Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is requesting that any industry organization interested in participating in the selection of nonvoting industry representatives to serve on the National Mammography Quality Assurance Advisory Committee (NMQAAC) and certain device panels of the Medical Devices Advisory Committee (MDAC) in the Center for Devices and Radiological Health (CDRH) notify FDA in writing. A nominee may either be self nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
Any industry organizations interested in participating in the selection of an appropriate nonvoting member to represent industry interests must send a letter stating that interest to the FDA by November 29, 2010, for the vacancies listed in this document. Concurrently, nomination materials for prospective candidates should be sent to FDA by November 29, 2010.
Send all letters of interest and nominations to Margaret J. Ames (see FOR FURTHER INFORMATION CONTACT).Start Further Info
FOR FURTHER INFORMATION CONTACT:
Margaret J. Ames, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5234, Silver Spring, Start Printed Page 66383MD 20993, 301-796-5960, e-mail: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
The agency intends to add nonvoting industry representatives to the following advisory committees:
I. CDRH—Various Committees and Panels
A. National Mammography Quality Assurance Advisory Committee (NMQAAC)
The Mammography Quality Standards Reauthorization Act of 2004 (Pub. L. 108-365) requires the addition of at least two industry representatives with expertise in mammography equipment to the NMQAAC.
B. Medical Devices Advisory Committee (MDAC)
Section 520(f)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C 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.
II. CDRH—Committee and Panels Functions
FDA is requesting nominations for nonvoting members representing industry interests for vacancies listed in table 1 of this document as follows:
|Committee name or panel||Approximate date needed|
|NMQAAC||February 1, 2011.|
|Anesthesiology and Respiratory Therapy Devices Panel||December 1, 2011.|
|General and Plastic Surgery Devices Panel||September 1, 2011.|
The functions of the NMQAAC are to advise FDA on: (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. Certain Panels of the 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 FD&C 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.
III. 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 résumés. 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 committee or 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.
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.
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 self nominate and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. Within 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 committee or device panel of interest. FDA will forward all nominations to the organizations expressing interest in participating in the selection process for the committee or 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 Start Printed Page 66384U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.Start Signature
Dated: October 22, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-27230 Filed 10-27-10; 8:45 am]
BILLING CODE 4160-01-P