Request for Nominations for Voting and Nonvoting Consumer Representative Members on Public Advisory Committees and Panels, 46442-46445 [E9-21558]

Download as PDF 46442 Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Notices Cosmetic Act (the act) (21 U.S.C. 360j(f)(3)), as amended by the Medical Device Amendments of 1976, provides that each medical device panel include one nonvoting member to represent the interests of the medical device manufacturing industry. FDA is requesting nominations for nonvoting members representing industry interests for the following vacancies listed in table 1 of this document. TABLE 1. Medical Devices Panels Approximate Date Needed Dental Products Panel November 1, 2009 General Hospital and Personal Use Devices Panel January 1, 2010 Hematology and Pathology Devices Panel March 1, 2010 Immunology Devices Panel March 1, 2010 Ophthalmic Devices Panel November 1, 2009 I. Functions The functions of the medical device panels are listed as follows: (1) Review and evaluate data on the safety and effectiveness of marketed and investigational devices and make recommendations for their regulation, (2) advise the Commissioner of Food and Drugs regarding recommended classification or reclassification of these devices into one of three regulatory categories, (3) advise on any possible risks to health associated with the use of devices, (4) advise on formulation of product development protocols, (5) review premarket approval applications for medical devices, (6) review guidelines and guidance documents, (7) recommend exemption to certain devices from the application of portions of the act, (8) advise on the necessity to ban a device, (9) respond to requests from the agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices, and (10) make recommendations on the quality in the design of clinical studies regarding the safety and effectiveness of marketed and investigational devices. cprice-sewell on DSK2BSOYB1PROD with NOTICES II. Selection Procedure Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests should send a letter stating that interest to the contact person (see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of this notice. Within the subsequent 30 days, FDA will send a letter to each organization that has expressed an interest, attaching a complete list of all such organizations, and a list of all nominees along with their current resumes. The letter will also state that it is the responsibility of the interested organizations to confer VerDate Nov<24>2008 15:47 Sep 08, 2009 Jkt 217001 with one another and to select a candidate, within 60 days after the receipt of the FDA letter, to serve as the nonvoting member to represent industry interests for a particular device panel. The interested organizations are not bound by the list of nominees in selecting a candidate. However, if no individual is selected within the 60 days, the Commissioner of Food and Drugs will select the nonvoting member to represent industry interests. III. Qualifications Persons nominated for the device panels should be full time employees of firms that manufacture products that would come before the panel, or consulting firms that represent manufacturers, or have similar appropriate ties to industry. IV. Application Procedure Individuals may self-nominate and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. Within the 30 days, the following information should be sent to the FDA contact person (see FOR FURTHER INFORMATION CONTACT): A current curriculum vitae of each nominee, current business and/or home address, telephone number, e-mail address, and the name of the device panel of interest. FDA will forward all nominations to the organizations expressing interest in participating in the selection process for the device panel. (Persons who nominate themselves as nonvoting industry representatives will not participate in the selection process). FDA has a special interest in ensuring that women, minority groups, individuals with physical disabilities, and small businesses are adequately represented on its advisory committees, and therefore, encourages nominations PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 for appropriately qualified candidates from these groups. 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: September 2, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–21555 Filed 9–8–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0412] Request for Nominations for Voting and Nonvoting Consumer Representative Members on Public Advisory Committees and Panels AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is requesting nominations for voting and nonvoting consumer representatives to serve on the National Mammography Quality Assurance Advisory Committee (NMQAAC) and certain devices panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health (CDRH). 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: Nominations will be accepted for current vacancies and for those that will or may occur through October 31, 2010. Because vacancies occur on various E:\FR\FM\09SEN1.SGM 09SEN1 Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Notices dates throughout the year, there is no cutoff date for the receipt of nominations. ADDRESSES: All nomination for membership should be sent electronically to CV@OC.FDA.GOV or by mail to Advisory Committee Oversight and Management Staff or by mail to Advisory Committee Oversight and Management Staff (HF–4), 5600 Fishers Lane, Rockville, MD 20857. Information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA’s Web site https://www.fda.gov/ AdvisoryCommittees/AboutAdvisory Committees/CommitteeMembership/ default.htm. FOR FURTHER INFORMATION CONTACT: For general information: Doreen 46443 Brandes, Office of the Commissioner (HF–4), Food and Drug Administration, 5600 Fishers Lane, rm. 14C–3, Rockville, MD 20857, 301–827–8858, email: doreen.brandes@fda.hhs.gov. For specific committee questions, contact the following persons listed in table 1 of this document. TABLE 1. Contact Person Committee/Panel Geretta P. Wood, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1682, Silver Spring, MD 20993, 301–796–5550, or e-mail Geretta.Wood@fda.hhs.gov Certain Device Panels of the Medical Devices Advisory Committee Normica Facey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4652, Silver Spring, MD 20993, e-mail: Normica.Facey@fda.hhs.gov National Mammography Quality Assurance Advisory Committee SUPPLEMENTARY INFORMATION: I. Vacancies FDA is requesting nominations for voting and nonvoting consumer representatives for the vacancies listed in table 2 of this document: TABLE 2. Current & Upcoming Vacancies Approximate Date Needed 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 1-nonvoting Immediately 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 1-nonvoting November 1, 2009 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 1-nonvoting Immediately 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 1-nonvoting 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 cprice-sewell on DSK2BSOYB1PROD with NOTICES Committee/Panel Expertise Needed 1-nonvoting March 1, 2010 Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee - experts with broad, cross-cutting scientific, clinical, analytical or mediation skills 1-nonvoting Immediately VerDate Nov<24>2008 15:47 Sep 08, 2009 Jkt 217001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\09SEN1.SGM 09SEN1 46444 Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Notices TABLE 2.—Continued Committee/Panel Expertise Needed Current & Upcoming Vacancies Approximate Date Needed 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, biofilm development; mycologists; clinical microbiologists and virologists; clinical virology and microbiology laboratory directors, with expertise in clinical diagnosis and in vitro diagnostic assays, e.g., hepatologists; molecular biologists 1-nonvoting Immediately 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, neonatologists. Individuals with training in inborn errors of metabolism, biochemical and/or molecular genetics, population genetics, epidemiology and related statistical training, and clinical molecular genetics testing (e.g., genotyping, array CGH, etc.) Individuals with experience in genetics counseling, medical ethics are also desired, and individuals with experience in ancillary fields of study will be considered 1-nonvoting June 1, 2010 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 1-nonvoting December 1, 2009 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 1-nonvoting February 1, 2010 Ophthalmic Devices Panel of the Medical Devices Advisory Committee - ophthalmologists specializing in cataract and refractive surgery and vitreo-retinal surgery, in addition to vision scientists, optometrists, and biostatisticians practiced in ophthalmic clinical trials 1-nonvoting November 1, 2009 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee - orthopedic surgeons (joint, spine, trauma, and pediatric); rheumatologists; engineers (biomedical, biomaterials, and biomechanical); experts in rehabilitation medicine, sports medicine, and connective tissue engineering; and biostatisticians 1-nonvoting Immediately 2-voting February 1, 2010 cprice-sewell on DSK2BSOYB1PROD with NOTICES National Mammography Quality Assurance Advisory Committee - physicians, practitioners, or other health professionals whose clinical practice, research specialization, or professional expertise include a significant focus on mammography II. Functions A. National Mammography Quality Assurance Advisory Committee The committee advises FDA on the following topics: (1) Developing appropriate quality standards and regulations for mammography facilities, (2) developing appropriate standards VerDate Nov<24>2008 15:47 Sep 08, 2009 Jkt 217001 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 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 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 E:\FR\FM\09SEN1.SGM 09SEN1 Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Notices 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. cprice-sewell on DSK2BSOYB1PROD with NOTICES B. 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 of 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, 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 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 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. III. Criteria for Members Persons nominated for membership as a consumer representatives on the committee/panels must 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 must 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. VerDate Nov<24>2008 15:47 Sep 08, 2009 Jkt 217001 IV. Selection Procedures Selection of members representing consumer interests is conducted through procedures that include the use of organizations representing the public interest and consumer advocacy groups. The organizations have the responsibility of recommending candidates of the agency’s selection. V. Nomination Procedures All nominations must include a cover letter, a curriculum vita or resume (that includes the nominee’s office address, telephone number, and e-mail address), and a list of consumer or communitybased organizations for which the candidate can demonstrate active participation. Nominations will specify the advisory committee or panel(s) for which the nominee is recommended. Nominations will include confirmation that the nominee is aware of the nomination. Any interested person or organization may nominate one or more qualified persons for membership as consumer representatives on the advisory committee/panels. Self-nominations are also accepted. Potential candidates will be required to provide detail information concerning such matters as financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of a conflict of interest. The nomination should specify the committee/panels of interest. The term of office is up to 4 years, depending on the appointment date. 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: September 2, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–21558 Filed 9–8–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR–5281–N–66] Notice of Submission of Proposed Information Collection to OMB; Emergency Comment Request; Broadband Research Project AGENCY: Office of Policy Development and Research, HUD. ACTION: Notice of proposed information collection. SUMMARY: The proposed information collection requirement described below has been submitted to the Office of PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 46445 Management and Budget (OMB) for emergency review and approval, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. DATES: Comments Due Date: September 16, 2009. ADDRESSES: Interested persons are invited to submit comments regarding this proposal. Comments must be received within fourteen (14) days from the date of this Notice. Comments should refer to the proposal by name and/or OMB approval number and should be sent to: Mr. Ross A. Rutledge, HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20502; e-mail: Ross_A._Rutledge@omb.eop.gov; fax: (202) 395–5806. FOR FURTHER INFORMATION CONTACT: Lillian Deitzer, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 Seventh Street, SW., Washington, DC 20410; email: Lillian.L.Deitzer@hud.gov; telephone (202) 402–8048. This is not a toll-free number. Copies of available documents should be submitted to OMB and may be obtained from Ms. Deitzer. SUPPLEMENTARY INFORMATION: This Notice informs the public that the U.S. Department of Housing and Urban Development (HUD) has submitted to OMB, for emergency processing, a proposed information collection as part of planning for the National Broadband Plan ordered under the American Recovery and Reinvestment Act of 2009. The information will describe the availability and usage of broadband internet services in HUD-assisted housing and at Neighborhood Networks Centers. The respondents are Public Housing Authorities, Tribes and managers of multi-family and HOME Investment Partnerships Program properties as well as managers of Neighborhood Networks Centers. HUD will survey all PHAs, Indian Tribes and managers of Neighborhood Networks Centers and a 500-respondent sample for each of Multi-Family managers with e-mail address, Multi-Family managers without e-mail addresses and HOME managers. For the Residential Broadband Survey, each respondent will be asked to voluntarily disclose whether broadband internet service is available in their project and approximately how many residents subscribe to that service. For the Neighborhood Networks Survey, each Center manager will be voluntarily asked to describe the programming offered at their Center as well as the number of users who utilize the Center. E:\FR\FM\09SEN1.SGM 09SEN1

Agencies

[Federal Register Volume 74, Number 173 (Wednesday, September 9, 2009)]
[Notices]
[Pages 46442-46445]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-21558]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0412]


Request for Nominations for Voting and Nonvoting Consumer 
Representative Members on Public Advisory Committees and Panels

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is requesting 
nominations for voting and nonvoting consumer representatives to serve 
on the National Mammography Quality Assurance Advisory Committee 
(NMQAAC) and certain devices panels of the Medical Devices Advisory 
Committee in the Center for Devices and Radiological Health (CDRH).
    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: Nominations will be accepted for current vacancies and for those 
that will or may occur through October 31, 2010. Because vacancies 
occur on various

[[Page 46443]]

dates throughout the year, there is no cutoff date for the receipt of 
nominations.

ADDRESSES: All nomination for membership should be sent electronically 
to CV@OC.FDA.GOV or by mail to Advisory Committee Oversight and 
Management Staff or by mail to Advisory Committee Oversight and 
Management Staff (HF-4), 5600 Fishers Lane, Rockville, MD 20857. 
Information about becoming a member on an FDA advisory committee can 
also be obtained by visiting FDA's Web site https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/CommitteeMembership/default.htm.

FOR FURTHER INFORMATION CONTACT:
    For general information: Doreen Brandes, Office of the Commissioner 
(HF-4), Food and Drug Administration, 5600 Fishers Lane, rm. 14C-3, 
Rockville, MD 20857, 301-827-8858, email: doreen.brandes@fda.hhs.gov.
    For specific committee questions, contact the following persons 
listed in table 1 of this document.

                                Table 1.
------------------------------------------------------------------------
             Contact Person                       Committee/Panel
------------------------------------------------------------------------
Geretta P. Wood, Center for Devices and   Certain Device Panels of the
 Radiological Health, Food and Drug        Medical Devices Advisory
 Administration, 10903 New Hampshire       Committee
 Ave., Bldg. 66, rm. 1682, Silver
 Spring, MD 20993, 301-796-5550, or e-
 mail Geretta.Wood@fda.hhs.gov
------------------------------------------------------------------------
Normica Facey, Center for Devices and     National Mammography Quality
 Radiological Health, Food and Drug        Assurance Advisory Committee
 Administration, 10903 New Hampshire
 Ave., Bldg. 66, rm. 4652, Silver
 Spring, MD 20993, e-mail:
 Normica.Facey@fda.hhs.gov
------------------------------------------------------------------------


SUPPLEMENTARY INFORMATION:

I. Vacancies

    FDA is requesting nominations for voting and nonvoting consumer 
representatives for the vacancies listed in table 2 of this document:

                                                    Table 2.
----------------------------------------------------------------------------------------------------------------
       Committee/Panel Expertise Needed          Current & Upcoming Vacancies         Approximate Date Needed
----------------------------------------------------------------------------------------------------------------
Circulatory System Devices Panel of the        1-nonvoting                       Immediately
 Medical Devices Advisory Committee -
 interventional cardiologists,
 electrophysiologists, invasive (vascular)
 radiologists, vascular and cardiothoracic
 surgeons, and cardiologists with special
 interest in congestive heart failure
----------------------------------------------------------------------------------------------------------------
Dental Products Panel of the Medical Devices   1-nonvoting                       November 1, 2009
 Advisory Committee - dentists, engineers and
 scientists who have expertise in the areas
 of dental implants, dental materials,
 periodontology, tissue engineering, and
 dental anatomy
----------------------------------------------------------------------------------------------------------------
General and Plastic Surgery Devices Panel of   1-nonvoting                       Immediately
 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
----------------------------------------------------------------------------------------------------------------
Hematology and Pathology Devices Panel of the  1-nonvoting                       Immediately
 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 Medical        1-nonvoting                       March 1, 2010
 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 Panel of    1-nonvoting                       Immediately
 the Medical Devices Advisory Committee -
 experts with broad, cross-cutting
 scientific, clinical, analytical or
 mediation skills
----------------------------------------------------------------------------------------------------------------

[[Page 46444]]

 
Microbiology Devices Panel of the Medical      1-nonvoting                        Immediately
 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, biofilm
 development; mycologists; clinical
 microbiologists and virologists; clinical
 virology and microbiology laboratory
 directors, with expertise in clinical
 diagnosis and in vitro diagnostic assays,
 e.g., hepatologists; molecular biologists
----------------------------------------------------------------------------------------------------------------
Molecular and Clinical Genetics Devices Panel  1-nonvoting                       June 1, 2010
 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. Individuals
 with training in inborn errors of
 metabolism, biochemical and/or molecular
 genetics, population genetics, epidemiology
 and related statistical training, and
 clinical molecular genetics testing (e.g.,
 genotyping, array CGH, etc.) Individuals
 with experience in genetics counseling,
 medical ethics are also desired, and
 individuals with experience in ancillary
 fields of study will be considered
----------------------------------------------------------------------------------------------------------------
Neurological Devices Panel of the Medical      1-nonvoting                       December 1, 2009
 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     1-nonvoting                       February 1, 2010
 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
----------------------------------------------------------------------------------------------------------------
Ophthalmic Devices Panel of the Medical        1-nonvoting                       November 1, 2009
 Devices Advisory Committee -
 ophthalmologists specializing in cataract
 and refractive surgery and vitreo-retinal
 surgery, in addition to vision scientists,
 optometrists, and biostatisticians practiced
 in ophthalmic clinical trials
----------------------------------------------------------------------------------------------------------------
Orthopaedic and Rehabilitation Devices Panel   1-nonvoting                       Immediately
 of the Medical Devices Advisory Committee -
 orthopedic surgeons (joint, spine, trauma,
 and pediatric); rheumatologists; engineers
 (biomedical, biomaterials, and
 biomechanical); experts in rehabilitation
 medicine, sports medicine, and connective
 tissue engineering; and biostatisticians
----------------------------------------------------------------------------------------------------------------
National Mammography Quality Assurance         2-voting                          February 1, 2010
 Advisory Committee - physicians,
 practitioners, or other health professionals
 whose clinical practice, research
 specialization, or professional expertise
 include a significant focus on mammography
----------------------------------------------------------------------------------------------------------------

II. Functions

A. National Mammography Quality Assurance Advisory Committee

    The committee advises 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

[[Page 46445]]

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.

B. 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 of 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, 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 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 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.

III. Criteria for Members

    Persons nominated for membership as a consumer representatives on 
the committee/panels must 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 must 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.

IV. Selection Procedures

    Selection of members representing consumer interests is conducted 
through procedures that include the use of organizations representing 
the public interest and consumer advocacy groups. The organizations 
have the responsibility of recommending candidates of the agency's 
selection.

V. Nomination Procedures

    All nominations must include a cover letter, a curriculum vita or 
resume (that includes the nominee's office address, telephone number, 
and e-mail address), and a list of consumer or community-based 
organizations for which the candidate can demonstrate active 
participation.
    Nominations will specify the advisory committee or panel(s) for 
which the nominee is recommended. Nominations will include confirmation 
that the nominee is aware of the nomination.
    Any interested person or organization may nominate one or more 
qualified persons for membership as consumer representatives on the 
advisory committee/panels. Self-nominations are also accepted. 
Potential candidates will be required to provide detail information 
concerning such matters as financial holdings, employment, and research 
grants and/or contracts to permit evaluation of possible sources of a 
conflict of interest. The nomination should specify the committee/
panels of interest. The term of office is up to 4 years, depending on 
the appointment date.
    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: September 2, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-21558 Filed 9-8-09; 8:45 am]
BILLING CODE 4160-01-S
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