Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is requesting nominations for nonvoting industry representatives to serve on the National Mammography Quality Assurance Advisory Committee (NMQAAC) in the Center for Devices and Radiological Health (CDRH). 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.
Industry organizations interested in participating in the selection of a nonvoting member to represent industry for the vacancies listed in this notice must send a letter to FDA by April 21, 2005, stating their interest in the Start Printed Page 14473committee (NMQAAC). Concurrently, nomination materials for prospective candidates should be sent to FDA by April 21, 2005. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative.
All letters of interest and nominations should be sent to the contact person listed in the FOR FURTHER INFORMATION section of this notice.Start Further Info
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.End Further Info End Preamble Start Supplemental Information
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 National Mammography Quality Assurance Advisory Committee.
I. Functions of NMQAAC
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.
II. Selection Procedure
Any organization representing the mammography device industry wishing to participate in the selection of a nonvoting member to represent industry should send a letter stating that interest to the FDA contact (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 member representing the a particular committee. If no individual is selected within the 60 days, the Commissioner of Food and Drugs (the Commissioner) may select the nonvoting member to represent industry interests.
Persons nominated for membership on the committee as an industry representative 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.
IV. Application Procedure
Individuals may nominate themselves, or an organization representing the mammography device industry may nominate one or more individuals to serve as nonvoting industry representatives. A current curriculum vitae (which includes the nominee's business address, telephone number, and e-mail address) and the name of the committee of interest should be sent to the FDA contact person. FDA will forward all nominations to the organizations that have expressed interest in participating in the selection process for the committee.
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.Start Signature
Dated: March 14, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-5551 Filed 3-21-05; 8:45 am]
BILLING CODE 4160-01-S