[Federal Register: April 19, 2010 (Volume 75, Number 74)]
[Notices]
[Page 20437-20441]
[DOCID:fr19ap10-116]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0521]

Amended Authorization of Emergency Use of the Antiviral Product
Peramivir Accompanied by Emergency Use Information; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the Emergency Use Authorization (EUA) (the Authorization)
for peramivir injection 200 milligrams (mg)/20 milliliter (mL) (10 mg/
mL) single use vial manufactured for BioCryst Pharmaceuticals, Inc.
(BioCryst) for intravenous (IV) administration in certain adult and
pediatric patients issued on October 23, 2009, under the Federal Food,
Drug, and Cosmetic Act (the act), as requested by the Centers for
Disease Control and Prevention (CDC). FDA received inquiries related to
the recommended dosing for patients with renal impairment. On November
19, 2009, FDA amended the Authorization letter and reissued the
Authorization letter in its entirety to provide additional
clarification. The Authorization letter, as amended and reissued, which
includes explanations for its reissuance, is reprinted in this notice.

DATES: The amended Authorization is effective as of November 19, 2009.

ADDRESSES: Submit written requests for single copies of the EUA to the
Office of Counterterrorism and Emerging Threats (HF-29), Food and Drug
Administration, 5600 Fishers Lane, rm. 14C-26, Rockville, MD 20857.
Send one self-addressed adhesive label to assist that office in
processing your request or include a fax number to which the
Authorization may be sent. See the SUPPLEMENTARY INFORMATION section
for electronic access to the Authorization.

FOR FURTHER INFORMATION CONTACT: RADM Boris Lushniak, Office of
Counterterrorism and Emerging Threats (HF-29), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Amendment to the October 23, 2009, Authorization for Peramivir IV

    On April 26, 2009, under section 564(b)(1)(C) of the act (21 U.S.C.
360bbb-3(b)(1)(C)), the Acting Secretary of Health and Human Services
determined that a public health emergency exists involving Swine
Influenza A (now known as 2009 H1N1 Influenza A, or 2009 H1N1 flu) that
affects, or has the significant potential to affect, national security.
The determination of emergency has been renewed. On October 20, 2009,
under section 564(b) of the act, and on the basis of such
determination, the Secretary declared an emergency justifying the
authorization of the emergency use of the antiviral peramivir,
accompanied by emergency use information subject to the terms of any
authorization issued under 21 U.S.C. 360bbb-3(a). On October 23, 2009,
in response to a request from CDC, FDA issued an EUA for the emergency
use of the unapproved drug peramivir administered intravenously. On
November 2, 2009, notice of the determination and declaration was
published in the Federal Register (74 FR 56640, November 2, 2009), as
was the notice of the Authorization (74 FR 56644, November 2, 2009). In
response to inquiries about dosing of Peramivir IV in certain patients
with severe renal impairment, including those who require continuous
renal replacement therapy or hemodialysis, on November 19, 2009, FDA
amended the Authorization letter to amend the Fact Sheet for Health
Care Providers to provide additional clarification regarding the dosing
recommendations for IV peramivir and reissued the Authorization letter
in its entirety. The amended dosing recommendations are provided in the
amended authorized version of the Fact Sheet for Health Care Providers.

II. Electronic Access

    An electronic version of this notice and the full text of the
Authorization are available on the Internet at http://
www.regulations.gov.

III. The Authorization

    Having concluded that the criteria for issuance of the
Authorization under section 564(c) of the act were met, on October 23,
2009, FDA authorized the emergency use of the unapproved drug peramivir
administered intravenously for treatment of 2009 H1N1 influenza virus
in certain adult and pediatric patients. The letter of Authorization in
its entirety (not including the amended authorized version of the Fact
Sheet for Health Care Providers), as amended on November 19, 2009,
follows:

 Thomas R. Frieden, MD, MPH
 Director, Centers for Disease Control and Prevention
 1600 Clifton Rd, MS D-14
 Atlanta, GA 30333

 Dear Dr. Frieden:

 On October 23, 2009, a letter was issued authorizing the emergency use of the unapproved drug peramivir in response to your request that the Food and Drug Administration (FDA) issue an
 Emergency Use Authorization (EUA) for the emergency use of peramivir administered intravenously for treatment of 2009 H1N1 influenza virus (hereafter ``2009 H1N1'') in certain adult and
 pediatric patients, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. Sec.   360bbb-3). FDA has received inquiries related to the recommended dosing for
 patients with renal impairment. The purpose of this letter is to amend the Fact Sheet for Health Care Providers to provide additional clarification regarding the dosing recommendations for IV
 peramivir in patients with severe renal impairment, including those who require continuous renal replacement therapy or hemodialysis. The amended authorized version of the Fact Sheet for
 Health Care Providers is enclosed with this letter. In addition, this version of the letter includes minor editorial changes. The letter of authorization, as amended, appears below in its
 entirety:

 This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for the emergency use of the unapproved drug peramivir
 administered intravenously for treatment of 2009 H1N1 influenza virus (hereafter ``2009 H1N1'') in certain adult and pediatric patients, pursuant to section 564 of the Federal Food, Drug, and
 Cosmetic Act (the Act) (21 U.S.C. Sec.   360bbb-3).

 On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. Sec.   360bbb-3(b)(1)(C)), the then Acting Secretary of the Department of Health and Human Services (HHS) determined
 that a public health emergency exists involving Swine Influenza A (now referred to as ``2009 H1N1'') that affects or has significant potential to affect national security. The Secretary has
 renewed the determination. Pursuant to section 564(b) of the Act (21 U.S.C. Sec.   360bbb-3(b)), and on the basis of such determination, the Secretary of HHS declared an emergency justifying
 the authorization of the emergency use of the antiviral peramivir, accompanied by emergency use information, subject to the terms of any authorization issued under section 564(a) of the Act
 (21 U.S.C. Sec.   360bbb-3(a)).

 Having consulted with the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH), and having concluded that the criteria for issuance of this
 authorization under section 564(c) of the Act (21 U.S.C. Sec.   360bbb-3(b)) are met, I am authorizing the emergency use of peramivir\1\ administered intravenously for treatment of 2009 H1N1
 in certain adult and pediatric patients, subject to the terms of this authorization.

 I. Criteria for Issuance of Authorization

 I have concluded that the emergency use of peramivir administered intravenously for treatment of 2009 H1N1 in certain adult and pediatric patients meets the criteria for issuance of an
 authorization under section 564(c) of the Act, because I have concluded that:

    (1) 2009 H1N1 can cause influenza, a serious or life-threatening disease or condition;

    (2) based on the totality of scientific evidence available to FDA, it is reasonable to believe that peramivir may be effective when administered intravenously for the treatment of 2009
     H1N1 in certain adult and pediatric patients, and that the known and potential benefits of peramivir, when administered intravenously for the treatment of 2009 H1N1 in certain adult and
     pediatric patients, outweigh the known and potential risks of peramivir; and

    (3) there is no adequate, approved, and available alternative to the emergency use of peramivir administered intravenously for the treatment of 2009 H1N1 in certain adult and pediatric
     patients.\2\

 Therefore, I have concluded that the emergency use of peramivir administered intravenously for the treatment of 2009 H1N1 in certain adult and pediatric patients meets the above statutory
 criteria for issuance of an authorization.

 II. Scope of Authorization

 I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the emergency use of authorized peramivir for the treatment of 2009 H1N1 in
 certain adult and pediatric patients. The emergency use of authorized peramivir under this EUA must be consistent with, and may not exceed, the terms of this letter, including the scope and
 the conditions of authorization set forth below.

 Peramivir (a neuraminidase inhibitor) is an unapproved drug that it is currently being studied in clinical investigations. Peramivir is not currently approved by FDA for any use in the United
 States.

 The authorized peramivir is as follows:

     Peramivir injection: 200mg/20mL (10 mg/mL) single use vial manufactured for BioCryst Pharmaceuticals, Inc. (BioCryst). (See Section IV.D.3. of this letter).

 1. The above peramivir product is authorized only for intravenous (IV) administration.

 2. The above peramivir product is authorized for the treatment of certain patients with suspected or laboratory confirmed 2009 H1N1 infection or infection due to nonsubtypable influenza A
 virus suspected to be 2009 H1N1 based on community epidemiology. Specifically, the peramivir product is authorized only for the following patients who are admitted to a hospital and under the
 care or consultation of a licensed clinician (skilled in the diagnosis and management of patients with potentially life-threatening illness and the ability to recognize and manage medication-
 related adverse events):
       a. Adult patients for whom therapy with an IV agent is clinically appropriate, based upon one or more of the following reasons:
         (i) patient not responding to either oral or inhaled antiviral therapy, or

         (ii) drug delivery by a route other than IV (e.g., enteral oseltamivir or inhaled zanamivir) is not expected to be dependable or is not feasible, or
         (iii) the clinician judges IV therapy is appropriate due to other circumstances.
       b. Pediatric patients for whom an IV agent is clinically appropriate because:
         (i) patient not responding to either oral or inhaled antiviral therapy, or
         (ii) drug delivery by a route other than IV (e.g., enteral oseltamivir or inhaled zanamivir) is not expected to be dependable or is not feasible.

 3. The above peramivir product may only include product distributed from Strategic National Stockpile (SNS), in which case such product is authorized only to be labeled with the enclosed
 label.

 4. The above peramivir product is authorized to be accompanied by the following written information pertaining to the emergency use, which is enclosed and authorized to be made available to
 health care providers and patients (and parents/caregivers):

        Fact Sheet for Health Care Providers
        Fact Sheet for Patients and Parents/Caregivers

 CDC, hospitals, and health care providers receiving authorized peramivir are also authorized to make available additional written information relating to the emergency use of authorized
 peramivir that is consistent with and does not exceed the terms of this letter of authorization (including the above referenced facts sheets).

 I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of authorized peramivir, when used for the treatment of H1N1
 in certain adult and pediatric patients, outweigh the known and potential risks of such product.

 I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized peramivir may
 be effective for the treatment of 2009 H1N1 in certain adult and pediatric patients pursuant to section 564(c)(2)(A) of the Act. FDA has reviewed the scientific information available,
 including the information supporting the conclusions described in Section I of this letter above, and concludes that the authorized peramivir when used for the treatment of 2009 H1N1 in
 certain adult and pediatric patients, meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.

 Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS's determination under section 564(b)(1)(C) described above and the Secretary of HHS's
 corresponding declaration under section 564(b)(1), the peramivir described above is authorized for the treatment of 2009 H1N1 in certain adult and pediatric patients.

 This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.

 III. Current Good Manufacturing Practice

 This letter covers authorized peramivir as previously manufactured for BioCryst as of the date of this letter as well as authorized peramivir that may be manufactured for BioCryst after such
 date, insofar as FDA has determined that the methods used in, and the facilities and controls used for, the manufacturing, processing and packing of authorized peramivir are adequate to
 preserve its identity, strength, quality and purity.

 Authorized peramivir should be held in accordance with its labeled and appropriate product storage conditions (ambient temperature, 15[deg]C-30[deg]C or 59[deg]F-86[deg]F). However, in order
 to ensure the delivery and availability of authorized peramivir, I am waiving current good manufacturing practice (CGMP) requirements with respect to proper storage conditions of temperature
 during the shipment and holding of authorized peramivir by CDC and/or its designees for a maximum of 90 days (consecutive or non-consecutive) from the date of shipment to CDC and/or its
 designees. Significant excursions from labeled storage conditions should be documented to the extent practicable given the circumstances of the emergency, and need not be supported by
 additional testing by CDC or its designees.

 IV. Conditions of Authorization

 Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:

 A. CDC

 A.1. CDC will decide how authorized peramivir will be distributed under its direction to Hospitals upon request by licensed treating clinicians at the Hospitals to the extent such decisions
 are consistent with and do not exceed the terms of this letter; except that CDC will ensure that authorized peramivir will be distributed to Hospitals as soon as possible within 24 hours of
 CDC's decision to distribute such product, to the extent practicable given the circumstances of the emergency.

 A.2. CDC will maintain adequate records regarding distribution under its direction of authorized peramivir (i.e., lot numbers, quantity, receiving site, receipt date, unique identifier(s)
 (e.g., Peramivir Request number(s))).

 A.3. CDC will notify FDA on a weekly basis (unless otherwise specified by FDA) of the quantity of and to which Hospitals authorized peramivir is distributed under its direction. CDC will also
 include in the notification the unique identifier(s) (e.g., Peramivir Request number(s)).

 A.4. CDC will ensure that authorized peramivir is distributed for use under its direction only within the expiry dates identified by FDA. CDC will inform Hospitals receiving authorized
 peramivir under its direction of the expiry dates by which authorized peramivir is to be used if authorized peramivir is nearing expiry. CDC will maintain adequate records regarding the
 expiry dates by which authorized peramivir is to be used.

 A.5. CDC will ensure that Hospitals receiving authorized peramivir under its direction are informed of this letter, including the terms and conditions as well as any authorized amendments
 thereto.

 A.6. CDC will make available through appropriate means to the Hospitals receiving authorized peramivir under its direction the authorized Fact Sheet for Health Care Providers and Fact Sheet
 for Patients and Parents/Caregivers as well as any authorized amendments thereto.

 A.7. CDC will perform adverse event monitoring and compliance activities (e.g., follow-up surveys) designed: (1) to ensure that selected adverse events and all medication errors associated
 with the use of authorized peramivir are reported to FDA as follows: the MedWatch FDA Form 3500 must be completed either online at www.fda.gov/medwatch/report.htm or by using a postage-paid
 FDA Form 3500 (available at http://www.fda.gov/medwatch/safety/FDA-3500_fillable.pdf) and returning by fax (1-800-FDA-0178) or by mail (MedWatch, 5600 Fishers Lane, Rockville, MD 20852-
 9787). If there is no online internet access such reports must be made by calling 1-800-FDA-1088; (2) to ensure that such reports include in the description section of the MedWatch Form 3500
 the words ``Peramivir EUA'' and include unique identifier(s) (e.g., Peramivir Request number(s)), and (3) to ensure that such reports are made within seven calendar days from the onset of the
 event. CDC will report such information to FDA upon request.

 A.8. CDC will only make available additional written information relating to the emergency use of authorized peramivir to the extent that it is consistent with and does not exceed the terms
 of this letter (including the facts sheets referenced in Section II of this letter).

 A.9. CDC will make available to FDA upon request any records maintained in connection with this letter.

 B. Hospitals to Which Authorized Peramivir is Distributed

 B.1 Such Hospitals will make available through appropriate means to relevant health care providers this letter, including the terms and conditions as well as any authorized amendments
 thereto.

 B.2. Such Hospitals will make available through appropriate means to relevant health care providers and patients and/or parents/caregivers the authorized Fact Sheet for Health Care Providers
 and Fact Sheet for Patients and Parents/Caregivers as well as any authorized amendments thereto.

 B.3. Such Hospitals will ensure that relevant health care providers abide by the institutional procedures regarding drug accountability. Such Hospitals will maintain adequate records showing
 receipt, use, and disposition of authorized peramivir.

 B.4. Such Hospitals will ensure that the emergency use of authorized peramivir is limited to patients who are under the care or consultation of a licensed clinician (e.g., skilled in the
 diagnosis and management of patients with systemic illness, including recognition and management of medication-related adverse events).

 B.5. Such Hospitals will conduct any follow-up requested by FDA and/or CDC regarding medication errors and adverse events.

 B.6. Such Hospitals will only make available additional written information relating to the emergency use of authorized peramivir to the extent that it is consistent with and does not exceed
 the terms of this letter of authorization (including the facts sheets referenced in Section II of this letter).

 B.7. Such Hospitals will make available to FDA and/or CDC upon request any records maintained in connection with this letter. Upon request, such Hospitals will report to FDA and/or CDC
 information with respect to the emergency use of authorized peramivir.

 C. Health Care Providers Conducting Activities With Respect to Authorized Peramivir\3\

 C.1. Health Care Providers will be aware of this letter, including the terms and conditions as well as any authorized amendments thereto. Health Care Providers will read the Fact Sheet for
 Health Care Providers, including the sections on Mandatory Requirements for Peramivir Administration Under Emergency Use Authorization and Considerations Prior to Peramivir Use Under EUA as
 well as any amendments thereto. (See Fact Sheet for Health Care Providers).

 C.2. Health Care Providers prescribing and/or administering authorized peramivir will ensure that the authorized Fact Sheet for Patients and Parents/Caregivers, as well as any authorized
 amendments thereto, have been made available to patients and/or parents/caregivers through appropriate means. Such Health Care Providers (to the extent practicable given the circumstances of
 the emergency) will document in the patient's medical record that: (a) patients/caregivers have been given the Fact Sheet for Patients and Parents/Caregivers, (b) patients/caregivers have
 been informed of the alternatives to receiving authorized peramivir, and (c) patients/caregivers have been informed that peramivir is an unapproved drug that is authorized for use under
 Emergency Use Authorization.

 C.3. Prescribing Health Care Providers (or their designees) will ensure that: (1) selected adverse events and all medication errors associated with the use of authorized peramivir are
 reported as follows: the MedWatch FDA Form 3500 must be completed either online at www.fda.gov/medwatch/report.htm or by using a postage-paid FDA Form 3500 (available at http://www.fda.gov/
 medwatch/safety/FDA-3500_fillable.pdf) and returning by fax (1-800-FDA-0178) or by mail (MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787). If there is no online internet access such
 reports must be made by calling 1-800-FDA-1088; (2) that such reports include in the description section of the MedWatch Form 3500 the words ``Peramivir EUA'' and include unique identifier(s)
 (e.g., Peramivir Request number(s)); and (3) that such reports are made within seven calendar days from the onset of the event. Such Health Care Providers or their designees will conduct any
 follow-up requested by FDA and/or CDC.

 C.4. Health Care Providers will prescribe and/or administer authorized peramivir only for the treatment of certain patients with suspected or laboratory confirmed 2009 H1N1 infection or
 infection due to nonsubtypable influenza A virus suspected to be 2009 H1N1 based on community epidemiology. Specifically, peramivir is authorized only for the following patients who are
 admitted to a hospital and under the care or consultation of a licensed clinician (skilled in the diagnosis and management of patients with potentially life-threatening illness and the
 ability to recognize and manage medication-related adverse events):

    a. Adult patients for whom therapy with an IV agent is clinically appropriate, based upon one or more of the following reasons:
      (i) patient not responding to either oral or inhaled antiviral therapy, or
      (ii) drug delivery by a route other than IV (e.g., enteral oseltamivir or inhaled zanamivir) is not expected to be dependable or is not feasible, or

      (iii) the clinician judges IV therapy is appropriate due to other circumstances.
    b. Pediatric patients for whom an IV agent is clinically appropriate because:
      (i) patient not responding to either oral or inhaled antiviral therapy, or
      (ii) drug delivery by a route other than IV (e.g., enteral oseltamivir or inhaled zanamivir) is not expected to be dependable or is not feasible.

 C.5. Health Care Providers will ensure that patients with known or suspected renal insufficiency have creatinine clearance determined prior to peramivir dose calculation and first
 administration. (See Fact Sheet For Health Care Providers; Dosage and Administration for Impaired Renal Function Dosing).

 C.6. Health Care Providers prescribing and/or administering authorized peramivir will ensure that patients with history of severe allergic reaction to any other neuraminidase inhibitor
 (zanamivir or oseltamivir) or any ingredient of peramivir will not receive authorized peramivir. (See Fact Sheet for Health Care Providers; Product Description.)

 C.7. Health Care Providers will only make available additional written information relating to the emergency use of authorized peramivir to the extent that it is consistent with and does not
 exceed the terms of this letter of authorization (including the facts sheets referenced in Section II of this letter).

 C.8. Heath Care Providers will make available to FDA and/or CDC upon request any records maintained in connection with this letter. Upon request, Health Care Providers will report to FDA and/
 or CDC information with respect to the emergency use of authorized peramivir.

 D. BioCryst

 D.1. BioCryst will post on its website the following statement: ``For information about the FDA-authorized emergency use of peramivir, please see www.cdc.gov/h1n1flu/eua.''

 D.2. BioCryst will distribute authorized peramivir only to CDC and/or its designees subject to the terms and conditions of this letter.

 D.3 BioCryst will contact FDA concerning the need for any FDA review and approval before any changes are made to the manufacturing, packaging, and labeling processes authorized as of the date
 of this letter.

 D.4. BioCryst (or anyone acting on behalf of BioCryst) will not represent authorized peramivir in a promotional context or otherwise promote authorized peramivir.

 D.5. BioCryst will make available to FDA and (as reasonably appropriate) CDC upon request any records maintained in connection with this letter. Upon request, BioCryst will report to FDA and/
 or (as reasonably appropriate) CDC information with respect to the emergency use of authorized peramivir.

 The emergency use of authorized peramivir as described in this letter of authorization must comply with the conditions above and all other terms of this authorization.

 V. Duration of Authorization

 This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is revoked under section 564(g) of the Act.

                   Joshua M. Sharfstein, M.D.
                   Principal Deputy Commissioner
                   Food and Drugs

 \1\ FDA is authorizing the emergency use of peramivir administered intravenously for treatment of 2009 H1N1 in certain adult and pediatric patients as described in the scope section of this
  letter (Setion II of thie letter). For ease of reference, this letter of authorization will also use the term ``authorized peramivir.''
\2\ No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.
\3\ The activites with respect to authorized peramivir refer to requesting, preparing, prescribing, and/or administering authorized peramivir, unless otherwise specified.

    Dated: April 9, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8604 Filed 4-16-10; 8:45 am]
BILLING CODE 4160-01-S


percent model average (2011$). The EPA estimates that in 2030, the
illustrative compliance approach for Option 1--Approach A in Guam and
Puerto Rico will yield monetized climate benefits of approximately $170
million with a 3 percent model average (2011$). For Option 2--Approach
A, the EPA estimates that in 2020, the illustrative compliance approach
for Guam and Puerto Rico will yield monetized climate benefits of
approximately $68 million with a 3 percent model average (2011$). The
EPA estimates that in 2025, the illustrative compliance approach for
Option 2--Approach A in Guam and Puerto Rico will yield monetized
climate benefits of approximately $99 million with a 3 percent model
average (2011$).
    For Guam and Puerto Rico, the EPA estimates that in 2020, the
illustrative compliance approach for Option 1--Approach B will yield
monetized climate benefits of approximately $77 million with a 3
percent model average (2011$). The EPA estimates that in 2030, the
illustrative compliance approach for Option 1--Approach B in Guam and
Puerto Rico will yield monetized climate benefits of approximately $180
million with a 3 percent model average (2011$). For Option 2--Approach
B, the EPA estimates that in 2020, the illustrative compliance approach
for Guam and Puerto Rico will yield monetized climate benefits of
approximately $73 million with a 3 percent model average (2011$). The
EPA estimates that in 2025, the illustrative compliance approach for
Option 2--Approach B in Guam and Puerto Rico will yield monetized
climate benefits of approximately $110 million with a 3 percent model
average (2011$).
    The EPA does not expect any additional benefits associated with
compliance for areas of Indian country with affected EGUs, as the
benefits for meeting the proposed goals for the lands of the Fort
Mojave Tribe and the Ute Tribe of the Uintah and Ouray Reservation were
already accounted for in the June 18, 2014, proposal, and the goal for
the lands of the Navajo Nation is expected to be met without any
further action beyond the shutdowns that are occurring.

VI. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review, and Executive
Order 13563: Improving Regulation and Regulatory Review

    Under section 3(f)(1) of Executive Order 12866 (58 FR 51735,
October 4, 1993), this action is an ``economically significant
regulatory action'' because it is likely to have an annual effect on
the economy of $100 million or more or to adversely affect in a
material way the economy, a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or state,
local, or tribal governments or communities. The $100 million threshold
can be triggered by either costs or benefits, or a combination of them.
Accordingly, the EPA submitted this action to OMB for review under
Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011), and
any changes made in response to OMB recommendations have been
documented in the docket for this action. The EPA also prepared an
analysis of the potential costs and benefits associated with this
action in the RIA for this supplemental proposal.
    Consistent with Executive Order 12866 and Executive Order 13563,
the EPA estimated the costs and benefits for illustrative compliance
approaches of implementing the proposed guidelines. This proposal sets
goals to reduce CO2 emissions from the electric power
industry in U.S. territories and in Indian country. Actions taken to
comply with the proposed guidelines will also reduce the emissions of
directly emitted PM2.5, SO2 and NOX.
The benefits associated with these PM, SO2 and
NOX reductions are referred to as co-benefits, as these
reductions are not the primary objective of this rule.\44\
---------------------------------------------------------------------------

    \44\ More details about the health benefits associated with
reductions in PM2.5, SO2 and NOX
can be found in the RIA for the June 18, 2014, proposal.
---------------------------------------------------------------------------

    The EPA has used the SCC estimates (i.e., the monetary value of
impacts associated with a marginal change in CO2 emissions
in a given year) to analyze CO2 climate impacts of this
rulemaking. The four SCC estimates are associated with different
discount rates (model average at 2.5 percent discount rate, 3 percent,
and 5 percent; 95th percentile at 3 percent), and each increases over
time. In this summary, the EPA provides the estimate of climate
benefits associated with the SCC value deemed to be central by the U.S.
government (the model average at 3 percent discount rate). There will
likely be significant health co-benefits associated with reductions of
SO2 and NOX. However, the EPA is unable to
quantify health co-benefits SO2 and NOX
reductions in the U.S. territories because the benefit-per-ton values
that the EPA often uses for this purpose are only appropriate for areas
within the continental U.S. In addition, the EPA could not monetize
other important benefits, including climate benefits from reducing
emissions of non-CO2 GHG and co-benefits from reducing
exposure to HAP (e.g., Hg and HCl) concentrations, as well as ecosystem
and visibility benefits.
    For Guam and Puerto Rico, the EPA estimates that in 2020, the
illustrative compliance approach for Option 1--Approach A will yield
monetized climate benefits of approximately $73 million with a 3
percent model average (2011$). The annual illustrative compliance costs
are a savings of approximately $140 million (2011$) in 2020. The EPA
estimates that in 2030, the illustrative compliance approach for Option
1--Approach A in Guam and Puerto Rico will yield monetized climate
benefits of approximately $170 million with a 3 percent model average
(2011$). The annual illustrative compliance costs are a savings of
approximately $350 million (2011$) in 2030. For Option 2--Approach A,
the illustrative compliance approach for Guam and Puerto Rico will
yield monetized climate benefits of approximately $68 million with a 3
percent model average (2011$) in 2025. The annual illustrative
compliance costs are a savings of approximately $130 million (2011$) in
2020. The EPA estimates that in 2025, the illustrative compliance
approach for Option 2 in Guam and Puerto Rico will yield monetized
climate benefits of approximately $99 million with a 3 percent model
average (2011$). The annual illustrative compliance costs result in a
net savings of approximately $190 million (2011$) in 2025, including
reduced fuel expenditures associated with energy efficiency programs
and re-dispatch.
    For Guam and Puerto Rico, the EPA estimates that in 2020, the
illustrative compliance approach for Option 1--Approach B will yield
monetized climate benefits of approximately $77 million with a 3
percent model average (2011$). The annual illustrative compliance costs
are a savings of approximately $140 million (2011$) in 2020. The EPA
estimates that in 2030, the illustrative compliance approach for Option
1--Approach B in Guam and Puerto Rico will yield monetized climate
benefits of approximately $180 million with a 3 percent model average
(2011$). The annual illustrative compliance costs are a savings of
approximately $360 million (2011$) in 2030. For Option 2--Approach B,
the illustrative compliance approach for Guam and Puerto Rico will
yield monetized climate benefits of approximately $73 million with a 3
percent model average (2011$) in 2020. The annual illustrative
compliance costs are a savings of approximately $130 million (2011$) in
2020. The EPA estimates that in 2025, the illustrative compliance
approach for Option 2 in Guam and Puerto Rico will yield monetized
climate benefits of approximately $110 million with a 3 percent model
average (2011$). The annual illustrative compliance costs result in a
net savings of approximately $200 million (2011$) in 2025, including
reduced fuel expenditures associated with energy efficiency programs
and re-dispatch.
    The EPA does not expect any additional benefits associated with
compliance for areas of Indian country with affected EGUs, as the
benefits for meeting the proposed goals for the lands of the Fort
Mojave Tribe and the Ute Tribe of the Uintah and Ouray Reservation were
already accounted for in the June 18, 2014, proposal, and the goal for
the lands of the Navajo Nation is expected to be met without any
further action beyond the shutdowns that are occurring.

B. Paperwork Reduction Act

    The information collection requirements in this proposed rule have
been submitted for approval to OMB under the PRA, 44 U.S.C. 3501 et
seq. The Information Collection Request (ICR) document prepared by the
EPA has been assigned the EPA ICR number 2503.02.
    This proposal does not directly impose specific requirements on EGU
sources, including those located in U.S. territories and in Indian
country. The proposal also does not impose specific requirements on
tribal governments that have affected EGUs located in their area of
Indian country. For Indian country, the proposal establishes
CO2 emission performance goals that could be addressed
through either tribal or federal plans. A tribe would have the
opportunity under the TAR, but not the obligation, to apply to the EPA
for TAS for purposes of a CAA section 111(d) plan and, if approved by
the EPA, to establish a CAA section 111(d) plan for its area of Indian
country. To date, no tribe has requested or obtained TAS eligibility
for purposes of a CAA section 111(d) plan. For areas of Indian country

with affected sources where a tribe has not applied for TAS and
submitted any needed plan, if the EPA determines that a CAA section
111(d) plan is necessary or appropriate, the EPA would have the
responsibility to establish the plans. Because tribes are not required
to implement section 111(d) plans and because no tribe has yet sought
TAS eligibility for this purpose, this proposed action is not
anticipated to impose any information collection burden on tribal
governments over the 3-year period covered by this ICR.
    This proposal does impose specific requirements on U.S. territory
governments that have affected EGUs. Their information collection
requirements are based on the recordkeeping and reporting burden
associated with the requirement that the two affected U.S. territories
(i.e., Puerto Rico and Guam) develop, implement and enforce a plan to
limit CO2 emissions from existing sources in the power
sector within those U.S. territories. These recordkeeping and reporting
requirements are specifically authorized by CAA section 114 (42 U.S.C.
7414). All information submitted to the EPA pursuant to the
recordkeeping and reporting requirements for which a claim of
confidentiality is made is safeguarded according to agency policies set
forth in 40 CFR part 2, subpart B.
    The annual burden for this collection of information for the
territories (averaged over the first 3 years following promulgation of
this proposed action) is estimated to be 29,200 hours at a total annual
labor cost of $2.07 million. The total annual burden for the federal
government (averaged over the first 3 years following promulgation of
this proposed action) is estimated to be 2,530 hours at a total annual
labor cost of $141,000. Burden means the total time, effort or
financial resources expended by persons to generate, maintain, retain
or disclose or provide information to or for a federal agency. This
includes the time needed to review instructions; develop, acquire,
install and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information.
    An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for the
EPA's regulations in 40 CFR are listed in 40 CFR part 9.
    To comment on the agency's need for this information, the accuracy
of the provided burden estimates, and any suggested methods for
minimizing respondent burden, the EPA has established a public docket
for this rule, which includes this ICR, under Docket ID No. EPA-HQ-OAR-
2013-0602. Submit any comments related to the ICR to the EPA and to
OMB. See the ADDRESSES section at the beginning of this action for
where to submit comments to the EPA. Send comments to OMB at the Office
of Information and Regulatory Affairs, Office of Management and Budget,
725 17th Street NW., Washington, DC 20503, Attention: Desk Officer for
the EPA. Since OMB is required to make a decision concerning the ICR
between 30 and 60 days after November 4, 2014, a comment to OMB is best
assured of having its full effect if OMB receives it by December 4,
2014. The final rule will respond to any OMB or public comments on the
information collection requirements contained in this proposal.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations and small governmental jurisdictions.
    For purposes of assessing the impacts of this rule on small
entities, small entity is defined as: (1) A small business that is
defined by the Small Business Administration's (SBA's) regulations at
13 CFR 121.201 (for the electric power generation industry, the small
business size standard is an ultimate parent entity with less than 750
employees). The North American Industry Classification System (NAICS)
codes for the affected industry are in Table 11 below); (2) a small
governmental jurisdiction that is a government of a city, county, town,
school district or special district with a population of less than
50,000; and (3) a small organization that is any not-for-profit
enterprise which is independently owned and operated and is not
dominant in its field.

       Table 11--Potentially Regulated Categories and Entities \a\
------------------------------------------------------------------------
                                                 Examples of potentially
             Category               NAICS code     regulated entities
------------------------------------------------------------------------
Industry.........................       221112  Fossil fuel electric
                                                 power generating units.
State/Territorial/Local             \b\ 221112  Fossil fuel electric
 Government.                                     power generating units
                                                 owned by
                                                 municipalities.
------------------------------------------------------------------------
 \a\ Include NAICS categories for source categories that own and operate
  electric power generating units (includes boilers and stationary
  combined cycle combustion turbines).
 \b\ State, territory or local government-owned and operated
  establishments are classified according to the activity in which they
  are engaged.

    After considering the economic impacts of this proposed rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities.
    The proposed rule will not impose any requirements on small
entities. Specifically, emission guidelines established under CAA
section 111(d) do not impose any requirements on regulated entities
and, thus, will not have a significant economic impact upon a
substantial number of small entities. After emission guidelines are
promulgated, each affected U.S. territory establishes standards on
existing sources, and it is those requirements that could potentially
impact small entities. Our analysis here is consistent with the
analysis of the analogous situation arising when the EPA establishes
national ambient air quality standards (NAAQS), which do not impose any
requirements on regulated entities. As here with regard to U.S.
territories, any impact of a NAAQS on small entities would only arise
when states take subsequent action to maintain and/or achieve the NAAQS
through their state implementation plans. See American Trucking Assoc.
v. EPA, 175 F.3d 1029, 1043-45 (D.C. Cir. 1999) (NAAQS do not have
significant

impacts upon small entities because NAAQS themselves impose no
regulations upon small entities).
    Nevertheless, the EPA is aware that there is substantial interest
in the proposed rule among small entities. As detailed in section II.D
of this supplemental proposal and section III.A of the preamble to the
proposed carbon pollution emission guidelines for existing EGUs (79 FR
34845-34847, June 18, 2014), the EPA has conducted an unprecedented
amount of stakeholder outreach on setting emission guidelines for
existing EGUs. While formulating the provisions of the June 18, 2014,
proposed rule, as well as this proposed rule, the EPA considered the
input provided over the course of the stakeholder outreach. Sections
II.D and VI.F of this supplemental proposal and section III.B of the
preamble to the June 18, 2014, proposal (79 FR 34847) describe the key
issues and messages from stakeholders. The EPA invites comments on all
aspects of this proposal and its impacts, including potential impacts
on small entities.

D. Unfunded Mandates Reform Act

    This proposed action does not contain a federal mandate that may
result in expenditures of $100 million or more for state,\45\ local and
tribal governments, in the aggregate, or the private sector in any one
year. The emission guidelines proposed under CAA section 111(d) do not
impose any direct compliance requirements on EGU sources. As explained
in section VI.B above, the proposal also does not impose specific
requirements on tribal governments that have affected EGUs located in
their area of Indian country. The proposal does impose specific
requirements on U.S. territory governments that have affected EGUs.
Specifically, the U.S. territories are required to develop plans to
implement the guidelines under CAA section 111(d) for affected EGUs.
The burden for U.S. territories to develop CAA section 111(d) plans in
the 3-year period following promulgation of the rule was estimated and
is listed in section VI.B above, but this burden is estimated to be
below $100 million in any one year. Thus, this proposed rule is not
subject to the requirements of section 202 or section 205 of the UMRA.
---------------------------------------------------------------------------

    \45\ ``State'' is defined under the Unfunded Mandates Reform Act
(UMRA) as ``a State of the United States, the District of Columbia,
a territory or possession of the United States, and an agency,
instrumentality, or fiscal agent of a State but does not mean a
local government of a State.''
---------------------------------------------------------------------------

    This proposed rule is also not subject to the requirements of
section 203 of UMRA because it contains no regulatory requirements that
might significantly or uniquely affect small governments. Specifically,
the governments with affected EGUs for which this action proposes
specific requirements (i.e., the U.S. territories of Puerto Rico and
Guam) are not considered small governments.
    In light of the interest among governmental entities, the EPA
initiated outreach with U.S. territory and tribal governmental entities
while formulating the provisions of this proposed rule. Section III.A
of the preamble to the proposed carbon pollution emission guidelines
for existing EGUs (79 FR 34845-34847, June 18, 2014) describes the
extensive stakeholder outreach the EPA has conducted on setting
emission guidelines for existing EGUs. Section II.D of this
supplemental proposal details the specific outreach that the EPA
conducted to the U.S. territories with potentially affected EGUs. In
addition, section VI.F of this supplemental proposal and section XI.F
of the preamble to the June 18, 2014, proposed rule describe outreach
to tribes and consultation with tribal officials. The EPA considered
the input provided over the course of its stakeholder outreach
developing the provisions of these proposed emission guidelines.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132. Executive Order 13132 applies only
to states, whereas this action proposes emission performance goals
covering affected power plants located in the U.S. territories and in
specified areas of Indian country.\46\ Thus, Executive Order 13132 does
not apply to this action.
---------------------------------------------------------------------------

    \46\ ``State'' or ``States'' are defined under Executive Order
13132 as ``the States of the United States of America, individually
or collectively, and, where relevant, to State governments,
including units of local government and other political subdivisions
established by the States.''
---------------------------------------------------------------------------

    Nevertheless, as described in section II.D of this supplemental
proposal and section III.A of the preamble to the proposed carbon
pollution emission guidelines for existing EGUs (79 FR 34845-34847,
June 18, 2014), the EPA has conducted an unprecedented amount of
stakeholder outreach on setting emission guidelines for existing EGUs.
Section II.D of this supplemental proposal details the outreach that
the EPA conducted to the U.S. territories with potentially affected
EGUs. In addition, section VI.F of this supplemental proposal and
section XI.F of the preamble to the June 18, 2014, proposed rule
describe outreach to tribes and consultation with tribal officials.
    In the spirit of Executive Order 13132, and consistent with the
EPA's policy to promote communications between the EPA and State and
local governments, the EPA welcomes comment on this proposed action
from U.S. territory and tribal officials.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    Subject to Executive Order 13175 (65 FR 67249, November 9, 2000)
the EPA may not issue a regulation that has tribal implications, that
imposes substantial direct compliance costs on tribal governments and
that is not required by statute, unless the federal government provides
the funds necessary to pay the direct compliance costs incurred by
tribal governments, or the EPA consults with tribal officials early in
the process of developing the proposed regulation and develops a tribal
summary impact statement.
    The EPA has concluded that this action may have tribal
implications. However, it will neither impose substantial direct
compliance costs on tribal governments, nor preempt tribal law. Tribes
are not required to develop or adopt CAA programs, but they may apply
to the EPA for TAS and, if approved, do so. Tribes are not required to
develop plans to implement the guidelines under CAA section 111(d) for
affected EGUs in their areas of Indian country. To the extent that a
tribal government seeks and attains TAS status for that purpose, these
proposed emission guidelines would require that planning requirements
be met and emission management implementation plans be executed by the
tribes. The EPA notes that this proposal does not directly impose
specific requirements on affected EGUs, including those located in
Indian country, but provides guidance to any tribe approved by the EPA
to address CO2 emissions from EGU sources found subject to
section 111(d) of the CAA. The EPA also notes that none of the affected
EGUs are owned or operated by tribal governments.
    The June 18, 2014, proposed rule and this supplemental proposal
were developed after extensive and vigorous outreach to stakeholders,
including tribes. Tribes were invited to participate in the national
informational webinar, ``Building a Common Understanding:

Clean Air Act and Upcoming Carbon Pollution Guidelines for Existing
Power Plants,'' held August 27, 2013. The EPA also held a series of
listening sessions prior to development of this proposed action. Tribes
participated in a session on September 9, 2013, together with the state
agencies, as well as in a separate tribe-only session on September 26,
2013. In addition, an outreach meeting was held on September 9, 2013,
with tribal representatives from some of the 566 tribes.
    As part of the outreach to tribes, EPA representatives also met
with tribal environmental staff with the National Tribal Air
Association, by teleconference, on July 25, 2013, December 19, 2013,
June 26, 2014, and webinars on August 4, 2014, and September 5, 2014.
In those teleconferences and webinars, the EPA provided background
information on the GHG emission guidelines to be developed and a
summary of issues being explored by the agency. Tribes have expressed
varied points of view. Some tribes raised concerns about the impacts of
the regulations on EGUs and the subsequent impact on jobs and revenue
for their tribes. Other tribes expressed concern about the impact the
regulations would have on the cost of water to their communities as a
result of increased costs to the EGU that provide energy to transport
the water to the tribes. Other tribes raised concerns about the impacts
of climate change on their communities, resources, ways of life and
hunting and treaty rights. The tribes were also interested in the scope
of the guidelines being considered by the agency (e.g., over what time
period, relationship to state and multi-state plans) and how tribes
will participate in these planning activities.
    The EPA conducted outreach to tribal environmental staff and
offered consultation with tribal officials in developing this action.
Because this supplemental proposal would affect sources located within
Indian country, the EPA offered consultation with tribal officials
early in the process of developing the proposed regulation to permit
tribes to have meaningful and timely input into its development. The
EPA sent consultation letters to the leaders of all of the federally
recognized tribes. The letters provided information regarding the EPA's
development of emission guidelines for existing power plants and
offered consultation. The EPA held a consultation with the Ute Tribe,
the Crow Nation, and the MHA Nation on July 18, 2014. On August 22,
2014, the EPA held a consultation with the Fort Mojave Tribe. On
September 15, 2014, the EPA held a consultation with the Navajo Nation.
The Navajo Nation sent a letter to the EPA on September 18, 2014,
summarizing the information presented at the consultation and the
Navajo Nation's position on this supplemental proposal. One issue
raised by tribal officials was the potential impacts of the June 18,
2014, proposal and this supplemental proposal on tribes with budgets
that are dependent on revenue from coal mines and power plants, as well
as employment at the mines and power plants. The tribes noted the high
unemployment rates and lack of access to basic services on their lands.
Tribal officials also asked whether the rules will have any impact on a
tribe's ability to seek TAS. Tribal officials also expressed interest
in agency actions with regard to facilitating power plant compliance
with regulatory requirements. The Navajo Nation made the following
recommendations in their letter of September 18, 2014: The Navajo
Nation supports a mass-based CO2 emission standard based on
the highest historical CO2 emissions since 1996; the Navajo
Nation requests that the EPA grant the Navajo Nation carbon credits and
that the Navajo Nation retains ownership and control of such credits;
building block 2 is not appropriate for the Navajo Nation because there
are no NGCC plants located on the Navajo Nation; building block 3 is
not appropriate for the Navajo Nation because the Navajo people already
receive virtually all of their electricity from carbon-free sources
(mostly hydroelectric power) and their use of electricity is negligible
compared to the generation at the power plants; building block 4 is not
appropriate for the Navajo Nation because of the inadequate access to
electricity, and the goal should allow for an increase in energy
consumption on the Navajo Nation; the supplemental proposal should
consider the useful life of the power plants located on the Navajo
Nation; and the supplemental proposal should clarify that RE projects
located within the Navajo Nation that provide electricity outside the
Navajo Nation should be counted toward meeting the relevant state's RE
goals under the Clean Power Plan.
    The EPA will continue the ongoing dialogue with tribal officials
regarding this proposed action. During the public comment period for
this proposal, the EPA will hold meetings with tribal environmental
staff to inform them of the content of this proposal, as well as offer
further consultation with tribal elected officials, where it is
appropriate. The EPA specifically solicits additional comment on this
proposed action from tribal officials.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 (62 FR 19885, April 23,
1997) as applying to those regulatory actions that concern health or
safety risks, such that the analysis required under section 5-501 of
the Executive Order has the potential to influence the regulation. This
action is not subject to Executive Order 13045 because it does not
involve decisions on environmental health or safety risks that may
disproportionately affect children. The EPA believes that the
CO2 emission reductions resulting from implementation of the
proposed guidelines, as well as substantial O3 and
PM2.5 emission reductions as a co-benefit, would further
improve children's health.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use

    This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not
likely to have a significant adverse effect on the supply, distribution
or use of energy. Affected EGUs in one area of Indian country are
expected to meet the proposed goal based on compliance with other
regulations; the impacts of meeting the proposed goals for the other
two areas of Indian country were already accounted for in the June 18,
2014, proposal. In U.S. territories, the EPA anticipates a small degree
of re-dispatch from coal- and oil-fired generation to natural gas-fired
generation. It is possible that some portion of this shift away from
coal- and oil-fired generation may occur in the absence of the rule,
due primarily to the relatively high cost of petroleum-based fuel and
electricity in these areas. For example, PREPA plans to add natural gas
capacity at existing petroleum-burning plants. Additionally, both Guam
and Puerto Rico are implementing Renewable Portfolio Standards programs
which may contribute to implementing these goals at a different cost
than projected in the RIA. The ``Technical Support Document for
Calculating Carbon Pollution Goals for Existing Power Plants in U.S.
Territories and Areas of Indian Country'' provides additional
information about PREPA's planned expansion of natural gas electricity
generation and the Guam and Puerto Rico Renewable Portfolio Standards
programs. The EPA does not account for

these existing trends in this analysis due to data limitations.
Additionally, since the EPA estimated these impacts without the use of
an economic dispatch model, the EPA is potentially overstating the
costs of implementation in these areas.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) of 1995 (Pub. L. 104-113; 15 U.S.C. 272 note) directs the
EPA to use voluntary consensus standards (VCS) in its regulatory and
procurement activities unless to do so would be inconsistent with
applicable law or otherwise impractical. VCS are technical standards
(e.g., materials specifications, test methods, sampling procedures and
business practices) that are developed or adopted by one or more VCS
bodies. The NTTAA directs the EPA to provide Congress, through OMB,
explanations when the agency does not use available and applicable VCS.
This proposed rulemaking does not involve technical standards.
    The EPA welcomes comments on this aspect of the proposed rulemaking
and specifically invites the public to identify potentially-applicable
VCS and to explain why such standards should be used in this action.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies and activities on minority populations and low-income
populations in the U.S.
    Section II.A of the preamble to the proposed carbon pollution
emission guidelines for existing EGUs (79 FR 34841-34843, June 18,
2014) summarizes the public health and welfare impacts from GHG
emissions that were detailed in the 2009 Endangerment Finding under CAA
section 202(a)(1).\47\ As part of the Endangerment Finding, the
Administrator considered climate change risks to minority or low-income
populations, finding that certain parts of the population may be
especially vulnerable based on their circumstances. These include the
poor, the elderly, the very young, those already in poor health, the
disabled, those living alone, and/or indigenous populations dependent
on one or a few resources. The Administrator placed weight on the fact
that certain groups, including children, the elderly and the poor, are
most vulnerable to climate-related health effects.
---------------------------------------------------------------------------

    \47\ ``Endangerment and Cause or Contribute Findings for
Greenhouse Gases Under Section 202(a) of the Clean Air Act,'' 74 FR
66496 (Dec. 15, 2009) (``Endangerment Finding'').
---------------------------------------------------------------------------

    Strong scientific evidence that the potential impacts of climate
change raise environmental justice issues is found in the major
assessment reports by the U.S. Global Change Research Program, the
Intergovernmental Panel on Climate Change and the National Research
Council of the National Academies, summarized in the record for the
Endangerment Finding. Their conclusions include that poor communities
can be especially vulnerable to climate change impacts because they
tend to have more limited adaptive capacities and are more dependent on
climate-sensitive resources such as local water and food supplies. In
addition, Native American tribal communities possess unique
vulnerabilities to climate change, particularly those on established
reservations that are restricted to reservation boundaries and,
therefore, have limited relocation options. Tribal communities whose
health, economic well-being and cultural traditions depend upon the
natural environment will likely be affected by the degradation of
ecosystem goods and services associated with climate change. Southwest
native cultures are especially vulnerable to water quality and
availability impacts. Native Alaskan communities are likely to
experience disruptive impacts, including shifts in the range or
abundance of wild species crucial to their livelihoods and well-being.
The most recent assessments continue to strengthen scientific
understanding of climate change risks to minority and low-income
populations.
    This proposed rule would limit GHG emissions by establishing
CO2 emission guidelines for use in developing CAA section
111(d) plans to address CO2 emissions from affected EGUs. In
addition to reducing CO2 emissions, implementing the
proposed rule through the development of CAA section 111(d) plans would
reduce other emissions from EGUs that become dispatched less frequently
due to their relatively low energy efficiency. These emission
reductions will include SO2 and NOX, which form
ambient PM2.5 and O3 in the atmosphere, and HAP,
such as Hg and HCl. In the final rule revising the annual
PM2.5 NAAQS,\48\ the EPA identified persons with lower
socioeconomic status as an at-risk population for experiencing adverse
health effects related to PM exposures. Persons with lower
socioeconomic status have been generally found to have a higher
prevalence of pre-existing diseases, limited access to medical
treatment, and increased nutritional deficiencies, which can increase
this population's risk to PM-related and O3-related
effects.\49\ Therefore, in areas where this rulemaking ultimately
results in reductions in exposure to PM2.5, O3
and methylmercury, persons with low socioeconomic status would also
benefit. The RIA for this rulemaking, included in the docket for this
rulemaking, provides additional information regarding the health and
ecosystem effects associated with these emission reductions.
---------------------------------------------------------------------------

    \48\ ``National Ambient Air Quality Standards for Particulate
Matter, Final Rule,'' 78 FR 3086 (Jan. 15, 2013).
    \49\ U.S. Environmental Protection Agency (U.S. EPA). 2009.
Integrated Science Assessment for Particulate Matter (Final Report).
EPA-600-R-08-139F. National Center for Environmental Assessment--RTP
Division. December. Available on the Internet at http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=216546.
---------------------------------------------------------------------------

    While there will be many locations with improved air quality for
PM2.5, O3 and HAP, there may also be EGUs whose
emissions of one or more of these pollutants or their precursors
increase as a result of implementation of the proposed emission
guidelines for existing fossil fuel-fired EGUs. This may occur at EGUs
that become dispatched more intensively than in the past because they
become more energy efficient. The EPA has considered the potential for
such increases and the environmental justice implications of such
increases.
    As noted in the preamble for the June 18, 2014, proposal, as part
of a jurisdiction's CAA section 111(d) plan, the jurisdiction may
require an affected EGU to undertake physical or operational changes to
improve the EGU's efficiency that result in an increase in the EGU's
dispatch and an increase in its annual emissions of GHGs and/or other
regulated pollutants. However, a jurisdiction can take steps to avoid
increased utilization of particular EGUs and emissions of regulated
pollutants whose environmental effects would be more localized around
the affected EGU. To the extent that jurisdictions take this path,
there would be no new environmental justice concerns in the areas near
such EGUs.

In addition, the applicable jurisdiction or federal permitting program
can adjust its CAA section 111(d) plan to ensure that there are no new
NAAQS exceedances and that no existing NAAQS exceedances are made
worse. For those EGUs in a permitting situation for which the EPA is
the permit reviewing authority, the EPA will consider environmental
justice issues as required by Executive Order 12898.
    In addition to some EGUs possibly being required by a jurisdiction
to make modifications for increased energy efficiency, another
potential effect of the proposed CO2 emission guidelines for
existing fossil fuel-fired EGUs would be increased utilization of
other, unmodified EGUs with relatively low GHG emissions per unit of
electrical output, in particular high efficiency gas-fired EGUs. Such
plants would have more hours in the year in which they operate and emit
pollutants, including pollutants whose environmental effects if any
would be localized rather than global as is the case with GHG
emissions. Changes in utilization already occur now as demands for and
sources of electrical energy evolve, but the proposed CO2
emission guidelines for existing fossil fuel-fired EGUs can be expected
to cause more such changes. Because gas-fired EGUs emit essentially no
Hg, increased utilization would not increase methylmercury
concentrations in their vicinities. Increased utilization generally
would not cause higher peak concentrations of
PM2.5, NOX or O3 around
such EGUs than is already occurring because peak hourly or daily
emissions generally would not change, but increased utilization may
make periods of relatively high concentrations more frequent. It should
be noted that the gas-fired sources that are likely to become
dispatched more frequently than at present have very low emissions of
primary PM, SO2 and HAP per unit of electrical output, such
that local (or regional) air quality for these pollutants is likely to
be affected very little. For natural gas-fired EGUs, the EPA found that
regulation of HAP emissions ``is not appropriate or necessary because
the impacts due to HAP emissions from such EGUs are negligible based on
the results of the study documented in the utility RTC [response to
comments].'' \50\ In studies done by the U.S. Department of Energy's
National Energy Technology Laboratory comparing cost and performance of
coal- and natural gas-fired generation, they assumed SO2, PM
(and Hg) emissions to be ``negligible.'' Their studies predict
NOX emissions from a NGCC unit to be approximately 10 times
lower than a subcritical or supercritical coal-fired boiler. Many are
also very well controlled for emission of NOX through the
application of after combustion controls such as selective catalytic
reduction, although not all gas-fired sources are so equipped.
Depending on the specificity of the jurisdiction's CAA section 111(d)
plan, the jurisdiction may be able to predict which EGUs and
communities may be in this type of situation and to address any
concerns about localized NOX concentrations in the design of
the CAA section 111(d) program, or separately from the CAA section
111(d) program but before its implementation. In any case, existing
tracking systems will allow jurisdictions and the EPA to be aware of
the EGUs whose utilization has increased most significantly, and, thus,
to be able to prioritize our efforts to assess whether air quality has
changed in the communities in the vicinity of such EGUs. There are
multiple mechanisms in the CAA to address situations in which air
quality has degraded significantly. In conclusion, this proposed rule
would result in regional and national pollutant reductions; however,
there likely would also be some locations with more times during the
year of relatively higher concentrations of pollutants with potential
for effects on localized communities than would be experienced in the
absence of the proposed rule. The EPA cannot exactly predict how
emissions from specific EGUs would change as an outcome of the proposed
rule due to the jurisdiction-led implementation. Therefore, the EPA has
concluded that it is not practicable to determine whether there would
be disproportionately high and adverse human health or environmental
effects on minority, low income or indigenous populations from this
proposed rule.
---------------------------------------------------------------------------

    \50\ 65 FR 79831.
---------------------------------------------------------------------------

    In order to provide opportunities for meaningful involvement early
on in the rule making process, the EPA has hosted webinars and
conference calls on August 27, 2013, and September 9, 2013, for the
June 18, 2014, proposal specifically for environmental justice and
tribal communities and has taken all comments and suggestions into
consideration in the design of the emission guidelines. Additionally,
after the June 18, 2014, rule was proposed, the EPA hosted public
hearings in Denver, Colorado, Atlanta, Georgia, Washington, DC and
Pittsburgh, Pennsylvania, from July 29-August 1, 2014. Additionally, as
referenced in the public hearing section of this proposal, the EPA will
also be holding a public hearing on this supplemental proposal. Also,
as part of the outreach conducted for the Clean Power Plan, the EPA has
created interactive maps that provide the locations of fossil fuel
fired power plants covered by the proposed Clean Power Plan and
summaries that describe each area's power sector CO2
emission rates (using 2012 data) and each area's proposed emission rate
goal. These interactive maps are available at: http://cleanpowerplanmaps.epa.gov/CleanPowerPlan/. Additionally, the public is
invited to submit comments or identify peer-reviewed studies and data
that assess effects of exposure to the pollutants addressed by this
proposal.

VII. Statutory Authority

    The statutory authority for this action is provided by sections
111, 301, 302, and 307(d)(1)(V) of the CAA, as amended (42 U.S.C. 7411,
7601, 7602, 7607(d)(1)(V)). This action is also subject to section
307(d) of the CAA (42 U.S.C. 7607(d)).

Proposed Rule Amendment With Changes

    To facilitate understanding of the amendments to the proposed
subpart UUUU being proposed in this action, the EPA is providing a
Technical Support Document in the docket for this rulemaking that shows
in track changes the proposed amendments to the text of the proposed
subpart UUUU in the June 18, 2014, Federal Register publication.

List of Subjects in 40 CFR Part 60

    Environmental protection, Administrative practice and procedure,
Air pollution control, Intergovernmental relations, Reporting and
recordkeeping requirements.

    Dated: October 28, 2014.
Gina McCarthy,
Administrator.

    For the reasons stated in the preamble, title 40, chapter I, part
60 of the Code of the Federal Regulations, as proposed to be amended at
79 FR 34830, June 18, 2014, is proposed to be further amended as
follows:

PART 60--STANDARDS OF PERFORMANCE FOR NEW STATIONARY SOURCES

0
1. The authority citation for part 60 continues to read as follows:

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

Subpart UUUU--Emission Guidelines for Greenhouse Gas Emissions and
Compliance Times for Electric Utility Generating Units

0
2. Revise Sec.  60.5710 to read as follows:

Sec.  60.5710  Am I affected by this subpart?

    If you are the Administrator of an air quality program of a state,
the Commonwealth of Puerto Rico, Guam and any other United States'
territory, or an Indian tribe that has been approved by EPA pursuant to
40 CFR 49.9 as eligible to administer this subsection (hereinafter a
state) in state with one or more affected EGUs that commenced
construction on or before January 8, 2014, you must submit a state plan
to the U.S. Environmental Protection Agency (EPA) that implements the
emission guidelines contained in this subpart. You must submit a
negative declaration letter in place of the state plan if there are no
affected EGUs for which construction commenced on or before January 8,
2014 in your state.
0
3. Amend Table 1 to Subpart UUUU of Part 60--State Rate-Based
CO2 Emission Performance Goals (Pounds of CO2 per
net MWh)by adding entries for Puerto Rico, Guam, Lands of the Navajo
Nation, Lands of the Ute Tribe of the Uintah and Ouray Reservation, and
Lands of the Fort Mojave Tribe to the end as follows:

    Table 1 to Subpart UUUU of Part 60--State Rate-Based CO2 Emission
                            Performance Goals
                       [Pounds of CO2 per net MWh]
------------------------------------------------------------------------
                  State                    Interim goal     Final goal
------------------------------------------------------------------------

                              * * * * * * *
Puerto Rico.............................           1,470           1,413
Guam....................................           1,733           1,586
Lands of the Navajo Nation..............           1,991           1,989
Lands of the Ute Tribe of the Uintah and           2,000           1,988
 Ouray Reservation......................
Lands of the Fort Mojave Tribe..........             856             855
------------------------------------------------------------------------

[FR Doc. 2014-26112 Filed 10-30-14; 4:15 pm]
BILLING CODE 6560-50-P


[Federal Register: November 14, 2007 (Volume 72, Number 219)]
[Notices]
[Page 64094]
[DOCID:fr14no07-82]

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

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Pub. L. 94-409, that the Securities and
Exchange Commission will hold an Open Meeting on Thursday, November 15,
2007 at 10 a.m., in Room L-002, the Auditorium.
    The subject matters of the Open Meeting will be:
    1. The Commission will consider rule proposals to improve mutual
fund disclosure by providing investors with a summary prospectus
containing key information in plain English in a clear and concise
format, and by enhancing the availability on the Internet of more
detailed information to investors. The Commission also will consider
whether to propose related amendments to Form N-1A.
    2. The Commission will consider whether to adopt amendments to Form
20-F, Rules 1-02, 3-10 and 4-01 of Regulation S-X, Forms F-4 and S-4,
and Rule 701 under the Securities Act to accept financial statements
prepared in accordance with International Financial Reporting Standards
as issued by the International Accounting Standards Board without
reconciliation to generally accepted accounting principles as used in
the United States when contained in the filings of foreign private
issuers with the Commission.
    3. The Commission will consider whether to adopt amendments to its
disclosure and reporting requirements under the Securities Act of 1933
and Securities Exchange Act of 1934 to expand the number of companies
that qualify for scaled disclosure requirements for smaller reporting
companies. Companies with less than $75 million in public equity float
would qualify for the scaled requirements, and companies without a
calculable public equity float would qualify if their annual revenues
were below $50 million. To streamline and simplify regulation, the
amendments to be considered would move the scaled disclosure
requirements from Regulation S-B into Regulation S-K and would
eliminate the ``SB'' forms.
    4. The Commission will consider whether to adopt amendments to Rule
144 to shorten the holding period for the resale of restricted
securities if the issuer of the securities is subject to the Exchange
Act reporting requirements. The amendments also substantially reduce
the restrictions applicable to resales of restricted securities by non-
affiliates of both reporting and non-reporting companies. In addition,
the amendments codify several staff interpretations relating to Rule
144 and revise the manner of sale requirements, volume limitations, and
Form 144 filing thresholds. Finally, the Commission also will consider
whether to adopt related amendments to Rule 145.
    5. The Commission will consider whether to adopt amendments to Rule
12h-1 under the Exchange Act to provide two exemptions from the
registration requirements of the Exchange Act for compensatory employee
stock options. The first exemption would be available to issuers that
are not required to file periodic reports under the Exchange Act, and
the second exemption would be available to issuers that are required to
file those reports because they have registered a class of security
under section 12 of the Exchange Act or are required to file those
reports pursuant to section 15(d) of the Exchange Act.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: November 7, 2007.
Nancy M. Morris,
Secretary.
[FR Doc. E7-22169 Filed 11-13-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 171 (Friday, September 2, 2011)]
[Notices]
[Pages 54764-54765]
[FR Doc No: 2011-22503]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER11-4357-000]

Marathon Power LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Marathon Power LLC's application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is September 13, 2011.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create

and validate an eRegistration account using the eRegistration link.
Select the eFiling link to log on and submit the intervention or
protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: August 24, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-22503 Filed 9-1-11; 8:45 am]
BILLING CODE 6717-01-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on July 10, 2006

NOTICE OF ACTION TAKEN -- DOCKET OST-2006-25208

________________________________________________________________________
__________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of FRONTIER AIRLINES, INC. (FRONTIER) filed 6/22/06 for:

XX  Exemption for two years under 49 U.S.C. 40109 to provide the
following service:

Scheduled foreign air transportation of persons, property, and mail
between San Diego, California, and Cancun, Mexico, and to combine this
authority with its existing certificate and exemption authorities.
Frontier proposes to operate these services on a seasonal basis
beginning December 16, 2006.

Applicant rep:  Edward P. Faberman<PHONE_NUMBER>  DOT Analyst:  Thuy H.
Cooper<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted, in part (subject to conditions, see below)

XX  Dismissed request for route integration authority2

The above action was effective when taken: July 10, 2006, through July
10, 2008.

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

XX  The authority granted is consistent with the aviation agreement
between the United States and Mexico.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:

	XX  Holder’s certificates of public convenience and necessity

	XX  Standard Exemption Conditions (attached)

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

Conditions: The U.S.-Mexico exemption authority granted is subject to
the dormancy notice requirements set forth in condition 7 of Appendix A
of Order 88-10-2.  Consistent with our policy, the dormancy notice
period will begin on December 16, 2006, Frontier’s proposed start-up
date for the above-mentioned service.

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

On the basis of data officially noticeable under Rule 24(g) of the
Department’s regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the authority was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted or dismissed, we denied all requests in the
referenced Dockets.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security, including, but not limited to, 49 CFR Part 1544.
To assure compliance with all applicable U.S. Government requirements
concerning security, the holder shall, before commencing any new service
(including charter flights) to or from a foreign airport, contact its
International Principal Security Inspector (IPSI) to advise the IPSI of
its plans and to find out whether the Transportation Security
Administration has determined that security is adequate to allow such
airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

05/2004

 Frontier’s application indicated that the carrier planned a December
2006 startup.  On June 28, 2006, the
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Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me and loved ones, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I would like to respond to. I want to provide my thoughts and comments on many of these issues as possible, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life and many others that have chosen this alternative. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.