[Federal Register Volume 80, Number 6 (Friday, January 9, 2015)]
[Notices]
[Pages 1423-1424]
[FR Doc No: 2015-00116]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2258]

Determination That TAGAMET (Cimetidine) Tablets and Other Drug
Products Were Not Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that the
drug products listed in this document were not withdrawn from sale for
reasons of safety or effectiveness. This determination means that FDA
will not begin procedures to withdraw approval of abbreviated new drug
applications (ANDAs) that refer to these drug products, and it will
allow FDA to continue to approve ANDAs that refer to the products as
long as they meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Amy Hopkins, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6223, Silver Spring, MD 20993-0002, 301-
796-5418<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is generally known as the ``Orange
Book.'' Under FDA regulations, a drug is removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved, (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved, and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for safety or
effectiveness reasons, the Agency will initiate proceedings that could
result in the withdrawal of approval of the ANDAs that refer to the
listed drug.

    FDA has become aware that the drug products listed in the table in
this document are no longer being marketed. (As requested by the
applicants, FDA withdrew approval of NDA 017920 for TAGAMET
(cimetidine) Tablets in the Federal Register of June 8, 2011 (76 FR
33310), and NDA 018709 for CAPOZIDE (captopril and hydrochlorothiazide)
Tablets in the Federal Register of March 19, 2012 (77 FR 16039).)

------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
NDA 017920.............  TAGAMET (cimetidine)     GlaxoSmithKline, 5
                          Tablet; Oral, 200        Moore Dr., P.O. Box
                          milligram (mg); 300      13398, Research
                          mg; 400 mg; 800 mg.      Triangle Park, NC
                                                   27709.
NDA 018155.............  OPTICROM (cromolyn       Allergan Inc., 2525
                          sodium) Solution/        Dupont Dr., Irvine,
                          Drops; Ophthalmic, 4%.   CA 92623.
NDA 018709.............  CAPOZIDE (captopril and  Apothecon Inc., P.O.
                          hydrochlorothiazide)     Box 4500, Princeton,
                          Tablet; Oral, 25 mg/15   NJ 08543.
                          mg; 25 mg/25 mg; 50 mg/
                          15 mg; 50 mg/25 mg.
NDA 018976.............  LEVATOL (penbutolol      Auxilium
                          sulfate) Tablet; Oral,   Pharmaceuticals LLC,
                          10 mg; 20 mg.            640 Lee Rd.,
                                                   Chesterbrook, PA
                                                   19087.
NDA 019958.............  CUTIVATE (fluticasone    Fougera
                          propionate) Cream;       Pharmaceuticals Inc.,
                          Topical, 0.05%.          1 Health Plaza, Bldg.
                                                   434, East Hanover, NJ
                                                   07936.
NDA 020713.............  MIRCETTE (desogestrel    Teva Pharmaceutical
                          and ethinyl estradiol,   Products Inc., 41
                          and ethinyl estradiol)   Moores Rd, P.O. Box
                          Tablet; Oral-28, 0.15    4011, Frazer, PA
                          mg/0.02 mg; 0.01 mg.     19355.
NDA 021410.............  AVANDAMET (metformin     SmithKline Beecham
                          hydrochloride (HCl)      Cork Ltd., Ireland,
                          and rosiglitazone        2301 Renaissance
                          maleate) Tablet; Oral,   Blvd., MC RN 0420,
                          500 mg/Equivalent to 1   King of Prussia, PA
                          mg Base.                 19406.
NDA 021571.............  IQUIX (levofloxacin)     Santen Inc., 555
                          Solution/Drops;          Gateway Dr., Napa, CA
                          Ophthalmic, 1.5%.        94558.
NDA 021726.............  NIRAVAM (alprazolam)     UCB Inc., 1950 Lake
                          Orally Disintegrating    Park Dr., Smyrna, GA
                          Tablets; Oral, 0.25      30080.
                          mg; 0.5 mg; 1 mg; 2 mg.
NDA 021768.............  FLUDEOXYGLUCLOSE F-18    Weill Medical College
                          Injectable;              Cornell University,
                          Intravenous 10-100       516 East 72nd St.,
                          millicuries/milliliter.  New York, NY 10065.
ANDA 076699............  PARCOPA (carbidopa and   UCB Inc., 1950 Lake
                          levodopa) Orally         Park Dr., Smyrna, GA
                          Disintegrating           30080.
                          Tablets; Oral, 10 mg/
                          100 mg; 25 mg/100 mg;
                          25 mg/250 mg.
ANDA 080248............  ALBALON (naphazoline     Allergan Inc., 2525
                          HCl) Solution/Drops;     Dupont Dr., Irvine,
                          Ophthalmic, 0.1%.        CA 92623.
------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list the drug products listed
in this document in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' identifies,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness.
    Approved ANDAs that refer to the NDAs and ANDAs listed in this
document are unaffected by the discontinued marketing of the products
subject to those NDAs and ANDAs. Additional ANDAs that refer to these
products may also be approved by the Agency if they comply with
relevant legal and regulatory requirements. If FDA determines that
labeling for these drug products should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.

    Dated: January 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00116 Filed 1-8-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 79 (Wednesday, April 24, 2019)]
[Notices]
[Pages 17161-17162]
[FR Doc No: 2019-08304]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9992-27-OA]

Request for Nominations of Candidates for EPA's Science Advisory
Board Computable General Equilibrium Model Review Panel

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) Science
Advisory Board (SAB) Staff Office invites nominations of environmental
economists and other experts with expertise in computable general
equilibrium (CGE) modeling to be considered for appointment to the
SAB's CGE Model Review Panel.

DATES: Nominations should be submitted in time to arrive no later than
May 15, 2019.

FOR FURTHER INFORMATION CONTACT: Any member of the public wishing
further information regarding this Notice and Request for Nominations
may contact Dr. Holly Stallworth, Designated Federal Officer (DFO), EPA
Science Advisory Board Staff Office (1400R), U.S. Environmental
Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460;
by telephone at<PHONE_NUMBER> or at [email protected]. General
information concerning the EPA SAB can be found at the EPA SAB website
at http://www.epa.gov/sab.

SUPPLEMENTARY INFORMATION:
    Background: The SAB (42 U.S.C. 4365) is a chartered Federal
Advisory Committee that provides independent scientific and technical
peer review, advice and recommendations to the EPA Administrator on the
technical basis for EPA actions. As a Federal Advisory Committee, the
SAB conducts business in accordance with the Federal Advisory Committee
Act (FACA) (5 U.S.C. App. 2) and related regulations. The SAB CGE Model
Review Panel will be an ad hoc panel of the SAB that provides advice
through the chartered SAB. It will be charged with reviewing a CGE
model developed by EPA's National Center for Environmental Economics
(NCEE) for use by agency analysts for the economic analysis of
environmental regulations. Experts

selected for the panel will be asked to review the model code and
documentation, run the model and independently verify how it works to
respond to NCEE's charge questions. Thus, the SAB Staff Office is
seeking nominations of environmental economists and other experts with
extensive experience building and using CGE models. The SAB CGE Model
Review Panel will comply with the provisions of FACA and all
appropriate SAB Staff Office procedural policies. The SAB CGE Model
Review Panel will operate under the auspices of the SAB.
    Request for Nominations: The SAB Staff Office is seeking
nominations of environmental economists and other experts with CGE
modeling experience.
    Process and Deadline for Submitting Nominations: Any interested
person or organization may nominate qualified individuals with CGE
modeling experience for possible service on the SAB CGE Model Review
Panel identified in this notice. Nominations should be submitted in
electronic format (preferred) following the instructions for
``Nominating Experts to Advisory Panels and Ad hoc Committees Being
Formed,'' provided on the SAB website (see the ``Nomination of
Experts'' link under ``Current Activities'') at http://www.epa.gov.sab.
    To receive full consideration, EPA's SAB Staff Office requests
contact information about the person making the nomination; contact
information about the nominee; the disciplinary and specific areas of
expertise of the nominee; the nominee's resume or curriculum vitae;
sources of recent grant and/or contract support; and a biographical
sketch of the nominee indicating current position, educational
background, research activities, and recent service on other national
advisory committees or national professional organizations.
    Persons having questions about the nomination procedures, or who
are unable to submit nominations through the SAB website, should
contact Dr. Holly Stallworth as indicated above in this notice.
Nominations should be submitted in time to arrive no later than May 15,
2019. EPA values and welcomes diversity. All qualified candidates are
encouraged to apply regardless of sex, race, disability, or ethnicity.
    The EPA SAB Staff Office will acknowledge receipt of nominations.
The names and biosketches of qualified nominees identified by
respondents to this Federal Register notice, and additional experts
identified by the SAB Staff, will be posted in a List of Candidates on
the SAB website at http://www.epa.gov/sab. Public comments on the List
of Candidates will be accepted for 21 days. The public will be
requested to provide relevant information or other documentation on
nominees that the SAB Staff Office should consider in evaluating
candidates.
    For the EPA SAB Staff Office, a balanced review panel includes
candidates who possess the necessary domains of knowledge, the relevant
scientific perspectives (which, among other factors, can be influenced
by work history and affiliation), and the collective breadth of
experience. The SAB Staff Office will consider public comments on the
List of Candidates, information provided by the candidates themselves,
and background information independently gathered by the SAB Staff
Office. Selection criteria to be used for panel membership include: (a)
Scientific and/or technical expertise, knowledge, and experience
(primary factors), e.g. journal publications within the last ten years
that rely on and discuss CGE model results; (b) availability and
willingness to serve; (c) absence of financial conflicts of interest;
(d) absence of an appearance of a loss of impartiality; and (e) skills
working in panels and advisory committees; and, (f) for the panel as a
whole, diversity of expertise and scientific points of view.
    The SAB Staff Office's evaluation of an absence of financial
conflicts of interest will include a review of the ``Confidential
Financial Disclosure Form for Special Government Employees'' (EPA Form
3110-48). This confidential form allows government officials to
determine whether there is a statutory conflict between a person's
public responsibilities (which include membership on an EPA federal
advisory committee) and private interests and activities, or the
appearance of a loss of impartiality, as defined by federal regulation.
The form may be viewed and downloaded from the following URL address
http://yosemite.epa.gov/sab/sabproduct.nsf/Web/ethics?OpenDocument.

    Dated: April 9, 2019.
Khanna Johnston,
Deputy Director, EPA Science Advisory Board Staff Office.
[FR Doc. 2019-08304 Filed 4-23-19; 8:45 am]
 BILLING CODE 6560-50-P


Distributions of Observed Breathing Rates in Working Coal Miners 0 2 4 6 8 10 12 14 16 18 20 12 14 16 18 20 22 24 26 28 30 Mean, Z = 0 1 Std. Dev. 1 Std. Dev. Z = + 1 Z =  1 3 2 1 0  1  2  3 10 20 30 40 Fit of a Normal Distribution to the Minute Volumes Observed in 62 British Coal Miners ( Data of Jones et al., 1981)

Z Score y = 20.760 + 4.6980x R^ 2 = 0.983 3 2 1 0  1  2  3 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 Fit of a Lognormal Distribution to the Minute Volumes of 62 British Coal Miners ( Data of Jones et al., 1981)

Z Score log(

Min.

Vol.) y = 1.3055 + 0.10273x R^ 2 = 0.962 3 2 1 0  1  2  3 2.0 2.2 2.4 2.6 2.8 3.0 Children S 12 Yrs Adolescents and Adults Lognormal Distributions of Cal EPA Estimated 1 Day Activity Based Breathing Rates Z Score Log(

L/

kg Body Weight)

Estimated Activity

Based Ventilation Rates y = 2.66 + .0618x R^ 2 = 0.983 y = 2.36 + 0.117x R^ 2 = 0.940


[Federal Register: June 28, 2011 (Volume 76, Number 124)]
[Notices]
[Page 37808-37809]
[DOCID:fr28jn11-79]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER11-3322-000]

PJM Interconnection, L.L.C.; Notice of Discussion Topics for
Staff Technical Conference

    Take notice that a technical conference in the above captioned
proceeding will be held on July 29, 2011, beginning at 9 a.m. (EDT) in
the Commission Meeting Room at the Commission's headquarters, located
at 888 First Street, NE., Washington, DC 20426. The technical
conference will be led by Commission staff. Commissioners may be in
attendance. All interested parties are invited to attend. Registration
is not required.
    On June 3, 2011, the Commission issued an order in this proceeding,
which accepted and suspended proposed tariff changes submitted by PJM
Interconnection, L.L.C. (PJM), subject to refund and the outcome of a
technical conference.\1\ This notice establishes the topics for
discussion at the technical conference to be held in order to discuss
the performance measurement of demand response in PJM's capacity
market, the Reliability Pricing Model (RPM).
---------------------------------------------------------------------------

    \1\ 135 FERC ] 61,212 (2011).
---------------------------------------------------------------------------

    The purpose of the technical conference is to discuss issues
surrounding PJM's April 7, 2011 filing, which proposes to modify the
reference point of capacity demand response load reductions so that
each end-use customer's actual load reduction results in a metered load
that is less than the customer's Peak Load Contribution (PLC).\2\
---------------------------------------------------------------------------

    \2\ PJM describes the PLC as the average of the end-user's
actual load during the five coincident peak hours of the preceding
delivery year. PJM April 7, 2011 Filing at note 11.
---------------------------------------------------------------------------

    In addition to the issues identified by the Commission in the June
3 Order, there will be a discussion on the topics identified in the
Appendix.
    Also, to supplement the record, PJM should provide information and
data on the following issues, as relevant to the proceeding, by July
11, 2011. PJM should provide examples and/or details regarding how an
increase in the number of aggregators reporting compliance in excess of
PLC presents a threat to system reliability. In addition, PJM should
explain whether the 1,000 MW of demand response that was in excess of
PLC in 2010 was concentrated in one zone or whether the demand response
was spread out over several zones. PJM should also provide data
regarding whether the customer reductions in 2010 that ranged from 150
percent to 300 percent or more of their PLC, and which accounted for 28
percent of total guaranteed load drop (GLD) reductions, were associated
solely with aggregation or if these reductions were also associated
with individual market participants.\3\ Further, PJM should provide
information on the prevalence of PJM customers with limited curtailment
capability, particularly with regards to customers associated with the
48 percent of total GLD reductions that were recorded at less than or
equal to 75 percent of the customer's PLCs, as detailed in the 2010
State of the Market Report for PJM. Finally, PJM should describe the
prevalence of peak-shaving activity in the PJM market and whether it is
possible to distinguish between peak-shaving activity and changes in
peak demand over time.
---------------------------------------------------------------------------

    \3\ Monitoring Analytics, Vol II, at 135 (2010), available at
http://www.monitoringanalytics.com/reports/PJM_State_of_the_
Market/2010/2010-som-pjm-volume2.pdf.
---------------------------------------------------------------------------

    Other parties are also free to file data related to these issues.
While responses should be provided by July 11, 2011, Commission staff
may further discuss the responses, and may have additional questions,
during the technical conference.
    Parties will have 15 days after the technical conference to respond
to the issues raised at the conference as well as PJM's responses to
the issues detailed above.
    Parties that have intervened in the proceeding and that are
interested in participating on a panel should contact Tristan Cohen at
<EMAIL_ADDRESS>or<PHONE_NUMBER> by July 1, 2011. A subsequent
notice will be issued announcing panelists and the format of the
conference.
    The conference will be transcribed. Transcripts will be available
immediately for a fee from Ace Reporting Company<PHONE_NUMBER> or 1-
800-336-6646). A free webcast of this event is also available through
http://www.ferc.gov. Anyone with Internet access who desires to view
this event can do so by navigating to http://www.ferc.gov's Calendar of
Events and locating this event in the calendar. The event will contain
a link to its webcast. The Capitol Connection provides technical
support for the free webcasts. If you have any questions, visit http://
www.CapitolConnection.org or call<PHONE_NUMBER>.
    FERC conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations please
send an e-mail to<EMAIL_ADDRESS>or call toll free (866) 208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a fax to<PHONE_NUMBER>
with the required accommodations.
    Parties seeking additional information regarding this conference
should contact Tristan Cohen at<EMAIL_ADDRESS>or (202) 502-
6598.

    Dated: June 21, 2011.
Kimberly D. Bose,
Secretary.

Appendix

Discussion Topics for Technical Conference on Performance Measurement
of Demand Response in the PJM Capacity Market, July 29, 2011

I. Reliability Issues

    1. Whether the customer baseline load (CBL) or peak load
contribution (PLC) is a more accurate capacity market performance
measure of what a demand response customer would have consumed in
the absence of an instruction to reduce load.
    2. Whether a demand response resource should be obligated to
reduce below its PLC during an emergency event, even if the
magnitude of supply that the resource is providing is otherwise
equivalent to its capacity commitment.
    3. Whether the current PJM add-back process under the guaranteed
load drop (GLD) option, which is used to calculate peak load for
capacity for the following delivery year, accurately reflects the
fact that the load reduction of an over-performing demand response
customer (a customer that provides a level of response greater than
the MW nominated for it in the capacity auction) has been used to
support an under-performing customer (a customer that provides a
level of response less than the nominated MW) in a portfolio
aggregated to meet the capacity commitment.
    4. Whether PJM dispatchers account for PLCs during an emergency.
    5. Whether any load in PJM can be at load levels in excess of
PLC during an emergency.

II. Capacity Obligations

    6. Discuss the capacity obligations of end-use customers whose
demand response resources have been committed in a prior RPM
auction.
    7. Whether the PLC limit on nominations in the capacity auction
should serve as a basis for requiring load reductions of capacity
resources to be below PLC.

III. Load Reductions and Incentives

    8. Whether the same MW reduction that is voluntarily made by a
peak shaving customer in order to reduce capacity costs should also
be eligible to receive incentives from PJM's Load Management
programs.
    9. Whether the current GLD option provides an incentive for
aggregators to offset under-performing resources with resources that
over-perform.

IV. Impact of PJM's Proposal

    10. Whether PJM's proposal undermines the GLD methodology.
    11. Whether PJM's proposal unduly discriminates against
resources on days other than the coincident peak days and whether
PJM's proposal negatively affects Annual Demand Resource
aggregations.

[FR Doc. 2011-16174 Filed 6-27-11; 8:45 am]
BILLING CODE 6717-01-P


1 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D. C., 20460 MEMORANDUM Date: September 22, 2005 SUBJECT: EFED RED Chapter for Napropamide chronic risk recalculation spreadsheet supporting documentation for mammals PC Code No. 103001; DP Barcode 308276 FROM: Donna M. Randall, Senior Effects Scientist, ERB II Environmental Fate and Effects Division ( 7507C) Office of Pesticide Programs THRU: Tom Bailey, Branch Chief, ERB II Environmental Fate and Effects Division ( 7507C) Office of Pesticide Programs TO: Demson Fuller, Chemical Review Manager Special Reregistration Review Division ( 7508C) Office of Pesticide Programs TREX model input and output spreadsheets documenting risk quotients calculated using the 30 mg/ kg bw/ day NOAEL in place of 30 mg/ kg diet are attached. A table of contents is provided for ease of identification.

Table of Contents Application: Single application per year at 1 lb a. i./ acre, broadcast................................. 2 Application: Two applications at 1.33 lb ai/ acre, banded ................................................. 6 Application: Single application at 2.0 lbs ai/ acre, banded ............................................. 10 Application: Single application at 2 lbs a. i./ acre, broadcast ........................................... 14 Application: Two applications at 3 lbs ai/ acre, broadcast.............................................. 18 Application: Single application at 4 lbs ai/ acre, broadcast ............................................ 22 Application: Two applications at 4 lbs ai/ acre, broadcast.............................................. 26 Application: Single application at 6 lbs ai/ acre, broadcast ............................................ 30 2 Application: Single application per year at 1 lb a. i./ acre, broadcast 3 4 5 6 Application: Two applications at 1.33 lb ai/ acre, banded ( By this label banded application is equated to result in 0.442 lb ai/ acre) 7 8 9 10 Application: Single application at 2.0 lbs ai/ acre, banded ( By banding this application is equated to result in 0.667 lbs ai/ A) 11 12 13 14 Application: Single application at 2 lbs a. i./ acre, broadcast ( Single application at 6 lbs ai/ acre applied banded is equivalent to 2 lbs ai/ acre) 15 16 17 18 Application: Two applications at 3 lbs ai/ acre, broadcast 19 20 21 22 Application: Single application at 4 lbs ai/ acre, broadcast 23 24 25 26 Application: Two applications at 4 lbs ai/ acre, broadcast 27 28 29 30 Application: Single application at 6 lbs ai/ acre, broadcast 31 32 33


Total Hours and Costs

                                     Legal
                                    Manager
                                   Technical
                                   Clerical
                            Respon.
Hours/ Activity
                             Labor
Cost/
Activity
                             Capital/
Startup
Cost
                            O&M
Cost/ Activity
                       Number of
Respondents/ Activities
                               Total Hours/
Year
                               Total
Cost/
Year
INFORMATION COLLECTION ACTIVITY
                                   $99.56/Hr
                                   $82.25/Hr
                                   $43.92/Hr
                                   $23.27/Hr

READING THE REGULATIONS
Read the regulations
                                     0.00
                                     0.00
                                     1.00
                                     0.00
                                     1.00
                                    $43.92
                                     $0.00
                                     $0.00
                                      33
                                     33.00
                                   $1,449.36
Subtotal
                                     0.00
                                     0.00
                                     1.00
                                     0.00
                                     1.00
                                    $43.92
                                     $0.00
                                     $0.00
                                      33
                                     33.00
                                   $1,449.36
NOTIFICATION OF INTENT TO COMPLY WITH SUBPART K AND RECORDKEEPING OF AGREEMENTS (40 CFR 262.203)
Eligible Academic Entities
Prepare and submit Site Identification Form
                                     0.00
                                     0.10
                                     0.30
                                     0.10
                                     0.50
                                    $23.73
                                     $0.00
                                     $3.41
                                      33
                                     16.50
                                    $895.64
Keep a copy of the notification on file
                                     0.00
                                     0.00
                                     0.00
                                     0.10
                                     0.10
                                     $2.33
                                     $0.00
                                     $0.00
                                      33
                                     3.30
                                    $76.89
Teaching Hospitals
Keep a copy of the formal written affiliation agreement on file
                                     0.00
                                     0.00
                                     0.00
                                     0.10
                                     0.10
                                     $2.33
                                     $0.00
                                     $0.00
                                       1
                                     0.10
                                     $2.33
Non-Profit Research Institutes
Keep a copy of the formal written affiliation agreement on file
                                     0.00
                                     0.00
                                     0.00
                                     0.10
                                     0.10
                                     $2.33
                                     $0.00
                                     $0.00
                                       2
                                     0.20
                                     $4.66
Subtotal
                                     0.00
                                    varies
                                    varies
                                    varies
                                    varies
                                    varies
                                     $0.00
                                    varies
                                    varies
                                     20.10
                                    $979.52
NOTIFICATION OF WITHDRAWAL FROM SUBPART K (40 CFR 262.204)
Prepare and submit Site Identification Form
                                     0.00
                                     0.10
                                     0.30
                                     0.10
                                     0.50
                                    $23.73
                                     $0.00
                                     $3.41
                                       0
                                     0.00
                                     $0.00
Keep a copy of the withdrawal notice on file
                                     0.00
                                     0.00
                                     0.00
                                     0.10
                                     0.10
                                     $2.33
                                     $0.00
                                     $0.00
                                       0
                                     0.00
                                     $0.00
Subtotal
                                     0.00
                                     0.10
                                     0.30
                                     0.20
                                     0.60
                                    $26.06
                                     $0.00
                                     $3.41
                                       0
                                     0.00
                                     $0.00
LABELING OF CONTAINERS OF UNWANTED MATERIAL IN THE LABORATORY (40 CFR 262.206)
Label the containers as specified
                                     0.00
                                     0.00
                                     0.017
                                     0.00
                                     0.017
                                     $0.75
                                     $0.00
                                     $0.14
                                    742,442
                                   12,621.51
                                  $660,439.43
Subtotal
                                     0.00
                                     0.00
                                     0.017
                                     0.00
                                     0.017
                                     $0.75
                                     $0.00
                                     $0.14
                                    742,442
                                   12,621.51
                                  $660,439.43
TRAINING (40 CFR 262.207)
Provide training to all individuals in a laboratory
                                     0.00
                                     0.00
                                     0.00
                                     0.00
                                     0.00
                                     $0.00
                                     $0.00
                                     $0.00
                                      99
                                     0.00
                                     $0.00
Maintain documentation demonstrating training for all laboratory workers (LQGs only)
                                     0.00
                                     0.00
                                     0.00
                                     0.00
                                     0.00
                                     $0.00
                                     $0.00
                                     $0.00
                                      27
                                     0.00
                                     $0.00
Subtotal
                                     0.00
                                     0.00
                                     0.00
                                     0.00
                                     0.00
                                     $0.00
                                     $0.00
                                     $0.00
                                    varies
                                     0.00
                                     $0.00

EXHIBIT 1 (continued)

GENERATOR STANDARDS APPLICABLE TO LABORATORIES OWNED BY ELIGIBLE ACADEMIC ENTITIES [a]

ESTIMATED ANNUAL RESPONDENT HOUR AND COST BURDEN

                        Hours and Costs per Respondent
                             Total Hours and Costs

                                     Legal
                                    Manager
                                   Technical
                                   Clerical
                            Respon.
Hours/ Activity
                             Labor
Cost/
Activity
                             Capital/
Startup
Cost
                            O&M
Cost/ Activity
                       Number of
Respondents/ Activities
                               Total Hours/
Year
                               Total
Cost/
Year
INFORMATION COLLECTION ACTIVITY
                                   $99.56/Hr
                                   $82.25/Hr
                                   $43.92/Hr
                                   $23.27/Hr

REMOVING CONTAINERS OF UNWANTED MATERIAL FROM THE LABORATORY (40 CFR 262.208)
Ensure that containers of unwanted material that exceed volume limits have the date of the exceedence on the label
                                     0.00
                                     0.00
                                     0.017
                                     0.00
                                     0.017
                                     $0.75
                                     $0.00
                                     $0.00
                                       0
                                     0.00
                                     $0.00
Subtotal
                                     0.00
                                     0.00
                                     0.017
                                     0.00
                                     0.017
                                     $0.75
                                     $0.00
                                     $0.00
                                       0
                                     0.00
                                     $0.00
MAKING THE HAZARDOUS WASTE DETERMINATION IN THE LABORATORY (40 CFR 262.210)
Make the hazardous waste determination
                                     0.00
                                     0.00
                                     0.00
                                     0.00
                                     0.00
                                     $0.00
                                     $0.00
                                     $0.00
                                    10,032
                                     0.00
                                     $0.00
Place hazardous waste codes on the container label
                                     0.00
                                     0.00
                                     0.017
                                     0.00
                                     0.017
                                     $0.75
                                     $0.00
                                     $0.00
                                    10,032
                                    170.54
                                   $7,524.00
Subtotal
                                     0.00
                                     0.00
                                     0.017
                                     0.00
                                     0.017
                                    $0.75
                                    $0.00
                                    $0.00
                                    10,032
                                    170.54
                                   $7,524.00
MAKING THE HAZARDOUS WASTE DETERMINATION IN AN ON-SITE CENTRAL ACCUMULATION AREA (40 CFR 262.211)
Make hazardous waste determination
                                     0.00
                                     0.00
                                     0.00
                                     0.00
                                     0.00
                                     $0.00
                                     $0.00
                                     $0.00
                                    732,410
                                     0.00
                                     $0.00
Place hazardous waste codes on the container label
                                     0.00
                                     0.00
                                     0.017
                                     0.00
                                     0.017
                                     $0.75
                                     $0.00
                                     $0.00
                                    732,410
                                   12,450.97
                                  $549,307.50
Subtotal
                                     0.00
                                     0.00
                                     0.017
                                     0.00
                                     0.017
                                    $0.75
                                    $0.00
                                    $0.00
                                   732,410
                                   12,450.97
                                  $549,307.50
MAKING THE HAZARDOUS WASTE DETERMINATION AT AN ON-SITE INTERIM STATUS OR PERMITTED TREATMENT, STORAGE, OR DISPOSAL FACILITY (40 CFR 262.212)
Make hazardous waste determination
                                     0.00
                                     0.00
                                     0.00
                                     0.00
                                     0.00
                                     $0.00
                                     $0.00
                                     $0.00
                                       0
                                     0.00
                                     $0.00
Place hazardous waste codes on the container label
                                     0.00
                                     0.00
                                     0.017
                                     0.00
                                     0.017
                                     $0.75
                                     $0.00
                                     $0.00
                                       0
                                     0.00
                                     $0.00
Subtotal
                                     0.00
                                     0.00
                                     0.017
                                     0.00
                                     0.017
                                    $0.75
                                    $0.00
                                    $0.00
                                      0
                                     0.00
                                     $0.00
LABORATORY CLEAN-OUTS (40 CFR 262.213)
Document the activities of the laboratory clean-out
                                     0.00
                                     0.00
                                     0.03
                                     0.00
                                     0.03
                                     $1.32
                                     $0.00
                                     $0.00
                                    14,849
                                    445.47
                                  $19,600.47
Maintain records of the clean-out
                                     0.00
                                     0.00
                                     0.00
                                     0.03
                                     0.03
                                     $0.70
                                     $0.00
                                     $0.00
                                    14,849
                                    445.47
                                  $10,394.19
Subtotal
                                     0.00
                                     0.00
                                     0.03
                                     0.03
                                     0.06
                                    $2.02
                                    $0.00
                                    $0.00
                                    14,849
                                    890.94
                                  $29,994.66
LABORATORY MANAGEMENT PLAN (40 CFR 262.214)
Develop Laboratory Management Plan, or revise an existing written plan
                                     0.00
                                     5.12
                                     35.80
                                     0.00
                                     40.92
                                   $1,993.46
                                     $0.00
                                     $0.00
                                      33
                                   1,350.36
                                  $65,784.18
Retain, review and revise the Laboratory Management Plan
                                     0.00
                                     0.00
                                     1.33
                                     0.00
                                     1.33
                                    $58.41
                                     $0.00
                                     $0.00
                                      99
                                    131.67
                                   $5,782.59
Make the Laboratory Management Plan available to others
                                     0.00
                                     0.00
                                     0.00
                                     0.50
                                     0.50
                                    $11.64
                                     $0.00
                                     $0.00
                                      99
                                     49.50
                                   $1,152.36
Subtotal
                                     0.00
                                    varies
                                    varies
                                    varies
                                    varies
                                    varies
                                    $0.00
                                    $0.00
                                    varies
                                   1,531.53
                                  $72,719.13
TOTAL
                                     0.00
                                    varies
                                    varies
                                    varies
                                    varies
                                    varies
                                    $0.00
                                    varies
                                    varies
                                   27,718.59
                                 $1,322,413.60
a  Exhibit contains rounding error.

EXHIBIT 2

GENERATOR STANDARDS APPLICABLE TO LABORATORIES OWNED BY ELIGIBLE ACADEMIC ENTITIES[a]

ESTIMATED ANNUAL RESPONDENT HOUR AND COST BURDEN - NEW AND EXISTING PAPERWORK REQUIREMENTS

                                  ICR Number
                                  Hours/Year
                                Labor Cost/Year
                               Capital Cost/Year
                               O&M Cost/Year
                                Total Cost/Year
Paperwork Requirements
New Paperwork Requirements
Generator Standards Applicable to Laboratories at Eligible Academic Entities
                                     2317
                                    27,719
                                  $1,218,694
                                      $0
                                   $103,720
                                  $1,322,414
Existing Paperwork Requirements
Requirements for Generators, Transporters, and Waste Management Facilities under the RCRA Hazardous Waste Manifest System
                                      801
                                    (1,612)
                                   ($81,667)
                                    ($244)
                                    ($998)
                                   ($82,909)
Hazardous Waste Generator Standards
                                      820
                                     (249)
                                   ($15,845)
                                      $0
                                     ($19)
                                   ($15,864)
The Hazardous Waste Report
                                      976
                                     (41)
                                   ($1,660)
                                      $0
                                     ($14)
                                   ($1,674)
Subtotal: Existing Paperwork Requirements
                                    (1,902)
                                   ($99,172)
                                    ($244)
                                   ($1,031)
                                  ($100,447)
Total under the Final Rule: New and Existing Paperwork
                                    25,817
                                  $1,119,521
                                    ($244)
                                   $102,689
                                  $1,221,967
[a] Table includes rounding error.  Savings shown in parentheses.

EXHIBIT 3

GENERATOR STANDARDS APPLICABLE TO LABORATORIES OWNED BY ELIGIBLE ACADEMIC ENTITIES [a]

ESTIMATED ANNUAL AGENCY HOUR AND COST BURDEN

                        Hours and Costs per Respondent
                             Total Hours and Costs

                                     Legal
                                    Manager
                                   Technical
                                   Clerical
                            Agency
Hours/ Activity
                             Labor
Cost/
Activity
                             Capital/
Startup
Cost
                            O&M
Cost/ Activity
                          Number of Agency Activities
                               Total Hours/
Year
                               Total
Cost/
Year
INFORMATION COLLECTION ACTIVITY
                                   $67.27/Hr
                                   $67.32/Hr
                                   $55.62/Hr
                                   $25.99/Hr

NOTIFICATION OF INTENT TO COMPLY WITH SUBPART K AND RECORDKEEPING OF AGREEMENTS (40 CFR 262.203)
Review and process Site Identification Forms
                                     0.00
                                     0.00
                                     0.25
                                     0.50
                                     0.75
                                    $26.90
                                     $0.00
                                     $0.00
                                      33
                                     24.75
                                    $887.70
Subtotal
                                     0.00
                                     0.00
                                     0.25
                                     0.50
                                     0.75
                                    $26.90
                                     $0.00
                                     $0.00
                                      33
                                     24.75
                                    $887.70
NOTIFICATION OF WITHDRAWAL FROM SUBPART K (40 CFR 262.204)
Review and process Site Identification Forms
                                     0.00
                                     0.00
                                     0.25
                                     0.50
                                     0.75
                                    $26.90
                                     $0.00
                                     $0.00
                                       0
                                     0.00
                                     $0.00
Subtotal
                                     0.00
                                     0.00
                                     0.25
                                     0.50
                                     0.75
                                    $26.90
                                     $0.00
                                     $0.00
                                       0
                                     0.00
                                     $0.00
TOTAL
                                     0.00
                                     0.00
                                    varies
                                    varies
                                    varies
                                    varies
                                    $0.00
                                    $0.00
                                    varies
                                     24.75
                                    $887.70
a  Exhibit contains rounding error.

	ATTACHMENT 1

	INFORMATION COLLECTION REQUEST 2317.02
	BURDEN ESTIMATE METHODOLOGY

                                 Introduction

	The Academic Laboratories Rule of 40 CFR part 262 subpart K, (also known as the "Labs Rule" or "Subpart K") allows eligible academic entities to opt into an alternative set of generator regulations in lieu of the standard set of RCRA generator regulations.  Opting into Subpart K entails some amount of burden for those choosing to opt in.  In accordance with the 1995 Paperwork Reduction Act (as amended), EPA must estimate respondent burden associated with all regulatory activities.  Once burden estimates are developed, EPA submits an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for approval.  This document describes the methodology for updated burden estimates for the renewal of the ICR covering the regulatory activities cited above.

	EPA consulted with six individuals about a total of eight different institutions:  seven institutions that have already chosen to opt into Subpart K and one institution that is in the planning stages of opting in.

                           Summary of Consultations

	Jeremy Kuhar<PHONE_NUMBER>) wears several hats at Gettysburg College; he is an instructor, Chemical Hygiene Officer, and Lab Coordinator.  He confirmed that Gettysburg College opted into Subpart K.  He indicated that although Gettysburg College probably qualifies as a conditionally exempt small quantity generator (CESQG), the school notified and operates as a RCRA small quantity generator (SQG), just to be on the safe side.  His institution has approximately 60 labs and a central accumulation area.  He estimates the labs at the school generate 80-100 containers of hazardous waste per year.  When he developed the school's laboratory management plan (LMP), he incorporated it into the school's chemical hygiene plan (CHP), a plan that is required by OSHA.  He estimates that developing both plans (and reading the Federal Register notice) took 100-150 hours.  His school has not conducted any "documented" laboratory clean-outs since he did not anticipate that it would affect the school's hazardous waste generator status.

	Aisha Holloman<PHONE_NUMBER>) is the Environmental Health & Safety Manager at Gateway University Research Park, a new non-profit research institute that opened in December 2011.  She confirmed that the research park is an SQG that has opted into Subpart K.  The research park has 15 labs and two central accumulation areas.  Given that the research park is so new, she does not have an estimate of the number of containers of hazardous waste that each lab generates per year and she has not had the need to conduct laboratory clean-outs.  She estimates that it took 60 hours to develop the LMP and the CHP together.

	Eric Engelberger<PHONE_NUMBER>) is the Safety Officer at Southern Arkansas University.  He confirmed that Souther Arkansas University has opted into Subpart K and that his school is a SQG.  His school has 21-22 labs and a central accumulation area.  He said that the laboratories do not generate containers of hazardous waste except during laboratory clean-outs.  He said that the Science Department is currently writing the LMP and incorporating it into the school's OSHA CHP.  He estimates that it will take 80 hours to develop the LMP and the CHP together.  His school has conducted laboratory clean-outs when they moved into a new science building.  Based on the amount of hazardous waste generated during the laboratory clean-out, the school would have become an LQG if it had not been operating under Subpart K, but it stayed an SQG.

	Jen Stones<PHONE_NUMBER>) is the Hazardous Materials Manager at the University of Utah.  She confirmed that her school is an LQG that has opted into Subpart K.  Her school has 800-900 labs and a central accumulations area.  She estimates that the laboratories generate 22-28 55-gallons drums of hazardous waste per month.  She developed the LMP as a separate document and estimates that it took 40 hours to write.  Her school has not conducted laboratory clean-outs.

	Craig Barnhart<EMAIL_ADDRESS>works at Butler University.  He confirmed that his school has opted into Subpart K and is an SQG.  The school has 65-70 laboratories and a central accumulation area.  He estimates that is laboratories generate 3500-4000 pounds of hazardous waste per year.  Working in tandem with another person, he estimates that it took 2-3 full working days to develop the LMP, which is a separate document.  His school has not conducted any laboratory clean-outs.

	Victoria Justus<PHONE_NUMBER>) is a consultant with WasteStrategies.  She works with colleges and universities, assisting them with their environmental compliance, which sometimes includes opting into Subpart K.  She discussed three institutions with us:  Milwaukee School of Engineering (MSOE), Lakewood College, and Philadelphia University (which is in the process of opting in).

      Victoria confirmed that MSOE opted into Subpart K for two sites  -  one is CESQG and one is an SQG.  The CESQG site has 9-10 labs and no central accumulation area while the SQG site has 50-65 laboratories and a central accumulation area.  The CESQG site generates 4-5 drums of hazardous waste per year, while the SQG site generates 400-450 containers per year (1 liter  -  5 gallon containers).  She developed one LMP for both MSOE sites as part of OSHA's CHP and estimates it took 100 hours.  MSOE has conducted laboratory clean-outs and would have become an LQG if it had not been operating under Subpart K; but remained CESQG and SQG.

      Victoria confirmed that Lakewood College opted into Subpart K and is an SQG.  The school has 20-25 labs and no central accumulation area.  The school's laboratories generate 150-200 containers of hazardous waste per year.  She does not have an estimate of the number of hours it took to develop the school's LMP.  The school has not conducted any laboratory clean-outs.

      Victoria informed us that Philadelphia University, an SQG, is in the process of opting into Subpart K.  The school has 40-45 laboratories, with 30 more opening over the next 2 years.  The school does not have a central accumulation area currently, but plans to establish one.  She estimates that the school's laboratories generate 12-15 drums and 300 containers of hazardous waste per year.  The school's LMP is currently under development and they have not yet conducted any laboratory clean-outs.

                              Estimates of Burden

	The estimates of burden associated with all regulatory activities identified in the Academic Laboratories ICR are updated based on the information obtained from the six consultations described above.  If no information was obtained or available on an activity, it was assumed that the burden information contained in the previous pertinent ICR (2317.01) did not change for that activity.  For this renewal, it was assumed that all LQGs have a central accumulation area because the waste quantities generated necessitate one and that no CESQGs have a central accumulation area, because the regulations do not provide for one.

	In several cases during the consultations, a range was given for the number of laboratories at an eligible academic entity.  In these cases, the average was taken to establish the number of laboratories.  Only one consultation was with an eligible academic entity that is an LQG.  It has a central accumulation area, and 850 laboratories, so it is a large LQG.  Seven sites are SQGs.  Five of the SQG sites have central accumulation areas, three of which have more than 50 laboratories, 2 of which of less than 50 laboratories.  Two of the SQG sites do not have central accumulation areas and both have fewer than 50 laboratories so they are considered small SQGs.  Only one of the sites consulted was a CESQG.  It did not have a central accumulation area and with only 10 laboratories, it is considered a small CESQG.  For categories of schools and hospitals not represented via consultations, the number of laboratories is assumed to be the same as in the previous pertinent ICR.

	When asked how many containers of hazardous waste are generated in the laboratories each year, respondents provided answers in ranges and in various units.  For example, the University of Utah said they generate 22-28 55-gallon drums per month.  To arrive at a number of containers when a range was given, the average was taken to establish the number of containers.  To convert 55-gallon drums to a number of containers per year, we assumed that the average container size for collecting hazardous waste in a laboratory is 1 gallon.  Therefore, each 55-gallon drum generated equates to 55 1-gallons containers. The consultant for MSOE also reported the volume of hazardous waste at the CESQG site in the number of 55-gallon drums it generates.  The same conversion was used for MSOE.  Butler University provided its estimate of hazardous waste in pounds.  To convert this to a number of containers, it was assumed that each 1-gallon container weighs 8 pounds (the approximate weight of a gallon of water).  Gateway University Research Park indicated that since the facility just opened in December 2011, it does not have an estimate of the number of containers of hazardous waste its laboratories generate, so this was excluded.  Southern Arkansas University stated that it does not routinely generate containers of hazardous waste except during laboratory clean-outs, so the number of containers per year is assumed to be zero.

	When calculating the average number of hours that it took an eligible academic entity to develop its LMP, the following assumptions were made.  If an answer was provided that was a range, an average was taken to establish the number of hours.  Butler University reported their answer in "working days."  It was assumed that a working day was eight hours.  If a respondent indicated that the LMP was developed as part of updating its OSHA CHP, the number of hours reported was divided by two; half the time was assumed to be taken to develop or update the CHP and half the time was assumed to be taken to develop the LMP.  Most respondents indicated that they wrote the LMP and management reviewed it.  It was assumed that the bulk of the time was spend writing the LMP (7/8 of the time) and a much small portion was spent reviewing it (1/8 of the time).  Jeremy Kuhar of Gettysburg College said that his time estimate included reading the Federal Register notice, so two hours was subtracted to account for this.  The number of hours for reviewing and making revisions to the LMP as well as making it available to others is assumed to be the same as in the previous pertinent ICR.

                                 ATTACHMENT 2

                       Summary of Universe Calculations

      The Academic Laboratories Rule (the "Labs Rule" or "Subpart K") was finalized in December 2008.  It is optional for eligible academic entities to use the Labs Rule in lieu of standard RCRA generator regulations.  Since the rule became effective, 39 eligible academic entities have opted into the rule, according to the data in Resource Conservation and Recovery Act Information (RCRAInfo) national database.  The generator status of each of the 39 facilities was also determined using data available in RCRAInfo.  Two of the eligible academic entities did not have a generator status listed in RCRAInfo.  These two were eliminated from the universe calculations.

Eligible Academic Entities (EAEs) Opting into Subpart K, cumulative by year

                                     Year
                          EAEs opting in (cumulative)
                                     2009
                                       1
                                     2010
                                      19
                                     2011
                                      28
                                     2012
                            37 (as of May 3, 2012)

Eligible Academic Entities (EAEs) Opting into Subpart K, by year:

                                     Year
                           EAEs opting in each year
                                     2009
                                       1
                                     2010
                                      18
                                     2011
                                       9
                                     2012
                             9 (as of May 3, 2012)
                        22 (projected for all of 2012)

Generator Status of Eligible Academic Entities (EAEs) that have Opted into Subpart K:

                               Generator Status
                                Number of EAEs
                             Percent of total EAEs
                                      LQG
                                      18
                                      49%
                                      SQG
                                      10
                                      27%
                                     CESQG
                                       9
                                      24%
                                     Total
                                      37
                                     100%

      Since the data are not complete for 2012, we must project how many schools will opt into Subpart K for the remainder of 2012.  If we project the same rate of adoption for the remainder of 2012, we should expect to see 13 more eligible academic entities opt in, for a total of 22 eligible academic entities opting in during 2012.

      Excluding 2009, since the rule was new and states were just beginning to adopt the Labs Rule, the average number of eligible academic entities that have opted in during the three year period of 2010-2012, is 16 per year.  If we project the same rate of adoption over the next three years (2013-2015), 49 new eligible academic entities will have adopted by the end of the next three year period.

      Adding the 49 new eligible academic entities to the projected 13 more for 2012, we estimate that there will be 62 new eligible academic entities using Subpart K.  If we add this to the existing 37 existing eligible academic entities already using the rule, we project a total of 99 eligible academic entities will have adopted by the end of the 2015.

      If we project that the 62 new eligible academic entities will have the same proportion of LQGs, SQGs, and CESQGs, then we would expect to see the following:

Generator Status of Eligible Academic Entities (EAEs) that Will Opt into Subpart K:

                               Generator Status
                         Projected Number of New EAEs
                        Projected Number of total EAEs
                                      LQG
                                      30
                                      48
                                      SQG
                                      17
                                      27
                                     CESQG
                                      15
                                      24
                                     Total
                                      62
                                      99

	When eligible academic entities opt into Subpart K they must notify as either a college/university (C/U), a non-profit research institute (NPRI), a teaching hospital, or any combination of the above.  Using data from RCRAInfo, the type of eligible academic entity was determined for each eligible academic entity that has opted into Subpart K.  Then the percentage of each type of eligible academic entity was calculated by generator status.  These same percentages were used to project the proportion of the types of eligible academic entities that will opt into Subpart K over the next three year period.  Eligible academic entities that notified as both a college/university and a teaching hospital were counted as college/universities since based on professional experience, the number of teaching and research laboratories at that part of the institution usually outnumber those found at the teaching hospital.  This information was used to update Table 1 of the Supporting Statement for the ICR renewal.


[Federal Register Volume 85, Number 180 (Wednesday, September 16, 2020)]
[Rules and Regulations]
[Pages 57696-57698]
[FR Doc No: 2020-17790]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R08-OAR-2020-0110; FRL-10013-30-Region 8]

Approval and Promulgation of Air Quality Implementation Plans;
Colorado; Revisions to Air Pollution Emission Notice Rules

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: In accordance with section 110 of the Clean Air Act (CAA), the
Environmental Protection Agency (EPA) is taking final action to approve
State Implementation Plan (SIP) revisions submitted by the State of
Colorado on May 8, 2019. The EPA is taking final action to approve
amendments to the State's Stationary Source Permitting and Air
Pollution Emission Notice Requirements. The EPA is taking this action
pursuant to sections 110 of the CAA.

DATES: This final rule is effective on October 16, 2020.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R08-OAR-2020-0110. All documents in the docket are
listed on the http://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
confidential business information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available through http://www.regulations.gov, or please
contact the person identified in the FOR FURHTER INFORMATION CONTACT
section for additional availability information.

FOR FURTHER INFORMATION CONTACT: Kevin Leone, Air and Radiation
Division, EPA, Region 8, Mailcode 8ARD-IO, 1595 Wynkoop Street, Denver,
Colorado 80202-1129,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' means the EPA.

I. Background

    The EPA is taking final action to approve all SIP revisions
submitted by the State of Colorado on May 8, 2019. The SIP revisions
that we are acting on contain amendments to 5 CCR 1001-5, Regulation
Number 3 (Stationary Source Permitting and Air Pollution Emission
Notice Requirements). In particular, these amendments would revise Part
A, VI.C. (Annual Emissions Fees) and VI.D. (Fee Schedule). The State
adopted these revisions on October 18, 2018, and they became state
effective on November 30, 2018. We are taking final action to approve
of all revisions submitted on May 8, 2019.
    The EPA published a proposed rulemaking on June 5, 2020 (85 FR
34559), which contains a detailed summary of the SIP revisions in
question and an explanation of the bases for our proposed approval. We
invited comment on all aspects of our proposal, and provided a 30-day
comment period, which ended on July 6, 2020.

II. Response to Comments

    We received no comments during the public comment period.

III. Final Action

    As outlined in our proposed rulemaking, EPA is taking final action
to approve the addition of new and revised rules to Regulation Number
3, Part A, Section VI.C: VI.C.2; Section VI.D: VI.D.1, VI.D.2, and
VI.D.3 as submitted on May 8, 2019.

IV. Incorporation by Reference

    In this document, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of the State of
Colorado's revisions to its SIP as described in section III. of this
preamble. The EPA has made, and will continue to make, these materials
generally available through www.regulations.gov and at the EPA Region 8
Office (please contact the person identified in the FOR FURTHER
INFORMATION CONTACT section of this preamble for more information).
Therefore, these materials have been approved by EPA for inclusion in
the SIP, have been incorporated by reference by the EPA into that plan,
are fully federally enforceable under sections 110 and 113 of the CAA
as of the effective date of the final rulemaking of EPA's approval, and
will be incorporated by reference in the next update to the SIP
compilation.\1\
---------------------------------------------------------------------------

    \1\ 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

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 Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the 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 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, 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, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    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).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by November 16, 2020. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(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, Volatile
organic compounds.

    Dated: August 10, 2020.
Gregory Sopkin,
Regional Administrator, Region 8.

    For the reasons stated in the preamble, the EPA amends 40 CFR part
52 as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart G--Colorado

0
2. In Sec.  52.320, the table in paragraph (c) is amended by revising
the entry ``VI. Fees'' under the heading ``5 CCR 1001-05, Regulation
Number 3, Part A, Concerning General Provisions Applicable to Reporting
and Permitting'' to read as follows:

Sec.  52.320  Identification of plan.

* * * * *
    (c) * * *

----------------------------------------------------------------------------------------------------------------
                                        State       EPA effective
              Title                effective date       date       Final rule citation/date        Comments
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
5 CCR 1001-05, Regulation Number 3, Part A, Concerning General Provisions Applicable to Reporting and Permitting
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
VI. Fees.........................      11/30/2018      10/16/2020  [insert Federal Register  ...................
                                                                    citation], 9/16/2020.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2020-17790 Filed 9-15-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 227 (Wednesday, November 25, 2015)]
[Notices]
[Pages 73756-73758]
[FR Doc No: 2015-29918]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL 9939-27-OA]

Announcement of the Board of Directors for the National
Environmental Education Foundation

AGENCY: Office of External Affairs and Environmental Education,
Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The National Environmental Education and Training Foundation
(doing business as The National Environmental Education Foundation or
NEEF) was created by Section 10 of Public Law 101-619, the National
Environmental Education Act of 1990. It is a private 501(c)(3) non-
profit organization established to promote and support education and
training as necessary tools to further environmental protection and
sustainable,

environmentally sound development. It provides the common ground upon
which leaders from business and industry, all levels of government,
public interest groups, and others can work cooperatively to expand the
reach of environmental education and training programs beyond the
traditional classroom. The Foundation promotes innovative environmental
education and training programs such as environmental education for
medical healthcare providers and broadcast meteorologists; it also
develops partnerships with government and other organizations to
administer projects that promote the development of an environmentally
literal public. The Administrator of the U.S. Environmental Protection
Agency, as required by the terms of the Act, announces the following
appointment to the National Environmental Education Foundation Board of
Directors. The appointee is Mr. Robert Garcia, is a civil rights
advocate who engages, educates, and empowers communities for equal
access to public resources.

FOR FURTHER INFORMATION CONTACT: For information regarding this Notice
of Appointment, please contact Mr. Micah Ragland, Associate
Administrator for Office of Public Engagement and Environmental
Education, U.S. EPA 1200 Pennsylvania Ave. NW., Washington, DC 20460.
General information concerning NEEF can be found on their Web site at:
http://www.neefusa.org.

SUPPLEMENTARY INFORMATION:
    Additional Considerations: Great care has been taken to assure that
this new appointee not only has the highest degree of expertise and
commitment, but also brings to the Board diverse points of view
relating to environmental education. This appointment is a four-year
term which may be renewed once for an additional four years pending
successful re-election by the NEEF nominating committee.
    This appointee will join the current Board members which include:
     Decker Anstrom (NEEF Chairman), Former U.S. Ambassador,
Retired Chairman, The Weather Channel Companies
     Diane Wood (NEEF Secretary) President, National
Environmental Education Foundation
     Carlos Alcazar, Founder and Chairman, Culture ONE World
     Megan Reilly Cayten, Co-Founder and Chief Executive
Officer, Catrinka, LLC
     David M. Kiser (NEEF Treasurer), Vice President,
Environment, Health, Safety and Sustainability, International Paper
     Wonya Lucas, President and CEO, Public Broadcasting
Atlanta
     Shannon Schuyler, Principal, Corporate Responsibility
Leader, PricewaterhouseCoopers (PwC)
     Jacqueline M. Thomas, Vice President of Corporate
Responsibility, Toyota Motor Sales USA Inc.
     Raul Perea-Henze, MD, MPH, Managing Director, HORUS
Advisors, Washington, DC
     George Basile, Ph.D., Professor, School of Sustainability,
Arizona State University, Tempe, AZ
     Jennifer Harper-Taylor, Siemens Foundation (in process)
    Background: Section 10 (a) of the National Environmental Education
Act of 1990 mandates a National Environmental Education Foundation. The
Foundation is established in order to extend the contribution of
environmental education and training to meeting critical environmental
protection needs, both in this country and internationally; to
facilitate the cooperation, coordination, and contribution of public
and private resources to create an environmentally advanced educational
system; and to foster an open and effective partnership among Federal,
State, and local government, business, industry, academic institutions,
community based environmental groups, and international organizations.
    The Foundation is a charitable and nonprofit corporation whose
income is exempt from tax, and donations to which are tax deductible to
the same extent as those organizations listed pursuant to section
501(c) of the Internal Revenue Code of 1986. The Foundation is not an
agency or establishment of the United States. The purposes of the
Foundation are--
    (A) subject to the limitation contained in the final sentence of
subsection (d) herein, to encourage, accept, leverage, and administer
private gifts for the benefit of, or in connection with, the
environmental education and training activities and services of the
United States Environmental Protection Agency;
    (B) to conduct such other environmental education activities as
will further the development of an environmentally conscious and
responsible public, a well-trained and environmentally literate
workforce, and an environmentally advanced educational system;
    (C) to participate with foreign entities and individuals in the
conduct and coordination of activities that will further opportunities
for environmental education and training to address environmental
issues and problems involving the United States and Canada or Mexico.
    The Foundation develops, supports, and/or operates programs and
projects to educate and train educational and environmental
professionals, and to assist them in the development and delivery of
environmental education and training programs and studies.
    The Foundation has a governing Board of Directors (hereafter
referred to in this section as `the Board'), which consists of 13
directors, each of whom shall be knowledgeable or experienced in the
environment, education and/or training. The Board oversees the
activities of the Foundation and assures that the activities of the
Foundation are consistent with the environmental and education goals
and policies of the Environmental Protection Agency and with the
intents and purposes of the Act. The membership of the Board, to the
extent practicable, represents diverse points of view relating to
environmental education and training. Members of the Board are
appointed by the Administrator of the Environmental Protection Agency.
    Within 90 days of the date of the enactment of the National
Environmental Education Act, and as appropriate thereafter, the
Administrator will publish in the Federal Register an announcement of
appointments of Directors of the Board. Such appointments become final
and effective 90 days after publication in the Federal Register. The
directors are appointed for terms of 4 years. The Administrator shall
appoint an individual to serve as a director in the event of a vacancy
on the Board within 60 days of said vacancy in the manner in which the
original appointment was made. No individual may serve more than 2
consecutive terms as a director.

    Dated: November 10, 2015.
Gina McCarthy,
Administrator.

Mr. Robert Garcia

    Mr. Robert Garcia, is the Founding Director and Counsel of The City
Project, a non-profit legal and policy advocacy team in Los Angeles,
California. The City Project works with diverse allies on equal access
to (1) healthy green land use through community planning; (2) climate
justice; (3) quality education including physical education; (4) health
equity; and (5) economic vitality for all, including creating jobs and
avoiding displacement. He received the President's Award from the
American

Public Health Association. PODER Magazine named him one of the Top 100
Latino Green Leaders. Hispanic Business Magazine has recognized him as
one of the 100 most influential Latinos in the United States. Green 2.0
celebrates his work as an accomplished leader of color in the
environmental field. Robert graduated from Stanford University and
Stanford Law School, where he served on the Board of Editors of the
Stanford Law Review. He is an Assistant Professor at Charles Drew
University of Medicine and Science.
    President Barack Obama and federal agencies are catapulting The
City Project's work on green access to the national level. As the
President recognized in dedicating the San Gabriel Mountains National
Monument, ``Too many children . . . especially children of color, don't
have access to parks where they can run free, breathe fresh air,
experience nature, and learn about their environment. This is an issue
of social justice.'' Conservation isn't about locking away our natural
treasures. ``It's about working with communities to open up our
glorious heritage to everybody--young and old, black, white, Latino,
Asian, Native American--to make sure everybody can experience these
incredible gifts.''
    The National Park Service and the US Army Corps of Engineers agree.
Their studies on green access and the Santa Monica Mountains, the San
Gabriel Mountains, and the Los Angeles River rely on The City Project's
analyses to document that there are disparities in access to green
space for people of color and low-income people in Los Angeles, that
these disparities contribute to health disparities, and that
environmental justice requires agencies to address these disparities.
The City Project worked with Ranking Member Raul Grijalva and the House
Natural Resources Committee to organize the historic forum on
environmental justice, climate, and health. The forum included seven
Members of Congress and community advocates at the L.A. River Center in
2015.
    He has extensive experience in public policy, legal advocacy,
mediation, and litigation involving complex social justice, civil
rights, human health, environmental, education, and criminal justice
matters. He has influenced the investment of over $43 billion in
underserved communities, working at the intersection of equal justice,
public health, and the built environment. He served as chairman of the
Citizens' School Bond Oversight Committee for five years, helping raise
over $27 billion to build new, and modernize existing, public schools
as centers of their communities in Los Angeles. He has helped
communities create and preserve great urban parks and preserve access
to beaches and trails. He has helped diversify support for and access
to state resource bonds, with unprecedented levels of support among
communities of color and low-income communities, and billions of
dollars for urban parks. He served on the Development Team for the
National Park Service Healthy Parks, Healthy People Community
Engagement eGuide. He served on Cardinal Roger Mahony's Justice and
Peace Committee for the Archdiocese of Los Angeles.
    He served as an Assistant United States Attorney for the Southern
District of New York, and an attorney with the NAACP Legal Defense &
Education Fund. He received the President's Award from the California
Attorneys for Criminal Justice for helping release Geronimo Pratt, the
former Black Panther leader, from prison after 27 years for a crime he
did not commit. He represented people on Death Row in Georgia, Florida,
and Mississippi. Stanford Law School called him a ``civil rights
giant'' and Stanford Magazine ``an inspiration.'' He is an immigrant
who came to the U.S. from Guatemala at age four.
    He has lectured widely on the vision for healthy parks, schools,
and communities. Recent keynote speeches include conferences at the
National Recreation and Park Association (NRPA), Johns Hopkins
Bloomberg School of Public Health, U.S. Environmental Protection Agency
New Partners for Smart Growth, and Smithsonian Anacostia Community
Museum. Other presentations include Stanford, Yale, Duke, Harvard Law
School, Howard, UCLA, USC, Dalhousie University in Nova Scotia, Canada,
FLAC in Dublin, Ireland, Centers for Disease Control (CDC), and
National Council of La Raza (NCLR). The City Project [is] working to
broaden access to parks and open space for inner-city residents and . .
. to fight childhood obesity by guaranteeing that . . . students get
enough physical education.''--New York Times.
[FR Doc. 2015-29918 Filed 11-24-15; 8:45 am]
BILLING CODE 6560-50-P