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, 11114-11116 [E9-5536]
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11114
Federal Register / Vol. 74, No. 49 / Monday, March 16, 2009 / Notices
Additional Information: Copies of the
proposed collection may be obtained 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. All requests should
be identified by the title of the
information collection. E-mail address:
OPREinfocollection@acf.hhs.qov.
OMB Comment: 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 0MB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: March 9, 2009.
Brendan C. Kelly,
OPRE Reports Clearance Officer.
[FR Doc. E9–5511 Filed 3–13–09; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0556]
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 April 15,
2009.
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,
VerDate Nov<24>2008
15:38 Mar 13, 2009
Jkt 217001
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed 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:
Elizabeth Berbakos, Office of
Information Management (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–796–3792.
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 PDUFA Products (OMB
Control Number 0910–0429)—Extension
This information collection approval
request is for an FDA guidance on the
procedures for formal meetings between
FDA and sponsors or applicants
regarding the development and review
of Prescription Drug User Fee Act
(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 (the
Modernization Act), 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-New Drug
Application meeting. The information
collection provisions under § 312.47
have been approved by OMB (OMB
control no. 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.
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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: FDA Form
1571 (OMB control no. 0910–0014) and
FDA Form 356h (OMB control no.
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
as follows:
• 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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Federal Register / Vol. 74, No. 49 / Monday, March 16, 2009 / Notices
• 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: (1) Determine the utility of
the meeting, (2) identify agency staff
necessary to discuss proposed agenda
items, and (3) 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);
• 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
formal meeting with the agency
regarding the development and review
of a PDUFA product.
Burden Estimate: An estimate of the
annual reporting burden for the
submission of meeting requests and
information packages under the
guidance is provided in table 1 of this
document.
III. Request for a Formal Meeting
Based on data collected from the
review divisions and offices within
CDER and CBER, FDA estimates that
approximately 907 sponsors and
applicants (respondents) request
approximately 2,210 formal meetings
with CDER annually and approximately
144 respondents request approximately
287 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 774 respondents
submitted approximately 1,705
information packages to CDER annually
and approximately 120 respondents
submitted approximately 198
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: (1) Information on how the
agency will interpret and apply section
119(a) of the Modernization Act, (2)
specific PDUFA goals for the
management of meetings associated
with the review of human drug
applications for PDUFA products, and
(3) 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
(OMB control no. 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 these additional estimates
for OMB approval.
In the Federal Register of November
13, 2008 (73 FR 67184), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Meeting Requests and Information
Packages
No. of
Respondents
No. of Responses
per Respondent
Total Annual
Responses
Hours per
Response
Total Hours
Meeting Requests
CDER
907
2.44
2,210
10
22,100
CBER
144
1.99
287
10
2,870
Total
24,970
Information Packages
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Federal Register / Vol. 74, No. 49 / Monday, March 16, 2009 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
Meeting Requests and Information
Packages
No. of
Respondents
No. of Responses
per Respondent
Total Annual
Responses
Hours per
Response
Total Hours
CDER
774
2.20
1,705
18
30,690
CBER
120
1.65
198
18
3,564
Total
34,254
Grand Total
1 There
59,224
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 9, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–5536 Filed 3–13–09; 8:45 am]
SUPPLEMENTARY INFORMATION:
BILLING CODE 4160–01–S
Emergency Shortages Data Collection
System (formerly ‘‘Emergency Medical
Device Shortages Program Survey’’)—
(Federal Food, Drug, and Cosmetic Act,
Section 903 (d)(2) (OMB Control
Number 0910–0491)—Extension
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0635]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Emergency
Shortages Data Collection System
(formerly ‘‘Emergency Medical Device
Shortages Program Survey’’)
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 April 15,
2009.
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:
202–395–6974, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0491. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
VerDate Nov<24>2008
15:38 Mar 13, 2009
Jkt 217001
Under section 903(d)(2) of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 393(d)(2)), the FDA
Commissioner is authorized to
implement general powers (including
conducting research) to carry out
effectively the mission of FDA.
Subsequent to the events of September
11, 2001, and as part of broader counterterrorism and emergency preparedness
activities, FDA’s Center for Devices and
Radiological Health (CDRH) began
developing operational plans and
interventions that would enable the
Center to anticipate and respond to
medical device shortages that might
arise in the context of federally-declared
disasters/emergencies or regulatory
actions. In particular, CDRH identified
the need to acquire and maintain
detailed data on domestic inventory,
manufacturing capabilities, distribution
plans and raw material constraints for
medical devices that would be in high
demand, and/or would be vulnerable to
shortages in specific disaster/emergency
situations, or following specific
regulatory actions. Such data could
support prospective risk assessment,
help inform risk mitigation strategies,
and support real-time decision making
by the Department of Health and Human
Services during actual emergencies or
emergency preparedness exercises.
‘‘The Emergency Medical Device
Shortage Program Survey’’ was
developed in 2002 to support the
acquisition of such data from medical
device manufacturers. In 2004, CDRH
changed the process for the data
collection, and the electronic database
in which the data were stored and was
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
formally renamed the ‘‘Emergency
Shortages Data Collection System’’
(ESDCS). Recognizing that some of the
data collected may be commercially
confidential, access to ESDCS is
restricted to members of the FDA
Emergency Shortage Team (EST) and
senior management with a need-toknow. At this time, the need-to-know
senior management personnel are
limited to 5 senior managers. Further,
the data are used by this defined group
only for decision making and planning
in the context of a federally-declared
disaster/emergency, an official
emergency preparedness exercise, or a
potential public health risk posed by
nondisaster-related device shortage.
The data procurement process
consists of an initial scripted telephone
call to a regulatory officer at a registered
manufacturer of one or more key
medical devices being tracked in the
emergency shortages data collection
system. In this initial call, the intent and
goals of the data collection effort are
described, and the specific data request
is made. After the initial call, one or
more additional follow-up calls and/or
electronic mail correspondence may be
required to verify/validate data sent
from the manufacturer, confirm receipt
and/or request additional detail.
Although the regulatory officer is the
agent who is initially contacted, they
may designate an alternate
representative within their organization
to correspond subsequently with the
CDRH EST member who is collecting or
verifying/validating the data.
Because of the dynamic nature of the
medical device industry, particularly
with respect to specific product lines,
manufacturing capabilities and raw
material/subcomponent sourcing, it is
necessary to update the data in the
ESDCS at regular intervals. This is done
on a weekly basis, but efforts are made
to limit the frequency of outreach to a
specific manufacturer to no more than
every 4 months.
The ESDCS will only include those
medical devices for which there will
likely be high demand during a specific
E:\FR\FM\16MRN1.SGM
16MRN1
]]>Agencies
[Federal Register Volume 74, Number 49 (Monday, March 16, 2009)]
[Notices]
[Pages 11114-11116]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-5536]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0556]
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 April
15, 2009.
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: 202-395-6974, or e-mailed 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: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3792.
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 an FDA guidance
on the procedures for formal meetings between FDA and sponsors or
applicants regarding the development and review of Prescription Drug
User Fee Act (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 (the Modernization Act), 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-New Drug Application meeting.
The information collection provisions under Sec. 312.47 have been
approved by OMB (OMB control no. 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: FDA Form 1571 (OMB control no. 0910-
0014) and FDA Form 356h (OMB control no. 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 as follows:
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;
[[Page 11115]]
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: (1) Determine the
utility of the meeting, (2) identify agency staff necessary to discuss
proposed agenda items, and (3) 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);
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: An estimate of the annual reporting burden for the
submission of meeting requests and information packages under the
guidance is provided in table 1 of this document.
III. Request for a Formal Meeting
Based on data collected from the review divisions and offices
within CDER and CBER, FDA estimates that approximately 907 sponsors and
applicants (respondents) request approximately 2,210 formal meetings
with CDER annually and approximately 144 respondents request
approximately 287 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 774 respondents
submitted approximately 1,705 information packages to CDER annually and
approximately 120 respondents submitted approximately 198 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: (1) Information on how
the agency will interpret and apply section 119(a) of the Modernization
Act, (2) specific PDUFA goals for the management of meetings associated
with the review of human drug applications for PDUFA products, and (3)
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 (OMB control no. 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
these additional estimates for OMB approval.
In the Federal Register of November 13, 2008 (73 FR 67184), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Meeting Requests
and Information No. of No. of Responses Total Annual Hours per Total Hours
Packages Respondents per Respondent Responses Response
----------------------------------------------------------------------------------------------------------------
Meeting Requests
----------------------------------------------------------------------------------------------------------------
CDER 907 2.44 2,210 10 22,100
----------------------------------------------------------------------------------------------------------------
CBER 144 1.99 287 10 2,870
----------------------------------------------------------------------------------------------------------------
Total 24,970
----------------------------------------------------------------------------------------------
Information Packages
----------------------------------------------------------------------------------------------------------------
[[Page 11116]]
CDER 774 2.20 1,705 18 30,690
----------------------------------------------------------------------------------------------------------------
CBER 120 1.65 198 18 3,564
----------------------------------------------------------------------------------------------------------------
Total 34,254
----------------------------------------------------------------------------------------------
Grand Total 59,224
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: March 9, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-5536 Filed 3-13-09; 8:45 am]
BILLING CODE 4160-01-S
