[Federal Register Volume 72, Number 237 (Tuesday, December 11, 2007)]
[Notices]
[Pages 70334-70336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-24000]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0469]


Establishment of Fiscal Year 2008 User Fee Rates for Advisory 
Review of Direct-to-Consumer Television Advertisements for Prescription 
Drug and Biological Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing this notice, 
as required by the Food and Drug Administration Amendments Act of 2007 
(FDAAA), to establish the fiscal year (FY) 2008 fees that will be 
charged for each FY 2008 advisory review submission to FDA and to fund 
the operating reserve established under FDAAA. The Federal Food, Drug, 
and Cosmetic Act (the act), as amended by FDAAA, authorizes FDA to 
collect user fees for certain direct-to-consumer (DTC) television 
advertisements submitted to FDA for advisory review.

ADDRESSES:  Information about the DTC television user fee program is 
available on the Internet at http://www.fda.gov/cder/ddmac/user_fees/default.htm.

FOR FURTHER INFORMATION CONTACT:  For questions about rates, invoices, 
or payments: Ashley Linkous, Office of Regulatory Policy (HFD-7), 
Center for Drug Evaluation and Research (CDER), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.
    For questions about where or how to submit proposed DTC television 
advertisements for advisory review, what to include in your submission, 
the status of pending DTC television advertisements submitted for 
advisory review, or your remaining balance of advisory reviews under 
the DTC television user fee program: Wayne Amchin, Division of Drug 
Marketing, Advertising, and Communications, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, rm. 1454, Silver Spring, MD 20993-0002, 301-796-1200, FAX: 
301-796-9878, e-mail [email protected].
    For questions about submissions to the Advertising and Promotional 
Labeling Branch (APLB) in the Center for Biologics Evaluation and 
Review (CBER): Ele Ibarra-Pratt, Advertising and Promotional Labeling 
Branch, Center for Biologics Evaluation and Research (HFM-602), Food 
and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 
301-827-6331.

SUPPLEMENTARY INFORMATION:

I. Introduction

    On September 27, 2007, the President signed into law FDAAA (Public 
Law 110-85). Section 104 of this statute created new section 736A of 
the act, which in addition to reauthorizing the Prescription Drug User 
Fee Act (PDUFA) for FYs 2008-2012, also authorized a new and separate 
user fee program for the advisory review of DTC prescription drug 
television advertisements. Participation in the program is voluntary. 
Sponsors can decide, at their own discretion, whether to seek FDA 
advisory review of DTC prescription drug television advertisements in 
advance of publicly broadcasting them. However, under the new law, if a 
sponsor decides to seek FDA advisory review of a DTC television 
advertisement, the sponsor must pay all applicable fees for that review 
under the DTC television user fee program.
    In the Federal Register of October 25, 2007 (72 FR 60677), FDA 
issued a participation notice asking companies: (1) To notify FDA by 
November 26, 2007, if they intend to participate in the DTC television 
user fee program during FY 2008 and (2) if they do plan to participate, 
to identify the number of DTC television advertisements for 
prescription drug and biological products they plan to submit to CDER 
or CBER for advisory review during FY 2008. The information gathered in 
response to the participation notice is the basis for the fees this 
notice establishes that will be charged for each FY 2008 advisory 
review submission to FDA and to fund the operating reserve established 
under FDAAA.

II. Establishing the Advisory Review Fee and Operating Reserves

A. Basis for the Fee

    The advisory review fee for FY 2008 will be $41,390 for each 
proposed television advertisement voluntarily submitted for advisory 
review. The fee is based on the number of advertisements identified by 
all companies in response to the participation notice. The advisory 
review fees in FY 2008 are set at a level to generate target revenues 
of $6.25 million in the first year of the program. Individual fees have 
been determined by dividing the target revenue, established in the 
statute, by 151 (the number of television advertisements all

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companies have indicated in response to the participation notice that 
they intend to submit during FY 2008 for advisory review).
    A participant who does not pay the fees on time as specified in the 
billing instructions included with the invoice will be assessed a fee 
of $62,085 because the statute establishes a 50 percent penalty for 
fees not paid on time. A participant who submits more advertisements 
for advisory review in FY 2008 than it has told FDA it plans to submit 
in response to the participation notice will be assessed for each 
additional submission a fee that is 50 percent greater than the 
established individual fee. A participant who intends to submit 
additional advertisements should notify Wayne Amchin (see FOR FURTHER 
INFORMATION CONTACT).
    The target revenue figures will be adjusted annually for inflation 
and workload on a compounded basis in subsequent years. In each 
subsequent year of the program, FDA will issue a new notice of 
participation by June 1 of that year and a second notice by August 1 
establishing the fees.

B. Operating Reserves

    To establish operating reserves for the program, in the first year 
of their participation in the program, participants will be assessed a 
one-time participation fee that will be based on the number of 
submissions the participant identifies for that year. In this way, FDA 
will collect revenues of $6.25 million to be placed in reserve from 
which funds can be drawn if target revenues fluctuate downward in 
subsequent years. For companies who responded by November 26, 2007 (the 
date given in the participation notice), the operating reserve fee for 
each participant in FY 2008 will be an amount equal to the total amount 
assessed that company for the annual advisory review fees for FY 2008. 
For companies who responded to the participation notice by November 26, 
2007, but do not pay the assessed operating reserve fee within the time 
period specified in the invoice, the operating reserve fee will be 50 
percent higher than what they would have owed had they paid on time. 
For participants who join the program late in FY 2008 (i.e., those who 
did not notify FDA of their intent to participate by November 26, 
2007), the operating reserve fee will be 50 percent higher than what 
they would have owed had they both notified FDA and paid on time.
    Companies who join the program in subsequent fiscal years (FYs 
2009-2012) will be assessed an amount for the operating reserve fee 
that will be at least as much as the amount they would have been 
assessed if they had joined the program at the start of FY 2008. 
Specifically, in subsequent years, the operating reserve fee for new 
participants will be the higher of: (1) The total amount of advisory 
review fees for all of the new participant's proposed DTC television 
advertisements in the year the participant joins the program or (2) the 
total amount of advisory review fees that would have been assessed in 
FY 2008 for that number of proposed DTC television advertisements. This 
statutory fee structure limits the incentive for companies to join the 
program late, which could prevent the program from receiving sufficient 
funding in the initial year and place a disproportionate share of the 
cost of the program on those participants who join the program in its 
initial year of operation.

C. Effect of Inadequate Funding

    The statute provides that if FDA fails to receive sufficient 
funding from companies by January 25, 2008, the program will not 
commence. Sufficient funding consists of a combined total amount of at 
least $11.25 million from advisory review fees and operating reserve 
fees. In the event that insufficient funding is received and the 
program does not commence, all collected fees will be refunded to the 
companies who paid.

III. Participating in the DTC Television User Fee Program

A. How Do Participating Companies Pay the User Fees for Advisory 
Review?

    FDA will send invoices to each company for all submissions 
identified in response to the participation notice, and the advisory 
review fees and the operating reserve fees are due and payable on the 
date specified in the invoices. Participating companies should not send 
payment until after receipt of the invoice. FDA will also assign each 
participant a series of unique user fee ID numbers to correspond with 
the number of advisory reviews that participants have identified in 
response to the participation notice. For example, a company that has 
identified 10 advisory reviews will receive 10 unique user fee ID 
numbers in its invoice. Companies should assign one of its unique user 
fee ID numbers to each submission of a DTC television advertisement for 
FDA advisory review and reference this number in the submission cover 
letter and outer package. FDA will track this unique user fee ID number 
against the invoice to ensure that all applicable fees have been paid 
and that the company has an available balance of advisory reviews for 
each submission received by the FDA. A company's advisory review 
submission will be considered incomplete and not accepted for review 
until all fees owed by the company for all advisory reviews and the 
operating reserve fee have been paid.

B. How Do I Send In DTC Television Advertisements for Advisory Review 
Under the DTC Television User Fee Program?

    FDA intends to issue guidance for industry explaining how to submit 
proposed DTC television Advisory Review Request Packages for review by 
CDER and CBER under the DTC television user fee program. The guidance 
document will provide details on the contents, format, and procedures 
that FDA recommends be followed. The guidance will also explain how and 
where to submit advisory review packages to start the DTC television 
user fee program performance clock. FDA will issue a Federal Register 
notice to announce the availability of this guidance. Prior to 
availability of the guidance, for questions about where or how to 
submit proposed DTC television advertisements for advisory review, what 
to include in your submission, the status of pending DTC television 
advertisements submitted for advisory review, or your remaining balance 
of advisory reviews under the DTC television user fee program, please 
contact Wayne Amchin (see FOR FURTHER INFORMATION CONTACT).
    For questions about submissions to CBER (APLB), please contact Ele 
Ibarra-Pratt (see FOR FURTHER INFORMATION CONTACT).

C. What Happens if I Send In a DTC Television Advertisement for 
Advisory Review After October 1, 2007, but Before I'm Invoiced by FDA 
for My FY 2008 Fees?

    The effective date for the assessment and collection of fees for 
DTC television advertisements under this program is October 1, 2007. 
Therefore, any proposed DTC television advertisement voluntarily 
submitted for advisory review in FY 2008 is subject to the fees 
established in this notice. FDA recognizes that, due to the timing of 
the enactment of FDAAA, the advisory review and operating reserve fees 
for FY 2008 were not established and billed before October 1, 2007, and 
that there will be a gap between the start of the fiscal year and the 
date that fees are due. FDA will contact companies who submit DTC 
television advertisements

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in this time period to request written confirmation from these 
companies of their commitment to pay these fees; if companies do not 
agree to make this commitment, FDA will request that they withdraw 
their submission(s), and such submissions will not be reviewed. For 
further information, contact Wayne Amchin (see FOR FURTHER INFORMATION 
CONTACT).
    For information on how FDA will treat DTC television advertisement 
advisory review submissions not identified in response to the 
participation notice that are submitted after the 30-calendar-day time 
period for responding to that notice has elapsed, see sections II.A 
``Basis for the Fee'' and II.B ``Operating Reserves'' of this document.

    Dated: December 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-24000 Filed 12-10-07; 8:45 am]
BILLING CODE 4160-01-S