Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products, 32130-32132 [2018-14800]
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32130
Federal Register / Vol. 83, No. 133 / Wednesday, July 11, 2018 / Notices
Estimated Total Annual Burden
Hours: 6,188.
DATES: Comments due within 30 days of
publication. OMB is required to make a
decision concerning the collection of
information between 30 and 60 days
after publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
Written comments and
recommendations for the proposed
information collection should be sent
directly to the following:
ADDRESSES:
Office of Management and Budget,
Paperwork Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn: Desk
Officer for the Administration for Children
and Families.
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW,
Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. Email address:
OPREinfocollection@acf.hhs.gov.
(Authority: Section 413 of the Social Security
Act, as amended by the FY 2017
Consolidated Appropriations Act, 2017 (Pub.
L. 115–31)
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2018–14793 Filed 7–10–18; 8:45 am]
BILLING CODE 4184–09–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2434]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Formal Meetings With
Sponsors and Applicants for
Prescription Drug User Fee Act
Products
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
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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 contained in the guidance for
industry on formal meetings with
sponsors and applicants for Prescription
Drug User Fee Act (PDUFA) products.
DATES: Submit either electronic or
written comments on the collection of
information by September 10, 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 September 10,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of September 10, 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.
PO 00000
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• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–N–2434 for ‘‘Guidance for
Industry on Formal Meetings with
Sponsors and Applicants for PDUFA
Products.’’ 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.
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Federal Register / Vol. 83, No. 133 / Wednesday, July 11, 2018 / Notices
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.
daltland on DSKBBV9HB2PROD with NOTICES
Guidance for Industry on Formal
Meetings With Sponsors and
Applicants for Prescription Drug User
Fee Act Products
OMB Control Number 0910–0429—
Extension
This information collection supports
the above captioned Agency guidance
document. The guidance document was
issued to help individuals with
procedures on formal meetings between
FDA and sponsors or applicants
regarding the development and review
of PDUFA products. The guidance
describes procedures for requesting,
scheduling, conducting, and
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documenting such formal meetings. The
guidance provides information on how
FDA interprets and applies section
119(a) of the Food and Drug
Administration Modernization Act of
2007 (FDAMA) (Pub. L. 105–115),
specific PDUFA goals for the
management of meetings associated
with the review of human drug
applications for PDUFA products, and
provisions of existing regulations
describing certain meetings (§§ 312.47
and 312.82 (21 CFR 312.47 and 312.82)).
The collection of information described
in the guidance reflects the current and
past practice of sponsors and applicants
to submit meeting requests and
background information prior to a
scheduled meeting. Agency regulations
currently permit such requests and
recommend the submission of an
information package before an ‘‘end-ofphase 2 meeting’’ (§§ 312.47(b)(1)(ii)
and (iv)) and a ‘‘pre-NDA meeting’’
(§ 312.47(b)(2)). While the information
collection provisions of § 312.47 are
currently approved under OMB control
number 0910–0014, the guidance
provides additional recommendations
for submitting information to FDA in
support of a meeting request. The
guidance document is available on our
website at: https://www.fda.gov/
downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/
UCM590547.pdf.
Request for a Meeting—Consistent
with recommendations found in the
guidance, a sponsor or applicant
interested in meeting with the Center for
Drug Evaluation and Research (CDER) or
the Center for Biologics Evaluation and
Research (CBER) should submit a
meeting request to the appropriate FDA
component as an amendment to the
application for the underlying product
in accordance with our regulations
(§§ 312.23, 314.50, and 601.2 (21 CFR
312.23, 314.50, and 601.2)). Information
provided to the Agency as part of an
investigational new drug application
(IND), NDA, or biological license
application (BLA) must be submitted
with an appropriate cover form. Form
FDA 1571 must accompany IND
submissions, and Form FDA 356h must
accompany NDA and BLA submissions.
These Agency forms are approved under
OMB control numbers 0910–0014 and
0910–0338, respectively.
We recommend that a request be
submitted in this manner to ensure that
each request is kept in the
administrative file with the complete
application, and to ensure that pertinent
information about the request is entered
into appropriate tracking databases.
Using information from our tracking
databases enables us to monitor progress
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32131
on activities attendant to scheduling
and holding a formal meeting and to
ensure that appropriate steps will be
taken in a timely manner.
The guidance recommends that
meeting requests include the following
information:
• Information identifying and
describing the product
• the type of meeting being requested
• a brief statement of the purpose of the
meeting
• a list of objectives and expected
outcomes from the meeting
• a preliminary proposed agenda
• a draft list of questions to be raised at
the meeting
• a list of individuals who will
represent the sponsor or applicant at
the meeting
• a list of Agency staff requested to be
in attendance
• the approximate date that the
information package will be sent to
the Agency
• suggested dates and times for the
meeting
We use the information to determine
the purpose of the meeting, the
necessary participants, the proposed
agenda, and to schedule the meeting.
Information Package—The guidance
also recommends that a sponsor or
applicant submitting an information
package provide summary information
relevant to the product and
supplementary information pertaining
to any issue raised by the sponsor,
applicant, or FDA. Information packages
should generally include:
• Identifying information about the
underlying product
• a brief statement of the purpose of the
meeting
• a list of objectives and expected
outcomes of the meeting
• a proposed agenda for the meeting
• a list of specific questions to be
addressed at the meeting
• a summary of clinical data that will be
discussed (as appropriate)
• a summary of preclinical data that
will be discussed (as appropriate)
• chemistry, manufacturing, and
controls information that may be
discussed (as appropriate)
The information package enables
Agency staff to prepare for the meeting
and allows appropriate time for
reviewing relevant product data.
Although FDA reviews similar
information in the meeting request, the
information package should provide
updated data reflecting the most current
and accurate information available to
the sponsor or applicant.
We estimate the burden of the
information collection as follows:
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32132
Federal Register / Vol. 83, No. 133 / Wednesday, July 11, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Guidance recommendations
Meeting Requests:
CDER ............................................................................
CBER ............................................................................
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
1,319
301
2.31
1.21
3,058
363
10
10
30,580
3,630
Subtotal ..................................................................
Information Packages:
CDER ............................................................................
CBER ............................................................................
........................
........................
........................
........................
34,210
1,149
187
2.19
1.12
2,522
210
18
18
45,396
3,780
Subtotal ..................................................................
........................
........................
........................
........................
49,176
Total ................................................................
........................
........................
........................
........................
83,386
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
daltland on DSKBBV9HB2PROD with NOTICES
Our estimated burden for the
information collection reflects an
overall increase since the previous OMB
approval. We attribute this adjustment
to an increase in the number of meeting
requests and information packages
received over the last few years.
Based on Agency data, we estimate
1,319 sponsors and applicants
(respondents) request 3,058 formal
meetings with CDER annually, and 301
respondents request 363 formal
meetings with CBER annually regarding
the development and review of a
PDUFA product. The hours per
response, which is the estimated
number of hours that a respondent
spends preparing the information to be
submitted with a meeting request in
accordance with the guidance, is
estimated to be 10 hours. We expect it
takes this amount of time to gather and
copy brief statements about the product
as well as a description of the purpose
and details of the meeting.
Also consistent with Agency data, we
estimate 1,149 respondents submitted
2,522 information packages to CDER
annually, and 187 respondents
submitted 210 information packages to
CBER annually, prior to a formal
meeting regarding the development and
review of a PDUFA product. We
estimate 18 hours is needed to prepare
the information package in accordance
with the guidance.
Dated: July 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–14800 Filed 7–10–18; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0253]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Postmarketing
Adverse Drug and Biological Product
Experience Reporting and
Recordkeeping
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 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
provisions of FDA’s postmarketing
adverse drug experience reporting and
recordkeeping requirements.
DATES: Submit either electronic or
written comments on the collection of
information by September 10, 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 September 10,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of September 10, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
SUMMARY:
PO 00000
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Sfmt 4703
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
E:\FR\FM\11JYN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 133 (Wednesday, July 11, 2018)]
[Notices]
[Pages 32130-32132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14800]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-2434]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Formal Meetings With Sponsors
and Applicants for Prescription Drug User Fee Act Products
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 contained in the
guidance for industry on formal meetings with sponsors and applicants
for Prescription Drug User Fee Act (PDUFA) products.
DATES: Submit either electronic or written comments on the collection
of information by September 10, 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 September 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of September 10, 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-2018-N-2434 for ``Guidance for Industry on Formal Meetings with
Sponsors and Applicants for PDUFA Products.'' 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.
[[Page 32131]]
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 on Formal Meetings With Sponsors and Applicants
for Prescription Drug User Fee Act Products
OMB Control Number 0910-0429--Extension
This information collection supports the above captioned Agency
guidance document. The guidance document was issued to help individuals
with procedures on formal meetings between FDA and sponsors or
applicants regarding the development and review of PDUFA products. The
guidance describes procedures for requesting, scheduling, conducting,
and documenting such formal meetings. The guidance provides information
on how FDA interprets and applies section 119(a) of the Food and Drug
Administration Modernization Act of 2007 (FDAMA) (Pub. L. 105-115),
specific PDUFA goals for the management of meetings associated with the
review of human drug applications for PDUFA products, and provisions of
existing regulations describing certain meetings (Sec. Sec.
[thinsp]312.47 and 312.82 (21 CFR 312.47 and 312.82)). The collection
of information described in the guidance reflects the current and past
practice of sponsors and applicants to submit meeting requests and
background information prior to a scheduled meeting. Agency regulations
currently permit such requests and recommend the submission of an
information package before an ``end-of-phase 2 meeting'' (Sec. Sec.
[thinsp]312.47(b)(1)(ii) and (iv)) and a ``pre-NDA meeting'' (Sec.
[thinsp]312.47(b)(2)). While the information collection provisions of
Sec. [thinsp]312.47 are currently approved under OMB control number
0910-0014, the guidance provides additional recommendations for
submitting information to FDA in support of a meeting request. The
guidance document is available on our website at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM590547.pdf.
Request for a Meeting--Consistent with recommendations found in the
guidance, a sponsor or applicant interested in meeting with the Center
for Drug Evaluation and Research (CDER) or the Center for Biologics
Evaluation and Research (CBER) should submit a meeting request to the
appropriate FDA component as an amendment to the application for the
underlying product in accordance with our regulations (Sec. Sec.
[thinsp]312.23, 314.50, and 601.2 (21 CFR 312.23, 314.50, and 601.2)).
Information provided to the Agency as part of an investigational new
drug application (IND), NDA, or biological license application (BLA)
must be submitted with an appropriate cover form. Form FDA 1571 must
accompany IND submissions, and Form FDA 356h must accompany NDA and BLA
submissions. These Agency forms are approved under OMB control numbers
0910-0014 and 0910-0338, respectively.
We recommend that a request be submitted in this manner to ensure
that each request is kept in the administrative file with the complete
application, and to ensure that pertinent information about the request
is entered into appropriate tracking databases. Using information from
our tracking databases enables us to monitor progress on activities
attendant to scheduling and holding a formal meeting and to ensure that
appropriate steps will be taken in a timely manner.
The guidance recommends that meeting requests include the following
information:
Information identifying and describing the product
the type of meeting being requested
a brief statement of the purpose of the meeting
a list of objectives and expected outcomes from the meeting
a preliminary proposed agenda
a draft list of questions to be raised at the meeting
a list of individuals who will represent the sponsor or
applicant at the meeting
a list of Agency staff requested to be in attendance
the approximate date that the information package will be sent
to the Agency
suggested dates and times for the meeting
We use the information to determine the purpose of the meeting, the
necessary participants, the proposed agenda, and to schedule the
meeting.
Information Package--The guidance also recommends that a sponsor or
applicant submitting an information package provide summary information
relevant to the product and supplementary information pertaining to any
issue raised by the sponsor, applicant, or FDA. Information packages
should generally include:
Identifying information about the underlying product
a brief statement of the purpose of the meeting
a list of objectives and expected outcomes of the meeting
a proposed agenda for the meeting
a list of specific questions to be addressed at the meeting
a summary of clinical data that will be discussed (as
appropriate)
a summary of preclinical data that will be discussed (as
appropriate)
chemistry, manufacturing, and controls information that may be
discussed (as appropriate)
The information package enables Agency staff to prepare for the
meeting and allows appropriate time for reviewing relevant product
data. Although FDA reviews similar information in the meeting request,
the information package should provide updated data reflecting the most
current and accurate information available to the sponsor or applicant.
We estimate the burden of the information collection as follows:
[[Page 32132]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Guidance recommendations Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Meeting Requests:
CDER........................ 1,319 2.31 3,058 10 30,580
CBER........................ 301 1.21 363 10 3,630
-------------------------------------------------------------------------------
Subtotal................ .............. .............. .............. .............. 34,210
Information Packages:
CDER........................ 1,149 2.19 2,522 18 45,396
CBER........................ 187 1.12 210 18 3,780
-------------------------------------------------------------------------------
Subtotal................ .............. .............. .............. .............. 49,176
-------------------------------------------------------------------------------
Total............... .............. .............. .............. .............. 83,386
----------------------------------------------------------------------------------------------------------------
\1\ There 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 since the previous OMB approval. We attribute this
adjustment to an increase in the number of meeting requests and
information packages received over the last few years.
Based on Agency data, we estimate 1,319 sponsors and applicants
(respondents) request 3,058 formal meetings with CDER annually, and 301
respondents request 363 formal meetings with CBER annually regarding
the development and review of a PDUFA product. The hours per response,
which is the estimated number of hours that a respondent spends
preparing the information to be submitted with a meeting request in
accordance with the guidance, is estimated to be 10 hours. We expect it
takes this amount of time to gather and copy brief statements about the
product as well as a description of the purpose and details of the
meeting.
Also consistent with Agency data, we estimate 1,149 respondents
submitted 2,522 information packages to CDER annually, and 187
respondents submitted 210 information packages to CBER annually, prior
to a formal meeting regarding the development and review of a PDUFA
product. We estimate 18 hours is needed to prepare the information
package in accordance with the guidance.
Dated: July 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14800 Filed 7-10-18; 8:45 am]
BILLING CODE 4164-01-P
