[Federal Register Volume 78, Number 168 (Thursday, August 29, 2013)]
[Rules and Regulations]
[Pages 53249-53250]
[FR Doc No: 2013-20919]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2012-0790; FRL-9842-4]

Revisions to the California State Implementation Plan, Placer
County Air Pollution Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is finalizing approval of revisions to the Placer County
Air Pollution Control District (PCAPCD) portion of the California State
Implementation Plan (SIP). This action was proposed in the Federal
Register on November 9, 2012 and concerns oxides of nitrogen
(NOX) emissions from biomass boilers. We are approving a
local rule that regulates these emission sources under the Clean Air
Act (CAA or the Act).

DATES: This rule will be effective on September 30, 2013.

ADDRESSES: EPA has established docket number EPA-R09-OAR-2012-0790 for
this action. Generally, documents in the docket for this action are
available electronically at http://www.regulations.gov or in hard copy
at EPA Region IX, 75 Hawthorne Street, San Francisco, California 94105-
3901. While all documents in the docket are listed at  http://www.regulations.gov, some information may be publicly available only at
the hard copy location (e.g., copyrighted material, large maps, multi-
volume reports), and some may not be available in either location
(e.g., confidential business information (CBI)). To inspect the hard
copy materials, please schedule an appointment during normal business
hours with the contact listed in the FOR FURTHER INFORMATION CONTACT
section.

FOR FURTHER INFORMATION CONTACT: Nancy Levin, EPA Region IX, (415) 972-
3848<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. Proposed Action
II. Public Comments and EPA Responses
III. EPA Action
IV. Statutory and Executive Order Reviews

I. Proposed Action

    On November 9, 2012 (77 FR 67322), EPA proposed to approve the
following rule into the SIP.

----------------------------------------------------------------------------------------------------------------
            Local agency                  Rule No.            Rule title            Amended         Submitted
----------------------------------------------------------------------------------------------------------------
PCAPCD..............................             233   Biomass Boilers........        06/14/12         09/21/12
----------------------------------------------------------------------------------------------------------------

    We proposed to approve this rule because we determined that it
complied with the relevant CAA requirements. Our proposed action
contains more information on the rule and our evaluation.

II. Public Comments and EPA Responses

    EPA's proposed action provided a 30-day public comment period.
During this period, we received no comments.

III. EPA Action

    No comments were submitted. Therefore, as authorized in section
110(k)(3) of the Act, EPA is fully approving this rule into the
California SIP. Final approval of this rule satisfies California's
obligation to implement RACT under CAA section 182 for this source
category and terminates both the sanctions clocks and the Federal
Implementation Plan (FIP) clock associated with our limited approval
and limited disapproval of an earlier version of this rule. (77 FR
2643, January 19, 2012).

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve State
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves State law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by State law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     does not provide EPA with the discretionary authority to
address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and recordkeeping requirements.

    Dated: July 22, 2013.
Jared Blumenfeld,
Regional Administrator, Region IX.

    Part 52, Chapter I, Title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for Part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart F--California

0
2. Section 52.220 is amended by adding paragraph (c)(423)(i)(A)(7) to
read as follows:

Sec.  52.220  Identification of plan.

* * * * *
    (c) * * *
    (423) * * *
    (i) * * *
    (A) * * *
    (7) Rule 233, ``Biomass Boilers,'' amended on June 14, 2012.
* * * * *
[FR Doc. 2013-20919 Filed 8-28-13; 8:45 am]
BILLING CODE 6560-50-P


United States Court of Appeals FOR THE DISTRICT OF COLUMBIA CIRCUIT Argued September 3, 2002 Decided October 22, 2002 No. 99 1255 Ethyl Corporation, Petitioner v.

Environmental Protection Agency and Christine Todd Whitman, Administrator, Environmental Protection Agency, Respondents Association of International Automobile Manufacturers, Inc., et al., Intervenors Consolidated with 00 1515, 01 1464 On Petitions for Review of Final Action of the Environmental Protection Agency

Kevin L. Fast argued the cause for petitioner. With him on the briefs were Douglas S. Burdin and Andrew J. Turner.

Alan D. Greenberg, Attorney, U. S. Department of Justice, argued the cause for respondents. With him on the brief was John T. Hannon, Attorney, U. S. Environmental Protection Agency. Lois J. Schiffer, Assistant Attorney General, Christopher S. Vaden and Eric G. Hostetler, Attorneys, U. S. Department of Justice, and Mark M. Kataoka, Attorney, U. S. Environmental Protection Agency, entered appearances.

Mitchell H. Bernstein argued the cause for intervenors Alliance of Automobile Manufacturers and Association of International Automobile Manufacturers, Inc. With him on the brief were Richard A. Penna, Charles R. Sensiba, Julie C. Becker and Charles H. Lockwood II.

Before: Edwards and Rogers, Circuit Judges, and Williams, Senior Circuit Judge.

Opinion for the Court filed by Senior Circuit Judge Williams. Williams, Senior Circuit Judge: Title II of the Clean Air Act, 42 U. S. C. s 7521 et seq. ( 1955), sets up a program for the regulation of both motor vehicles and their fuels in order to reduce harmful emissions. Section 206 charges the Envi ronmental Protection Agency with testing new motor vehicles to ensure that each vehicle's emissions will comply with federal emissions standards throughout its " useful life." 42 U. S. C. s 7525( a)( 1). Section 206( d) says that the agency " shall by regulation establish methods and procedures for making tests under this section." Id. s 7525( d) ( emphasis added).

In a rulemaking pursuant to s 206, the EPA adopted a Compliance Assurance Program or " CAP 2000." 64 Fed. Reg. 23,906 ( 1999). CAP 2000 does not, however, set out " methods and procedures for making tests." Rather, it es tablishes a framework for automobile manufacturers to devel op their own tests, to be used once the EPA gives approval, case by case, after private proceedings with each manufactur er.

Petitioner Ethyl manufactures and markets fuel and lubri cant additives for use in motor vehicles. It argues that CAP 2000 violates the Act because it provides for test procedures and methods to be vetted in individual closed proceedings rather than in a notice and comment rulemaking. And it claims to be injured because the mechanism adopted by the EPA deprives it of the opportunity to observe the rulemaking process and thus gain information useful in its efforts both to develop and improve its products and to key them to the certification tests. For the reasons given below we grant the petition.

* * *

Before a manufacturer may introduce a new motor vehicle into commerce, it must obtain an EPA certificate indicating compliance with the requirements of the Act and applicable regulations. It submits an application containing test data and other information specified by the EPA, which issues a certificate if the manufacturer has shown, among other things, that the vehicle's emissions control systems will achieve compliance with emissions standards over the vehi cle's full useful life. See 40 CFR s 86.1848 01.

Critical here is the question of the control systems' possible deterioration over time. Before 1993 EPA had had a durabil ity test that called for prototype vehicles to be driven over a 50,000 mile course known as the Automobile Manufacturers Association (" AMA") driving cycle. 58 Fed. Reg. 3994, 3995/ 1 ( 1993). In 1993 it adopted a " revised durability program" or " RDP" that retained that test " as the standard EPA defined procedure." Id. But the RDP regulations also permitted automobile companies to develop alternative test methods and procedures provided that they ( a) obtained EPA approval for each such test and ( b) performed in use testing to verify the accuracy of the emissions deterioration predictions made by their tests. See id. at 3995. The EPA did not adopt these tests through rulemaking but simply approved them on a case by case basis.

In May 1999 the EPA replaced RDP with CAP 2000. These regulations eliminate the AMA driving cycle as an EPA defined test method. Instead, the program available as an alternative in 1993 99, under which manufacturers are to develop their own emissions durability test methods and procedures, has become the sole method. Thus, rather than promulgating methods and procedures for durability testing itself, the EPA now requires, through CAP 2000, that "[ t] he manufacturer shall propose" a durability program. 40 C. F. R. s 86.1823 01. Each manufacturer is required to obtain EPA approval for its tests, and must verify its results through in use testing.

Manufacturer proposed tests under CAP 2000 must ( a) " effectively predict the expected deterioration of candidate in use vehicles over their full and intermediate useful life," and ( b) be " consistent with good engineering judgment." 40 C. F. R. s 86.1823 01( a). Within these criteria, the manufacturer developed mileage accumulation procedures are to be based upon whole vehicle full mileage accumulation, whole vehicle accelerated mileage accumulation ( e. g., where 40,000 miles on a severe accumulation cycle is equivalent to 100,000 miles of normal in use driving), bench aging of individual components or systems, or other approaches approved by the Administrator.

40 C. F. R. s 86.1823 01( a)( 1)( ii). The " bench aging" referred to is a system whereby components are removed from the vehicle and tested for durability separately. 40 C. F. R. s 86.1823 01( a)( 1)( B).

In adopting this system of individualized test approval, the EPA explicitly found that " rulemaking for each durability program is not required." 64 Fed. Reg. at 23,914/ 3. It also said, in a response to petitions for reconsideration by Ethyl, that public participation in the certification process would interfere with the process of reviewing manufacturers' sub missions " because of the large amount of information claimed confidential" and that, because the process was annual, the use of notice and comment procedures would be " administra tively burdensome." August 23, 2001 Response to Ethyl Corporation Petitions Denying Reconsideration of Three EPA regulations: CAP 2000, Heavy Duty Gasoline, and OBD/ IM, EPA Air Docket A 96 50, No. VI C 03, 39.

Ethyl challenges not only CAP 2000 but also regulations governing the certification of heavy duty vehicles and en gines, 65 Fed. Reg. 59,896 ( 2000), which incorporate the CAP 2000 regulations by reference, and EPA's denial of its various petitions for reconsideration, 66 Fed. Reg. 45,777 ( 2001).

* * *

The EPA argues that we need not reach the merits be cause, it says, Ethyl lacks both Article III and " prudential" standing. We think it has both.

As is well known, Article III requires a party seeking judicial relief to show ( 1) that it has suffered an " injury in fact"; ( 2) that the injury is caused by or fairly traceable to the challenged actions of the defendant; and ( 3) that it is likely that the injury will be redressed by a favorable deci sion. Lujan v. Defenders of Wildlife, 504 U. S. 555, 560 561 ( 1992).

Ethyl's assertions of injury fall into two categories. First, as we've already mentioned, it says that as a manufacturer of additives for motor vehicle fuels it has an interest in under standing the test methods and procedures by which the EPA certifies new motor vehicles. CAP 2000' s provision for closed door adoption of emission test procedures deprives Ethyl of information that might well help it develop and improve its products with an eye to conformity to emissions needs.

Second, Ethyl says that CAP 2000 deprives it of informa tion that might be useful for securing EPA approval for its own fuel additive products under the Act. It points in particular to s 211( f), which prohibits use of any fuel or fuel additive that is not " substantially similar" to the fuels used to certify vehicles under s 206, unless a waiver is obtained from EPA. See 42 U. S. C. s 7545( f).

EPA's response to this focuses almost entirely on Ethyl's asserted interest in the s 211( f) waiver process, completely ignoring its interest in obtaining information about vehicle certification for present day research and development of products that will be judged ( by both the government and consumers) according to their effect on vehicle emissions. The Supreme Court has made clear, however, that a denial of access to information can work an " injury in fact" for stand ing purposes, at least where a statute ( on the claimants' reading) requires that the information " be publicly disclosed" and there " is no reason to doubt their claim that the information would help them." Federal Election Comm'n v. Akins, 524 U. S. 11, 21 ( 1998). Here, against Ethyl's fairly detailed description of how the information that open rulemaking proceedings provide would prove useful to it, the EPA offers little more than a vague shrug of skepticism. Because Article III standing is clear from Ethyl's informa tional and market interests in the vehicle testing program, we need not address the interest based on its need to seek variances under s 211( f).

To show " prudential" standing, Ethyl must fall within the " zone of interests" protected or regulated by the Act. See Bennett v. Spear, 520 U. S. 154, 162 ( 1997). The test is not a particularly demanding one, Clarke v. Securities Industry Association, 479 U. S. 388, 399 ( 1987), and includes not only those challengers expressly mentioned by Congress, but also unmentioned potential challengers that Congress would have thought useful for the statute's purpose ( whose challenges thereby support an inference that Congress would have in tended eligibility). See Hazardous Waste Treatment Council v. EPA, 861 F. 2d 277, 283 ( D. C. Cir. 1988). It excludes parties whose interests are not consistent with the purposes of the statute in question. See Clarke, 479 U. S. at 399. As a manufacturer of fuel additives seeking an open process for testing the emissions control systems whose character may affect the efficacy of its products, Ethyl's interests appear congruent with those of the statute, i. e., the development of products that will reduce harmful air pollutants. Indeed, this court has long recognized the interdependence between motor vehicle certification under the Act ( the process at stake here) and fuel regulations ( under which Ethyl is a direct regulatee). See e. g., Lubrizol Corp. v. EPA, 562 F. 2d 807, 810 ( D. C. Cir. 1977); Amoco Oil Co. v. EPA, 501 F. 2d 722, 737 ( D. C. Cir. 1974). The case is not unlike National Cottonseed Products Association v. Brock, 825 F. 2d 482, 489 492 ( D. C. Cir. 1987), where we found standing for a manufacturer whose respira tors had been assigned a low rating by an agency supervising conditions in a workplace for which the respirators were a potential means of compliance. We treated the respirator seller's interest, and that of the regulated firms, as " ' two sides of the same coin.' " Id. at 491 ( quoting FAIC Sec., Inc. v. United States, 768 F. 2d 352, 359 ( D. C. Cir. 1985)).

On to the merits: As we said, s 206( d) of the Act states that the administrator " shall by regulation establish methods and procedures for making tests under this section." 42 U. S. C. s 7525( d). Although special provisions govern review under the Act, here the relevant provisions are the same as under the Administrative Procedure Act. We are to reverse the challenged EPA actions if they are " arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law" or " in excess of statutory jurisdiction, authority, or limitations." 42 U. S. C. s 7607( d)( 9)( A), ( C). CAP 2000 does not, as s 206 directs, " establish methods and procedures for making tests," and it is the only " regula tion" in the picture. Instead, it provides criteria for individu al automobile manufacturers to develop their own test meth ods and procedures, which the EPA approves in a process that does not involve rulemaking.

Conceivably s 206( d)' s requirement that EPA use regula tion to " establish methods and procedures for making tests" could be squared with the record by reading " making tests" as referring to devising the tests rather than conducting them. Thus Congress would be mandating that the EPA use regulations merely to set up a system for picking tests ( which might then be picked any old way) rather than mandating the use of regulations to decide how the tests themselves should be conducted. But nothing in the context of the provision suggests that the " establish[ ment]" under s 206( d) is to be so remote from the actual process of conducting tests, and it is hard to see any congressional purposes that would be served by such a requirement. Indeed, neither in the administrative proceedings nor before us has the EPA invoked such a reading.

Rather, the EPA seeks to defend CAP 2000 by treating the issue as involving simply the level of specificity or generality at which it was supposed to act, citing American Trucking Associations v. Department of Transportation, 166 F. 3d 374 ( D. C. Cir. 1999) ( agency to promulgate by regulation safety rating " requirements" and means to determine whether carri ers had met the requirements), and New Mexico v. EPA, 114 F. 3d 290 ( D. C. Cir. 1997) ( agency to promulgate " criteria" for a certification process). In those cases, as Congress had not specified the level of specificity expected of the agency, we held that the agency was entitled to broad deference in picking the suitable level. See American Trucking, 166 F. 3d at 379 80; New Mexico, 114 F. 3d at 294. But here Ethyl's challenge is not that the EPA was too general in establishing test procedures by regulation, but that it didn't establish them by regulation at all.

EPA's failure to act by regulation is thus similar to, and controlled by, our decision in MST Express v. Department of Transportation, 108 F. 3d 401 ( 1997), which preceded Ameri can Trucking and involved the same statutory requirement of proceeding by regulation in setting safety requirements for common carriers. Rather than promulgate regulations stat ing the means for determining whether carriers met the safety fitness requirements, the agency had simply required a carrier to " demonstrate that it has adequate controls in place" to ensure compliance with the substantive requirements, and had developed a " safety fitness rating methodology." Id. at 402, 403. This methodology provided agency inspectors with detailed guidelines for evaluating a motor carrier's safety rating but it was not the product of notice and comment rulemaking. See id. at 403. We found that the agency had " failed to carry out its statutory obligation to establish by regulation a means of determining whether a carrier has complied with the safety fitness requirements." Id. at 406. EPA's error here is similar.

There may, of course, be cases in which it is hard to distinguish between promulgations of ( 1) vaguely articulated test procedures ( which would be reviewed deferentially under such cases as American Trucking) and ( 2) procedures for later development of tests ( invalid under MST Express). Both, after all, necessarily imply a later ( or at least different) proceeding in which the agency will fill in details. In this case, however, one can distinguish on the basis of the lan guage used by the agency. With CAP 2000, the EPA does not claim to have itself articulated even a vague durability test. Rather, CAP 2000 requires that "[ t] he manufacturer shall propose a durability program" for EPA approval. 40 C. F. R. s 86.1823 01( a). It thus falls on the forbidden side of the line.

The EPA also defends CAP 2000 on grounds that seem to flout the evident congressional purpose. First, it argues that because it has chosen to approve test procedures only for one model year at a time, proceeding by regulation would be administratively burdensome. Obviously this cannot over come a clear congressional command. Further, it is true only in the sense that an open procedure the very thing mandat ed by Congress is less convenient than a closed one. It may be. Other parties may raise questions or find fault in proce dures that look fine to the agency and the auto makers. But Congress has already made the trade off. Nothing in our opinion requires that EPA use only a " one size fits all" test method. All that is required is that it establish its proce dures, no matter how variegated, " by regulation."

Finally, both EPA and the auto manufacturers who inter vene on its behalf argue that the approach of CAP 2000 is necessary because of the presence of what the manufacturers believe to be " confidential business information" (" CBI"). If the EPA were to establish test methods and procedures by regulation, they say, important CBI might become public, allowing competitors to " back engineer" their products. See Tr. of Oral Argument at 29 30. Moreover, they argue that the sheer " amount of claimed confidential business informa tion would significantly reduce the usefulness of public notice and an opportunity to comment upon manufacturers' durabili ty programs." EPA Br. at 44.

It is hard to know what to make of this argument. First and foremost, s 208( c) provides that the administrator may protect the confidentiality of " methods or processes entitled to protection as trade secrets." 42 U. S. C. s 7542( c). Espe cially given this available remedy, it seems to us a complete non sequitur to suggest that because a procedure ( the rule making mandated by s 206( d)) may involve some protectable CBI, the entire procedure should be short circuited and replaced with a cluster of closed bargaining sessions between the EPA and each manufacturer. Congress obviously expect ed that rulemakings would proceed despite the existence of CBI that would require protection under s 208( c). Plainly the theory provides no basis for disregarding the congression al command.

* * *

CAP 2000, rather than constituting an EPA establishment " by regulation" of " methods and procedures for making tests," as required by s 206( d), is instead a promulgation of criteria for the later establishment of such methods and procedures by private negotiation between the EPA and each regulated auto maker. So it is " not in accordance with law." We therefore vacate the CAP 2000 program and remand the case to the EPA with instructions to establish test methods and procedures by regulation.

So ordered.


[Federal Register Volume 83, Number 180 (Monday, September 17, 2018)]
[Notices]
[Pages 46959-46960]
[FR Doc No: 2018-20090]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0001]

Pathogen Reduction Technologies for Blood Safety; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
following public workshop entitled ``Pathogen Reduction Technologies
for

Blood Safety.'' The purpose of the public workshop is to foster the
development and implementation of pathogen reduction technologies for
blood components intended for transfusion. The workshop will include
presentations and panel discussions by experts from academic
institutions, industry, and government agencies.

DATES: The public workshop will be held on November 29, 2018, from 8
a.m. to 5 p.m., and on November 30, 2018, from 9 a.m. to 1 p.m. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.

ADDRESSES: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great
Room (Rm. 1503, sections B and C), Silver Spring, MD 20993. Entrance
for the public workshop participants (non-FDA employees) is through
Building 1, where routine security check procedures will be performed.
For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Loni Warren Henderson or Sherri
Revell, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-
402-8010, email: [email protected] (subject line: Pathogen
Reduction Technology and Blood Safety).

SUPPLEMENTARY INFORMATION:

I. Background

    Pathogen reduction technology has the potential to improve blood
safety by reducing or eliminating infectious organisms, including
bacteria, viruses, and parasites, from blood components intended for
transfusion. FDA granted approvals for use of a pathogen reduction
technology platform in manufacturing plasma and apheresis platelets for
transfusion. Ideally, pathogen reduction technology should also be
available for whole blood and red blood cells. Implementation of safe
and effective pathogen reduction technology may also permit alternative
donor screening or donation testing strategies in the future. The
purpose of the public workshop is to foster the development and
implementation of pathogen reduction technologies for all blood
components intended for transfusion.

II. Topics for Discussion at the Public Workshop

    The first day of the workshop will include presentations and panel
discussions on the following topics: (1) Transfusion-transmitted
infectious agents and their impact on blood safety; (2) status of
pathogen reduction technology for blood components intended for
transfusion, including challenges to implementation in the United
States; and (3) the development of pathogen reduction technology for
whole blood and red blood cells.
    The second day of the workshop will include presentations and panel
discussions on the following topics: (1) Emerging pathogen reduction
technologies and alternative approaches to controlling risk; (2)
potential funding opportunities for research; and (3) a summary of all
workshop sessions, panel discussions, and future directions.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the
following website: https://www.eventbrite.com/e/pathogen-reduction-technologies-for-blood-safety-public-workshop-tickets-4464956605.
Please provide complete contact information for each attendee,
including name, title, affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by November 8, 2018, midnight Eastern Time.
Early registration is recommended because seating is limited;
therefore, FDA may limit the number of participants from each
organization. If time and space permit, onsite registration on the day
of the public workshop will be provided, beginning at 7 a.m.
    If you need special accommodations, due to a disability, please
contact Loni Warren Henderson or Sherri Revell no later than November
19, 2018 (see FOR FURTHER INFORMATION CONTACT). Request for sign
language interpretation or Computer Aided Realtime Translation (CART)/
captioning should be made 2 weeks in advance of the event, no later
than November 15, 2018. A request for either interpreting or captioning
should be sent directly to the FDA Interpreting Services Staff email
account: [email protected].
    Streaming Webcast of the Public Workshop: This public workshop will
also be webcast. Individuals who wish to view the webcast should
register for the workshop at https://www.eventbrite.com/e/pathogen-reduction-technologies-for-blood-safety-public-workshop-tickets-4464956605. A link to the live webcast will be provided upon
registration.
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
    Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. A link to the transcript will also be available on
the internet at https://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/default.htm.

    Dated: September 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20090 Filed 9-14-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 243 (Wednesday, December 18, 2019)]
[Proposed Rules]
[Pages 69349-69351]
[FR Doc No: 2019-27274]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2019-0103; FRL-10003-48-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
West Virginia; Infrastructure Requirements for the 2015 Ozone Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a state implementation plan (SIP) revision submittal from the
State of West Virginia pursuant to the Clean Air Act (CAA). Whenever
new or revised national ambient air quality standards (NAAQS or
standards) are promulgated, the CAA requires states to submit a plan
for the implementation, maintenance, and enforcement of such NAAQS. The
plan is required to address basic program elements, including, but not
limited to, regulatory structure, monitoring, modeling, legal
authority,

and adequate resources necessary to assure attainment and maintenance
of the standards. These elements are referred to as infrastructure
requirements. West Virginia made a submittal addressing most of the
infrastructure requirements for the 2015 ozone NAAQS and later
supplemented the submittals to address the interstate transport
elements; EPA is not proposing any action on the interstate transport
elements at this time.

DATES: Written comments must be received on or before January 17, 2020.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R03-
OAR-2019-0103 at https://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be confidential business information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Joseph Schulingkamp, Planning &
Implementation Branch (3AD30), Air & Radiation Division, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103. The telephone number is (215) 814-
2021. Mr. Schulingkamp can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On October 26, 2015, EPA revised both the
primary and secondary NAAQS for ozone based on 8-hour average
concentrations to 0.070 parts per million (ppm). See 80 FR 65292.
Pursuant to CAA section 110(a)(1), states are required to submit SIPs
meeting the applicable requirements of section 110(a)(2) within three
years after promulgation of a new or revised NAAQS or within such
shorter period as EPA may prescribe. Section 110(a)(2) requires states
to address basic SIP elements such as requirements for monitoring,
basic program requirements and legal authority that are designed to
assure attainment and maintenance of the NAAQS. Section 110(a) imposes
the obligation upon states to make a SIP submission to EPA for a new or
revised NAAQS, but the contents of that submission may vary depending
upon the facts and circumstances. In particular, the data and
analytical tools available at the time the state develops and submits
the SIP for a new or revised NAAQS affects the content of the
submission. The content of such SIP submissions may also vary depending
upon what provisions the state's existing SIP already contains.
    In the case of the 2015 ozone NAAQS, states typically have met the
basic program elements required in section 110(a)(2) through earlier
SIP submissions in connection with the 1997 and 2008 ozone NAAQS.
Section 110(a)(1) of the CAA provides the procedural and timing
requirements for SIPs, while section 110(a)(2) lists specific elements
that states must meet for infrastructure SIP requirements related to a
newly established or revised NAAQS. As mentioned earlier, these
requirements include basic SIP elements such as requirements for
monitoring, basic program requirements and legal authority that are
designed to assure attainment and maintenance of the NAAQS.

I. Background

    On September 14, 2018, WVDEP submitted a revision to its SIP to
satisfy the requirements of CAA section 110(a)(2) for the 2015 ozone
NAAQS (hereafter the ``2015 Infrastructure SIP''). This submittal
addressed the following elements of CAA section 110(a)(2): (A), (B),
(C), (D)(i)(II), (E), (F), (G), (H), (J), (K), (L), and (M). This
submittal did not address CAA section 110(a)(2)(D)(i)(I) (interstate
transport), however, the state committed to submitting a supplemental
SIP revision to fully address this requirement. On February 4, 2019,
the WVDEP supplemented its 2015 Infrastructure SIP to address the
interstate transport elements of CAA section 110(a)(2)(D)(i)(I)
(hereafter the ``2015 Transport SIP''). At this time, EPA is not taking
action on West Virginia's 2015 Transport SIP and will address that
submittal in a later separate action.

II. How EPA Evaluates Infrastructure SIPs

    Pursuant to CAA section 110(a), states must provide SIP revisions
addressing relevant infrastructure SIP elements from section
110(a)(2)(A) through (M) or provide certification that the existing SIP
contains provisions adequately addressing these elements for the 2015
ozone NAAQS.
    EPA reviews each infrastructure SIP submission for compliance with
the applicable statutory provisions of CAA section 110(a)(2), as
appropriate. Historically, EPA has elected to use non-binding guidance
documents to make recommendations for states' development and EPA
review of infrastructure SIPs, in some cases conveying needed
interpretations on newly arising issues, and in others conveying
interpretations that have already been developed and applied to
individual SIP submissions for particular elements. EPA guidance
applicable to these infrastructure SIP submissions is embodied in
several documents.\1\ Unless otherwise noted below, EPA is following
that existing approach in acting on this submission. In addition, in
the context of acting on such infrastructure submissions, EPA evaluates
the submitting state's SIP for facial compliance with statutory and
regulatory requirements, not for the state's implementation of its
SIP.\2\ EPA has other authority to address any issues concerning a
state's implementation of the rules, regulations, consent orders, etc.
that comprise its SIP.
---------------------------------------------------------------------------

    \1\ EPA explains its approach in its September 13, 2013
Infrastructure SIP Guidance (available at https://www3.epa.gov/airquality/urbanair/sipstatus/docs/Guidance_on_Infrastructure_SIP_Elements_Multipollutant_FINAL_Sept_2013.pdf), as well as in numerous agency actions, including EPA's prior
action on West Virginia's infrastructure SIP to address the 2008
ozone NAAQS (79 FR 19001 (April 7, 2014)).
    \2\ See Montana Environ. Info. Center v. EPA, 902 F.3d 971 (9th
Cir. 2018).
---------------------------------------------------------------------------

III. EPA's Analysis

    West Virginia's 2015 Infrastructure SIP submittal addressed the
following infrastructure elements, or portions thereof, for the 2015
ozone NAAQS: CAA section 110(a)(2)(A), (B), (C), D(i)(II), D(ii), (E),
(F), (G), (H), (J), (K), (L), and (M). The 2015 Infrastructure SIP
submittal did not address element (I) which pertains to the
nonattainment requirements of part D, title I of the CAA, since this
element is not required to be submitted by the 3-year submission
deadline of section 110(a)(1) and will be addressed in a separate
process.
    EPA has analyzed the 2015 Infrastructure SIP submission and is

proposing to make a determination that the submittal meets the
requirements of the identified elements. A detailed summary of EPA's
review and rationale for approving West Virginia's submittal may be
found in the technical support document (TSD) for this proposed
rulemaking action which is available online at www.regulations.gov,
docket number EPA-R03-OAR-2019-0103.

IV. Proposed Action

    EPA is proposing to approve West Virginia's September 14, 2018
submittal which provides the basic program elements, or portions
thereof, specified in section 110(a)(2)(A), (B), (C), (D)(i)(II),
(D)(ii), (E), (F), (G), (H), (J), (K), (L), and (M) necessary to
implement, maintain, and enforce the 2015 ozone NAAQS. This proposed
rulemaking action does not include action on section 110(a)(2)(I) which
pertains to the nonattainment planning requirements of part D, title I
of the CAA, because this element is not required to be submitted by the
3-year submission deadline of section 110(a)(1) of the CAA and will be
addressed in a separate process. This proposed rulemaking action also
does not address section 110(a)(2)(D)(i)(I) which pertains to the
interstate transport of emissions; EPA will propose action on West
Virginia's 2015 Transport SIP in a later separate action. EPA is
soliciting public comments on the issues discussed in this document
which will be considered before taking final rulemaking action.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rule, pertaining to West Virginia's
section 110(a)(2) infrastructure requirements for the 2015 ozone NAAQS,
does not have tribal implications as specified by Executive Order 13175
(65 FR 67249, November 9, 2000), because the SIP is not approved to
apply in Indian country located in the state, and EPA notes that it
will not impose substantial direct costs on tribal governments or
preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Volatile organic compounds.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: December 12, 2019.
Diana Esher,
Acting Regional Administrator, Region III.
[FR Doc. 2019-27274 Filed 12-17-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: April 20, 2009 (Volume 74, Number 74)]
[Notices]
[Page 17967-17970]
[DOCID:fr20ap09-54]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0143]

Risk Evaluation and Mitigation Strategies for Certain Opioid
Drugs; Notice of Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting to obtain input on developing Risk Evaluation and Mitigation
Strategies (REMS) for certain opioid drugs. The REMS would be intended
to ensure that the benefits of these drugs continue to outweigh certain
risks. The agency has long been concerned about adverse events
associated with this class of drug and has taken steps in cooperation
with drug manufacturers to address these risks. We intend to use the
agency's REMS authority under the Food and Drug Administration
Amendments Act of 2007 (FDAAA) to mitigate the risks of these drugs.
The purpose of the public meeting is to receive information and
comments on this topic.

DATES: The public meeting will be held on May 27 and 28, 2009, from 8
a.m. to 5 p.m. Register to attend the meeting by May 15, 2009. See
section III of this document for information on how to register or make
an oral presentation at the meeting. Written or electronic comments
will be accepted until June 30, 2009.

ADDRESSES: The public meeting will be held at the Hilton Washington, DC
North/Gaithersburg Hotel, 620 Perry Pkwy., Gaithersburg, MD 20877.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061.
Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov. All comments should be identified with the docket
number found in brackets in the heading of this document. Transcripts
of the meeting will be available for review at the Division of Dockets
Management and on the Internet at http://www.regulations.gov
approximately 30 days after the meeting.

FOR FURTHER INFORMATION CONTACT: Theresa (Terry) Martin, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6184, Silver Spring, MD 20993-0002, 301-
796-3448, FAX:<PHONE_NUMBER>, or Anne Henig, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg 51, rm. 6176, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX:
301-847-8753, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDAAA (Public Law 110-85) created section 505-1 of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355-1). Under section
505-1 of the act,

FDA may require a REMS when FDA determines that a REMS is necessary to
ensure the benefits of a drug outweigh the risks associated with the
drug. On February 6, 2009, FDA sent letters to manufacturers of certain
opioid drug products, indicating that these drugs will be required to
have a REMS to ensure that the benefits of the drugs continue to
outweigh the risks. An example of the text of these letters is
available on the agency's Web site at http://www.fda.gov/cder/drug/
infopage/opioids/meeting_template.pdf. A table of opioid products that
may be required to have REMS is also available on the agency's Web site
at http://www.fda.gov/cder/drug/infopage/opioids/Opioid_Products_
chart.htm. Copies of these documents may also be requested from Terry
Martin or Anne Henig (see FOR FURTHER INFORMATION CONTACT).
    The affected opioid drugs include brand name and generic products
and are formulated with the following active ingredients: Fentanyl,
hydromorphone, methadone, morphine, oxycodone, and oxymorphone. The
REMS would be intended to ensure that the benefits of these drugs
continue to outweigh the risks associated with: (1) Use of high doses
of long acting opioids and extended release opioid products in non-
opioid tolerant and inappropriately selected individuals; (2) abuse;
(3) misuse; and (4) overdose, both accidental and intentional. REMS for
opioids would likely include elements to assure safe use to ensure that
prescribers, dispensers, and patients are aware of and understand the
risks and how these products should be used. The purpose of this
meeting is to examine specific features of REMS for these drugs and
provide interested persons an opportunity to comment. The meeting will
also address issues associated with creating and implementing the REMS
and evaluating its effectiveness.

A. Opioids

    Opioid drugs have effects similar or identical to those of opiates
produced naturally in the opium poppy. On the molecular level, they act
at protein sites called opioid receptors, which are found in the brain,
spinal cord, gastrointestinal tract, peripheral nerve terminals, and
other peripheral sites. The actions of these drugs at certain opioid
receptors in the brain, spinal cord, and other sites can effectively
block the transmission of pain messages to the brain. Opioid drugs
currently marketed in the United States for pain relief include
products formulated with active ingredients such as fentanyl,
hydromorphone, methadone, morphine, oxycodone, and oxymorphone.
Individual patients respond differently to different opioid drug
substances, and some patients develop tolerance to the effects of a
particular opioid after chronic exposure. Physicians use a technique
known as ``opioid rotation'' whereby they switch a patient from one
opioid to another if the patient develops tolerance to the drug's
analgesic effects and cannot get adequate pain relief from any single
drug.
    Some opioids are naturally long acting; others are incorporated
into extended release formulations. Long acting opioids and extended
release opioid formulations are often useful for the management of
persistent, moderate to severe pain in patients requiring continuous,
around-the-clock pain relief for an extended period of time. Long
acting products allow these patients to have their pain controlled for
long periods of time without the need for another dose and to
significantly reduce the number of tablets the patient must take each
day. Therefore, having long acting opioids and extended release opioid
formulations available provides important pain relief options for
patients who require management of persistent, moderate to severe pain.
    The expected duration of treatment with long acting opioids and
extended release opioid formulations ranges from a few weeks to months
or longer. In some cases, moderate to severe pain requiring continuous,
around-the-clock opioid therapy is associated with a serious condition
that is unlikely to improve.
    These types of opioids are widely prescribed, posing challenges for
the development of REMS for these products. Long acting and extended
release opioid formulations were used by nearly 4 million patients in
the United States in 2007. Physicians who prescribe and administer long
acting and extended release opioid drugs practice in a wide variety of
areas including family practice, anesthesiology, internal medicine,
orthopedic surgery, physiatry, neurology, rheumatology, oncology, and
other areas. A REMS, to adequately manage the risks of these products
without unduly burdening the health care system or reducing patient
access to these medications, must be carefully designed.

B. Adverse Events Associated With Opioids

    The most serious of the known adverse events associated with opioid
pain relievers are: Respiratory depression, central nervous system
depression, addiction, and death. Adverse events are associated with
improper dosing, indication, and patient selection, as well as with
abuse and addiction. For example, some products and doses are indicated
only for the management of persistent moderate to severe pain in
patients who have demonstrated opioid tolerance. Use of these products
in non-opioid-tolerant patients may result in fatal respiratory
depression. In other cases, when extended release products are
intentionally crushed or dissolved, the controlled-release mechanism
may be defeated, allowing a large dose to be taken at once. This
presents a risk of fatal overdose, particularly in individuals who are
not tolerant to opioids.

C. Efforts to Address the Risks of Opioid Use

    FDA and drug manufacturers have taken steps to decrease abuse and
misuse of long acting opioids and extended release opioids while
seeking to ensure that they remain available for patients who suffer
daily from chronic pain. Since 2001, FDA has required boxed warnings,
the agency's strongest warning, on the labeling of long acting opioid
drugs to educate physicians and patients on the risks and proper uses
of these products. The agency has also required risk management plans
for many of these products. These plans have incorporated educational
programs for prescribers, pharmacists, and patients, and surveillance
systems to monitor for signals of increasing abuse, misuse, and
diversion, as well as plans for intervention when these signals are
noted. In addition, drug manufacturers have sought to incorporate
features into their products intended to deter abuse. For example, the
active ingredient may be incorporated into a matrix from which it
cannot easily be extracted or that is not easily ground into powder. In
other cases, an opioid antagonist is sequestered in the inner core of
an extended release tablet, designed to be released if the tablet is
crushed or dissolved.

D. REMS for Long Acting and Extended Release Opioids

    Despite existing efforts to address the risks associated with
opioid drugs, misuse and abuse are increasing. Data from multiple
sources, including the Centers for Disease Control (CDC) and the
Substance Abuse and Mental Health Services Administration (SAMHSA),
indicate increasing misuse and abuse of prescription opioid analgesic
medications over the past decade. For example, SAMHSA's National Survey
on Drug Use and Health estimates that

11 million Americans over the age of 12, or 4.7 percent of that
population, took pain relievers for nonmedical use in 2002. That number
increased to 12.5 million, or 5.0 percent of the population over 12, in
2007. Likewise, data compiled by SAMHSA show a significant increase
from 2000 to 2006 in admissions to substance abuse treatment services
for individuals abusing opioid analgesics. Much of this misuse has
involved the extended release opioid analgesics and methadone. To
address this public health problem, the agency has indicated it will
require REMS for certain opioid products.
    Section 505-1 of the act authorizes FDA to require persons
submitting certain drug approval applications to submit a proposed REMS
as part of the application. FDA may require a REMS when FDA determines
that a REMS is necessary to ensure the benefits of the drug outweigh
the risks associated with the drug. Section 505-1 of the act also
authorizes FDA to require holders of certain drug applications approved
without a REMS to submit a proposed REMS if the agency becomes aware of
new safety information and makes a determination that a REMS is
necessary to ensure the benefits of the drug outweigh the risks. Once
FDA notifies the holder of an approved covered application that a REMS
is necessary, the holder must submit a proposed REMS within 120 days,
or within such other reasonable time as FDA requires.
    Every REMS must include a timetable for the submission of
assessments of the REMS. A REMS may also include a Medication Guide (as
provided in 21 CFR part 208), a patient package insert, a communication
plan, and certain ``elements to assure safe use.'' The elements to
assure safe use must include one or more goals to mitigate a specific
serious risk listed in the labeling of the drug. These elements may
include the following requirements:
     Health care providers who prescribe the drug have
particular training or experience, or are specially certified.
     Pharmacies, practitioners, or health care settings that
dispense the drug are specially certified.
     The drug is dispensed to patients only in certain health
care settings.
     The drug is dispensed to patients with evidence of safe
use conditions, such as laboratory test results.
     Each patient using the drug is subject to certain
monitoring.
     Each patient using the drug is enrolled in a registry.
    The elements to assure safe use may also include an implementation
plan, whereby the applicant monitors, evaluates, and works to improve
the implementation of certain of these elements. FDAAA states that when
elements to assure safe use are required for a drug that is also
marketed in one or more generic forms, the pioneer drug and the
generic(s) shall use a single, shared system unless the generic
applicant obtains a waiver in accordance with statutory criteria. A
waiver may be granted if the burden of creating a single, shared system
outweighs the benefits of a single, shared system or if an aspect of
the elements to assure safe use is entitled to protection as a trade
secret or is protected by a patent for which the generic applicant has
unsuccessfully sought a license (section 505-1(i)(1) of the act).
    We are mindful of the provisions in FDAAA that state the elements
to assure safe use must be, among other things, commensurate with the
specific serious risk listed in the labeling of the drug, not be unduly
burdensome on patient access to the drug, and be designed to be
compatible with established distribution, procurement, and dispensing
systems (section 505-1(f)(2) of the act). Marketed opioid products
include both innovator and generic drugs. FDAAA requires, with limited
exception, that innovator and generic drugs use a single, shared system
for a REMS that contains elements to assure safe use. Putting together
a workable system will involve innovator and generic sponsors working
together to develop a single, shared system.

II. Scope of Meeting

    FDA is holding this public meeting to allow affected sponsors and
other interested persons to present comments and information on what a
REMS should look like for these products, how to minimize the burden on
the health care community and patients while achieving the objective of
ensuring that the benefits of these drugs continue to outweigh the
risks, and how FDA should evaluate the REMS to determine whether it is
achieving these objectives.
    FDA is interested in obtaining information and public comment on
the following issues:

A. Elements of the REMS

    1. FDA believes that one key element to assure safe use for these
products will be prescriber certifications to ensure prescribers are
educated about the risks of these products and proper patient
selection, and the importance of counseling patients on the safe and
appropriate use of their prescription medication. Please comment on
what type of education should be provided to prescribers and how this
certification should be administered (e.g., through state Medical
Boards, DEA (Drug Enforcement Agency), other Federal or state systems,
or privately, through a contractor established to administer the REMS).
Some combination of administration could also be considered.
    2. FDA believes that another key element to assure safe use for
these products will be certifications of pharmacists, prescribers, and
other health care providers or institutions that dispense or directly
administer covered opioid products to ensure these representatives of
the health care system also are educated about the risks of these
products and the importance of counseling patients on the safe and
appropriate use of their prescription medication. These representatives
of the health care system could be asked to check that the prescriber
has obtained the certification necessary to prescribe these products.
Please comment on what type of education should be provided to
pharmacists and other health care providers who dispense or directly
administer covered products and how this certification should be
administered (e.g., through state Boards of Pharmacy, DEA, other
Federal or state systems, or privately, through a contractor
established to administer the REMS). Some combination of administration
could also be considered.
    3. FDA believes patient education, in conjunction with a
prescriber-patient agreement, is another key element of the REMS. What
education should be provided to patients, and should the system be
designed to ensure such education is provided? For example, other REMS
programs require prescriber-patient agreements that patients sign
before receiving a prescription to acknowledge that they have been
advised about the risks and appropriate use of the products and
received a Medication Guide or other appropriate patient information.
Is such a system necessary for opioid products?
    4. Are other REMS elements necessary to support the safe use of
approved opioids? A list of possible REMS elements is provided in
section I.D of this document.

B. System Issues

    1. How restrictive a system should be designed? For example, in
some previously approved risk management systems, covered drugs are
provided only when prescribers, pharmacists, and patients are all
enrolled in a program designed to ensure that all understand the risks
and appropriate use of the

products. Such systems have been put in place for drugs that are or are
suspected to be teratogenic, and the programs are designed to ensure
patients are not pregnant and will not become pregnant while taking the
drug. Such systems create burdens on patients and the health care
system. Is such a system necessary for opioids? How would such a
program be implemented given the number of patients, prescribers, and
other health care providers involved in their use?
    2. Should the REMS include controls on distributors who distribute
products to pharmacies and other health care providers? What controls
are necessary, and how can they be efficiently provided without being
unduly burdensome on the health care system?
    3. What existing systems (for example, in pharmacies) already exist
that could be used to implement a REMS? For example, could patient
information be provided through existing pharmacy systems to patients?
Are there systems for providing education to prescribers that could be
used to provide the educational component of a REMS?
    4. FDAAA requires that innovator and generic application holders
use a single, shared system to provide a REMS with elements to assure
safe use. What obstacles need to be addressed before such a system
could be developed?
    5. What metrics should be used to assess the success of the REMS?
Please comment on the metrics that should be applied to measure the
success of each of the components of the REMS (e.g., educational
requirements) as well as metrics to assess the impact of the overall
REMS on decreasing abuse and misuse of long acting opioids and extended
release opioids while seeking to ensure that they remain available for
patients who suffer daily from chronic pain.

III. Attendance and Registration

    Register via email to<EMAIL_ADDRESS>by providing complete
contact information for each attendee (including name, title,
affiliation, address, email address, and phone number(s)) by May 15,
2009. Registration is free and will be on a first-come, first-served
basis. Early registration is recommended because seating is limited.
Please send no more than two individuals from your organization.
Registration on the first day of the meeting will be provided on a
space available basis beginning at 8 a.m.
    If you wish to make an oral presentation at the meeting, you must
indicate this at the time of registration. FDA has included questions
for comment in section II of this document. You should also identify by
number each question you wish to address in your presentation. FDA will
do its best to accommodate requests to speak. Individuals and
organizations with common interests are urged to consolidate or
coordinate their presentations, and to request time for a joint
presentation. FDA will determine the amount of time allotted to each
presenter and the approximate time that each oral presentation is
scheduled to begin. If you need special accommodations because of
disability, please e-mail<EMAIL_ADDRESS>at least 7 days before
the meeting.

IV. Comments

    Regardless of attendance at the public meeting, interested persons
may submit written or electronic comments to the Division of Dockets
Management (see ADDRESSES). Submit a single copy of electronic comments
or two paper copies of any mailed comments, except that individuals may
submit one paper copy. Comments are to be identified with the docket
number found in brackets in the heading of this document. To ensure
consideration, submit comments by June 30, 2009. Received comments may
be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.

V. Transcripts

    Transcripts of the meeting will be available for review at the
Division of Dockets Management and on the Internet at http://
www.regulations.gov approximately 30 days after the meeting. A
transcript will also be made available in either hard copy or on CD-
ROM, upon submission of a Freedom of Information request. Written
requests are to be sent to Division of Freedom of Information (HFI-35),
Office of Management Programs, Food and Drug Administration, 5600
Fishers Lane, rm. 6-30, Rockville, MD 20857.

    Dated: April 14, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-8992 Filed 4-17-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: November 28, 2006 (Volume 71, Number 228)]
[Notices]
[Page 68849-68850]
[DOCID:fr28no06-92]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon written request, copies available from: Securities and Exchange
Commission, Office of Filings and Information Services, Washington, DC
20549.
Extension: Rule 12b-1, SEC File No. 270-188, OMB Control No. 3235-
0212.
    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) the Securities and Exchange Commission
(the ``Commission'') is soliciting comments on the collections of
information summarized below. The Commission plans to submit these
existing collections of information to the Office of Management and
Budget (``OMB'') for extension and approval.
    Rule 12b-1 (17 CFR 270.12b-1) permits a registered open-end
investment company (``mutual fund'') to distribute its own shares and
pay the expenses of distribution out of the mutual fund's assets
provided, among other things, that the mutual fund adopts a written
plan (``Rule 12b-1 plan'') and has in writing any agreements relating
to the implementation of the Rule 12b-1 plan. The rule in part requires
that (i) the adoption or material amendment of a Rule 12b-1 plan be
approved by the mutual fund's directors and shareholders; (ii) the
board review quarterly reports of amounts spent under the Rule 12b-1
plan; and (iii) the board consider continuation of the Rule 12b-1 plan
at least annually. Rule 12b-1 also requires funds relying on the rule
to preserve for six years, the first two years in an easily accessible
place, copies of the Rule 12b-1 plan, related agreements and reports,
as well as minutes of board meetings that describe the factors
considered and the basis for adopting or continuing a Rule 12b-1 plan.
    The board and shareholder approval requirements of Rule 12b-1 are
designed to ensure that fund shareholders and directors receive
adequate information to evaluate and approve a Rule 12b-1 plan. The
requirement of quarterly reporting to the board is designed to ensure
that the Rule 12b-1 plan continues to benefit the fund and its
shareholders. The recordkeeping requirements of the rule are necessary
to enable Commission staff to oversee compliance with the rule.
    The number of hours required to comply with Rule 12b-1 will vary
considerably depending on several factors, including the complexity of
the plan and the number of classes of fund shares covered by the plan,
and is expected to be higher in the first year following adoption of
the proposed amendments than in subsequent years. Based on information
filed with the Commission by funds, Commission staff estimates that
there are approximately 6,536 mutual fund portfolios with Rule 12b-1
plans.
    Rule 12b-1 requires the board of each fund with a Rule 12b-1 plan
to (i) review quarterly reports of amounts spent under the plan, (ii)
annually consider the plan's continuation (which generally is combined
with the fourth quarterly review), (iii) have each fund document the
policies and procedures it has implemented to enable it to effect
portfolio securities transactions through an executing broker that also
distributes the fund's shares, and (iv) approve those policies and
procedures.
    The number of annual responses per fund portfolio will be four per
year. Thus, there will be an estimated 26,144 industry responses (6,536
fund portfolios x 4 responses per fund portfolio= 26,144 responses) in
the first year and in each subsequent year. Thus, we estimate that
there will be an average of 26,144 industry responses per year over the
three year period for which we are requesting approval of the
information collection burden.
    Based on conversations with fund industry representatives,
Commission staff estimates that for each of the 6,536 mutual fund
portfolios that currently have a Rule 12b-1 plan, the average annual
burden of complying with the rule is 100 hours to maintain the plan.
This estimate takes into account the time needed to prepare quarterly
reports to the board of directors, the board's consideration of those
reports, and the board's annual consideration of the plan's
continuation. The total burden hours per year for all fund portfolios
to comply with current information collection requirements under Rule
12b-1, therefore, is estimated to be 653,600 hours (6,536 fund
portfolios x 100 hours per fund portfolio = 653,600 hours). The annual
cost of the hourly burden per fund under the rule is estimated to be
$11,135.00. Thus, we estimate that the total annual cost to all funds
of the Rule 12b-1 hour burden is $72,778,360.00 (6,536 fund portfolios
with Rule 12b-1 plans x $11,135.00 per fund portfolio =
$72,778,360.00).
    If a currently operating fund seeks to (i) adopt a new Rule 12b-1
plan or (ii) materially increase the amount it spends for distribution
under its Rule 12b-1 plan, Rule 12b-1 requires that the fund obtain
shareholder approval. As a consequence, the fund will incur the cost of
a proxy. Based on conversations with fund industry representatives,
Commission staff estimates that approximately three funds per year
prepare a proxy in connection with the adoption or material amendment
of a Rule 12b-1 plan. The staff further estimates that the cost of each
fund's proxy is $30,000. Thus the total annual cost burden of Rule 12b-
1 to the fund industry is $90,000 (3 funds requiring a proxy x $30,000
per proxy).
    The collections of information required by Rule 12b-1 are necessary
to obtain the benefits of the rule. Notices to the Commission will not
be kept confidential. 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 control number.
    Written comments are invited on: (a) Whether the proposed
collection of

information is necessary for the proper performance of the functions of
the agency, including whether the information will have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
collection of information; (c) ways to enhance the quality, utility,
and clarity of the information collected; and (d) ways to minimize the
burden of the collection of information on respondents, including
through the use of automated collection techniques or other forms of
information technology. Consideration will be given to comments and
suggestions submitted in writing within 60 days of this publication.
    Please direct your written comments to R. Corey Booth, Director/
Chief Information Officer, Securities and Exchange Commission, C/O
Shirley Martinson, 6432 General Green Way, Alexandria, VA 22312 or send
an e-mail to<EMAIL_ADDRESS>
    Dated: November 20, 2006.
Nancy M. Morris,
Secretary.
[FR Doc. E6-20055 Filed 11-27-06; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: March 5, 2009 (Volume 74, Number 42)]
[Notices]
[Page 9651-9654]
[DOCID:fr05mr09-88]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59468; File No. SR-NYSEALTR-2009-16]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by NYSE Alternext US LLC Amending
Rule 300.10T--NYSE Alternext Equities To Provide a Grace Period Under
That Rule for Member Organizations That Have Applied for a Trading
License To Comply With Certain Exchange Rules

February 27, 2009.
    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 February 24, 2009, NYSE Alternext US, LLC (``NYSE Alternext'' or the
``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. NYSE
Alternext has designated the proposed rule change as constituting a
non-controversial rule change under Rule 19b-4(f)(6) under the Act,\3\
which renders the proposal effective upon filing with the Commission.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    The Exchange proposes to amend Rule 300.10T--NYSE Alternext
Equities to provide a grace period under that rule for member
organizations that have applied for a trading license to comply with
certain Exchange rules.

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

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

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

1. Purpose
    The Exchange proposes to amend Rule 300.10T--NYSE Alternext
Equities (``Rule 300.10T'') to provide for a six-month grace period for
member organizations that have applied for, but not received a trading
license, to comply with certain Exchange rules. The Exchange intended
Rule 300.10T to provide holders of a valid permit to trade on the NYSE
Alternext systems and facilities located at 86 Trinity Place (``86
Trinity Permit'') seeking to trade equities at the Exchange with a
grace period to comply with the Exchange membership requirements under
the NYSE Alternext Equities rules. The proposed amendment seeks to
clarify the rule to reflect the original purpose of the provision.\4\
---------------------------------------------------------------------------

    \4\ The New York Stock Exchange LLC (``NYSE'') is proposing
conforming amendments to its Rule 300.10T. Because NYSE Alternext's
perspective of its member organizations differs from those of the
NYSE, the rule text proposed by the NYSE is not identical to that
proposed by NYSE Alternext, but is the same in substance. See SR-
NYSE-2009-19 (formally submitted on February 24, 2009).
---------------------------------------------------------------------------

Background of Merger
    As described more fully in a related rule filing (the ``Merger
filing''),\5\ NYSE Euronext acquired The Amex Membership Corporation
(``AMC'') pursuant to an Agreement and Plan of Merger, dated January
17, 2008 (the ``Merger''). In connection with the Merger, the
Exchange's predecessor, the American Stock Exchange LLC (``Amex''), a
subsidiary of AMC, became a subsidiary of NYSE Euronext and was renamed
NYSE Alternext US LLC (``NYSE Alternext'' or the ``Exchange''), and
continues to operate as a national securities exchange registered under
Section 6 of the Securities Exchange Act of 1934, as amended (the
``Act'').\6\ The effective date of the Merger was October 1, 2008.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 58673 (September 29,
2008), 73 FR 57707 (October 3, 2008) (SR-NYSE-2008-60 and SR-Amex
2008-62) (approving the Merger).
    \6\ 15 U.S.C. 78f.
---------------------------------------------------------------------------

    As described more fully in the Merger filing, in connection with
the Mergers, Amex demutualized by separating all trading rights from
equity ownership in Amex. As part of the demutualization, all trading
rights appurtenant to the Amex Regular Members' memberships or Options
Principal Members' (``OPM'') memberships were cancelled. Immediately
following the closing of the Mergers, those persons and entities that

were authorized to trade on the Amex before the closing of the Mergers
were deemed to have satisfied applicable qualification requirements
necessary to trade in NYSE Alternext's demutualized marketplace and
were issued 86 Trinity Permits at no cost. The 86 Trinity Permit
authorizes owners, lessees or nominees of Amex Regular Members or OPMs,
Amex limited trading permit holders, and Amex associate members who
were authorized to trade on the Amex immediately before the Mergers to
continue to trade at NYSE Alternext's systems and facilities at 86
Trinity Place, New York, New York (the ``86 Trinity Trading Systems'').
NYSE Alternext recognizes the former Amex (i) owners, lessees, or
nominees of Regular Members or OPMs, (ii) limited trading permit
holders, and (iii) associate members as either NYSE Alternext member
organizations or members, as applicable.
    In connection with the Merger, on December 1, 2008, NYSE Alternext
relocated all equities trading conducted on its 86 Trinity Trading
Systems to trading systems and facilities located at 11 Wall Street,
New York, New York (the ``Equities Relocation''). The Exchange's equity
trading systems and facilities at 11 Wall Street (the ``NYSE Alternext
Trading Systems'') are operated by the NYSE on behalf of NYSE
Alternext.\7\
---------------------------------------------------------------------------

    \7\ See Securities Exchange Act Release No. 58705 (October 1,
2008), 73 FR 58995 (October 8, 2008) (SR-Amex 2008-63) (approving
the Equities Relocation).
---------------------------------------------------------------------------

    As part of the Equities Relocation, NYSE Alternext adopted NYSE
Rules 1-1004, subject to such changes as necessary to apply the Rules
to the Exchange, as the NYSE Alternext Equities Rules to govern trading
on the NYSE Alternext Trading Systems (the ``Equities Rule
filing'').\8\ The NYSE Alternext Equities Rules, which became operative
on December 1, 2008, are substantially identical to the current NYSE
Rules 1-1004 and the Exchange continues to update the NYSE Alternext
Equities Rules as necessary to conform with rule changes to
corresponding NYSE Rules filed by the NYSE.
---------------------------------------------------------------------------

    \8\ See Securities Exchange Act Release No. 58705 (October 1,
2008), 73 FR 58995 (October 8, 2008) (SR-Amex 2008-63); Securities
Exchange Act Release No. 58833 (October 22, 2008), 73 FR 64642
(October 30, 2008) (SR-NYSE-2008-106); Securities Exchange Act
Release No. 58839 (October 23, 2008), 73 FR 64645 (October 30, 2008)
(SR-NYSEALTR-2008-03); Securities Exchange Act Release No. 59022
(November 26, 2008), 73 FR 73683 (December 3, 2008) (SR-NYSEALTR-
2008-10); and Securities Exchange Act Release No. 59027 (November
28, 2008), 73 FR 73681 (December 3, 2008) (SR-NYSEALTR-2008-11).
---------------------------------------------------------------------------

    Similarly, NYSE Alternext will relocate all options trading
conducted on the 86 Trinity Trading Systems to new facilities of NYSE
Alternext to be located at 11 Wall Street, which facilities will
utilize a trading system based on the options trading system used by
NYSE Arca, Inc. (``NYSE Arca'') (``Options Relocation,'' and, together
with the Equities Relocation, the ``Relocations'').
NYSE Alternext Equities Trading License Requirements
    To trade equities on NYSE Alternext Trading Systems, a member
organization must meet NYSE Alternext membership qualifications and
obtain a trading license pursuant to Rule 300--NYSE Alternext Equities.
As set forth in more detail in the Merger filing, an 86 Trinity Permit
holder is eligible to obtain an NYSE Alternext equities trading license
or options trading permit (``ATP'') pursuant to an expedited ``waive
in'' process up to the Options Relocation date. After the Equities
Relocation, an 86 Trinity Permit entitles holders only to trade
products other than those that have relocated to NYSE Alternext Trading
Systems. As a result of the Equities Relocation, as well as the
discontinuation of Exchange Traded Fund (``ETF'') and bond trading at
86 Trinity Place, 86 Trinity Permits currently only entitle holders to
trade listed options on NYSE Alternext. After the Options Relocation,
the 86 Trinity Permits will be cancelled.\9\ Stated otherwise, an 86
Trinity Permit may not be used to trade equities on NYSE Alternext
Trading Systems and a trading license under Rule 300--NYSE Alternext
Equities must be obtained. Upon the Options Relocation, a former 86
Trinity Permit holder will need an ATP to trade options on NYSE
Alternext Trading Systems and the 86 Trinity Permit will no longer
entitle the holder to trade any products at NYSE Alternext.
---------------------------------------------------------------------------

    \9\ See Securities Exchange Act Release No. 58673 (September 29,
2008), 73 FR 57707 (October 3, 2008) (SR-NYSE-2008-60 and SR-Amex
2008-62) (approving the Merger).
---------------------------------------------------------------------------

    In recognition of the fact that NYSE Alternext member organizations
would be subject to different or additional requirements than were
previously required under Amex rules, the Exchange adopted Rule
300.10T. As described in the Equities Rule filing, Rule 300.10T
provides NYSE Alternext member organizations that exchanged the
equities portion of a valid 86 Trinity Permit for an equities trading
license under Rule 300--NYSE Alternext Equities with a six-month grace
period within which to comply with NYSE Alternext Equities Rules 2
(defining the terms members and member organizations), 300-308
(governing the admission of members and member organizations), 311 (the
formation and approval of member organizations), 312 (changes within
member organizations), and 313 (submission of partnership articles and
corporate documents) (collectively, the ``NYSE Alternext Equities
Member Organization Rules'').
    Among the differing requirements of the NYSE Alternext Equities
Member Organization Rules as compared to the Amex rules that governed
trading at 86 Trinity Trading Systems, a member organization must be a
member of the Financial Industry Regulatory Authority, Inc.
(``FINRA''). In addition, unlike the Amex rules, Rule 313.20--NYSE
Alternext Equities requires member organizations to submit to the
Exchange an opinion of counsel that a member corporation's stock is
validly issued and outstanding and that the restrictions and provisions
required by the Exchange on the transfer, issuance, conversion and
redemption of its stock have been made legally effective.
    The current six-month grace period under Rule 300.10T begins to run
from the date that the member organization receives its NYSE Alternext
equities trading license in exchange for the equities portion of a
valid 86 Trinity Permit. However, a subset of member organizations that
have applied for a trading license are not FINRA members. As a result,
the Exchange determined that it cannot issue an equities trading
license to such member organizations at this time. Because these member
organizations have not been issued a trading license in exchange for
the equities portion of an 86 Trinity Permit, the grace period within
which to comply with the NYSE Alternext Equities Member Organization
Rules has not been triggered.
Proposed Amendment to Rule 300.10T
    To reflect the intent of the original adoption of Rule 300.10T,
i.e., to provide member organizations with a grace period to comply
with the NYSE Alternext Equities Member Organization Rules, the
Exchange proposes to amend Rule 300.10T to provide for a six-month
grace period for those member organizations that have applied for, but
have not been issued a trading license.
    As proposed, to be eligible for the grace period, a member
organization must be a holder of a valid 86 Trinity Permit as of the
date that it applied for an equities trading license. In other words,
once the 86 Trinity Permits are cancelled, i.e., the Options Relocation
date, an Exchange member organization would not be eligible to apply
for an

equities trading license and also benefit from the Rule 300.10T grace
period. As proposed, if a member organization meets the amended
eligibility threshold, it has six months from the earlier of either
receiving the equity trading license (which is the current standard) or
the cancellation of the 86 Trinity Permits (the Options Relocation
date) within which to comply with the NYSE Alternext Equities
Membership Rules, including the FINRA requirement. By adding the
cancellation of the 86 Trinity Permits as a trigger for the six-month
grace period, the proposed rule provides those member organizations
that applied for a trading license, but were not issued a trading
license because they are not currently FINRA members, time to meet the
NYSE Alternext Equities Member Organization Rule requirements.
    In addition, the Exchange proposes deleting subsection (i) of the
rule, as that language is not applicable for NYSE Alternext. The
intention of Rule 300.10T was to provide a grace period for 86 Trinity
Permit holders. This rule was added at the same time that the NYSE
added its version of Rule 300.10T, which needed the Rule 2.10
reference. Rule 2.10 provides that NYSE member organizations are deemed
approved as NYSE Alternext member organizations. Because NYSE member
organizations that were not previously Amex member organizations never
received an 86 Trinity Permit, this prerequisite is inapplicable for
the purpose of Rule 300.10T.
    As is currently part of the rule, if an NYSE Alternext member
organization fails to meet the requirements of the NYSE Alternext
Equities Member Organization Rules by the close of the grace period
applicable to that member organization, the Exchange would either
revoke the member organization's approval to trade, if a trading
license has already been issued, or not issue a trading license. The
Exchange may also commence proceedings to revoke the membership of such
member organization.
2. Statutory Basis
    The statutory basis for the proposed rule change is Section 6(b)(5)
of the Act \10\ which requires the rules of an exchange to promote just
and equitable principles of trade, to remove impediments to and perfect
the mechanism of a free and open market and a national market system
and, in general, to protect investors and the public interest. The
proposed rule change also is designed to support the principles of
Section 11A(a)(1) \11\ of the Act in that it seeks to assure fair
competition among brokers and dealers and among exchange markets and
the practicability of brokers executing investor's orders in the best
market.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b)(5).
    \11\ 15 U.S.C. 78k-1(a)(1).
---------------------------------------------------------------------------

    Specifically, the Exchange already permits a holder of a valid 86
Trinity Permit to apply for and receive an equities trading license
under Rule 300--NYSE Alternext Equities. This filing would simply
provide those eligible NYSE Alternext member organizations with a valid
86 Trinity Permit additional time to exchange their 86 Trinity Permit
for an NYSE equity trading license and to comply with Exchange
membership requirements without first without having to apply as a new
member organization.

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

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

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

    No written comments were either solicited or received.

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

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

    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file 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.
NYSE Alternext 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) \15\ permits the Commission to
designate a shorter time if such action is consistent with the
protection of investors and the public interest. NYSE Alternext
requests that the Commission waive the 30-day operative delay. The
Exchange requests the 30-day operative delay because the Options
Relocation date is imminent and is currently scheduled for March 2,
2009, and the Exchange needs to immediately implement this rule change
so that NYSE Alternext member organizations can meet the new rule
requirements. For these reasons, the Commission believes that waiving
the 30-day operative delay \16\ is consistent with the protection of
investors and the public interest and designates the proposal operative
upon filing.
---------------------------------------------------------------------------

    \14\ 17 CFR 240.19b-4(f)(6).
    \15\ 17 CFR 240.19b-4(f)(6).
    \16\ For purposes only of waiving the 30-day operative delay,
the Commission has 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 may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEALTR-2009-16 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEALTR-2009-16. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the

Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for inspection and copying in the
Commission's Public Reference Room, 100 F Street, NE., Washington, DC
20549, on official business days between the hours of 10 a.m. and 3
p.m. Copies of such filing also will be available for inspection and
copying at the principal office of the Exchange. All comments received
will be posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make publicly available. All submissions
should refer to File Number SR-NYSEALTR-2009-16 and should be submitted
on or before March 25, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

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

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-4678 Filed 3-4-09; 8:45 am]

BILLING CODE 8011-01-P


Ron Evans/RTP/USEPA/US

02/28/2008 03:35 PM

To

"King, Heidi R."<EMAIL_ADDRESS> cc

Al McGartland/DC/USEPA/US@EPA, Cynthia Morgan/DC/USEPA/US@EPA, Darryl Weatherhead/RTP/USEPA/US@EPA, Elizabeth Kopits/DC/USEPA/US@EPA, Janet Cakir/RTP/USEPA/US@EPA, Larry Sorrels/RTP/USEPA/US@EPA, Lydia Wegman/RTP/USEPA/US@EPA, Nathalie Simon/DC/USEPA/US@EPA, Rosalina Rodriguez/RTP/USEPA/US@EPA, Tom Walton/RTP/USEPA/US@EPA, Tricia Crabtree/RTP/USEPA/US@EPA

Subject

RE: Explaining the Hybrid Approach, material for 3:30 meeting today

919-541-4376

"King, Heidi R."<EMAIL_ADDRESS> 02/28/2008 03:31 PM

To

Ron Evans/RTP/USEPA/US@EPA

cc

Lydia Wegman/RTP/USEPA/US@EPA, Al McGartland/DC/USEPA/US@EPA, Tricia Crabtree/RTP/USEPA/US@EPA, Nathalie Simon/DC/USEPA/US@EPA, Tom Walton/RTP/USEPA/US@EPA, Darryl Weatherhead/RTP/USEPA/US@EPA, Larry Sorrels/RTP/USEPA/US@EPA, Cynthia Morgan/DC/USEPA/US@EPA, Elizabeth Kopits/DC/USEPA/US@EPA, Janet Cakir/RTP/USEPA/US@EPA, Rosalina Rodriguez/RTP/USEPA/US@EPA

Subject

RE: Explaining the Hybrid Approach, material for 3:30 meeting today

Does anyone know what call-in we're using?  I don't recall whether I

have it & can't find it --

Thx

h

-----Original Message-----

From<EMAIL_ADDRESS><EMAIL_ADDRESS> Sent: Thursday, February 28, 2008 1:38 PM

To: King, Heidi R.

Cc<EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS> Subject: Fw: Explaining the Hybrid Approach, material for 3:30 meeting

today

Per our conversation, here is the background paper we would like to walk

thru this afternoon.   Thanks for makeing the time.

----- Forwarded by Ron Evans/RTP/USEPA/US on 02/28/2008 01:33 PM -----

             Darryl

             Weatherhead/RTP/

             USEPA/US                                                To

                                      Evans.Ron@epamail.epa.gov@EPA

             02/28/2008 12:57                                        cc

             PM                       Tom Walton/RTP/USEPA/US@EPA,

                                      Cakir.Janet@epamail.epa.gov@EPA

                                                                Subject

                                      Explaining the Hybrid Approach

(See attached file: Explaining the Hybrid Approach.doc)

_______________________________ Darryl A. Weatherhead, Economist U.S.

EPA/OAQPS/ABCG Mail Drop: C439-02, RTP, NC 27711

Phone:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>