Agency Information Collection Activities; Proposed Additional Collection; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications; Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants, 64529-64531 [2019-25328]
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Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section/environmental impact considerations
25.15(a)
25.15(a)
25.15(a)
25.40(a)
and
and
and
and
Average
burden per
response
Total annual
responses
Total hours
(d) (to cover CEs under 25.32(i)) ...................
(d) (to cover CEs under 25.32(o)) .................
(d) (to cover CEs under 25.32 (q)) ................
(c) EAs ...........................................................
47
1
3
57
1
1
1
1
47
1
3
57
8
8
8
180
376
8
24
10,260
Total ..............................................................................
........................
........................
........................
........................
10,668
1 There
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Number of
responses per
respondent
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimates for respondents and
numbers of responses are based on the
annualized numbers of petitions and
notifications qualifying for CEs listed
under § 25.32(i) and (q) (21 CFR 25.32(i)
and (q)) that we have received in the
past 3 years. To avoid counting the
burden attributed to § 25.32(o) as zero,
we have estimated the burden for this
categorical exclusion at one respondent
making one submission a year for a total
of one annual submission. The burden
for submitting a categorical exclusion is
captured under 21 CFR 25.15(a) and (d).
To calculate the estimate for the hours
per response values, we assumed that
the information requested in this
guidance for each of these three
categorical exclusions is readily
available to the submitter. For the
information requested for the exclusion
in § 25.32(i), we expect that the
submitter will need to gather
information from appropriate persons in
the submitter’s company and to prepare
this information for attachment to the
claim for categorical exclusion. We
believe that this effort should take no
longer than 8 hours per submission. For
the information requested for the
categorical exclusions in § 25.32(o) and
(q), the submitters will copy existing
documentation and attach it to the claim
for categorical exclusion. We believe
that collecting this information should
take no longer than 8 hours per
submission.
For the information requested for the
environmental assessments in 21 CFR
25.40(a) and (c), we believe that
submitters will submit an average of 57
environmental assessments annually.
We estimate that each submitter will
prepare an EA within 3 weeks (120
hours) and revise the EA based on
Agency comments (between 40 to 60
hours), for a total preparation time of
180 hours.
Based on a current review of the
information collection, we have made
no adjustments to the currently
approved estimate.
VerDate Sep<11>2014
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Dated: November 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–25370 Filed 11–21–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0129]
Agency Information Collection
Activities; Proposed Additional
Collection; Comment Request; General
Licensing Provisions; Section 351(k)
Biosimilar Applications; Formal
Meetings Between the Food and Drug
Administration and Sponsors or
Applicants
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
proposed collection of information,
including each proposed extension/
revision of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
‘‘General Licensing Provisions; Section
351(k) Biosimilar Applications; Formal
Meetings Between the FDA and
Sponsors or Applicants.’’
DATES: Submit either electronic or
written comments on the collection of
information by January 21, 2020.
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 January 21,
2020. The https://www.regulations.gov
SUMMARY:
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electronic filing system will accept
comments until midnight Eastern Time
at the end of January 21, 2020.
Comments 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
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identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2012–N–0129 for ‘‘General Licensing
Provisions; Section 351(k) Biosimilar
Applications; Formal Meetings Between
the FDA and Sponsors or Applicants.’’
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/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
VerDate Sep<11>2014
16:57 Nov 21, 2019
Jkt 250001
Landsdown St. North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), 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
additional 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.
General Licensing Provisions; Section
351(k) Biosimilar Applications; Formal
Meetings Between the FDA and
Sponsors or Applicants
OMB Control Number 0910–0719—
Revision
The Biologics Price Competition and
Innovation Act of 2009 (BPCI Act)
amended the Public Health Service Act
(PHS Act) and other statutes to create an
abbreviated licensure pathway for
biological products shown to be
biosimilar to, or interchangeable with an
FDA-licensed reference product. Section
351(k) of the PHS Act (42 U.S.C. 262(k)),
added by the BPCI Act, sets forth the
requirements for an application for a
proposed biosimilar product and an
application or a supplement for a
proposed interchangeable product. In
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
addition to the submission requirements
associated with a 351(k) application for
a proposed biosimilar or
interchangeable biological product, FDA
is committed to meeting certain
performance goals in connection with
the FDA Reauthorization Act of 2017
(FDARA) and its Biosimilar User Fee
(BsUFA) program. These performance
goals are found in the commitment
letter entitled, ‘‘Biosimilar Biological
Product Reauthorization Performance
Goals and Procedures Fiscal Years 2018
Through 2022’’ available from our
website at: https://www.fda.gov/media/
100573/download. Included in the
performance goals is information
collection associated with meetings and
other communications with FDA, and
we are therefore revising the
information collection to cover these
provisions. Also consistent with the
commitment letter, we have developed
the associated guidance document
entitled ‘‘Formal Meetings Between the
FDA and Sponsors or Applicants of
BsUFA Products.’’ The guidance
document discusses the BsUFA meeting
management goal provisions set forth in
the commitment letter and provides
instruction and recommendations to
respondents on formal meetings
between FDA and sponsors or
applicants relating to the development
and review of biosimilar biological
products regulated by the Center for
Drug Evaluation and Research (CDER) or
the Center for Biologics Evaluation and
Research (CBER). The guidance is
intended to assist sponsors or applicants
in generating and submitting meeting
requests and associated meeting
packages to FDA for biosimilar
biological products. A formal meeting
includes any meeting that is requested
by a sponsor or applicant following the
procedures provided in the guidance
and includes meetings conducted in any
format (i.e., face to face, teleconference/
videoconference, written response only
(WRO)). The guidance, available from
our website at https://www.fda.gov/
media/113913/download, includes the
following recommendations pertaining
to BsUFA meeting requests and
information packages:
A. Request for a Meeting
We recommend that a sponsor or
applicant interested in meeting with
CDER or CBER submit a meeting request
electronically to the sponsor’s or
applicant’s application (i.e.,
investigational new drug application,
biologics license application). If there is
no application, a sponsor or applicant
should submit the request to either the
appropriate CDER division director,
with a copy sent to the division’s chief
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of project management staff, or to the
division director of the appropriate
product office within CBER, but only
after first contacting the appropriate
review division or the Biosimilars
Program staff, CDER, Office of New
Drugs to determine to whom the request
should be directed, how it should be
submitted, and the appropriate format
for the request and to arrange for
confirmation of receipt of the request.
We recommend the following
information be included in the meeting
request:
1. Application number (if previously
assigned),
2. development-phase code name of
the product (if prelicensure),
3. proper name (if post licensure),
4. structure (if applicable),
5. proper and proprietary names of
the reference product,
6. proposed indication(s) or context of
product development,
7. pediatric study plans, if applicable,
8. human factors engineering plan, if
applicable,
9. combination product information
(e.g., constituent parts, including details
of the device constituent part, intended
packaging, planned human factors
studies), if applicable,
10. meeting type being requested (the
rationale for requesting the meeting type
should be included),
11. proposed format of the meeting
(face to face, tele-conference/videoconference/WRO),
12. a brief statement of the purpose of
the meeting, including a brief
background of the issues underlying the
agenda. It can also include a brief
summary of completed or planned
studies and clinical trials or data the
sponsor or applicant intends to discuss
at the meeting, the general nature of the
critical questions to be asked, and where
the meeting fits in the overall
development plans.
13. a list of specific objectives/
outcomes expected from the meeting,
14. a proposed agenda, including
times required for each agenda item,
15. a list of questions grouped by
discipline and a brief explanation of the
context and purpose of each question,
16. a list of all individuals with their
titles and affiliations who will attend
the requested meeting from the
requestor’s organization and any
consultants and interpreters,
17. a list of FDA staff, if known, or
disciplines asked to participate in the
requested meeting, and
18. suggested dates and times for the
meeting.
We use the information to determine the
utility of the meeting, to identify FDA
staff necessary to discuss proposed
agenda items, and to schedule the
meeting.
B. Information Package
We recommend that a sponsor or
applicant submit a meeting package to
the appropriate review division with the
meeting request and that the following
information be included in the package:
1. Application number (if previously
assigned),
2. development-phase code name of
product (if pre-licensure) or proper
name (if post-licensure),
3. structure (if applicable),
4. proprietary and proper names of
the reference product,
5. proposed indication(s) or context of
product development,
6. dosage form, route of
administration, dosing regimen
(frequency and duration), and
presentation(s),
7. pediatric study plans, if applicable,
8. human factors engineering plan, if
applicable,
9. combination product information,
if applicable,
10. a list of all individuals with their
titles and affiliations who will attend
the requested meeting from the
requestor’s organization and any
consultants and interpreters,
11. background that includes a brief
history of the development program and
the status of product development (e.g.,
chemistry, manufacturing, and controls;
nonclinical; and clinical, including any
development outside the United States,
as applicable),
12. a brief statement summarizing the
purpose of the meeting,
13. the proposed agenda, and
14. a list of questions for discussion
grouped by discipline and with a brief
summary for each question to explain
the need or context for the question, and
data to support discussion organized by
discipline and question.
The purpose of the meeting package is
to provide FDA staff the opportunity to
adequately prepare for the meeting,
including the review of relevant data
concerning the product.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
BsUFA information collection
Average
burden per
response
Total annual
responses
Total hours
CDER Meeting Requests .....................................................
CDER Information Packages ...............................................
CBER Meeting Requests .....................................................
CBER Information Packages ...............................................
36
29
2
2
2.5
2.2
1
2
89
64
2
4
15
30
15
30
1,335
1,920
30
120
Total ..............................................................................
........................
........................
........................
........................
3,405
1 There
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Number of
responses per
respondent
are no capital costs or operating and maintenance costs associated with this collection of information.
Since last OMB review of the
information collection we have
increased our burden estimate by 95
annual responses and 1,965 annual
hours. This adjustment corresponds
with an increase in submissions
received by the Agency over the past 3
years.
Dated: November 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–25328 Filed 11–21–19; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
BILLING CODE 4164–01–P
Product-Specific Guidances; Draft and
Revised Draft Guidances for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
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]]>Agencies
[Federal Register Volume 84, Number 226 (Friday, November 22, 2019)]
[Notices]
[Pages 64529-64531]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25328]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0129]
Agency Information Collection Activities; Proposed Additional
Collection; Comment Request; General Licensing Provisions; Section
351(k) Biosimilar Applications; Formal Meetings Between the Food and
Drug Administration and Sponsors or Applicants
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/revision of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on ``General Licensing
Provisions; Section 351(k) Biosimilar Applications; Formal Meetings
Between the FDA and Sponsors or Applicants.''
DATES: Submit either electronic or written comments on the collection
of information by January 21, 2020.
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 January 21, 2020. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of January 21, 2020. Comments 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
[[Page 64530]]
identified, as confidential, if submitted as detailed in
``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2012-N-0129 for ``General Licensing Provisions; Section 351(k)
Biosimilar Applications; Formal Meetings Between the FDA and Sponsors
or Applicants.'' 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,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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 additional 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.
General Licensing Provisions; Section 351(k) Biosimilar Applications;
Formal Meetings Between the FDA and Sponsors or Applicants
OMB Control Number 0910-0719--Revision
The Biologics Price Competition and Innovation Act of 2009 (BPCI
Act) amended the Public Health Service Act (PHS Act) and other statutes
to create an abbreviated licensure pathway for biological products
shown to be biosimilar to, or interchangeable with an FDA-licensed
reference product. Section 351(k) of the PHS Act (42 U.S.C. 262(k)),
added by the BPCI Act, sets forth the requirements for an application
for a proposed biosimilar product and an application or a supplement
for a proposed interchangeable product. In addition to the submission
requirements associated with a 351(k) application for a proposed
biosimilar or interchangeable biological product, FDA is committed to
meeting certain performance goals in connection with the FDA
Reauthorization Act of 2017 (FDARA) and its Biosimilar User Fee (BsUFA)
program. These performance goals are found in the commitment letter
entitled, ``Biosimilar Biological Product Reauthorization Performance
Goals and Procedures Fiscal Years 2018 Through 2022'' available from
our website at: https://www.fda.gov/media/100573/download. Included in
the performance goals is information collection associated with
meetings and other communications with FDA, and we are therefore
revising the information collection to cover these provisions. Also
consistent with the commitment letter, we have developed the associated
guidance document entitled ``Formal Meetings Between the FDA and
Sponsors or Applicants of BsUFA Products.'' The guidance document
discusses the BsUFA meeting management goal provisions set forth in the
commitment letter and provides instruction and recommendations to
respondents on formal meetings between FDA and sponsors or applicants
relating to the development and review of biosimilar biological
products regulated by the Center for Drug Evaluation and Research
(CDER) or the Center for Biologics Evaluation and Research (CBER). The
guidance is intended to assist sponsors or applicants in generating and
submitting meeting requests and associated meeting packages to FDA for
biosimilar biological products. A formal meeting includes any meeting
that is requested by a sponsor or applicant following the procedures
provided in the guidance and includes meetings conducted in any format
(i.e., face to face, teleconference/videoconference, written response
only (WRO)). The guidance, available from our website at https://www.fda.gov/media/113913/download, includes the following
recommendations pertaining to BsUFA meeting requests and information
packages:
A. Request for a Meeting
We recommend that a sponsor or applicant interested in meeting with
CDER or CBER submit a meeting request electronically to the sponsor's
or applicant's application (i.e., investigational new drug application,
biologics license application). If there is no application, a sponsor
or applicant should submit the request to either the appropriate CDER
division director, with a copy sent to the division's chief
[[Page 64531]]
of project management staff, or to the division director of the
appropriate product office within CBER, but only after first contacting
the appropriate review division or the Biosimilars Program staff, CDER,
Office of New Drugs to determine to whom the request should be
directed, how it should be submitted, and the appropriate format for
the request and to arrange for confirmation of receipt of the request.
We recommend the following information be included in the meeting
request:
1. Application number (if previously assigned),
2. development-phase code name of the product (if prelicensure),
3. proper name (if post licensure),
4. structure (if applicable),
5. proper and proprietary names of the reference product,
6. proposed indication(s) or context of product development,
7. pediatric study plans, if applicable,
8. human factors engineering plan, if applicable,
9. combination product information (e.g., constituent parts,
including details of the device constituent part, intended packaging,
planned human factors studies), if applicable,
10. meeting type being requested (the rationale for requesting the
meeting type should be included),
11. proposed format of the meeting (face to face, tele-conference/
video-conference/WRO),
12. a brief statement of the purpose of the meeting, including a
brief background of the issues underlying the agenda. It can also
include a brief summary of completed or planned studies and clinical
trials or data the sponsor or applicant intends to discuss at the
meeting, the general nature of the critical questions to be asked, and
where the meeting fits in the overall development plans.
13. a list of specific objectives/outcomes expected from the
meeting,
14. a proposed agenda, including times required for each agenda
item,
15. a list of questions grouped by discipline and a brief
explanation of the context and purpose of each question,
16. a list of all individuals with their titles and affiliations
who will attend the requested meeting from the requestor's organization
and any consultants and interpreters,
17. a list of FDA staff, if known, or disciplines asked to
participate in the requested meeting, and
18. suggested dates and times for the meeting.
We use the information to determine the utility of the meeting, to
identify FDA staff necessary to discuss proposed agenda items, and to
schedule the meeting.
B. Information Package
We recommend that a sponsor or applicant submit a meeting package
to the appropriate review division with the meeting request and that
the following information be included in the package:
1. Application number (if previously assigned),
2. development-phase code name of product (if pre-licensure) or
proper name (if post-licensure),
3. structure (if applicable),
4. proprietary and proper names of the reference product,
5. proposed indication(s) or context of product development,
6. dosage form, route of administration, dosing regimen (frequency
and duration), and presentation(s),
7. pediatric study plans, if applicable,
8. human factors engineering plan, if applicable,
9. combination product information, if applicable,
10. a list of all individuals with their titles and affiliations
who will attend the requested meeting from the requestor's organization
and any consultants and interpreters,
11. background that includes a brief history of the development
program and the status of product development (e.g., chemistry,
manufacturing, and controls; nonclinical; and clinical, including any
development outside the United States, as applicable),
12. a brief statement summarizing the purpose of the meeting,
13. the proposed agenda, and
14. a list of questions for discussion grouped by discipline and
with a brief summary for each question to explain the need or context
for the question, and data to support discussion organized by
discipline and question.
The purpose of the meeting package is to provide FDA staff the
opportunity to adequately prepare for the meeting, including the review
of relevant data concerning the product.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
BsUFA information collection Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
CDER Meeting Requests........... 36 2.5 89 15 1,335
CDER Information Packages....... 29 2.2 64 30 1,920
CBER Meeting Requests........... 2 1 2 15 30
CBER Information Packages....... 2 2 4 30 120
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Total....................... .............. .............. .............. .............. 3,405
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Since last OMB review of the information collection we have
increased our burden estimate by 95 annual responses and 1,965 annual
hours. This adjustment corresponds with an increase in submissions
received by the Agency over the past 3 years.
Dated: November 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25328 Filed 11-21-19; 8:45 am]
BILLING CODE 4164-01-P
