[Federal Register: December 11, 2007 (Volume 72, Number 237)]
[Notices]
[Page 70334-70336]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11de07-53]
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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 dtcp@fda.hhs.gov.
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