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49656 Federal Register / Vol. 70, No.

163 / Wednesday, August 24, 2005 / Notices

independent laboratories that engage in information obtained from the Center FDA estimates the burden of this
quality control and testing for registered for Biologics Evaluation and Research’s collection as follows:
blood product establishments. database and FDA experience with the
FDA estimates the burden of this blood establishment registration and
collection of information based upon product listing requirements.

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1


Annual
No. of Frequency Total Annual Hours per Total
21 CFR Section Form FDA 2830 Respondents per Responses Response Hours
Response

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 Reregistration 2,775 1 2,775 0.5 1,388
607.40

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. ACTION: Notice. individuals with disabilities are
Jeffrey Shuren, adequately represented on advisory
SUMMARY: The Food and Drug committees and, therefore, encourages
Assistant Commissioner for Policy. Administration (FDA) is requesting
[FR Doc. 05–16847 Filed 8–23–05; 8:45 am] nominations of qualified candidates
nominations for voting members to
BILLING CODE 4160–01–S serve on certain device panels of the from these groups.
Medical Devices Advisory Committee, DATES: Because scheduled vacancies
the National Mammography Quality occur on various dates throughout each
DEPARTMENT OF HEALTH AND Assurance Advisory Committee, the year, no cutoff date is established for the
HUMAN SERVICES Device Good Manufacturing Practice receipt of nominations. However, when
Advisory Committee, and the Technical possible, nominations should be
Food and Drug Administration Electronic Products Radiation Safety received at least 6 months before the
Standards Committee in the Center for date of scheduled vacancies for each
Request for Nominations for Voting Devices and Radiological Health.
Members on Public Advisory Panels or year, as indicated in this notice.
Nominations will be accepted for
Committees current vacancies and those that will or ADDRESSES: Send all nominations and
may occur through August 31, 2006. curricula vitae to the following contact
AGENCY: Food and Drug Administration, FDA has a special interest in ensuring persons in table 1 of this document:
HHS. that women, minority groups, and

TABLE 1.
Contact Person Committee/Panel

Nancy J. Pluhowski, Center for Devices and Radiological Health (HFZ–400), Food and Certain Device Panels of the Medical Devices Advi-
Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301–594–2022, or sory Committee
e-mail: NJP@CDRH.FDA.GOV

Charles A. Finder, Center for Devices and Radiological Health (HFZ–240), Food and National Mammography Quality Assurance Advisory
Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, e-mail: Committee
CAF@CDRH.FDA.GOV

Collin L. Figueroa, Center for Devices and Radiological Health (HFZ–342), Food and Device Good Manufacturing Practice Advisory Com-
Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, e-mail: mittee
CXF@CDRH.FDA.GOV

Richard V. Kaczmarek, Center for Devices and Radiological Health (HFZ–240), Food Technical Electronic Product Radiation Safety
and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, e-mail: Standards Committee
RVK@CDRH.FDA.GOV

FOR FURTHER INFORMATION CONTACT: Rd., Rockville, MD 20850, 240–276– I. Vacancies


Kathleen L. Walker, Center for Devices 0450, ext. 114, e-mail: FDA is requesting nominations of
and Radiological Health (HFZ–17), Food KLW@CDRH.FDA.GOV. voting members for vacancies listed as
and Drug Administration, 2098 Gaither SUPPLEMENTARY INFORMATION: follows:

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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 2 Immediately


Medical Devices Advisory Committee—anesthesiologists, pul-
monary medicine specialists, or other experts who have spe-
cialized interests in ventilator support, pharmacology, physi-
ology, or the effects and complications of anesthesia

Clinical Chemistry and Clinical Toxicology Devices Panel of the 2 March 1, 2006
Medical Devices Advisory Committee—doctors of medicine or
philosophy with experience in clinical chemistry (e.g., cardiac
markers), clinical toxicology, clinical pathology, clinical labora-
tory medicine, and endocrinology

Dental Products Panel of the Medical Devices Advisory Com- 2 November 1, 2005
mittee—dentists, engineers and scientists who have expertise
in the areas of dental implants, dental materials,
temporomandibular joint (TMJ) dysfunction, tissue engineer-
ing, and dental anatomy

Gastroenterology and Urology Devices Panel of the Medical 1 Immediately


Devices Advisory Committee—gastroenterologists, urologists 1 January 1, 2006
and nephrologists

General and Plastic Surgery Devices Panel of the Medical De- 2 September 1, 2005
vices Advisory Committee—surgeons (general, plastic, recon- 2 September 1, 2006
structive, pediatric, thoracic, abdominal, pelvic and
endoscopic); dermatologists; experts in biomaterials, lasers,
wound healing, and quality of life; and biostatisticians

General Hospital and Personal Use Devices Panel of the Med- 3 Immediately
ical Devices Advisory Committee—internists, pediatricians, 4 January 1, 2006
neonatologists, endocrinologists, gerontologists, nurses, bio-
medical engineers or microbiologists/infection control practi-
tioners or experts

Hematology and Pathology Devices Panel of the Medical De- 3 March 1, 2006
vices Advisory Committee—hematologists (benign and/or ma-
lignant hematology), hematopathologists (general and special
hematology, coagulation and homeostasis, and hematological
oncology), gynecologists with special interests in gyneco-
logical oncology, cytopathologists, and molecular pathologists
with special interests in development of predictive and prog-
nostic biomarkers

Medical Devices Dispute Resolution Panel of the Medical De- 1 October 1, 2005
vices Advisory Committee—experts with broad, cross-cutting
scientific, clinical, analytical or mediation skills

Microbiology Devices Panel of the Medical Devices Advisory 3 Immediately


Committee—infectious disease clinicians, e.g., pulmonary dis- 2 March 1, 2006
ease specialists, sexually transmitted disease specialists, pe-
diatric infectious disease specialists, experts in tropical medi-
cine and emerging infectious diseases, mycologists; clinical
microbiologists and virologists; clinical virology and microbi-
ology laboratory directors, with expertise in clinical diagnosis
and in vitro diagnostic assays, e.g., hepatologists; molecular
biologists

Neurological Devices Panel of the Medical Devices Advisory 3 December 1, 2005


Committee—neurosurgeons (cerebrovascular and pediatric),
neurologists (stroke, pediatric, pain management, and move-
ment disorders), interventional neuroradiologists, psychia-
trists, and biostatisticians

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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 De- 1 February 1, 2006
vices Advisory Committee—experts in perinatology, embry-
ology, reproductive endocrinology, pediatric gynecology, gyn-
ecological oncology, operative hysteroscopy, pelviscopy,
electrosurgery, laser surgery, assisted reproductive tech-
nologies, contraception, postoperative adhesions, and cer-
vical cancer and colposcopy; biostatisticians and engineers
with experience in obstetrics/gynecology devices;
urogynecologists; experts in breast care; experts in gyne-
cology in the older patient; experts in diagnostic (optical)
spectroscopy; experts in midwifery; labor and delivery nursing

Orthopaedic and Rehabilitation Devices Panel of the Medical 1 Immediately


Devices Advisory Committee—orthopedic surgeons (joint, 1 September 1, 2005
spine, trauma, and pediatric); rheumatologists; engineers 3 September 1, 2006
(biomedical, biomaterials, and biomechanical); experts in re-
habilitation medicine, sports medicine, and connective tissue
engineering; and biostatisticians

Radiological Devices Panel of the Medical Devices Advisory 2 February 1, 2006


Committee—physicians with experience in general radiology,
mammography, other radiological subspecialties and radiation
oncology; scientists with experience in diagnostic devices, ra-
diation physics, statistical analysis, digital imaging and image
analysis

National Mammography Quality Assurance Advisory Com- 2 February 1, 2006


mittee—one medical physicist, one physician, practitioner, or
other health professional whose clinical practice, research
specialization, or professional expertise includes a significant
focus on mammography

Device Good Manufacturing Practice Advisory Committee: Nine 9 Immediately


vacancies occurring immediately; three government rep-
resentatives, two industry representatives, two public rep-
resentatives and two health professionals

Technical Electronic Product Radiation Safety Standards Com- 5 Immediately


mittee—Five vacancies occurring immediately, two govern- 5 January 1, 2006
ment representatives, one industry representative and two
general public representatives; five vacancies occurring Janu-
ary 1, 2006, one industry representative, two government rep-
resentatives and two general public representatives

II. Functions reviews premarket approval panel are to evaluate and recommend
applications for medical devices, (5) whether various prescription drug
A. Medical Devices Advisory Committee
reviews guidelines and guidance products should be changed to over-the-
The committee reviews and evaluates documents, (6) recommends exemption counter status and to evaluate data and
data on the safety and effectiveness of of certain devices from the application make recommendations concerning the
marketed and investigational devices of portions of the act, (7) advises on the approval of new dental drug products
and makes recommendations for their necessity to ban a device, and (8) for human use.
regulation. The panels engage in a responds to requests from the agency to
number of activities to fulfill the The Medical Devices Dispute
review and make recommendations on Resolution Panel provides advice to the
functions the Federal Food, Drug, and specific issues or problems concerning
Cosmetic Act (the act) envisions for Commissioner on complex or contested
the safety and effectiveness of devices.
device advisory panels. With the scientific issues between FDA and
With the exception of the Medical
exception of the Medical Devices medical device sponsors, applicants, or
Devices Dispute Resolution Panel, each
Dispute Resolution Panel, each panel, manufacturers relating to specific
according to its specialty area performs panel, according to its specialty area,
products, marketing applications,
the following duties: (1) Advises the may also make appropriate
regulatory decisions and actions by
Commissioner of Food and Drugs (the recommendations to the Commissioner
on issues relating to the design of FDA, and agency guidance and policies.
Commissioner) regarding recommended The panel makes recommendations on
classification or reclassification of clinical studies regarding the safety and
effectiveness of marketed and issues that are lacking resolution, are
devices into one of three regulatory highly complex in nature, or result from
categories, (2) advises on any possible investigational devices.
challenges to regular advisory panel
risks to health associated with the use The Dental Products Panel also proceedings or agency decisions or
of devices, (3) advises on formulation of functions at times as a dental drug
actions.
product development protocols, (4) panel. The functions of the dental drug

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

B. National Mammography Quality representatives of the interests of the C. Device Good Manufacturing Practice
Assurance Advisory Committee general public. Advisory Committee
The functions of the committee are to D. Technical Electronic Product Persons nominated for membership as
advise FDA on the following topics: (1) Radiation Safety Standards Committee a government representative or health
Developing appropriate quality The function of the committee is to professional should have knowledge of
standards and regulations for provide advice and consultation on the or expertise in any one or more of the
mammography facilities, (2) developing technical feasibility, reasonableness, following areas: Quality assurance
appropriate standards and regulations and practicability of performance concerning the design, manufacture,
for bodies accrediting mammography standards for electronic products to and use of medical devices. To be
facilities under this program, (3) control the emission of radiation from eligible for selection as a representative
developing regulations with respect to such products. The committee may of the general public or industry,
sanctions, (4) developing procedures for recommend electronic product radiation nominees should possess appropriate
monitoring compliance with standards, safety standards for consideration.
qualifications to understand and
(5) establishing a mechanism to Section 534(f) of the act (21 U.S.C.
360kk(f)), as amended by the Safe contribute to the committee’s work. The
investigate consumer complaints, (6)
Medical Devices Act of 1990, provides particular needs at this time for this
reporting new developments concerning
breast imaging which should be that the Technical Electronic Product committee are listed in section I of this
considered in the oversight of Radiation Safety Standards Committee document. The term of office is up to 4
mammography facilities, (7) include five members from years, depending on the appointment
determining whether there exists a governmental agencies, including State date.
shortage of mammography facilities in or Federal Governments, five members D. Technical Electronic Product
rural and health professional shortage from the affected industries, and five
Radiation Safety Standards Committee
areas and determining the effects of members from the general public, of
personnel on access to the services of which at least one shall be a Persons nominated must be
such facilities in such areas, (8) representative of organized labor. technically qualified by training and
determining whether there will exist a III. Qualifications experience in one or more fields of
sufficient number of medical physicists science or engineering applicable to
after October 1, 1999, and (9) A. Panels of the Medical Devices electronic product radiation safety. The
determining the costs and benefits of Advisory Committee
particular needs at this time for this
compliance with these requirements. Persons nominated for membership committee are listed in section I of this
C. Device Good Manufacturing Practice on the panels shall have adequately document. The term of office is up to 4
Advisory Committee diversified experience appropriate to years, depending on the appointment
the work of the panel in such fields as date.
The functions of the committee are to clinical and administrative medicine,
review proposed regulations issuance engineering, biological and physical IV. Nomination Procedures
regarding good manufacturing practices sciences, statistics, and other related
professions. The nature of specialized Any interested person may nominate
governing the methods used in, and the
training and experience necessary to one or more qualified persons for
facilities and controls used for
manufacture, packaging, storage, qualify the nominee as an expert membership on one or more of the
installation, and servicing of devices, suitable for appointment may include advisory panels or advisory committees.
and make recommendations regarding experience in medical practice, Self-nominations are also accepted.
the feasibility and reasonableness of teaching, and/or research relevant to the Nominations shall include complete
those proposed regulations. The field of activity of the panel. The curriculum vitae of each nominee,
committee also reviews and makes particular needs at this time for each current business address and telephone
recommendations on proposed panel are listed in section I of this number, and shall state that the
guidelines developed to assist the document. The term of office is up to 4 nominee is aware of the nomination, is
medical device industry in meeting the years, depending on the appointment willing to serve as a member, and
good manufacturing practice date. appears to have no conflict of interest
requirements, and provides advice with B. National Mammography Quality that would preclude membership. FDA
regard to any petition submitted by a Assurance Advisory Committee will ask the potential candidates to
manufacturer for an exemption or provide detailed information concerning
Persons nominated for membership
variance from good manufacturing such matters as financial holdings,
should be physicians, practitioners, and
practice regulations. employment, and research grants and/or
other health professionals, whose
Section 520 of the act (21 U.S.C. clinical practice, research contracts to permit evaluation of
360(j)), as amended, provides that the specialization, or professional expertise possible sources of conflict of interest.
Device Good Manufacturing Practice include a significant focus on This notice is issued under the
Advisory Committee shall be composed mammography and individuals Federal Advisory Committee Act (5
of nine members as follows: (1) Three of identified with consumer interests. Prior U.S.C. app. 2) and 21 CFR part 14
the members shall be appointed from experience on Federal public advisory relating to advisory committees.
persons who are officers or employees committees in the same or similar
of any Federal, State, or local subject areas will also be considered Dated: August 18, 2005.
government; (2) two shall be relevant professional expertise. Scott Gottlieb,
representatives of interests of the device The particular needs at this time for Deputy Commissioner for Policy.
manufacturing industry; (3) two shall be this committee are listed in section I of [FR Doc. 05–16845 Filed 8–23–05; 8:45 am]
representatives of the interests of this document. The term of office is up BILLING CODE 4160–01–S
physicians and other health to 4 years, depending on the
professionals; and (4) two shall be appointment date.

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