[Federal Register Volume 85, Number 66 (Monday, April 6, 2020)]
[Notices]
[Pages 19149-19150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07175]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0989]


Assessing the Resource Needs of the Prescription Drug User Fee 
Act and Biosimilar User Fee Act; Publication of Report; 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 or Agency) is announcing 
the publication of a report providing options and recommendations for a 
new methodology to accurately assess changes in the resource and 
capacity needs of the human drug and biosimilar biologic review 
programs. FDA, in both the Prescription Drug User Fee Amendments of 
2017 (PDUFA VI) and Biosimilar User Fee Amendments of 2017 (BsUFA II) 
committed to obtaining this report through a contract with an 
independent accounting or consulting firm and publishing it before 
September 30, 2020. This was also codified in the respective 
authorizing statutory language. FDA is announcing publication of this 
report and the opening of a docket to receive public comment on this 
report. Per the respective statutory sections, after review of this 
report and receipt and review of public comment thereon, FDA will 
establish a capacity planning methodology for adjusting the annual fee 
revenue amounts for the PDUFA and BsUFA programs.

DATES: Submit either electronic or written comments on the report by 
May 6, 2020, to ensure that the Agency considers your comment on this 
report before it implements the capacity planning adjustment 
methodology.

ADDRESSES: You may submit comments on this report at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2020-N-0989 for ``Assessing the Resource Needs of the Prescription 
Drug User Fee Act, Biosimilar User Fee Act, Report Publication; Request 
for Comments.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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

[[Page 19150]]

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 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 301-
796-5003, Fax: 301-847-8443, Graham.Thompson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is announcing the publication of a 
report providing options and recommendations for a new methodology to 
accurately assess changes in the resource and capacity needs of the 
human drug and biosimilar biologic review programs. FDA, in both the 
PDUFA VI and BsUFA II commitment letters, committed to obtaining this 
report and publishing it before September 30, 2020. These commitments 
were also codified in the statute authorizing these programs (sections 
736(c)(2)(C) and 744H(c)(2)(B) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379h(c)(2)(C) and 379j-52(c)(2)(B)).
    PDUFA and BsUFA, (referred to collectively here as ``UFA(s)'') each 
establish fee amounts for each fiscal year. Although the specifics for 
each UFA are different, the process for each generally involves the 
following: Taking an annual base revenue amount and adjusting that base 
revenue amount for inflation and other UFA-specific adjustments to 
establish a target revenue amount for the fiscal year for the UFA. The 
target revenue amount sets the total amount of fee revenue for the UFA 
that FDA expects to collect for that fiscal year. The target revenue 
amount is then divided up based on UFA-specific processes to set the 
individual fee amounts for the fiscal year.
    While this process creates a relatively predictable source of UFA 
fee revenue for FDA, it also requires a method for adjustment to 
account for changes in workload. For example, without an adjustment for 
workload, during a period of growth in regulatory submissions the 
target revenue will remain fixed and a higher number of submissions 
results in the same total revenue collected; in other words, the Agency 
would have more work while fee revenue remains fixed and would not be 
able to afford hiring the additional staff required to maintain review 
timeline performance.
    This issue was recognized by PDUFA-program stakeholders, and in 
2003, the first year of PDUFA III, a Workload Adjustment was 
introduced. This adjustment created a means to adjust the annual PDUFA 
target revenue to account for long-term changes in the volume of 
certain regulatory submissions. Although an important mechanism to help 
ensure that the PDUFA target revenue keeps pace with regulatory 
submissions, the Workload Adjustment has been a topic in each PDUFA 
reauthorization negotiation since its inception. As such, it has 
undergone a number of changes, notably the addition and later removal 
of a factor to adjust revenue based on the complexity of submissions. 
It has also been the subject of a number of studies. A theme emerging 
from these studies identified the Workload Adjuster methodology as 
suboptimal, but the best method reasonably possible based on the data 
available to FDA at that time.
    In PDUFA VI (fiscal years 2018 to 2022), FDA made commitments to 
help improve the available data and in turn the adjuster methodology. 
These commitments included establishing a Resource Capacity Planning 
capability and modernizing FDA's activity-based time reporting to 
provide better data to inform current and likely future resource needs. 
PDUFA VI changed the name of the adjustment to the Capacity Planning 
Adjustment, established an interim methodology for the early years of 
PDUFA VI, and outlined a process to implement a new fee adjustment 
methodology.
    The process calls for FDA to obtain, through a contract with an 
independent accounting or consulting firm, an evaluation of options and 
recommendations for a new methodology to accurately assess changes in 
the resource and capacity needs of the human drug review program. Booz 
Allen Hamilton was commissioned to produce this report. The report is 
publicly available on FDA's website at: https://www.fda.gov/industry/fda-user-fee-programs/resource-capacity-planning-and-modernized-time-reporting, and FDA will review public comments on the report. After 
review of the public comments, FDA can then implement a new robust 
methodology for assessing the resource needs of the program that 
results from sustained increases in PDUFA workload, as appropriate and 
warranted in light of comments we receive.
    Within BsUFA II (fiscal years 2018 to 2022), FDA made a commitment 
to use this same study to also assess options and recommendations for a 
new methodology to assess changes in the resource and capacity needs of 
the biosimilar biological product review program. Whereas PDUFA has an 
interim Capacity Planning Adjustment in place now, BsUFA does not have 
and has not had an adjustment designed to accomplish similar goals for 
the BsUFA program. Like with the process outlined with PDUFA, FDA can 
also implement an adjustment methodology following the publication of 
the report and review of any public comments, as appropriate and 
warranted in light of comments we receive.

    Dated: April 1, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-07175 Filed 4-3-20; 8:45 am]
 BILLING CODE 4164-01-P


