[Federal Register Volume 86, Number 196 (Thursday, October 14, 2021)]
[Notices]
[Page 57164]
[FR Doc No: 2021-22402]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4535-DR; Docket ID FEMA-2021-0001]

Wyoming; Amendment No. 5 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Wyoming (FEMA-4535-DR), dated April 11, 2020, and
related determinations.

DATES: This change occurred on July 6, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Tammy L.
Littrell, of FEMA is appointed to act as the Federal Coordinating
Officer for this disaster.
    This action terminates the appointment of Nancy J. Dragani as
Federal Coordinating Officer for this disaster.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-22402 Filed 10-13-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 84, Number 65 (Thursday, April 4, 2019)]
[Notices]
[Pages 13302-13304]
[FR Doc No: 2019-06565]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1163]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Providing Regulatory
Submissions in Electronic and Non-Electronic Format--Promotional
Labeling and Advertising Materials for Human Prescription Drugs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 May 6,
2019.

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:<PHONE_NUMBER>, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-NEW and
title ``Providing Regulatory Submissions in Electronic and Non-
Electronic Format--Promotional Labeling and Advertising Materials for
Human Prescription Drugs.'' Also include the FDA docket number found in
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

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.

Providing Regulatory Submissions in Electronic and Non-Electronic
Format--Promotional Labeling and Advertising Materials for Human
Prescription Drugs--OMB Control Number 0910-NEW

    This information collection request supports recommendations found
in the Agency guidance document entitled, ``Providing Regulatory
Submissions in Electronic and Non-Electronic Format--Promotional
Labeling and Advertising Materials for Human Prescription Drugs.'' The
guidance document outlines the requirements and recommendations for
manufacturers, packers, and distributors (firms) that may either be the
applicant or acting on behalf of the applicant, to make submissions
pertaining to promotional materials for human prescription drugs
(``drugs'') to the Office of Prescription Drug Promotion (OPDP) in the
Center for Drug Evaluation and Research (CDER) and the Advertising and
Promotional Labeling Branch (APLB) in the Center for Biologics
Evaluation and Research (CBER). References to ``drugs'' in the guidance
also include human biological products that fall within the definition
of ``drug'' under section 201(g) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 321(g)).
    The guidance describes the various types of submissions of
promotional materials and general considerations for submissions. The
guidance discusses the specific aspects of submission of promotional
materials using module 1 of the electronic Common Technical Document
(eCTD) using version 3.3 or higher of the us-regional-backbone file.
The guidance does not address the more general requirements for a valid
electronic submission using eCTD or the specifications for module 1 of
the eCTD. The guidance contains both binding and nonbinding provisions.
The provisions that are binding implement section 745A(a) of the FD&C
Act (21 U.S.C. 379k-1(a)), which requires that certain submissions be
submitted in electronic format specified by FDA, beginning no earlier
than 24 months after FDA issues a final guidance specifying such
electronic submission format.
    The guidance provides recommendations for what to include with each
type of submission and the number of copies to include if it is a paper
submission. For promotional labeling submitted for advisory comments,
including resubmissions, a submission generally includes correspondence
stating that it is a request for advisory comments, a clean version of
the draft promotional materials, an annotated copy of the promotional
materials, and the most current FDA-approved prescribing information
(PI); if applicable, a submission also includes the FDA-approved
patient labeling or Medication Guide with annotations cross-referenced
to the proposed promotional materials and annotated references to
support product and disease or epidemiology claims not contained in the
PI cross-referenced to the promotional material. Amendments should be
submitted if the previous submission to FDA is missing one or more
promotional materials or if an incorrect document file was included
with a submission in eCTD format. Amendments should include
correspondence stating it is an amendment and include the accompanying
materials that were previously missing, an annotated copy of the
promotional materials that were omitted from a previous submission to
FDA, the FDA-approved patient labeling or Medication Guide with
annotations

cross-referenced to the proposed promotional materials, and annotated
references to support product and disease or epidemiology claims not
contained in the PI cross-referenced to the promotional material.
    General correspondence submissions and submissions requesting to
withdraw a previous submission to FDA include correspondence stating
the purpose of the submission.
    Responses to untitled or warning letter submissions include
correspondence stating that it is a response to an untitled or warning
letter, and include the firm's initial or subsequent responses and the
corrective piece(s), if applicable.
    Responses to information request submissions include the firm's
response to the questions and issues raised in FDA's letter of inquiry,
including any materials that FDA has requested.
    Reference document submissions include correspondence stating that
it is a reference document submission and the specific information
regarding what is in the submission along with the annotated
references, annotated promotional materials, and/or annotated labeling.
    Promotional labeling submitted for advisory comments, including
resubmissions and amendments; general correspondence; requests to
withdraw a previous submission; responses to untitled or warning
letters; responses to information requests; and reference documents can
be submitted in paper or electronic form, and the burden estimates for
these submissions in table 1 apply to both paper and electronic form.
    Complaints include correspondence stating that it is a complaint
and supporting information or documentation, if available. Complaints
are not accepted in electronic form and should be submitted as paper
copies. The burden estimate for complaints in table 1 thus applies to
paper copies only.
    The guidance also describes the number of paper copies that should
be sent to OPDP and APLB for each submission type (if applicable).
    The guidance provides recommendations for presentation
considerations such as appearance, layout, format, and visible
impression of promotional materials submitted for all promotional
submission types.
    The guidance also provides instructions on how to submit
promotional labeling and advertising materials to FDA electronically in
eCTD format. It explains that for submissions of promotional materials
that fall within the ambit of section 745A(a) of the FD&C Act (21
U.S.C. 379k-1(a)), as amended by section 1136 of the Food and Drug
Administration Safety and Innovation Act (Pub. L. 112-144), such
submissions must be made in the electronic format specified by FDA in
the guidance, beginning no earlier than 24 months after the guidance is
finalized. Specifically, (1) postmarketing submissions of promotional
materials using Form FDA 2253 (required by 21 CFR 314.81(b)(3)(i) and
601.12(f)(4)), and (2) submissions of promotional materials for
accelerated approval products (required by FD&C Act section
506(c)(2)(B) (21 U.S.C. 356(c)(2)(B)), and 21 CFR 314.550 and 601.45)
and other products where such submissions are required for approval,
fall within the scope of section 745A(a) and are, therefore, subject to
the mandatory electronic submission requirement.
    When the mandatory electronic submission requirement takes effect
for these types of submissions, they will be accepted by CDER only in
eCTD format using version 3.3 or higher of the us-regional-backbone
file. CBER will be able to accept eCTD submissions using previous
versions of the us-regional-backbone file until 24 months after
publication of the guidance. The guidance also provides that, while
only promotional submissions that fall under section 745A(a) will be
required to be submitted electronically no sooner than 24 months after
the guidance is finalized, firms are strongly encouraged, but not
required, to submit electronically the other types of promotional
submissions discussed in the guidance.
    In the Federal Register of April 22, 2015 (80 FR 22529), we
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received requesting
clarification on the submission of annotated versions of promotional
materials for Form FDA 2253 submissions. We appreciate the comment and
have revised the guidance to further clarify that annotated versions of
promotional materials are encouraged, not required. The guidance was
also revised to encourage the submission of a CD copy of paper
submissions and burden estimates have been updated accordingly. Any
increase in burden is expected to be nominal.
    We estimate the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
       Type of submission            Number of     responses per   Total annual    per response     Total hours
                                    respondents     respondent       responses        (hours)
----------------------------------------------------------------------------------------------------------------
Promotional labeling submitted                76              13           1,024              51          52,224
 for advisory comments,
 including resubmissions and
 amendments.....................
General correspondence submitted              84               4             359               3           1,077
 to FDA.........................
Requests to withdraw a previous               15               1              22               3              66
 submission to FDA..............
Responses to untitled or warning               7               2              13              13             169
 letters........................
Responses to information                       6               1               3              13              39
 requests.......................
Reference documents.............               7               2              14              13             182
Complaints submitted to FDA.....              82               1             117              13           1,521
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          55,278
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimate is based on our experience with the submission of
labeling materials for human prescription drugs. Because this is a new
collection of information, we are specifically interested in receiving
comments from respondents to the information collection regarding our
burden estimate.

    Dated: March 29, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06565 Filed 4-3-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 113 (Thursday, June 12, 2014)]
[Notices]
[Pages 33790-33791]
[FR Doc No: 2014-13694]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72343; File No. SR-NYSEMKT-2014-50]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Amending the NYSE Amex
Options Fee Schedule

June 6, 2014.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on June 2, 2014, NYSE MKT LLC (the ``Exchange'' or ``NYSE
MKT'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to amend the NYSE Amex Options Fee Schedule
(``Fee Schedule''). The proposed changes will be operative on June 2,
2014. The text of the proposed rule change is available on the
Exchange's Web site at www.nyse.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend the Fee Schedule as described below.
The proposed changes will be operative on June 2, 2014.
    The Exchange proposes to modify the existing tier, specifically
Tier 1B, where Order Flow Providers (``OFPs'') can qualify to earn a
rebate under the OFP Electronic ADV Tiers. The Exchange is reducing the
volume requirement under existing Tier 1B from .75% of Total Industry
Customer equity and ETF option ADV to .45% of Total Industry Customer
equity and ETF option ADV. No other changes are being proposed by the
Exchange at this time.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6(b) \4\ of the Act, in general, and
Section 6(b)(4) and (5) \5\ of the Act, in particular, in that it is
designed to provide for the equitable allocation of reasonable dues,
fees, and other charges among its members and other persons using its
facilities and does not unfairly discriminate between customers,
issuers, brokers, or dealers.
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    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(4) and (5).
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    The Exchange believes that the proposal to modify the existing
criteria used by OFPs to qualify and earn a rebate under Tier 1B of the
OFP Customer Electronic ADV is reasonable, equitable and not unfairly
discriminatory for the following reasons.
    First, the Exchange is making it easier for all OFPs to potentially
earn a rebate on certain of their electronic volumes under the newly
proposed criteria under Tier 1B by reducing the percentage of Total
Industry Customer equity and ETF options ADV from .75% to .45%. By
making the threshold lower, it should be easier for more OFPs to
qualify for the rebate and in doing so will lower their overall cost of
doing business on the Exchange, which may, in turn, lead to cost
reductions for the clients of OFPs. The Exchange believes that offering
OFPs a $0.06 per contract rebate under the terms and conditions
proposed in Tier 1B is also reasonable as the rebate is designed to
attract additional Customer volumes along with Non-NYSE Amex Options
Market Maker, Firm, Professional Customer and Broker Dealer volumes to
the Exchange, which benefits all other participants by increasing the
opportunities to trade, enhancing transparency and price discovery.
Requiring a certain level and type of activity before qualifying for a
rebate on a different type of activity is also not new or novel.
Specifically, two other exchanges currently require participants to
commit to a certain level and type of activity before qualifying for a
rebate on other activity.\6\ The Exchange also believes that excluding
certain volumes from being eligible for the rebate, specifically QCC
volumes, electronic Customer Complex volumes, Strategy Executions and
orders routed away in conjunction with the Options Order Protection and
Locked/Crossed Market Plan referenced in Rule 991NY, is also reasonable
as these volumes are already eligible for either reduced rates, rebates
or capped fees and offering additional discounts on these volumes is
not desirable as to do so may lead to increased costs for other
participants. Further, the Exchange notes that excluding such volumes
is consistent with the existing fee schedule.\7\ As the proposed
revision to the qualifying threshold under Tier 1B of the OFP
Electronic ADV Tiers and the associated rebates will be available to
all participants who route electronic Customer business, the Exchange
believes the proposal is also equitable and not unfairly
discriminatory.
---------------------------------------------------------------------------

    \6\ See Chicago Board Options Exchange, Inc. (``CBOE'') Fee
Schedule, available here, http://www.cboe.com/publish/feeschedule/CBOEFeeSchedule.pdf and the CBOE Proprietary Products Sliding Scale
which offers Clearing Trading Permit Holders reduced rates in CBOE
Proprietary Products (SPX, VIX, etc.) if the Clearing Trading Permit
Holder achieves certain ADV thresholds in multiply-listed options.
See also NASDAQ OMX PHLX Fee Schedule, available here, http://www.nasdaqtrader.com/Micro.aspx?id=PHLXPricing and the ``Customer
Rebate Program'' and Tier 3 where, ``The Exchange will pay a $0.02
per contract rebate in addition to the applicable Tier 2 and 3
rebate to a Specialist or Market Maker or its member or member
organization affiliate under Common Ownership provided the
Specialist or Market Maker has reached the Monthly Market Maker Cap,
as defined in Section II.''
    \7\ See Securities and Exchange Commission Release No. 68036
(October 12, 2012) [sic], 77 FR 63900 (October 17, 2012) (SR-
NYSEMKT-2012-50) (establishing OFP Rebates with exclusions for
volume attributable to QCC orders, electronic Customer Complex
volumes, Strategy Executions and orders routed away in conjunction
with the Options Order Protection and Locked/Crossed Market Plan
referenced in Rule 991NY).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange believes that
the proposed

changes will enhance the competiveness of the Exchange relative to
other exchanges. The Exchange notes that it operates in a highly
competitive market in which market participants can readily favor
competing venues if they deem fee levels at a particular venue to be
excessive. In such an environment, the Exchange must continually
review, and consider adjusting, its fees and credits to remain
competitive with other exchanges. For the reasons described above, the
Exchange believes that the proposed rule change reflects this
competitive environment.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \8\ of the Act and subparagraph (f)(2) of Rule 19b-
4 \9\ thereunder, because it establishes a due, fee, or other charge
imposed by the Exchange.
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    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \10\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEMKT-2014-50 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEMKT-2014-50. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEMKT-2014-50, and should
be submitted on or before July 3, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-13694 Filed 6-11-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 112 (Tuesday, June 13, 2017)]
[Rules and Regulations]
[Pages 27015-27016]
[FR Doc No: 2017-12164]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2017-0491]

Safety Zones; Recurring Fireworks Displays Within the Fifth Coast
Guard District

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce safety zones for the Town of
Chesapeake Beach fireworks display taking place over the Chesapeake
Bay, Chesapeake Beach, MD, on July 2, 2017 and the Havre de Grace 4th
of July Celebration fireworks display taking place over the Susquehanna
River, Havre de Grace, MD, on July 2, 2017. During the enforcement
periods, vessels may not enter, remain in, or transit through the
safety zones unless authorized by the Captain of the Port or designated
Coast Guard patrol personnel on scene. This action is necessary to
ensure safety of life on navigable waters during these events.

DATES: The regulations in 33 CFR 165.506, listed as event (b.) 10,
Chesapeake Bay, Chesapeake Beach, MD; Safety Zone, in the table to 33
CFR 165.506 will be enforced from 8:30 p.m. to 10:30 p.m. on July 2,
2017; and in the case of inclement weather enforcement

will be from 8:30 p.m. to 10:30 p.m. on July 3, 2017. The regulations
in 33 CFR 165.506, listed as event (b.) 28, Susquehanna River, Havre de
Grace, MD; Safety Zone, in the table to 33 CFR 165.506 will be enforced
from 8:30 p.m. to 10:30 p.m. on July 2, 2017; and in the case of
inclement weather enforcement will be from 8:30 p.m. to 10:30 p.m. on
July 3, 2017.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email Mr. Ron Houck, U.S. Coast Guard
Sector Maryland-National Capital Region (WWM Division); telephone 410-
576-2674, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The safety zone for the Town of Chesapeake
Beach fireworks display will include all waters within 200 yard radius
of the fireworks barge in approximate position latitude 38[deg]41'36''
N., longitude 076[deg]31'30'' W., and within a 200 yard radius of the
fireworks barge in approximate position latitude 38[deg]41'28'' N.,
longitude 076[deg]31'29'' W. The safety zone for the Havre de Grace 4th
of July Celebration fireworks display will include all waters within a
150 yard radius of the fireworks barge in approximate position latitude
39[deg]32'19'' N., longitude 076[deg]04'58.3'' W.
    This action is being taken to provide for the safety of life on
navigable waterways during these events. As specified in Sec.  165.506
(d), during the enforcement period, vessels may not enter, remain in,
or transit through the safety zone unless authorized by the Coast Guard
Captain of the Port (COTP) or designated Coast Guard patrol personnel
on scene. All persons and vessels shall comply with the instructions of
the COTP, Coast Guard Patrol Commander or the designated on-scene-
patrol personnel. Other Federal, State and local agencies may assist
these personnel in the enforcement of the safety zone. If the COTP or
his designated on-scene patrol personnel determine the regulated area
need not be enforced for the full duration stated in this notice, a
Broadcast Notice to Mariners may be used to grant general permission to
enter the regulated area.
    This notice of enforcement is issued under authority of 33 CFR
165.506(d) and 5 U.S.C. 552(a). In addition to this notice of
enforcement in the Federal Register, the Coast Guard will provide
notification of this enforcement period via the Local Notice to
Mariners and marine information broadcasts.

    Dated: June 8, 2017.
Lonnie P. Harrison, Jr.,
Captain, U.S. Coast Guard, Captain of the Port Maryland-National
Capital Region.
[FR Doc. 2017-12164 Filed 6-12-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 78, Number 178 (Friday, September 13, 2013)]
[Notices]
[Pages 56719-56720]
[FR Doc No: 2013-22311]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Challenging Regulatory and Reimbursement Paradigms for Medical
Devices in the Treatment of Metabolic Diseases: How to Estimate and
Reward True Patient-Centric Value in Innovation; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Changing Regulatory and Reimbursement Paradigms for
Medical Devices in the Treatment of Metabolic Diseases: How to Estimate
and Reward True Patient-Centric Value in Innovation.'' FDA is
cosponsoring the workshop with the American Gastroenterological
Association (AGA). The purpose of the workshop is to facilitate
discussion between FDA, AGA, and other interested parties of the
development of medical devices for the treatment of morbid obesity and
other metabolic diseases and evolving approaches for the regulation and
reimbursement of minimally invasive procedures.
    Dates and Times: The public workshop will be held on October 17,
2013, from 8:30 a.m. to 5 p.m. and October 18, 2013, from 8:30 a.m. to
12:15 p.m.
    Location: The public workshop will be held at the Grand Hyatt
Washington,

1000 H St. NW., Washington, DC 20001,<PHONE_NUMBER>.
    Contact Person: Herbert Lerner, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. G114, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    Registration: Registration is limited and is available on a first-
come, first-served basis. Persons interested in attending this public
workshop must register online by 4 p.m. (EDT), October 10, 2013. Onsite
registration will be available after this date. To register for the
public workshop, please visit AGA's Web site at http://www.gastro.org/education-meetings/live-meetings/aga-fda-regulation-and-reimbursement-workshop. For more information on the workshop, please visit FDA's
Medical Devices News & Events--Workshops & Conferences calendar at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)
    The AGA will collect a registration fee to cover its share of the
expenses associated with the public workshop, which is included in the
registration information on the AGA Web site.
    If you need special accommodations due to a disability, please
contact Herbert Lerner (see ``Contact Person'') at least 7 days before
the public workshop.

SUPPLEMENTARY INFORMATION:

I. Background

    The purpose of the public workshop is to facilitate discussion
between FDA, the AGA and other interested parties on the issues of
device development, public and private payer reimbursement, venture
capital, and regulatory pathways for device innovation and marketing.
The workshop will provide a forum for discussing new approaches for the
treatment of morbid obesity and other metabolic diseases as well as
evolving approaches for the regulation and reimbursement of minimally
invasive procedures.

II. Topics for Discussion at the Public Workshop

    Topics to be discussed at the public workshop include, but are not
limited to:
     Challenges to MedTech Innovation in the United States;
     Evolving Approaches for the Regulation of Minimally
Invasive Procedures: The FDA Benefit/Risk Paradigm;
     Evolving Approaches for the Reimbursement of Minimally
Invasive Procedures: How to Put a Price on Value;
     Obesity as a Disease: Redefining the Regulatory and
Reimbursement Context; and
     The ``Process''--Investigational Device Exemption Review.

    Dated: September 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22311 Filed 9-12-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: December 13, 2006 (Volume 71, Number 239)]
[Notices]
[Page 74966-74967]
[DOCID:fr13de06-77]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54883; File No. SR-CBOE-2006-102]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change To Increase the Class Quoting Limit in the Option Class
NYSE Group, Inc. (NYX)

December 6, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on December 1, 2006, the Chicago Board Options Exchange, Incorporated
(``CBOE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I and II below, which Items have been prepared by the CBOE. The
Exchange has designated this proposal as one constituting a stated
policy, practice, or interpretation with respect to the meaning,
administration, or enforcement of an existing rule under Section
19(b)(3)(A)(i) of the Act,\3\ and Rule 19b-4(f)(1) thereunder,\4\ which
renders the proposal effective upon filing with the Commission. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(i).
    \4\ 17 CFR 240.19b-4(f)(1).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    CBOE proposes to increase the class quoting limit in the option
class NYSE Group, Inc. (NYX). The text of the proposed rule change is

http://www.cboe.com), at the CBOE's Office of the Secretary, and at the

Commission's public reference room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the CBOE included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The CBOE has prepared summaries, set forth in Sections
A, B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    CBOE Rule 8.3A, Maximum Number of Market Participants Quoting
Electronically per Product, establishes class quoting limits (``CQLs'')
for each class traded on the Hybrid Trading System.\5\ A CQL is the
maximum number of quoters that may quote electronically in a given
product and the current levels are established from 25-40, depending on
the trading activity of the particular product.
---------------------------------------------------------------------------

    \5\ See CBOE Rule 8.3A.01.
---------------------------------------------------------------------------

    CBOE Rule 8.3A, Interpretation .01(c) provides a procedure by which
the President of the Exchange may increase the CQL for a particular
product. In this regard, the President of the Exchange may increase the
CQL in exceptional circumstances, which are defined in the rule as ``*
* * substantial trading volume, whether actual or expected.'' \6\ The
effect of an increase in the CQL is procompetitive in that it increases
the number of market participants that may quote electronically in a
product. The purpose of this filing is to increase the CQL in the
option class NYX from its current limit of 30 to 40.
---------------------------------------------------------------------------

    \6\ ``Any actions taken by the President of the Exchange
pursuant to this paragraph will be submitted to the SEC in a rule
filing pursuant to Section 19(b)(3)(A) of the Exchange Act.'' CBOE
Rule 8.3A.01(c).
---------------------------------------------------------------------------

    The national average daily volume in NYX has increased
substantially over the last two months. Increasing the CQL in NYX
options will enable the Exchange to enhance the liquidity offered,
thereby offering deeper and more liquid markets.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations under the Act applicable to a
national securities exchange and, in particular, the requirements of
Section 6(b) of the Act.\7\ Specifically, the Exchange believes the
proposed rule change is consistent with the Section 6(b)(5) \8\
requirements that the rules of an exchange be designed to promote just
and equitable principles of trade, to prevent fraudulent and
manipulative acts and, in general, to protect investors and the public
interest.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    CBOE does not believe that the proposed rule change will impose any
burden on competition not necessary or appropriate in furtherance of
the purposes of the Exchange Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange neither received nor solicited written comments on the
proposal.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing proposed rule change will take effect upon filing
with the Commission pursuant to Section 19(b)(3)(A)(i) of the Act \9\
and Rule 19b-4(f)(1) thereunder,\10\ because it constitutes a stated
policy, practice, or interpretation with respect to the meaning,
administration, or enforcement of an existing rule.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A)(i).
    \10\ 17 CFR 240.19b-4(f)(1).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-CBOE-2006-102 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-CBOE-2006-102. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the CBOE. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-CBOE-2006-102 and should be submitted on or before
January 3, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E6-21160 Filed 12-12-06; 8:45 am]

BILLING CODE 8011-01-P


SUPPORTING STATEMENT

ENVIRONMENTAL PROTECTION AGENCY

NESHAP for Leather Finishing Operations (40 CFR Part 63, Subpart TTTT)
(Renewal)

1.  Identification of the Information Collection

1(a)  Title of the Information Collection

NESHAP for Leather Finishing Operations (40 CFR Part 63, Subpart TTTT)
(Renewal),            EPA ICR Number 1985.04, OMB Control Number
2060-0478

1(b)  Short Characterization/Abstract

The National Emission Standards for Hazardous Air Pollutants (NESHAP)
for Leather Finishing Operations were proposed (65 FR 58702) on October
2, 2000, and promulgated on February 27, 2002.  This standard applies to
each existing, reconstructed, or new leather finishing operation.
Leather finishing is defined as a single process or group of processes
used to adjust and improve the physical and aesthetic characteristics of
the leather surface through the multistage application of a coating
comprising of dyes, pigments, film-forming materials, and performance
modifiers dissolved or suspended in liquid carriers.  A leather
finishing operation is only subject to the regulation if it is a major
source of hazardous air pollutant (HAP) emissions, or is collocated with
other sources that are individually or collectively a major source of
HAP emissions.  A major source emits or has the potential to emit any
single HAP at the rate of 10 tons (9.07 megagrams) or more per year or
any combination of HAP at a rate of 25 tons (22.68 megagrams) or more
per year.

In general, all NESHAP standards require initial notifications,
performance tests, and periodic reports by the owners/operators of the
affected facilities.  They are also required to maintain records of the
occurrence and duration of any startup, shutdown, or malfunction in the
operation of an affected facility, or any period during which the
monitoring system is inoperative. These notifications, reports, and
records are essential in determining compliance and are required of all
affected facilities subject to NESHAP.

Owners or operators of new or existing leather finishing operations must
develop a plan for demonstrating compliance which specifies procedures
to measure finish amounts used, HAP content of finishes, and production
levels for each leather product process operation.  The plan for
demonstrating compliance must be completed by the compliance date and
kept on the site and available for inspection.  The source must document
the finish amount used, the HAP content of the finish, and the
production level for each leather product process operation.  Once a
leather finishing operation has collected twelve months of leather
production data after the date of initial notification, the leather
finishing operation must submit an annual compliance status
certification report each year.

Any owner or operator subject to the provisions of this part will
maintain a file of these measurements, and retain the file for at least
five years following the date of such measurements, maintenance reports,
and records.  Each file will be on the site for at least two years after
the date of each occurrence, measurement, maintenance, report or record
and off-site for the remaining three years.  All reports are sent to the
delegated state or local authority.  In the event that there is no such
delegated authority, the reports are sent directly to the United States
Environmental Protection Agency (EPA) regional office.

Approximately ten respondents are currently subject to the regulation,
and it is estimated that no additional respondents per year will become
subject to the regulation in the next three years.

There are approximately ten leather finishing operations facilities in
the United States, which are owned and operated by the leather finishing
industry.  None of these ten facilities are owned by state, local,
tribal or the Federal government.  Instead, they are all privately-owned
and operated by for-profit businesses.  You can find the burden to the
“Affected Public” listed in Table 1: Annual Industry Burden and Cost
- NESHAP for Leather Finishing Operations (40 CFR Part 63, Subpart TTTT)
(Renewal).  The Federal government burden associated with the review of
reports submitted by the respondent is shown in Table 2: Average Annual
EPA Burden - NESHAP for Leather Finishing Operations (40 CFR Part 63,
Subpart TTTT) (Renewal).

The Office of Management and Budget (OMB) approved the currently active
Information Collection Request (ICR) without any “Terms of
Clearance.”

2.  Need for and Use of the Collection

2(a)  Need/Authority for the Collection

The EPA is charged under section 112 of the Clean Air Act, as amended,
to establish standards of performance for each category or subcategory
of major sources and area sources of HAP.  These standards are
applicable to new or existing sources of HAP and shall require the
maximum degree of emission reduction.  In addition, section 114(a)
states that the Administrator may require any owner or operator subject
to any requirement of this Act to:

(A) Establish and maintain such records; (B) make such reports;    (C)
install, use, and maintain such monitoring equipment, and use such audit
procedures, or methods; (D) sample such emissions (in accordance with
such procedures or methods, at such locations, at such intervals, during
such periods, and in such manner as the Administrator shall prescribe);
(E) keep records on control equipment parameters, production variables
or other indirect data when direct monitoring of emissions is
impractical; (F) submit compliance certifications in accordance with
Section 114(a)(3); and (G) provide such other information as the
Administrator may reasonably require.

In the Administrator's judgment, HAP emissions from leather finishing
operations cause  or contribute to air pollution that may reasonably be
anticipated to endanger public health or welfare.  Therefore, the NESHAP
was promulgated for this source category at 40 CFR part 63,
subpart TTTT.

2(b)  Practical Utility/Users of the Data

The recordkeeping and reporting requirements in the standard ensure
compliance with the applicable regulations which where promulgated in
accordance with the Clean Air Act.  The collected information is also
used for targeting inspections and as evidence in legal proceedings.

Performance tests are required in order to determine an affected
facility’s initial capability to comply with the emission standard.
Continuous emission monitors are used to ensure compliance with the
standard at all times.  During the performance tests, a record of the
operating parameters under which compliance was achieved may be recorded
and used to determine compliance in place of a continuous emission
monitor.

The notifications required in the standard are used to inform the Agency
or delegated authority when a source becomes subject to the requirements
of the regulations.  The reviewing authority may then inspect the source
to ensure that the pollution control devices are properly installed and
operated, that leaks are being detected and repaired, and that the
standards are being met.  The performance test may also be observed.

3.  Non-duplication, Consultations, and Other Collection Criteria

The requested recordkeeping and reporting are required under 40 CFR part
63, subpart TTTT.

3(a)  Non-duplication

If the subject standards have not been delegated, the information is
sent directly to the appropriate EPA regional office.  Otherwise, the
information is sent directly to the delegated state or local agency.  If
a state or local agency has adopted their own similar standards to
implement the Federal standards, a copy of the report submitted to the
state or local agency can be sent to the Administrator in lieu of the
report required by the Federal standards.  Therefore, no duplication
exists.

3(b)  Public Notice Required Prior to ICR Submission to OMB

An announcement of a public comment period for the renewal of this ICR
was published in the Federal Register (72 FR 10735) on March 9, 2007.
No comments were received on the burden published in the Federal
Register.

3(c)  Consultations

The Agency’s industry experts have been consulted, and the Agency’s
internal data sources and projections of industry growth over the next
three years have been considered.  The primary source of information as
reported by industry, in compliance with the recordkeeping and reporting
provisions in the standard, is the Online Tracking Information System
(OTIS) which is operated and maintained by the EPA Office of Compliance.
 OTIS is the EPA database for the collection, maintenance, and retrieval
of all compliance data.  The growth rate for the industry is based on
our consultations with the Agency’s internal industry experts.
Approximately 10 respondents will be subject to the standard over the
three-year period covered by this ICR.

Industry trade associations and other interested parties were provided
an opportunity to comment on the burden associated with the standard as
it was being developed, and the standard has been previously reviewed to
determine the minimum information needed for compliance purposes.

It is our policy to respond after a thorough review of comments received
since the last ICR renewal as well as those submitted in response to the
first Federal Register notice.

3(d)  Effects of Less Frequent Collection

Less frequent information collection would decrease the margin of
assurance that facilities are continuing to meet the standards.
Requirements for information gathering and recordkeeping are useful
techniques to ensure that good operation and maintenance practices are
applied and emission limitations are met.  If the information required
by these standards was collected less frequently, the proper operation
and maintenance of control equipment and the possibility of detecting
violations would be less likely.

3(e)  General Guidelines

None of these reporting or recordkeeping requirements violate any of the
regulations established by OMB at 5 CFR part 1320, section 1320.5.

These standards require the respondents to maintain all records,
including reports and notifications for at least five years.  This is
consistent with the General Provisions as applied to the standards.  EPA
believes that the five-year records retention requirement is consistent
with the Part 70 permit program and the five-year statute of limitations
on which the permit program is based.  The retention of records for five
years allows EPA to establish the compliance history of a source, any
pattern of non-compliance, and to determine the appropriate level of
enforcement action.   EPA has found that the most flagrant violators
have violations extending beyond the five years.    In addition, EPA
would be prevented from pursuing the violators due to either the
destruction or nonexistence of essential records.

3(f)  Confidentiality

Any information submitted to the Agency for which a claim of
confidentiality is made will be safeguarded according to the Agency
policies set forth in title 40, chapter 1, part 2, subpart B -
Confidentiality of Business Information (CBI) (see 40 CFR 2; 41 FR
36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43
FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979).

3(g)  Sensitive Questions

None of the reporting or recordkeeping requirements contain sensitive
questions.

4.  The Respondents and the Information Requested

4(a)  Respondents/SIC Codes

The respondents to the recordkeeping and reporting requirements are
leather finishing operations.  The United States Standard Industrial
Classification (SIC) code for the respondents affected by the standard
is 3111 which correspond to the North American Industry Classification
System (NAICS) code 316110 for Leather and Hide Tanning and Finishing.

4(b)  Information Requested

None of these reporting or recordkeeping requirements violate any of the
regulations established by OMB at 5 CFR part 1320, section 1320.5.

(i)  Data Items

In this ICR, all the data recorded or reported is required by the
National Emission Standards for Hazardous Air Pollutants for Leather
Finishing Operations (40 CFR Part 63, Subpart TTTT).

A source must make the following reports:

Notifications

Initial notification	63.5415(b), 63.5415(d) and 63.9(b)

Notification of intent to construct or reconstruct	63.5415(d) and
63.9(b)

Notification of actual startup	63.5415(b) and 63.9(b)

Notification of site-specific test plan	63.5415(e) and 63.7(b)

Notification of compliance status	63.5415(f) and 63.9(h)

Annual compliance status certification	63.5420(a)

Deviation report	63.5420(b)

A source must keep the following records:

Recordkeeping

Maintain records of finish inventory	63.5430(d) and 63.5335(b)

Maintain records of HAP content	63.5430(e) and 63.5390

Maintain records of leather inventory	63.5430(f) and 63.5400

Record 12 months compliance ratio	63.5330 and 63.5430

Electronic Reporting

Some of the respondents are using monitoring equipment that
automatically records parameter data.  Although personnel at the
affected facility must still evaluate the data, internal automation has
significantly reduced the burden associated with monitoring and
recordkeeping at a plant site.

Also, regulatory agencies in cooperation with the respondents continue
to create reporting systems to transmit data electronically.  However,
electronic reporting systems are still not widely used.  At this time,
it is estimated that approximately 10 percent of the respondents use
electronic reporting.

Respondent Activities

Read instructions.

Install, calibrate, maintain, and operate leather finishing operations
processes.

Perform initial performance test, Reference Methods 24, 311 tests, and
repeat performance tests if necessary.

Write the notifications and reports listed above.

Enter information required to be recorded above.

Submit the required reports developing, acquiring, installing, and
utilizing technology and systems for the purpose of collecting,
validating, and verifying information.

Develop, acquire, install, and utilize technology and systems for the
purpose of processing and maintaining information.

Develop, acquire, install, and utilize technology and systems for the
purpose of disclosing and providing information.

Adjust the existing ways to comply with any previously applicable
instructions and requirements.

Train personnel to be able to respond to a collection of information.

Transmit, or otherwise disclose the information.

	Currently, sources are using monitoring equipment that provides
parameter data in an automated way (e.g., continuous parameter
monitoring system.)  Although personnel at the source still need to
evaluate the data, this type of monitoring equipment has significantly
reduced the burden associated with monitoring and recordkeeping.

5.  The Information Collected: Agency Activities, Collection
Methodology, and Information Management

5(a)  Agency Activities

EPA conducts the following activities in connection with the
acquisition, analysis, storage, and distribution of the required
information.

Agency Activities

Observe initial performance tests and repeat performance tests if
necessary.

Review notifications and reports, including performance test reports,
excess emissions reports, required to be submitted by industry.

Audit facility records.

Input, analyze, and maintain data in the Online Tracking Information
System (OTIS).

5(b)  Collection Methodology and Management

Following notification of startup, the reviewing authority might inspect
the source to determine whether the pollution control devices are
properly installed and operational.   Performance test reports are used
by the Agency to discern a source’s initial capability to comply with
the emission standard, and note the operating conditions under which
compliance was achieved.  Data and records maintained by the respondents
are tabulated and published for use in compliance and enforcement
programs.

Information contained in the reports is entered into OTIS which is
operated and maintained by the EPA Office of Compliance.  OTIS is the
EPA database for the collection, maintenance, and retrieval of
compliance data for approximately 125,000 industrial and
government-owned facilities.  EPA uses OTIS for tracking air pollution
compliance and enforcement by local and state regulatory agencies, EPA
regional offices, and EPA headquarters.  EPA delegated Authorities can
edit, store, retrieve and analyze the data.

The records required by this regulation must be retained by the owner or
operator for five years.

5(c)  Small Entity Flexibility

The majority of the respondents are large entities (i.e., large
businesses).  However, the impact on small entities (i.e., small
businesses) was taken into consideration during the development of the
regulation.  Due to technical considerations involving the process
operations and the types of control equipment employed, the
recordkeeping and reporting requirements are the same for both small and
large entities.  The Agency considers these to be the minimum
requirements needed to ensure compliance and, therefore, cannot reduce
them further for small entities.  To the extent that larger businesses
can use economies of scale to reduce their burden, the overall burden
will be reduced.

5(d)  Collection Schedule

The specific frequency for each information collection activity within
this request is shown in Table 1: Annual Industry Burden for NESHAP
Leather Finishing Operations (40 CFR Part 63, Subpart TTTT) (Renewal),
below.

6.  Estimating the Burden and Cost of the Collection

Table 1 documents the computation of individual burdens for the
recordkeeping and reporting requirements applicable to the industry for
the subpart included in this ICR.  The individual burdens are expressed
under standardized headings believed to be consistent with the concept
of burden under the Paperwork Reduction Act.  Wherever appropriate,
specific tasks and major assumptions have been identified.  Responses to
this information collection are mandatory.

The Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB Control Number.

6(a)  Estimating Respondent Burden

The average annual burden to industry over the next three years from
these record-  keeping and reporting requirements is estimated to be 334
(see Total Labor Hours from Table 1).  These hours are based on Agency
studies and background documents from the development of the regulation,
Agency knowledge and experience with the NESHAP program, the previously
approved ICR, and any comments received.

6(b)  Estimating Respondent Costs

(i)  Estimating Labor Costs

	This ICR uses the following labor rates:

Managerial 	$96.41   ($45.91 + 110%)

Technical	$82.74   ($39.40 + 110%)

Clerical	$42.25   ($20.12 + 110%)

These rates are from the United States Department of Labor, Bureau of
Labor Statistics, September 2004, “Table 10. Private industry, by
occupational and industry group.”  The rates are from column 1,
“Total Compensation.”  The rates have been increased by 110 percent
to account for the benefit packages available to those employed by
private industry.

(ii)  Estimating Capital/Startup and Operation and Maintenance Costs

The only costs to the regulated industry resulting from information
collection activities required by the subject standards are labor costs.
 There are no capital/startup or operation and maintenance costs,
because the leather finishing operations does not require any special
monitoring or recordkeeping equipment; therefore, no capital and
operations and maintenance costs are associated with recordkeeping or
reporting to the rule.

(iii)  Capital/Startup vs. Operation and Maintenance (O&M) Costs

The only type of industry costs associated with the information
collection activity in the regulations is labor costs.  There are no
capital/startup or operation and maintenance costs.

6(c)  Estimating Agency Burden and Cost

The only costs to the Agency are those costs associated with analysis of
the reported information.  The EPA compliance and enforcement program
includes activities such as: the examination of records maintained by
the respondents, periodic inspection of sources of emissions, and the
publication and distribution of collected information.

The average annual Agency cost during the three years of the ICR is
estimated to be $9,097.

This cost is based on the average hourly labor rate as follows:

Managerial	$54.66   (GS-13, Step 5, $34.16 + 60%)

Technical	$40.56   (GS-12, Step 1, $25.35 + 60%)

Clerical	$21.95   (GS-6, Step 3, $13.72 + 60%)

These rates are from the Office of Personnel Management (OPM) “2004
General Schedule” which excludes locality rates of pay.  The rates
have been increased by 60 percent to account for the benefit packages
available to government employees.  Details upon which this estimate is
based appear in Table 2: Average Annual EPA Burden, NESHAP for Leather
Finishing Operations (40 CFR Part 63, Subpart TTTT) (Renewal), below.

6(d)  Estimating the Respondent Universe and Total Burden and Costs

	Based on our research for this ICR, on average over the next three
years, approximately 10 respondents will be subject to the standard.  It
is estimated that no additional sources per year will become subject.
The overall average number of respondents, as shown in the table below
is 10 per year.

	The number of respondents is calculated using the following table which
addresses the three years covered by this ICR.

Number of Respondents

Year	(A)

Number of New Respondents 1	(B)

Number of Existing Respondents	(C)

Number of Existing Respondents That Keep Records But Do Not Submit
Reports	(D)

Number of Existing Respondents That Are Also New Respondents	(E)

Number of Respondents

(E=A+B+C-D)

1	0	10	0	0	10

2	0	10	0	0	10

3	0	10	0	0	10

Average	0	10	0	0	10

1 New respondents include sources with constructed, reconstructed and
modified affected facilities.

To avoid double-counting respondents, column D is subtracted.  As shown
above, the average Number of Respondents over the three-year period of
this ICR is 10.

The total number of annual responses per year is calculated using the
following table:

Total Annual Responses

(A)

Information Collection Activity	(B)

Number of Respondents	(C)

Number of Responses	(D)

Number of Existing Respondents That Keep Records But Do Not Submit
Reports	(E)

Total Annual Responses

E=(BxC)+D

Initial notification	0	1	N/A	0

Notification of intent to construct or reconstruct	0	1	N/A	0

Notification of actual startup	0	1	N/A	0

Notification of site-specific test plant	0	1	N/A	0

Notification of compliance status	0	1	N/A	0

Annual compliance status certification	10	1	N/A	10

Deviation report	0	1	N/A	0

	Total	10

The number of Total Annual Responses is 10.

The total annual labor costs are $21,279.  Details regarding these
estimates may be found in Table 1: Annual Industry Burden and Cost -
NESHAP for Leather Finishing Operations (40 CFR Part 63, Subpart TTTT)
(Renewal), below.

6(e)  Bottom Line Burden Hours Burden Hours and Cost Tables

The detailed bottom line burden hours and cost calculations for the
respondents and the Agency are shown in Tables 1 and 2, respectively,
and summarized below.

(i)  Respondent Tally

The total annual labor costs are $21,279.  Details regarding these
estimates may be found in Table 1: Annual Respondent Burden and Cost:
NESHAP for Leather Finishing Operations (40 CFR Part 63, Subpart TTTT)
(Renewal), below.  Furthermore, the annual public reporting and
recordkeeping burden for this collection of information is estimated to
average 33 hours per response.

The total annual capital/startup and O&M costs to the regulated entity
are $0.

(ii)  The Agency Tally

The average annual Agency burden and cost over next three years is
estimated to be 230 labor hours at a cost of $9,097.  See Table 2:
Annual Agency Burden and Cost: NESHAP for Leather Finishing Operations
(40 CFR Part 63, Subpart TTTT) (Renewal), below.

6(f)  Reasons for Change in Burden

There is no change in the labor hours or cost in this ICR compared to
the previous ICR.  This is due to two considerations: 1) the regulations
have not changed over the past three years and are not anticipated to
change over the next three years; and 2) the growth rate for the
industry is very low, negative or non-existent, so there is no
significant change in the overall burden.

Since there are no changes in the regulatory requirements and there is
no significant industry growth, the labor hours and cost figures in the
previous ICR are used in this ICR, and there is no change in burden to
industry.

6(g)  Burden Statement

The annual public reporting and recordkeeping burden for this collection
of information is estimated to average 33 hours per response.  Burden
means the total time, effort, or financial resources expended by persons
to generate, maintain, retain, or disclose or provide information to or
for a Federal agency.  This includes the time needed to review
instructions; develop, acquire, install, and utilize technology and
systems for the purposes of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; adjust the existing ways to comply with any
previously applicable instructions and requirements; train personnel to
be able to respond to a collection of information; search data sources;
complete and review the collection of information; and transmit or
otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a valid OMB
Control Number.  The OMB Control Numbers for EPA’s regulations are
listed at 40 CFR part 9 and 48 CFR chapter 15.

To comment on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID Number
EPA-HQ-OECA-2007-0064.  An electronic version of the public docket is
available at   HYPERLINK "http://www.regulations.gov/"
http://www.regulations.gov/  which may be used to obtain a copy of the
draft collection of information, submit or view public comments, access
the index listing of the content of the docket, and to access those
documents in the public docket that are available electronically.  When
in the system, select “search” than key in the docket ID number
identified in this document.  The documents are also available for
public viewing at the Enforcement and Compliance Docket       and
Information Center in the EPA Docket Center (EPA/DC), EPA West, Room
3334, 1301 Constitution Avenue, N.W., Washington, DC.  The EPA Docket
Center Public Reading Room      is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal holidays.  The telephone number
for the Reading Room is<PHONE_NUMBER>, and the telephone number for the
Enforcement and Compliance Docket and Information Center Docket is (202)
566-1927.           Also, you can send comments to the Office of
Information and Regulatory Affairs, Office of Management and Budget, 725
17th Street, N.W., Washington, DC 20503, Attention: Desk Officer for
EPA.  Please include the EPA Docket ID Number EPA-HQ-OECA-2007-0064 and
OMB Control Number 2060-0478 in any correspondence.

Part B of the Supporting Statement

This part is not applicable because no statistical methods were used in
collecting this information.

Table 1:  Annual Respondent Burden and Cost – NESHAP for Leather
Finishing Operations (40 CFR Part 63, Subpart TTTT) (Renewal)

Burden item	(A)

Person hours per occurrence	(B)

No. of occurrences per respondent per year	(C)

Person hours per respondent per year

(C=AxB)	(D)

Respondents per year  a	(E)

Technical person- hours per year

(E=CxD)	(F)

Management person hours per year

(Ex0.05)	(G)

Clerical person hours per year

(Ex0.1)	(H)

Total Cost

Per year b

1.  Applications	N/A

	2.  Survey and Studies	N/A

	3.  Reporting requirements

     A.  Read instructions 	4	1	4	0	0	0	0	$0

     B.  Required activities

           Leather production determination	1	12	12	0	0	0	0	$0

           Type of Product process determination	2	4	8	0	0	0	0	$0

           Allowable HAP loss determination	1	12	12	0	0	0	0	$0

           Actual HAP loss determination	1	12	12	0	0	0	0	$0

     C.  Create information	N/A

	     D.  Gather existing information	See 4E

	     E.  Write Report

          Initial notification	2	1	2	0	0	0	0	$0

          Notification of intent to construct	2	1	2	0	0	0	0	$0

          Notification of startup	2	1	2	0	0	0	0	$0

          Notification of site-specific test plan	2	1	2	0	0	0	0	$0

          Submit annual compliance status certification c	12	1	12	10	120
6	12	$8,805.00

          Deviation report d	5	1	5	0	0	0	0	$0

4.  Recordkeeping requirements

     A.  Read instructions 	See 3A

	     B.  Develop compliance plan	50	1	50	0	0	0	0	$0

     C.  Time to enter information

          Finish inventory	1	12	12	0	0	0	0	$0

          HAP content of finish	1	12	12	0	0	0	0	$0

          Leather subcategory production levels	1	12	12	0	0	0	0	$0

     D.  Record compliance ratio e	1	12	12	10	120	6	12	$8,805.00

     E.  Time to train personnel f	5	1	5	10	50	2.5	5	$3,668.75

     G.  Time for audits	N/A

	Subtotals Labor Burden and cost

	290	14.5	29	$21,278.75

TOTAL LABOR BURDEN AND COST (rounded)

333.5

334 (rounded)

$21,279

Assumptions:

a  We have assumed that there are approximately ten  sources that are
subject to the standard, and no additional new sources will become
subject to the rule over the next three years.

b  This ICR uses the following labor rates:  $95.32 per hour for
Executive, Administrative, and Managerial labor; $64.60 per hour for
Technical labor, and $40.09

per hour for Clerical labor.  These rates are from the United States
Department of Labor, Bureau of Labor Statistics, December 2003, “Table
10: Private industry, by occupational and industry group.”  The rates
are from column 1, “Total Compensation.”  The rates have been
increased by 110 percent to account for the benefit packages available
to those employed by private industry.

c  We have assumed that it will take each respondent twelve hours to
complete the compliance status certification report.

d  We have assumed that no respondent will submit a deviation report.

e  We have assumed that each respondent is required to record compliance
ratio determination report on a monthly basis.

f  We have assumed that it will take each respondent five hours to train
personnel.

Table 2:  Average Annual EPA Burden - NESHAP for Leather Finishing
Operations (40 CFR Part 63, Subpart TTTT) (Renewal)

Activity	(A)

EPA person- hours per occurrence	(B)

No. of occurrences per plant per year	(C)

EPA person- hours per plant per year

(C=AxB)	(D)

Plants per year  a	(E)

Technical person- hours per year

(E=CxD)	(F)

Management person-hours per year

(Ex0.05)

	(G)

Clerical person-hours per year

(Ex0.1)	(H)

Cost, $ b

Activity

Review reports

     a.  Initial notification 	4	1	4	0	0	0	0	$0

     b.  Notification of intent to construct	4	1	4	0	0	0	0	$0

     c.  Notification of startup	4	1	4	0	0	0	0	$0

     d.  Notification of site-specific test	4	1	4	0	0	0	0	$0

Periodic reports

     a.  Review annual compliance status

          certification c	20	1	20	10	200	10	20	$9,097.00

     b.  Review deviation reports d  	10	1	10	0	0	0	0	$0

Optional

      Review compliance plan	20	1	20	0	0	0	0	$0

Subtotals Labor Burden and cost

	200	10	20	$9,097.00

TOTAL ANNUAL BURDEN AND COST (rounded)

	230	$9,097

 	Assumptions:

    a  We have assumed that there are approximately ten  sources that
are subject to the standard, and no additional new sources will become
subject to the rule over the next

   three years.

b  This cost is based on the following hourly labor rates times a 1.6
benefits multiplication factor to account for government overhead
expenses: $54.66 for Managerial (GS-13, Step 5, $34.16 x 1.6), $40.56
for Technical (GS-12, Step 1, $25.35 x 1.6) and $21.95 Clerical (GS-6,
Step 3, $13.72 x 1.6).  These rates are from the Office of Personnel
Management (OPM) “2004 General Schedule” which excludes locality
rates of pay.

c  We have assumed that each respondents will take 20 hours to review
the annual compliance status certification report.

d  We have assumed that no respondent will submit a deviation report.

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