Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products, 60913-60915 [2015-25624]
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Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices
8 These
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9 These
60913
notifications recommend the submission of Form FDA 3480.
notifications recommend the submission of Form FDA 3480A.
The estimates in table 1 are based on
our current experience with the food
contact substance notification program
and informal communication with
industry.
Beginning in row 1, we estimate 10
respondents will submit 2 notifications
annually for food contact substance
formulations (Form FDA 3479), for a
total of 20 responses. We calculate a
reporting burden of 2 hours per
response, for a total of 40 hours. In row
2 we estimate six respondents. We
believe the hourly burden for preparing
these notifications will primarily consist
of the manufacturer or supplier
completing Form FDA 3480, verifying
that a previous notification is effective,
and preparing necessary documentation.
We estimate one submission for each
respondent, for a total of six responses.
We calculate a reporting burden of 25
hours per response, for a total of 150
hours.
In rows 3, 4, and 5, we identify three
tiers of FCNs that reflect different levels
of burden applicable to the respective
information collection items (denoted as
Categories C, D, and E). We estimate 6
respondents will submit 2 Category C
submissions annually, for a total of 12
responses. We calculate a reporting
burden of 120 hours per response, for a
total burden of 1,440 hours. We estimate
42 respondents will submit 2 Category
D submissions annually, for a total of 84
responses. We calculate a reporting
burden of 150 hours per response, for a
total burden of 12,600 hours. We
estimate 38 respondents will submit 1
Category E submission annually, for a
total of 38 responses. We calculate a
reporting burden of 150 hours per
response, for a total burden of 5,700
hours.
In row 6, we estimate 190 respondents
will submit information to a prenotification consultation or a master file
in support of FCN submission using
Form FDA 3480. We calculate a
reporting burden of 0.5 hours per
response, for a total burden of 95 hours.
In row 7 we estimate 100 respondents
will submit an amendment (Form FDA
3480A) to a substantive or nonsubstantive request of additional
information to an incomplete FCN
submission, an amendment to a prenotification consultation, or an
amendment to a master file in support
of an FCN. We calculate a reporting
burden of 0.5 hours per response, for a
total burden of 50 hours.
In row 8, we estimate one respondent
will submit one indirect food additive
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petition under § 171.1, for a total of one
response. We calculate a reporting
burden of 10,995 hours per response, for
a total burden of 10,995 hours.
Finally, in row 9, we estimate 10
respondents will utilize the
recommendations in the guidance
document entitled, ‘‘Use of Recycled
Plastics in Food Packaging: Chemistry
Considerations,’’ to develop the
additional information for one such
submission annually, for a total of 10
responses. We calculate a reporting
burden of 25 hours per response, for a
total burden of 250 hours.
Dated: October 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–25625 Filed 10–7–15; 8:45 am]
BILLING CODE 4164–01–P
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0247]
Agency Information Collection
Activities; Proposed Collection;
Submission for Office of Management
and Budget Review; 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) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by November
9, 2015.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
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
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Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2012–N–0247 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Submission for Office of
Management and Budget Review;
Guidance for Industry on Formal
Meetings With Sponsors and Applicants
for PDUFA Products.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
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
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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 Division of Dockets
Management. 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.fda.gov/regulatory
information/dockets/default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
To ensure that comments on the
information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0429.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Guidance for Industry on Formal
Meetings With Sponsors and
Applicants for PDUFA Products—OMB
Control Number 0910–0429—Extension
This information collection approval
request is for FDA guidance on the
procedures for formal meetings between
FDA and sponsors or applicants
regarding the development and review
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of PDUFA products. The guidance
describes procedures for requesting,
scheduling, conducting, and
documenting such formal meetings. The
guidance provides information on how
the Agency will interpret and apply
section 119(a) of the Food and Drug
Administration Modernization Act
(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 guidance describes two
collections of information: The
submission of a meeting request
containing certain information and the
submission of an information package in
advance of the formal meeting. Agency
regulations at §§ 312.47(b)(1)(ii), (1)(iv),
and (2) describe information that should
be submitted in support of a request for
an end-of-phase 2 meeting and a preNDA meeting. The information
collection provisions of § 312.47 have
been approved by OMB control number
0910–0014. However, the guidance
provides additional recommendations
for submitting information to FDA in
support of a meeting request. As a
result, FDA is submitting additional
estimates for OMB approval.
I. Request for a Meeting
Under 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 underlying
application. FDA regulations (§§ 312.23,
314.50, and 601.2 (21 CFR 312.23,
314.50, and 601.2)) state that
information provided to the Agency as
part of an investigational new drug
application (IND), new drug application
(NDA), or biological license application
(BLA) must be submitted with an
appropriate cover form. Form FDA 1571
must accompany submissions under
INDs and Form FDA 356h must
accompany submissions under NDAs
and BLAs. Both forms have valid OMB
control numbers as follows: Form FDA
1571—OMB control number 0910–0014
and Form FDA 356h—OMB control
number 0910–0338.
In the guidance document, CDER and
CBER ask that a request for a formal
meeting be submitted as an amendment
to the application for the underlying
product under the requirements of
§§ 312.23, 314.50, and 601.2; therefore,
requests should be submitted to the
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Agency with the appropriate form
attached, either Form FDA 1571 or Form
FDA 356h. The Agency recommends
that a request be submitted in this
manner for two reasons: (1) To ensure
that each request is kept in the
administrative file with the entire
underlying application, and (2) to
ensure that pertinent information about
the request is entered into the
appropriate tracking databases. Use of
the information in the Agency’s tracking
databases enables the Agency to monitor
progress on the activities attendant to
scheduling and holding a formal
meeting and to ensure that appropriate
steps will be taken in a timely manner.
Under the guidance, the Agency
requests that sponsors and applicants
include in meeting requests certain
information about the proposed
meeting. Such information includes:
• 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; and
• suggested dates and times for the
meeting.
This information will be used by the
Agency to determine the utility of the
meeting, to identify Agency staff
necessary to discuss proposed agenda
items, and to schedule the meeting.
II. Information Package
A sponsor or applicant submitting an
information package to the Agency in
advance of a formal meeting should
provide summary information relevant
to the product and supplementary
information pertaining to any issue
raised by the sponsor, applicant, or
Agency. The Agency recommends that
information packages 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);
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Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices
• a summary of preclinical data that
will be discussed (as appropriate); and
• chemistry, manufacturing, and
controls information that may be
discussed (as appropriate).
The purpose of the information
package is to provide Agency staff the
opportunity to adequately prepare for
the meeting, including the review of
relevant data concerning the product.
Although FDA reviews similar
information in the meeting request, the
information package should provide
updated data that reflect the most
current and accurate information
available to the sponsor or applicant.
The Agency finds that reviewing such
information is critical to achieving a
productive meeting.
The collection of information
described in the guidance reflects the
current and past practice of sponsors
and applicants to submit meeting
requests as amendments to INDs, NDAs,
and BLAs and to submit 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 (§§ 312.47(b)(1)(ii) and (iv)) and
a pre-NDA meeting (§ 312.47(b)(2)).
Description of Respondents: A
sponsor or applicant for a drug or
biological product who requests a
formal meeting with the Agency
regarding the development and review
of a PDUFA product.
Burden Estimate: Provided in this
document is an estimate of the annual
reporting burden for the submission of
meeting requests and information
packages under the guidance.
III. Request for a Formal Meeting
Based on data collected from the
review divisions and offices within
CDER and CBER, FDA estimates that
approximately 1,099 sponsors and
applicants (respondents) request
approximately 2,366 formal meetings
with CDER annually and approximately
175 respondents request approximately
264 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
would spend preparing the information
to be submitted with a meeting request
in accordance with the guidance, is
estimated to be approximately 10 hours.
Based on FDA’s experience, the Agency
expects it will take respondents this
amount of time to gather and copy brief
statements about the product and a
description of the purpose and details of
the meeting.
IV. Information Package
Based on data collected from the
review divisions and offices within
CDER and CBER, FDA estimates that
approximately 959 respondents
submitted approximately 1,901
information packages to CDER annually
and approximately 142 respondents
submitted approximately 193
information packages to CBER annually
prior to a formal meeting regarding the
development and review of a PDUFA
product. The hours per response, which
is the estimated number of hours that a
respondent would spend preparing the
information package in accordance with
the guidance, is estimated to be
approximately 18 hours. Based on
FDA’s experience, the Agency expects it
will take respondents this amount of
time to gather and copy brief statements
about the product, a description of the
details for the anticipated meeting, and
data and information that generally
would already have been compiled for
submission to the Agency.
In the Federal Register of May 20,
2015 (80 FR 29010), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
As stated earlier, the guidance
provides information on how the
Agency will interpret and apply section
119(a) of FDAMA, 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). The information collection
provisions in § 312.47 concerning endof-phase 2 meetings and pre-NDA
meetings have been approved by OMB
control number 0910–0014. However,
the guidance provides additional
recommendations for submitting
information to FDA in support of a
meeting request. As a result, FDA is
submitting for OMB approval these
additional estimates.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Meeting requests and information packages
Meeting Requests:
CDER ............................................................................
CBER ............................................................................
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
1,099
175
2.15
1.51
2,366
264
10
10
23,660
2,640
Total .......................................................................
Information Packages:
CDER ............................................................................
CBER ............................................................................
........................
........................
........................
........................
26,300
959
142
1.99
1.36
1,901
193
18
18
34,218
3,474
Total .......................................................................
........................
........................
........................
........................
37,692
Grand Total ....................................................
........................
........................
........................
........................
63,992
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–25624 Filed 10–7–15; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)]
[Notices]
[Pages 60913-60915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25624]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0247]
Agency Information Collection Activities; Proposed Collection;
Submission for Office of Management and Budget Review; 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) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
November 9, 2015.
ADDRESSES: You may submit comments as follows:
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2012-N-0247 for ``Agency Information Collection Activities;
Proposed Collection; Submission for Office of Management and Budget
Review; Guidance for Industry on Formal Meetings With Sponsors and
Applicants for PDUFA Products.''
Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Division of Dockets Management
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
[[Page 60914]]
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 Division of Dockets
Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
To ensure that comments on the information collection are received,
OMB recommends that written comments be faxed to the Office of
Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX:
202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0429.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Guidance for Industry on Formal Meetings With Sponsors and Applicants
for PDUFA Products--OMB Control Number 0910-0429--Extension
This information collection approval request is for FDA guidance on
the procedures for 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 the Agency will interpret and apply section 119(a) of the Food
and Drug Administration Modernization Act (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. 312.47 and
312.82 (21 CFR 312.47 and 312.82)).
The guidance describes two collections of information: The
submission of a meeting request containing certain information and the
submission of an information package in advance of the formal meeting.
Agency regulations at Sec. Sec. 312.47(b)(1)(ii), (1)(iv), and (2)
describe information that should be submitted in support of a request
for an end-of-phase 2 meeting and a pre-NDA meeting. The information
collection provisions of Sec. 312.47 have been approved by OMB control
number 0910-0014. However, the guidance provides additional
recommendations for submitting information to FDA in support of a
meeting request. As a result, FDA is submitting additional estimates
for OMB approval.
I. Request for a Meeting
Under 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
underlying application. FDA regulations (Sec. Sec. 312.23, 314.50, and
601.2 (21 CFR 312.23, 314.50, and 601.2)) state that information
provided to the Agency as part of an investigational new drug
application (IND), new drug application (NDA), or biological license
application (BLA) must be submitted with an appropriate cover form.
Form FDA 1571 must accompany submissions under INDs and Form FDA 356h
must accompany submissions under NDAs and BLAs. Both forms have valid
OMB control numbers as follows: Form FDA 1571--OMB control number 0910-
0014 and Form FDA 356h--OMB control number 0910-0338.
In the guidance document, CDER and CBER ask that a request for a
formal meeting be submitted as an amendment to the application for the
underlying product under the requirements of Sec. Sec. 312.23, 314.50,
and 601.2; therefore, requests should be submitted to the Agency with
the appropriate form attached, either Form FDA 1571 or Form FDA 356h.
The Agency recommends that a request be submitted in this manner for
two reasons: (1) To ensure that each request is kept in the
administrative file with the entire underlying application, and (2) to
ensure that pertinent information about the request is entered into the
appropriate tracking databases. Use of the information in the Agency's
tracking databases enables the Agency to monitor progress on the
activities attendant to scheduling and holding a formal meeting and to
ensure that appropriate steps will be taken in a timely manner.
Under the guidance, the Agency requests that sponsors and
applicants include in meeting requests certain information about the
proposed meeting. Such information includes:
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; and
suggested dates and times for the meeting.
This information will be used by the Agency to determine the
utility of the meeting, to identify Agency staff necessary to discuss
proposed agenda items, and to schedule the meeting.
II. Information Package
A sponsor or applicant submitting an information package to the
Agency in advance of a formal meeting should provide summary
information relevant to the product and supplementary information
pertaining to any issue raised by the sponsor, applicant, or Agency.
The Agency recommends that information packages 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);
[[Page 60915]]
a summary of preclinical data that will be discussed (as
appropriate); and
chemistry, manufacturing, and controls information that
may be discussed (as appropriate).
The purpose of the information package is to provide Agency staff
the opportunity to adequately prepare for the meeting, including the
review of relevant data concerning the product. Although FDA reviews
similar information in the meeting request, the information package
should provide updated data that reflect the most current and accurate
information available to the sponsor or applicant. The Agency finds
that reviewing such information is critical to achieving a productive
meeting.
The collection of information described in the guidance reflects
the current and past practice of sponsors and applicants to submit
meeting requests as amendments to INDs, NDAs, and BLAs and to submit
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.
312.47(b)(1)(ii) and (iv)) and a pre-NDA meeting (Sec. 312.47(b)(2)).
Description of Respondents: A sponsor or applicant for a drug or
biological product who requests a formal meeting with the Agency
regarding the development and review of a PDUFA product.
Burden Estimate: Provided in this document is an estimate of the
annual reporting burden for the submission of meeting requests and
information packages under the guidance.
III. Request for a Formal Meeting
Based on data collected from the review divisions and offices
within CDER and CBER, FDA estimates that approximately 1,099 sponsors
and applicants (respondents) request approximately 2,366 formal
meetings with CDER annually and approximately 175 respondents request
approximately 264 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 would spend
preparing the information to be submitted with a meeting request in
accordance with the guidance, is estimated to be approximately 10
hours. Based on FDA's experience, the Agency expects it will take
respondents this amount of time to gather and copy brief statements
about the product and a description of the purpose and details of the
meeting.
IV. Information Package
Based on data collected from the review divisions and offices
within CDER and CBER, FDA estimates that approximately 959 respondents
submitted approximately 1,901 information packages to CDER annually and
approximately 142 respondents submitted approximately 193 information
packages to CBER annually prior to a formal meeting regarding the
development and review of a PDUFA product. The hours per response,
which is the estimated number of hours that a respondent would spend
preparing the information package in accordance with the guidance, is
estimated to be approximately 18 hours. Based on FDA's experience, the
Agency expects it will take respondents this amount of time to gather
and copy brief statements about the product, a description of the
details for the anticipated meeting, and data and information that
generally would already have been compiled for submission to the
Agency.
In the Federal Register of May 20, 2015 (80 FR 29010), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
As stated earlier, the guidance provides information on how the
Agency will interpret and apply section 119(a) of FDAMA, 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. 312.47 and 312.82).
The information collection provisions in Sec. 312.47 concerning end-
of-phase 2 meetings and pre-NDA meetings have been approved by OMB
control number 0910-0014. However, the guidance provides additional
recommendations for submitting information to FDA in support of a
meeting request. As a result, FDA is submitting for OMB approval these
additional estimates.
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Meeting requests and information Number of responses per Total annual Average burden Total hours
packages respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Meeting Requests:
CDER........................ 1,099 2.15 2,366 10 23,660
CBER........................ 175 1.51 264 10 2,640
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Total................... .............. .............. .............. .............. 26,300
Information Packages:
CDER........................ 959 1.99 1,901 18 34,218
CBER........................ 142 1.36 193 18 3,474
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Total................... .............. .............. .............. .............. 37,692
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Grand Total......... .............. .............. .............. .............. 63,992
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: October 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25624 Filed 10-7-15; 8:45 am]
BILLING CODE 4164-01-P
