Establishment of Fiscal Year 2008 User Fee Rates for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biological Products, 70334-70336 [E7-24000]
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70334
Federal Register / Vol. 72, No. 237 / Tuesday, December 11, 2007 / Notices
Generally, specific labeling is required
to make sure that certain drugs,
approved for use in animal feed or
drinking water but not in liquid
medicated feed, are not diverted to use
in liquid feeds. Section 558.5(i) permits
an applicant to seek a waiver from this
requirement (§ 558.5(h)), if there is
evidence that it is unlikely a new
animal drug would be used in the
manufacture of a liquid medicated feed.
If FDA receives one NADA per year
seeking approval of the use of a liquid
medicated feed and on average it takes
5 hours to prepare the request for
waiver, the estimated paperwork burden
is 5 hours.
Risk assessment of antimicrobial new
animal drugs with regard to their
microbiological effects on bacteria of
human health concern (§§ 514.1(b)(8)
and 514.8(c)(1)). FDA estimates that it
receives ten risk assessments evaluating
the microbial food safety of
antimicrobial new animal drugs per
year. FDA estimates that it takes on
average 90 hours to put together the
references and other materials in the
format recommended by Guidance 152
and to summarize the hazards and
associated risk(s). Thus, the total burden
hours for preparing such risk
assessments for submission to FDA is
estimated to be 900 hours.
Form FDA 356V. FDA requests that an
applicant fill out and send in with
NADAs and supplemental NADAs, and
requests for phased review of data to
support NADAs, a Form FDA 356V to
ensure efficient and accurate processing
of information to support new animal
drug approval. Over the past 5 fiscal
years, FDA has received an average of
511 NADAs and supplements and 267
submissions of data to support NADAs.
FDA estimates that it takes an average
of 5 hours to read the instructions and
fill out Form FDA 356V and organize
the information that it will accompany.
This results in a total of 3,890 burden
hours.
Dated: December 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–23998 Filed 12–10–07; 8:45 am]
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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.
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 https://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
PO 00000
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(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
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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
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70335
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 IbarraPratt (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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Federal Register / Vol. 72, No. 237 / Tuesday, December 11, 2007 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Drug Safety and Risk Management
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
pwalker on PROD1PC71 with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Drug Safety and
Risk Management Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on February 1, 2008, from 8 a.m.
to 5 p.m.
Location: Hilton Washington DC/
Silver Spring, Maryland Ballroom, 8727
Colesville Rd., Silver Spring, MD. The
hotel phone number is 301–589–5200.
Contact Person: Teresa Watkins,
Center for Drug Evaluation and Research
(HFD–21), Food and Drug
Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm.
1093), Rockville, MD 20857, 301–827–
7001, FAX: 301–827–6776, e-mail:
Teresa.Watkins@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512535. Please call the Information
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Line for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: The committee will discuss
the efficacy and safety of new drug
application (NDA) 22–054, INJECTAFER
(ferric carboxymaltose injection),
Luitpold Pharmaceuticals Incorporated,
used for the treatment of iron deficiency
anemia in patients with postpartum
hemorrhage or heavy uterine bleeding.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm, click on the
year 2008 and scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before January 17, 2008.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those desiring to make
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before January 9, 2008. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by January 10, 2008.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
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meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Teresa
Watkins at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/oc/advisory/
default.htm for procedures on public
conduct during advisory committee
meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: December 4, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7–24003 Filed 12–10–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Advisory Committees; Filing of Closed
Meeting Reports
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that, as required by the Federal
Advisory Committee Act, the agency has
filed with the Library of Congress the
annual reports of those FDA advisory
committees that held closed meetings
during fiscal year 2007.
ADDRESSES: Copies are available from
the Dockets Management Branch (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852, 301–827–6860.
FOR FURTHER INFORMATION CONTACT:
Theresa L. Green, Committee
Management Officer, Advisory
Committee and Oversight Management
Staff (HF–4), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1220.
SUPPLEMENTARY INFORMATION: Under
section 10(d) of the Federal Advisory
Committee Act (5 U.S.C. app.1) and 21
CFR 14.60(d), FDA has filed with the
Library of Congress the annual reports
for the following FDA advisory
committees that held closed meetings
during the period October 1, 2006
through September 30, 2007:
Center for Biologics Evaluation and
Research:
Cellular, Tissue and Gene Therapies
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]]>Agencies
[Federal Register Volume 72, Number 237 (Tuesday, December 11, 2007)]
[Notices]
[Pages 70334-70336]
From the Federal Register Online via the Government Printing 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.
-----------------------------------------------------------------------
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 https://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
[[Page 70335]]
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
[[Page 70336]]
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
