[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Notices]
[Pages 59786-59787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25117]


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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 of 2012 (FDASIA). Independent 
consulting firms conducted two assessments during PDUFA V. This is the 
second assessment to evaluate whether the adjustment reasonably 
represents actual changes in workload volume and complexity in the 
human drug review program and to 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 November 2, 2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0418 for ``An Evaluation of the Prescription Drug User Fee 
Act Workload Adjuster; Request for Comments.'' Received comments will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other

[[Page 59787]]

applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Alice Tsai, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 1149, Silver Spring, MD 20993-0002, 240-402-6069, 
[email protected].

SUPPLEMENTARY INFORMATION: 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, health care professionals, and other public stakeholders 
from July 2010 through May 2011. These recommendations included an FDA 
commitment to contract with an independent accounting or consulting 
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 (NDAs) and 
biologics license applications (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; hereafter referred to as the Complexity Factor) 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 consulting firm. The study, conducted by Deloitte & Touche, 
LLP, in fiscal year (FY) 2009, found that the adjustment methodology 
used by FDA reasonably captures changes in the workload complexity for 
reviewing human drug applications under PDUFA IV. Although the FY 2009 
evaluation concluded that the adjustment methodology was reasonable at 
that 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 of 2007 
(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. The first assessment (to examine the performance 
of the workload adjuster since FY 2009) conducted by IBM in FY 2013, 
found that the workload adjuster does reasonably represent changes in 
workload volume associated with the human drug review process. However, 
the report concluded that methodology was flawed with respect to 
measuring workload complexity, because it does not represent total 
amount of work per submission. The report recommended that FDA consider 
removing the Complexity Factor. In addition, the report found that the 
workload adjuster's use of 5-year rolling averages to measure changes 
in workload against the base years was not as sensitive to recent 
trends as 3-year rolling averages would be. The report is available at 
http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM350567. After reviewing the report and 
public comments, FDA discontinued the use of the Complexity Factor in 
the adjustment methodology and adopted 3-year averages to measure 
changes in workload volume.
    The second assessment (to address the recommendations from the 
first evaluation and assess the continued performance of the workload 
adjuster) was just completed. The independent consulting firm is 
required to submit a report based on its assessment. The report will 
evaluate whether the workload adjuster reasonably represents actual 
changes in workload volume and will present options to discontinue, 
retain, or modify any elements of the adjustment. After review of the 
report and receipt of public comment, FDA, if warranted, may adopt 
appropriate changes to the methodology.
    FDA is seeking public comment now on the second assessment of the 
PDUFA Workload Adjuster, available at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM464878.pdf.

    Dated: September 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25117 Filed 10-1-15; 8:45 am]
 BILLING CODE 4164-01-P