilities in
rural and health professional shortage
areas and determining the effects of
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personnel on access to the services of
such facilities in such areas, (8)
determining whether there will exist a
sufficient number of medical physicists
after October 1, 1999, and (9)
determining the costs and benefits of
compliance with these requirements.
C. Device Good Manufacturing Practice
Advisory Committee
The functions of the committee are to
review proposed regulations issuance
regarding good manufacturing practices
governing the methods used in, and the
facilities and controls used for
manufacture, packaging, storage,
installation, and servicing of devices,
and make recommendations regarding
the feasibility and reasonableness of
those proposed regulations. The
committee also reviews and makes
recommendations on proposed
guidelines developed to assist the
medical device industry in meeting the
good manufacturing practice
requirements, and provides advice with
regard to any petition submitted by a
manufacturer for an exemption or
variance from good manufacturing
practice regulations.
Section 520 of the act (21 U.S.C.
360(j)), as amended, provides that the
Device Good Manufacturing Practice
Advisory Committee shall be composed
of nine members as follows: (1) Three of
the members shall be appointed from
persons who are officers or employees
of any Federal, State, or local
government; (2) two shall be
representatives of interests of the device
manufacturing industry; (3) two shall be
representatives of the interests of
physicians and other health
professionals; and (4) two shall be
representatives of the interests of the
general public.
D. Technical Electronic Product
Radiation Safety Standards Committee
The function of the committee is to
provide advice and consultation on the
technical feasibility, reasonableness,
and practicability of performance
standards for electronic products to
control the emission of radiation from
such products. The committee may
recommend electronic product radiation
safety standards for consideration.
Section 534(f) of the act (21 U.S.C.
360kk(f)), as amended by the Safe
Medical Devices Act of 1990, provides
that the Technical Electronic Product
Radiation Safety Standards Committee
include five members from
governmental agencies, including State
or Federal Governments, five members
from the affected industries, and five
members from the general public, of
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which at least one shall be a
representative of organized labor.
III. Qualifications
A. Panels of the Medical Devices
Advisory Committee
Persons nominated for membership
on the panels should have adequately
diversified experience appropriate to
the work of the panel in such fields as
clinical and administrative medicine,
engineering, biological and physical
sciences, statistics, and other related
professions. The nature of specialized
training and experience necessary to
qualify the nominee as an expert
suitable for appointment may include
experience in medical practice,
teaching, and/or research relevant to the
field of activity of the panel. The
particular needs at this time for each
panel are listed in section I of this
document. The term of office is up to 4
years, depending on the appointment
date.
B. National Mammography Quality
Assurance Advisory Committee
Persons nominated for membership
should be physicians, practitioners, and
other health professionals, whose
clinical practice, research
specialization, or professional expertise
include a significant focus on
mammography and individuals
identified with consumer interests. Prior
experience on Federal public advisory
committees in the same or similar
subject areas will also be considered
relevant professional expertise. The
particular needs at this time for this
committee are listed in section I of this
document. The term of office is up to 4
years, depending on the appointment
date.
C. Device Good Manufacturing Practice
Advisory Committee
Persons nominated for membership as
a health professional or officer or
employee of any Federal, State, or local
government should have knowledge of
or expertise in any one or more of the
following areas: Quality assurance
concerning the design, manufacture,
and use of medical devices. To be
eligible for selection as a representative
of the general public or industry,
nominees should possess appropriate
qualifications to understand and
contribute to the committee’s work. The
particular needs at this time for this
committee are listed in section I of this
document. The term of office is up to 4
years, depending on the appointment
date.
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D. Technical Electronic Product
Radiation Safety Standards Committee
Persons nominated should be
technically qualified by training and
experience in one or more fields of
science or engineering applicable to
electronic product radiation safety. The
particular needs at this time for this
committee are listed in section I of this
document. The term of office is up to 4
years, depending on the appointment
date.
IV. Nomination Procedures
Any interested person may nominate
one or more qualified persons for
membership on one or more of the
advisory panels or advisory committees.
Self-nominations are also accepted.
Nominations will include complete
curriculum vitae of each nominee,
current business address and telephone
number. Nominations will specify the
advisory panel(s) or advisory
committee(s) for which the nominee is
recommended. Nominations will
include confirmation that the nominee
is aware of the nomination, is willing to
serve as a member of the advisory
committee if selected, and appears to
have no conflict of interest that would
preclude membership. Potential
candidates will be required to provide
detailed information concerning such
matters as financial holdings,
employment, and research grants and/or
contracts to permit evaluation of
possible sources of conflict of interest.
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 3, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. E6–16679 Filed 10–10–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004E–0444]
Redetermination of Regulatory Review
Period for Purposes of Patent
Extension; BONIVA; Correction
AGENCY:
Food and Drug Administration,
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HHS.
ACTION:
Notice; correction.
SUMMARY: The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of June 22, 2006 (71 FR 35918).
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The document announced that FDA had
determined the regulatory review period
for BONIVA. The notice provided that
on or before August 21, 2006, anyone
with knowledge that any of the dates as
published are incorrect may submit a
request for a redetermination of the
regulatory review period. A request for
revision of the regulatory review period
was filed for the product on July 25,
2006. FDA reviewed its records and
found that the effective date of the
investigational new drug application
(IND) was incorrect because of a clerical
error. Therefore, FDA is republishing a
determination of the regulatory review
period to reflect the corrected effective
date for the IND. FDA has made a
determination of the regulatory review
period because of the submission of an
application to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that human drug product.
ADDRESSES: Submit written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy (HFD–007), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–2041.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
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Director of Patents and Trademarks may
award (for example, half the testing
phase must be subtracted as well as any
time that may have occurred before the
patent was issued), FDA’s determination
of the length of a regulatory review
period for a human drug product will
include all of the testing phase and
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA recently approved for marketing
the human drug product BONIVA
(ibandronate sodium). BONIVA is
indicated for treatment and prevention
of osteoporosis in postmenopausal
women. Subsequent to this approval,
the Patent and Trademark Office
received a patent term restoration
application for BONIVA (U.S. Patent
No. 4,927,814) from Hoffmann-La
Roche, Inc., and the Patent and
Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated October 19, 2004, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of BONIVA
represented the first permitted
commercial marketing or use of the
product. Shortly thereafter, the Patent
and Trademark Office requested that
FDA determine the product’s regulatory
review period.
FDA has determined that the
applicable adjusted regulatory review
period for BONIVA is 3,122 days. Of
this time, 2,817 days occurred during
the testing phase of the regulatory
review period, while 305 days occurred
during the approval phase. These
periods of time were derived from the
following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
355(i)) became effective: October 30,
1994. FDA has verified the applicant’s
claim that the date the IND became
effective was on October 30, 1994.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: July 16, 2002. FDA has
verified the applicant’s claim that the
new drug application (NDA) for
BONIVA (NDA 21–455) was initially
submitted on July 16, 2002.
3. The date the application was
approved: May 16, 2003. FDA has
verified the applicant’s claim that NDA
21–455 was approved on May 16, 2003.
This redetermination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
E:\FR\FM\11OCN1.SGM
11OCN1
]]>Agencies
[Federal Register Volume 71, Number 196 (Wednesday, October 11, 2006)]
[Notices]
[Pages 59793-59797]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-16679]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Request for Nominations for Voting Members on Public Advisory
Panels or Committees
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting members to serve on the Device Good
Manufacturing Practice Advisory Committee, certain device panels of the
Medical Devices Advisory Committee, the National Mammography Quality
Assurance Advisory Committee, and the Technical Electronic Products
Radiation Safety Standards Committee in the Center for Devices and
Radiological Health. Nominations will be accepted
[[Page 59794]]
for current vacancies and those that will or may occur through August
31, 2007.
FDA has a special interest in ensuring that women, minority groups,
and individuals with disabilities are adequately represented on
advisory committees and, therefore, encourages nominations of qualified
candidates from these groups.
DATES: Because scheduled vacancies occur on various dates throughout
each year, no cutoff date is established for the receipt of
nominations. However, when possible, nominations should be received at
least 6 months before the date of scheduled vacancies for each year, as
indicated in this notice.
ADDRESSES: Send all nominations and curricula vitae to the following
contact persons in table 1 of this document:
Table 1.
------------------------------------------------------------------------
Contact Person Committee/Panel
------------------------------------------------------------------------
Geretta P. Wood, Center for Devices Certain Device Panels of the
and Radiological Health (HFZ-400), Medical Devices Advisory Committee
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD
20850, 301-594-2022, e-mail:
geretta.wood@fda.hhs.gov
------------------------------------------------------------------------
Nancy M. Wynne, Center for Devices National Mammography Quality
and Radiological Health (HFZ-240), Assurance Advisory Committee
Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850,
e-mail: nancy.wynne@fda.hhs.gov
------------------------------------------------------------------------
Collin L. Figueroa, Center for Device Good Manufacturing Practice
Devices and Radiological Health Advisory Committee
(HFZ-342), Food and Drug
Administration, 2094 Gaither Rd.,
Rockville, MD 20850, e-mail:
collin.figueroa@fda.hhs.gov
------------------------------------------------------------------------
Richard V. Kaczmarek, Center for Technical Electronic Product
Devices and Radiological Health Radiation Safety Standards
(HFZ-240), Food and Drug Committee
Administration, 1350 Piccard Dr.,
Rockville, MD 20850, e-mail:
richard.kaczmarek@fda.hhs.gov
------------------------------------------------------------------------
FOR FURTHER INFORMATION CONTACT: Kathleen L. Walker, Center for Devices
and Radiological Health (HFZ-17), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855, 301-827-7293, e-mail:
kathleen.walker@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Vacancies
FDA is requesting nominations of voting members for vacancies
listed as follows:
Table 2.
------------------------------------------------------------------------
Current and
Committee/Panel Expertise Needed Upcoming Approximate
Vacancies Date Needed
------------------------------------------------------------------------
Anesthesiology and Respiratory 2 Immediately
Therapy Devices Panel of the Medical 2 December 1,
Devices Advisory Committee-- 2006
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 4 July 1, 2007
the Medical Devices Advisory
Committee--interventional
cardiologists, electrophysiologists,
invasive (vascular) radiologists,
vascular and cardiothoracic
surgeons, and cardiologists with
special interest in congestive heart
failure
------------------------------------------------------------------------
Clinical Chemistry and Clinical 2 March 1, 2007
Toxicology Devices Panel of the
Medical Devices Advisory Committee--
doctors of medicine or philosophy
with experience in clinical
chemistry (e.g., cardiac markers),
clinical toxicology, clinical
pathology, clinical laboratory
medicine, and endocrinology
------------------------------------------------------------------------
Dental Products Panel of the Medical 2 November 1,
Devices Advisory Committee-- 2006
dentists, engineers, and scientists
who have expertise in the areas of
dental implants, dental materials,
periodontology, tissue engineering,
and dental anatomy
------------------------------------------------------------------------
Ear, Nose, and Throat Devices Panel 1 November 1,
of the Medical Devices Advisory 2006
Committee--otologists,
neurotologists, and audiologists
------------------------------------------------------------------------
Gastroenterology and Urology Devices 2 January 1,
Panel of the Medical Devices 2007
Advisory Committee--
gastroenterologists, urologists, and
nephrologists
------------------------------------------------------------------------
General and Plastic Surgery Devices 2 Immediately
Panel of the Medical Devices 2 September 1,
Advisory Committee--surgeons 2007
(general, plastic, reconstructive,
pediatric, thoracic, abdominal,
pelvic, and endoscopic);
dermatologists; experts in
biomaterials, lasers, wound healing,
and quality of life; and
biostatisticians
------------------------------------------------------------------------
[[Page 59795]]
Hematology and Pathology Devices 3 Immediately
Panel of the Medical Devices
Advisory Committee--hematologists
(benign and/or malignant
hematology), hematopathologists
(general and special hematology,
coagulation and homeostasis, and
hematological oncology),
gynecologists with special interests
in gynecological oncology,
cytopathologists, and molecular
pathologists with special interests
in development of predictive and
prognostic biomarkers
------------------------------------------------------------------------
Immunology Devices Panel of the 2 March 1, 2007
Medical Devices Advisory Committee--
persons with experience in medical,
surgical, or clinical oncology,
internal medicine, clinical
immunology, allergy, molecular
diagnostics, or clinical laboratory
medicine
------------------------------------------------------------------------
Medical Devices Dispute Resolution 1 Immediately
Panel of the Medical Devices
Advisory Committee--experts with
broad, cross-cutting scientific,
clinical, analytical, or mediation
skills
------------------------------------------------------------------------
Microbiology Devices Panel of the 3 Immediately
Medical Devices Advisory Committee-- 2 March 1, 2007
infectious disease clinicians (e.g.,
pulmonary disease specialists,
sexually transmitted disease
specialists, pediatric infectious
disease specialists, experts in
tropical medicine and emerging
infectious diseases, and
mycologists); clinical
microbiologists and virologists;
clinical virology and microbiology
laboratory directors, with expertise
in clinical diagnosis and in vitro
diagnostic assays (e.g.,
hepatologists and molecular
biologists)
------------------------------------------------------------------------
Molecular and Clinical Genetics 1 Immediately
Devices Panel of the Medical Devices 3 June 1, 2007
Advisory Committee--experts in human
genetics and in the clinical
management of patients with genetic
disorders (e.g., pediatricians,
obstetricians, and neonatologists);
individuals with training in inborn
errors of metabolism, biochemical
and/or molecular genetics,
population genetics, epidemiology,
and related statistical training;
individuals with experience in
genetic counseling or medical
ethics; ancillary fields of study
will be considered as well
------------------------------------------------------------------------
Obstetrics and Gynecology Devices 2 February 1,
Panel of the Medical Devices 2007
Advisory Committee--experts in
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;
biostatisticians and engineers with
experience in obstetrics/gynecology
devices; urogynecologists; experts
in breast care; experts in
gynecology in the older patient;
experts in diagnostic (optical)
spectroscopy; experts in midwifery;
labor and delivery nursing
------------------------------------------------------------------------
Radiological Devices Panel of the 1 February 1,
Medical Devices Advisory Committee-- 2007
physicians with experience in
general radiology, mammography,
ultrasound, magnetic resonance,
computed tomography, other
radiological subspecialties, and
radiation oncology; scientists with
experience in diagnostic devices,
radiation physics, statistical
analysis, digital imaging, and image
analysis
------------------------------------------------------------------------
National Mammography Quality 1 February 1,
Assurance Advisory Committee-- 2007
physician, practitioner, or other
health professional whose clinical
practice, research specialization,
or professional expertise includes a
significant focus on mammography
------------------------------------------------------------------------
Device Good Manufacturing Practice 9 Immediately
Advisory Committee--Nine vacancies
occurring immediately; three
government representatives, two
industry representatives, two public
representatives, and two health
professionals
------------------------------------------------------------------------
Technical Electronic Product 10 Immediately
Radiation Safety Standards 5 January 1,
Committee--10 vacancies occurring 2007
immediately, 4 government
representatives, 2 industry
representatives, and 4 general
public representatives; 5 vacancies
occurring January 1, 2007, 3
industry representatives, 1
government representative, and 1
general public representative
------------------------------------------------------------------------
II. Functions
A. 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 act) envisions for device advisory panels. With the
exception of the Medical Devices Dispute Resolution Panel, each panel,
according to its specialty area, performs the following duties: (1)
Advises the Commissioner of Food and Drugs (the Commissioner) regarding
recommended 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)
[[Page 59796]]
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 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 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.
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.
B. National Mammography Quality Assurance Advisory Committee
The functions of the committee are to advise FDA on the following
topics: (1) Developing appropriate quality standards and regulations
for mammography facilities, (2) developing appropriate standards and
regulations for bodies accrediting mammography facilities under this
program, (3) developing regulations with respect to sanctions, (4)
developing procedures for monitoring compliance with standards, (5)
establishing a mechanism to investigate consumer complaints, (6)
reporting new developments concerning breast imaging which should be
considered in the oversight of mammography facilities, (7) determining
whether there exists a shortage of mammography facilities in rural and
health professional shortage areas and determining the effects of
personnel on access to the services of such facilities in such areas,
(8) determining whether there will exist a sufficient number of medical
physicists after October 1, 1999, and (9) determining the costs and
benefits of compliance with these requirements.
C. Device Good Manufacturing Practice Advisory Committee
The functions of the committee are to review proposed regulations
issuance regarding good manufacturing practices governing the methods
used in, and the facilities and controls used for manufacture,
packaging, storage, installation, and servicing of devices, and make
recommendations regarding the feasibility and reasonableness of those
proposed regulations. The committee also reviews and makes
recommendations on proposed guidelines developed to assist the medical
device industry in meeting the good manufacturing practice
requirements, and provides advice with regard to any petition submitted
by a manufacturer for an exemption or variance from good manufacturing
practice regulations.
Section 520 of the act (21 U.S.C. 360(j)), as amended, provides
that the Device Good Manufacturing Practice Advisory Committee shall be
composed of nine members as follows: (1) Three of the members shall be
appointed from persons who are officers or employees of any Federal,
State, or local government; (2) two shall be representatives of
interests of the device manufacturing industry; (3) two shall be
representatives of the interests of physicians and other health
professionals; and (4) two shall be representatives of the interests of
the general public.
D. Technical Electronic Product Radiation Safety Standards Committee
The function of the committee is to provide advice and consultation
on the technical feasibility, reasonableness, and practicability of
performance standards for electronic products to control the emission
of radiation from such products. The committee may recommend electronic
product radiation safety standards for consideration.
Section 534(f) of the act (21 U.S.C. 360kk(f)), as amended by the
Safe Medical Devices Act of 1990, provides that the Technical
Electronic Product Radiation Safety Standards Committee include five
members from governmental agencies, including State or Federal
Governments, five members from the affected industries, and five
members from the general public, of which at least one shall be a
representative of organized labor.
III. Qualifications
A. Panels of the Medical Devices Advisory Committee
Persons nominated for membership on the panels should have
adequately diversified experience appropriate to the work of the panel
in such fields as clinical and administrative medicine, engineering,
biological and physical sciences, statistics, and other related
professions. The nature of specialized training and experience
necessary to qualify the nominee as an expert suitable for appointment
may include experience in medical practice, teaching, and/or research
relevant to the field of activity of the panel. The particular needs at
this time for each panel are listed in section I of this document. The
term of office is up to 4 years, depending on the appointment date.
B. National Mammography Quality Assurance Advisory Committee
Persons nominated for membership should be physicians,
practitioners, and other health professionals, whose clinical practice,
research specialization, or professional expertise include a
significant focus on mammography and individuals identified with
consumer interests. Prior experience on Federal public advisory
committees in the same or similar subject areas will also be considered
relevant professional expertise. The particular needs at this time for
this committee are listed in section I of this document. The term of
office is up to 4 years, depending on the appointment date.
C. Device Good Manufacturing Practice Advisory Committee
Persons nominated for membership as a health professional or
officer or employee of any Federal, State, or local government should
have knowledge of or expertise in any one or more of the following
areas: Quality assurance concerning the design, manufacture, and use of
medical devices. To be eligible for selection as a representative of
the general public or industry, nominees should possess appropriate
qualifications to understand and contribute to the committee's work.
The particular needs at this time for this committee are listed in
section I of this document. The term of office is up to 4 years,
depending on the appointment date.
[[Page 59797]]
D. Technical Electronic Product Radiation Safety Standards Committee
Persons nominated should be technically qualified by training and
experience in one or more fields of science or engineering applicable
to electronic product radiation safety. The particular needs at this
time for this committee are listed in section I of this document. The
term of office is up to 4 years, depending on the appointment date.
IV. Nomination Procedures
Any interested person may nominate one or more qualified persons
for membership on one or more of the advisory panels or advisory
committees. Self-nominations are also accepted. Nominations will
include complete curriculum vitae of each nominee, current business
address and telephone number. Nominations will specify the advisory
panel(s) or advisory committee(s) for which the nominee is recommended.
Nominations will include confirmation that the nominee is aware of the
nomination, is willing to serve as a member of the advisory committee
if selected, and appears to have no conflict of interest that would
preclude membership. Potential candidates will be required to provide
detailed information concerning such matters as financial holdings,
employment, and research grants and/or contracts to permit evaluation
of possible sources of conflict of interest.
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 3, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-16679 Filed 10-10-06; 8:45 am]
BILLING CODE 4160-01-S
