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2010-09-24
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Export Certificates; FDA Export Reform and Enhancement Act of 1996; Certification Fees for Drugs, Animal Drugs, and Devices
Notices
D09002ee1be02b671
D09002ee1be02b719
United States
Department of Health and Human Services
originator
org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the fees for issuing export certificates. The FDA Export Reform and Enhancement Act of 1996 provides that any person who exports a drug, animal drug, or device may request FDA to certify in writing that the exported drug, animal drug, or device meets certain specified requirements. It further provides that FDA shall issue such a certification within 20 days of the receipt of a request for such certification, and that FDA may charge up to $175 for each certification that is issued within the 20 days. This notice describes the fee schedule for export certifications, the costs that form the basis for those fees, and the billing and collection processes. The agency requests comments on the fee schedule and its effects on small business.
61 FR 57445
https://www.govinfo.gov/app/details/FR-1996-11-06/96-28529
96-28529
fr06no96-111
4160-01-F
Docket No. 96N-0383
https://www.govinfo.gov/app/details/FR-1996-11-06/96-28529
https://www.govinfo.gov/content/pkg/FR-1996-11-06/html/96-28529.htm
https://www.govinfo.gov/content/pkg/FR-1996-11-06/pdf/96-28529.pdf
2 p.
57445
57446
61 FR 57445
Export Certificates; FDA Export Reform and Enhancement Act of 1996; Certification Fees for Drugs, Animal Drugs, and Devices; Federal Register Vol. 61, Issue
NOTICE
96-28529
DEPARTMENT OF HEALTH AND HUMAN SERVICES
1996-10-01
1997-02-04
Docket No. 96N-0383
4160-01-F
96-28529
Notice.
The Food and Drug Administration (FDA) is announcing the fees for issuing export certificates. The FDA Export Reform and Enhancement Act of 1996 provides that any person who exports a drug, animal drug, or device may request FDA to certify in writing that the exported drug, animal drug, or device meets certain specified requirements. It further provides that FDA shall issue such a certification within 20 days of the receipt of a request for such certification, and that FDA may charge up to $175 for each certification that is issued within the 20 days. This notice describes the fee schedule for export certifications, the costs that form the basis for those fees, and the billing and collection processes. The agency requests comments on the fee schedule and its effects on small business.
The fees described herein for export certificates for drugs, animals drugs, and devices became effective October 1, 1996. Written comments should be submitted by February 4, 1997.
Lance S. Siegall, Office of Financial Management, Accounting Reports and Analysis Branch (HFA-120), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443- 1768.
Federal Register
Vol. 61, no. 216
Office of the Federal Register, National Archives and Records Administration
1996-11-06
continuing
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306 p.
Table of Contents:
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https://www.govinfo.gov/app/details/FR-1996-11-06
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https://www.govinfo.gov/app/details/FR-1996-11-06
https://www.govinfo.gov/content/pkg/FR-1996-11-06/pdf/FR-1996-11-06.pdf
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