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. 

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 

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 

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 


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Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Notices 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 

http://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/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 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. 

Committee/Panel Expertise Needed 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 

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 


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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 

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 

2-voting February 1, 2010 

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 


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Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Notices 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 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 

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. 


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