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2010-09-22
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Guidance for Industry, Food and Drug Administration, and Foreign Governments; Fiscal Year 2008 Medical Device User Fee Small Business Qualification and Certification; Availability
Notices
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United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``FY 2008 Medical Device User Fee Small Business Qualification and Certification.'' This guidance explains how a business headquartered in the United States or headquartered in a foreign nation may respectively qualify as ``small business'' under the medical device user fee provisions of the Federal Food, Drug, and Cosmetic Act (the act). A ``small business'' may pay certain medical device user fees at a substantial discount from the standard (full) fee rates and may obtain a one-time fee waiver for its first premarket application (a premarket approval application (PMA), biologics license application (BLA), product development protocol (PDP), or premarket report (PMR)).
72 FR 60023
https://www.govinfo.gov/app/details/FR-2007-10-23/07-5226
07-5226
fr23oc07-50
4160-01-S
Docket No. 2007D-0401
https://www.govinfo.gov/app/details/FR-2007-10-23/07-5226
https://www.govinfo.gov/content/pkg/FR-2007-10-23/html/07-5226.htm
https://www.govinfo.gov/content/pkg/FR-2007-10-23/pdf/07-5226.pdf
3 p.
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72 FR 60023
Guidance for Industry, Food and Drug Administration, and Foreign Governments; Fiscal Year 2008 Medical Device User Fee Small Business Qualification and Certification; Availability; Federal Register Vol. 72, Issue
NOTICE
07-5226
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. 2007D-0401
4160-01-S
07-5226
Notice.
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``FY 2008 Medical Device User Fee Small Business Qualification and Certification.'' This guidance explains how a business headquartered in the United States or headquartered in a foreign nation may respectively qualify as ``small business'' under the medical device user fee provisions of the Federal Food, Drug, and Cosmetic Act (the act). A ``small business'' may pay certain medical device user fees at a substantial discount from the standard (full) fee rates and may obtain a one-time fee waiver for its first premarket application (a premarket approval application (PMA), biologics license application (BLA), product development protocol (PDP), or premarket report (PMR)).
Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time.
Joseph V. Puleo, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3150, ext. 116, e-mail: joseph.puleo@fda.hhs.gov.
Reports and guidance documents; availability, etc.:
Medical device user fee small business qualification and certification (FY 2008); industry guidance,
dsmica@fda.hhs.gov
joseph.puleo@fda.hhs.gov
http://www.fda.gov/cdrh
http://www.fda.gov/cdrh/guidance.html
http://www.fda.gov/dockets/ecomments
http://www.fda.gov/ohrms/dockets
http://www.regulations.gov
Federal Register
Vol. 72, no. 204
Office of the Federal Register, National Archives and Records Administration
2007-10-23
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295 p.
Table of Contents:
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https://www.govinfo.gov/app/details/FR-2007-10-23
https://www.govinfo.gov/content/pkg/FR-2007-10-23/pdf/FR-2007-10-23.pdf
https://www.govinfo.gov/content/pkg/FR-2007-10-23/xml/FR-2007-10-23.xml
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