49656 Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 

independent laboratories that engage in 

quality control and testing for registered 

blood product establishments.

FDA estimates the burden of this 

collection of information based upon 

information obtained from the Center 

for Biologics Evaluation and Research’s 

database and FDA experience with the 

blood establishment registration and 

product listing requirements.

FDA estimates the burden of this 

collection as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section Form FDA 2830

No. of

Respondents

Annual 

Frequency 

per

Response

Total Annual 

Responses 

Hours per 

Response 

Total 

Hours 

607.20(a), 607.21, 607.22, 607.25, and 607.40 Initial registration 100 1 100 1 100

607.21, 607.22, 607.25, 607.26, 607.31, and 

607.40

Reregistration 2,775 1 2,775 0.5 1,388

607.21, 607.25, 607.30, 607.31, and 607.40 Product listing update 180 1 180 0.25 45

Total 1,533

1 There are no capital costs of operating and maintenance costs associated with this collection of information.

Dated: August 17, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 05–16847 Filed 8–23–05; 8:45 am]

BILLING CODE 4160–01–S

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 certain device panels of the 

Medical Devices Advisory Committee, 

the National Mammography Quality 

Assurance Advisory Committee, the 

Device Good Manufacturing Practice 

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, 2006.

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 

Nancy J. Pluhowski, Center for Devices and Radiological Health (HFZ–400), Food and 

Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301–594–2022, or 

e-mail: NJP@CDRH.FDA.GOV

Certain Device Panels of the Medical Devices Advisory Committee

Charles A. Finder, Center for Devices and Radiological Health (HFZ–240), Food and 

Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, e-mail: 

CAF@CDRH.FDA.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: 

CXF@CDRH.FDA.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: 

RVK@CDRH.FDA.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, 2098 Gaither 

Rd., Rockville, MD 20850, 240–276–

0450, ext. 114, e-mail: 

KLW@CDRH.FDA.GOV.

SUPPLEMENTARY INFORMATION:

I. Vacancies

FDA is requesting nominations of 

voting members for vacancies listed as 

follows:

Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 49657

TABLE 2.

Committee/Panel Expertise Needed Current & 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 Immediately

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, 2006

Dental Products Panel of the Medical Devices Advisory Committee—dentists, engineers and scientists who have expertise 

in the areas of dental implants, dental materials, 

temporomandibular joint (TMJ) dysfunction, tissue engineering, and dental anatomy

2 November 1, 2005

Gastroenterology and Urology Devices Panel of the Medical 

Devices Advisory Committee—gastroenterologists, urologists 

and nephrologists

1

1

Immediately 

January 1, 2006

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

September 1, 2005

September 1, 2006

General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee—internists, pediatricians, 

neonatologists, endocrinologists, gerontologists, nurses, biomedical engineers or microbiologists/infection control practitioners or experts

3

4

Immediately 

January 1, 2006

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 March 1, 2006

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

scientific, clinical, analytical or mediation skills

1 October 1, 2005

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, 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

3

2

Immediately 

March 1, 2006

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

3 December 1, 2005

49658 Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 

TABLE 2.—Continued

Committee/Panel Expertise Needed Current & Upcoming Vacancies Approximate Date Needed 

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 February 1, 2006

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

1

3

Immediately 

September 1, 2005

September 1, 2006

Radiological Devices Panel of the Medical Devices Advisory 

Committee—physicians with experience in general radiology, 

mammography, other radiological subspecialties and radiation 

oncology; scientists with experience in diagnostic devices, radiation physics, statistical analysis, digital imaging and image 

analysis

2 February 1, 2006

National Mammography Quality Assurance Advisory Committee—one medical physicist, one physician, practitioner, or 

other health professional whose clinical practice, research 

specialization, or professional expertise includes a significant 

focus on mammography

2 February 1, 2006

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—Five vacancies occurring immediately, two government representatives, one industry representative and two 

general public representatives; five vacancies occurring January 1, 2006, one industry representative, two government representatives and two general public representatives

5

5

Immediately 

January 1, 2006

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) 

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.

Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 49659

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 shall 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 government representative or health 

professional 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.

D. Technical Electronic Product 

Radiation Safety Standards Committee

Persons nominated must 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 shall include complete 

curriculum vitae of each nominee, 

current business address and telephone 

number, and shall state that the 

nominee is aware of the nomination, is 

willing to serve as a member, and 

appears to have no conflict of interest 

that would preclude membership. FDA 

will ask the potential candidates to 

provide detailed information concerning 

such matters as financial holdings, 

employment, and research grants and/or 

contracts to permit evaluation of 

possible sources of 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: August 18, 2005.

Scott Gottlieb,

Deputy Commissioner for Policy.

[FR Doc. 05–16845 Filed 8–23–05; 8:45 am]

BILLING CODE 4160–01–S