An Evaluation of the Prescription Drug User Fee Act Workload Adjuster; Request for Comments, 26374-26375 [2013-10626]
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26374
Federal Register / Vol. 78, No. 87 / Monday, May 6, 2013 / Notices
400B, Rockville, MD 20850, 301–796–
5156, daniel.gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Electronic Submission Process for
Voluntary Complaints to the Center for
Devices and Radiological Health—
(OMB Control Number 0910–NEW)
This ICR collects information
voluntarily submitted to the Center for
Devices and Radiological Health (CDRH)
on actual or potential health risk
concerns about a medical device or
radiological product or its use. Because
there has been no established guidelines
or instructions on how to submit a
compliant to CDRH, complaints often
contain minimal information and are
received via phone calls, emails, or
conversationally from any CDRH staff.
CDRH seeks to establish a consistent
format and process for the submission of
device complaints that will enhance our
timeliness in receiving, assessing and
evaluating voluntary complaints. The
information provided in the complaints
received by CDRH may be used to
clarify the recurrence or emergence of
significant device-related risks to the
general public and the need to initiate
educational outreach or regulatory
action to minimize or mitigate identified
risks.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
respondents
1
Total annual
responses
Average
burden per
response
Total hours
1
700
.25 (15
minutes)
125
There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–10597 Filed 5–3–13; 8:45 am]
BILLING CODE 4160–01–P
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.
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,
SUMMARY:
mstockstill on DSK4VPTVN1PROD with NOTICES
Number of
responses per
respondent
700
Activity
VerDate Mar<15>2010
17:53 May 03, 2013
Jkt 229001
‘‘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 https://
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.
PO 00000
Frm 00059
Fmt 4703
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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, Giles.Mills@fda.hhs.gov.
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
E:\FR\FM\06MYN1.SGM
06MYN1
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 87 / Monday, May 6, 2013 / Notices
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
VerDate Mar<15>2010
17:06 May 03, 2013
Jkt 229001
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 https://
www.fda.gov/ForIndustry/UserFees/
PrescriptionDrugUserFee.
II. Comments
Interested persons may submit either
electronic comments regarding the
Analysis to https://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 https://
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
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Fmt 4703
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26375
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Food and Drug Administration/
International Society for
Pharmaceutical Engineering CoSponsorship Educational Workshop:
Redefining the ‘C’ in CGMP (Current
Good Manufacturing Practices):
Creating, Implementing, and
Sustaining a Culture of Quality
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public conference.
The Food and Drug Administration
(FDA), in co-sponsorship with the
International Society of Pharmaceutical
Engineering (ISPE), is announcing a
conference entitled ‘‘Redefining the ‘C’
in CGMP: Creating, Implementing and
Sustaining a Culture of Quality’’
Pharmaceutical Quality System (ICH
Q10) Conference.
The conference will span 3 days and
is dedicated to teaching the principles
of CGMP, reaping the benefits that come
from establishing and maintaining a
state of control, implementing continual
improvement, enhancing regulatory
compliance, and meeting quality
objectives every day. The conference
will take place in Baltimore, MD, and
will draw on the best industry and
regulator contributors on this topic.
Date and Time: The conference will
be held on June 11, 2013, from 8:30 a.m.
to 5 p.m.; June 12, 2013, from 8 a.m. to
5 p.m.; and June 13, 2013, from 8 a.m.
to 4:30 p.m.
Location: The event will be held at the
Renaissance Baltimore Harborplace
Hotel, 202 East Pratt St., Baltimore, MD
21201, 1–800–535–1201.
Contact Person: Nancy Berg,
President, International Society for
Pharmaceutical Engineering, 600 North
Westshore Blvd., suite 900, Tampa, FL
33609, Web site: https://www.ISPE.org/
CGMP.
Conference attendees are responsible
for their own accommodations.
Registration: You are encouraged to
register at your earliest convenience.
The ISPE registration fees cover the cost
of facilities, materials, and breaks. Seats
are limited; please submit your
registration as soon as possible.
Conference space will be filled in order
of receipt of registration. Those accepted
to the conference will receive
confirmation. Registration will close
after available conference space is filled.
Onsite registration will be available on
a space available basis on the day of the
E:\FR\FM\06MYN1.SGM
06MYN1
]]>Agencies
[Federal Register Volume 78, Number 87 (Monday, May 6, 2013)]
[Notices]
[Pages 26374-26375]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10626]
-----------------------------------------------------------------------
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 (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 https://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, Giles.Mills@fda.hhs.gov.
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 https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee.
II. Comments
Interested persons may submit either electronic comments regarding
the Analysis to https://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 https://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
