Manual of Standard Operating Procedures and Policies

Regulatory - Compliance

Review of Import for Export Requests Under
FD&C Act Section 801(d)(4)

SOPP 8503.2

Version #1

Date: February 21, 2001
  1. Purpose
    2.

    This SOPP describes to the procedures for administrative processing and review of an import for export request (IFER) or additional information to an approved IFER (IFERA) for blood and blood products submitted under section 801(d)(4) of the Act.

  2. Definitions
    3.

    Import for Export Request (IFER) - A request submitted under the provisions of 801(d)(4) of the FD&C Act, under which a manufacturer can import material to be used in the manufacture of an unapproved product for export only.

    Import for Export Request, additional information (IFERA) - additional information to a previously approved IFER. The submission may include information that is mainly administrative in nature (e.g., corporate name change) or may include information that is a substantive change to the initial request (e.g., change in the imported article, change in supplier of the imported article, or required information in the IFER).

  3. References
    4.

    The Food and Drug Administration (FDA) Export Reform and Enhancement Act of 1996, which was signed into law on April 26, 1996, resulted in significant changes in how the agency regulates imports and exports. Section 801(d)(3) allows importation of any component of a drug, component part or accessory of a device, or other article of a device requiring further processing, if it is to be further processed or incorporated into a product that is to be exported from the United States by the initial owner or consignee in accordance with section 801(e) or 802 of the FD&C Act, or section 351(h) of the PHS Act. Under section 801(d)(4) of the Export Reform and Enhancement) Act, blood, blood components, Source Plasma, Source Leukocytes or a component or accessory or part thereof, (including plasma derivatives), may not be imported pursuant to section 801(d)(3) unless the importation complies with section 351(a) of the Public Health Service Act (PHS Act) or the Secretary permits the importation under appropriate circumstances and conditions, as determined by the Secretary. The importation of tissue or a component or part of a tissue is not permitted pursuant to section 801(d)(3) unless the importation complies with section 361 of the PHS Act.

    A request to import products for export pursuant to 801(d)(4) should be submitted ninety (90) days prior to the date the U.S. manufacturer intends to begin importing the material. The import for export request must demonstrate that appropriate conditions exist to warrant CBER's approval of importation under section 801(d)(4).

    An IFERA may be submitted to an approved IFER to keep the file current. If the additional information is a significant change to the initial IFER, such as a change in the imported article, foreign supplier or required information in the IFER, then the additional information must be approved by CBER prior to implementation by the importer. Minor changes in the IFER, such as a corporate name change, will be reviewed by the CSO in Office of Compliance and Biologics Quality (OCBQ) and added to the file.

  4. Policy
    5.

    It is the policy of CBER that we will respond to a complete IFER or IFERA that requires approval within 90 days of receipt of the request.

  5. Responsibilities
    6.

    OCBQ / DCM / Biological Drug and Device Compliance Branch (BDDCB)

    • Administratively processes IFERs and IFERAs.
    • Maintains a database to track requests.
    • Communicates with requestors.
    • Performs an initial review of the packages to determine if all appropriate information is included.
    • Coordinates the review with the appropriate center components
    • Approves or disapproves IFERs and IFERA, with appropriate input from product offices.
    • Requests any additional information from the applicant.

    Review divisions

    • Review the submissions. The review is not expected to be as extensive as the review of a typical license application, but is intended to provide the agency with assurance that manufacture of the imported article into an unapproved product for export will not represent a public health risk. See Appendix 3 for review criteria.
    • Provide a written response to BDDCB via e-mail or official memorandum according to internal operating procedures within 60 days of receipt of the package.
    • Advise BDDCB if any additional information is required to complete the review of the IFER or IFERA.
    • a file will be maintained containing the response to formal RFDs.

  6. Procedures

    1. BDDCB will log the request into the export database.

    2. BDDCB will perform an initial review of the submission to determine if the submission is complete.

      If the submission is an IFERA, BDDCB will determine if the IFERA represents a significant change to the IFER during its initial review. A significant change is one that would require prior approval, such as a change in the imported article or foreign supplier. If the IFERA represents a significant change, it will be processed the same as an IFER. If the change is not significant, BDDCB will review the submission for completeness and advise the submitter of whether or not it is acceptable. It will not be forwarded to the product offices for review.

    3. If the IFER is complete, BDDCB will forward it to the appropriate Offices/Center for review. If a the final product is not regulated by CBER, BDDCB will forward the submission for review to the Center with product jurisdiction, e.g., the Center for Drug Evaluation and Research (CDER) or the Center for Devices and Radiological Health (CDRH). If the IFER is not complete, BDDCB will contact the requester and describe the information that is missing or incomplete. BDDCB will not forward the submission to the review offices until it is complete.

    4. The review offices should review the package and provide comments to BDDCB via email or memorandum, according to their internal operating procedures, within 60 days of receipt of the package.

    5. If the reviewer needs additional information to complete the review of the IFER or IFERA, the reviewer should contact the BDDCB. The BDDCB will request the information from the submitter.

    6. Once BDDCB receives comments from the reviewing Offices and/or Centers, BDDCB will notify the submitter in writing, approving or disapproving the IFER or IFERA. (Attachment A). BDDCB will not approve an IFER or IFERA if the firm that will manufacture the unapproved final product for export is not in GMP compliance.

    7. When the approval letter is issued, BDDCB will log the approval date of the IFER or IFERA into the Export Database.

  1. Appendices

    2.

    Chart

    Sample Approval Letter

    Review Criteria

  2. Effective Date
    3.

    February 21, 2001

  3. History
    4.

    Written/Revised Approved Approval Date Version Number Comment
    OCBQ Robert Devine
    2/21/2001
    		1 First Issuance of this SOPP

 
Updated: March 2, 2001