[Federal Register Volume 77, Number 213 (Friday, November 2, 2012)]
[Notices]
[Page 66183]
[FR Doc No: 2012-26876]

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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9005-8]

Environmental Impacts Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or http://www.epa.gov/compliance/nepa/.

Weekly receipt of Environmental Impact Statements
Filed 10/22/2012 Through 10/26/2012

    Pursuant to 40 CFR 1506.9.
    Notice: Section 309(a) of the Clean Air Act requires that EPA make
public its comments on EISs issued by other Federal agencies. EPA's
comment letters on EISs are available at: http://www.epa.gov/compliance/nepa/eisdata.html.

SUPPLEMENTARY INFORMATION:  As of October 1, 2012, EPA will not accept
paper copies or CDs of EISs for filing purposes; all submissions on or
after October 1, 2012 must be made through e-NEPA.
    While this system eliminates the need to submit paper or CD copies
to EPA to meet filing requirements, electronic submission does not
change requirements for distribution of EISs for public review and
comment. To begin using e-NEPA, you must first register with EPA's
electronic reporting site--https://cdx.epa.gov/epa_home.asp.

EIS No. 20120344, Final EIS, BLM, AZ, Restoration Design Energy
Project, Proposed Resource Management Plan Amendments, Identifying
Lands Across Arizona Suitable for Renewable Energy Development, AZ,
Review Period Ends: 12/03/2012, Contact: Kathryn Pedrick<PHONE_NUMBER>.
EIS No. 20120345, Revised Draft EIS, USFS, ID, Lower Orogrande Project,
Analysis of Three Alternatives, North Fork Ranger District, Clearwater
National Forest, Clearwater County, ID, Comment Period Ends: 12/17/
2012, Contact: Kathy Rodriguez<PHONE_NUMBER>.
EIS No. 20120346, Final EIS, USFS, CA, Two Bit Vegetation Management
Project, Happy Camp Ranger District, Klamath National Forest, Siskiyou
County, CA, Review Period Ends: 12/17/2012, Contact: Wendy Coats 530-
841-4470
EIS No. 20120347, Draft EIS, USFS, OR, Summit Logan Valley Grazing
Authorization Project, Prairie City Ranger District, Malheur National
Forest, Grant County, OR, Comment Period Ends: 12/17/2012, Contact:
Randy Gould<PHONE_NUMBER>.
EIS No. 20120348, Draft EIS, USFS, AZ, Show Low South Land Exchange,
Apache-Sitgreaves National Forests, Coconino National Forest, and
Prescott National Forest, Yavapai, Navajo, Greenlee, and Apache
Counties, AZ, Comment Period Ends: 12/17/2012, Contact: Stephen James
928-333-6266.
EIS No. 20120349, Draft EIS, FHWA, VA, Interstate 64 Peninsula, from
Interstate 95 in the City of Richmond to Interstate 664 in the City of
Hampton, VA, Comment Period Ends: 01/07/2013, Contact: John Simkins
804-371-6831.
EIS No. 20120350, Final EIS, BLM, CA, Desert Harvest Solar Project,
Construction, Operation, Maintenance, and Decommissioning of an 150-
megawatt Photovoltaic Solar Energy Facility and Generation-Intertie
Transmission Line, Consideration of Issuance of a Right-of-Way Grant,
Riverside County, CA, Review Period Ends: 12/03/2012, Contact: Frank
McMenimen<PHONE_NUMBER>.
EIS No. 20120351, Final EIS, VCT, NM, Valles Caldera National Preserve
Public Access and Use Plan, Sandoval and Rio Arriba Counties, NM,
Review Period Ends: 12/05/2012, Contact: Marie Rodriguez<PHONE_NUMBER>.

    Dated: October 29, 2012.
Dawn R. Roberts,
Management Analyst, NEPA Compliance Division, Office of Federal
Activities.
[FR Doc. 2012-26876 Filed 11-1-12; 8:45 am]
BILLING CODE 6560-50-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

 National Vehicle and Fuel Emissions Laboratory

                              2565 Plymouth Road

                    Ann Arbor, Michigan 48105-2498

											OFFICE OF

										      AIR AND RADIATION

September 29, 2008

MEMORANDUM

FROM:  	Todd Sherwood

Assessment and Standards Division, US EPA

TO:	   	Docket ID No. EPA-HQ-OAR-2005-0047

SUBJECT:	HDOBD Meetings with Caterpillar

Meeting Date

EPA staff met with representatives of Caterpillar on April 28, 2008.

EPA Attendees

EPA staff in attendance at the meeting were:

Todd Sherwood

Brian Nelson

Caterpillar Attendees

Caterpillar representatives in attendance at the meeting were:

George Lin

Gordon Gerber

Lonny Johnson

Brian Mann

Thomas Crowell

Mike Mikos

Chris Reiser

Vinod Polina

Vipul Patel

Topics Discussed

Topics discussed at this meeting were:

Status of EPA’s final rule

Status of development of Caterpillar’s HDOBD monitors

Meeting Date

EPA staff met with representatives of Caterpillar on June 10, 2008.

EPA Attendees

EPA staff in attendance at the meeting were:

Todd Sherwood

Anthony Neam

Hugh Harris

Jason Gumbs

Caterpillar Attendees

Caterpillar representatives in attendance at the meeting were:

George Lin

Anthony Rodman

Yanchai Zhang

Vinod Polina

David Kapparos

Topics Discussed

Topics discussed at this meeting were:

Status of development of Caterpillar’s HDOBD monitors, in particular, the DPF monitor trapping efficiency and NMHC conversion efficiency.

 Some of these attendees may be contract employees and not actual Caterpillar employees.

 Some of these attendees may be contract employees and not actual Caterpillar employees.

Page   PAGE  1  of   NUMPAGES  2


[Federal Register Volume 86, Number 225 (Friday, November 26, 2021)]
[Proposed Rules]
[Pages 67424-67426]
[FR Doc No: 2021-25590]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 194

[EPA-HQ-OAR-2019-5304; FRL-9213-01-OAR]

Notification of Completeness of the Department of Energy's
Compliance Recertification Application for the Waste Isolation Pilot
Plant

AGENCY: Environmental Protection Agency (EPA).

ACTION: Plant 2019 Compliance Recertification Application is complete;
end of comment period concerning the 2019 Compliance Recertification
Application.

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SUMMARY: The Environmental Protection Agency (EPA or the Agency) has
determined that the Department of Energy (DOE) 2019 Compliance
Recertification Application (CRA) for the Waste Isolation Pilot Plant
(WIPP) is complete. The EPA provided written notice of the completeness
decision to the Department of Energy on November 17, 2021.The Agency
has determined that the CRA is complete, in accordance with the,
``Criteria for the Certification and Recertification of the WIPP's
Compliance with the Disposal Regulations'' (Compliance Certification
Criteria). The EPA also gives notice of the end of the comment period
relating to the CRA.

DATES: The EPA opened the public comment period after receipt of some
documentation of continued compliance and before the completeness
determination concerning the CRA and gave notice that the comment
period would remain open until after the completeness determination to
a date which would be specified later (84 FR 50367, September 25,
2019). Comments must be received on or before December 27, 2021.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2019-5304, to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or withdrawn. The
EPA may publish any comment received to its public docket. Do not
submit electronically any information you consider to be Confidential
Business Information (CBI), or other information of which disclosure is
restricted by statute. Multimedia submissions (audio, video, etc.) must
be accompanied by a written comment. The written comment is considered
the official comment and should include discussion of all points

you wish to make. The EPA will generally not consider comments or
comment contents located outside of the primary submission (i.e., on
the web, cloud, or other file sharing system). For additional
submission methods, the full EPA public comment policy, information
about CBI or multimedia submissions, and general guidance on making
effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets. The EPA is temporarily suspending its Docket
Center and Reading Room for public visitors, with limited exceptions,
to reduce the risk of transmitting COVID-19. Our Docket Center staff
will continue to provide remote customer service via email, phone, and
webform. We encourage the public to submit comments via https://www.regulations.gov or email, as there may be a delay in processing
mail and faxes. Hand deliveries and couriers may be received by
scheduled appointment only. For further information on EPA Docket
Center services and the current status, please visit us online at
https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Ray Lee, Radiation Protection
Division, Center for Radiation Information and Outreach, Mail Code
6608T, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number: 202-
343-2305; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to the EPA
through www.regulations.gov or email. Clearly mark the part or all of
the information that you claim to be CBI. For CBI information in a disk
or CD ROM that you mail to the EPA, mark the outside of the disk or CD
ROM as CBI and then identify electronically within the disk or CD ROM
the specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.

II. Background

    The WIPP is a disposal system for transuranic (TRU) radioactive
waste. The WIPP Land Withdrawal Act, Public Law 102-579 (Oct. 30, 1972)
\1\ (LWA) imposed various conditions or restrictions on the WIPP,
including limiting radioactive waste disposal in the WIPP to TRU
radioactive wastes generated by defense-related activities. The waste
proposed for disposal at the WIPP derives from federal facilities
across the United States, including locations in California, Colorado,
Idaho, New Mexico, Nevada, Ohio, South Carolina, Tennessee and
Washington. The LWA also provides that the DOE will submit information
to the EPA to determine whether the WIPP complies with the Agency's
final disposal regulations, 40 CFR part 191, subparts B and C (Disposal
Regulations). This includes an initial determination or certification
of compliance, and then subsequent, periodic recertifications of
continued compliance. LWA Sec.  8. Under the LWA, the periodic
recertifications occur on a five-year cycle, beginning five years after
the initial receipt of transuranic waste for disposal at the WIPP. LWA
Sec.  8(f)(1). The EPA promulgated the Compliance Certification
Criteria to set out criteria for the certification and recertification
of the WIPP's compliance with the Disposal Regulations. Among the
criteria is the requirement that information submitted by the DOE shall
be complete and accurate and a preliminary step for the EPA to
determine and notify DOE, in writing, that a complete recertification
application has been received. 40 CFR 194.11. The completeness
determination is an administrative step; it does not imply in any way
that the CRA demonstrates compliance with the Compliance Certification
Criteria or the disposal regulations. The EPA is now engaged in the
final technical review that will determine if the WIPP remains in
compliance with the disposal regulations.
---------------------------------------------------------------------------

    \1\ The 1992 WIPP Land Withdrawal Act was amended by the ``Waste
Isolation Pilot Plant Land Withdrawal Act Amendments,'' a part of
the National Defense Authorization Act for Fiscal Year 1997. Public
Law 104-201, Title 31, Subtitle F (Sept. 23, 1996).
---------------------------------------------------------------------------

    The DOE submitted its first documentation of continued compliance
and request for recertification of the WIPP, typically referred to as a
compliance recertification application, in March 2004. The DOE
submitted the second compliance recertification application in March
2009 and the third in March 2014. In March 2019, the DOE submitted the
CRA, its fourth, and currently pending compliance recertification
application. In September 2019, after receipt of the CRA, the EPA gave
notice of receipt of the CRA and requested comment on all aspects of
the application. 84 FR 50367 (Sept. 25, 2019). The Agency indicated
that the comment period would remain open until a date after the EPA's
completeness determination in accordance with Sec.  194.11, a date that
EPA would specify in a subsequent notice.\2\
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    \2\ For additional background information concerning the WIPP,
the LWA, and periodic compliance recertification, see the September
25, 2019 notice of receipt and availability of the CRA and opening
of the comment period. 84 FR 50367.
---------------------------------------------------------------------------

    After receiving the CRA, the EPA engaged in a preliminary review of
the information submitted for completeness. The Agency's review
identified multiple topics for which additional information was
necessary to perform a technical evaluation. The EPA sent a series of
letters to the DOE requesting additional information, and the
Department provided documents and analyses in response to these
requests. This completeness-related correspondence--along with other
supporting documentation--is available in the Agency's public dockets
(https://www.regulations.gov; Docket ID: EPA-HQ-OAR-2019-5304). Links
to the electronic docket and additional information are also available
at the EPA's WIPP website (https://www.epa.gov/radiation/certification-and-recertification-wipp).

    In addition, since the opening of the public comment period on the
2019 CRA, the Agency has received 12 sets of public comments regarding
the application and the recertification process in general. In addition
to soliciting written public comments, the EPA held a virtual, informal
public meeting in August 2021 to discuss stakeholders' concerns and
issues related to recertification. All submitted public comments can
also be referenced via https://www.regulations.gov; Docket ID: EPA-HQ-
OAR-2019-5304.
    In a letter dated November 17, 2021, from the EPA's Director of the
Office of Radiation and Indoor Air to the Assistant Secretary of the
Office of Environmental Management, Department of Energy, the Agency
notified the DOE that the CRA for the WIPP is complete. This letter can
be referenced via https://www.regulations.gov; Docket ID: EPA-HQ-OAR-
2019-5304. This determination is solely an administrative measure and
does not reflect any conclusion regarding the WIPP's continued
compliance with the disposal regulations.
    The EPA will now undertake a full technical evaluation of the
complete 2019 CRA to determine whether the WIPP continues to comply
with the Disposal Regulations. The Agency will consider relevant public
comments and other information relevant to the WIPP's compliance. The
Agency is most interested in whether new or changed information has
been appropriately incorporated into the performance assessment
calculations for the WIPP and whether the potential long-term effects
of changes are properly characterized.
    If the Agency approves the CRA, it will then serve as the baseline
for the next recertification. As required by the WIPP LWA, the EPA will
make a final recertification decision within six months of issuing the
completeness determination letter to the Secretary of Energy. In
accordance with the Compliance Certification Criteria, the Agency will
seek to publish notice of EPA's recertification decision. 40 CFR
194.64.

Jonathan D. Edwards,
Director, Office of Radiation and Indoor Air.
[FR Doc. 2021-25590 Filed 11-24-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 134 (Thursday, July 12, 2018)]
[Notices]
[Pages 32303-32305]
[FR Doc No: 2018-14871]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2258]

Human Gene Therapy for Rare Diseases; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft document entitled ``Human Gene Therapy for
Rare Diseases; Draft Guidance for Industry.'' The draft guidance
document provides recommendations to stakeholders developing a human
gene therapy (GT) product intended to treat a rare disease in adult
and/or pediatric patients regarding the manufacturing, preclinical, and
clinical trial design issues for all phases of the clinical development
program. Such information is intended to assist sponsors in designing
clinical development programs for such products, where there may be
limited study population size and potential feasibility and safety
issues as well as issues relating to the interpretability of
bioactivity/efficacy outcomes that may be unique to rare diseases or to
the nature of the GT product itself.

DATES: Submit either electronic or written comments on the draft
guidance by October 10, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the

instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for Written/Paper
Submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment as well as any
attachments, except for information submitted, marked, and identified
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-2258 for ``Human Gene Therapy for Rare Diseases; Draft
Guidance for Industry.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies, total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments, and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist the office in
processing your requests. The draft guidance may also be obtained by
mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.

FOR FURTHER INFORMATION CONTACT: Jonathan McKnight, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    The Orphan Drug Act of 1983 (Pub. L. 97-414) defines a rare disease
as a disease or condition that affects fewer than 200,000 persons in
the United States. Since most rare diseases have no approved therapies,
there is a significant unmet need for effective treatments. However,
developing safe and effective products to treat rare diseases can be
challenging. For example, it may be more difficult to find and recruit
such patients into clinical trials, and many rare diseases exhibit a
number of variations or subtypes. Consequently, patients may have
highly diverse clinical manifestations and rates of disease progression
with unpredictable clinical courses. Despite these challenges, GT-
related research and development continue to grow at a rapid rate, with
several products advancing in clinical development.
    FDA is announcing the availability of a document entitled ``Human
Gene Therapy for Rare Diseases; Draft Guidance for Industry.'' The
draft guidance provides recommendations to stakeholders developing a GT
product intended to treat a rare disease in adult and/or pediatric
patients regarding the manufacturing, preclinical, and clinical trial
design issues for all phases of the clinical development program. Such
information is intended to assist sponsors in designing clinical
development programs for such products, where there may be limited
study population size and potential feasibility and safety issues as
well as issues relating to the interpretability of bioactivity/efficacy
outcomes that may be unique to rare diseases or to the nature of the GT
product itself.
    Elsewhere in this issue of the Federal Register, FDA is announcing
the availability of two other human gene therapy draft guidance
documents entitled ``Human Gene Therapy for Hemophilia; Draft Guidance
for Industry'' and ``Human Gene Therapy for Retinal Disorders; Draft
Guidance for Industry.''
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Human Gene
Therapy for Rare Diseases.'' It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations. This guidance is not subject to Executive
Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information subject to review by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
The collections of information in 21 CFR part 50 have been approved
under OMB control number 0910-0755; the

collections of information in 21 CFR part 58 have been approved under
OMB control number 0910-0119; the collections of information in 21 CFR
part 312 have been approved under OMB control number 0910-0014; the
collections of information in 21 CFR part 601 have been approved under
OMB control number 0910-0338; the collections of information in the
guidance entitled ``Expedited Programs for Serious Conditions--Drugs
and Biologics'' have been approved under OMB control number 0910-0765;
and the collections of information in the guidance entitled ``Formal
Meetings Between the FDA and Sponsors or Applicants'' have been
approved under OMB control number 0910-0429.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: July 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14871 Filed 7-11-18; 8:45 am]
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