61140 Federal Register / Vol. 73, No. 200 / Wednesday, October 15, 2008 / Notices 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/oc/advisory/ 

default.htm for procedures on public 

conduct during advisory committee 

meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: October 7, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–24356 Filed 10–14–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0038] 

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 

for current vacancies and those that will 

or may occur through August 31, 2009. 

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: All nomination for 

membership should be sent 

electronically to CV@OC.FDA.GOV, or 

by mail to Advisory Committee 

Oversight & Management Staff (HF–4), 

5600 Fishers Lane, rm. 15A–12, 

Rockville, MD 20857. Information about 

becoming a member on a FDA advisory 

committee can also be obtained by 

visiting FDA’s Web site at http:// 

www.fda.gov/oc/advisory/default.htm. 

FOR FURTHER INFORMATION CONTACT: 

Kathleen L. Walker, Center for Devices 

and Radiological Health (HFZ–17), Food 

and Drug Administration, 7520 Standish 

Pl., (MPN1), Rockville, MD 20855, 240– 

276–8938, e-mail: 

Kathleen.Walker@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Vacancies 

FDA is requesting nominations of 

voting members for vacancies listed as 

follows: 

TABLE 1. 

Committee/Panel and Expertise Needed 

Current & 

Upcoming 

Vacancies 

Approximate Date 

Needed 

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 

3 Immediately 

Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee—experts with broad, 

cross-cutting scientific, clinical, analytical, or mediation skills 

1 Immediately 

1 October 1, 2008 

Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee—otologists, 

neurotologists, audiologists 

3 November 1, 2008 

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee—transplant specialists, gastroenterologists, urologists, and nephrologists 3 January 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 2 September 1, 2009 

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 

2 Immediately 

2 March 1, 2009 

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 Immediately 

2 March 1, 2009 


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Federal Register / Vol. 73, No. 200 / Wednesday, October 15, 2008 / Notices 61141 

TABLE 1.—Continued 

Committee/Panel and 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 

4 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 

3 Immediately 

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 

2 Immediately 

2 December 1, 2008 

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 

3 Immediately 

1 February 1, 2009 

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 

3 November 1, 2008 

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 

3 Immediately 

2 September 1, 2009 

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 

2 February 1, 2009 

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 

1 Immediately 

3 February 1, 2009 

Device Good Manufacturing Practice Advisory Committee—vacancies include three government representatives, two public representatives, and two health professionals 7 Immediately 

Technical Electronic Product Radiation Safety Standards Committee—vacancies include five government 

representatives, five industry representatives, and five general public representatives 

15 Immediately 

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 of the Federal Food, Drug, and 

Cosmetic Act (the act) 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) 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 


jlentini on PROD1PC65 with NOTICES
61142 Federal Register / Vol. 73, No. 200 / Wednesday, October 15, 2008 / Notices 

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 

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 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 to 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 the 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. The agency will publish 

a separate notice announcing the 

vacancies of two representatives of 

interests of the device manufacturing 

industry. 

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, 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. 

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. 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 200 / Wednesday, October 15, 2008 / Notices 61143 

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, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–24358 Filed 10–14–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Child Health and Human Development 

Special Emphasis Panel; Reproduction 

Centers Meeting. 

Date: November 12–14, 2008. 

Time: 7 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications and/or proposals. 

Place: The Legacy Hotel, 1775 Rockville 

Pike, Rockville, MD 20852. 

Contact Person: Dennis E. Leszczynski, 

PhD, Scientific Review Administrator, 

Division of Scientific Review, National 

Institute of Child Health and Human 

Development, NIH, 6100 Executive Blvd., 

Rm. 5b01, Bethesda, MD 20892, (301) 435– 

6884, leszczyd@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: October 7, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–24498 Filed 10–14–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2); notice 

is hereby given of the following 

meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; Tumor 

Stem Cells in Cancer Biology, Prevention and 

Therapy (P01). 

Date: November 19–20, 2008. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda North Marriott and 

Conference Center, 5701 Marinelli Road, 

North Bethesda, MD 20852. 

Contact Person: Sherwood Githens, PhD, 

Scientific Review Officer, Special Review 

and Logistics Branch, Division of Extramural 

Activities, National Cancer Institute, 6116 

Executive Blvd., Room 8053, Bethesda, MD 

20892, 301–435–1822, 

githenss@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; NCI SPORE 

in Ovarian and Gynecologic Cancers. 

Date: February 11–13, 2009. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Washington/Rockville, 1750 

Rockville Pike, Rockville, MD 20852. 

Contact Person: Caron Lyman, PhD, 

Scientific Review Officer, Division of 

Extramural Activities, National Cancer 

Institute, National Institutes of Health, 6116 

Executive Blvd. Room 8119, Bethesda, MD 

20892–8328, 301–451–4761, 

lymanc@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: October 8, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–24471 Filed 10–14–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice; 60-day notice and 

request for comments; Extension, 

without change, of a currently approved 

collection, OMB Number 1660–0038, 

FEMA Form—None. 

SUMMARY: The Federal Emergency 

Management Agency, as part of its 

continuing effort to reduce paperwork 

and respondent burden, invites the 

general public and other Federal 

agencies to take this opportunity to 

comment on a continuing information 

collection. In accordance with the 

Paperwork Reduction Act of 1995, this 

notice seeks comments concerning 

information collected from new 

applicants to the National Flood 

Insurance Program (NFIP), Write-YourOwn (WYO) Program. 

SUPPLEMENTARY INFORMATION: Under the 

WYO Program, the Federal Emergency 

Management Agency may enter into 

arrangements authorized by the 

National Flood Insurance Act of 1968, 


jlentini on PROD1PC65 with NOTICES