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U.S. Department of Health and Human Services

For Industry

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PDUFA Dear Colleague Letter for 2002

6/12/2002

Dear Colleague:

On June 12, 2002, the President signed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which includes the Prescription Drug User Fee Amendments of 2002 (PDUFA III). Among other things, this law authorizes the Food and Drug Administration (FDA) to continue to collect three types of user fees from applicants who submit certain new drug and biological product applications and supplements and for certain products and establishments. FDA was first authorized to collect user fees through September 30, 1997, under the Prescription Drug User Fee Act of 1992 (PDUFA I). The Food and Drug Administration Modernization Act of 1997, which included Subtitle A - Fees Relating to Drugs (PDUFA II), authorized FDA to collect fees for an additional 5 years, through September 30, 2002. PDUFA III extends FDA's authority to collect fees for 5 more years, through September 30, 2007, and includes a number of technical revisions that affect the way certain fees are assessed and collected.

The purpose of this letter is to alert you to some of the technical revisions to the Federal Food, Drug, and Cosmetic Act (the Act) and to request your prompt assistance in providing the additional information necessary under PDUFA III to accurately prepare the fiscal year (FY) 2003 invoices for product and establishment fees.

I. What Are the Technical Revisions to the Act?

The changes described below affect the way product and establishment fees will be assessed for FY 2003.

A. When are annual product and establishment fees due?

Unlike PDUFA I and PDUFA II,1 annual product and establishment fees for PDUFA III are due on October 1 each year,2 so that FDA no longer needs to carry forward large cash surpluses from year to year. FDA will also have access to revenue as early in FY 2003 as invoices can be issued and fees collected, rather than waiting until January 31 to collect funds. We expect to send out invoices for FY 2003 in August of this year.3

 

B. How will product fees be assessed under PDUFA III?

1. For Drug Products

Under PDUFA III, the term "prescription drug product" has been modified to use the Prescription Drug Product List in the Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book) (the active portion) as the basis for identifying which products are considered prescription drug products for fee assessment purposes. Products identified in the Orange Book Prescription Drug Product List with no generic competition will be assessed a fee regardless of drug listing status. Those products in the Orange Book with generic competition will not be assessed a fee. Under PDUFA I and PDUFA II, any prescription drug product (including a licensed biological) approved and eligible for drug listing not subject to generic competition was subject to user fees.

2. For Biological Products

In addition to the Orange Book technical change to the Act, PDUFA III includes the addition of the reference to a list of products approved under human drug applications under section 351 of the Public Health Service Act created and maintained by the Secretary. Because biologics approved under section 351 of the Public Health Service Act are not listed in the Orange Book, a separate listing of licensed products which are user fee liable will be maintained. All non-revoked biological products meeting the definition of human drug products will be included in the billable biologics list. Please note that the products on the list are subject to user fee regardless of whether they are currently being manufactured or not. This refers to the current FDA method of identifying biological products considered to be prescription drug products for fee assessment purposes.

3. Drug Listing

The drug listing criterion4 for assessing product fees is omitted in PDUFA III. Determining eligibility for listing is administratively complex and sometimes resource intensive, in part because the drug listing process under section 510 of the Act is often controlled by a repacker or distributor, rather than the sponsor of a product. For example, the sponsor may not be distributing the drug product; however, if the drug product is listed under section 510 of the Act by anyone, including a repacker or distributor, then the sponsor was still responsible for paying a product fee. Many sponsors had a difficult time convincing repackers and distributors to delist their drug product appropriately and in a timely fashion. Additionally, biologics manufacturers often were not clear on the requirement to list their biologic products.

The Orange Book and billable biologics list criterion5 provides sponsors with control of their list of billed products and should provide an easier way to remove products from the billing list. Sponsors can review what the product portion of their annual bill will look like by monitoring the Orange Book or billable biologics list on the Internet.6

  • C. Are There Other Changes to the Act Relating to User Fees?
  • Yes. For other changes to the Act relating to prescription drug user fees, please refer to the attached document (Attachment D) which was excerpted from the House of Representatives Conference Report 107-481 to Accompany H.R. 3448 - Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The excerpt includes Title V - Additional Provisions, Subtitle A - Prescription Drug User Fees, and Subtitle B - Additional Authorizations of Appropriations Regarding Food and Drug Administration.

    II. What Else Is Attached to This Letter?

    We have enclosed a list of product and establishments for which you were assessed fees in FY 2002 (Attachment B). The list contains all products and establishments that appeared on invoices issued in January 2002. We have also attached a list of all the products for which you are listed as the sponsor in the active portion of the Orange Book (Attachment C). If we were to issue the FY 2003 bill today, this second list would indicate how the product portion of your new bill would appear. These two lists may differ.

    III. What Does FDA Need to Ensure an Accurate Bill for FY 2003?

    To ensure that the August invoices accurately assess FY 2003 product and establishment fees under PDUFA III, we are asking for your assistance in providing the following information:

    • A. Product Lists (Attachment B and Attachment C)

      Please revise the list of products as follows:

    • Note on the lists any products submitted under section 505(b)(2) of the Act.
    • Note on the list any products that have generic competition.
    • Mark on the list any products that are large volume parenteral (LVP) DRUG products (under PDUFA III DRUG LVPs are not assessed a product fee). BIOLOGICAL products intended for single dose injection for intravenous use or infusion are still fee liable. You should not delete them from the list.
    • Add any approved product not on the list that you believe should be assessed a fee (e.g., new approval). Please include the reason why you believe it should be assessed a fee.
    • Please contact the Orange Book Staff, HFD-093 with any corrections to the Orange Book. For example, if you are no longer marketing your drug product and you have delisted it under section 510 of the Act, you should alert the Orange Book Staff, so that the drug product can be moved to the discontinued portion of the Orange Book. Conversely, if you are marketing your drug product and it is in the discontinued portion of the Orange Book, you should also notify the Orange Book Staff.

      In order for the Agency to make all the necessary changes to the Orange Book and issue invoices in August, you must notify the Orange Book Staff by close of business July 1, 2002. Please note this information on the product list as well.

      You can contact the Orange Book staff by e-mail:

      DRUGPRODUCTS@CDER.FDA.GOV

      You can send them information by facsimile at 301-594-6463. If you wish to send a paper copy confirming the faxed or e-mailed information you can mail it to:

      FDA/CDER Orange Book Staff, HFD-093
      5600 Fishers Lane
      Rockville, Maryland 20857
      Note:
      Address and Fax number are outdated for the Orange Book.

      See 2003 Letter for updated contact information
      If you wish to send it using an overnight courier service (e.g., FedEx, DHL) you can send it to:

      FDA/CDER Orange Book Staff, HFD-093
      Park Building, Suite 3-22
      12420 Parklawn Drive
      Rockville, Maryland 20857

       

      · For licensed biologics, please contact the Regulatory Information Staff, 301-827-3503 about any questions or discrepancies.

      B. Establishment List

      Please revise the list of establishments as follows:

      · Add to the list of establishments the name, site address, and CFN number (if known) of all approved manufacturing sites (not the corporate headquarters address) engaged in the manufacture of final dosage forms of any of your prescription drug products on the updated Orange Book product list. Include establishments owned by contract manufacturers. Do not include establishments that function solely as packagers or that do not make final dosage forms.

      · Delete any establishments from the list that do not manufacture any prescription drug products in final dosage form. Please include a brief statement of the reason for deletion (for example, state the operation performed at the establishment to be deleted). If an establishment owned by your firm is not associated with the production of any of your products, but contracts to make products for another firm, please indicate that the facility serves as a contract manufacturer only.

      C. Matching the Product List with the Corresponding Establishment

      For each product on the list, please indicate the establishment or establishments where the final dosage form of the product is produced. We suggest numbering the establishments after all the additions and deletions have been made and writing the number or numbers you assigned to each establishment next to each product produced in final dosage form at that establishment.

      D. Contact Information

      Finally, update the Attachment A information with the appropriate name, address, title, phone, and fax number of your company contact for user fee purposes. Keep in mind that all correspondence regarding user fees will be addressed to this contact name.

     

    Please return the information by facsimile (301-827-5562) to Michael Jones. If you wish to send a paper copy confirming the faxed information, you can mail it to:

    Michael Jones
    Special Assistant
    Office of Regulatory Policy, HFD-5
    Center for Drug Evaluation and Research
    Food and Drug Administration
    5600 Fishers Lane
    Rockville, Maryland 20857
     
    If you wish to send it using an overnight courier service (e.g., FedEx, DHL) you can send it to:

    Michael Jones
    Special Assistant
    Office of Regulatory Policy, HFD-5
    Center for Drug Evaluation and Research
    Food and Drug Administration
    1451 Rockville Pike,
    Rockville, Maryland 20852

     

    We apologize for the short notice for this request but we believe that much time and effort will be saved by ensuring that the information from which the FY 2003 invoices are generated is accurate and up-to-date. To allow time for us to process the information you provide, we are requesting that you respond by close of business Monday, July 1, 2002. If you have any questions, please call Michael Jones, Beverly Friedman, or Tawni Schwemer at 301-594-2041.

    Your assistance is greatly appreciated. FDA is committed to continue working jointly with industry to ensure the continued success of this program.

    Sincerely yours,

    /s/

    Helen S. Horn, Acting Director
    Office of Financial Management

    Attachment A - Contact Information

    Attachment B - January 2002 Invoice

    Attachment C - Proposed FY 2003 Product List

    Attachment D - Excerpt from Conference Report


     

     1 Under PDUFA I and PDUFA II, annual product and establishment fees were due on January 31 of each year.

     2 Section 736(a)(2)(A) of the Act as amended by the Prescription Drug User Fee Amendments of 2002.

     3 Prescription Drug user Fee Rates for FY 2003 will be calculated and published in a Federal Register notice in August 2002.

     4 Section 736(a)(3)(i) of the Act under PDUFA I and PDUFA II.

     5 Section 736(a)(3) of the Act as amended by the Prescription Drug User Fee Amendments of 2002.

     6 The Orange Book is accessible at Electronic Orange Book. The biologics listing will be available in August 2002 at: CBER Biologic Products.