Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Fast Track Drug Development Programs: Designation, Development, and Application Review, 44780-44782 [2014-18168]
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44780
Federal Register / Vol. 79, No. 148 / Friday, August 1, 2014 / Notices
study stimuli while they are still in the
developmental stage. FDA will collect,
analyze, and interpret information
gathered through this generic clearance
in order to: (1) Better understand
characteristics of the target audience—
its perceptions, knowledge, attitudes,
beliefs, and behaviors—and use these in
the development of appropriate survey/
research questions, study stimuli or
communications; (2) more efficiently
and effectively design survey/research
questions and study stimuli; and (3)
more efficiently and effectively design
experimental studies.
FDA is requesting approval of this
new generic for collecting information
through the use of qualitative methods
(i.e., individual interviews, small group
discussions and focus groups) for
studies involving all tobacco products
regulated by FDA. This information will
be used as a first step to explore
concepts of interest and assist in the
development of quantitative study
proposals, complementing other
important research efforts in the
Agency. This information may also be
used to help identify and develop
communication messages, which may
be used in education campaigns. Focus
groups play an important role in
gathering information because they
allow for an in-depth understanding of
individuals’ attitudes, beliefs,
motivations, and feelings. Focus group
research serves the narrowly defined
need for direct and informal public
opinion on a specific topic.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
In Person Individual In-Depth Interviews ........................
General Public Focus Group Interviews .........................
Telephone Screening Interviews .....................................
Telephone Individual In-Depth Interviews .......................
350
18,850
4,800
50
Total .........................................................................
Total
annual
responses
Dated: July 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–18195 Filed 7–31–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0996]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry: Fast Track Drug
Development Programs: Designation,
Development, and Application Review
Food and Drug Administration,
HHS.
ACTION:
350
18,850
4,800
50
Total hours
1 .........................
1.5 ......................
.08 (5 minutes) ...
1 .........................
350
28,275
384
50
........................
29,059
are no capital costs or operating and maintenance costs associated with this collection of information.
The number of respondents to be
included in each new pretest may vary,
depending on the nature of the material
or message being tested and the target
audience. Table 1 provides examples of
the types of studies that may be
administered and estimated burden
levels during the 3-year period. Time to
read, view, or listen to the message
being tested is built into the ‘‘Hours Per
Response’’ figures.
AGENCY:
1
1
1
1
Hours per
response
24,050
1 There
tkelley on DSK3SPTVN1PROD with NOTICES
Number of
responses
per
respondent
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
SUMMARY:
VerDate Mar<15>2010
22:09 Jul 31, 2014
Jkt 232001
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, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the proposed collection of information
concerning requests by sponsors of
investigational new drugs and
applicants for new drug or biologics
licenses for fast track designation as
provided in the Guidance for Industry
on Fast Track Drug Development
Programs: Designation, Development,
and Application Review.
DATES: Submit either electronic or
written comments on the collection of
information by September 30, 2014.
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\01AUN1.SGM
01AUN1
44781
Federal Register / Vol. 79, No. 148 / Friday, August 1, 2014 / Notices
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Guidance for Industry: Fast Track Drug
Development Programs: Designation,
Development, and Application
Review—(OMB Control Number 0910—
0389)—Extension
Section 112(a) of the Food and Drug
Administration Modernization Act of
1997 (FDAMA) (Pub. L. 105–115)
amended the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) by adding
section 506 (21 U.S.C. 356). The section
authorizes FDA to take appropriate
action to facilitate the development and
expedite the review of new drugs,
including biological products, intended
to treat a serious or life-threatening
condition and that demonstrate a
potential to address an unmet medical
need. Under section 112(b) of FDAMA,
FDA issued guidance to industry on fast
track policies and procedures outlined
in section 506 of the FD&C Act. The
guidance discusses collections of
information that are specified under
section 506 of the FD&C Act, other
sections of the Public Health Service
Act (the PHS Act), or implementing
regulations. The guidance describes
three general areas involving the
collection of information: (1) Fast track
designation requests, (2) premeeting
packages, and (3) requests to submit
portions of an application. Of these, fast
track designation requests and
premeeting packages, in support of
receiving a fast track program benefit,
provide for additional collections of
information not covered elsewhere in
statute or regulation. Information in
support of fast track designation or fast
track program benefits that has
previously been submitted to the
Agency, may, in some cases, be
incorporated into the request by
referring to the information rather than
resubmitting it.
Under section 506(a)(1) of the FD&C
Act, an applicant who seeks fast track
designation is required to submit a
request to the Agency showing that the
drug product: (1) Is intended for a
serious or life-threatening condition and
(2) has the potential to address an
unmet medical need. Mostly, the
Agency expects that information to
support a designation request will have
been gathered under existing provisions
of the FD&C Act, the PHS Act, or the
implementing regulations. If such
information has already been submitted
to the Agency, the information may be
summarized in the fast track designation
request. The guidance recommends that
a designation request include, where
applicable, additional information not
specified elsewhere by statute or
regulation. For example, additional
information may be needed to show that
a product has the potential to address an
unmet medical need where an approved
therapy exists for the serious or lifethreatening condition to be treated.
Such information may include clinical
data, published reports, summaries of
data and reports, and a list of references.
The amount of information and
discussion in a designation request need
not be voluminous, but it should be
sufficient to permit a reviewer to assess
whether the criteria for fast track
designation have been met.
After the Agency makes a fast track
designation, a sponsor or applicant may
submit a premeeting package that may
include additional information
supporting a request to participate in
certain fast track programs. The
premeeting package serves as
background information for the meeting
and should support the intended
objectives of the meeting. As with the
request for fast track designation, the
Agency expects that most sponsors or
applicants will have gathered such
information to meet existing
requirements under the FD&C Act, the
PHS Act, or implementing regulations.
These may include descriptions of
clinical safety and efficacy trials not
conducted under an investigational new
drug application (i.e., foreign studies)
and information to support a request for
accelerated approval. If such
information has already been submitted
to FDA, the information may be
summarized in the premeeting package.
Consequently, FDA anticipates that the
additional collection of information
attributed solely to the guidance will be
minimal.
Under section 506(c) of the FD&C Act,
a sponsor must submit sufficient
clinical data for the Agency to
determine, after preliminary evaluation,
that a fast track product may be
effective. Section 506(c) also requires
that an applicant provide a schedule for
the submission of information necessary
to make the application complete before
FDA can commence its review. The
guidance does not provide for any new
collection of information regarding the
submission of portions of an application
that are not required under section
506(c) of the FD&C Act or any other
provision of the FD&C Act.
All forms referred to in the guidance
have current OMB approval: Forms FDA
1571 (OMB control number 0910–0014),
356h (OMB control number 0910–0338),
and 3397 (OMB control number 0910–
0297).
Respondents to this information
collection are sponsors and applicants
who seek fast track designation under
section 506 of the FD&C Act. The
Agency estimates the total annual
number of respondents submitting
requests for fast track designation to the
Center for Biologics Evaluation and
Research and the Center for Drug
Evaluation and Research is
approximately 81, and the number of
requests received is approximately 115
annually. FDA estimates that the
number of hours needed to prepare a
request for fast track designation is
approximately 60 hours per request.
Not all requests for fast track
designation may meet the statutory
standard. Of the requests for fast track
designation made per year, the Agency
granted approximately 100 requests
from 81 respondents, and for each of
these granted requests a premeeting
package was submitted to the Agency.
FDA estimates that the preparation
hours are approximately 100 hours per
premeeting package.
FDA estimates the burden of this
collection of information as follows:
tkelley on DSK3SPTVN1PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Guidance for industry: Fast track drug development programs: Designation, development, and application review
Number of
respondents
Designation Requests ..........................................................
Premeeting Packages ..........................................................
VerDate Mar<15>2010
22:09 Jul 31, 2014
Jkt 232001
PO 00000
Frm 00044
Number of
responses
per
respondent
81
81
Fmt 4703
Sfmt 4703
Total annual
responses
1.42
1.09
E:\FR\FM\01AUN1.SGM
115
88
01AUN1
Average
burden per
response
60
100
Total hours
6,900
8,800
44782
Federal Register / Vol. 79, No. 148 / Friday, August 1, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
........................
........................
........................
........................
Guidance for industry: Fast track drug development programs: Designation, development, and application review
Total ..............................................................................
1 There
[FR Doc. 2014–18168 Filed 7–31–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1048]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Device
Labeling Regulations
Food and Drug Administration,
HHS.
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, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection associated
with the medical device labeling
regulations.
DATES: Submit either electronic or
written comments on the collection of
information by September 30, 2014.
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
SUMMARY:
tkelley on DSK3SPTVN1PROD with NOTICES
15,700
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
AGENCY:
Total hours
VerDate Mar<15>2010
22:09 Jul 31, 2014
Jkt 232001
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Medical Device Labeling Regulations—
21 CFR 800, 801, and 809 (OMB Control
Number 0910–0485)—Extension
Section 502 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 352), among other things,
establishes requirements for the label or
labeling of a medical device so that it is
not misbranded and subject to a
regulatory action. Certain provisions
under section 502 require
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
manufacturers, importers, and
distributors of medical devices to
disclose information about themselves
or the devices, on the labels or labeling
for the devices.
Section 502(b) of the FD&C Act
requires that for packaged devices, the
label must bear the name and place of
business of the manufacturer, packer, or
distributor as well as an accurate
statement of the quantity of the
contents. Section 502(f) of the FD&C Act
requires that the labeling for a device
must contain adequate directions for
use. FDA may however, grant an
exemption, if the Agency determines
that the adequate directions for use
labeling requirements are not necessary
for the particular case, as it relates to
protection of the public health.
FDA regulations under parts 800, 801,
and 809 (21 CFR parts 800, 801, and
809) require disclosure of specific
information by manufacturers,
importers, and distributors of medical
devices about themselves or the devices,
on the label or labeling for the devices
to health professionals and consumers.
FDA issued these regulations under the
authority of sections 201, 301, 502, and
701 of the FD&C Act (21 U.S.C. 321,
331, 352, and 371). Most of the
regulations under parts 800, 801, and
809 are derived from requirements of
section 502 of the FD&C Act, which
provides in part, that a device shall be
misbranded if, among other things, its
label or labeling fails to bear certain
required information concerning the
device, is false or misleading in any
particular way, or fails to contain
adequate directions for use.
Recordkeeping Burden
Section 801.150(a)(2) establishes
recordkeeping requirements for
manufacturers of devices to retain a
copy of the agreement containing the
specifications for the processing,
labeling, or repacking of the device for
2 years after the shipment or delivery of
the device. Section 801.150(a)(2) also
requires that the subject respondents
make copies of this agreement available
for inspection at any reasonable hour to
any officer or employee of the
Department of Health and Human
Services (HHS) who requests them.
E:\FR\FM\01AUN1.SGM
01AUN1
]]>Agencies
[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Notices]
[Pages 44780-44782]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18168]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0996]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry: Fast Track Drug Development
Programs: Designation, Development, and Application Review
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,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the proposed collection of
information concerning requests by sponsors of investigational new
drugs and applicants for new drug or biologics licenses for fast track
designation as provided in the Guidance for Industry on Fast Track Drug
Development Programs: Designation, Development, and Application Review.
DATES: Submit either electronic or written comments on the collection
of information by September 30, 2014.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: 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
[[Page 44781]]
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
Guidance for Industry: Fast Track Drug Development Programs:
Designation, Development, and Application Review--(OMB Control Number
0910--0389)--Extension
Section 112(a) of the Food and Drug Administration Modernization
Act of 1997 (FDAMA) (Pub. L. 105-115) amended the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) by adding section 506 (21 U.S.C. 356).
The section authorizes FDA to take appropriate action to facilitate the
development and expedite the review of new drugs, including biological
products, intended to treat a serious or life-threatening condition and
that demonstrate a potential to address an unmet medical need. Under
section 112(b) of FDAMA, FDA issued guidance to industry on fast track
policies and procedures outlined in section 506 of the FD&C Act. The
guidance discusses collections of information that are specified under
section 506 of the FD&C Act, other sections of the Public Health
Service Act (the PHS Act), or implementing regulations. The guidance
describes three general areas involving the collection of information:
(1) Fast track designation requests, (2) premeeting packages, and (3)
requests to submit portions of an application. Of these, fast track
designation requests and premeeting packages, in support of receiving a
fast track program benefit, provide for additional collections of
information not covered elsewhere in statute or regulation. Information
in support of fast track designation or fast track program benefits
that has previously been submitted to the Agency, may, in some cases,
be incorporated into the request by referring to the information rather
than resubmitting it.
Under section 506(a)(1) of the FD&C Act, an applicant who seeks
fast track designation is required to submit a request to the Agency
showing that the drug product: (1) Is intended for a serious or life-
threatening condition and (2) has the potential to address an unmet
medical need. Mostly, the Agency expects that information to support a
designation request will have been gathered under existing provisions
of the FD&C Act, the PHS Act, or the implementing regulations. If such
information has already been submitted to the Agency, the information
may be summarized in the fast track designation request. The guidance
recommends that a designation request include, where applicable,
additional information not specified elsewhere by statute or
regulation. For example, additional information may be needed to show
that a product has the potential to address an unmet medical need where
an approved therapy exists for the serious or life-threatening
condition to be treated. Such information may include clinical data,
published reports, summaries of data and reports, and a list of
references. The amount of information and discussion in a designation
request need not be voluminous, but it should be sufficient to permit a
reviewer to assess whether the criteria for fast track designation have
been met.
After the Agency makes a fast track designation, a sponsor or
applicant may submit a premeeting package that may include additional
information supporting a request to participate in certain fast track
programs. The premeeting package serves as background information for
the meeting and should support the intended objectives of the meeting.
As with the request for fast track designation, the Agency expects that
most sponsors or applicants will have gathered such information to meet
existing requirements under the FD&C Act, the PHS Act, or implementing
regulations. These may include descriptions of clinical safety and
efficacy trials not conducted under an investigational new drug
application (i.e., foreign studies) and information to support a
request for accelerated approval. If such information has already been
submitted to FDA, the information may be summarized in the premeeting
package. Consequently, FDA anticipates that the additional collection
of information attributed solely to the guidance will be minimal.
Under section 506(c) of the FD&C Act, a sponsor must submit
sufficient clinical data for the Agency to determine, after preliminary
evaluation, that a fast track product may be effective. Section 506(c)
also requires that an applicant provide a schedule for the submission
of information necessary to make the application complete before FDA
can commence its review. The guidance does not provide for any new
collection of information regarding the submission of portions of an
application that are not required under section 506(c) of the FD&C Act
or any other provision of the FD&C Act.
All forms referred to in the guidance have current OMB approval:
Forms FDA 1571 (OMB control number 0910-0014), 356h (OMB control number
0910-0338), and 3397 (OMB control number 0910-0297).
Respondents to this information collection are sponsors and
applicants who seek fast track designation under section 506 of the
FD&C Act. The Agency estimates the total annual number of respondents
submitting requests for fast track designation to the Center for
Biologics Evaluation and Research and the Center for Drug Evaluation
and Research is approximately 81, and the number of requests received
is approximately 115 annually. FDA estimates that the number of hours
needed to prepare a request for fast track designation is approximately
60 hours per request.
Not all requests for fast track designation may meet the statutory
standard. Of the requests for fast track designation made per year, the
Agency granted approximately 100 requests from 81 respondents, and for
each of these granted requests a premeeting package was submitted to
the Agency. FDA estimates that the preparation hours are approximately
100 hours per premeeting package.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Guidance for industry: Fast
track drug development programs: Number of Number of Total annual Average
Designation, development, and respondents responses per responses burden per Total hours
application review respondent response
----------------------------------------------------------------------------------------------------------------
Designation Requests............ 81 1.42 115 60 6,900
Premeeting Packages............. 81 1.09 88 100 8,800
���������������������������������
[[Page 44782]]
Total....................... .............. .............. .............. .............. 15,700
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: July 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18168 Filed 7-31-14; 8:45 am]
BILLING CODE 4164-01-P
