80 FR 59786 - An Evaluation of the Prescription Drug User Fee Act Workload Adjuster; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 191 (October 2, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 191 (October 2, 2015)
| Page Range | 59786-59787 | |
| FR Document | 2015-25117 |
[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)] [Notices] [Pages 59786-59787] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-25117] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![59786 Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Notices
assessments provided by applicants in DEPARTMENT OF HEALTH AND comments, that information will be
their regulatory submissions. HUMAN SERVICES posted on http://www.regulations.gov.
• If you want to submit a comment
Recognizing that there are many
Food and Drug Administration with confidential information that you
reasonable approaches for conducting a
[Docket No. FDA–2013–N–0418]
do not wish to be made available to the
benefit-risk assessment, M4E(R2) does public, submit the comment as a
not specify a particular approach to be written/paper submission and in the
used by industry. However, the An Evaluation of the Prescription Drug
User Fee Act Workload Adjuster; manner detailed (see ‘‘Written/Paper
document does offer specific guidance Submissions’’ and ‘‘Instructions’’).
Request for Comments
on the major elements that should be
included in the benefit-risk assessment. AGENCY: Food and Drug Administration, Written/Paper Submissions
Furthermore, consistent with the HHS. Submit written/paper submissions as
concept paper that laid the groundwork ACTION: Notice; request for comments. follows:
for the Expert Working Group, the • Mail/Hand delivery/Courier (for
SUMMARY: The Food and Drug written/paper submissions): Division of
revised draft guidance does not dictate
Administration (FDA) is announcing an Dockets Management (HFA–305), Food
an approach used by a regulator in
opportunity for public comment on an and Drug Administration, 5630 Fishers
conducting a benefit-risk assessment. assessment of the Prescription Drug Lane, Rm. 1061, Rockville, MD 20852.
This draft guidance is being issued User Fee Act (PDUFA) Workload • For written/paper comments
consistent with FDA’s good guidance Adjuster conducted by an independent submitted to the Division of Dockets
practices regulation (21 CFR 10.115). consulting firm. This assessment was Management, FDA will post your
The draft guidance, when finalized, will conducted to fulfill FDA performance comment, as well as any attachments,
represent the current thinking of FDA commitments made as part of the fifth except for information submitted,
on this topic. It does not establish any authorization of PDUFA in section XV, marked and identified, as confidential,
rights for any person and is not binding ‘‘Improving FDA Performance if submitted as detailed in
on FDA or the public. You can use an Management,’’ subsection B, which was ‘‘Instructions.’’
alternative approach if it satisfies the reauthorized by the Food and Drug Instructions: All submissions received
requirements of the applicable statutes Administration Safety and Innovation must include the Docket No. FDA–
and regulations. Act of 2012 (FDASIA). Independent 2013–N–0418 for ‘‘An Evaluation of the
consulting firms conducted two Prescription Drug User Fee Act
II. Comments assessments during PDUFA V. This is Workload Adjuster; Request for
the second assessment to evaluate Comments.’’ Received comments will be
Interested persons may submit either whether the adjustment reasonably placed in the docket and, except for
electronic comments regarding this represents actual changes in workload those submitted as ‘‘Confidential
document to http://www.regulations.gov volume and complexity in the human Submissions,’’ publicly viewable at
or written comments to the Division of drug review program and to present http://www.regulations.gov or at the
Dockets Management (see ADDRESSES). options to discontinue, retain, or modify Division of Dockets Management
It is only necessary to send one set of any elements of the adjustment. After between 9 a.m. and 4 p.m., Monday
comments. Identify comments with the review of the report and receipt of through Friday.
docket number found in brackets in the public comment, FDA can adopt • Confidential Submissions—To
heading of this document. Received appropriate change to the workload submit a comment with confidential
comments may be seen in the Division adjustment methodology, if warranted. information that you do not wish to be
of Dockets Management between 9 a.m. DATES: Submit electronic or written made publicly available, submit your
and 4 p.m., Monday through Friday, and comments by November 2, 2015. comments only as a written/paper
will be posted to the docket at http:// ADDRESSES: You may submit comments submission. You should submit two
www.regulations.gov. as follows: copies total. One copy will include the
information you claim to be confidential
III. Electronic Access Electronic Submissions with a heading or cover note that states
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
Persons with access to the Internet
following way: CONFIDENTIAL INFORMATION’’. The
may obtain the document at http:// • Federal eRulemaking Portal: http:// Agency will review this copy, including
www.regulations.gov, http:// www.regulations.gov. Follow the the claimed confidential information, in
www.fda.gov/Drugs/Guidance instructions for submitting comments. its consideration of comments. The
ComplianceRegulatoryInformation/ Comments submitted electronically, second copy, which will have the
Guidances/default.htm, or http:// including attachments, to http:// claimed confidential information
www.fda.gov/BiologicsBloodVaccines/ www.regulations.gov will be posted to redacted/blacked out, will be available
GuidanceComplianceRegulatory the docket unchanged. Because your for public viewing and posted on http://
Information/Guidances/default.htm. comment will be made public, you are www.regulations.gov. Submit both
Dated: September 28, 2015. solely responsible for ensuring that your copies to the Division of Dockets
Leslie Kux,
comment does not include any Management. If you do not wish your
confidential information that you or a name and contact information to be
Associate Commissioner for Policy.
mstockstill on DSK4VPTVN1PROD with NOTICES
third party may not wish to be posted, made publicly available, you can
[FR Doc. 2015–25122 Filed 10–1–15; 8:45 am] such as medical information, your or provide this information on the cover
BILLING CODE 4164–01–P anyone else’s Social Security number, or sheet and not in the body of your
confidential business information, such comments and you must identify this
as a manufacturing process. Please note information as ‘‘confidential.’’ Any
that if you include your name, contact information marked as ‘‘confidential’’
information, or other information that will not be disclosed except in
identifies you in the body of your accordance with 21 CFR 10.20 and other
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![Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Notices 59787
applicable disclosure law. For more In PDUFA IV, the workload adjuster not represent total amount of work per
information about FDA’s posting of was expanded to account for the submission. The report recommended
comments to public dockets, see 80 FR workload complexity (known as the that FDA consider removing the
56469, September 18, 2015, or access adjustment for changes in review Complexity Factor. In addition, the
the information at: http://www.fda.gov/ activities; hereafter referred to as the report found that the workload
regulatoryinformation/dockets/ Complexity Factor) associated with the adjuster’s use of 5-year rolling averages
default.htm. review of NDAs/BLAs and active to measure changes in workload against
Docket: For access to the docket to commercial INDs. The NDA/BLA the base years was not as sensitive to
read background documents or the complexity is measured by changes in recent trends as 3-year rolling averages
electronic and written/paper comments the number of labeling supplements, would be. The report is available at
received, go to http:// annual report reviews, and NDA/BLA http://www.fda.gov/downloads/
www.regulations.gov and insert the meetings per NDA/BLA. IND ForIndustry/UserFees/
docket number, found in brackets in the complexity is measured by changes in PrescriptionDrugUserFee/UCM350567.
heading of this document, into the the number of special protocol After reviewing the report and public
‘‘Search’’ box and follow the prompts assessments and IND meetings per comments, FDA discontinued the use of
and/or go to the Division of Dockets active commercial IND. the Complexity Factor in the adjustment
Management, 5630 Fishers Lane, rm. As part of the PDUFA IV methodology and adopted 3-year
1061, Rockville, MD 20852. recommendations, FDA committed to an averages to measure changes in
FOR FURTHER INFORMATION CONTACT:
evaluation of the adjustment for changes workload volume.
Alice Tsai, Center for Drug Evaluation in review activities by an independent The second assessment (to address the
and Research, Food and Drug consulting firm. The study, conducted recommendations from the first
Administration, 10903 New Hampshire by Deloitte & Touche, LLP, in fiscal year evaluation and assess the continued
Ave., Bldg. 51, Rm. 1149, Silver Spring, (FY) 2009, found that the adjustment performance of the workload adjuster)
MD 20993–0002, 240–402–6069, methodology used by FDA reasonably was just completed. The independent
Alice.Tsai@fda.hhs.gov. captures changes in the workload consulting firm is required to submit a
complexity for reviewing human drug report based on its assessment. The
SUPPLEMENTARY INFORMATION: On July 9,
applications under PDUFA IV. Although report will evaluate whether the
2012, the President signed into law the FY 2009 evaluation concluded that workload adjuster reasonably represents
FDASIA. This new law includes the the adjustment methodology was actual changes in workload volume and
reauthorization of PDUFA that provides reasonable at that time, the complexity will present options to discontinue,
FDA with the necessary resources to of new drug applications and FDA’s retain, or modify any elements of the
maintain a predictable and efficient regulatory responsibilities are adjustment. After review of the report
review process for human drug and constantly evolving. Moreover, the and receipt of public comment, FDA, if
biologic products. complexity component of the PDUFA IV warranted, may adopt appropriate
Title I of FDASIA is the fifth workload adjuster was formulated changes to the methodology.
authorization of PDUFA and includes before the enactment of the Food and FDA is seeking public comment now
by reference the performance goals and Drug Administration Amendments Act on the second assessment of the PDUFA
procedures for PDUFA V transmitted by of 2007 (FDAAA). Thus, the workload Workload Adjuster, available at http://
the Secretary of Health and Human adjuster does not account for new and www.fda.gov/downloads/ForIndustry/
Services to Congress in a commitment significant review activities required by UserFees/PrescriptionDrugUserFee/
letter. FDA developed recommendations FDAAA, such as risk evaluation and UCM464878.pdf.
for PDUFA V in consultation with drug mitigation strategies, safety labeling Dated: September 29, 2015.
industry representatives, patient and changes, advisory committee meetings,
consumer advocates, health care Leslie Kux,
and post-market safety requirements, Associate Commissioner for Policy.
professionals, and other public among others.
stakeholders from July 2010 through [FR Doc. 2015–25117 Filed 10–1–15; 8:45 am]
Given the dynamic nature of drug
May 2011. These recommendations products and FDA’s regulatory BILLING CODE 4164–01–P
included an FDA commitment to responsibilities, FDA committed to
contract with an independent periodic reassessments of the workload
accounting or consulting firm to review adjuster in PDUFA V to ensure that it is DEPARTMENT OF HEALTH AND
the adequacy of the PDUFA adjustment achieving its intended role of adjusting HUMAN SERVICES
for changes in workload (hereafter the user fee revenues to reflect actual Food and Drug Administration
referred to as the workload adjuster). changes in FDA s workload volume and
The workload adjuster was complexity. [Docket No. FDA–2015–N–0684]
introduced in PDUFA III to allow for The PDUFA V commitment letter
FDA to augment the total user fee instructs FDA to contract with an Identification of Alternative In Vitro
revenue amount each fiscal year (after independent accounting or consulting Bioequivalence Pathways Which Can
adjusting for inflation) to account for firm to conduct two assessments of the Reliably Ensure In Vivo Bioequivalence
changes in workload volume in the workload adjuster. The first assessment of Product Performance and Quality of
human drug application review process. (to examine the performance of the Non-Systemically Absorbed Drug
Workload volume is measured by the workload adjuster since FY 2009) Products for Animals; Reopening of
the Comment Period
mstockstill on DSK4VPTVN1PROD with NOTICES
changes in the number of new drug conducted by IBM in FY 2013, found
applications (NDAs) and biologics that the workload adjuster does AGENCY: Food and Drug Administration,
license applications (BLAs), active reasonably represent changes in HHS.
commercial investigational new drugs workload volume associated with the ACTION:Request for comments;
(INDs), efficacy supplements, and human drug review process. However, reopening of the comment period.
manufacturing supplements submitted the report concluded that methodology
to the human drug review program was flawed with respect to measuring SUMMARY: The Food and Drug
during the most recent 5-year period. workload complexity, because it does Administration (FDA) is reopening the
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Document Created: 2015-12-15 08:44:37
Document Modified: 2015-12-15 08:44:37
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice; request for comments. | |
| Dates | Submit electronic or written comments by November 2, 2015. | |
| 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] | |
| FR Citation | 80 FR 59786 |
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