Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products, 42744-42746 [2012-17557]
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42744
Federal Register / Vol. 77, No. 140 / Friday, July 20, 2012 / Notices
ANNUAL BURDEN ESTIMATES
Annual
number of
respondents
Instrument
12 Month Follow-up Survey ...........................................................................
Tracking Letters .............................................................................................
Baseline Information Form (Modification) ......................................................
Program Leadership/Managers Interview Guide ...........................................
Instructional Staff Interview Guide .................................................................
Case Managers/Advisors Interview Guide ....................................................
Partners Interview Guide ...............................................................................
Employers Interview Guide ............................................................................
Instructional Staff Survey ...............................................................................
Case Managers/Advisors Survey ..................................................................
Study Participant Interview Guide .................................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Estimated Total Annual Burden
Hours: 6,119.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: OPRE Reports Clearance Officer.
Email address:
OPREinfocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on (a) whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer, Administration for
Children and Families.
[FR Doc. 2012–17641 Filed 7–19–12; 8:45 am]
BILLING CODE 4184–09–P
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18:18 Jul 19, 2012
Jkt 226001
Number of
responses per
respondent
3,600
10,800
3,500
13
21
16
16
19
26
24
80
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0247]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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) 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 August 20,
2012.
ADDRESSES: 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. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–7651,
juanmanuel.vilela@fda.hhs.gov.
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
1
3
1
1
1
1
1
1
1
1
1
Average
burden hours
per response
Total annual
burden hours
0.833
0.083
0.05
2
2
2
2
1
0.5
0.5
1
2,999
2,689
175
26
42
32
32
19
13
12
80
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Guidance for Industry on Formal
Meetings with Sponsors and Applicants
for Prescription Drug User Fee Act
(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), 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),
(b)(1)(iv), and (b)(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
§ 312.47 have been approved by OMB
(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.
E:\FR\FM\20JYN1.SGM
20JYN1
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 140 / Friday, July 20, 2012 / Notices
A. 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
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;
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18:18 Jul 19, 2012
Jkt 226001
• 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.
B. 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);
• 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 (b)(1)(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
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
42745
formal meeting with the Agency
regarding the development and review
of a PDUFA product.
Burden Estimate: Provided below is
an estimate of the annual reporting
burden for the submission of meeting
requests and information packages
under the guidance.
C. Request for a Formal Meeting
Based on data collected from the
review divisions and offices within
CDER and CBER, FDA estimates that
approximately 975 sponsors and
applicants (respondents) request
approximately 2,014 formal meetings
with CDER annually and approximately
127 respondents request approximately
253 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.
D. Information Package
Based on data collected from the
review divisions and offices within
CDER and CBER, FDA estimates that
approximately 756 respondents
submitted approximately 1,394
information packages to CDER annually
and approximately 112 respondents
submitted approximately 203
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.
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
E:\FR\FM\20JYN1.SGM
20JYN1
42746
Federal Register / Vol. 77, No. 140 / Friday, July 20, 2012 / Notices
and 312.82). The information collection
provisions in § 312.47 concerning Endof-Phase 2 meetings and Pre-NDA
meetings have been approved by OMB
(OMB control number 0910 0014).
However, the guidance provides
comment on the proposed collection of
information. FDA received no
comments on the information
collection.
FDA estimates the burden of this
collection of information as follows:
additional recommendations for
submitting information to FDA in
support of a meeting request.
In the Federal Register of March 20,
2012 (77 FR 16235), FDA published a
60-day notice requesting public
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
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
975
127
2.06
1.99
2,014
253
10
10
20,140
2,530
Total .......................................................................
Information Packages:
CDER ............................................................................
CBER ............................................................................
........................
........................
........................
........................
22,670
756
112
1.84
1.81
1,394
203
18
18
25,092
3,654
Total .......................................................................
........................
........................
........................
........................
28,746
Grand Total ....................................................
........................
........................
........................
........................
51,416
Dated: July 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–17557 Filed 7–19–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Advisory Committee for
Pharmaceutical Science and Clinical
Pharmacology; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Advisory
Committee for Pharmaceutical Science
and Clinical Pharmacology.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on August 8, 2012, from 8 a.m. to
5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (rm.
1503), Silver Spring, MD 20993–0002.
Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
VerDate Mar<15>2010
18:18 Jul 19, 2012
Jkt 226001
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Yvette Waples, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
ACPS-CP@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), to find out
further information regarding FDA
advisory committee information. A
notice in the Federal Register about last
minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site at
https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
Agenda: During the first session, the
committee will discuss the uses and
limitations of in vitro dissolution testing
and propose future direction for
evaluation including possible research.
During the second session, the
committee will receive an update on the
FDA’s recently posted draft guidances
for industry on biosimilar products.
This will be an awareness topic and
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
there will not be formal Committee
discussion or recommendation.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before August 1, 2012. Oral
presentations from the public will be
scheduled between approximately
11 a.m. to 12 noon for the first session,
and 3:45 p.m. to 4:15 p.m. for the
second session. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before July 24,
2012. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
E:\FR\FM\20JYN1.SGM
20JYN1
]]>Agencies
[Federal Register Volume 77, Number 140 (Friday, July 20, 2012)]
[Notices]
[Pages 42744-42746]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17557]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0247]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) 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 August
20, 2012.
ADDRESSES: 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.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-7651,
juanmanuel.vilela@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 Prescription Drug User Fee Act (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), 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. 312.47(b)(1)(ii), (b)(1)(iv), and (b)(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 (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.
[[Page 42745]]
A. 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.
B. 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);
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.
312.47(b)(1)(ii) and (b)(1)(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 below is an estimate of the annual
reporting burden for the submission of meeting requests and information
packages under the guidance.
C. Request for a Formal Meeting
Based on data collected from the review divisions and offices
within CDER and CBER, FDA estimates that approximately 975 sponsors and
applicants (respondents) request approximately 2,014 formal meetings
with CDER annually and approximately 127 respondents request
approximately 253 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.
D. Information Package
Based on data collected from the review divisions and offices
within CDER and CBER, FDA estimates that approximately 756 respondents
submitted approximately 1,394 information packages to CDER annually and
approximately 112 respondents submitted approximately 203 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.
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
[[Page 42746]]
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 (OMB control number 0910 0014). However, the guidance
provides additional recommendations for submitting information to FDA
in support of a meeting request.
In the Federal Register of March 20, 2012 (77 FR 16235), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received no comments on the information
collection.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Number of Average
Meeting requests and information Number of responses per Total annual burden per Total hours
packages respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Meeting Requests:
CDER........................ 975 2.06 2,014 10 20,140
CBER........................ 127 1.99 253 10 2,530
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Total................... .............. .............. .............. .............. 22,670
Information Packages:
CDER........................ 756 1.84 1,394 18 25,092
CBER........................ 112 1.81 203 18 3,654
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Total................... .............. .............. .............. .............. 28,746
===============================================================================
Grand Total......... .............. .............. .............. .............. 51,416
----------------------------------------------------------------------------------------------------------------
Dated: July 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17557 Filed 7-19-12; 8:45 am]
BILLING CODE 4160-01-P
