Agency Information Collection Activities; Proposed Collection; Comment Request; Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition, 64218-64220 [2013-25300]
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64218
Federal Register / Vol. 78, No. 208 / Monday, October 28, 2013 / Notices
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• Awards may be subject to federal
income taxes and HHS will comply with
IRS withholding and reporting
requirements, where applicable.
Basis Upon Which Winner Will Be
Selected
Winning solution proposals to this
Challenge will at a minimum meet the
following Requirements:
(1) System is capable of capturing
essential data from durable medical
equipment (DME), including, but not
limited to:
• Loss of external power;
• Power level and status of internal
battery, including remaining battery life
time, if appropriate;
• Unique identifier of the DME or at
minimum, brand and model;
• GPS location;
• Current time/date;
• Device diagnostic information to
determine operational status of DME;
and
• User identifying information.
(2) System is capable of securely
sending all captured data over various
spectrums:
• Send information over medical
body area network (MBAN);
• Robustly transmit over at least two
communication methods/technologies;
e.g. Ethernet, Wi-Fi, Mobile (CDMA,
GSM, LTE), Amateur Radio, ZigBee;
• Ability to switch between/rollover
spectrum/technologies depending on
resource availability;
• Ability to send data automatically
or upon manual command (e.g. at
specified intervals of time, on-demand,
or when triggered by external events);
• No interference with the operation
of the DME;
• Securely transmit ‘‘read only’’ data
collected from DME; and
• Data need to be distributed to a
predetermined list of responders in a
format defined by ASPR.
(3) System is accessible to all in-home
patients with DME:
• Easy to install and set up user
defined characteristics;
• Simple registration process; and
• Simple to use, particularly for
elderly or frail individuals.
A solution may include the use of a
device(s). If this is the case, these
additional specifications must be met:
(1) Low-power consumption
transmitter
• Ideally be constructed of readily
available open source components;
• Consumes low level of standby
power;
• If integrated into DME, consumes
minimal power with no impact upon
DME performance; and
• Alternatively, has its own power
source separate from the DME.
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ASPR is currently working to develop
a piece of open source hardware capable
of executing these functionalities. While
the hardware is near completion, coding
software is still needed and additional
methods (e.g., mobile and social media
apps) are required to establish the
infrastructure needed to support
information transmission using multiple
channels. Hence, ASPR is interested in
additional types of hardware, a
combination of hardware and software,
or a non-technical solution.
Include in your submission a detailed
description of the system (process and/
or device) that will be used under
routine and emergency conditions to:
• Uniquely identify DME;
• Report the current power status of
the device, to include remaining battery
time;
• Report the location of the device;
• Determine the operational status of
DME; and
• Identify a way to contact the DME
user.
Be sure to include the rationale for the
solution and specific ideas to address
the following questions.
• How would people obtain the
system?
• How could they register?
• How will data be transferred to
recipients?
The solution most likely includes a
device, but ASPR is interested in a
versatile submission that would benefit
people from all socioeconomic
backgrounds.
Submitted proposals along with all
relevant supporting data should include
the information described in the
Detailed Description of the Challenge.
Submitted proposals should not
include any personal identifying
information the participants do not
want to make public, or any information
the participant may consider as their
intellectual property that they do not
want to share.
After the Challenge deadline, a review
panel of technical advisers will
complete the review process and make
a decision with regards to the winning
solution(s). All participants that submit
a proposal will be notified about the
status of their submissions; however, no
detailed evaluation of individual
submissions will be provided.
Additional Information
Ownership of intellectual property is
determined by the following:
• Each entrant retains title and full
ownership in and to their submission.
Entrants expressly reserve all
intellectual property rights not
expressly granted under the challenge
agreement. By participating in the
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challenge, each entrant hereby
irrevocably grants to sponsor and
administrator a perpetual, nonexclusive, royalty free, worldwide
license and right to reproduce, publicly
perform, publicly display, and use the
submission to the extent necessary to
administer the challenge, and to
publicly perform and publicly display
the submission, including, without
limitation, for advertising and
promotional purposes relating to the
challenge.
About ASPR
ASPR leads HHS in preparing the
nation to respond to and recover from
adverse health effects of emergencies,
supporting communities’ ability to
withstand adversity, strengthening
health and response systems, and
enhancing national health security. To
learn more about ASPR and
preparedness, response, and recovery
from the health impacts of disasters,
visit the HHS public health and medical
emergency Web site, www.phe.gov.
Dated: October 22, 2013.
Nicole Lurie,
Assistant Secretary for Preparedness and
Response.
[FR Doc. 2013–25280 Filed 10–25–13; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1147]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Preparing a Claim
of Categorical Exclusion or an
Environmental Assessment for
Submission to the Center for Food
Safety and Applied Nutrition
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) 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 provisions of our guidance
SUMMARY:
E:\FR\FM\28OCN1.SGM
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64219
Federal Register / Vol. 78, No. 208 / Monday, October 28, 2013 / Notices
document entitled, ‘‘Preparing a Claim
of Categorical Exclusion or an
Environmental Assessment for
Submission to the Center for Food
Safety and Applied Nutrition.’’
DATES: Submit either electronic or
written comments on the collection of
information by December 27, 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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
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.
Preparing a Claim of Categorical
Exclusion or an Environmental
Assessment for Submission to the
Center for Food Safety and Applied
Nutrition (CFSAN) (OMB Control
Number 0910–0541)—Extension
As an integral part of its decision
making process, we are obligated under
the National Environmental Policy Act
of 1969 (NEPA) to consider the
environmental impact of our actions,
including allowing notifications for food
contact substances to become effective
and approving food additive petitions,
color additive petitions, Generally
Recognized As Safe affirmation
petitions, requests for exemption from
regulation as a food additive, and
actions on certain food labeling citizen
petitions, nutrient content claims
petitions, and health claims petitions. In
1997, we amended our regulations in
part 25 (21 CFR part 25) to provide for
categorical exclusions for additional
classes of actions that do not
individually or cumulatively have a
significant effect on the human
environment (62 FR 40570, July 29,
1997). As a result of that rulemaking, we
no longer routinely require submission
of information about the manufacturing
and production of our regulated articles.
We also have eliminated the previously
required Environmental Assessment
(EA) and abbreviated EA formats from
the amended regulations. Instead, we
have provided guidance that contains
sample formats to help industry submit
a claim of categorical exclusion or an
EA to CFSAN. The guidance document
entitled, ‘‘Preparing a Claim of
Categorical Exclusion or an
Environmental Assessment for
Submission to the Center for Food
Safety and Applied Nutrition’’
identifies, interprets, and clarifies
existing requirements imposed by
statute and regulation, consistent with
the Council on Environmental Quality
regulations (40 CFR 1507.3). It consists
of recommendations that do not
themselves create requirements; rather,
they are explanatory guidance for our
own procedures in order to ensure full
compliance with the purposes and
provisions of NEPA.
The guidance provides information to
assist in the preparation of claims of
categorical exclusion and EAs for
submission to CFSAN. The following
questions are covered in this guidance:
(1) What types of industry-initiated
actions are subject to a claim of
categorical exclusion? (2) What must a
claim of categorical exclusion include
by regulation? (3) What is an EA? (4)
When is an EA required by regulation
and what format should be used? (5)
What are extraordinary circumstances?
and (6) What suggestions does CFSAN
have for preparing an EA?
Although CFSAN encourages industry
to use the EA formats described in the
guidance because standardized
documentation submitted by industry
increases the efficiency of the review
process, alternative approaches may be
used if these approaches satisfy the
requirements of the applicable statutes
and regulations. We are requesting the
extension of OMB approval for the
information collection provisions in the
guidance.
Description of Respondents: The
likely respondents include businesses
engaged in the manufacture or sale of
food, food ingredients, and substances
used in materials that come into contact
with food.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of
respondents
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21 CFR Part 25; Environmental impact considerations
No. of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
§ 25.32(i) ..............................................................................
§ 25.32(o) .............................................................................
§ 25.32(q) .............................................................................
42
1
2
1
1
1
42
1
2
1
1
1
42
1
2
Total ..............................................................................
........................
........................
........................
........................
45
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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64220
Federal Register / Vol. 78, No. 208 / Monday, October 28, 2013 / Notices
The above estimates for respondents
and numbers of responses are based on
the annualized numbers of petitions and
notifications qualifying for § 25.32(i)
and (q) that the Agency has received in
the past 3 years. Please note that, in the
past 3 years, there have been no
submissions that requested an action
that would have been subject to the
categorical exclusion in § 25.32(o). To
avoid counting this burden as zero, we
have estimated the burden for this
categorical exclusion at one respondent
making one submission a year for a total
of one annual submission.
To calculate the estimate for the hours
per response values, we assumed that
the information requested in this
guidance for each of these three
categorical exclusions is readily
available to the submitter. For the
information requested for the exclusion
in § 25.32(i), we expect that submitter
will need to gather information from
appropriate persons in the submitter’s
company and to prepare this
information for attachment to the claim
for categorical exclusion. We believe
that this effort should take no longer
than 1 hour per submission. For the
information requested for the exclusions
in § 25.32(o) and (q), the submitters will
almost always merely need to copy
existing documentation and attach it to
the claim for categorical exclusion. We
believe that collecting this information
should also take no longer than 1 hour
per submission.
Dated: October 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–25300 Filed 10–25–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0804]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Premarket
Notification
AGENCY:
Food and Drug Administration,
wreier-aviles on DSK5TPTVN1PROD with NOTICES
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.
SUMMARY:
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14:52 Oct 25, 2013
Jkt 232001
Fax written comments on the
collection of information by November
27, 2013.
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 0910–0120. Also
include the FDA docket number found
in brackets in the heading of this
document.
DATES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
FOR FURTHER INFORMATION CONTACT:
Premarket Notification—(OMB Control
Number 0910–0120)—Extension
Section 510(k) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360(k)) and the implementing
regulation under part 807 (21 CFR part
807, subpart E) requires a person who
intends to market a medical device to
submit a premarket notification
submission to FDA at least 90 days
before proposing to begin the
introduction, or delivery for
introduction into interstate commerce,
for commercial distribution of a device
intended for human use. Based on the
information provided in the
notification, FDA must determine
whether the new device is substantially
equivalent to a legally marketed device,
as defined in § 807.92(a)(3). If the device
is determined to be not substantially
equivalent to a legally marketed device,
it must have an approved premarket
approval application (PMA), product
development protocol, humanitarian
device exemption (HDE), petition for
Evaluation of Automatic Class III
Designation (de novo), or be reclassified
into class I or class II before being
marketed. FDA makes the final decision
of whether a device is substantially
equivalent or not equivalent.
Section 807.81 states when a
premarket notification is required. A
premarket notification is required to be
submitted by a person who is:
(1) Introducing a device to the market
for the first time;
(2) introducing a device into
commercial distribution for the first
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Fmt 4703
Sfmt 4703
time by a person who is required to
register; and
(3) introducing or reintroducing a
device which is significantly changed or
modified in design, components,
method of manufacturer, or the
intended use that could affect the safety
and effectiveness of the device.
Form FDA 3514, a summary cover
sheet form, assists respondents in
categorizing administrative 510(k)
information for submission to FDA. This
form also assists respondents in
categorizing information for other FDA
medical device programs such as PMAs,
investigational device exemptions, and
HDEs. Under § 807.87(h), each 510(k)
submitter must include in the 510(k)
either a summary of the information in
the 510(k) as required by § 807.92
(510(k) summary) or a statement
certifying that the submitter will make
available upon request the information
in the 510(k) with certain exceptions as
per § 807.93 (510(k) statement). If the
510(k) submitter includes a 510(k)
statement in the 510(k) submission,
§ 807.93 requires that the official
correspondent of the firm make
available within 30 days of a request all
information included in the submitted
premarket notification on safety and
effectiveness. This information will be
provided to any person within 30 days
of a request if the device described in
the 510(k) submission is determined to
be substantially equivalent. The
information provided will be a
duplicate of the 510(k) submission
including any safety and effectiveness
information, but excluding all patient
identifiers and trade secret and
commercial confidential information.
Section 204 of the Food and Drug
Administration Modernization Act
(FDAMA) (Pub. L. 105–115) amended
section 514 of the FD&C Act (21 U.S.C.
360d). Amended section 514 allows
FDA to recognize consensus standards
developed by international and national
organizations for use in satisfying
portions of device premarket review
submissions including premarket
notifications or other requirements. FDA
has published and updated the list of
recognized standards regularly since
enactment of FDAMA and has allowed
510(k) submitters to certify conformance
to recognized standards to meet the
requirements of § 807.87. Form FDA
3654, the 510(k) Standards Data Form,
standardizes the format for submitting
information on consensus standards that
a 510(k) submitter chooses to use as a
portion of their premarket notification
submission (Form FDA 3654 is not for
declarations of conformance to a
recognized standard). FDA believes that
use of this form will simplify the 510(k)
E:\FR\FM\28OCN1.SGM
28OCN1
]]>Agencies
[Federal Register Volume 78, Number 208 (Monday, October 28, 2013)]
[Notices]
[Pages 64218-64220]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25300]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1147]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Preparing a Claim of Categorical Exclusion or an
Environmental Assessment for Submission to the Center for Food Safety
and Applied Nutrition
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) 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
provisions of our guidance
[[Page 64219]]
document entitled, ``Preparing a Claim of Categorical Exclusion or an
Environmental Assessment for Submission to the Center for Food Safety
and Applied Nutrition.''
DATES: Submit either electronic or written comments on the collection
of information by December 27, 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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, 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.
Preparing a Claim of Categorical Exclusion or an Environmental
Assessment for Submission to the Center for Food Safety and Applied
Nutrition (CFSAN) (OMB Control Number 0910-0541)--Extension
As an integral part of its decision making process, we are
obligated under the National Environmental Policy Act of 1969 (NEPA) to
consider the environmental impact of our actions, including allowing
notifications for food contact substances to become effective and
approving food additive petitions, color additive petitions, Generally
Recognized As Safe affirmation petitions, requests for exemption from
regulation as a food additive, and actions on certain food labeling
citizen petitions, nutrient content claims petitions, and health claims
petitions. In 1997, we amended our regulations in part 25 (21 CFR part
25) to provide for categorical exclusions for additional classes of
actions that do not individually or cumulatively have a significant
effect on the human environment (62 FR 40570, July 29, 1997). As a
result of that rulemaking, we no longer routinely require submission of
information about the manufacturing and production of our regulated
articles. We also have eliminated the previously required Environmental
Assessment (EA) and abbreviated EA formats from the amended
regulations. Instead, we have provided guidance that contains sample
formats to help industry submit a claim of categorical exclusion or an
EA to CFSAN. The guidance document entitled, ``Preparing a Claim of
Categorical Exclusion or an Environmental Assessment for Submission to
the Center for Food Safety and Applied Nutrition'' identifies,
interprets, and clarifies existing requirements imposed by statute and
regulation, consistent with the Council on Environmental Quality
regulations (40 CFR 1507.3). It consists of recommendations that do not
themselves create requirements; rather, they are explanatory guidance
for our own procedures in order to ensure full compliance with the
purposes and provisions of NEPA.
The guidance provides information to assist in the preparation of
claims of categorical exclusion and EAs for submission to CFSAN. The
following questions are covered in this guidance: (1) What types of
industry-initiated actions are subject to a claim of categorical
exclusion? (2) What must a claim of categorical exclusion include by
regulation? (3) What is an EA? (4) When is an EA required by regulation
and what format should be used? (5) What are extraordinary
circumstances? and (6) What suggestions does CFSAN have for preparing
an EA?
Although CFSAN encourages industry to use the EA formats described
in the guidance because standardized documentation submitted by
industry increases the efficiency of the review process, alternative
approaches may be used if these approaches satisfy the requirements of
the applicable statutes and regulations. We are requesting the
extension of OMB approval for the information collection provisions in
the guidance.
Description of Respondents: The likely respondents include
businesses engaged in the manufacture or sale of food, food
ingredients, and substances used in materials that come into contact
with food.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
No. of Average
21 CFR Part 25; Environmental No. of responses per Total annual burden per Total hours
impact considerations respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Sec. 25.32(i)................. 42 1 42 1 42
Sec. 25.32(o)................. 1 1 1 1 1
Sec. 25.32(q)................. 2 1 2 1 2
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 45
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 64220]]
The above estimates for respondents and numbers of responses are
based on the annualized numbers of petitions and notifications
qualifying for Sec. 25.32(i) and (q) that the Agency has received in
the past 3 years. Please note that, in the past 3 years, there have
been no submissions that requested an action that would have been
subject to the categorical exclusion in Sec. 25.32(o). To avoid
counting this burden as zero, we have estimated the burden for this
categorical exclusion at one respondent making one submission a year
for a total of one annual submission.
To calculate the estimate for the hours per response values, we
assumed that the information requested in this guidance for each of
these three categorical exclusions is readily available to the
submitter. For the information requested for the exclusion in Sec.
25.32(i), we expect that submitter will need to gather information from
appropriate persons in the submitter's company and to prepare this
information for attachment to the claim for categorical exclusion. We
believe that this effort should take no longer than 1 hour per
submission. For the information requested for the exclusions in Sec.
25.32(o) and (q), the submitters will almost always merely need to copy
existing documentation and attach it to the claim for categorical
exclusion. We believe that collecting this information should also take
no longer than 1 hour per submission.
Dated: October 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-25300 Filed 10-25-13; 8:45 am]
BILLING CODE 4160-01-P
