Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Act, 11652-11654 [2013-03705]
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Federal Register / Vol. 78, No. 33 / Tuesday, February 19, 2013 / Notices
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
‘‘Manufactured Food Regulatory
Program Standards.’’
DATES: Submit either electronic or
written comments on the collection of
information by April 22, 2013.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., P150–
400B, Rockville, MD 20850, 301–796–
7726, Ila.Mizrachi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Manufactured Food Regulatory
Program Standards—(OMB Control
Number 0910–0601)—Extension
In the Federal Register of July 20,
2006 (71 FR 41221), FDA announced the
availability of a draft document entitled
‘‘Manufactured Food Regulatory
Program Standards (MFRPS).’’ These
draft program standards are the
framework that States should use to
design and manage its manufactured
food program. The implementation of
the standards will be negotiated as an
option for payment under the State food
contract. States that are awarded this
option will receive up to $25,000 over
a period of 5 years to fully implement
the program standards. Additionally, 26
States may receive up to $300,000 each
year for a period of 5 years to be in
compliance with the 10 standards.
In the first year of implementing the
program standards, the State program
conducts a baseline self-assessment to
determine if they meet the elements of
each standard. The State program
should use the worksheets and forms
contained herein; however, it can use
alternate forms that are equivalent. The
State program maintains the documents
and verifying records required for each
standard. The information contained in
the documents must be current and fitfor-use. If the State program fails to meet
all program elements and
documentation requirements of a
standard, it develops a strategic plan
which includes the following: (1) The
individual element of documentation
requirement of the standard that was not
met; (2) improvements need to meet the
program element or documentation
requirement of the standard; and (3)
projected completion dates for each
task.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Respondent
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total hours
State Departments of Agriculture or Health ........................
44
1
44
303
13,332
TKELLEY on DSK3SPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden has been calculated to
303 hours per respondent. This burden
was determined by capturing the
average amount of time for each
respondent to assess the current state of
the program and work toward
implementation of each of the 10
standards contained in MFRPS. The
hours per respondent will remain the
same as implementation to account for
continuing improvement and selfsufficiency in the program.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0093]
Dated: February 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Evaluation of the
Program for Enhanced Review
Transparency and Communication for
New Molecular Entity New Drug
Applications and Original Biologics
License Applications in Prescription
Drug User Fee Act
[FR Doc. 2013–03707 Filed 2–15–13; 8:45 am]
AGENCY:
BILLING CODE 4160–01–P
HHS.
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PO 00000
Food and Drug Administration,
Frm 00031
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ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
a proposed information collection
involving interviews of pharmaceutical
manufacturers who submit new
molecular entity (NME) new drug
SUMMARY:
E:\FR\FM\19FEN1.SGM
19FEN1
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Federal Register / Vol. 78, No. 33 / Tuesday, February 19, 2013 / Notices
applications (NDAs) and original
biologics license applications (BLAs) to
FDA under the Program for Enhanced
Review Transparency and
Communication (‘‘the Program’’) during
fiscal years (FYs) 2013–2017. The
Program is part of the FDA performance
commitments under the fifth
authorization of the Prescription Drug
User Fee Act (PDUFA), which allows
FDA to collect user fees for the review
of human drug and biologics
applications for FYs 2013–2017.
DATES: Submit either electronic or
written comments on the collection of
information by April 22, 2013.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7726. Ila.Mizrachi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Evaluation of the Program for
Enhanced Review Transparency and
Communication for New Molecular
Entity New Drug Applications and
Original Biologics License Applications
in PDUFA V: Interviews of Applicants
in the Program (OMB Control Number
0910–New)
As part of its commitments in PDUFA
V, FDA has established a new review
Program to promote greater
transparency and increased
communication between the FDA
review team and the applicant on the
most innovative products reviewed by
the Agency. The Program applies to all
NME NDAs and original BLAs that are
received from October 1, 2012, through
September 30, 2017. The Program is
described in detail in section II.B of the
document entitled ‘‘PDUFA
Reauthorization Performance Goals and
Procedures Fiscal Years 2013 through
2017’’ (the ‘‘Commitment Letter’’)
(available at https://www.fda.gov/
downloads/ForIndustry/UserFees/
PrescriptionDrugUserFee/
UCM270412.pdf.
The goals of the Program are to
increase the efficiency and effectiveness
of the first review cycle and decrease
the number of review cycles necessary
for approval so that patients have timely
access to safe, effective, and highquality new drugs and biologics. A key
aspect of the Program is an interim and
final assessment that will evaluate how
well the parameters of the Program have
achieved the intended goals. The
PDUFA V Commitment Letter specifies
that the assessments be conducted by an
independent contractor and that they
include interviews of pharmaceutical
manufacturers who submit NME NDAs
and original BLAs to the Program in
PDUFA V. The contractor for the
assessments of the Program is Eastern
Research Group, Inc. (ERG), and the
statement of work for the assessments is
available at https://www.fda.gov/
downloads/ForIndustry/UserFees/
PrescriptionDrugUserFee/
UCM304793.pdf.
Therefore, in accordance with the
PDUFA V Commitment Letter, FDA
proposes to have ERG conduct
independent interviews of applicants
after FDA issues a first-cycle action for
applications reviewed under the
Program. The purpose of these
interviews is to collect feedback from
applicants on the success of the Program
in increasing review transparency and
communication during the review
process. ERG will anonymize and
aggregate sponsor responses prior to
inclusion in the assessments and any
presentation materials at public
meetings. FDA will publish ERG’s
assessments (with interview results and
findings) in the Federal Register for
public comment.
FDA typically reviews approximately
40 to 45 NME NDAs and original BLAs
per year. ERG will interview 1 to 3
sponsor representatives at a time for
each application that receives a firstcycle action from FDA—up to 135
sponsor representatives per year. Thus,
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
TKELLEY on DSK3SPTVN1PROD with NOTICES
Portion of study
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Pretest ..................................................................................
Interviews .............................................................................
5
135
1
1
5
135
1.5
1.5
7.50
202.50
Total ..............................................................................
........................
........................
........................
........................
210
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
ERG will conduct a pretest of the
interview protocol with five
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respondents. FDA estimates that it will
take 1.0 to 1.5 hours to complete the
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pretest, for a total of a maximum of 7.5
hours. We estimate that up to 135
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Federal Register / Vol. 78, No. 33 / Tuesday, February 19, 2013 / Notices
respondents will take part in the postaction interviews each year, with each
interview lasting 1.0 to 1.5 hours, for a
total of a maximum of 202.5 hours.
Thus, the total estimated annual burden
is 210 hours. FDA’s burden estimate is
based on prior experience with similar
interviews with the regulated
community.
Dated: February 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–03705 Filed 2–15–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0117]
Draft Guidance for Industry and Food
and Drug Administration Staff;
Providing Information About Pediatric
Uses of Medical Devices Under Section
515A of the Federal Food, Drug, and
Cosmetic Act; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Draft Guidance for Industry
and Food and Drug Administration
Staff: Providing Information About
Pediatric Uses of Medical Devices
Under Section 515A of the Federal
Food, Drug, and Cosmetic Act.’’ FDA is
issuing this guidance document to
describe how to compile and submit the
readily available pediatric use
information required under the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act). This draft guidance is not
final nor is it in effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by April 22, 2013.
Submit comments on information
collection issues under the Paperwork
Reduction Act of 1995 by April 22,
2013, (see the ‘‘Paperwork Reduction
Act of 1995’’ section of this document).
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘Draft Guidance for
Industry and Food and Drug
Administration Staff: Providing
Information About Pediatric Uses of
TKELLEY on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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Medical Devices Under Section 515A of
the Federal Food, Drug, and Cosmetic
Act’’ to the Division of Small
Manufacturers, International, and
Consumer Assistance, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4613,
Silver Spring, MD 20993–0002; or the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
that office in processing your request, or
fax your request to 301–847–8149. See
the SUPPLEMENTARY INFORMATION section
for information on electronic access to
the guidance.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
With regard to the guidance: Sheila
Brown, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1651,
Silver Spring, MD 20993–0002, 301–
796–6563; or
Stephen Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville,
MD 20852, 301–827–6210.
With regard to the proposed collection
of information: Daniel Gittleson, Office
of Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–5156, daniel.gittleson@fda.hhs.gov.
I. Background
On September 27, 2007, the Food and
Drug Administration Amendments Act
of 2007 (FDAAA) 1 (Pub. L. 110–85)
amended the FD&C Act by adding,
among other things, a new section 515A
(21 U.S.C. 360e–1) of the FD&C Act.
Section 515A(a) of the FD&C Act
requires persons who submit certain
medical device applications to include,
if readily available:
1. A description of any pediatric
subpopulations that suffer from the
1 Title III of FDAAA, which includes new section
515A, is also known as the Pediatric Medical
Device Safety and Improvement Act of 2007.
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Frm 00033
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Sfmt 4703
disease or condition that the device is
intended to treat, diagnose, or cure; and
2. The number of affected pediatric
patients.
The purpose of this guidance
document is to describe the type of
information that FDA believes is readily
available to the applicant, and the
information FDA believes should be
included in a submission to meet the
requirements of section 515A(a) of the
FD&C Act.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on the requirements relating to the
submission of information on pediatric
subpopulations that suffer from the
disease or condition that a device is
intended to treat, diagnose, or cure. It
does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov or from
CBER at https://www.fda.gov/Biologics
BloodVaccines/GuidanceCompliance
RegulatoryInformation/default.htm. To
receive ‘‘Draft Guidance for Industry
and Food and Drug Administration
Staff: Providing Information About
Pediatric Uses of Medical Devices
Under Section 515A of the Federal
Food, Drug, and Cosmetic Act,’’ you
may either send an email request to
dsmica@fda.hhs.gov to receive an
electronic copy of the document or send
a fax request to 301–847–8149 to receive
a hard copy. Please use the document
number 1801 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
Under the PRA (44 U.S.C. 3501–
3520), Federal Agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information that they conduct or
sponsor. ‘‘Collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320(c) and includes Agency requests or
requirements that members of the public
E:\FR\FM\19FEN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 33 (Tuesday, February 19, 2013)]
[Notices]
[Pages 11652-11654]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03705]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0093]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Evaluation of the Program for Enhanced Review
Transparency and Communication for New Molecular Entity New Drug
Applications and Original Biologics License Applications in
Prescription Drug User Fee Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on a proposed information collection involving
interviews of pharmaceutical manufacturers who submit new molecular
entity (NME) new drug
[[Page 11653]]
applications (NDAs) and original biologics license applications (BLAs)
to FDA under the Program for Enhanced Review Transparency and
Communication (``the Program'') during fiscal years (FYs) 2013-2017.
The Program is part of the FDA performance commitments under the fifth
authorization of the Prescription Drug User Fee Act (PDUFA), which
allows FDA to collect user fees for the review of human drug and
biologics applications for FYs 2013-2017.
DATES: Submit either electronic or written comments on the collection
of information by April 22, 2013.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. All comments should be identified with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-7726. Ila.Mizrachi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Evaluation of the Program for Enhanced Review Transparency and
Communication for New Molecular Entity New Drug Applications and
Original Biologics License Applications in PDUFA V: Interviews of
Applicants in the Program (OMB Control Number 0910-New)
As part of its commitments in PDUFA V, FDA has established a new
review Program to promote greater transparency and increased
communication between the FDA review team and the applicant on the most
innovative products reviewed by the Agency. The Program applies to all
NME NDAs and original BLAs that are received from October 1, 2012,
through September 30, 2017. The Program is described in detail in
section II.B of the document entitled ``PDUFA Reauthorization
Performance Goals and Procedures Fiscal Years 2013 through 2017'' (the
``Commitment Letter'') (available at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf.
The goals of the Program are to increase the efficiency and
effectiveness of the first review cycle and decrease the number of
review cycles necessary for approval so that patients have timely
access to safe, effective, and high-quality new drugs and biologics. A
key aspect of the Program is an interim and final assessment that will
evaluate how well the parameters of the Program have achieved the
intended goals. The PDUFA V Commitment Letter specifies that the
assessments be conducted by an independent contractor and that they
include interviews of pharmaceutical manufacturers who submit NME NDAs
and original BLAs to the Program in PDUFA V. The contractor for the
assessments of the Program is Eastern Research Group, Inc. (ERG), and
the statement of work for the assessments is available at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM304793.pdf.
Therefore, in accordance with the PDUFA V Commitment Letter, FDA
proposes to have ERG conduct independent interviews of applicants after
FDA issues a first-cycle action for applications reviewed under the
Program. The purpose of these interviews is to collect feedback from
applicants on the success of the Program in increasing review
transparency and communication during the review process. ERG will
anonymize and aggregate sponsor responses prior to inclusion in the
assessments and any presentation materials at public meetings. FDA will
publish ERG's assessments (with interview results and findings) in the
Federal Register for public comment.
FDA typically reviews approximately 40 to 45 NME NDAs and original
BLAs per year. ERG will interview 1 to 3 sponsor representatives at a
time for each application that receives a first-cycle action from FDA--
up to 135 sponsor representatives per year. Thus, FDA estimates the
burden of this collection of information as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Portion of study Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Pretest......................... 5 1 5 1.5 7.50
Interviews...................... 135 1 135 1.5 202.50
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 210
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
ERG will conduct a pretest of the interview protocol with five
respondents. FDA estimates that it will take 1.0 to 1.5 hours to
complete the pretest, for a total of a maximum of 7.5 hours. We
estimate that up to 135
[[Page 11654]]
respondents will take part in the post-action interviews each year,
with each interview lasting 1.0 to 1.5 hours, for a total of a maximum
of 202.5 hours. Thus, the total estimated annual burden is 210 hours.
FDA's burden estimate is based on prior experience with similar
interviews with the regulated community.
Dated: February 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03705 Filed 2-15-13; 8:45 am]
BILLING CODE 4160-01-P
