E6-16438. Request for Nominations for Nonvoting Members Representing Industry Interests 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 nonvoting industry representatives to serve on the National Mammography Quality Assurance Advisory Committee (NMQAAC) and certain device panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health.

DATES:

Industry organizations interested in participating in the selection of a nonvoting member to represent industry for the vacancies listed in this document must send a letter to FDA by November 6, 2006, stating their interest in the NMQAAC or one or more panels. Concurrently, nomination materials for prospective candidates should be sent to FDA by November 6, 2006. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative.

ADDRESSES:

All letters of interest and nominations should be sent to Kathleen L. Walker (see FOR FURTHER INFORMATION CONTACT).

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, 301-827-7293, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

A. NMQAAC

The Mammography Quality Standards Reauthorization Act of 2004 (Public Law 108-365) requires the addition of at least two industry representatives with expertise in mammography equipment to the NMQAAC.

B. Medical Devices Advisory Committee

Section 520(f)(3) of the Federal Food, Drug and 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.

Committee/Panel	Approximate Date Representative is Needed
NMQAAC	February 1, 2007
Certain Panels of the Medical Devices Advisory Committee
General and Plastic Surgery Devices Panel	Immediate
Hematology and Pathology Devices Panel	Immediate

II. Functions

A. NMQAAC

The functions of the NMQAAC 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.

B. Medical Devices Advisory Committee

The medical device panels perform the following functions: (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 (the Commissioner) 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 organization representing the mammography device industry or the medical device manufacturing industry wishing to participate in the selection of a nonvoting member to represent industry should send a letter stating that interest to the contact person (see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of this notice. Persons who nominate themselves as industry representatives will not participate in the selection process. It is, therefore, recommended that nominations be made by someone within an organization, trade association, or firm who is willing to participate in the selection process. Within the subsequent 30 days, FDA will send a letter to each organization and a list of all nominees along with their resumes. The letter will state that the interested organizations are responsible for conferring with one another to select a candidate, within 60 days after receiving the letter, to serve as the nonvoting industry representative on a particular committee or device panel. If no individual is selected within that 60 days, the Commissioner may select the nonvoting member to represent industry interests.

IV. Qualifications

A. NMQAAC

Persons nominated for membership as an industry representative on the NMQAAC must meet the following criteria: (1) Demonstrate expertise in mammography equipment and (2) be able to discuss equipment specifications and quality control procedures affecting mammography equipment. The industry representative must be able to represent the industry perspective on issues and actions before the advisory committee, serve as liaison between the committee and interested industry parties, and facilitate dialogue with the advisory committee on mammography equipment issues.

B. Medical Devices Advisory Committee

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.

V. Application Procedure

Individuals may nominate themselves, or an organization representing the mammography device industry or medical device industry may nominate one or more individuals to serve as a nonvoting industry representative. A current curriculum vitae (which includes the nominee's business address, telephone number, and e-mail address) and the name of the committee or panel of interest should be sent to the contact person (see FOR FURTHER INFORMATION CONTACT). FDA will forward all nominations to the organizations that have expressed interest in participating in the selection process for that committee or panel.

FDA has a special interest in ensuring that women, minority groups, individuals with disabilities, and small businesses are adequately represented on its advisory committees. Therefore, the agency 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 28, 2006.

Randall W. Lutter,

Associate Commissioner for Policy and Planning.