Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants, 28234-28236 [2018-12968]
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Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices
Compensation Program Act of 2000 (42
U.S.C. 7384–7385) was enacted. This
Act established a federal compensation
program for employees of the
Department of Energy (DOE) and certain
of its contractors, subcontractors and
vendors, who have suffered cancers and
other designated illnesses as a result of
exposures sustained in the production
and testing of nuclear weapons.
Executive Order 13179, issued on
December 7, 2000, delegated authorities
assigned to ‘‘the President’’ under the
Act to the Departments of Labor, Health
and Human Services, Energy and
Justice. The Department of Health and
Human Services (DHHS) was delegated
the responsibility of establishing
methods for estimating radiation doses
received by eligible claimants with
cancer applying for compensation.
NIOSH is applying the following
methods to estimate the radiation doses
of individuals applying for
compensation.
In performance of its dose
reconstruction responsibilities, under
the Act, NIOSH is providing voluntary
interview opportunities to claimants (or
their survivors) individually and
providing them with the opportunity to
assist NIOSH in documenting the work
history of the employee by
characterizing the actual work tasks
performed. In addition, NIOSH and the
claimant may identify incidents that
may have resulted in undocumented
radiation exposures, characterizing
radiological protection and monitoring
practices, and identify co-workers and
other witnesses as may be necessary to
confirm undocumented information. In
this process, NIOSH uses a computer
assisted telephone interview (CATI)
system, which allows interviews to be
conducted more efficiently and quickly
as opposed to a paper-based interview
instrument. Both interviews are
voluntary and failure to participate in
either or both interviews will not have
a negative effect on the claim, although
voluntary participation may assist the
claimant by adding important
information that may not be otherwise
available.
There are no changes to the questions
contained in the package, or the
estimated burden hours. This
Information Collection Request (ICR) is
being submitted as a reinstatement
because the previous ICR expired on
April 30, 2018 and the updated ICR was
not submitted before the expiration
date. NIOSH uses the data collected in
this process to complete an individual
dose reconstruction that accounts, as
fully as possible, for the radiation dose
incurred by the employee in the line of
duty for DOE nuclear weapons
production programs. After dose
reconstruction, NIOSH also performs a
brief, voluntary final interview with the
claimant to explain the results and to
allow the claimant to confirm or
question the records NIOSH has
compiled. This will also be the final
opportunity for the claimant to
supplement the dose reconstruction
record.
At the conclusion of the dose
reconstruction process, the claimant
submits a form to confirm that the
claimant has no further information to
provide to NIOSH about the claim at
this time. The form notifies the claimant
that signing the form allows NIOSH to
forward a dose reconstruction report to
DOL and to the claimant, and closes the
record on data used for the dose
reconstruction. Signing this form does
not indicate that the claimant agrees
with the outcome of the dose
reconstruction. The dose reconstruction
results will be supplied to the claimant
and to the DOL, the agency that will
utilize them as one part of its
determination of whether the claimant
is eligible for compensation under the
Act.
Total annualized burden is estimated
to be 3900 hours. There is no cost to
respondents other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Claimant ..........................................................
Claimant ..........................................................
Initial Interview ...............................................
Conclusion form OCAS–1 ..............................
Jeffrey M. Zirger,
Acting Chief, Information Collection Review
Office, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2018–12972 Filed 6–15–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0286]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry: Formal Meetings Between the
Food and Drug Administration and
Biosimilar Biological Product
Sponsors or Applicants
amozie on DSK3GDR082PROD with NOTICES1
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.
SUMMARY:
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PO 00000
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3,600
3,600
Number of
responses
per
respondent
Average
burden per
response
(in hours)
1
1
1
5/60
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 formal meetings
between FDA and biosimilar biological
product sponsors or applicants.
DATES: Submit either electronic or
written comments on the collection of
information by August 17, 2018.
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 August 17,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
E:\FR\FM\18JNN1.SGM
18JNN1
Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices
at the end of August 17, 2018.
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’’).
amozie on DSK3GDR082PROD with NOTICES1
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–D–0286 for ‘‘Guidance for
Industry: Formal Meetings Between
Between the FDA and Biosimilar
Biological Product 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
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18:00 Jun 15, 2018
Jkt 244001
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
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.
PO 00000
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28235
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.
Guidance for Industry: Formal
Meetings Between the FDA and
Biosimilar Biological Product Sponsors
or Applicants
OMB Control Number 0910–0802—
Extension
The Biologics Price Competition and
Innovation Act of 2009, the Biosimilar
User Fee Act of 2012, and the recent
passage of the Biosimilar User Fee
Amendments of 2017 (BsUFA II) under
Title IV of the Food and Drug
Administration Reauthorization Act of
2017, authorizes user fees for biosimilar
biological products. FDA has committed
to meeting certain performance goals in
connection with the reauthorized
biosimilar user fee program. FDA
developed a guidance for industry
entitled ‘‘Formal Meetings Between
FDA and Biosimilar Biological Products
Sponsors or Applicants’’ to provide
recommendations to industry 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) and assist sponsors
and applicants in generating and
submitting meeting requests and the
associated meeting packages to FDA for
biosimilar biological products. The
guidance describes FDA’s current
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Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices
thinking on how the Agency intends to
interpret and apply certain provisions of
BsUFA II and provides information on
specific performance goals for the
management of meetings associated
with the development and review of
biosimilar biological products. The
guidance includes two types of
information collections: (1) The
submission of a meeting request
containing certain information and (2)
the submission of the information
package(s) that accompany the meeting
request. This information collection
supports this Agency guidance
document.
A. Request for a Meeting
Under the guidance, a sponsor or
applicant interested in meeting with
CDER or CBER should submit a meeting
request 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 of project
management staff, or to the division
director of the appropriate product
office within CBER. However, a sponsor
or applicant should only submit such a
request 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, the appropriate
format for the request, and to arrange for
confirmation of receipt of the request.
Under the guidance, FDA requests
that sponsors and applicants
incorporate certain information in the
meeting request including:
1. Product name,
2. application number (if applicable),
3. proposed proper name or proper
name (post licensure),
4. structure,
5. reference product name,
6. proposed indication(s) or context of
product development,
7. meeting type being requested (the
rationale for requesting the meeting type
should be included),
8. a brief statement of the purpose of
the meeting, including a brief
background of the issues underlying the
agenda and, as applicable, 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,
9. a list of specific objectives/
outcomes expected from the meeting,
10. a proposed agenda, including
times required for each agenda item,
11. a list of questions grouped by
discipline and a brief explanation of the
context and purpose of each question,
12. a list of all individuals with their
titles and affiliations who will attend
the requested meeting from the
requestor’s organization and
consultants,
13. a list of FDA staff, if known, or
disciplines asked to participate in the
requested meeting,
14. suggested dates and times for the
meeting, and
15. the proposed format of the
meeting (i.e., face to face meeting,
teleconference, or videoconference).
This information is be used by FDA
to facilitate formal meetings with
biosimilar biological product sponsors.
B. Information Package
FDA requests that a sponsor or
applicant submit a meeting package to
the appropriate review division with the
meeting request. FDA recommends that
the information packages generally
include:
1. Product name and application
number (if applicable),
2. proposed proper name or proper
name (post licensure),
3. structure,
4. reference product name,
5. proposed indication(s) or context of
product development,
6. dosage form, route of
administration, dosing regimen
(frequency and duration), and
presentation(s),
7. a list of all sponsor’s or applicant’s
attendees and consultants with their
titles and affiliations who will attend
the requested meeting,
8. 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),
9. a brief statement summarizing the
purpose of the meeting,
10. the proposed agenda,
11. 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
12. data to support discussion of the
listed questions, 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.
Description of Respondents: A
sponsor or applicant for a biosimilar
biological product who requests a
formal meeting with FDA regarding the
development and review of a biosimilar
biological product.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Guidance for Industry: Formal Meetings Between FDA and
Biosimilar Biological Product Sponsors or Applicants
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
CDER Meeting Requests .....................................................
CBER Meeting Requests .....................................................
CDER Information Packages ...............................................
CBER Information Packages ...............................................
36
2
29
2
2.5
1
2.2
2
89
2
64
4
15
15
30
30
1,335
30
1,920
120
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 the last OMB approval there has
been an increase in meeting requests
with CDER and a corresponding
increase in the number of information
packages. Accordingly, we have
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adjusted our estimate of CDER meeting
requests upward by six respondents. We
attribute this change to an increase in
biosimilar product development.
PO 00000
Dated: June 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12968 Filed 6–15–18; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 83, Number 117 (Monday, June 18, 2018)]
[Notices]
[Pages 28234-28236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12968]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0286]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry: Formal Meetings Between the
Food and Drug Administration and Biosimilar Biological Product 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 of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on formal meetings between FDA and biosimilar
biological product sponsors or applicants.
DATES: Submit either electronic or written comments on the collection
of information by August 17, 2018.
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 August 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time
[[Page 28235]]
at the end of August 17, 2018. 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 identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2013-D-0286 for ``Guidance for Industry: Formal Meetings Between
Between the FDA and Biosimilar Biological Product 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. 3501-3520), 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.
Guidance for Industry: Formal Meetings Between the FDA and Biosimilar
Biological Product Sponsors or Applicants
OMB Control Number 0910-0802--Extension
The Biologics Price Competition and Innovation Act of 2009, the
Biosimilar User Fee Act of 2012, and the recent passage of the
Biosimilar User Fee Amendments of 2017 (BsUFA II) under Title IV of the
Food and Drug Administration Reauthorization Act of 2017, authorizes
user fees for biosimilar biological products. FDA has committed to
meeting certain performance goals in connection with the reauthorized
biosimilar user fee program. FDA developed a guidance for industry
entitled ``Formal Meetings Between FDA and Biosimilar Biological
Products Sponsors or Applicants'' to provide recommendations to
industry 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) and
assist sponsors and applicants in generating and submitting meeting
requests and the associated meeting packages to FDA for biosimilar
biological products. The guidance describes FDA's current
[[Page 28236]]
thinking on how the Agency intends to interpret and apply certain
provisions of BsUFA II and provides information on specific performance
goals for the management of meetings associated with the development
and review of biosimilar biological products. The guidance includes two
types of information collections: (1) The submission of a meeting
request containing certain information and (2) the submission of the
information package(s) that accompany the meeting request. This
information collection supports this Agency guidance document.
A. Request for a Meeting
Under the guidance, a sponsor or applicant interested in meeting
with CDER or CBER should submit a meeting request 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 of project
management staff, or to the division director of the appropriate
product office within CBER. However, a sponsor or applicant should only
submit such a request 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, the appropriate format for the request, and to arrange for
confirmation of receipt of the request.
Under the guidance, FDA requests that sponsors and applicants
incorporate certain information in the meeting request including:
1. Product name,
2. application number (if applicable),
3. proposed proper name or proper name (post licensure),
4. structure,
5. reference product name,
6. proposed indication(s) or context of product development,
7. meeting type being requested (the rationale for requesting the
meeting type should be included),
8. a brief statement of the purpose of the meeting, including a
brief background of the issues underlying the agenda and, as
applicable, 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,
9. a list of specific objectives/outcomes expected from the
meeting,
10. a proposed agenda, including times required for each agenda
item,
11. a list of questions grouped by discipline and a brief
explanation of the context and purpose of each question,
12. a list of all individuals with their titles and affiliations
who will attend the requested meeting from the requestor's organization
and consultants,
13. a list of FDA staff, if known, or disciplines asked to
participate in the requested meeting,
14. suggested dates and times for the meeting, and
15. the proposed format of the meeting (i.e., face to face meeting,
teleconference, or videoconference).
This information is be used by FDA to facilitate formal meetings
with biosimilar biological product sponsors.
B. Information Package
FDA requests that a sponsor or applicant submit a meeting package
to the appropriate review division with the meeting request. FDA
recommends that the information packages generally include:
1. Product name and application number (if applicable),
2. proposed proper name or proper name (post licensure),
3. structure,
4. reference product name,
5. proposed indication(s) or context of product development,
6. dosage form, route of administration, dosing regimen (frequency
and duration), and presentation(s),
7. a list of all sponsor's or applicant's attendees and consultants
with their titles and affiliations who will attend the requested
meeting,
8. 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),
9. a brief statement summarizing the purpose of the meeting,
10. the proposed agenda,
11. 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
12. data to support discussion of the listed questions, 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.
Description of Respondents: A sponsor or applicant for a biosimilar
biological product who requests a formal meeting with FDA regarding the
development and review of a biosimilar biological product.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Guidance for Industry: Formal
Meetings Between FDA and Number of Number of Total annual Average burden
Biosimilar Biological Product respondents responses per responses per response Total hours
Sponsors or Applicants respondent
----------------------------------------------------------------------------------------------------------------
CDER Meeting Requests........... 36 2.5 89 15 1,335
CBER Meeting Requests........... 2 1 2 15 30
CDER Information Packages....... 29 2.2 64 30 1,920
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 the last OMB approval there has been an increase in meeting
requests with CDER and a corresponding increase in the number of
information packages. Accordingly, we have adjusted our estimate of
CDER meeting requests upward by six respondents. We attribute this
change to an increase in biosimilar product development.
Dated: June 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12968 Filed 6-15-18; 8:45 am]
BILLING CODE 4164-01-P
