Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Assessing User Fees Under the Biosimilar User Fee Amendments of 2017, 29792-29793 [2018-13688]
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29792
Federal Register / Vol. 83, No. 123 / Tuesday, June 26, 2018 / Notices
information submitted, marked and
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as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–N–1073 for ‘‘Antimicrobial Drugs
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FOR FURTHER INFORMATION CONTACT:
Kalyani Bhatt, Center for Drug
Evaluation and Research, Food and
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Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, Fax: 301–847–8533, email:
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Therefore, you should always check the
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AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The committee will discuss
new drug application (NDA) 210607,
tafenoquine tablet, 100 milligram (mg),
sponsored by 60 Degrees
Pharmaceuticals, LLC, for the proposed
indication of prevention of malaria in
adults for up to 6 months of continuous
dosing.
FDA intends to make background
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than 2 business days before the meeting.
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meeting, the background material will
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location of the advisory committee
meeting, and the background material
will be posted on FDA’s website after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. All electronic and
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Docket (see the ADDRESSES section) on
or before July 12, 2018, will be provided
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from the public will be scheduled
between approximately 1:30 p.m. and
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in making formal oral presentations
should notify the contact person and
submit a brief statement of the general
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they wish to present, the names and
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an indication of the approximate time
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or before July 3, 2018. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
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speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by July 5, 2018.
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(see FOR FURTHER INFORMATION CONTACT)
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ucm111462.htm for procedures on
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committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: June 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–13711 Filed 6–25–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–6209]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry: Assessing User Fees Under
the Biosimilar User Fee Amendments
of 2017
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:
E:\FR\FM\26JNN1.SGM
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29793
Federal Register / Vol. 83, No. 123 / Tuesday, June 26, 2018 / Notices
DATES:
Fax written comments on the
collection of information by July 26,
2018.
Guidance for Industry: Assessing User
Fees Under the Biosimilar User Fee
Amendments of 2017
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 0910–0718. Also
include the FDA docket number found
in brackets in the heading of this
document.
OMB Control Number 0910–0718—
Revision
This information collection supports
the above captioned Agency guidance
and implementation of the Biosimilar
User Fee Amendments of 2017 (BsUFA
II). Under BsUFA II, FDA’s authority is
extended to collect user fees from fiscal
years 2018–2022 and includes a number
of technical revisions that affect what
fees and how fees are collected. Fees
authorized by this legislation help fund
the review process for biosimilar
biological product applications and play
an important role in expediting the
review and approval process.
We have developed the guidance
document entitled ‘‘Assessing User Fees
Under the Biosimilar User Fee
Amendments of 2017’’ to assist industry
in understanding when these fees are
incurred and the process by which
applicants can submit payments. The
guidance also provides information on
the consequences of failing to pay
BsUFA II fees, as well as processes for
submitting reconsideration and appeal
requests. The guidance document is
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:
available on our website at: https://
www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/
UCM584984.pdf.
In the Federal Register of November
16, 2017 (82 FR 53505), we published a
notice announcing availability of the
subject guidance document, including a
60-day notice requesting public
comment on the information collection.
One comment was received in response
to the notice from a trade organization
indicating that interested persons ‘‘have
reviewed the draft guidance and
appreciate(s) FDA applying the user fee
provisions consistent with the BsUFA II
negotiations and Commitment Letter.’’
In addition, and upon our own review,
we believe it is appropriate to include
the guidance document under the
existing information collection
‘‘Biosimilar User Fee Cover Sheet’’
currently approved under OMB control
number 0910–0718 rather than to
establish a new collection. FDA is
preparing to renew OMB control
number 0910–0718 and will include the
guidance document accordingly.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity
Average
burden per
response
(hours)
Total annual
responses
Total hours
Request for discontinuation from biological product development program ...............................................................
Request to move products to discontinued section of the
biosimilar list .....................................................................
Small business waiver of the BsUFA application fee ..........
Small business waiver reconsiderations ..............................
Small business waiver appeals ...........................................
Annual Fee Determination Survey .......................................
Annual BsUFA Fees Correspondence ................................
2
1
2
1
2
5
1
1
1
35
35
1
1
1
1
1
1
5
1
1
1
35
35
* 0.5
16
24
12
1
2
2.5
16
24
12
35
70
Total ..............................................................................
........................
........................
........................
........................
161.5
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
* 30 minutes.
Our estimate is based on the number
of Biosimilars User Fee submissions we
have received since establishing the
program.
sradovich on DSK3GMQ082PROD with NOTICES
Dated: June 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–13688 Filed 6–25–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
HRSA is publishing this
notice of petitions received under the
National Vaccine Injury Compensation
SUMMARY:
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Program (the Program), as required by
the Public Health Service (PHS) Act, as
amended. While the Secretary of HHS is
named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
For
information about requirements for
filing petitions and the Program in
general, contact Lisa L. Reyes, Clerk of
Court, United States Court of Federal
FOR FURTHER INFORMATION CONTACT:
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]]>Agencies
[Federal Register Volume 83, Number 123 (Tuesday, June 26, 2018)]
[Notices]
[Pages 29792-29793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13688]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-6209]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for
Industry: Assessing User Fees Under the Biosimilar User Fee Amendments
of 2017
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.
[[Page 29793]]
DATES: Fax written comments on the collection of information by July
26, 2018.
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 0910-0718.
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.
Guidance for Industry: Assessing User Fees Under the Biosimilar User
Fee Amendments of 2017
OMB Control Number 0910-0718--Revision
This information collection supports the above captioned Agency
guidance and implementation of the Biosimilar User Fee Amendments of
2017 (BsUFA II). Under BsUFA II, FDA's authority is extended to collect
user fees from fiscal years 2018-2022 and includes a number of
technical revisions that affect what fees and how fees are collected.
Fees authorized by this legislation help fund the review process for
biosimilar biological product applications and play an important role
in expediting the review and approval process.
We have developed the guidance document entitled ``Assessing User
Fees Under the Biosimilar User Fee Amendments of 2017'' to assist
industry in understanding when these fees are incurred and the process
by which applicants can submit payments. The guidance also provides
information on the consequences of failing to pay BsUFA II fees, as
well as processes for submitting reconsideration and appeal requests.
The guidance document is available on our website at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM584984.pdf.
In the Federal Register of November 16, 2017 (82 FR 53505), we
published a notice announcing availability of the subject guidance
document, including a 60-day notice requesting public comment on the
information collection. One comment was received in response to the
notice from a trade organization indicating that interested persons
``have reviewed the draft guidance and appreciate(s) FDA applying the
user fee provisions consistent with the BsUFA II negotiations and
Commitment Letter.'' In addition, and upon our own review, we believe
it is appropriate to include the guidance document under the existing
information collection ``Biosimilar User Fee Cover Sheet'' currently
approved under OMB control number 0910-0718 rather than to establish a
new collection. FDA is preparing to renew OMB control number 0910-0718
and will include the guidance document accordingly.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity Number of responses per Total annual per response Total hours
respondents respondent responses (hours)
----------------------------------------------------------------------------------------------------------------
Request for discontinuation from 2 1 2 1 2
biological product development
program........................
Request to move products to 5 1 5 * 0.5 2.5
discontinued section of the
biosimilar list................
Small business waiver of the 1 1 1 16 16
BsUFA application fee..........
Small business waiver 1 1 1 24 24
reconsiderations...............
Small business waiver appeals... 1 1 1 12 12
Annual Fee Determination Survey. 35 1 35 1 35
Annual BsUFA Fees Correspondence 35 1 35 2 70
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 161.5
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
* 30 minutes.
Our estimate is based on the number of Biosimilars User Fee
submissions we have received since establishing the program.
Dated: June 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-13688 Filed 6-25-18; 8:45 am]
BILLING CODE 4164-01-P
