PDUFA Dear Colleague Letter for 2005
May
5, 2005
Dear
Colleague:
The Federal
Food, Drug, and Cosmetic Act (the Act) authorizes the Food and Drug
Administration (FDA) to collect annual user fees for certain products
and establishments.
We plan to issue the fiscal year (FY) 2006
product and establishment invoices in August 2005,
and the fees will be due on October 1, 2005. To prepare for the FY
2006 invoices, we are asking for your assistance in updating our
records. Please provide the following information for your company:
(1) contact for user fee invoices (Attachment A) and (2) a list of
products and establishments subject to user fees (Attachment B). In
addition, this year we are asking firms with biologic products to
update Attachment B with the brand names
of your products so that the brand names may be included on future
invoices. See section II.B below for instructions.
I.
What Is Attached to This Letter?
Attachment
A [HTML] [PDF]
shows the contact information of the person designated by your company
to receive correspondence, invoices, and inquiries concerning user
fees. Attachment B [HTML]
[PDF]
is a list of the products
and establishments for which you were assessed fees in FY 2005.
This list contains all products and establishments that appeared on
your FY 2005 invoice issued in August 2004.
II.
What Information Does FDA Need to Ensure an Accurate Invoice
for FY 2006?
To ensure
that the FY 2006 product and establishment fees are accurately
assessed under the Act, we ask that you provide the information
described in the following subsections.
A. Attachment A -
User Fee Contact Information
Review the
contact information that we have on Attachment A and make any
necessary additions or corrections. Then sign the attachment.
Include your title and date.
B. Attachment B -
Product List
Please
review Attachment B and note the following items:
-
Add any approved product not on the list that you
believe should be assessed a fee (e.g., new approval) and include
the reason why you believe it should be assessed a fee.
-
Delete any product on the list for which you believe
there is a valid reason it should not be assessed a fee (e.g.,
generic competition, no longer marketed) and include a brief
explanation of why you believe it should not be assessed a fee.
-
For all products that should be on the list,
indicate the establishment or establishments where the final dosage
forms of each product are produced.
·
For biologic products: Next to the product name, print
all brand names currently used by your firm. Do not list
distributor brand names. If you have questions regarding this
request, please contact CBER’s Regulatory Information Management Staff
at 301-827-3503 or e-mail CBERRIMS@cber.FDA.gov.
1. Where can you find a
current list of your company's prescription drug products?
A current
list of your company's prescription drug products is included in the
Prescription Drug Product List of the Approved Drug Products with
Therapeutic Equivalence Evaluations (Orange Book). The Orange
Book can be viewed on the Internet at
http://www.fda.gov/cder/ob/.
After making any necessary updates to the list of your products on
Attachment B, please review your company's current list of drug
products in the Orange Book. If you find that the Orange Book is not
up-to-date, please contact the Orange Book Staff with any
corrections. For example, if you are no longer marketing a drug
product, you have delisted it under section 510 of the Act (21 U.S.C.
360), and the product is on the Prescription Drug Products List, then
you should alert the Orange Book Staff so the product can be moved to
the Discontinued Drug Product List. Conversely, if you are marketing
your drug product and it is on the Discontinued Drug Product List of
the Orange Book, you should also notify the Orange Book Staff so the
drug product can be moved to the Prescription Drug Product List of the
Orange Book.
2. Where can you
find a current list of your company's billable, licensed biologic
products?
On October 1, 2003, FDA transferred
certain product oversight responsibilities from the Center for
Biologics Evaluation and Research (CBER) to the Center for Drug
Evaluation and Research (CDER). For user fee eligible licensed biologic therapeutic products where
regulatory responsibility, review, and continuing oversight is held in
CDER, a current list is available on the Internet at
www.fda.gov/cder/biologics/pdufa/billable.pdf.
For user fee eligible licensed
biologic products where regulatory responsibility, review, and
continuing oversight is held in CBER, a current list is available on
the Internet at
www.fda.gov/cber/pdufa/billable.htm.
You may need to view both Web sites to obtain a complete list of your
user fee eligible biologic products.
C. Attachment B -
Establishment List
If your FY
2006 invoice were issued today, we would assess establishment fees for
the same establishments listed in your FY 2005 invoice. Please review
the list and revise it as follows:
-
Add to the list of establishments the name, site
address, and central file number (CFN) (if known) of any additional
approved manufacturing sites (not the corporate headquarters
address) engaged in the manufacture of final dosage forms of any of
your prescription drug products on Attachment B - Product List.
Include establishments owned by contract manufacturers. Do not
include establishments that function solely as packagers or those
that do not make final dosage forms.
-
Number all establishments that should be on the
list. For example, if you have 10 establishments, number them 1
through 10. Then go back to Attachment B - Product List and write
the corresponding establishment number next to each product produced
in final dosage form at that establishment.
-
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 (e.g.,
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
user fee products for another firm, please indicate (1) that the
facility serves as a contract manufacturer only, (2) which products
it manufactures, and (3) for which firms it manufactures the
products.
III.
How and When Does FDA Want the Requested Information?
A. User Fee Staff
To allow
time for us to process the information you provide, the User Fee Staff
requests you return Attachments A and B as soon as possible, and no
later than close of business Friday, June 17, 2005. If you
have any questions, please call Michael Jones, Beverly Friedman, or
Tawni Schwemer at 301-594-2041. Please return Attachments A and B by
facsimile to Michael Jones, at 301-827-5562. 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, MD 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
5515 Security Lane, Room 1118
Rockville, MD 20852
B. CBER's Regulatory
Information Management Staff
CBER's
Regulatory Information Management Staff works with the Center for Drug
Evaluation and Research's (CDER's) User Fee Staff in processing the
information that you provide to the User Fee Staff (i.e., Attachments
A and B). Because the Regulatory Information Management Staff and
User Fee Staff work together to accurately assess user fees for your
licensed biological products, you do not need to send any separate
updates to the Regulatory Information Management Staff. However, if
you have any questions regarding your biological products, please call
the Regulatory Information Management Staff at 301-827-3503.
C. Orange Book Staff
The Orange
Book Staff requests that you return to them any changes to the current
list of your company's products located on the Internet at
http://www.fda.gov/cder/ob/. For the Orange Book Staff
to receive your changes in a consistent format, please print your
company's list of products from the Internet and note any changes
directly on the printed list. To allow time to process the
information you provide and factor it into the billing, the Orange
Book Staff requests that you send your changes to them as soon as
possible but no later than
Thursday, June 30, 2005.
Please send your Orange Book changes by facsimile to 301-827-5911. If
you wish to send a paper copy confirming the faxed information, you
can mail it (by regular mail or by overnight courier service) to:
FDA/CDER Orange Book Staff
Office of Generic Drugs, HFD-610
7500 Standish Place
Rockville, MD 20855-2773
If you
have any questions about your company's current list, please call the
Orange Book Staff at 301-827-5846 or send an e-mail to
drugproducts@cder.fda.gov. To ensure changes made are
reflected in your invoices, please send a courtesy copy of any
information sent to the Orange Book Staff to the User Fee Staff.
Your
assistance is greatly appreciated. FDA is committed to continue
working jointly with industry to ensure the continued success of this
program.
Sincerely yours,
Helen S.
Horn, Director
Office of Financial Management
Attachments:
Attachment A -
User Fee Contact Information
[HTML] [PDF]
Attachment B – List of Products and
Establishments Invoiced for FY 2005
[HTML]
[PDF]
(Sent in August 2004)
Date created: May 6, 2005 |