United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2002_register executive 2010-09-23 article Part I Notices D09002ee1c818a2b3 D09002ee1c818a365 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing the rates and interim procedures for medical device user fees for fiscal year (FY) 2003. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107-250), authorizes FDA to collect user fees for certain medical device applications. This notice establishes fee rates for FY 2003. These fees are effective for applications submitted on October 1, 2002, and will remain in effect through September 30, 2003. However, FDA may not begin to collect these fees until enabling appropriations are enacted. FDA will issue invoices for all fees payable for applications submitted between October 1, 2002, and 30 days after the date of the Federal Register notice the agency will issue after enactment of enabling appropriations. Those invoices will be due and payable within 30 days of issuance. Subsequently, fees must be submitted to FDA at the time that applications are submitted. 67 FR 70228 https://www.govinfo.gov/app/details/FR-2002-11-21/02-29572 02-29572 fr21no02-85 4160-01-S https://www.govinfo.gov/app/details/FR-2002-11-21/02-29572 https://www.govinfo.gov/content/pkg/FR-2002-11-21/html/02-29572.htm https://www.govinfo.gov/content/pkg/FR-2002-11-21/pdf/02-29572.pdf 2 p. 70228 70229 67 FR 70228 Establishment of Medical Device User Fee Rates for Fiscal Year 2003 and Interim Procedures; Federal Register Vol. 67, Issue NOTICE 02-29572 I DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 4160-01-S 02-29572 Notice.

The Food and Drug Administration (FDA) is announcing the rates and interim procedures for medical device user fees for fiscal year (FY) 2003. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107-250), authorizes FDA to collect user fees for certain medical device applications. This notice establishes fee rates for FY 2003. These fees are effective for applications submitted on October 1, 2002, and will remain in effect through September 30, 2003. However, FDA may not begin to collect these fees until enabling appropriations are enacted. FDA will issue invoices for all fees payable for applications submitted between October 1, 2002, and 30 days after the date of the Federal Register notice the agency will issue after enactment of enabling appropriations. Those invoices will be due and payable within 30 days of issuance. Subsequently, fees must be submitted to FDA at the time that applications are submitted.

Frank Claunts, Office of Management and Systems (HFA-20), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4427. Reports and guidance documents; availability, etc.: Medical devices User fee rates and interim procedures, http://www.fda.gov/cdrh/mdufma/index.html Vol. 67, no. 225 Office of the Federal Register, National Archives and Records Administration 2002-11-21 continuing daily deposited born digital 203 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2002-11-21 P0b002ee1809da0f4 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr21no02 https://www.govinfo.gov/app/details/FR-2002-11-21 https://www.govinfo.gov/content/pkg/FR-2002-11-21/pdf/FR-2002-11-21.pdf https://www.govinfo.gov/content/pkg/FR-2002-11-21/xml/FR-2002-11-21.xml fdlp 70119 70307 DGPO 2010-09-23 2024-06-07 FR-2002-11-21 machine generated eng FR FR-2002-11-21 67 225