[Federal Register Volume 82, Number 145 (Monday, July 31, 2017)]
[Notices]
[Pages 35562-35563]
[FR Doc No: 2017-16000]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81199; File No. SR-CTA/CQ-2017-03]

Consolidated Tape Association; Notice of Filing and Immediate
Effectiveness of the Twenty-Eight Substantive Amendment to the Second
Restatement of the CTA Plan and the Twentieth Amendment to the Restated
CQ Plan

July 25, 2017.
    Pursuant to Section 11A of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 608 thereunder,\2\ notice is hereby given that
on June 30, 2017, the Consolidated Tape Association (``CTA'') Plan
participants (``Participants'') \3\ filed with the Securities and
Exchange Commission (``Commission'') a proposal to amend the Second
Restatement of the CTA Plan and the Restated Consolidated Quotation
(``CQ'') Plan (``Plans'').\4\ These amendments represent the Twenty-
Eighth Substantive Amendment to the CTA Plan and the Twentieth
Amendment to the CQ Plan (``Amendments''). The Amendments seek to amend
the Plans in order to reflect changes to the names and addresses of
certain Participants, as set forth in Section III(a) of the Plans.
Pursuant to Rule 608(b)(3)(ii) under Regulation NMS,\5\ the
Participants designate the Amendments as concerned solely with the
administration of the Plans and as ``Ministerial Amendments'' under
both Section IV(b) of the CTA Plan and Section IV(c) of the CQ Plan. As
a result, the Amendments were effective upon filing and were submitted
by the Chairman of the Plan's Operating Committee. The Commission is
publishing this notice to solicit comments from interested persons on
the proposed Amendments.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78k-1.
    \2\ 17 CFR 242.608.
    \3\ The Participants are: Bats BYX Exchange, Inc., BATS BZX
Exchange, Inc., Bats EDGA Exchange, Inc., Bats EDGX Exchange, Inc.,
Chicago Board Options Exchange, Inc., Chicago Stock Exchange, Inc.,
Financial Industry Regulatory Authority, Inc., International
Securities Exchange, LLC, Investors' Exchange LLC, NASDAQ BX, Inc.,
NASDAQ PHLX, Inc., NASDAQ Stock Market LLC, New York Stock Exchange
LLC, NYSE Arca, Inc., NYSE MKT LLC, and NYSE National, Inc.
    \4\ See Securities Exchange Act Release Nos. 10787 (May 10,
1974), 39 FR 17799 (May 20, 1974) (declaring the CTA Plan
effective); 15009 (July 28, 1978), 43 FR 34851 (August 7, 1978)
(temporarily authorizing the CQ Plan); and 16518 (January 22, 1980),
45 FR 6521 (January 28, 1980) (permanently authorizing the CQ Plan).
The most recent restatement of both Plans was in 1995. The CTA Plan,
pursuant to which markets collect and disseminate last sale price
information for non-NASDAQ listed securities, is a ``transaction
reporting plan'' under Rule 601 under the Act, 17 CFR 242.601, and a
``national market system plan'' under Rule 608 under the Act, 17 CFR
242.608. The CQ Plan, pursuant to which markets collect and
disseminate bid/ask quotation information for listed securities, is
a ``national market system plan'' under Rule 608 under the Act, 17
CFR 242.608.
    \5\ 17 CFR 242.608(b)(3)(ii).
---------------------------------------------------------------------------

I. Rule 608(a)

A. Purpose of the Amendments

    The Amendments effectuate changes that certain Participants have
made to their names and addresses, as set forth in Section III(a) of
the Plans.

B. Governing or Constituent Documents

    Not applicable.

C. Implementation of the Amendments

    Because the Amendments constitute ``Ministerial Amendments'' under
both Section IV(b) of the CTA Plan and Section IV(c) under the CQ Plan,
the Chairman of the Plan's Operating Committee may submit the
Amendments to the Commission on behalf of the Participants in the
Plans. Because the Participants have designated the Amendments as
concerned solely with the administration of the Plans, the Amendments
become effective upon filing with the Commission.

D. Development and Implementation Phases

    Not applicable.

E. Analysis of Impact on Competition

    The Participants assert that the Amendments do not impose any
burden on competition because they merely effectuate a change in the
names and addresses of certain Participants. For the same reasons, the
Participants do not believe that the Amendments introduce terms that
are unreasonably discriminatory for purposes of Section 11A(c)(1)(D) of
the Exchange Act.

F. Written Understanding or Agreements Relating to Interpretation of,
or Participation in, Plan

    Not applicable.

G. Approval by Sponsors in Accordance With Plan

    See Item I.C. above.

H. Description of Operation of Facility Contemplated by the Proposed
Amendments

    Not applicable.

I. Terms and Conditions of Access

    Not applicable.

J. Method of Determination and Imposition, and Amount of, Fees and
Charges

    Not applicable.

K. Method and Frequency of Processor Evaluation

    Not applicable.

L. Dispute Resolution

    Not applicable.

II. Rule 601(a)

A. Equity Securities for Which Transaction Reports Shall be Required by
the Plan

    Not applicable.

B. Reporting Requirements

    Not applicable.

C. Manner of Collecting, Processing, Sequencing, Making Available and
Disseminating Last Sale Information

    Not applicable.

D. Manner of Consolidation

    Not applicable.

E. Standards and Methods Ensuring Promptness, Accuracy and Completeness
of Transaction Reports

    Not applicable.

F. Rules and Procedures Addressed to Fraudulent or Manipulative
Dissemination

    Not applicable.

G. Terms of Access to Transaction Reports

    Not applicable.

H. Identification of Marketplace of Execution

    Not applicable.

III. Solicitation of Comments

    The Commission seeks general comments on the Amendments. Interested
persons are invited to submit written data, views, and arguments
concerning the foregoing, including whether the proposed Amendments are
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-CTA/CQ-2017-03 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CTA/CQ-2017-03. 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 Web site (http://www.sec.gov/rules/sro.shtml). Copies
of the submission, all written statements with respect to the proposed
Amendments that are filed with the Commission, and all written
communications relating to the proposed Amendments 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
the filing also will be available for Web site viewing and printing at
the principal office of the Plans. 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-CTA/CQ-2017-03 and should be submitted on or before
August 21, 2017.

    By the Commission.
Brent J. Fields,
Secretary.
[FR Doc. 2017-16000 Filed 7-28-17; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: December 20, 2006 (Volume 71, Number 244)]
[Notices]
[Page 76310]
[DOCID:fr20de06-68]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP91-143-057]

Notice of Revenue Sharing Report November 2005-October 2006;
Great Lakes Gas Transmission; Limited Partnership

December 14, 2006.
    Take notice that on December 11, 2006, Great Lakes Gas Transmission
Limited Partnership (Great Lakes) submitted its Interruptible/Overrun
(I/O) Revenue Sharing Report pursuant to the Stipulation and Agreement
(Settlement) filed on September 24, 1992, and approved by the
Commission's February 3, 1993 order issued in Docket No. RP91-143-000,
et al.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed on or before the date as indicated below. Anyone filing a
protest must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible online at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on December 21, 2006.

Magalie R. Salas,
Secretary.
[FR Doc. E6-21685 Filed 12-19-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 106 (Thursday, June 2, 2022)]
[Notices]
[Pages 33475-33476]
[FR Doc No: 2022-11832]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: PR22-44-000.
    Applicants: Louisville Gas and Electric Company.
    Description: Sec.  284.123 Rate Filing: LG&E_Operating Statement
Rate Change Revised Exhibit A to be effective 5/1/2022.
    Filed Date: 5/25/22.

    Accession Number: 20220525-5015.
    Comments/Protests Due: 5 p.m. ET 6/15/22.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf.
    For other information, call<PHONE_NUMBER> (toll free). For TTY,
call<PHONE_NUMBER>.

    Dated: May 26, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-11832 Filed 6-1-22; 8:45 am]
BILLING CODE 6717-01-P


             Approach to Estimating the U.S. Oil Security Premium
             for the Medium- and Heavy-Duty GHG/Fuel Economy Rule

                                 Paul N. Leiby
                     Oak Ridge National Laboratory (ORNL)
                              September 8th, 2010

	The Environmental Protection Agency (EPA) and the National Highway Traffic Safety Administration (NHTSA) ("the agencies") are announcing a first-ever program to reduce greenhouse gas (GHG) emissions and improve fuel efficiency in the medium and heavy-duty highway vehicle sector in the U.S.  This broad sector  -  ranging from large pickups to sleeper-cab tractors  -  represents the second largest contributor to U.S. oil consumption and GHG emissions, after light-duty passenger cars and trucks.
	Setting GHG emissions and fuel consumption standards for the medium and heavy-duty vehicle sector will improve the U.S.'s energy security by reducing the U.S.'s dependence on foreign oil, which has been a national objective since the first oil price shocks in the 1970s.  World crude oil production is highly concentrated, exacerbating the risks of supply disruptions and price shocks.  Tight global oil markets led to prices of over $100 per barrel in 2008, with fuel prices reaching as high as $4 per gallon in many parts of the U.S., causing financial hardship for many families and businesses.  Medium and heavy-duty vehicles account for about 17 percent of U.S. transportation oil use, which means that they alone account for about 12 percent of all U.S. oil consumption.
Background on Energy Security Methodology
	To provide a measure of the energy security implications of the Medium and Heavy-Duty GHG emissions/fuel economy Rule ("HD Rule"), an oil import security premium was estimated over the duration of the rule's phase-in and for years after its completion.  The HD Rule will reduce U.S. oil consumption and, to a similar extent, oil imports.  To estimate energy security benefits, ORNL focused on the benefits of the reduced U.S. oil import levels.  The oil import security premium is a measure of the marginal economic cost of oil imports to the U.S. economy beyond the private cost that is paid for oil, that is, beyond the market oil price.  Since these costs exceed the market price, reducing them is a societal benefit.  The import premium includes components that account for incremental costs during disrupted and normal oil market conditions.  The definition and methodology for estimating the oil import premium are presented in Leiby (2008), along with prior estimates.  This paper summarizes the differences between the premium analysis conducted in support of this HD Rule and that prior 2008 analysis.  The principal difference was the re-benchmarking of reference oil market conditions through 2035 to conform to the latest Annual Energy Outlook of the U.S. Energy Information Administration (AEO2010, Reference case). In addition, European Union (EU) oil demand assumptions are modified to account for recent EU policies related to the EU Emissions Trading Scheme (ETS).
   1. Definition of Oil Import Premium
	A useful measure of the energy security benefits of improved HD fuel economy is the marginal reduction in economic costs to the U.S. from reduced oil imports.  The oil import premium is defined as the difference between the marginal economic cost to society for petroleum imports and the market price paid.  This is measured and reported in dollars-per-barrel, for a small change in the number of barrels imported.  The approach estimates the incremental benefits to society, in dollars per barrel, of reducing U.S. imports.  This "oil import premium" approach identifies those energy-security related costs that are not reflected in the market price of oil, and that are expected to change in response to an incremental change in the level of oil imports.  Omitted from this premium calculation are environmental costs and possible non-economic or unquantifiable effects, such as effects on foreign policy flexibility or military policy.  Also omitted are any spillover-benefits that may accrue to U.S. allies and trading partners who are similarly reliant on oil, and who would benefit from a reduction in the level or volatility of world oil price.
   2. Methodology for Premium Calculation
	The estimation of security premium for the HD Rule closely followed the methodology used to support the RFS and Light Duty Fuel Economy/GHG emission rule regulatory analyses, as documented in Leiby (2008).  For comparability and consistency, most of the assumptions were held unchanged.
The primary assumptions made are:
   a) Supply/Demand Elasticities
	OPEC-supply behavior is treated parametrically, with a Monte Carlo simulation of possible future outcomes using elasticities of supply over a wide range (0.25 to 6.0, with a mean  of 1.8).   Combining the Non-OPEC region demand and Non-U.S. supply elasticities implies a (mode) net elasticity of import demand from Non-U.S./Non-OPEC regions of approximately -1.6, with a wide random distribution.   To account for the possibility, suggested by some but not yet definitively demonstrated or universally agreed upon, that the economy has become less sensitive to oil shocks over time, we applied the reduced range for the elasticity of Gross Domestic Product (GDP) with respect to oil price shocks.  That is, in the Monte Carlo simulation the GDP elasticity ranged from -0.01 to -0.054, with a mean value of
-0.032.  This approach was also taken in the main cases in the 2008 analysis.
   b) Changes from 2008 Estimation for the Light-duty Vehicle Rule
	In these estimates of HD vehicle energy security premiums, the primary change from previous estimates is the development of a revised time path for the premium on a year-by-year basis over a longer horizon, from 2011 to 2035, under the updated oil market projections embodied in the U.S. Energy Information Administration's 2010 Annual Energy Outlook (AEO2010).  Based on the AEO2010, evolving market conditions alter some of the factors influencing the oil import security premium.  In particular: base oil price, U.S. import and consumption levels, U.S. GDP, and OPEC production shares.   These assumptions together also imply an assumption about the value share of oil use in the U.S. economy.
	The following Table 1 compares keys assumptions that differ in these estimates compared to those used in the prior fuel economy/GHG rulemaking.

           Table 1: Evolving Oil Market Conditions and U.S. Oil Use

        2008 Report/LD Rule (AEO2007 Reference Case) Avg. for 2006-2015
              Current Study/HD Rule (AEO2010 Reference Case) 2011
              Current Study/HD Rule (AEO2010 Reference Case) 2015
              Current Study/HD Rule (AEO2010 Reference Case) 2025
Oil Price (2008$)
                                    $55.68
                                    $66.63
                                    $86.88
                                    $104.42
U.S. Oil Imports
                                    12.560
                                    10.826
                                    10.699
                                    10.519
U.S. Oil Demand
                                    22.190
                                    20.210
                                    20.668
                                    21.560
OPEC Supply
                                    34.430
                                    35.590
                                    37.382
                                    40.862
U.S. GDP (bill 2008$)
                                    $15,193
                                    $13,812
                                    $15,494
                                    $20.475
Oil Share of GDP
                                     2.83%
                                     3.56%
                                     4.23%
                                     4.01%

Evolving historical and projected oil market conditions influence the premium estimate.  Note that all these parameters are positively related to the size of the import premium, to varying degrees.  (Price is in $/bbl; imports, demand and supply are in millions of bbl/day; and GDP is in $billion per annum.) [Source: "Mapping and Testing OilPrem1997_to_2007 - Ver2.xls"]

   	Another change to previous estimates of energy security premiums is to assume that for the OECD-Europe area, oil demand is inelastic with respect to the HD Rule.  The European Union has committed to achieving a 20 per cent reduction in greenhouse gas emissions by 2020 from 1990 levels.  Phase 3 of the EU program begins in 2013 and broadens coverage on GHG emitting sources and establishes EU-wide rules for allowance availability and allocations.  Since the last time that ORNL estimated energy security premiums, the European Commission has proposed a Directive to alter the EU-Emissions Trading Scheme (ETS) structure for Phase 3 in January, 2008, and the Directive was amended and adopted by the European Parliament and by the Council of the EU in April 2009.  While the Directive is for GHG commitments, it is likely that the mix of energy sources, and the use of oil, would change only by a limited extent under changed prices. In any event, EU GHG emissions, given the cap, would be unaffected even if oil demand changed by a small amount with the EU-ETS.

   c) Results
   	Table 2 compares the premium estimates under the assumptions of the current analysis with those in the prior 2008 analysis.  Following the approach of most oil security premium estimates, these are the long-run import premiums, reflecting marginal import costs once the market has had time to fully respond to any change in the level of imports.  That is, they reflect the long-run elasticities of regional supply and demand.  The current premium estimates are computed yearly, for 2011, 2012, and at 5-year intervals between 2015 and 2035.  The oil import premium, measured in $/bbl of imports reduced, is not strongly affected by the estimated volume of oil imports displaced.  In all cases the volume of reduction in oil use from the HD rule is under 0.5 per cent of world demand, and 3 per cent of U.S. demand.
   	 The total current premium for 2011 is about 17 per cent larger than the prior premium in the 2008 analysis, which was calculated for average market conditions from 2006-2015.  This premium increase reflects the mixed effects of changes in projected reference oil market conditions.  Such changes include 26 per cent higher projected oil prices, slightly higher OPEC supply, and a higher value share of oil expenditures in GDP.  Offsetting these drivers are projected oil consumption and import levels that are 9 per cent and 14 per cent lower, respectively, than projected in AEO2007.  For years after 2011, the EIA projected real oil price, GDP, and OPEC supply, and oil value share continue to grow.  Oil consumption grows slowly and oil imports are little changed.  Together, these conditions yield a steadily increasing oil security premium through 2035.

      Table 2: Summary Results  -  Comparison of Current and 2008 Report
 Effect / Study
                                Prior Analysis:
                               ORNL 2008 Report
                      (2008$/BBL, average for 2006-2015)
                               Current Analysis:
                             2010 HD Rule Analysis
                      (2008$/BBL, for example year 2011)
 Monopsony Component
                                     $8.03
                               ($3.00 - $14.21)
                                    $9.58
                               ($3.26 - $17.87)

 Macroeconomic Disruption/
 Adjustment Costs
                                     $4.97
                                ($2.28 - $8.02)
                                    $5.63
                                ($2.60 - $8.79)

 Total Mid-point

                                    $13.00
                               ($7.23 - $19.45)
                                    $15.21
                               ($8.02 - $23.62)
Results in 2008$.  Columns report mean estimate and ranges.  Results for 2008 report match those in Leiby 2008, in 2005$.  The ranges include 90% of results from the risk-analysis simulation, with simulations done around the EIA Reference Outlook only.

	For this proposed rule, ORNL also estimated energy security premiums for the years 2020, 2030 and 2040. These premiums are presented in Table 3 as well as a breakdown of the components of the energy security premiums for each of these years.   Variations over time reflect changing reference oil price levels, U.S. import levels, and global market balances.  There are no assumed changes in global oil market disruption risk.

           Table 3: Energy Security Premiums in 2020, 2030 and 2040
                                 (2008$/Barrel)
 Effect
                                     2020
                                     2030
                                     2040
 Monopsony Component
                                    $12.28
                               ($4.16 - $23.74)
                                    $12.69
                               ($4.43  -  23.80)
                                    $12.68
                              ($4.41  -  $23.41)
 Macroeconomic Disruption/
 Adjustment Costs
                                     $7.39
                              ($3.39  -  $11.92)
                                     $8.54
                              ($4.10  -  $13.60)
                                     $8.99
                               ($4.48 - $14.08)
 Total Mid-point

                                    $19.66
                               ($10.27 - $30.90)
                                    $21.23
                               ($11.30 - $32.88)
                                    $21.67
                               ($11.54 - $33.11)
Results in 2008$.  Columns report mean estimate and ranges resulting from Monte Carlo Simulation.

      	The EU oil demand assumption doesn't have a large impact on estimated energy security premiums estimated for the HD vehicle rule.  For instance, for 2020, the total energy security premium with the inelastic EU oil demand is $19.66/barrel.  If oil demand in the EU is demand responsive, then the energy security premium is $18.88/barrel. The macro-disruption component of the energy security premium is unchanged at $7.39/barrel in 2020 with both cases. The disruption component is not sensitive to the assumption regarding EU demand elasticity since it is more a function of disruption risk, U.S. oil import levels and import elasticity, and U.S. GDP sensitivity to shocks. The main reasons for this limited effect of inelastic EU demand is that the EU comprises a limited and declining share of world oil demand outside of the U.S., and that the premium is largely determined by supply behavior in all world regions. Since the HD rule only counts the macro-disruption portion of the energy security premium when valuing the energy security benefits of the HD vehicle rule, whether EU oil demand is inelastic or demand responsive has only a relatively small impact on the overall energy security benefits of the rule.

References

Leiby, Paul N. 2008.  "Estimating the Energy Security Benefits of Reduced U.S. Oil Imports," Final Report, Oak Ridge National Laboratory, ORNL/TM-2007/028, revised March 14.

Parker, L., 2010, "Climate Change and the EU Emissions Trading Scheme (ETS); Looking to 2020", Congressional Research Service.

Toman, Michael A. 1993.  "The Economics of Energy Security: Theory, Evidence, Policy," Handbook of Natural Resource and Energy Economics, vol. III, edited by A.V. Kneese and J.L. Sweeney, Chapter 25.  (New York: Elsevier Science Publishers B.V.).

Toman, Michael A. 2002. "International Oil Security Problems and Policies," The Brookings Review, 20(2):20-23, Spring.


[Federal Register Volume 75, Number 247 (Monday, December 27, 2010)]
[Notices]
[Pages 81266-81267]
[FR Doc No: 2010-32449]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2010-1029; FRL-9242-9]

Access by EPA Contractors to Information Claimed as Confidential
Business Information (CBI) Submitted Under the Clean Air Act and
Related to the Mandatory Greenhouse Gas (GHG) Reporting Rule, 40 CFR
Part 98, Subparts A, LL and MM

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA's Office of Transportation and Air Quality (OTAQ) plans to
authorize various contractors to access information which will be
submitted to EPA under the Clean Air Act that may be claimed as, or may
be determined to be, confidential business information (CBI).
Contractor access to this information, which is related to the
Mandatory Greenhouse Gas (GHG) Reporting Rule, 40 CFR Part 98, subparts
A, LL and MM, will begin January 6, 2011.

DATES: EPA will accept comments on this Notice through January 3, 2011.

FOR FURTHER INFORMATION CONTACT: Anne-Marie C. Pastorkovich,
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW. (6406J),
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number: 202-
343-2801; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Does this notice apply to me?

    This action is directed to the general public. However, this action
may be of particular interest to parties such as suppliers of coal-
based liquid fuels and suppliers of petroleum products, as described in
40 CFR Part 98 subparts LL and MM, respectively. (40 CFR Part 98,
subpart A contains general provisions related to registration and
reporting.) Parties who may be interested in this notice include
refiners, importers, and exporters of these products. Since other
parties may also be interested, the Agency has not attempted to
describe all the specific parties that may be affected by this action.
If you have further questions regarding the applicability of this
action to a particular party, please contact the person listed in FOR
FURTHER INFORMATION CONTACT.

II. How can I get copies of this document and other related
information?

A. Electronically

    EPA has established a public docket for this Federal Register
notice under Docket EPA-HQ-OAR-2010-1029.
    All documents in the docket are identified in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, such as confidential
business information (CBI) or other information for which disclosure is
restricted by statute. Certain materials, such as copyrighted material,
will only be available in hard copy at the EPA Docket Center.

B. EPA Docket Center

    Materials listed under Docket EPA-HQ-OAR-2010-1029 will be
available for public viewing at the EPA Docket Center (EPA/DC), EPA
West, Room 3334, 1301 Constitution Avenue, NW., Washington, DC 20460.
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 Air Docket is<PHONE_NUMBER>.

III. Description of Programs and Potential Disclosure of Information
Claimed as Confidential Business Information (CBI) to Contractors

    EPA's Office of Transportation and Air Quality (OTAQ) has
responsibility for protecting public health and the environment by
regulating air pollution from motor vehicles, engines, and the fuels
used to operate them, and by encouraging travel choices that minimize
emissions. In order to implement various Clean Air Act programs, and to
permit regulated entities flexibility in meeting regulatory
requirements (e.g., compliance on average), we collect compliance
reports and other information from them. Occasionally, the information
submitted is claimed to be confidential business information (CBI).
Information submitted under such a claim is handled in accordance with
EPA's regulations at 40 CFR part 2, subpart B and in accordance with
EPA procedures, including comprehensive system security plans (SSPs)
that are consistent with those regulations. When EPA has determined
that disclosure of information claimed as CBI to contractors is
necessary, the corresponding contract must address the appropriate use
and handling of the information by the contractor and the contractor
must require its personnel who require access to information claimed as
CBI to sign written non-disclosure agreements before they are granted
access to data.
    In accordance with 40 CFR 2.301(h), we have determined that the
contractors, subcontractors, and grantees (collectively referred to as
``contractors'') listed below require access to CBI submitted to us
under the Clean Air Act and in connection with the Mandatory GHG
Reporting program. We are providing notice and an opportunity to
comment. OTAQ collects this data in order to monitor compliance with
the Mandatory GHG Reporting program. We are issuing this Federal
Register notice to inform all submitters of information within our
reporting system that we plan to grant access to material that may be
claimed as CBI to the contractors identified below on a need-to-know
basis.
    Under Contract Number EP-W-09-22, PowerSolv, Incorporated, 1801
Robert Fulton Drive 550, Reston, Virginia, 20191 and its
subcontractor, Indus Corporation, 1951 Kidwell Drive--8th Floor,
Vienna, Virginia, 22182 provides technical support and information
technology services that involve access to information claimed as CBI
related to the Mandatory GHG Reporting Rule. Access to data, including
information claimed as CBI, will commence on January 6, 2011 and will
continue until May 31, 2011. If the contract is extended, this access
will continue for the remainder of the contract without further notice.
    Under Contract Number EP-W-10-15, Compass Solutions, Incorporated,
2760 Eisenhower Avenue, Suite 404, Alexandria, Virginia 22314 provides
report processing and program support that involves access to
information claimed as CBI related to the Mandatory GHG Reporting Rule.
Access to data, including information claimed as CBI, will commence on
January 6, 2011 and will continue until September 30, 2011. If the
contract is extended, the access described in this paragraph will
continue for the remainder of the contract and any further extensions
without further notice.
    Under Contract Number GS35F4797H, CGI, Incorporated, 12601 Fair
Lakes Circle, Fairfax, Virginia, 22033 provides technical and
information technology support related to submission of data via EPA's
Central Data Exchange (CDX). Access to fuels data, including
information claimed as CBI, will

commence on January 6, 2011 and will continue until March 31, 2012. If
the contract is extended, this access will continue for the remainder
of the contract and any further extensions without further notice.
    OTAQ utilizes the services of enrollees under the Senior
Environmental Employment (SEE) program. Some SEE enrollees are provided
through Grant Number CQ-83880-01, Senior Service America, Inc., (SSAI),
8403 Colesville Road, Suite 1200, Silver Spring, Maryland 20910-3314.
SEE enrollees are also provided through Grant Number CQ-833436, the
National Association for Hispanic Elderly (NAHE), 234 E. Colorado
Blvd., Suite 300, Pasadena, California 91101. Access to data related to
the Mandatory GHG Reporting Rule, including information claimed as CBI
will commence on January 6, 2011 and will continue until August 31,
2011. If these grants are extended, this access will continue for the
remainder of the grants and any future extensions without further
notice.
    Parties who wish further information about this Federal Register
notice or about OTAQ's disclosure of information claimed as CBI to
contactors may contact the person listed under FOR FURTHER INFORMATION
CONTACT.

    Dated: December 10, 2010.
Karl J. Simon,
Director, Compliance and Innovative Strategies Division, Office of
Transportation & Air Quality, Office of Air and Radiation.
[FR Doc. 2010-32449 Filed 12-23-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 29 (Friday, February 11, 2011)]
[Notices]
[Page 7836]
[FR Doc No: 2011-3154]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL11-20-000]

PJM Power Providers Group v. PJM Interconnection, L.L.C.; Notice
of Complaint

    Take notice that on February 1, 2011, pursuant to section 206 of
the Federal Power Act, and Rule 206 of the Federal Energy Regulatory
Commission's (Commission) Rules of Practice and Procedure, 18 CFR
385.206, PJM Power Providers Group (Complainant) filed a formal
complaint against PJM Interconnection, L.L.C. (Respondent), alleging
that the tariffs governing the Respondent's Reliability Pricing Model
are unjust and unreasonable and could be subject to manipulation.
    The Complainants certifies that copies of the complaint were served
on the contacts for the Respondent as listed on the Commission's list
of Corporate Officials and on parties and regulatory agencies the
Respondent reasonably expects to be affected by this Complaint.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY,
call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on February 22, 2011.

    Dated: February 4, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-3154 Filed 2-10-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: March 6, 2009 (Volume 74, Number 43)]
[Rules and Regulations]
[Page 9759-9765]
[DOCID:fr06mr09-2]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 310 and 347

[Docket No. FDA-1978N-0007] (Formerly Docket No. 78N-021A)
RIN 0910-AF42

Astringent Drug Products That Produce Aluminum Acetate; Skin
Protectant Drug Products for Over-the-Counter Human Use; Technical
Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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

SUMMARY: We (Food and Drug Administration (FDA)) are amending the final
monograph (FM) for over-the-counter (OTC) skin protectant astringent
drug products. This amendment clarifies that aluminum acetate
solutions, produced by dissolving aluminum sulfate tetradecahydrate and
calcium acetate monohydrate in powder or tablet form in water, are
generally recognized as safe and effective (GRASE) and not misbranded
as astringent drug products. The amendment also describes how
manufacturers should relabel these products to comply with the FM. We
are issuing this amendment in response to a citizen petition (CP) that
we received from a manufacturer of OTC astringent drug products. This
final rule is part of our ongoing review of OTC drug products.

DATES: Effective Date: This regulation is effective March 6, 2009.
    Compliance Date: The compliance date for all products, regardless
of annual sales, is September 6, 2010.

FOR FURTHER INFORMATION CONTACT: Matthew R. Holman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, MS 5411, Silver Spring, MD 20993, 301-796-
2090.

SUPPLEMENTARY INFORMATION:

I. What Is the Regulatory History of This Rulemaking?

A. Advance Notice of Proposed Rulemaking (ANPR)

    We published an ANPR for certain OTC skin protectant drug products
in the Federal Register on September 7, 1982 (47 FR 39436) (the 1982
ANPR). In the 1982 ANPR, the agency reported that the Advisory Review
Panel on OTC Miscellaneous External Drug Products (the Panel)
recommended that we classify solutions containing 2.5 to 5 percent
aluminum acetate as GRASE for topical use as an astringent. The 1982
ANPR includes the following terms when referring to this ingredient (47
FR 39436 at 39444 through 39446):
     ``aluminum acetate''
     ``aluminum acetate solution''
     ``Burow's solution''
    Although some of the aluminum acetate products that the Panel
evaluated were powders and tablets that were dissolved in water (Refs.
1 and 2), those products, as manufactured, did not contain aluminum
acetate. Rather, those powders and tablets contained aluminum sulfate
and calcium acetate, which produced an aluminum acetate solution when
dissolved in water.
    In addition, the Panel separately evaluated aluminum sulfate and
calcium acetate as OTC astringent single active ingredients (i.e., when
not in combination with each other). The Panel recommended that
aluminum sulfate, as a single active ingredient, is GRASE and not
misbranded only for use in a styptic pencil (47 FR 39436 at 39447 and
39448).\1\ The Panel recommended that calcium acetate be classified as
not GRASE or misbranded when used as a single active ingredient (47 FR
39436 at 39444). The Panel was not aware of any data demonstrating the
safety and effectiveness of calcium acetate, as a single active
ingredient, when used as an OTC astringent active ingredient in any
formulation.
---------------------------------------------------------------------------

    \1\ In the 1982 ANPR, we stated that the Panel had concluded
that aluminum sulfate is safe but that there were insufficient data
to establish its effectiveness for use as a styptic pencil (47 FR
39436 at 39447 and 39448). In the Federal Register of April 3, 1989
(54 FR 13490 at 13493), we stated that an apparent administrative
error had occurred in that the Panel had voted to classify aluminum
sulfate as GRASE and not misbranded for use in a styptic pencil.
---------------------------------------------------------------------------

B. Proposed Rule

    In the Federal Register of April 3, 1989 (54 FR 13490), we
published a proposed rule amending the tentative final monograph (TFM)
for OTC skin protectant drug products to include astringent drug
products (the 1989 TFM). In the 1989 TFM, we proposed monograph status
for aluminum acetate, as recommended by the Panel (54 FR 13490 at
13494). However, we revised the Panel's recommended concentration to
0.13 to 0.5 percent, indicating that the Panel did not take into
account further dilution of the 2.5 to 5 percent aluminum acetate
solution (54 FR 13490 at 13494 and 13496). We agreed with the Panel's
recommendation for calcium acetate and proposed that the ingredient be
classified as nonmonograph (54 FR 13490 at 13496). We also noted that
one comment mentioned that the USP (United States Pharmacopeia)
procedure for preparing Burow's Solution (aluminum acetate solution) de
novo does not pertain to modified aluminum acetate solutions prepared
from tablets or powders (54 FR 13490 at 13494).

C. Final Rule

    In the Federal Register of October 21, 1993 (58 FR 54458), we
published a final rule in the form of a FM for OTC skin protectant drug
products that established conditions under which OTC astringent drug
products are GRASE and not misbranded (the 1993 skin protectant FM).
The 1993 skin protectant FM added GRASE astringent active ingredients
and labeling for astringents to 21 CFR part 347 subpart A. The 1993
skin protectant FM, which became effective on October 21, 1994,
includes 0.13 to 0.5 percent aluminum acetate as an active ingredient
in Sec.  347.12 (21 CFR 347.12) (then Sec.  347.10(a) (21 CFR
347.10(a))). The 1993 skin protectant FM specifies that, depending on
the formulation and concentration of the marketed product, the
manufacturer must provide adequate directions so that the resulting
solution to be used by consumers contains 0.13 to 0.5 percent aluminum
acetate.
    In the 1993 skin protectant FM, we noted that calcium acetate was
listed in Sec.  310.545(a)(18)(ii) (21 CFR 310.545(a)(18)(ii)) as
nonmonograph in a final rule published on May 10, 1993 (58 FR 27636 at
27642).

D. Feedback Letter

    A manufacturer submitted a letter in 1994 requesting clarification
whether its OTC astringent drug product, a powder containing aluminum
sulfate and calcium acetate, could continue to be marketed under the
1993 skin protectant FM (Ref. 3). The manufacturer stated that it
markets one of the products reviewed by the Panel in which aluminum
acetate was determined to be GRASE for OTC astringent drug products.
When dissolved in water according to labeled directions, the
manufacturer's product becomes an aluminum acetate solution with a
calcium sulfate precipitate.
    In a 1995 letter to the manufacturer, we stated that the product
fails to comply with the 1993 skin protectant FM because it contains
the nonmonograph ingredient calcium acetate (Ref. 4). We suggested that
the manufacturer contact us to amend the 1993 skin protectant FM to
allow continued marketing of its product. Subsequently, the
manufacturer submitted a CP (Ref. 5).

II. Why Is FDA Issuing This Document?

    We are issuing this technical amendment in response to the CP
submitted by an OTC astringent drug product manufacturer in 1995 (the
1995 CP) (Ref. 5). The 1995 CP was submitted by a manufacturer who
marketed one of the products reviewed by the Panel in which aluminum
acetate was determined to be GRASE for OTC astringent drug products
(see section I.D of this document). The 1995 CP requested that we
revise the skin protectant FM (Sec.  347.12(a) (then Sec.  347.10(a))
as follows, or in equivalent language having the same effect (Ref. 5):
``Aluminum acetate, 0.13 to 0.5 percent

(where the product as marketed consists of salts other than aluminum
acetate, or where the aluminum acetate concentration of the product as
marketed is other than 0.13 to 0.5 percent, the manufacturer must
provide adequate directions so that the resulting solution to be used
by the consumer consists of 0.13 to 0.5 percent aluminum acetate).''
The manufacturer intended ``salts other than aluminum acetate'' to
include dry formulations of aluminum sulfate plus calcium acetate. The
manufacturer argued that its labeled directions produce an aluminum
acetate solution that falls within the concentration range specified in
the 1993 skin protectant FM.
    We have not taken any enforcement action against these powder and
tablet products that produce an aluminum acetate solution while
developing this document as our response to the 1995 CP. In this
document, we are granting the request in the 1995 CP to revise the 1993
skin protectant FM by including the combination of aluminum sulfate and
calcium acetate in powder and tablet dosage forms to prepare an
aluminum acetate solution.

III. What Changes to the Skin Protectant FM Is FDA Making in This
Document?

    This document adds the GRASE combination of aluminum sulfate
tetradecahydrate and calcium acetate monohydrate in powder or tablet
form to produce a 0.13 to 0.5 percent aluminum acetate solution when
the powder or tablet is dissolved in the volume of water specified in
``Directions.'' This technical amendment also includes additional
labeling requirements for OTC astringent drug products that consist of
this GRASE combination of active ingredients.
    Since we issued the 1993 skin protectant FM, the United States
Pharmacopeia/National Formulary (USP/NF) has added monographs for
     Aluminum Sulfate and Calcium Acetate Tablets for Topical
Solution (Ref. 6) and
     Aluminum Sulfate and Calcium Acetate for Topical Solution
(Ref. 7).
The second USP monograph is for products formulated as powders. The USP
monographs state that these products contain aluminum sulfate
tetradecahydrate and calcium acetate monohydrate, which are the hydrate
forms of aluminum sulfate and calcium acetate. When a tablet or powder
containing the aluminum sulfate tetradecahydrate and calcium acetate
monohydrate is dissolved in water, a chemical reaction occurs that
produces an aluminum acetate solution and a calcium sulfate
precipitate.
    Rather than amend the aluminum acetate section of the 1993 skin
protectant FM as requested in the 1995 CP, we are redesignating
existing Sec.  347.20(b) as Sec.  347.20(c), and adding a new Sec.
347.20(b), to include the combination of aluminum sulfate
tetradecahydrate and calcium acetate monohydrate in powder and tablet
dosage forms to prepare an aluminum acetate solution. We are limiting
the combination of ingredients to powder and tablet dosage forms
because there are corresponding USP monographs for these dosage forms,
but not for other dosage forms (Refs. 6 and 7). New Sec.  347.20(b)
states:``Combination of ingredients to prepare an aluminum acetate
solution. Aluminum sulfate tetradecahydrate may be combined with
calcium acetate monohydrate in powder or tablet form to provide a 0.13
to 0.5 percent aluminum acetate solution when the powder or tablet is
dissolved in the volume of water specified in `Directions'.'' This
amendment provides an alternate approach to prepare the aluminum
acetate solution described in Sec.  347.12(a).
    Marketed products have contained varying amounts of aluminum
sulfate and calcium acetate based on the amount of water in which the
powder or tablet is dissolved to make an aluminum acetate solution. For
example, a product with directions to use 16 ounces of water requires a
larger amount of each ingredient than a product with directions to use
12 ounces of water. Generally, the products have contained between 53
and 59 percent aluminum sulfate and 40 to 44 percent calcium acetate in
each tablet or powder. Inactive ingredients account for the other
amounts to make 100 percent.
    Because of the varying amount of aluminum sulfate and calcium
acetate, we are not specifying an amount for each active ingredient
required in a product. However, this information is required to appear
in the product's labeling (see 21 U.S.C. 352(e)(1)(A)(ii) and Sec.
201.66(c)(2) (21 CFR 201.66(c)(2))). Labeling must state the amount of
each active ingredient in the product and those amounts, when dissolved
in the amount of water stated in the product's labeling, must produce a
0.13 to 0.5 percent aluminum acetate solution. We are providing
labeling in this document to allow manufacturers to continue to market
these products in this manner.
    We are revising Sec.  347.52 (Labeling of astringent drug products)
(21 CFR 347.52), which describes specific labeling for products
containing aluminum sulfate tetradecahydrate and calcium acetate
monohydrate in powder or tablet dosage forms (see Sample OTC Astringent
Drug Product Label). ``Aluminum sulfate tetradecahydrate'' and
``calcium acetate monohydrate'' must appear under the ``Active
ingredients'' heading in Drug Facts, as is typical for OTC drug
products. Under the ``Purpose'' heading, an asterisk should follow the
word ``Astringent''. In addition, a statement explaining the asterisk
should be included in the ``Active ingredients/Purpose'' section:
``*When combined together in water, these ingredients form the active
ingredient aluminum acetate. See Directions.'' The ``Directions''
section should include instructions on preparing the aluminum acetate
solution (0.13 to 0.5 percent) from the powder(s) or tablet(s). These
directions will inform consumers that a solution is produced by
dissolving the powder(s) or tablet(s) in water. We believe this
labeling in the ``Active ingredients/Purpose'' and ``Directions''
sections adequately informs consumers that aqueous aluminum acetate is
acting as the astringent active ingredient.
    The combination product containing aluminum sulfate
tetradecahydrate and calcium acetate monohydrate has the same
indications and warnings as other monograph astringent products
containing aluminum acetate. We are requiring that the ``for use as a
soak'' and ``for use as a compress or wet dressing'' subheadings in the
``Directions'' section appear in bold type to make it easier for
consumers to read and follow the different parts of the directions for
these products (see Sample OTC Astringent Drug Product Label). For
consistency in labeling, we are also requiring that the same two
subheadings in the ``Directions'' section of OTC aluminum acetate
solution drug products described in Sec.  347.12(a) appear in bold
type. The information under these subheadings for both types of
aluminum acetate drug products (i.e., dry and solution formulations) is
still required to appear in a bulleted format (see Sec.
347.52(d)(1)(i) and (d)(1)(ii)).
    The following sample OTC astringent drug product label illustrates
the labeling for products containing aluminum sulfate tetradecahydrate
and calcium acetate monohydrate in powder or tablet dosage forms to
produce an aluminum acetate solution:
BILLING CODE 4160-01-S

[GRAPHIC] [TIFF OMITTED] TR06MR09.000

BILLING CODE 4160-01-C

This sample label includes the specific labeling required for these
products in this technical amendment as well as the general labeling
required by the 1993 skin protectant FM. The format and sequence of the
information and the font sizes for the title, heading, subheadings,
text, and other graphic features must be in accordance with Sec.
201.66.
    In addition to adding new Sec.  347.20(b), we are revising Sec.
310.545(a)(18)(ii), which currently lists calcium acetate as a
nonmonograph active ingredient that cannot be included in OTC
astringent drug products. That section now reads as follows: ``Calcium
acetate (except calcium acetate monohydrate when combined with aluminum
sulfate tetradecahydrate to provide an aluminum acetate solution as
described in Sec.  347.20(b)).'' Therefore, calcium acetate is still
nonmonograph except in products marketed under new Sec.  347.20(b).
    Because this document adds new Sec.  347.20(b), we are
redesignating existing Sec.  347.20(b), (c), and (d) as Sec.
347.20(c), (d), and (e), respectively. We are also revising the
warnings in 21 CFR 347.50(c) to reflect the Drug Facts format in Sec.
201.66, while not changing the meaning of these warnings. The Sample
OTC Astringent Drug Product Label reflects all of these revisions.

IV. Analysis of Impacts

    We have examined the impacts of this final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). We conclude that this
final rule is not a significant regulatory action under the Executive
order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because only a limited number of products will need
to be relabeled, we certify that this final rule will not have a
significant economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $130 million, using the most current (2007) Implicit
Price Deflator for the Gross Domestic Product. We do not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
    The purpose of this final rule is to amend the 1993 skin protectant
FM to add the combination of aluminum sulfate tetradecahydrate and
calcium acetate monohydrate for products that include appropriate
amounts of these ingredients and adequate directions to produce an
aluminum acetate solution within the monograph concentration range.
This amendment describes a methodology for manufacturers of these OTC
astringent drug products to relabel their products and market them in
compliance with the 1993 skin protectant FM.
    We have identified two OTC skin protectant astringent drug
products, each with several stockkeeping units (SKUs) (individual
products, packages, and sizes), that may need to be relabeled. While we
are aware of several other products that are no longer marketed, there
may be a few marketed products of which we are not currently aware.
Accordingly, we estimate that there may be 5 products with 5 to 10 SKUs
that may be affected by this final rule.
    We have updated the weighted average cost to relabel that we
estimated for the final rule requiring uniform label formats of OTC
drug products (64 FR 13254 at 13279 to 13281, March 17, 1999) (i.e.,
$3,600 x 1.164\2\ = $4,190 per SKU). Assuming up to 10 affected OTC
SKUs in the marketplace, total one-time costs of relabeling could be
$41,900 (i.e., 10 x $4,190). Because frequent labeling redesigns are a
recognized cost of doing business in the OTC drug industry, these costs
may be less. Manufacturers that make voluntary market-driven changes to
their labeling during the implementation period can implement the
regulatory requirements for a nominal cost. All products, including
those with annual sales less than $25,000, will have 18 months
following publication of the final rule to comply with the 1993 skin
protectant FM. Therefore, many of the labeling revisions may be done in
the normal course of business. These steps should help to minimize the
impact on small entities by providing enough time for implementation to
enable entities to use up existing labeling stock. In addition, the
final rule does not require any new reporting or recordkeeping
activities.
---------------------------------------------------------------------------

    \2\ The annual PPI for pulp, paper, and allied products (the
major cost driver for labeling) rose from 174.1 to 202.6 between
1998 and 2005 (see http://data.bls.gov/cgi-bin/surveymost). We have
verified the Web site address, but we are not responsible for
subsequent changes to the Web site after this document publishes in
the Federal Register.
---------------------------------------------------------------------------

    This final rule also requires manufacturers of the aluminum acetate
solution products described in Sec.  347.12(a) to make two very minor
changes in the labeling of their products. They will need to change the
two ``for use'' subheadings in the directions from standard to bold
type and should be able to do so at a negligible cost. We estimate that
less than 10 SKUs will be affected by this minor change. This final
rule will not impose a significant economic burden on affected
entities. Therefore, we certify that this final rule will not have a
significant economic impact on a substantial number of small entities.
No further analysis is required under the Regulatory Flexibility Act (5
U.S.C. 605(b)).

V. Paperwork Reduction Act of 1995

    We conclude that the labeling requirements in this document are not
subject to review by the Office of Management and Budget because they
do not constitute a ``collection of information'' under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Rather, the labeling
statements are a ``public disclosure of information originally supplied
by the Federal Government to the recipient for the purpose of
disclosure to the public'' (5 CFR 1320.3(c)(2)).

VI. Environmental Impact

    We have determined under 21 CFR 25.31(a) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VII. Federalism

    We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. We have determined that the rule
will have a preemptive effect on State law. Section 4(a) of the
Executive order requires agencies to ``construe * * * a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress

intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.'' Section 751 of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 379r) is an express preemption provision.
Section 751(a) of the act (21 U.S.C. 379r(a)) provides that:
``* * * no State or political subdivision of a State may establish or
continue in effect any requirement--* * * (1) that relates to the
regulation of a drug that is not subject to the requirements of section
503(b)(1) or 503(f)(1)(A); and (2) that is different from or in
addition to, or that is otherwise not identical with, a requirement
under this Act, the Poison Prevention Packaging Act of 1970 (15 U.S.C.
1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451
et seq.).''
    Currently, this provision operates to preempt States from imposing
requirements related to the regulation of nonprescription drug
products. (See section 751(b) through (e) of the act for the scope of
the express preemption provision, the exemption procedures, and the
exceptions to the provision.) This final rule clarifies that OTC
astringent drug products containing aluminum sulfate tetradecahydrate
and calcium acetate monohydrate in powder or tablet form for dissolving
in water to produce an aluminum acetate solution are GRASE and not
misbranded. The final rule also describes how manufacturers should
relabel these products to comply with the 1993 skin protectant FM.
Although this final rule would have a preemptive effect, in that it
would preclude States from issuing requirements related to these OTC
astringent drug products that are different from or in addition to, or
not otherwise identical with a requirement in the final rule, this
preemptive effect is consistent with what Congress set forth in section
751 of the act. Section 751(a) of the act displaces both State
legislative requirements and State common law duties. We also note that
even where the express preemption provision is not applicable, implied
preemption may arise. See Geier v. American Honda Co., 529 U.S. 861
(2000).
    We believe that the preemptive effect of the final rule would be
consistent with Executive Order 13132. Section 4(e) of the Executive
order provides that ``when an agency proposes to act through
adjudication or rulemaking to preempt State law, the agency shall
provide all affected State and local officials notice and an
opportunity for appropriate participation in the proceedings.'' We
provided the States with an opportunity for appropriate participation
in this rulemaking when we sought input from all stakeholders through
publication of the 1993 skin protectant FM. We received no comments
from any States on the final rulemaking.
    In addition, on December 17, 2008, FDA's Division of Federal and
State Relations provided notice via fax and e-mail transmission to
elected officials of State governments and their representatives of
national organizations. The notice provided the States with further
opportunity for input on the rule. It advised the States of the
publication of the final rule and encouraged State and local
governments to review the notice and to provide any comments to the
docket (Docket No. 1978N-0021A), by a date 30 days from the date of the
notice (i.e., by January 16, 2009), or to contact certain named
individuals. We did not receive any comments in response to this
notice. The notice has been filed in the above-numbered docket.
    In conclusion, we believe that we have complied with all of the
applicable requirements under the Executive order and have determined
that the preemptive effects of this rule are consistent with Executive
Order 13132.

VIII. References

    The following references are on display in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852, under Docket No. FDA-1978N-0007
(formerly Docket No. 1978N-021A) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Bluboro product label, Appendix A to CP1.
    2. Domeboro product label.
    3. Letter from S. Buxbaum, Allergan, to R. Heller, FDA, dated
January 24, 1994, Appendix C to CP1.
    4. Letter from B. Williams, FDA, to T. Mead, Allergan, dated
January 2, 1995, Appendix D to CP1.
    5. CP1.
    6. The United States Pharmacopeia 31-National Formulary 26, The
United States Pharmacopeial Convention, Inc., Rockville, MD, pp.
1360, 2008.
    7. The United States Pharmacopeia 31-National Formulary 26, The
United States Pharmacopeial Convention, Inc., Rockville, MD, p.
1359, 2008.

List of Subjects

21 CFR Part 310

    Administrative practice and procedures, Drugs, Labeling, Medical
devices, Reporting and recordkeeping requirements.

21 CFR Part 347

    Labeling, Over-the-counter drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
310 and 347 are amended as follows:

PART 310--NEW DRUGS

0
1. The authority citation for 21 CFR part 310 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f,
360j, 361(a), 371, 374, 375, 379e; 42 U.S.C. 216, 241, 242(a), 262,
263b-263n.

0
2. Section 310.545 is amended by revising the entry for calcium acetate
in paragraph (a)(18)(ii), by revising paragraph (d) introductory text
and paragraph (d)(11), and by adding new paragraph (d)(39) to read as
follows:

Sec.  310.545  Drug products containing certain active ingredients
offered over-the-counter (OTC) for certain uses.

    (a) * * *
    (18) * * *
    (ii) * * *
* * * * *

Calcium acetate (except calcium acetate monohydrate when combined with
aluminum sulfate tetradecahydrate to provide an aluminum acetate
solution as described in Sec.  347.20(b)) of this chapter
* * * * *
    (d) Any OTC drug product that is not in compliance with this
section is subject to regulatory action if initially introduced or
initially delivered for introduction into interstate commerce after the
dates specified in paragraphs (d)(1) through (d)(39) of this section.
* * * * *
    (11) November 10, 1993, for products subject to paragraphs
(a)(8)(ii), (a)(10)(v) through (a)(10)(vii), (a)(18)(ii) (except
products that contain ferric subsulfate as covered by paragraph (d)(22)
of this section and except products that contain calcium acetate
monohydrate as covered by paragraph (d)(39) of this section) through
(a)(18)(v)(A), (a)(18)(vi)(A), (a)(22)(ii), (a)(23)(i), (a)(24)(i), and
(a)(25) of this section.
* * * * *
    (39) September 6, 2010, for products subject to paragraph
(a)(18)(ii) of this section that contain calcium acetate monohydrate,
except as provided in Sec.  347.20(b) of this chapter.

PART 347--SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN
USE

0
3. The authority citation for 21 CFR part 347 continues to read as
follows:

    Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

0
4. Section 347.20 is amended by redesignating paragraphs (b), (c), and
(d) as paragraphs (c), (d), and (e), respectively, and by adding new
paragraph (b) to read as follows:

Sec.  347.20  Permitted combinations of active ingredients.

* * * * *
    (b) Combination of ingredients to prepare an aluminum acetate
solution. Aluminum sulfate tetradecahydrate may be combined with
calcium acetate monohydrate in powder or tablet form to provide a 0.13
to 0.5 percent aluminum acetate solution when the powder or tablet is
dissolved in the volume of water specified in ``Directions.''
* * * * *

0
5. Section 347.52 is amended by revising paragraph (a) and (b)(1)
paragraph heading, and by revising paragraphs (c) and (d)(1), and by
adding new paragraph (d)(4) to read as follows:

Sec.  347.52  Labeling of astringent drug products.

    (a) Statement of identity. The labeling of the product contains the
established name of the drug, if any, and identifies the product as an
``astringent.'' For products containing the combination of aluminum
sulfate tetradecahydrate and calcium acetate monohydrate identified in
Sec.  347.20(b), under the ``Purpose'' heading identified in Sec.
201.66(c)(3) of this chapter, the labeling of each active ingredient in
the product states ``Astringent*'', which is followed by the statements
``* When combined together in water, these ingredients form the active
ingredient aluminum acetate. See [the following in bold italic type]
Directions.''
    (b) Indications. * * *
    (1) For products containing aluminum acetate identified in Sec.
347.12(a) or the combination of aluminum sulfate tetradecahydrate and
calcium acetate monohydrate identified in Sec.  347.20(b). * * *
* * * * *
    (c) Warnings. The labeling of the product contains the following
warnings under the heading ``Warnings'':
    (1) For all products--(i) The labeling states ``For external use
only''.
    (ii) The labeling states ``When using this product [bullet] avoid
contact with eyes. If contact occurs, rinse thoroughly with water.''
    (2) For products containing aluminum acetate identified in Sec.
347.12(a), witch hazel identified in Sec.  347.12(c), or the
combination of aluminum sulfate tetradecahydrate and calcium acetate
monohydrate identified in Sec.  347.20(b). The labeling states ``Stop
use and ask a doctor if [bullet] condition worsens or symptoms last
more than 7 days''.
    (3) For products containing aluminum acetate identified in Sec.
347.12(a) or the combination of aluminum sulfate tetradecahydrate and
calcium acetate monohydrate identified in Sec.  347.20(b) when labeled
for use as a compress or wet dressing. The labeling states ``When using
this product [bullet] do not cover compress or wet dressing with
plastic to prevent evaporation''.
    (4) For products containing aluminum acetate identified in Sec.
347.12(a) or the combination of aluminum sulfate tetradecahydrate and
calcium acetate monohydrate identified in Sec.  347.20(b) when labeled
for use as a soak, compress, or wet dressing. The labeling states
``When using this product [bullet] in some skin conditions, soaking too
long may overdry''.
    (d) Directions. * * *
    (1) For products containing aluminum acetate identified in Sec.
347.12(a) or the combination of aluminum sulfate tetradecahydrate and
calcium acetate monohydrate identified in Sec.  347.20(b)--(i) For
products used as a soak. ``For use as a soak: [preceding words in bold
type] [bullet] soak affected area for 15 to 30 minutes as needed, or as
directed by a doctor [bullet] repeat 3 times a day or as directed by a
doctor [bullet] discard solution after each use'' .
    (ii) For products used as a compress or wet dressing. ``For use as
a compress or wet dressing: [preceding words in bold type] [bullet]
soak a clean, soft cloth in the solution [bullet] apply cloth loosely
to affected area for 15 to 30 minutes [bullet] repeat as needed or as
directed by a doctor [bullet] discard solution after each use''.
* * * * *
    (4) For products containing the combination of aluminum sulfate
tetradecahydrate and calcium acetate monohydrate identified in Sec.
347.20(b)--(i) For powder dosage form. The labeling states ``[bullet]
dissolve 1 to 3 packets in [insert volume] of cool or warm water
[bullet] stir until fully dissolved; do not strain or filter. The
resulting mixture contains [insert percent] (1 packet), [insert
percent] (2 packets), or [insert percent] (3 packets) aluminum acetate
and is ready for use.'' These statements shall be the first statements
under the heading ``Directions''.
    (ii) For tablet dosage form. The labeling states ``[bullet]
dissolve 1 to 3 tablets in [insert volume] of cool or warm water
[bullet] stir until fully dissolved; do not strain or filter. The
resulting mixture contains [insert percent] (1 tablet), [insert
percent] (2 tablets), or [insert percent] (3 tablets) aluminum acetate
and is ready for use.'' These statements shall be the first statements
under the heading ``Directions''.
* * * * *

    Dated: February 23, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-4746 Filed 3-5-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 85, Number 211 (Friday, October 30, 2020)]
[Notices]
[Page 68873]
[FR Doc No: 2020-24129]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2007-0478, FRL-10016-43-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Regulation of Fuels and Fuel Additives:
Gasoline Volatility (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), Regulation of Fuels and Fuel
Additives: Gasoline Volatility (EPA ICR Number 1367.13, OMB Control
Number 2060-0178) to the Office of Management and Budget (OMB) for
review and approval in accordance with the Paperwork Reduction Act
(PRA). This is a proposed extension of the ICR, which is currently
approved through December 31, 2020. Public comments were previously
requested via the Federal Register on April 1, 2020 during a 60-day
comment period. This notice allows for an additional 30 days for public
comments. A fuller description of the ICR is given below, including its
estimated burden and cost to the public. An 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.

DATES: Additional comments may be submitted on or before November 30,
2020.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2007-0478, online using www.regulations.gov (our preferred method), by
email to<EMAIL_ADDRESS>or by mail to: EPA Docket Center,
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania
Ave. NW, Washington, DC 20460. EPA's policy is that all comments
received will be included in the public docket without change including
any personal information provided, unless the comment includes
profanity, threats, information claimed to be Confidential Business
Information (CBI), or other information whose disclosure is restricted
by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: James W. Caldwell, Compliance
Division, Office of Transportation and Air Quality, Mail Code 6406J,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
https://www.regulations.gov or in person at the EPA Docket Center, EPA
West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The
telephone number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: Gasoline volatility, as measured by Reid Vapor Pressure
(RVP) in pounds per square inch (psi), is controlled in the spring and
summer in order to minimize evaporative hydrocarbon emissions from
motor vehicles. RVP is subject to a Federal standard of 7.8 psi or 9.0
psi, depending on location. The addition of ethanol to gasoline
increases the RVP by about 1 psi. Gasoline that contains nine volume
percent to 15 volume percent ethanol is subject to a standard that is
1.0 psi greater. As an aid to industry compliance and EPA enforcement,
the product transfer document (PTD), which is prepared by the producer
or importer and which accompanies a shipment of gasoline containing
ethanol, is required by regulation to contain a legible and conspicuous
statement that the gasoline contains ethanol and the percentage
concentration of ethanol. This is intended to deter the mixing within
the distribution system, particularly in retail storage tanks, of
gasoline which contains ethanol in the nine to 15 percent range with
gasoline which does not contain ethanol in that range. Such mixing
would likely result in a gasoline which is in violation of its RVP
standard. Also, a party wishing a testing exemption, for research on
gasoline that is not in compliance with the applicable volatility
standard, must submit certain information to EPA. EPA has additional
PTD requirements for gasoline containing ethanol at 40 CFR 80.1503.
Those requirements are covered in a separate ICR.
    Form Numbers: None.
    Respondents/affected entities: Entities potentially affected by
this action are those who produce or import gasoline containing
ethanol, or who wish to obtain a testing exemption.
    Respondent's obligation to respond: Mandatory per 40 CFR 80.27(d)
and (e).
    Estimated number of respondents: 2,200 (total).
    Frequency of response: On occasion.
    Total estimated burden: 1,410 hours per year. Burden is defined at
5 CFR 1320.03(b).
    Total estimated cost: $154,030, includes $10 annualized capital or
operation & maintenance costs.
    Changes in estimates: With nearly all PTDs now being computer
generated, the average time to include the regulatory language on each
PTD has decreased from one second to 0.1 second. As a result, the total
annual burden has decreased from 12,330 hours per year to 1,410 hours
per year.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2020-24129 Filed 10-29-20; 8:45 am]
BILLING CODE 6560-50-P