Performance Improvement 1996. Food and Drug Administration

02/01/1996

Contents

Assessment of the Mammography Quality Standards Act of 1992 (MQSA)

Nationwide Evaluation of X-Ray Trends (NEXT)

Third Annual Performance Report on the Prescription Drug User Fee Act of 1992: Fiscal Year 1995 Report to Congress

TITLE: Assessment of the Mammography Quality Standards Act of 1992 (MQSA)

ABSTRACT NUMBER: 055

ABSTRACT: FDA is charged with ensuring that accessibility to quality mammography services is maintained for all facilities performing mammographies, in accordance with MQSA. Under this statute, FDA is required to certify and annually inspect over 10,000 mammography facilities. Prior to the passage of MQSA, FDA's oversight responsibility was limited to approving new mammographic processors, X rays, and tubing. However, MQSA requires that facilities within its jurisdiction meet quality standards developed by FDA if these facilities are to obtain certification by the Agency. FDA is concerned that recent trends by third-party payers to captivate payments for mammography services have severely limited the ability of facilities to absorb any cost increases caused by the quality standards. These cost increases, as well as excess capacity, may cause low-volume facilities to leave the industry. This project addresses these problems in two ways. First, it measures the effect of standards on patient access to mammography, especially in rural areas. It also develops a cost model that will be used to predict the impact of proposed standards on the costs of providing mammography. This project addresses these issues by collecting and analyzing data from facilities that provide mammography services.

AGENCY SPONSOR: Office of Planning and Evaluation

FEDERAL CONTACT: Steve Tucker

PHONE NUMBER: 301/443-1839

PIC ID: 6080

PERFORMER ORGANIZATION: Eastern Research Group, Inc., Rosslyn, VA

TITLE: Nationwide Evaluation of X-Ray Trends (NEXT)

ABSTRACT NUMBER: 056

ABSTRACT: NEXT is a collaborative program conducted jointly between FDA and State radiation control agencies. The study estimates the radiation dosage from diagnostic X-ray examinations, using data collected from previous NEXT surveys of different types of X-ray examinations. The study generates data on image quality, photographic processing quality, and types of practice. The data are used by public health and professional organizations to set policy. The studies are conducted in cooperation with the Conference of Radiation Control Directors. Products generated in the study include (1) "National Survey of Mammographic Facilities," in 1985, 1988, and 1992; (2) "Mammography (and Radiology?) Is Still Plagued With Poor Quality in Photographic Processing and Darkroom Fog"; (3) "Assessment of Skin Entrance Kerma in the United States: The Nationwide Evaluation of X Ray Trends (NEXT)"; (4) "How Good (or Bad) Is Film Processing?"; and (5) "Automatic Film Processing: Analysis of 9 Years of Observations."

AGENCY SPONSOR: Center for Devices and Radiological Health

FEDERAL CONTACT: Orhan Suleiman

PHONE NUMBER: 301/594-3332

PIC ID: 4984

PERFORMER ORGANIZATION: Conference of Radiation Control Directors, Washington, DC

TITLE: Third Annual Performance Report on the Prescription Drug User Fee Act of 1992: Fiscal Year 1995 Report to Congress

ABSTRACT NUMBER: 057

ABSTRACT: Fiscal 1995 marked the third year of the 5-year implementation of the Prescription Drug User Fee Act (PDUFA) of 1992. This Act authorized the collection of fees from the pharmaceutical industry in order to facilitate FDA's timely review of human drug applications. The Act mandates that FDA prepare yearly reports for each fiscal year in which fees are collected. This third annual report, for fiscal 1995, was prepared in response to that mandate. It presents findings as to how well FDA has accomplished its performance goals for fiscal 1995. These performance-related goals were jointly established by FDA and the pharmaceutical industry and fall into three main categories: eliminating overdue backlogs, building excellence into the review process, and achieving high performance. The report finds that (1) New Drug Applications (NDAs) approval was 23 percent higher after PDUFA's enactment than in the 2 years prior; (2) a high percentage of first reviews were accomplished within the 12-month timeframe specified in the PDUFA; and (3) other reasons for quicker approval times include high rates of affirmative first actions, quick action on approvables, and effective "refuse-to-file" screening. (Final report 24 pages, plus appendixes.)

AGENCY SPONSOR: Office of Planning and Evaluation

FEDERAL CONTACT: Paul Coppinger and Kate McEvoy

PHONE NUMBER: 301/443-4230

PIC ID: 6079

PERFORMER ORGANIZATION: Office of Planning and Evaluation, Food and Drug Administration, Rockville, MD