

[Federal Register: January 16, 2008 (Volume 73, Number 11)]
[Notices]               
[Page 2924]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ja08-62]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0390]

 
User Fee Program for Advisory Review of Direct-to-Consumer 
Television Advertisements for Prescription Drug and Biological 
Products; Program Will Not Be Implemented

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing this notice 
to inform companies that the Direct-to-Consumer (DTC) television 
advertisement user fee program will not commence because the necessary 
user fees for the program were not ``provided in advance in 
appropriations Acts'' as required by the Food and Drug Administration 
Amendments Act of 2007 (FDAAA) and the previously issued notice 
establishing user fee rates for the program for fiscal year (FY) 2008 
is being withdrawn.

FOR FURTHER INFORMATION CONTACT: Wayne Amchin, 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.

SUPPLEMENTARY INFORMATION: On September 27, 2007, the President signed 
into law FDAAA (Public Law 110-85). Title I of FDAAA reauthorized the 
Prescription Drug User Fee Act for FYs 2008 to 2012. In addition, Title 
I created new section 736A of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 379h-1), which authorized a new and separate user 
fee program for the advisory review of DTC prescription drug television 
advertisements. The DTC user fee program would have been available to 
companies interested in voluntarily submitting to FDA for advisory 
review a DTC television advertisement, as defined in section 736A(h)(4) 
of the act. FDAAA provided, however, that if FDA fails to receive at 
least $11,250,000 in advisory review fees and operating reserve fees 
combined by 120 days after the legislation is enacted (i.e., by January 
25, 2008), the program shall not commence (section 736A(f)(1) of the 
act). FDAAA also provided that the fees authorized for the DTC program 
``shall be collected and available for obligation only to the extent 
and in the amount provided in advance in appropriations Acts.'' 
(section 736A(g)(1) of the act).
    On December 26, 2007, the President signed the Consolidated 
Appropriations Act, 2008 (Public Law 110-161). The law does not 
appropriate user fee funds for the voluntary review of DTC television 
advertisements. As a result, under section 736A(g)(1) of the act, FDA 
does not have the authority to collect and spend user fees for this 
purpose. Furthermore, as noted previously, section 736A(f)(1) of the 
act provides that if FDA has not collected at least $11,250,000 in 
advisory review fees and operating reserve fees combined by 120 days 
after the legislation is enacted (i.e., by January 25, 2008), the 
program shall not commence. Therefore, no invoices will be sent. 
Advertisements voluntarily submitted for FDA review will be reviewed in 
as timely a manner as resources permit. In addition, FDA is withdrawing 
the previously issued Federal Register notice establishing the user fee 
rates for this program for FY 2008 (72 FR 70334, December 11, 2007).

    Dated: January 10, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-740 Filed 1-15-08; 8:45 am]

BILLING CODE 4160-01-S
