Mr. Bonilla: Please provide a table that shows FDA's fiscal year 2003 budget initiatives

by program.

Response: I would be happy to provide that information for the record.

[The information follows.]

CODEX ALIMENTARIUS COMMISSION

Mr. Bonilla: Please indicate the amount spent by FDA in fiscal year 2001 in direct support of the Codex Alimentarius Commission, showing the resources spent on travel separately.

Response: In FY 2001, FDA spent $2,021,740 on non-travel expenses, and $167,567 on travel for a total of $2,189,301 in support of Codex Alimentarius Commission.

CONTINGENCY FUND

Mr. Bonilla: Did you use the contingency/emergency fund in fiscal year 2001, and for what? Has it been used thus far in fiscal year 2002? What is the current balance? Response: Yes, the FDA utilized $1.880 million from the Contingency Fund for activities related to the Bovine Spongiform Encephalopathy (BSE) threat. No request for utilization of the Contingency Fund has been made so far in fiscal year 2002. The current balance of the Contingency Fund is $1.160 million.

CURRENT SERVICES

Mr. Bonilla: In the current year, the Committee provided full funding of pay costs. $45.2 million. What effect did this have on agency operations?

Response: Full funding for pay cost has allowed the Agency to maintain staffing levels for critical functions such as assuring safety and efficacy of medical products, protecting the food supply and maintaining our capacity to support counter-terrorism activities. Pay increases have allowed the Agency to support increased examinations of food imports, improve the drug review process, assure the safety of regulated products, inspect and investigate domestic and foreign manufacturers and participate in Mutual Recognition Agreements to establish global standards for foods and pharmaceuticals.

DEVICE 510(k) APPLICATION

Mr. Bonilla: Please provide a definition of the device 510(k) applications, and provide the US Code citation.

Response: A premarket notification, generally referred to as a 510(k) application, is a marketing application submitted to FDA to demonstrate that a medical device manufacturer wishes to market a device that is substantially equivalent to another device that is currently, or was previously, legally marketed within the United States. Premarket notification is required by section 510(k) of the Federal Food, Drug, and Cosmetic Act, 21 USC 360(k). FDA's regulatory requirements for premarket notification are provided by 21 CFR Part 807, Subpart E.

Most class I devices are now exempt from the requirement to submit a 510(k) application. FDA uses other general controls, such as establishment registration, device listing, and our Quality System regulation in 21 CFR Part 820 to ensure the safety and effectiveness of devices exempt from 510(k). A manufacturer who wishes to market a non-exempt device must submit either a 510(k) application or, in the case of more complex devices, a premarket approval application or PMA, a product development

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protocol or PDP, or a request for a humanitarian device exemption or HDE. Marketing of a non-exempt device may begin only after FDA clears the 510(k), or approves the PMA, PDP, or HDE.

Mr. Bonilla: Update the chart provided for last year's hearing volume p. 113 showing the backlog of 510(k) review.

Response: In our plan to implement the Food and Drug Administration Modernization Act of 1997 or FDAMA, we defined an overdue 510(k) as one that has been under review in the current review cycle for more than 90 days. I will be happy to provide a table that shows this statistic as of the end of each fiscal year. We have also provided information on the number of 510(k)s pending with total cumulative FDA review time of more than 90 days in all review cycles. Both measures demonstrate significant and sustained improvement in the timeliness of FDA reviews since FY 1994.

[The information follows:]

Fiscal Year

FY 1994

FY 1995

FY 1996

FY 1997

FY 1998

FY 1999

FY 2000

FY 2001

510(k) Review Performance

Fiscal Years 1994-2001

Decision Cohorts-As of the End of Each Fiscal Year

*Cumulative FDA review days; includes all pending 510(k)s - under review and on hold. Cumulative FDA review days are for all cycles of a review. These are the number of 510(k)s where total cumulative review was greater than 90 days when totaling all FDA reviews in all cycles.

Mr. Bonilla: How many 510(k)s were approved each year, for the past five years? Response: DA cleared 3,428 510(k)s during FY 2001, slightly fewer than in FY 2000. The long-term decline in the number of 510(k)s cleared over the past several years reflects FDA's ongoing efforts to exempt selected lower-risk devices from our premarket notification requirements, reducing unnecessary regulatory burdens and permitting us to focus our resources on higher-priority public health workloads. I will be happy to provide a table that shows data for 510(k) applications.

Mr. Bonilla: Provide a table with mean and median review times for 510(k)s for each year since fiscal year 1995.

Response: 510(k) review time continued to improve during FY 2001. FDA's median review time has been falling from a high of 91 days in FY 1995 to 68 days in FY 2001. I will be happy to provide a table with 510(k) review times.

Mr. Bonilla: How many 510(k)s are pending currently, and how many of that number are overdue?

Response: At the close of FY 2001, FDA had 1,316 510(k) applications pending, including 382 510(k)s on hold and 934 under active review in FDA's center for Devices and Radiological Health. We had no overdue 510(k)s at the close of FY 2001.

DEVICES

Mr. Bonilla: Provide a table showing the number of regulatory actions in the device area for the past 3 years.

Response: Regulatory actions concerning medical devices during FY 2001 were generally at levels comparable to the two previous fiscal years, though significantly more warning letters were issued than in FY 1999. The increase in warning letters is attributed