Agency Information Collection Activities; Proposed Collection; Comment Request; Review Transparency and Communication in Reviews of 351(k) Biologics License Applications in Biosimilars User Fee Act, 8877-8879 [2019-04429]
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8877
Federal Register / Vol. 84, No. 48 / Tuesday, March 12, 2019 / Notices
including each proposed extension of an
existing 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.
Substances Generally Recognized as
Safe: Notification Procedure—21 CFR
170, Subpart E and 21 CFR 570,
Subpart E
OMB Control Number 0910–0342—
Extension
The Federal Food, Drug, and Cosmetic
Act (FD&C Act) requires that all food
additives (as defined by section 201(s)
(21 U.S.C. 321(s)) be approved by FDA
before they are marketed. Section 409 of
the FD&C Act (21 U.S.C. 349)
establishes a premarket approval
requirement for ‘‘food additives.’’
Section 201(s) of the FD&C Act provides
an exclusion to the definition of food
additive and thus from the premarket
approval requirement, for uses of
substances that are GRAS by qualified
experts. The GRAS provision of section
201(s) of the FD&C Act is implemented
in 21 CFR part 170 (part 170) and 21
CFR part 570 (part 570) for human food
and animal food, respectively. Part 170,
subpart E and part 570, subpart E
provide a standard format for the
submission of a notice. This collection
utilizes a voluntary administrative
procedure for notifying FDA about a
conclusion that a substance is GRAS
under the conditions of its intended use
in human food or animal food. The
information submitted to us in a GRAS
notice is necessary to allow us to
administer efficiently the FD&C Act’s
various provisions that apply to the use
of substances added to food, specifically
with regard to whether a substance is
GRAS under the conditions of its
intended use or is a food additive
subject to premarket review. We use the
information collected through the GRAS
notification procedures to complete our
evaluation within specific timelines.
Description of Respondents: The
respondents to this collection of
information are manufacturers of
substances used in human food and
animal food and feed.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity; 21 CFR section
GRAS notification procedure for human food; 170.210–
170.280 (part 170, subpart E) ..........................................
GRAS notification procedure for animal food and animal
feed; 570.210–570.280 (part 570, subpart E) ..................
Total ..............................................................................
1 There
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
100
1
100
170
17,000
25
1
25
170
4,250
........................
........................
75
........................
21,250
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
overall increase of 8,500 hours, which
results from an increase in the estimated
number of GRAS submissions for
human food from 50 to 100 per year. We
attribute this adjustment to an increase
in the number of submissions we
received over the last 2 years.
Dated: March 6, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–04449 Filed 3–11–19; 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; Proposed Collection;
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 or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
SUMMARY:
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proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection involving interviews of
pharmaceutical manufacturers who
submit 351(k) biologics license
applications (BLAs) to FDA under the
Program for Enhanced Review
Transparency and Communication (the
Program) during FYs 2018 through
2021.
Submit either electronic or
written comments on the collection of
information by May 13, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before May 13, 2019.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of May 13, 2019. Comments
DATES:
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8878
Federal Register / Vol. 84, No. 48 / Tuesday, March 12, 2019 / Notices
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
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
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–
2013–N–0093 for ‘‘Agency Information
Collection Activities; Proposed
Collection; 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 and
351(k) Biologics License Applications in
Biosimilars User Fee Act.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
VerDate Sep<11>2014
16:50 Mar 11, 2019
Jkt 247001
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
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
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. 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 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: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
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.
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
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
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,
including each proposed extension of an
existing 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.
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/
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Federal Register / Vol. 84, No. 48 / Tuesday, March 12, 2019 / Notices
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
ERG’s assessments with interview
results and findings.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Portion of study
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
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 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 1.0 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 1.0 to 1.5 hours, we calculate a total
of 112.5 annual burden hours.
Dated: March 6, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–04429 Filed 3–11–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
[CFDA NUMBER: 93.164]
Loan Repayment Program for
Repayment of Health Professions
Educational Loans; Announcement
Type: Initial
Key Dates: March 15, 2019, first award
cycle deadline date; August 15, 2019,
last award cycle deadline date;
VerDate Sep<11>2014
16:50 Mar 11, 2019
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September 15, 2019, last award cycle
deadline date for supplemental loan
repayment program funds; September
30, 2019, entry on duty deadline date.
I. Funding Opportunity Description
The Indian Health Service (IHS)
estimated budget for fiscal year (FY)
2019 includes $27,500,000 for the IHS
Loan Repayment Program (LRP) for
health professional educational loans
(undergraduate and graduate) in return
for full-time clinical service as defined
in the IHS LRP policy at https://
www.ihs.gov/loanrepayment/
policiesandprocedures/ in Indian health
programs.
This notice is being published early to
coincide with the recruitment activity of
the IHS which competes with other
Government and private health
management organizations to employ
qualified health professionals.
This program is authorized by the
Indian Health Care Improvement Act
(IHCIA) Section 108, codified at 25
U.S.C. 1616a.
II. Award Information
The estimated amount available is
approximately $17,750,000 to support
approximately 384 competing awards
averaging $46,205 per award for a twoyear contract. The estimated amount
available is approximately $9,750,000 to
support approximately 392 competing
awards averaging $24,840 per award for
a one-year extension. One-year contract
extensions will receive priority
consideration in any award cycle.
Applicants selected for participation in
the FY 2019 program cycle will be
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Sfmt 4703
expected to begin their service period
no later than September 30, 2019.
III. Eligibility Information
A. Eligible Applicants
Pursuant to 25 U.S.C. 1616a(b), to be
eligible to participate in the LRP, an
individual must:
(1)(A) Be enrolled—
(i) In a course of study or program in
an accredited institution, as determined
by the Secretary, within any State and
be scheduled to complete such course of
study in the same year such individual
applies to participate in such program;
or
(ii) In an approved graduate training
program in a health profession; or
(B) Have a degree in a health
profession and a license to practice in
a State; and
(2)(A) Be eligible for, or hold an
appointment as a commissioned officer
in the Regular Corps of the Public
Health Service (PHS); or
(B) Be eligible for selection for service
in the Regular Corps of the PHS; or
(C) Meet the professional standards
for civil service employment in the IHS;
or
(D) Be employed in an Indian health
program without service obligation; and
(3) Submit to the Secretary an
application for a contract to the LRP.
The Secretary must approve the contract
before the disbursement of loan
repayments can be made to the
participant. Participants will be
required to fulfill their contract service
agreements through full-time clinical
practice at an Indian health program site
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]]>Agencies
[Federal Register Volume 84, Number 48 (Tuesday, March 12, 2019)]
[Notices]
[Pages 8877-8879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04429]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0093]
Agency Information Collection Activities; Proposed Collection;
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 or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection involving
interviews of pharmaceutical manufacturers who submit 351(k) biologics
license applications (BLAs) to FDA under the Program for Enhanced
Review Transparency and Communication (the Program) during FYs 2018
through 2021.
DATES: Submit either electronic or written comments on the collection
of information by May 13, 2019.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before May 13, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 13, 2019. Comments
[[Page 8878]]
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
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 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-2013-N-0093 for ``Agency Information Collection Activities;
Proposed Collection; 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 and 351(k) Biologics License
Applications in Biosimilars User Fee Act.'' Received comments, those
filed in a timely manner (see ADDRESSES), 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 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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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
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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
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.
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, including
each proposed extension of an existing 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.
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/
[[Page 8879]]
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 ERG's assessments with interview
results and findings.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Portion of study Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Pre-test........................ 5 1 5 1.5 7.5
Interviews...................... 75 1 75 1.5 112.5
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Total....................... .............. .............. .............. .............. 120
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Since 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 1.0 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 1.0 to 1.5 hours, we
calculate a total of 112.5 annual burden hours.
Dated: March 6, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04429 Filed 3-11-19; 8:45 am]
BILLING CODE 4164-01-P
