Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Acts, 47398-47399 [2016-17185]
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47398
Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Notices
Julia
Oriani, Center for Veterinary Medicine
(HFV–151), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0788,
julia.oriani@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Dated: July 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
I. Background
FDA is announcing the availability of
a draft revised guidance for industry #3
entitled ‘‘General Principles for
Evaluating the Human Food Safety of
New Animal Drugs used in FoodProducing Animals.’’ This draft revised
guidance is intended to inform sponsors
of the scientific data and/or information
that may provide an acceptable basis to
determine that the residue of a new
animal drug in or on food, when
consumed, presents a reasonable
certainty of no harm to humans. This
guidance describes a recommended
approach for providing human food
safety scientific data and/or
information. CVM acknowledges that
alternate approaches also may be
appropriate and encourages sponsors to
discuss with CVM whether an alternate
approach may be appropriate for
specific new animal drugs.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
II. Significance of Guidance
This level 1 draft revised guidance is
being issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft revised guidance,
when finalized, will represent the
current thinking of FDA on the type of
information sponsors provide to address
the human food safety of new animal
drugs used in food-producing animals.
It does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
III. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 514 have
been approved under OMB control
number 0910–0032.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
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[FR Doc. 2016–17188 Filed 7–20–16; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
[Docket No. 2013–N–0093]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Evaluation of the
Program for Enhanced Review
Transparency and Communication for
New Molecular Entity New Drug
Applications and Original Biologics
License Applications in Prescription
Drug User Fee Acts
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(the PRA).
SUMMARY:
Fax written comments on the
collection of information by August 22,
2016.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0746. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
Evaluation of the Program for
Enhanced Review Transparency and
Communication for New Molecular
Entity New Drug Applications (NME
NDAs) and Original Biologics License
Applications (BLAs) in Prescription
Drug User Fee Acts (OMB Control
Number 0910–0746)—Extension
As part of its commitments in the
Prescription Drug User Fee Act
(PDUFA) V, FDA established a new
review Program to promote greater
transparency and increased
communication between the FDA
review team and the applicant on the
most innovative products reviewed by
the Agency. The Program applies to all
NME NDAs and original BLAs that are
received from October 1, 2012, through
September 30, 2017. The Program is
described in detail in section II.B of the
document entitled ‘‘PDUFA
Reauthorization Performance Goals and
Procedures Fiscal Years 2013 through
2017’’ (the Commitment Letter)
(available at https://www.fda.gov/
downloads/ForIndustry/UserFees/
PrescriptionDrugUserFee/
UCM270412.pdf.
The goals of the Program are to
increase the efficiency and effectiveness
of the first review cycle and decrease
the number of review cycles necessary
for approval so that patients have timely
access to safe, effective, and highquality new drugs and biologics. A key
aspect of the Program is an interim and
final assessment that will evaluate how
well the parameters of the Program have
achieved the intended goals. The
PDUFA V Commitment Letter specifies
that the assessments be conducted by an
independent contractor and that they
include interviews of pharmaceutical
manufacturers who submit NME NDAs
and original BLAs to the Program in
PDUFA V. The contractor for the
assessments of the Program is Eastern
Research Group, Inc. (ERG), and the
statement of work for the assessments is
available at https://www.fda.gov/
downloads/ForIndustry/UserFees/
PrescriptionDrugUserFee/
UCM304793.pdf.
In accordance with the PDUFA V
Commitment Letter, FDA contracted
with ERG to conduct independent
interviews of applicants after FDA
issues a first-cycle action for
applications reviewed under the
Program. The purpose of these
interviews is to collect feedback from
applicants on the success of the Program
in increasing review transparency and
communication during the review
process. ERG will anonymize and
aggregate sponsor responses prior to
inclusion in the assessments and any
E:\FR\FM\21JYN1.SGM
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47399
Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Notices
presentation materials at public
meetings. FDA will publish ERG’s
assessments, with interview results and
findings, in the Federal Register for
public comment.
60-day notice requesting public
comment on the proposed extension of
this collection of information. No
comments were received.
We estimate the burden of this
collection of information as follows:
Description of Respondents: The
respondents to this collection of
information are sponsor representatives
for NME NDAs and original BLAs.
In the Federal Register of December
10, 2015 (80 FR 76699), we published a
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Portion of study
Number of
responses per
respondent
Total
annual
responses
Average
burden
per response
Total hours
Pre-test .................................................................................
Interviews .............................................................................
5
135
1
1
5
135
1.5
1.5
7.50
202.50
Total ..............................................................................
........................
........................
........................
........................
210
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA typically reviews approximately
40 to 45 NME NDAs and original BLAs
per year. ERG interviews 1 to 3 sponsor
representatives at a time for each
application that receives a first-cycle
action from FDA, up to 135 sponsor
representatives per year. ERG conducts
a pretest of the interview protocol with
five respondents. FDA estimates that it
will take 1.0 to 1.5 hours to complete
the pretest, for a total of a maximum of
7.5 hours. We estimate that up to 135
respondents will take part in the postaction interviews each year, with each
interview lasting 1.0 to 1.5 hours, for a
total of a maximum of 202.5 hours.
Thus, the total estimated annual burden
is 210 hours. FDA’s burden estimate is
based on prior experience with similar
interviews with the regulated
community.
Dated: July 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
Electronic Submissions
[FR Doc. 2016–17185 Filed 7–20–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–E–0406]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; QUTENZA
AGENCY:
Food and Drug Administration,
asabaliauskas on DSK3SPTVN1PROD with NOTICES
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
QUTENZA and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
SUMMARY:
VerDate Sep<11>2014
17:15 Jul 20, 2016
Jkt 238001
application to the Director of the U.S.
Patent and Trademark Office (USPTO),
Department of Commerce, for the
extension of a patent which claims that
human drug product.
DATES: Anyone with knowledge that any
of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by September 19, 2016.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
January 17, 2017. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows:
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
PO 00000
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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–
2010–E–0406 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; QUTENZA.’’
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
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
E:\FR\FM\21JYN1.SGM
21JYN1
]]>Agencies
[Federal Register Volume 81, Number 140 (Thursday, July 21, 2016)]
[Notices]
[Pages 47398-47399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17185]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2013-N-0093]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Evaluation of the
Program for Enhanced Review Transparency and Communication for New
Molecular Entity New Drug Applications and Original Biologics License
Applications in Prescription Drug User Fee Acts
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (the PRA).
DATES: Fax written comments on the collection of information by August
22, 2016.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0746.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Food and Drug Administration, 8455
Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Evaluation of the Program for Enhanced Review Transparency and
Communication for New Molecular Entity New Drug Applications (NME NDAs)
and Original Biologics License Applications (BLAs) in Prescription Drug
User Fee Acts (OMB Control Number 0910-0746)--Extension
As part of its commitments in the Prescription Drug User Fee Act
(PDUFA) V, FDA established a new review Program to promote greater
transparency and increased communication between the FDA review team
and the applicant on the most innovative products reviewed by the
Agency. The Program applies to all NME NDAs and original BLAs that are
received from October 1, 2012, through September 30, 2017. The Program
is described in detail in section II.B of the document entitled ``PDUFA
Reauthorization Performance Goals and Procedures Fiscal Years 2013
through 2017'' (the Commitment Letter) (available at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf.
The goals of the Program are to increase the efficiency and
effectiveness of the first review cycle and decrease the number of
review cycles necessary for approval so that patients have timely
access to safe, effective, and high-quality new drugs and biologics. A
key aspect of the Program is an interim and final assessment that will
evaluate how well the parameters of the Program have achieved the
intended goals. The PDUFA V Commitment Letter specifies that the
assessments be conducted by an independent contractor and that they
include interviews of pharmaceutical manufacturers who submit NME NDAs
and original BLAs to the Program in PDUFA V. The contractor for the
assessments of the Program is Eastern Research Group, Inc. (ERG), and
the statement of work for the assessments is available at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM304793.pdf.
In accordance with the PDUFA V Commitment Letter, FDA contracted
with ERG to conduct independent interviews of applicants after FDA
issues a first-cycle action for applications reviewed under the
Program. The purpose of these interviews is to collect feedback from
applicants on the success of the Program in increasing review
transparency and communication during the review process. ERG will
anonymize and aggregate sponsor responses prior to inclusion in the
assessments and any
[[Page 47399]]
presentation materials at public meetings. FDA will publish ERG's
assessments, with interview results and findings, in the Federal
Register for public comment.
Description of Respondents: The respondents to this collection of
information are sponsor representatives for NME NDAs and original BLAs.
In the Federal Register of December 10, 2015 (80 FR 76699), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Portion of study Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Pre-test........................ 5 1 5 1.5 7.50
Interviews...................... 135 1 135 1.5 202.50
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 210
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA typically reviews approximately 40 to 45 NME NDAs and original
BLAs per year. ERG interviews 1 to 3 sponsor representatives at a time
for each application that receives a first-cycle action from FDA, up to
135 sponsor representatives per year. ERG conducts a pretest of the
interview protocol with five respondents. FDA estimates that it will
take 1.0 to 1.5 hours to complete the pretest, for a total of a maximum
of 7.5 hours. We estimate that up to 135 respondents will take part in
the post-action interviews each year, with each interview lasting 1.0
to 1.5 hours, for a total of a maximum of 202.5 hours. Thus, the total
estimated annual burden is 210 hours. FDA's burden estimate is based on
prior experience with similar interviews with the regulated community.
Dated: July 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17185 Filed 7-20-16; 8:45 am]
BILLING CODE 4164-01-P
