[Federal Register Volume 78, Number 87 (Monday, May 6, 2013)]
[Notices]
[Pages 26374-26375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-10626]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0418]


An Evaluation of the Prescription Drug User Fee Act Workload 
Adjuster; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on an assessment of the Prescription 
Drug User Fee Act (PDUFA) Workload Adjuster conducted by an independent 
consulting firm. This assessment was conducted to fulfill FDA 
performance commitments made as part of the fifth authorization of 
PDUFA in section XV, ``Improving FDA Performance Management,'' 
subsection B, which was reauthorized by the Food and Drug 
Administration Safety and Innovation Act (FDASIA) of 2012. The 
assessment will be conducted by an independent consultant in two 
phases. This is the first assessment of two during PDUFA V to evaluate 
whether the adjustment reasonably represents actual changes in workload 
volume and complexity in the human drug review program and present 
options to discontinue, retain, or modify any elements of the 
adjustment. After review of the report and receipt of public comment, 
FDA can adopt appropriate change to the workload adjustment 
methodology, if warranted.

DATES: Submit electronic or written comments by June 5, 2013.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Giles Mills, Office of Planning, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 3288, 
Silver Spring, MD 20993-0002, 301-796-4707, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    On July 9, 2012, the President signed into law FDASIA. This new law 
includes the reauthorization of PDUFA that provides FDA with the 
necessary resources to maintain a predictable and efficient review 
process for human drug and biologic products.
    Title I of FDASIA is the fifth authorization of PDUFA and includes 
by reference the performance goals and procedures for PDUFA V 
transmitted by the Secretary of Health and Human Services to Congress 
in a commitment letter. FDA developed recommendations for PDUFA V in 
consultation with drug industry representatives, patient and consumer 
advocates, healthcare professionals, and other public stakeholders from 
July 2010 through May 2011. These recommendations included an FDA 
commitment to contract with an independent

[[Page 26375]]

accounting firm to review the adequacy of the PDUFA adjustment for 
changes in workload (hereafter referred to as the workload adjuster).
    The workload adjuster was introduced in PDUFA III to allow for FDA 
to augment the total user fee revenue amount each fiscal year (after 
adjusting for inflation) to account for changes in workload volume in 
the human drug application review process. Workload volume is measured 
by the changes in the number of new drug applications and biologics 
license applications (NDAs/BLAs), active commercial investigational new 
drugs (INDs), efficacy supplements, and manufacturing supplements 
submitted to the human drug review program during the most recent 5-
year period.
    In PDUFA IV, the workload adjuster was expanded to account for the 
workload complexity (known as the adjustment for changes in review 
activities) associated with the review of NDAs/BLAs and active 
commercial INDs. The NDA/BLA complexity is measured by changes in the 
number of labeling supplements, annual report reviews, and NDA/BLA 
meetings per NDA/BLA. IND complexity is measured by changes in the 
number of special protocol assessments and IND meetings per active 
commercial IND.
    As part of the PDUFA IV recommendations, FDA committed to an 
evaluation of the adjustment for changes in review activities by an 
independent accounting firm. The study, conducted by Deloitte & Touche, 
LLP, found that the adjustment methodology used by FDA reasonably 
captures changes in the workload complexity for reviewing human drug 
applications under PDUFA IV. While the FY 2009 evaluation concluded 
that the adjustment methodology was reasonable at that point in time, 
the complexity of new drug applications and FDA's regulatory 
responsibilities are constantly evolving. Moreover, the complexity 
component of the PDUFA IV workload adjuster was formulated before the 
enactment of the Food and Drug Administration Amendments Act (FDAAA). 
Thus, the workload adjuster does not account for new and significant 
review activities required by FDAAA, such as risk evaluation and 
mitigation strategies, safety labeling changes, advisory committee 
meetings, and post-market safety requirements, among others.
    Given the dynamic nature of drug products and FDA's regulatory 
responsibilities, FDA committed to periodic reassessments of the 
workload adjuster in PDUFA V to ensure that it is achieving its 
intended role of adjusting the user fee revenues to reflect actual 
changes in FDA's workload volume and complexity.
    The PDUFA V commitment letter instructs FDA to contract with an 
independent accounting or consulting firm to conduct two assessments of 
the workload adjuster. This first assessment (to examine the 
performance of the workload adjuster since FY 2009) was just completed. 
The independent accounting or consulting firm is required to submit 
reports based on their assessments. The reports will evaluate whether 
the workload adjuster reasonably represents actual changes in workload 
volume and complexity and will present recommendations to discontinue, 
retain, or modify any elements of the adjustment. After review of the 
reports and receipt of public comments, FDA, if warranted, may 
implement appropriate changes to the methodology. If FDA adopts changes 
to the methodology based on the first report, the changes are effective 
the fiscal year after FDA adopts the changes and each subsequent fiscal 
year.
    FDA is seeking public comment now on the first assessment of the 
PDUFA Workload Adjuster, available at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee.

II. Comments

    Interested persons may submit either electronic comments regarding 
the Analysis to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: April 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-10626 Filed 5-3-13; 8:45 am]
BILLING CODE 4160-01-P