Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by April 2, 2009.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or e-mailed to email@example.com. All comments should be identified with the OMB control number 0910-0498. Also include the FDA docket number found in brackets in the heading of this document.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-3794.Start Printed Page 9248End Further Info End Preamble Start Supplemental Information
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Export of Food and Drug Administration Regulated Products: Export Certificates (OMB Control Number 0910-0498)—Extension
In April 1996 a law entitled “The FDA Export Reform & Enhancement Act of 1996” (FDAERA) amended sections 801(e) and 802 of the act (21 U.S.C. 381(e) and 382). It was designed to ease restrictions on exportation of unapproved pharmaceuticals, biologics, and devices regulated by FDA. Section 801(e)(4) of the FDAERA provides that persons exporting certain FDA-regulated products may request FDA to certify that the products meet the requirements of 801(e) or 802 or other requirements of the act. This section of the law requires FDA to issue certification within 20 days of receipt of the request and to charge firms up to $175.00 for the certifications.
This new section of the act authorizes FDA to issue export certificates for regulated pharmaceuticals, biologics, and devices that are legally marketed in the United States, as well as for these same products that are not legally marketed but are acceptable to the importing country, as specified in sections 801(e) and 802 of the act. FDA has developed five types of certificates that satisfy the requirements of section 801(e)(4)(B) of the act: (1) Certificates to Foreign Governments, (2) Certificates of Exportability, (3) Certificates of a Pharmaceutical Product, (4) Non-Clinical Research Use Only Certificates, and (5) Certificates of Free Sale. Table 1 of this document lists the different certificates and details their use:
|Type of Certificate||Use|
|“Supplementary Information Certificate to Foreign Government Requests” “Exporter's Certification Statement Certificate to Foreign Government” “Exporter's Certification Statement Certificate to Foreign Government (For Human Tissue Intended for Transplantation)”||For the export of products legally marketed in the United States|
|“Supplementary Information Certificate of Exportability Requests” “Exporter's Certification Statement Certificate of Exportability”||For the export of products not approved for marketing in the United States (unapproved products) that meet the requirements of sections 801(e) or 802 of the act|
|“Supplementary Information Certificate of a Pharmaceutical Product” “Exporter's Certification Statement Certificate of a Pharmaceutical Product”||Conforms to the format established by the World Health Organization and is intended for use by the importing country when the product in question is under consideration for a product license that will authorize its importation and sale or for renewal, extension, amending, or reviewing a license|
|“Supplementary Information Non-Clinical Research Use Only Certificate” “Exporter's Certification Statement Non-Clinical Research Use Only”||For the export of a non-clinical research use only product, material, or component that is not intended for human use which may be marketed in, and legally exported from the United States under the act|
|Certificates of Free Sale||For food, cosmetic products, and dietary supplements that may be legally marketed in the United States|
FDA will continue to rely on self-certification by manufacturers for the first three types of certificates listed in table 1 of this document. Manufacturers are requested to self-certify that they are in compliance with all applicable requirements of the act, not only at the time that they submit their request to the appropriate center, but also at the time that they submit the certification to the foreign government.
The appropriate FDA centers will review product information submitted by firms in support of their certificate and any suspected case of fraud will be referred to FDA's Office of Criminal Investigations for follow-up. Making or submitting to FDA false statements on any documents may constitute violations of 18 U.S.C. 1001, with penalties including up to $250,000 in fines and up to 5 years imprisonment.
In the Federal Register of December 17, 2008 (73 FR 76655), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.
FDA estimates the burden of this collection of information as follows:
|FDA Center||No. of Respondents||Annual Frequency per Response||Total Annual Responses||Hours per Response||Total Hours|
|Center for Biologics Evaluation and Research||1,501||1||1,501||1||1,501|
|Center for Drug Evaluation and Research||7,046||1||7,046||1||7,046|
|Center for Devices and Radiological Health||6,091||1||6,091||2||12,182|
|Center for Veterinary Medicine||664||1||664||1||664|
|Start Printed Page 9249|
|Center for Food Safety and Applied Nutrition||1,794||5||8,970||2||17,940|
|1 There are no capital costs or operating and maintenance costs associated with this collection of information.|
The burden estimates were averaged based on the approximate number of requests for certificates the agency received over the past 3 years. The burden estimate for the Center for Drug Evaluation and Research was increased to reflect a more accurate average number of requests for certificates.Start Signature
Dated: February 23, 2009.
Associate Commissioner for Policy and Planning.
[FR Doc. E9-4457 Filed 3-2-09; 8:45 am]
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