miles from COTP city       (hours)
                                                                                (hours)
(i) Assessment & Planning:
    (A) Remote assessment and consultation.                     1                      1                      1
    (B) On-site fire assessment............                     2                      6                     12
(ii) Fire Suppression:
    (A) External firefighting teams........                     4                      8                     12
    (B) External vessel firefighting                            4                     12                     18
     systems...............................
----------------------------------------------------------------------------------------------------------------
\1\ Heavy lift services are not required to have definite hours for a response time. The planholder must still
  contract for heavy lift services, provide a description of the heavy lift response and an estimated response
  time when these services are required, however, none of the timeframes listed in the table in Sec.
  155.4030(b) will apply to these services.

    (c) Integration into the response organization. You must ensure
that all salvage and marine firefighting resource providers are
integrated into the response organizations listed in your plans. The
response organization must be consistent with the requirements set
forth in Sec. Sec.  155.1035(d), 155.1040(d) and 155.1045(d).
    (d) Coordination with other response resource providers, response
organizations and OSROs. Your plan must include provisions on how the
salvage and marine firefighting resource providers will coordinate with
other response resources, response organizations, and OSROs. For
example, you will need to identify how salvage

and marine firefighting assessment personnel will coordinate response
activity with oil spill removal organizations. For services that, by
law, require public assistance, there must be clear guidelines on how
service providers will interact with those organizations. The
information contained in the response plan must be consistent with
applicable Area Contingency Plans (ACPs) and the National Oil and
Hazardous Substances Pollution Contingency Plan as found in Sec.
155.1030(h).
    (e) Ensuring the proper emergency towing vessels are listed in your
VRP. Your VRP must identify towing vessels with the proper
characteristics, horsepower, and bollard pull to tow your vessel(s).
These towing vessels must be capable of operating in environments where
the winds are up to 40 knots.
    (f) Ensuring the proper type and amount of transfer equipment is
listed in your VRP. Your salvage resource provider must be able to
bring on scene a pumping capability that can offload the vessel's
largest cargo tank in 24 hours of continuous operation. This is
required for both emergency transfer and lightering operations.
    (g) Ensuring firefighting equipment is compatible with your vessel.
Your plan must list the proper type and amount of extinguishing agent
needed to combat a fire involving your vessel's cargo, other contents,
and superstructure. If your primary extinguishing agent is foam or
water, you must identify resources in your plan that are able to pump,
for a minimum of 20 minutes, at least 0.16 gallons per minute per
square foot of the deck area of your vessel, or an appropriate rate for
spaces that this rate is not suitable for and if needed, an adequate
source of foam. These resources described are to be supplied by the
resource provider, external to the vessel's own firefighting system.
    (h) Ensuring the proper subsurface product removal. You must have
subsurface product removal capability if your vessel(s) operates in
waters of 40 feet or more. Your resource provider must have the
capability of removing cargo and fuel from your sunken vessel to a
depth equal to the maximum your vessel operates in up to 150 feet.

Sec.  155.4032  Other resource provider considerations.

    (a) Use of resource providers not listed in the VRP. If another
resource provider, not listed in the approved plan for the specific
service required, is to be contracted for a specific response,
justification for the selection of that resource provider needs to be
provided to, and approved by, the FOSC. Only under exceptional
circumstances will the FOSC authorize deviation from the resource
provider listed in the approved vessel response plan in instances where
that would best affect a more successful response.
    (b) Worker health and safety. Your resource providers must have the
capability to implement the necessary engineering, administrative, and
personal protective equipment controls to safeguard their workers when
providing salvage and marine firefighting services, as found in 33 CFR
155.1055(e) and 29 CFR 1910.120(q).

Sec.  155.4035  Required pre-incident information and arrangements for
the salvage and marine firefighting resource providers listed in
response plans.

    (a) You must provide the information listed in Sec. Sec.
155.1035(c) and 155.1040(c) to your salvage and marine firefighting
resource providers.
    (b) Marine firefighting pre-fire plan.
    (1) You must prepare a vessel pre-fire plan in accordance with NFPA
1405, Guide for Land-Based Firefighters Who Respond to Marine Vessel
Fires, Chapter 9 (Incorporation by reference, see Sec.  155.140). If
the planholder's vessel pre-fire plan is one that meets another
regulation or international standard such as International Convention
for the Safety of Life At Sea (SOLAS), a copy of that specific fire
plan must also be given to the resource provider(s) and be attached to
the VRP.
    (2) The marine firefighting resource provider(s) you are required
to identify in your plan must be given a copy of the plan.
Additionally, they must certify in writing to you that they find the
plan acceptable and agree to implement it to mitigate a potential or
actual fire.
    (3) If a marine firefighting resource provider subcontracts to
other organizations, each subcontracted organization must also receive
a copy of the vessel pre-fire plan.

Sec.  155.4040  Response times for each salvage and marine firefighting
service.

    (a) You must ensure, by contract or other approved means, that your
resource provider(s) is capable of providing the services within the
required timeframes.
    (1) If your vessel is at the pier or transiting a COTP zone within
the continental United States (CONUS), the timeframes in Table
155.4030(b) apply as listed.
    (2) If your vessel is at the pier or transiting a COTP zone outside
the continental United States (OCONUS), the timeframes in Table
155.4030(b) apply as follows:
    (i) Inland waters and nearshore area timeframes apply from the COTP
city out to and including the 12 mile point.
    (ii) Offshore area timeframes apply from 12 to 50 miles outside the
COTP city.
    (3) If your vessel transits within an OCONUS COTP zone that is
outside the areas described in paragraph (a)(2) of this section, but
within the inland waters or the nearshore or offshore area, you must
submit in writing, in your plan, the steps you will take to address
salvage and marine firefighting needs in the event these services are
required.
    (b) The timeframe starts when anyone in your response organization
receives notification of a potential or actual incident. It ends when
the service reaches the ship, the outer limit of the nearshore area,
the outer limit of the offshore area, the 12 or 50-mile point from the
COTP city, or a point identified in your response plan for areas
OCONUS.
    (c) Table 155.4040(c) provides additional amplifying information
for vessels transiting within the nearshore and offshore areas of CONUS
or within 50 miles of an OCONUS COTP city.

            Table 155.4040(c)--Response Timeframe End Points
------------------------------------------------------------------------
           Service                    Response timeframe ends when
------------------------------------------------------------------------
(1) Salvage:                   .........................................
    (i) Remote assessment and  Salvor is in voice contact with Qualified
     consultation.              Individual (QI)/Master/Operator.
    (ii) Begin assessment of   A structural assessment of the vessel has
     structural stability.      been initiated.
    (iii) On-site salvage      Salvor on board vessel.
     assessment.
    (iv) Assessment of         Initial analysis is completed. This is a
     structural stability.      continual process, but at the time
                                specified an analysis needs to be
                                completed.
    (v) Hull and bottom        Survey completed.
     survey.
    (vi) Emergency towing....  Towing vessel on scene.
    vii) Salvage plan........  Plan completed and submitted to Incident
                                Commander/Unified Command.

    (viii) External emergency  External pumps on board vessel.
     transfer operations.
    (ix) Emergency lightering  Lightering equipment on scene and
                                alongside.
    (x) Other refloating       Salvage plan approved & resources on
     methods.                   vessel.
    (xi) Making temporary      Repair equipment on board vessel.
     repairs.
    (xii) Diving services      Required support equipment & personnel on
     support.                   scene.
    (xiii) Special salvage     Plan completed and submitted to Incident
     operations plan.           Commander/Unified Command.
    (xiv) Subsurface product   Resources on scene.
     removal.
    (xv) Heavy lift \1\......  Estimated.
(2) Marine Firefighting:       .........................................
    (i) Remote assessment and  Firefighter in voice contact with QI/
     consultation.              Master/Operator.
    (ii) On-site fire          Firefighter representative on site.
     assessment.
    (iii) External             Team and equipment on scene.
     firefighting teams.
    (iv) External vessel       Personnel and equipment on scene.
     firefighting systems.
------------------------------------------------------------------------
\1\ Heavy lift services are not required to have definite hours for a
  response time. The planholder must still contract for heavy lift
  services, provide a description of the heavy lift response and an
  estimated response time when these services are required, however,
  none of the timeframes listed in the table in Sec.   155.4030(b) will
  apply to these services.

    (d) How to apply the timeframes to your particular situation. To
apply the timeframes to your vessel's situation, follow these
procedures:
    (1) Identify if your vessel operates CONUS or OCONUS.
    (2) If your vessel is calling at any CONUS pier or an OCONUS pier
within 50 miles of a COTP city, you must list the pier location by
facility name or city and ensure that the marine firefighting resource
provider can reach the locations within the specified response times in
Table 155.4030(b).
    (3) If your vessel is transiting within CONUS inland waters,
nearshore or offshore areas or the Great Lakes, you must ensure the
listed salvage and marine firefighting services are capable of reaching
your vessel within the appropriate response times listed in Table
155.4030(b).
    (4) If your vessel is transiting within 12 miles or less from an
OCONUS COTP city, you must ensure the listed salvage and marine
firefighting services are capable of reaching a point 12 miles from the
harbor of the COTP city within the nearshore area response times listed
in Table 155.4030(b).
    (5) If your vessel is transiting between 12 and 50 miles from an
OCONUS COTP city, you must ensure the listed salvage and marine
firefighting services are capable of reaching a point 50 miles from the
harbor of the COTP city within the offshore area response times listed
in Table 155.4030(b).
    (6) If your vessel transits inland waters or the nearshore or
offshore areas OCONUS, but is more than 50 miles from a COTP city, you
must still contract for salvage and marine firefighting services and
provide a description of how you intend to respond and an estimated
response time when these services are required, however, none of the
time limits listed in Table 155.4030(b) will apply to these services.

Sec.  155.4045  Required agreements or contracts with the salvage and
marine firefighting resource providers.

    (a) You may only list resource providers in your plan that have
been arranged by contract or other approved means.
    (b) You must obtain written consent from the resource provider
stating that they agree to be listed in your plan. This consent must
state that the resource provider agrees to provide the services that
are listed in Sec. Sec.  155.4030(a) through 155.4030(h), and that
these services are capable of arriving within the response times listed
in Table 155.4030(b). This consent may be included in the contract with
the resource provider or in a separate document.
    (c) This written consent must be available to the Coast Guard for
inspection. The response plan must identify the location of this
written consent, which must be:
    (1) On board the vessel; or
    (2) With a qualified individual located in the United States.
    (d) Public marine firefighters may only be listed out to the
maximum extent of the public resource's jurisdiction, unless other
agreements are in place. A public marine firefighting resource may
agree to respond beyond their jurisdictional limits, but the Coast
Guard considers it unreasonable to expect public marine firefighting
resources to do this.

Sec.  155.4050  Ensuring that the salvors and marine firefighters are
adequate.

    (a) You are responsible for determining the adequacy of the
resource providers you intend to include in your plan.
    (b) When determining adequacy of the resource provider, you must
select a resource provider that meets the following selection criteria
to the maximum extent possible:
    (1) Resource provider is currently working in response service
needed.
    (2) Resource provider has documented history of participation in
successful salvage and/or marine firefighting operations, including
equipment deployment.
    (3) Resource provider owns or has contracts for equipment needed to
perform response services.
    (4) Resource provider has personnel with documented training
certification and degree experience (Naval Architecture, Fire Science,
etc.).
    (5) Resource provider has 24-hour availability of personnel and
equipment, and history of response times compatible with the time
requirements in the regulation.
    (6) Resource provider has on-going continuous training program. For
marine firefighting providers, they meet the training guidelines in
NFPA 1001, 1005, 1021, 1405, and 1561 (Incorporation by reference, see
Sec.  155.140), show equivalent training, or demonstrate qualification
through experience.
    (7) Resource provider has successful record of participation in
drills and exercises.
    (8) Resource provider has salvage or marine firefighting plans used
and approved during real incidents.
    (9) Resource provider has membership in relevant national and/or
international organizations.
    (10) Resource provider has insurance that covers the salvage and/or
marine firefighting services which they intend to provide.
    (11) Resource provider has sufficient up front capital to support
an operation.

    (12) Resource provider has equipment and experience to work in the
specific regional geographic environment(s) that the vessel operates in
(e.g., bottom type, water turbidity, water depth, sea state and
temperature extremes).
    (13) Resource provider has the logistical and transportation
support capability required to sustain operations for extended periods
of time in arduous sea states and conditions.
    (14) Resource provider has the capability to implement the
necessary engineering, administrative, and personal protective
equipment controls to safeguard the health and safety of their workers
when providing salvage and marine firefighting services.
    (15) Resource provider has familiarity with the salvage and marine
firefighting protocol contained in the local ACPs for each COTP area
for which they are contracted.
    (c) A resource provider need not meet all of the selection criteria
in order for you to choose them as a provider. They must, however, be
selected on the basis of meeting the criteria to the maximum extent
possible.
    (d) You must certify in your plan that these factors were
considered when you chose your resource provider.

Sec.  155.4052  Drills and exercises.

    (a) A vessel owner or operator required by Sec. Sec.  155.1035 and
155.1040 to have a response plan shall conduct exercises as necessary
to ensure that the plan will function in an emergency. Both announced
and unannounced exercises must be included.
    (b) The following are the minimum exercise requirements for vessels
covered by this subpart:
    (1) Remote assessment and consultation exercises, which must be
conducted quarterly;
    (2) Emergency procedures exercises, which must be conducted
quarterly;
    (3) Shore-based salvage and shore-based marine firefighting
management team tabletop exercises, which must be conducted annually;
    (4) Response provider equipment deployment exercises, which must be
conducted annually;
    (5) An exercise of the entire response plan, which must be
conducted every three years. The vessel owner or operator shall design
the exercise program so that all components of the response plan are
exercised at least once every three years. All of the components do not
have to be exercised at one time; they may be exercised over the 3-year
period through the required exercises or through an area exercise; and
    (6) Annually, at least one of the exercises listed in Sec.
155.4052(b)(2) and (4) must be unannounced. An unannounced exercise is
one in which the personnel participating in the exercise have not been
advised in advance of the exact date, time, or scenario of the
exercise.
    (7) Compliance with the National Preparedness for Response Exercise
Program (PREP) Guidelines will satisfy the vessel response plan
exercise requirements. These guidelines are available on the Internet
at https://Homeport.uscg.mil/exercises. Once on that Web site, select
the link for ``Preparedness for Response Exercise Program (PREP)'' and
then select ``Preparedness for Response Exercise Program (PREP)
Guidelines''. Compliance with an alternate program that meets the
requirements of 33 CFR 155.1060(a), and has been approved under 33 CFR
155.1065 will also satisfy the vessel response plan exercise
requirements.

Sec.  155.4055  Temporary waivers from meeting one or more of the
specified response times.

    (a) You may submit a request for a temporary waiver of a specific
response time requirement, if you are unable to identify a resource
provider who can meet the response time.
    (b) Your request must be specific as to the COTP zone, operating
environment, salvage or marine firefighting service, and response time.
    (c) Emergency lightering requirements set forth in Sec.
155.4030(b) will not be subject to the waiver provisions of this
subpart.
    (d) You must submit your request to the Commandant, Director of
Prevention Policy (CG-54), via the local COTP for final approval. The
local COTP will evaluate and comment on the waiver before forwarding
the waiver request, via the District to the Commandant (CG-54) for
final approval.
    (e) Your request must include the reason why you are unable to meet
the time requirements. It must also include how you intend to correct
the shortfall, the time it will take to do so, and what arrangements
have been made to provide the required response resources and their
estimated response times.
    (f) Commandant, Director of Prevention Policy (CG-54), will only
approve waiver requests up to a specified time period, depending on the
service addressed in the waiver request, the operating environment, and
other relevant factors. These time periods are listed in Table
155.4055(g).
    (g) Table 155.4055(g) lists the service waiver time periods.

             Table 155.4055(g)--Service Waiver Time Periods
------------------------------------------------------------------------
                                                                Maximum
                                                                 waiver
                           Service                                time
                                                                 period
                                                                (years)
------------------------------------------------------------------------
(1) Remote salvage assessment & consultation.................          0
(2) Remote firefighting assessment & consultation............          0
(3) On-site salvage & firefighting assessment................          1
(4) Hull and bottom survey...................................          2
(5) Salvage stabilization services...........................          3
(6) Fire suppression services................................          4
(7) Specialized salvage operations...........................          5
------------------------------------------------------------------------

    (h) You must submit your waiver request 30 days prior to any plan
submission deadlines identified in this or any other subpart of part
155 in order for your vessel to continue oil transport or transfer
operations.

    Dated: December 17, 2008.
Brian M. Salerno,
Rear Admiral, U.S. Coast Guard, Assistant Commandant for Marine Safety,
Security and Stewardship.
[FR Doc. E8-30604 Filed 12-30-08; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 81, Number 77 (Thursday, April 21, 2016)]
[Notices]
[Page 23536]
[FR Doc No: 2016-09207]

-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77635; File No. SR-FINRA-2016-010]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Designation of Longer Period for Commission
Action on a Proposed Rule Change To Adopt FINRA Rule 4554 (Alternative
Trading Systems--Recording and Reporting Requirements of Order and
Execution Information for NMS Stocks)

April 15, 2016.
    On February 29, 2016, the Financial Industry Regulatory Authority,
Inc. (``FINRA'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to require alternative trading systems (``ATSs'')
to submit additional order information to FINRA. The proposed rule
change was published for comment in the Federal Register on March 7,
2016.\3\ The Commission received one comment letter on the proposal.\4\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 77269 (March 1,
2016), 81 FR 11851 (March 7, 2016).
    \4\ See Letter to the Secretary from Theodore R. Lazo, Managing
Director and Associate General Counsel, Securities Industry and
Financial Markets Association (``SIFMA''), dated April 1, 2016
(``SIFMA Letter'').
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \5\ provides that, within 45 days of
the publication of the notice of the filing of a proposed rule change,
or within such longer period up to 90 days as the Commission may
designate if it finds such longer period to be appropriate and
publishes its reasons for so finding or as to which the self-regulatory
organization consents, the Commission shall approve the proposed rule
change, disapprove the proposed rule change, or institute proceedings
to determine whether the proposed rule change should be disapproved.
The 45th day for this filing is April 21, 2016.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission is extending this 45-day time period. The Commission
finds that it is appropriate to designate a longer period within which
to take action on the proposed rule change so that it has sufficient
time to consider the comment received on the proposal.
    Accordingly, pursuant to Section 19(b)(2) of the Act,\6\ the
Commission designates June 3, 2016, as the date by which the Commission
should approve, disapprove, or institute proceedings to determine
whether to disapprove the proposed rule change (File No. SR FINRA-2016-
010).
---------------------------------------------------------------------------

    \6\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(31).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2016-09207 Filed 4-20-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 227 (Monday, November 28, 2022)]
[Notices]
[Pages 73059-73060]
[FR Doc No: 2022-25786]

-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96368; File No. SR-EMERALD-2022-32]

Self-Regulatory Organizations; MIAX Emerald, LLC; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change to Amend
Exchange Rule 515 to Make a Minor, Non-Substantive Edit

November 21, 2022.
    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 November 10, 2022, MIAX Emerald, LLC (``MIAX Emerald'' 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 Exchange. The Exchange
filed the proposal as a ``non-controversial'' proposed rule change
pursuant to Section 19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-
4(f)(6) thereunder. 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)(iii).
---------------------------------------------------------------------------

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

    The Exchange proposes to make a minor, non-substantive edit to
Exchange Rule 515, Execution of Orders and Quotes.
    The text of the proposed rule change is available on the Exchange's
website at http://www.miaxoptions.com/rule-filings/emerald, at MIAX
Emerald's principal office, 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 Exchange 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 Exchange 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
    The Exchange proposes to amend Exchange Rule 515 to make a minor,
non-substantive edit to the numbering convention used in the rule to
provide accuracy, precision, and ease of reference within the rule
text.
    Specifically, the Exchange proposes to amend Rule 515(h)(4)(D) to
change the reference from subparagraph ``(D)'' to subparagraph
``(iv).'' On July 1, 2022, the Exchange submitted a substantive
proposal to adopt new paragraph (D) to Exchange Rule 515(h)(4).\4\
Concurrently, the Exchange filed a proposal to make a number of non-
substantive edits within rule 515 to, among other things, harmonize the
numbering hierarchy within the rule to that used throughout the
Exchange's Rulebook.\5\ However, this proposal did not include
paragraph (D) to Rule 515(h)(4) as that provision had not yet become
operative on the Exchange.
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 95272 (July 13,
2022), 87 FR 43065 (July 20, 2022) (SR-EMERALD-2022-23).
    \5\ See Securities Exchange Act Release No. 95343 (July 20,
2022), 87 FR 44475 (July 26, 2022) (SR-EMERALD-2022-24).
---------------------------------------------------------------------------

    The Exchange recently implemented its proposal that includes new
subparagraph (D) to Rule 515(h)(4) \6\ and now proposes to amend
subparagraph (D) to renumber as subparagraph (iv) to conform with the
numbering convention used throughout Rule 515. No other changes to the
rule are proposed.
---------------------------------------------------------------------------

    \6\ See MIAX Emerald Regulatory Circular 2022-59, Four Decimal
Precision for Pricing Stock-Option Complex Strategies (October 18,
2022) available at https://www.miaxoptions.com/sites/default/files/circular-files/MIAX_Emerald_Options_RC_2022_59.pdf.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule changes are consistent
with Section 6(b) of the Act \7\ in general, and furthers the
objectives of Section 6(b)(5) of the Act \8\ in particular, in that
they are designed to prevent fraudulent and manipulative acts and
practices, promote just and equitable principles of trade, foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, remove impediments to and
perfect the mechanisms of a free and open market and a national market
system and, in general, protect investors and the public interest.
---------------------------------------------------------------------------

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

    The Exchange believes that the proposed change to Exchange Rule 515
promotes just and equitable principles of trade and removes impediments
to and perfects the mechanism of a free and open market and a national
market system because the proposed rule change will provide greater
clarity to Members \9\ and the public regarding the Exchange's Rules by
conforming the numbering in Exchange Rule 515 to the existing
identification scheme in the Exchange's Rulebook. It is in the public
interest for rules to be accurate and concise so as to eliminate the
potential for confusion.
---------------------------------------------------------------------------

    \9\ The term ``Member'' means an individual or organization
approved to exercise the trading rights associated with a Trading
Permit. Members are deemed ``members'' under the Exchange Act. See
Exchange Rule 100.
---------------------------------------------------------------------------

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 not necessary or appropriate in
furtherance of the purposes of the Act. Specifically, the Exchange
believes the proposed change will not impose any burden on intra-market
competition as there is no functional change to the Exchange's System
\10\ and because the rules of the Exchange apply to all MIAX Emerald
participants equally. The Exchange believes the proposed rule change
will not impose any burden on intra-market competition as the proposed
change is not designed to address any competitive issue but rather is
designed to remedy a minor non-substantive issue and provide added
precision and accuracy to the rule text of Exchange Rule 515. In
addition, the Exchange does not believe the proposal will impose any
burden on inter-market competition as the proposal does not address any
competitive issues and is intended to protect investors by providing
further transparency and precision for referencing the Exchange's
Rules.
---------------------------------------------------------------------------

    \10\ The term ``System'' means the automated trading system used
by the Exchange for the trading of securities. See Exchange Rule
100.
---------------------------------------------------------------------------

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

    Written comments were neither solicited nor received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \11\ and Rule 19b-4(f)(6) \12\ thereunder
because the proposal does not: (i) significantly affect the protection
of investors or the public interest; (ii) impose any significant burden
on competition; and (iii) by its terms, become operative for 30 days
from the date on which it was filed, or such shorter time as the
Commission may designate if consistent with the protection of investors
and the public interest.\13\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6).
    \13\ In addition, Rule 19b-4(f)(6)(iii) requires the Exchange to
give the Commission written notice of the Exchange's intent to file
the proposed rule change, along with a brief description and text of
the proposed rule change, at least five business days prior to the
date of filing of the proposed rule change, or such shorter time as
designated by the Commission. The Exchange has satisfied this
requirement.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \14\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \15\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has asked the Commission to waive the 30-day operative delay so that
the proposal may become operative immediately upon filing.
---------------------------------------------------------------------------

    \14\ 17 CFR 240.19b-4(f)(6).
    \15\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    The Exchange states that waiver of the 30-day operative delay would
permit the Exchange to update the subparagraph numbering in Exchange
Rule 515 immediately, thereby avoiding any potential investor confusion
during the operative delay period. The Commission believes that waiver
of the 30-day operative delay is consistent with the protection of
investors and the public interest because the proposed rule change does
not raise any new or novel issues. Accordingly, the Commission hereby
waives the operative delay and designates the proposal operative upon
filing.\16\
---------------------------------------------------------------------------

    \16\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the 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.\17\
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78s(b)(3)(C).
---------------------------------------------------------------------------

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 protected]. Please include
File Number SR-EMERALD-2022-32.

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-EMERALD-2022-32. 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 website (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 website 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 the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-EMERALD-2022-32, and should be submitted
on or before December 19, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-25786 Filed 11-25-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: November 30, 2010 (Volume 75, Number 229)]
[Notices]
[Page 74061-74062]
[DOCID:fr30no10-95]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0594]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Focus Groups as Used by the Food and Drug
Administration (All Food and Drug Administration Regulated Products)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on focus groups as used by FDA to
gauge public opinion on all FDA-regulated products.

DATES: Submit either electronic or written comments on the collection
of information by January 31, 2011.

ADDRESSES: Submit electronic comments on the collection of information
to http://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: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
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.

Focus Groups as Used by the Food and Drug Administration (All FDA-
Regulated Products)--(OMB Control Number 0910-0497)--Extension

    FDA conducts focus group interviews on a variety of topics
involving FDA-regulated products, including drugs, biologics, devices,
food, tobacco, and veterinary medicine.
    Focus groups provide an important role in gathering information
because they allow for a more indepth understanding of consumers'
attitudes, beliefs, motivations, and feelings than do quantitative
studies. Focus groups serve the narrowly defined need for direct and
informal opinion on a specific topic and as a qualitative research tool
have three major purposes:
     To obtain consumer information that is useful for
developing variables and measures for quantitative studies,
     To better understand consumers' attitudes and emotions in
response to topics and concepts, and
     To further explore findings obtained from quantitative
studies.
    FDA will use focus group findings to test and refine their ideas
but will generally conduct further research before making important
decisions, such as adopting new policies and allocating or redirecting
significant resources to support these policies.
    FDA estimates the burden of this collection of information as
follows:

                                                      Table 1--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Annual
                              Activity                                  Number of      frequency per     Total annual      Hours per       Total hours
                                                                       respondents        response        responses         response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Focus Group Interviews.............................................           1,440                1            1,440             1.75            2,520
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with this collection of information.

    Annually, FDA projects about 20 focus group studies using 160 focus
groups with an average of 9 persons per group, and lasting an average
of 1.75 hours each. FDA is requesting this burden for unplanned focus
groups so as not to restrict the Agency's ability to gather information
on public sentiment of its proposals in its regulatory and
communications programs.

    Dated: November 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30037 Filed 11-29-10; 8:45 am]
BILLING CODE 4160-01-P


Vinson Hellwig<EMAIL_ADDRESS>08/31/2006 11:37 AM	To Keith Barnett/RTP/USEPA/US@EPA, Susan Thorneloe/RTP/USEPA/US@EPA cc

bcc

Subject Speciated Hg Test Results from Lafarge, Alpena, MI 	 	 	History:	 This message has been replied to and forwarded.

Attached is a copy of the stack test results for speciated test from Lafarge. Thanks,

G. Vinson Hellwig Chief, Air Quality Division Michigan Department of Environmental Quality 517-373-7069 <EMAIL_ADDRESS>


[Federal Register Volume 88, Number 246 (Tuesday, December 26, 2023)]
[Notices]
[Pages 88974-88975]
[FR Doc No: 2023-28337]

-----------------------------------------------------------------------

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2010-0013]

SolarPTL, LLC: Grant of Expansion of Recognition

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In this notice, OSHA announces the final decision to expand
the scope of recognition for SolarPTL, LLC as a Nationally Recognized
Testing Laboratory (NRTL).

DATES: The expansion of the scope of recognition becomes effective on
December 26, 2023.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor; telephone:<PHONE_NUMBER>;
email: [email protected].
    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor; telephone:
(202) 693-1911; email: [email protected]. OSHA's web page includes
information about the NRTL Program (see http://www.osha.gov/dts/otpca/nrtl/index.html).

SUPPLEMENTARY INFORMATION:

I. Notice of Final Decision

    OSHA hereby gives notice of the expansion of the scope of
recognition for SolarPTL LLC (PTL). PTL's expansion covers the addition
of two test standards to the NRTL scope of recognition.
    OSHA recognition of a NRTL signifies that the organization meets
the requirements specified in 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within the
scope of recognition. Each NRTL's scope of recognition includes (1) the
type of products the NRTL may test, with each type specified by the
applicable test standard and (2) the recognized site(s) that has/have
the technical capability to perform the product-testing and product-
certification activities for test standards within the NRTL's scope.
Recognition is not a delegation or grant of government authority;
however, recognition enables employers to use products approved by the
NRTL to meet OSHA standards that require product testing and
certification.
    The agency processes applications by a NRTL for initial
recognition, as well as for an expansion or renewal of recognition,
following requirements in Appendix A to 29 CFR 1910.7. This appendix
requires that the agency publish two notices in the Federal Register in
processing an application. In the first notice, OSHA announces the
application and provides the preliminary finding. In the second notice,
the agency provides the final decision on the application. These
notices set forth the NRTL's scope of recognition or modifications of
that scope. OSHA maintains an informational web page for each NRTL,
including PTL, which details that NRTL's scope of recognition. These
pages are available from the OSHA website at https://www.osha.gov/dts/otpca/nrtl/index.html.
    PTL submitted an application, dated December 21, 2018 (OSHA-2010-
0013-0007), to expand recognition as a NRTL to include one additional
test standard. The standard requested, UL 61730, was referenced in
application as a single standard; however this standard has two parts.
PTL amended the application on October 30, 2023 (OSHA-2010-0013-0008),
to clarify that the expansion request was for both parts of the
standard. OSHA staff performed a detailed analysis of the application
packet and reviewed other pertinent information. OSHA performed an on-
site assessment related to this application on August 16-17, 2022,
where OSHA found nonconformances with the requirements of 29 CFR part
1910. PTL addressed the nonconformances adequately and OSHA has no
objection to the addition of both parts of this standard to the NRTL
scope of recognition.
    OSHA published the preliminary notice announcing PTL's expansion
application in the Federal Register on November 21, 2023 (88 FR 81107).
The agency requested comments by December 6, 2023, but it received no
comments in response to this notice. OSHA now is proceeding with this
final notice to grant expansion of PTL's NRTL scope of recognition.

    To review copies of all public documents pertaining to PTL's
application, go to https://www.regulations.gov or contact the Docket
Office, Occupational Safety and Health Administration, U.S. Department
of Labor at<PHONE_NUMBER>. Docket No. OSHA-2010-0013 contains all
materials in the record concerning PTL's recognition. All submissions,
including copyrighted material, are available for inspection through
the OSHA Docket Office. Contact the OSHA Docket Office at (202) 693-
2350 for assistance in locating docket submissions.

II. Final Decision and Order

    OSHA staff examined PTL's expansion application, their capability
to meet the requirements of the test standards, and other pertinent
information. Based on its review of this evidence, OSHA finds that PTL
meets the requirements of 29 CFR 1910.7 for expansion of its
recognition, subject to the limitations and conditions listed below.
OSHA, therefore, is proceeding with this final notice to grant PTL's
scope of recognition. OSHA limits the expansion of PTL's recognition to
testing and certification of products for demonstration of conformance
to the test standards shown below in table 1.

Table 1--Appropriate Test Standards for Inclusion in PTL's NRTL Scope of
                               Recognition
------------------------------------------------------------------------
           Test standard                     Test standard title
------------------------------------------------------------------------
UL 61730--Part 1..................  Photovoltaic (PV) Module Safety
                                     Qualification--Part 1: Requirements
                                     for Construction; and
UL 61730--Part 2..................  Photovoltaic (PV) Module Safety
                                     Qualification--Part 2: Requirements
                                     for Testing.
------------------------------------------------------------------------

    OSHA's recognition of any NRTL for a particular test standard is
limited to equipment or materials for which OSHA standards require
third-party testing and certification before using them in the
workplace. Consequently, if a test standard also covers any products
for which OSHA does not require such testing and certification, a
NRTL's scope of recognition does not include these products.

A. Conditions

    Recognition is contingent on continued compliance with 29 CFR
1910.7, including but not limited to, abiding by the following
conditions of recognition:
    1. PTL must inform OSHA as soon as possible, in writing, of any
change of ownership, facilities, or key personnel, and of any major
change in its operations as a NRTL, and provide details of the
change(s);
    2. PTL must meet all the terms of its recognition and comply with
all OSHA policies pertaining to this recognition; and
    3. PTL must continue to meet the requirements for recognition,
including all previously published conditions on PTL's scope of
recognition, in all areas for which it has recognition.
    Pursuant to the authority in 29 CFR 1910.7, OSHA hereby expands the
scope of recognition of PTL as a NRTL, subject to the limitations and
conditions specified above.

III. Authority and Signature

    James S. Frederick, Deputy Assistant Secretary of Labor for
Occupational Safety and Health, 200 Constitution Avenue NW, Washington,
DC 20210, authorized the preparation of this notice. Accordingly, the
agency is issuing this notice pursuant to 29 U.S.C. 657(g)(2),
Secretary of Labor's Order No. 8-2020 (85 FR 58393; Sept. 18, 2020),
and 29 CFR 1910.7.

    Signed at Washington, DC.
James S. Frederick,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2023-28337 Filed 12-22-23; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 82, Number 161 (Tuesday, August 22, 2017)]
[Notices]
[Pages 39793-39795]
[FR Doc No: 2017-17703]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0258]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Submission of
Petitions: Food Additive, Color Additive (Including Labeling),
Submission of Information to a Master File in Support of Petitions; and
Electronic Submission Using Food and Drug Administration Form 3503

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by
September 21, 2017.

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_ADDRESS>All
comments should be identified with the OMB control number 0910-0016 and
title ``Submission of Petitions: Food Additive, Color Additive
(Including Labeling), Submission of Information to a Master File in
Support of Petitions; and Electronic Submission Using Food and Drug
Administration Form 3503.'' Also include the FDA docket number found in
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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.
    Submission of Petitions: Food Additive, Color Additive (Including
Labeling), Submission of Information to a Master File in Support of
Petitions; and Electronic Submission Using Food and Drug Administration
Form 3503--21 CFR 70.25, 71.1, and 171.1, and 21 CFR parts 172, 173,
179, and 180; OMB Control Number 0910-0016--Extension.
    Section 409(a) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 348(a)) provides that a food additive shall be
deemed to be unsafe, unless: (1) The additive and its use, or intended
use, are in conformity with a regulation issued under section 409 of
the FD&C Act that describes the condition(s) under which the additive
may be safely used; (2) the additive and its use, or intended use,
conform to the terms of an exemption for investigational use; or (3) a
food contact notification submitted under section 409(h) is effective.
Food additive petitions (FAPs) are submitted by individuals or
companies to obtain approval of a new food additive or to amend the
conditions of use permitted

under an existing food additive regulation. Section 171.1 of FDA's
regulations (21 CFR 171.1) specifies the information that a petitioner
must submit to establish that the proposed use of a food additive is
safe and to secure the publication of a food additive regulation
describing the conditions under which the additive may be safely used.
Parts 172, 173, 179, and 180 (21 CFR parts 172, 173, 179, and 180)
contain labeling requirements for certain food additives to ensure
their safe use.
    Section 721(a) of the FD&C Act (21 U.S.C. 379e(a)) provides that a
color additive shall be deemed to be unsafe unless the additive and its
use are in conformity with a regulation that describes the condition(s)
under which the additive may safely be used, or the additive and its
use conform to the terms of an exemption for investigational use issued
under section 721(f). Color additive petitions (CAPs) are submitted by
individuals or companies to obtain approval of a new color additive or
a change in the conditions of use permitted for a color additive that
is already approved. Section 71.1 of the Agency's regulations (21 CFR
71.1) specifies the information that a petitioner must submit to
establish the safety of a color additive and to secure the issuance of
a regulation permitting its use. FDA's color additive labeling
requirements in Sec.  70.25 (21 CFR 70.25) require that color additives
that are to be used in food, drugs, medical devices, or cosmetics be
labeled with sufficient information to ensure their safe use.
    FDA scientific personnel review FAPs to ensure the safety of the
intended use of the additive in or on food, or that may be present in
food as a result of its use in articles that contact food. Likewise,
FDA personnel review CAPs to ensure the safety of the color additive
prior to its use in food, drugs, medical devices, or cosmetics.
    Interested persons may transmit FAP or CAP regulatory submissions
in electronic format or paper format to the Office of Food Additive
Safety in the Center for Food Safety and Applied Nutrition using Form
FDA 3503. Form FDA 3503 helps the respondent organize their submission
to focus on the information needed for FDA's safety review. Form FDA
3503 can also be used to organize information within a master file
submitted in support of petitions according to the items listed on the
form. Master files can be used as repositories for information that can
be referenced in multiple submissions to the Agency, thus minimizing
paperwork burden for food and color additive approvals. FDA estimates
that the amount of time for respondents to complete Form FDA 3503 will
continue to be 1 hour.
    Description of Respondents: Respondents are businesses engaged in
the manufacture or sale of food, food ingredients, color additives, or
substances used in materials that come into contact with food.
    In the Federal Register of May 30, 2017 (82 FR 24718), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Total
                                                             Number of       Number of     Total annual       Average                      operating and
                 21 CFR section/FDA form                    respondents    responses per     responses      burden per      Total hours     maintenance
                                                                            respondent                       response                          costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                Color Additive Petitions
--------------------------------------------------------------------------------------------------------------------------------------------------------
70.25, 71.1.............................................               2               1               2           1,337           2,674          $5,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Food Additive Petitions
--------------------------------------------------------------------------------------------------------------------------------------------------------
171.1...................................................               3               1               3           7,093          21,279               0
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Form 3503...........................................               6               1               6               1               6               0
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............          23,959           5,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.

    The estimate of burden for food additive or color additive
petitions is based on FDA's experience with the petition process. The
burden for this information collection has changed since the last OMB
approval because the Generally Recognized as Safe affirmations have
been removed pursuant to the implementation of ``Substances Generally
Recognized as Safe; Final Rule,'' August 17, 2016 (81 FR 54960), 21 CFR
parts 20, 25, 170, 184, 186, and 570. FDA is retaining its prior
estimate of the number of petitions received because the average number
of petitions received annually has varied little over the past 10
years. The figures for hours per response are based on estimates from
experienced persons in the Agency and in industry. Although the
estimated hour burden varies with the type of petition submitted, an
average petition involves analytical work and appropriate toxicological
studies, as well as the work of drafting the petition itself. The
burden varies depending on the complexity of the petition, including
the amount and types of data needed for scientific analysis.
    Color additives are subjected to payment of fees for the
petitioning process. The listing fee for a color additive petition
ranges from $1,600 to $3,000, depending on the intended use of the
color additive and the scope of minimum information needed for labeling
in order that food and color manufacturers may comply with all
applicable provisions of the FD&C Act and other specific labeling acts
administered by FDA. Labeling information does not require any
additional information gathering beyond what is already required to
assure conformance with all specifications and limitations in any given
food or color additive regulation. Labeling information does not have
any specific recordkeeping requirements unique to preparing the label.
Therefore, because labeling requirements under Sec.  70.25 for a
particular color additive involve information required as part of the
CAP safety review process, the estimate for number of respondents is
the same for Sec. Sec.  70.25 and 71.1, and the burden hours

for labeling are included in the estimate for Sec.  71.1. Also, because
labeling requirements under parts 172, 173, 179, and 180 for particular
food additives involve information required as part of the FAP safety
review process under Sec.  171.1, the burden hours for labeling are
included in the estimate for Sec.  171.1.

    Dated: August 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17703 Filed 8-21-17; 8:45 am]
 BILLING CODE 4164-01-P