[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