Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Review Transparency and Communication in Reviews of 351(k) Biologics License Applications in Biosimilars User Fee Act, 42926-42927 [2019-17713]
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Federal Register / Vol. 84, No. 160 / Monday, August 19, 2019 / Notices
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VerDate Sep<11>2014
16:29 Aug 16, 2019
Jkt 247001
Dated: August 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–17724 Filed 8–16–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0093]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Review
Transparency and Communication in
Reviews of 351(k) Biologics License
Applications in Biosimilars User Fee
Act
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.
SUMMARY:
Fax written comments on the
collection of information by September
18, 2019.
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:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, 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:
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Fmt 4703
Sfmt 4703
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 and
351(k) Biologics License Applications
in Biosimilars User Fee Act
OMB Control Number 0910–0746—
Extension
This information collection supports
the above captioned review program
(‘‘the Program’’). The Program is part of
our performance commitment under the
fifth and sixth authorizations of the
Prescription Drug User Fee Act
(PDUFA), which allows us to collect
user fees for the review of human drug
and biologics applications for FYs 2013
through 2021, and the second
authorization of the Biosimilars User
Fee Act (BsUFA II), which applies to
351(k) BLAs for FYs 2018 through 2021.
The Program is described in detail in
FDA’s Commitment Letters for PDUFA
VI and BsUFA II, available at https://
www.fda.gov/downloads/ForIndustry/
UserFees/PrescriptionDrugUserFee/
UCM511438.pdf and https://
www.fda.gov/downloads/ForIndustry/
UserFees/BiosimilarUserFeeActBsUFA/
UCM521121.pdf.
The Program goals 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
extension of the Program to BsUFA II is
to conduct an interim and final
assessment that will evaluate how well
the parameters of the Program have
achieved the intended goals. The
BsUFA II Commitment Letter specifies
that an independent contractor can
conduct the assessments and specifies
that they include interviews of sponsors
who submit 351(k) BLAs to the Program
in BsUFA II. In accordance with the
PDUFA V and BsUFA II Commitment
Letters, we contracted Eastern Research
Group, Inc. (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 transparency and
communication of reviews during the
review process. ERG will anonymize
and aggregate sponsor responses before
inclusion in the assessments and
presentation materials at public
meetings. We will publish in the
Federal Register for public comment
E:\FR\FM\19AUN1.SGM
19AUN1
42927
Federal Register / Vol. 84, No. 160 / Monday, August 19, 2019 / Notices
ERG’s assessments with interview
results and findings.
In the Federal Register of March 12,
2019 (84 FR 8877), we published a 60-
day notice requesting public comment
on the proposed collection of
information. No comments were
received.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Portion of study
Total annual
responses
Average
burden per
response
Total hours
Pre-test .................................................................................
Interviews .............................................................................
5
75
1
1
5
75
1.5
1.5
7.5
112.5
Total ..............................................................................
........................
........................
........................
........................
120
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Since the last OMB approval of the
information collection, we have
adjusted our estimate downward by 60
survey respondents. We base our
estimate on the most recent number of
annual surveys. ERG interviews
between one and three sponsor
representatives for each 351(k) BLA
first-cycle action issued for applications
reviewed under the Program. ERG also
conducts a pretest of the interview
protocol with five respondents.
Assuming it will take 1 to 1.5 hours to
complete the pretest, we calculate a
total of 7.5 annual burden hours. We
estimate that up to 75 respondents will
take part in the post-action interviews
each year. Assuming each interview will
last 1 to 1.5 hours, we calculate a total
of 112.5 annual burden hours.
Dated: August 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–17713 Filed 8–16–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–2354]
jspears on DSK3GMQ082PROD with NOTICES
Number of
responses per
respondent
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products; Studies
To Evaluate the Metabolism and
Residue Kinetics of Veterinary Drugs
in Food-Producing Species: Marker
Residue Depletion Studies To
Establish Product Withdrawal Periods
in Aquatic Species; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
VerDate Sep<11>2014
16:29 Aug 16, 2019
Jkt 247001
announcing the availability of a final
guidance for industry (GFI) #257
entitled ‘‘Studies to Evaluate the
Metabolism and Residue Kinetics of
Veterinary Drugs in Food-Producing
Species: Marker Residue Depletion
Studies to Establish Product Withdrawal
Periods in Aquatic Species’’ (VICH
GL57). This guidance has been
developed for veterinary use by the
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products (VICH).
This VICH guidance document is
intended to provide study design
recommendations that will facilitate the
universal acceptance of the generated
residue depletion data to fulfill the
national/regional requirements. This
guidance document provides
recommendations on what should be
included in a marker residue depletion
study design for aquatic food-producing
species.
DATES: The announcement of the
guidance is published in the Federal
Register on August 19, 2019.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances 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
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
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–
2018–D–2354 for ‘‘Studies to Evaluate
the Metabolism and Residue Kinetics of
Veterinary Drugs in Food-Producing
Species: Marker Residue Depletion
Studies to Establish Product Withdrawal
Periods in Aquatic Species’’ (VICH
GL57). 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
E:\FR\FM\19AUN1.SGM
19AUN1
Agencies
[Federal Register Volume 84, Number 160 (Monday, August 19, 2019)]
[Notices]
[Pages 42926-42927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17713]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0093]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Review Transparency
and Communication in Reviews of 351(k) Biologics License Applications
in Biosimilars User Fee Act
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.
DATES: Fax written comments on the collection of information by
September 18, 2019.
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 [email protected]. 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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
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 and
Original Biologics License Applications in Prescription Drug User Fee
Acts and 351(k) Biologics License Applications in Biosimilars User Fee
Act
OMB Control Number 0910-0746--Extension
This information collection supports the above captioned review
program (``the Program''). The Program is part of our performance
commitment under the fifth and sixth authorizations of the Prescription
Drug User Fee Act (PDUFA), which allows us to collect user fees for the
review of human drug and biologics applications for FYs 2013 through
2021, and the second authorization of the Biosimilars User Fee Act
(BsUFA II), which applies to 351(k) BLAs for FYs 2018 through 2021. The
Program is described in detail in FDA's Commitment Letters for PDUFA VI
and BsUFA II, available at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf and https://www.fda.gov/downloads/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/UCM521121.pdf.
The Program goals 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 extension of the Program to BsUFA II is to conduct an interim and
final assessment that will evaluate how well the parameters of the
Program have achieved the intended goals. The BsUFA II Commitment
Letter specifies that an independent contractor can conduct the
assessments and specifies that they include interviews of sponsors who
submit 351(k) BLAs to the Program in BsUFA II. In accordance with the
PDUFA V and BsUFA II Commitment Letters, we contracted Eastern Research
Group, Inc. (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 transparency and
communication of reviews during the review process. ERG will anonymize
and aggregate sponsor responses before inclusion in the assessments and
presentation materials at public meetings. We will publish in the
Federal Register for public comment
[[Page 42927]]
ERG's assessments with interview results and findings.
In the Federal Register of March 12, 2019 (84 FR 8877), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of the information collection 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 7.5
Interviews...................... 75 1 75 1.5 112.5
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 120
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Since the last OMB approval of the information collection, we have
adjusted our estimate downward by 60 survey respondents. We base our
estimate on the most recent number of annual surveys. ERG interviews
between one and three sponsor representatives for each 351(k) BLA
first-cycle action issued for applications reviewed under the Program.
ERG also conducts a pretest of the interview protocol with five
respondents. Assuming it will take 1 to 1.5 hours to complete the
pretest, we calculate a total of 7.5 annual burden hours. We estimate
that up to 75 respondents will take part in the post-action interviews
each year. Assuming each interview will last 1 to 1.5 hours, we
calculate a total of 112.5 annual burden hours.
Dated: August 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17713 Filed 8-16-19; 8:45 am]
BILLING CODE 4164-01-P