[Federal Register Volume 85, Number 110 (Monday, June 8, 2020)]
[Notices]
[Pages 34736-34739]
[FR Doc No: 2020-12317]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0128]

Reauthorization of the Prescription Drug User Fee Act; Public
Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is hosting a
virtual public meeting to discuss proposed recommendations for the
reauthorization of the Prescription Drug User Fee Act (PDUFA) for
fiscal years (FYs) 2023 through 2027. PDUFA authorizes FDA to collect
user fees to support the process for the review of human drug
applications. The current legislative authority for PDUFA expires in
September 2022. At that time, new legislation will be required for FDA
to continue collecting prescription drug user fees in future fiscal
years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) directs that
FDA begin the PDUFA reauthorization process by publishing a notice in
the Federal Register requesting public input and holding a public
meeting where the public may present its views on the reauthorization.
FDA invites public comment as the Agency begins the process to
reauthorize the program in FYs 2023 through 2027. These comments will
be published and available on FDA's website.

DATES: The public meeting will be held on July 23, 2020, from 9 a.m. to
2 p.m., and will take place virtually and will be held by webcast only.
Submit either electronic or written comments on this public meeting by
August 23, 2020.

ADDRESSES: Registration to attend the meeting and other information can
be found at https://pdufavii-publicmeeting.eventbrite.com. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before August 23, 2020. The

https://www.regulations.gov electronic filing system will accept
comments until 11:59 p.m. Eastern Time at the end of August 23, 2020.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.

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-2010-N-0128 for ``Reauthorization of the Prescription Drug User Fee
Act; Public Meeting; Request for Comments.'' Received comments, those
filed in a timely manner (see ADDRESSES), 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.govinfo.gov/content/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,<PHONE_NUMBER>. Transcripts of the meeting
will be available on the FDA website at: https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee approximately 30 days
after the meeting.

FOR FURTHER INFORMATION CONTACT: Patrick Zhou, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1148, Silver Spring, MD 20993-0002, 301-
348-1817<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a virtual public meeting to begin the
reauthorization process of PDUFA, the legislation that authorizes FDA
to collect user fees to support the process for the review of human
drugs, including various components in FDA including the Center for
Drug Evaluation and Research (CDER), the Center for Biologics
Evaluation and Research (CBER), the Office of the Commissioner (OC),
and the Office of Regulatory Affairs (ORA). The current authorization
of the program (PDUFA VI) expires in September 2022. Without new
legislation, FDA will no longer be able to collect user fees for future
fiscal years to fund the human drug review process. Section 736B(f)(2)
of the FD&C Act (21 U.S.C. 379h-2(f)(2)) requires that before FDA
begins negotiations with the regulated industry on PDUFA
reauthorization, the Agency performs the following: (1) Publish a
notice in the Federal Register requesting public input on the
reauthorization; (2) hold a public meeting where the public may present
its views on the reauthorization; (3) provide a period of 30 days after
the public meeting to obtain written comments from the public; and (4)
publish the comments at https://www.fda.gov. This notice, the public
meeting, the 30-day comment period after the meeting, and the posting
of the comments on the FDA website will satisfy these requirements. The
purpose of the meeting is to hear stakeholder views on PDUFA as we
consider the features to propose, update, and discontinue in the next
PDUFA. FDA is interested in responses to the following three questions
and welcomes any other pertinent information stakeholders would like to
share:
     What is your assessment of the overall performance of
PDUFA VI thus far?
     What current features of PDUFA should be reduced or
discontinued to ensure the continued efficiency and effectiveness of
the human drug review process?
     What new features should FDA consider adding to the
program to enhance the efficiency and effectiveness of the human drug
review process?

II. What is PDUFA? What does it do?

    The following information is provided to help potential meeting
participants better understand the history and evolution of PDUFA and
its status. The Prescription Drug User Fee Act (PDUFA) is a law that
authorizes FDA to collect fees from drug companies that submit
marketing applications for certain human drug and biological products.
PDUFA was originally enacted in 1992 as the Prescription Drug User Fee
Act (Pub. L. 102-571) for a period of 5 years.

    In 1997, Congress passed the Food and Drug Administration
Modernization Act of 1997 (FDAMA, Pub. L. 105-115), which renewed the
program (PDUFA II) for an additional 5 years. Congress extended PDUFA
again for another 5 years (PDUFA III), through FY 2007, in the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002
(Pub. L. 107-188). In 2007, Title I of the Food and Drug Administration
Amendments Act of 2007 (FDAAA, Pub. L. 110-85) reauthorized PDUFA
through FY 2012 (PDUFA IV, Pub. L. 112-144) and in 2012 the Food and
Drug Administration Safety and Innovation Act (FDASIA) reauthorized the
law again through FY 2017 (PDUFA V). PDUFA was most recently renewed in
2017 under Title I of the FDA Reauthorization Act of 2017 (FDARA) which
lasts through FY 2022 (PDUFA VI).
    PDUFA's intent is to provide additional revenues so that FDA can
hire more staff, improve systems, and establish a better managed human
drug review process to make important therapies available to patients
sooner without compromising review quality or FDA's high standards for
safety, efficacy, and quality. As part of FDA's negotiated agreement
with industry during each reauthorization, the Agency agrees to certain
performance and procedural goals and other commitments that apply to
aspects of the human drug review program. These goals apply, for
example, to the process for the review of original new human drug and
biological product applications, postmarket safety activities, and new
data standards and technology enhancements.
    During the first few years of PDUFA I, the additional funding
enabled FDA to eliminate backlogs of original applications and
supplements. Phased in over the 5 years of PDUFA I, the goals were to
review and act on 90 percent of priority new drug applications (NDAs),
biologics license applications (BLAs), and efficacy supplements within
6 months of submission of a complete application; to review and act on
90 percent of standard original NDAs, BLAs, and efficacy supplements
within 12 months, and to review and act on resubmissions and
manufacturing supplements within 6 months. Over the course of PDUFA I,
FDA exceeded all these performance goals and significantly reduced
median review times of both priority and standard NDAs and BLAs.
    Under PDUFA II, the review performance goals were shortened, and
new procedural goals were added to improve FDA's interactions with
industry sponsors and to help facilitate the drug development process.
The procedural goals, for example, articulated time frames for
scheduling sponsor-requested meetings intended to address issues or
questions regarding specific drug development programs, as well as time
frames for the timely response to industry-submitted questions on
special study protocols. FDA met or exceeded all the review and
procedural goals under PDUFA II. However, concerns grew that overworked
review teams often had to return applications as ``approvable'' because
they did not have the resources and sufficient staff time to work with
the sponsors to resolve issues so that applications could be approved
in the first review cycle.
    A sound financial footing and support for limited postmarket risk
management were key themes of PDUFA III. Base user fee resources were
significantly increased and a mechanism to account for changes in human
drug review workload was adopted. PDUFA III also expanded the scope of
user fee activities to include postmarket surveillance of new therapies
for up to 3 years after marketing approval. FDA committed to the
development of guidance for industry on risk assessment, risk
management, and pharmacovigilance, as well as guidance to review staff
and industry on review management principles. In September 2018 the
draft guidance, ``Good Review Management Principles and Practices for
New Drug Applications and Biologics License Applications'' (GRMPs),
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/good-review-management-principles-and-practices-new-drug-applications-and-biologics-license, was published.\1\ Initiatives
to improve application submission and Agency-sponsor interactions
during the drug development and application review processes were also
adopted.
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    \1\ When finalized this will represent FDA's current thinking on
this issue.
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    With PDUFA's reauthorization under FDAAA Title I (PDUFA IV), FDA
obtained a significant increase in base fee funding and committed to
full implementation of GRMPs, which included providing a planned review
timeline for premarket review, development of new guidance for industry
on innovative clinical trials, modernization of postmarket safety, and
elimination of the 3-year limitation on fee support for postmarket
surveillance. Additional provisions in FDAAA (Titles IV, V, and IX)
gave FDA additional statutory authority that increased the pre- and
postmarket review process requirements, added new deadlines, and
effectively increased review workload. Specifically, the new provisions
expanded FDA's drug safety authorities, such as the authority to
require risk evaluation mitigation strategies (REMS), order safety
labeling changes, and require postmarket studies.
    Under Title I of FDASIA, the fourth renewal of PDUFA, FDA
implemented a new review program (``the Program'') to promote greater
transparency and increase communication between the FDA review team and
the applicant on the most innovative products reviewed by the Agency.
The Program applied to all new molecular entity (NME) NDAs and original
BLAs received by the Agency from October 1, 2012, through September 30,
2017. The Program added new opportunities for communication between the
FDA review team and the applicant during review of a marketing
application, including mid-cycle communications and late-cycle
meetings, while adding 60 days to the review clock to provide for this
increased interaction and to address review issues for these complex
applications. PDUFA V also required an assessment of the impact of the
Program. The independent assessment of the Program entitled
``Assessment of the Program for Enhanced Review Transparency and
Communication for NME NDAs and Original BLAs in PDUFA V,'' is available
at: https://www.fda.gov/media/101907/download.
    In addition to continued commitment to a significant set of review,
processing, and procedural goals, PDUFA V also included commitments
related to enhancing regulatory science and expediting drug
development, enhancing benefit-risk assessment in regulatory decision-
making, modernizing the FDA drug safety system, and improving the
efficiency of human drug review by requiring electronic submissions and
standardization of electronic drug application data.
    In August 2017, FDARA was enacted, which renewed the prescription
drug user fee program for a sixth time. This iteration of the program
continued and built upon the successes of PDUFA V. In PDUFA VI, FDA and
industry members agreed to continue ``the Program'' model developed in
PDUFA V to continue to promote the efficiency and effectiveness of the
first cycle review process. PDUFA VI includes commitments to enhance
regulatory science and expedite drug development by focusing on
enhancing communication between FDA and sponsors during drug
development,

early consultation on the use of new surrogate endpoints, and exploring
the use of real world evidence for use in regulatory decision-making,
among other enhancements. This iteration includes commitments to
enhance the use of regulatory tools to support drug development and
review through incorporation of the patient's voice in drug
development, expanded use of a benefit-risk framework in drug reviews,
and advancing the use of complex innovative trial designs and model
informed drug development. More information on these commitments can be
found in the PDUFA VI commitment letter at: https://www.fda.gov/media/99140/download.
    As part of the current authorization, FDA also modernized the user
fee structure to improve program funding predictability, stability, and
administrative efficiency. The new structure eliminated the supplement
fees, replaced the establishment and product fees with a program fee,
and shifted a greater proportion of the target revenue to the new more
predictable and stable annual program fee. The agreement also included
commitments to enhance management of user fee resources through the
development of a resource capacity planning capability and third-party
evaluation of program resource management, along with the publication
and annual update of a 5-year financial plan.
    Recognizing the challenges with hiring in PDUFA V, the current
authorization also includes several commitments to improve the hiring
and retention of critical review staff through modernization of FDA's
hiring system, augmentation of hiring staff capacity and capabilities,
creation of a dedicated function focused on staffing the program,
reporting on hiring metrics, and a comprehensive and continuous
assessment of hiring and retention. A list of the deliverables
developed to meet PDUFA VI commitments is available on the FDA web page
at: https://www.fda.gov/industry/prescription-drug-user-fee-amendments/completed-pdufa-vi-deliverables.

III. Public Meeting Information

A. Purpose and Scope of the Meeting

    In general, the meeting format will include presentations by FDA
and a series of panels representing different stakeholder groups. We
will also provide an opportunity for other stakeholders to provide
public comment at the meeting. FDA policy issues are beyond the scope
of these reauthorization discussions. Accordingly, the presentations
should focus on process enhancements and funding issues, and not focus
on policy issues.

B. Participating in the Public Meeting

    Registration: Persons interested in attending this virtual public
meeting should register online by 11:59 p.m. Eastern Time on June 23,
2020, at http://pdufavii-publicmeeting.eventbrite.com. Please provide
complete contact information for each attendee, including name, title,
affiliation, email, and telephone.
    Opportunity for Public Comment: Those who register online by June
23, 2020, will receive a notification about an opportunity to
participate in the public comment session of the meeting. If you wish
to speak during the public comment session, follow the instructions in
the notification and identify which topic(s) you wish to address. We
will do our best to accommodate requests to make public comments.
Individuals and organizations with common interests are urged to
consolidate or coordinate their comments and request time jointly. All
requests to make a public comment during the meeting must be received
by July 9, 2020, 11:59 p.m. Eastern Time. We will determine the amount
of time allotted to each commenter, the approximate time each comment
is to begin, and will select and notify participants by July 16, 2020.
No commercial or promotional material will be permitted to be presented
at the public meeting.
    Streaming Webcast of the Public Meeting: The webcast for this
public meeting is available at https://collaboration.fda.gov/pdufajuly2020/.
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
    Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/industry/fda-user-fee-programs/prescription-drug-user-fee-amendments.

    Dated: June 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-12317 Filed 6-5-20; 8:45 am]
 BILLING CODE 4164-01-P


[The description of the site (release) is based on information available at the time the site was evaluated with the HRS. The description may change as additional information is gathered on the sources and extent of contamination. See 56 FR 5600, February 11, 1991, or subsequent FR notices.] For more information about the hazardous substances identified in this narrative summary, including general information regarding the effects of exposure to these substances on human health, please see the Agency for Toxic Substances and Disease Registry (ATSDR) ToxFAQs. ATSDR ToxFAQs can be found on the Internet at http:// www. atsdr. cdc. gov/ toxfaq. html or by telephone at 1 888 42 ATSDR or 1 888 422 8737. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY NATIONAL PRIORITIES LIST (NPL) September 2002 OSWER/ OERR State, Tribal, and Site Identification Center Washington, DC 20460 REASOR CHEMICAL COMPANY Castle Hayne, North Carolina Conditions at Proposal (September 13, 2001): The Reasor Chemical Company site is an inactive pine stump rendering facility located at 5100 North College Road in Castle Hayne, New Hanover County, North Carolina. The facility is located approximately ½ mile south of Route NC 132 and US 117 and is approximately 25 acres in size. Although little information is available regarding specific site operations and hazardous substances used at the Reasor Chemical Company facility, elevated levels of metals, including lead and mercury, and organic compounds, including benzo( a) pyrene, toluene, and xylenes, have been detected in the waste lagoons and soils that comprise the source areas at the site. Dioxins also have been documented at elevated levels in the source areas. The site is being placed on the NPL because toluene and dioxins have been detected in wetlands adjacent to the facility. In addition, site related hazardous substances detected in drainage ditches that receive runoff from the source areas pose a threat to downstream wetlands and commercial and recreational fisheries.

Reasor Chemical Company produced turpentine, resin, pine oil, and related compounds from pine tree stumps at its facility from 1959 to 1972. By 1969, most operations at the facility had ceased, buildings were demolished, and equipment was removed. In April 1972, a fire destroyed additional structures. The property then was sold to Martin Marietta Corporation (MMC) for limestone mining purposes. After MMC's permit application was denied, the property was sold to the current owner, Cameron Company, on August 5, 1986. The site currently is vacant and receives no routine maintenance.

Features at the site include areas formerly housing an extraction unit, a refinery, distillation units, a scrap copper area where copper and plastic were burned, a pipe shop area, ten tank cradles, and a drum disposal area. The drums have since been removed. Other identified site features include five ponds and a sparsely vegetated sluice area. Four of the ponds (the waste lagoons) located near the former distillation and extraction areas drain via overland flow to a ditch that empties into wetlands located at the southern portion of the property. A gate restricts vehicle access to the site.

From 1997 to 1999, EPA conducted a Remedial Investigation (RI) at the Reasor Chemical Company facility. More than 130 samples were collected from facility soils, ponds, and drainage ditches. Surface water and sediment samples also were collected from a wetland and Prince George Creek, downgradient of the facility. Hazardous substances detected in the source, process, and drainage areas during the RI include volatile organic solvents (including ethylbenzene, toluene, and xylenes), metals (including arsenic, copper, lead, mercury, nickel, iron, and zinc), semivolatile organic compounds (including benzo (a) pyrene), and dioxins. Toluene was documented in a wetland sediment sample at 460 ug/ kg. Iron was documented in surface water samples at levels up to 13,000 ug/ L, which exceeds the Ambient Water Quality Criteria/ Ambient Aquatic Life Advisory Concentration benchmark.

Approximately 150 residences within ½ mile of the site are served either by private wells or one of two community wells. Low levels of solvents were detected in the shallow aquifer beneath the facility but have not been documented in the drinking water wells. Approximately 0.8 mile of wetland frontage has been impacted by the site, and site related hazardous substances pose a threat to more than 70 miles of wetland frontage that border the surface water migration pathway downstream of the area of documented contamination. The surface water pathway includes commercial and recreational fisheries and a habitat known to be used by Federally designated endangered species.

Status (September 2002): EPA is considering various alternatives for this site.

[The description of the site (release) is based on information available at the time the site was evaluated with the HRS. The description may change as additional information is gathered on the sources and extent of contamination. See 56 FR 5600, February 11, 1991, or subsequent FR notices.] United States Environmental Protection Agency ___________________________________________________________________________

For further information, call the Superfund Hotline, toll free 1 800 424 9346 or (703) 412 9810 in Washington, DC metropolitan area, or the U. S. EPA Superfund Regional Offices listed below*.

For publications, contact EPA Superfund Docket at (202) 566 0276 SUPERFUND. DOCKET@ EPA. GOV by Mail: Walk in Address (by Appt.): CERCLA Docket Office (5305T) CERCLA Docket Office Ariel Rios Building 1301 Constitution Avenue 1200 Pennsylvania Ave NW EPA West, Room B102 Washington, DC 20460 Washington, DC 20004 _________________________________________________________ Office of Emergency and Remedial Response (5204G) United States Environmental Protection Agency 401 M Street, SW Washington, DC 20460 (703) 603 8860 _________________________________________________________ Region 1 Connecticut New Hampshire Maine Rhode Island Massachusetts Vermont                         Region 1, U. S. EPA, Records Center, Mailcode HCS One Congress St., Suite 1100 Boston, MA 02114 2023 (617) 918 1225 _________________________________________________________ Region 2 New Jersey Puerto Rico New York Virgin Islands                         Region 2, U. S. EPA 290 Broadway New York, NY 10007 1866 (212) 637 4435 _________________________________________________________ Region 3 Delaware Pennsylvania District of Columbia Virginia Maryland West Virginia                         Region 3, U. S. EPA, Library 1650 Arch Street, Mailcode 3PM52 Philadelphia, PA 19103 (215) 814 5364 ______________________________________________________________________ Region 4 Alabama Mississippi Florida North Carolina Georgia South Carolina Kentucky Tennessee                         Region 4, U. S. EPA 61 Forsyth Street, SW, 9th floor Atlanta, GA 30303 (404) 562 8127 _________________________ Region 5 Illinois Minnesota Indiana Ohio Michigan Wisconsin                         Region 5, U. S. EPA, Records Center, Superfund Division SMR 7J Metcalfe Federal Building, 77 West Jackson Boulevard Chicago, IL 60604 (312) 353 5821 ________________________________________________________________________________________ _____________________________________________________________ Region 6 Arkansas Oklahoma Louisiana Texas New Mexico                         Region 6, U. S. EPA 1445 Ross Avenue, Mailcode 6SF RA Dallas, TX 75202 2733 (214) 665 7436 _____________________________________________________________ Region 7 Iowa Missouri Kansas Nebraska                         Region 7, U. S. EPA 901 North 5th Street Kansas City, KS 66101 (913) 551 7335 _____________________________________________________________ Region 8 Colorado South Dakota Montana Utah North Dakota Wyoming                         Region 8, U. S. EPA 999 18th Street, Suite 500, Mailcode 8EPR SA Denver, CO 80202 2466 (303) 312 6757 _________________________ Region 9 American Samoa Guam Northern Arizona Hawaii Trust Territories California Nevada                         Region 9, U. S. EPA 75 Hawthorne Street San Francisco, CA 94105 (415) 744 2343 __________________________________________________________ Region 10 Alaska Oregon Idaho Washington                         Region 10, U. S. EPA 11th Floor, 1200 6th Avenue, Mail Stop ECL 110 Seattle, WA 98101 (206) 553 6699 _____________________________________________________________ * All EPA telephone and telecommunications systems may be accessed via the Federal Telecommunications System (FTS).


[Federal Register Volume 81, Number 125 (Wednesday, June 29, 2016)]
[Rules and Regulations]
[Page 42250]
[FR Doc No: 2016-15352]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2016-0547]

Eighth Coast Guard District Annual Safety Zones; Table 165;
Sector Ohio Valley

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulations.

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SUMMARY: The Coast Guard will enforce recurring safety zones on
navigable waterways within the Sector Ohio Valley's area of
responsibility to protect vessels transiting the areas and event
spectators from the hazards associated with fireworks displays
requiring additional safety measures. During the enforcement period, no
vessels are allowed to enter, transit through, or anchor in the safety
zone, unless specifically authorized by the Captain of the Port Ohio
Valley (COTP) or a COTP designated representative.

DATES: The regulations in 33 CFR 165.801 Table 1, Eighth Coast Guard
District, will be enforced from July 2, 2016 through July 4, 2016 for
the safety zones within Sector Ohio Valley identified in the
SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email Petty Officer James Robinson,
Sector Ohio Valley, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety
zones in 33 CFR 165.801, Table 1, Nos. 14, 18, 19, 20, 26, and 51 as
follows:
    No. 14, Riverview Park Independence Festival, from 10 p.m. to 10:30
p.m. on July 2, 2016;
    No. 18, Louisville Bats Firework Show, from 9:30 p.m. to 11 p.m. on
July 3, 2016;
    No. 19, Waterfront Independence Festival, from 9:15 p.m. to 10:15
p.m. on July 4, 2016;
    No. 20, All American 4th of July, from 9 p.m. to 10 p.m. on July 2,
2016;
    No. 26, Grand Harbor Marina/Grand Harbor Marina July 4th
Celebration, from 9 p.m. to 9:30 p.m. on July 2, 2016.
    No. 51, Evansville Freedom Celebration, from 9:45 p.m. to 10:15
p.m. on July 4, 2016;
    The regulations for the Eighth Coast Guard District Annual Safety
Zones, Sec.  165.801, Table 1, specifies the locations of these safety
zones. As specified in Sec.  165.23, during the enforcement period, no
vessel may transit these safety zones without approval from the COTP or
a COTP designated representative. Sector Ohio Valley may be contacted
on VHF-FM radio channel 16 or phone at 1-800-253-7465.
    This notice of enforcement is issued under authority of 33 CFR
165.801 and 5 U.S.C. 552(a). In addition to this notice in the Federal
Register, the Coast Guard will provide the maritime community with
advance notification of this enforcement period via Local Notice to
Mariners and updates via Marine Information Broadcasts.

R.V. Timme,
Captain, U.S. Coast Guard, Captain of the Port Ohio Valley.
[FR Doc. 2016-15352 Filed 6-28-16; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 178 (Wednesday, September 14, 2011)]
[Notices]
[Pages 56774-56775]
[FR Doc No: 2011-23408]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4020-DR; Docket ID FEMA-2011-0001]

New York; Amendment No. 4 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of New York (FEMA-4020-DR), dated August 31, 2011, and
related determinations.

DATES: Effective Date: September 4, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of New York is hereby amended to include the following
area among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of August 31, 2011.

Sullivan County for Public Assistance, including direct federal
assistance (already designated for Individual Assistance).

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance

(Presidentially Declared Disasters); 97.039, Hazard Mitigation
Grant.)

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-23408 Filed 9-13-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: April 13, 2010 (Volume 75, Number 70)]
[Notices]
[Page 18871-18872]
[DOCID:fr13ap10-75]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2010-0119]

Notification of the Imposition of Conditions of Entry for Certain
Vessel Arriving to the United States From the Democratic Republic of
Sao Tome and Principe

AGENCY: Coast Guard, DHS.

ACTION: Notice.

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

SUMMARY: The Coast Guard announces that it will impose conditions of
entry on vessels arriving from the country of the Democratic Republic
of Sao Tome and Principe.

DATES: The policy announced in this notice will become effective April
27, 2010.

ADDRESSES: This notice will be available for inspection and copying at
the Docket Management Facility at the U.S. Department of
Transportation, Room W12-140 on the Ground Floor of the West Building,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call Mr. Michael Brown, International Port Security Evaluation
Division, Coast Guard, telephone<PHONE_NUMBER>. If you have questions
on viewing the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER> or (toll free) 1-800-647-5527.

SUPPLEMENTARY INFORMATION:

Background and Purpose

    Section 70110 of title 46, United States Code, enacted as part of
section 102(a) of the Maritime Transportation Security Act of 2002
(Pub. L. 107-295, Nov. 25, 2002), authorizes the Secretary of Homeland
Security to prescribe conditions of entry into the United States on
vessels arriving from ports that are not maintaining effective anti-
terrorism measures and may deny entry into the United States to any
vessel that does not meet such conditions. It also requires public
notice of the ineffective anti-terrorism measures. The Secretary has
delegated to the Coast Guard authority to carry out the provisions of
this section. Previous notices have imposed or removed conditions of
entry on vessels arriving from certain countries, and those conditions
of entry and the countries they pertain to remain in effect unless
modified by this notice.
    Based on an assessment conducted pursuant to the provisions of 46
U.S.C. 70108 and the International Ship and Port Facility (ISPS) Code,
the Coast Guard has determined that ports in the Democratic Republic of
Sao Tome and Principe are not maintaining effective anti-terrorism
measures. Inclusive to this determination is an assessment that the
Democratic Republic of Sao Tome and Principe presents significant risk
of introducing instruments of terror into international maritime
commerce. The Coast Guard notified the Department of State of this
determination pursuant to 46 U.S.C. 70110(c).
    The United States notified the Democratic Republic of Sao Tome and
Principe of this determination in July of 2009, and identified steps
necessary to improve the antiterrorism measures in use at ports in the
Democratic Republic of Sao Tome and Principe, as required by 46 U.S.C.
70109. The United States conducted a visit in February 2010
reconfirming that the identified deficiencies have not been corrected.
    Accordingly, effective April 27, 2010, the Coast Guard will impose
the following conditions of entry on vessels that visited ports in the
Democratic Republic of Sao Tome and Principe during their last five
port calls. Vessels must:
     Implement measures per the ship's security plan equivalent
to Security Level 2 while in a port in the Democratic Republic of Sao
Tome and Principe. As defined in the ISPS Code and incorporated herein,
``Security Level 2'' refers to the ``level for which appropriate
additional protective security measures shall be maintained for a
period of time as a result of heightened risk of a security incident.''
     Ensure that each access point to the ship is guarded and
that the guards have total visibility of the exterior (both landside
and waterside) of the vessel while the vessel is in ports in the
Democratic Republic of Sao Tome and Principe.
     Guards may be provided by the ship's crew; however,
additional crewmembers should be placed on the ship if necessary to
ensure that limits on maximum hours of work are not exceeded and/or
minimum hours of rest are met, or provided by outside security forces
approved by the ship's master and Company Security Officer. As defined
in the ISPS Code and incorporated herein, ``Company Security Officer''
refers to the ``person designated by the Company for ensuring that a
ship security assessment is carried out, that a ship security plan is
developed, submitted for approval, and thereafter implemented and
maintained and for liaison with port facility security officers and the
ship security officer.''
     Attempt to execute a Declaration of Security while in port
in the Democratic Republic of Sao Tome and Principe;
     Log all security actions in the ship's log; and
     Report actions taken to the cognizant Coast Guard Captain
of the Port prior to arrival into U.S. waters.
    In addition, based on the findings of a Coast Guard boarding or
examination, vessels may be required to ensure that each access point
to the ship is guarded by armed, private security guards and that they
have total visibility of the exterior (both landside and waterside) of
the vessel while in U.S. ports. The number and position of the guards
has to be acceptable to the cognizant Coast Guard Captain of the Port
prior to the vessel's arrival.
    Consistent with 46 U.S.C. 70110, the United States may deny entry
into the United States to any vessel that does not meet the conditions
set forth herein. This notice also informs passengers of the
ineffective anti-terrorism measures at ports in the Democratic Republic
of Sao Tome and Principe.
    This notice is issued under authority of 46 U.S.C. 70110(a)(3).

    Dated: March 25, 2010.
Sally Brice-O'Hara,
Rear Admiral, USCG, Deputy Commandant for Operations.
[FR Doc. 2010-8373 Filed 4-12-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 108 (Tuesday, June 6, 2023)]
[Notices]
[Pages 37053-37054]
[FR Doc No: 2023-12079]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP23-483-000]

Southern Star Central Gas Pipeline, Inc.; Notice of Request Under
Blanket Authorization and Establishing Intervention and Protest
Deadline

    Take notice that on May 22, 2023, Southern Star Central Gas
Pipeline, Inc. (Southern Star), 4700 State Route 56, Owensboro,
Kentucky 42301, filed in the above referenced docket, a prior notice
request pursuant to sections 157.205 and 157.208 of the Commission's
regulations under the Natural Gas Act (NGA), and Southern Star's
blanket certificate issued in Docket No. CP82-479-000, for
authorization to increase the maximum allowable operating pressure
(MAOP) on its Questar Skull Creek Interconnect to 1,480 pounds per
square inch gauge (psig) and to install and upgrade related auxiliary
equipment, all located in Sweetwater County, Wyoming (Questar Skull
Creek Interconnect Project). Southern Star's Questar Skull Creek
Interconnect is a bi-directional interconnect consisting of
approximately 60 feet of a 10-inch-diameter pipeline lateral connecting
to MountainWest Pipeline LLC (MountainWest).
    The current MAOP of the Questar Skull Creek Interconnect is 960
psig and the MAOP of the MountainWest pipeline is 1,250 psig. Southern
Star states that it is dependent on MountainWest to provide sufficient
over pressure protection. Southern Star asserts that the proposed MAOP
increase to 1,480 psig will address the discrepancy between
MountainWest's and Southern Star's facilities, give Southern Star full
operational pressure control at the Questar Skull Creek Interconnect,
and ensure compliance with Department of Transportation regulations.
Southern Star states that the proposed project will not increase
operating pressure or the MAOP on Southern Star's downstream Line WK.
Southern Star asserts that no increased capacity is expected to occur
from the MAOP increase of the Questar Skull Creek Interconnect.
Southern Star estimates the cost of the Questar Skull Creek
Interconnect Project to be approximately $1.2 million, all as more
fully set forth in the request which is on file with the Commission and
open to public inspection.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (www.ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room. For assistance, contact the Federal Energy Regulatory
Commission at [email protected] or call toll-free, (886) 208-
3676 or TTY<PHONE_NUMBER>.
    Any questions concerning this request should be directed to Cindy
Thompson, Director, Regulatory, Compliance & Information Governance,
Southern Star Central Gas Pipeline, Inc., 4700 State Route 56,
Owensboro, Kentucky 42301, by phone at<PHONE_NUMBER>, or by email at
[email protected].

Public Participation

    There are three ways to become involved in the Commission's review
of this project: you can file a protest to the project, you can file a
motion to intervene in the proceeding, and you can file comments on the
project. There is no fee or cost for filing protests, motions to
intervene, or comments. The deadline for filing protests, motions to
intervene, and comments is 5:00 p.m. Eastern Time on July 30, 2023. How
to file protests, motions to intervene, and comments is explained
below.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

Protests

    Pursuant to section 157.205 of the Commission's regulations under
the NGA,\1\ any person \2\ or the Commission's staff may file a protest
to the request. If no protest is filed within the time allowed or if a
protest is filed and then withdrawn within 30 days after the allowed
time for filing a protest, the proposed activity shall be deemed to be
authorized effective the day after the time allowed for protest. If a
protest is filed and not withdrawn within 30 days after the time
allowed for filing a protest, the instant request for authorization
will be considered by the Commission.
---------------------------------------------------------------------------

    \1\ 18 CFR 157.205.
    \2\ Persons include individuals, organizations, businesses,
municipalities, and other entities. 18 CFR 385.102(d).
---------------------------------------------------------------------------

    Protests must comply with the requirements specified in section
157.205(e) of the Commission's regulations,\3\ and must be submitted by
the protest deadline, which is July 30, 2023. A protest may also serve
as a motion to intervene so long as the protestor states it also seeks
to be an intervenor.
---------------------------------------------------------------------------

    \3\ 18 CFR 157.205(e).
---------------------------------------------------------------------------

Interventions

    Any person has the option to file a motion to intervene in this
proceeding. Only intervenors have the right to request rehearing of
Commission orders issued in this proceeding and to subsequently
challenge the Commission's orders in the U.S. Circuit Courts of Appeal.
    To intervene, you must submit a motion to intervene to the
Commission in accordance with Rule 214 of the Commission's Rules of
Practice and Procedure \4\ and the regulations under the NGA \5\ by the
intervention deadline for the project, which is July 30, 2023. As
described further in Rule 214, your motion to intervene must state, to
the extent known, your position regarding the proceeding, as well as
your interest in the proceeding. For an individual, this could include
your status as a landowner, ratepayer, resident of an impacted
community, or recreationist. You do not need to have property directly
impacted by the project in order to intervene. For more information
about motions to intervene, refer to the FERC website at https://www.ferc.gov/resources/guides/how-to/intervene.asp.
---------------------------------------------------------------------------

    \4\ 18 CFR 385.214.
    \5\ 18 CFR 157.10.
---------------------------------------------------------------------------

    All timely, unopposed motions to intervene are automatically
granted by operation of Rule 214(c)(1). Motions to intervene that are
filed after the intervention deadline are untimely and may be denied.
Any late-filed motion to intervene must show good cause for being late
and must explain why the time limitation should be waived and provide
justification by reference to factors set forth in Rule 214(d) of the
Commission's Rules and Regulations. A person obtaining party status
will be placed on the service list maintained by the Secretary of the
Commission and will receive copies (paper or electronic) of all
documents filed by the applicant and by all other parties.

Comments

    Any person wishing to comment on the project may do so. The
Commission considers all comments received about the project in
determining the appropriate action to be taken. To ensure that your
comments are timely and properly recorded, please submit your comments
on or before July 30, 2023. The filing of a comment alone will not
serve to make the filer a party to the proceeding. To become a party,
you must intervene in the proceeding.

How To File Protests, Interventions, and Comments

    There are two ways to submit protests, motions to intervene, and
comments. In both instances, please reference the Project docket number
CP23-483-000 in your submission.
    (1) You may file your protest, motion to intervene, and comments by
using the Commission's eFiling feature, which is located on the
Commission's website (www.ferc.gov) under the link to Documents and
Filings. New eFiling users must first create an account by clicking on
``eRegister.'' You will be asked to select the type of filing you are
making; first select ``General'' and then select ``Protest'',
``Intervention'', or ``Comment on a Filing''; or \6\
---------------------------------------------------------------------------

    \6\ Additionally, you may file your comments electronically by
using the eComment feature, which is located on the Commission's
website at www.ferc.gov under the link to Documents and Filings.
Using eComment is an easy method for interested persons to submit
brief, text-only comments on a project.
---------------------------------------------------------------------------

    (2) You can file a paper copy of your submission by mailing it to
the address below. Your submission must reference the Project docket
number CP23-483-000.
    To file via USPS: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    To file via any other method: Kimberly D. Bose, Secretary, Federal
Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland
20852.
    The Commission encourages electronic filing of submissions (option
1 above) and has eFiling staff available to assist you at (202) 502-
8258 or [email protected].
    Protests and motions to intervene must be served on the applicant
either by mail or email (with a link to the document) at: Cindy
Thompson, Director, Regulatory, Compliance & Information Governance,
Southern Star Central Gas Pipeline, Inc., 4700 State Route 56,
Owensboro, Kentucky 42301, or by email at
[email protected]. Any subsequent submissions by an
intervenor must be served on the applicant and all other parties to the
proceeding. Contact information for parties can be downloaded from the
service list at the eService link on FERC Online.

Tracking the Proceeding

    Throughout the proceeding, additional information about the project
will be available from the Commission's Office of External Affairs, at
(866) 208-FERC, or on the FERC website at www.ferc.gov using the
``eLibrary'' link as described above. The eLibrary link also provides
access to the texts of all formal documents issued by the Commission,
such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. For more information and to register, go to
www.ferc.gov/docs-filing/esubscription.asp.

    Dated: May 31, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-12079 Filed 6-5-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 2 (Tuesday, January 4, 2022)]
[Notices]
[Page 271]
[FR Doc No: 2021-28185]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Opportunity for Public Comment on Surplus Property
Release at Columbia Metropolitan Airport, Columbia, South Carolina

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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

SUMMARY: Notice is given that the Federal Aviation Administration (FAA)
is considering a request from the Richland-Lexington Airport District
to waive the requirement that 74 acres of surplus property, located at
the Columbia Metropolitan Airport be used for aeronautical purposes.
Currently, ownership of the property provides for protection of FAR
Part 77 surfaces and compatible land use which would continue to be
protected with deed restrictions required in the transfer of land
ownership.

DATES: Comments must be received on or before February 3, 2022.

ADDRESSES: Documents are available for review by prior appointment at
the following location: Atlanta Airports District Office, Attn: Joseph
Robinson, South Carolina Planner, 1701 Columbia Ave., Suite 220,
College Park, Georgia 30337-2747, Telephone:<PHONE_NUMBER>.
    Comments on this notice may be mailed or delivered in triplicate to
the FAA at the following address: Atlanta Airports District Office,
Attn: Joseph Robinson, South Carolina Planner, 1701 Columbia Ave.,
Suite 220, College Park, Georgia 30337-2747.
    In addition, one copy of any comments submitted to the FAA must be
mailed or delivered to Mike Gula, Executive Director, Richland-
Lexington Airport District at the following address: Columbia
Metropolitan Airport, 3250 Airport Blvd.--Suite 10, West Columbia,
South Carolina 29170.

FOR FURTHER INFORMATION CONTACT: Joseph Robinson, Airport Planner,
Atlanta Airports District Office, 1701 Columbia Ave., Suite 220,
College Park, Georgia 30337-2747,<PHONE_NUMBER>. The application may be
reviewed in person at this same location.

SUPPLEMENTARY INFORMATION: Under the provisions of Title 49, U.S.C.
47151(d), the FAA is reviewing a request by the Richland-Lexington
Airport District to release 74 of surplus property at the Columbia
Metropolitan Airport. This singular parcel was originally conveyed to
the County of Lexington on April 7, 1947 under the powers and authority
contained in the provisions of the Surplus Property Act of 1944 and
subsequently transferred to the Richland-Lextington Airport District on
July 12, 1962. Currently, this surplus property is located within the
Columbia Metropolitan Airport Foreign Trade Zone #124.
    Any person may inspect the request in person at the FAA office
listed above under FOR FURTHER INFORMATION CONTACT.
    In addition, any person may, upon request, inspect the request,
notice and other documents germane to the request in person at the
Columbia Metropolitan Airport.

    Issued in Atlanta, Georgia on December 22, 2021.
Joseph Parks Preston,
Assistant Manager, Atlanta Airports District Office, Southern Region.
[FR Doc. 2021-28185 Filed 1-3-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: April 18, 2006 (Volume 71, Number 74)]
[Proposed Rules]
[Page 19842-19848]
[DOCID:fr18ap06-21]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 260, 261, 262, 263, 264, 265, and 271

[EPA-HQ-RCRA-2001-0032; FRL-8159-3]
RIN 2050-AE21

Hazardous Waste Management System; Modification of the Hazardous
Waste Manifest System

AGENCY: Environmental Protection Agency.

ACTION: Notice of data availability and request for comment.

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

SUMMARY: This notice announces the availability of additional
information on the electronic manifest (e-manifest ) project.
Specifically, subsequent to EPA's proposal to develop a nearly
paperless electronic approach for implementing the manifest
requirements, EPA's Office of Solid Waste held a two-day public meeting
to discuss and obtain public input on a national e-manifest system. The
purpose of the meeting was to discuss with stakeholders our rulemaking
progress and to solicit their input and preferences on the development
and implementation of the e-manifest project. EPA also presented
material on alternative information technology (IT) approaches to the
e-manifest, including a centralized approach under which EPA would host
a web-based national

system. As a result of these discussions and subsequent analysis of
possible means to fund the development and operation of an e-manifest
system, EPA now believes that a centralized, national e-manifest system
is the preferred approach as we proceed with the rulemaking authorizing
the use of electronic manifests. EPA will consider the data obtained
from the public meeting and any new data from public comments received
on this notice in making a final decision on whether to develop a
national electronic manifest (e-manifest) system. Because the Agency
expects to go final based on the comments it receives on this notice,
as well as other comments received, any party interested in commenting
on this action should do so at this time.

DATES: Comments must be received on or before June 19, 2006.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
RCRA-2001-0032 by one of the following methods:
     http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>
     Mail: Environmental Protection Agency, EPA Docket Center
(EPA/DC), Resource Conservation and Recovery Act (RCRA) Docket, 5305T,
1200 Pennsylvania Avenue, NW., Washington, DC 20460. Please include a
total of 3 copies.
     Hand Delivery: Public Reading Room, Room B102, EPA West
Building, 1301 Constitution Avenue, NW., Washington, DC. Such
deliveries are only accepted during the docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-RCRA-
2001-0032. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information provided,

unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or e-mail.

The http://www.regulations.gov Web site is an ``anonymous access'' system,

which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through http://www.regulations.gov,

your e-mail address will be captured automatically and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http:// www.epa.gov/epahome/dockets.htm.

    Docket: All documents in the docket are listed in the
http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Resource Conservation and

Recovery Act (RCRA) Docket, EPA/DC, EPA West, Room B102, 1301
Constitution Ave., NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the Resource Conservation and
Recovery Act (RCRA) Docket is<PHONE_NUMBER>. Copies cost $0.15/page.

FOR FURTHER INFORMATION CONTACT: For further information regarding
specific aspects of this document, contact Richard LaShier, Office of
Solid Waste,<PHONE_NUMBER><EMAIL_ADDRESS>or Bryan Groce,
Office of Solid Waste,<PHONE_NUMBER><EMAIL_ADDRESS>Mail
inquiries may be directed to the Office of Solid Waste, (5304W), 1200
Pennsylvania Avenue, NW., Washington, DC 20460.

SUPPLEMENTARY INFORMATION:

A. Does This Rule Apply to Me?

    This rule would affect up to 139,000 entities in at least 45
industries involved in shipping approximately 12 million tons of RCRA
hazardous wastes annually (non-wastewaters and wastewaters), using
between 2.4 and 5.1 million EPA Uniform Hazardous Waste Manifests (EPA
Form 8700-22 and continuation sheets EPA Form 8700-22A). These entities
include, but are not limited to: Hazardous waste generators;
transporters; treatment, storage and disposal facilities (TSDFs);
federal facilities; state governments; and governmental enforcement
personnel dealing with hazardous waste transportation issues. If you
have any questions regarding the applicability of this rule to a
particular entity, consult the people listed under FOR FURTHER
INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit CBI information to EPA through
http://www.regulations.gov or e-mail. Clearly mark the part or all of the

information that you claim to be CBI. For CBI information on a disk or
CD-ROM that you mail to 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.
    Make sure to submit your comments by the comment period deadline
identified.
    The contents of today's notice are listed in the following outline:

I . Background of E-Manifest System

    A. May 2001 Proposed Rule Standards and Approach
    B. Comments on the Proposal
    C. Stakeholder Meeting to Discuss Centralized Alternatives
    D. Collaboration with GSA and Stakeholders after May 2004
II. The Agency's General Approach to a Centralized E-Manifest System
    A. Conceptual Design of the E-Manifest
III . Request for Comments

I. Background of E-Manifest System

A. May 2001 Proposed Rule Standards and Approach

    On May 22, 2001, EPA published a notice of proposed rulemaking
(NPRM) aimed at reducing the manifest system's paperwork burden on
users, while enhancing the effectiveness of the manifest as a tool to
track hazardous waste shipments from the site of generation to
treatment, storage, or disposal facilities (TSDFs). The proposed rule
included proposed manifest system reforms of two distinct types: (1)
Revisions to the manifest form itself and the procedures for using the
form; and (2) revisions to the paper-based manifest system aimed at
replacing it with a nearly paperless electronic approach for
completing, signing, transmitting and storing manifests, and tracking
hazardous waste shipments (hereafter, e-manifest). The proposed e-
manifest regulation represented a decentralized approach in which EPA
would issue several information technology (IT) standards, and private
parties such as waste management firms and IT vendors would develop and
market their own e-manifest systems complying with EPA's standards. The
proposed standards addressed such areas as Electronic Data Interchange
(EDI) transaction sets and mapping conventions, Extensible Markup
Language (XML) representations of the manifest, electronic signature
methods, and computer security standards that were viewed as necessary
to ensure trustworthy systems and data that would be free from
tampering or corruption. Significantly, under the proposed rule
approach, EPA's role would be limited to the development of the e-
manifest standards, and the Agency would not have had any role in
developing an IT system or in collecting electronic manifests.
    EPA explained in the 2001 proposed rule that it did not collect
paper manifests from the public, nor did it intend in 2001 to create
either a centralized reporting system for electronic manifests, nor a
national data base for tracking manifest data. While the Agency desired
to foster the development of electronic manifest systems by issuing
national standards that would guide the system development efforts of
private parties, EPA did not envision playing a role with respect to
electronic manifesting that was any different from the standard-setting
role the Agency had played in the past with respect to the Uniform
Manifest paper form. However, public comments criticized the
decentralized approach in our proposed rule and instead stated that the
e-manifest system would be unreliable without a nationally centralized
approach under which EPA would develop a single national IT system to
host e-manifest services. Most stakeholders who attended our two-day
public meeting in May 2004 also favored a centralized system for
tracking hazardous waste shipments and transmitting/storing manifest
data.

B. Comments on the Proposal

    EPA received 64 sets of public comments in response to the May 22,
2001 proposed rule from hazardous waste generators, transporters, waste
management firms, consultants, an information technology vendor and ten
state hazardous waste management agencies. Commenters generally
supported our goals of further standardizing the manifest form elements
and reducing variability among the manifests that authorized RCRA State
agencies currently distribute. However, there were a substantial number
of comments that took issue with our proposed decentralized approach to
the e-manifest, particularly with respect to the technical detail and
prescriptiveness of the proposed regulatory standards, and the proposed
rule's assumption that the regulated industry and IT vendors could or
would develop private e-manifest systems adhering to EPA's standards.
Other comments criticized the decentralized approach, because it was
not viewed as being cost-effective and, therefore, only a few entities
might be able to develop private systems, and these likely would be
inconsistent with one another. Several of these commenters expressed
the need for a nationally centralized approach, under which EPA would
take on a more ambitious role by developing a single national IT system
to host e-manifest services. The commenters believed that a national
web-based system would provide a more consistent, secure, and cost-
effective platform for e-manifest services. They also believed that a
national system would offer greater benefits to users and regulators,
such as one-stop manifest reporting, more effective oversight and
enforcement of the manifest requirements, nearly real-time tracking
services for waste shippers and receivers, and the possible
consolidation of duplicative State and Federal systems now in place to
collect and manage manifest data and similar waste receipt data
collected for biennial reporting purposes. They believed that a
centralized e-manifest approach would result in the development of a
consistent, interoperable and secure IT system that would offer more
benefits than would result from the operation of several decentralized
private systems.
    The comments addressing the e-manifest proposal raised significant
substantive issues that, in our opinion, required further analysis and
stakeholder outreach prior to adopting a final approach. Therefore, in
developing final actions on the May 2001 proposed rule, EPA separated
the e-manifest from the form revisions portion of the rulemaking. We
announced our final rule approach with respect to the manifest form
revisions in the March 4, 2005 Federal Register (70 FR 10776).

C. Stakeholder Meeting To Discuss Centralized Alternatives

    EPA announced in the Federal Register that the Office of Solid
Waste was holding a two-day public meeting on May 19-20, 2004, to
discuss and obtain public input on the e-manifest issue (69 FR 17145,
April 1, 2004). The purpose of this meeting was to engage interested
stakeholders in an exchange of ideas aimed at helping us identify how
best to proceed with selecting and implementing the future direction of
the e-manifest. The two-day meeting provided us with invaluable
information, all of which is available in the docket to today's notice.
Specifically, we heard from the attendees at the meeting that there is
a strong consensus in favor of implementing a centralized e-manifest
system. However, views varied on whether a national system should be
privately or publicly hosted and funded or developed as a joint public/
private venture. For instance, some stakeholders suggested that EPA
design and operate both the e-manifest ``front end'' interface that
would supply and process manifests during the movement of waste
shipments in transportation, as well as the ``back end'' repository
component of the system that would collect and archive official copies
of completed manifests. Others favored an approach where the e-manifest
``front end'' interface might be designed, funded, and operated by a
private consortium. The consortium then would look to EPA to clarify
what is necessary

to constitute a valid electronic manifest transaction (e.g., by
defining the legal and performance standards for such a system, as well
as the auditing requirements) and perhaps to develop and operate the
``back end'' repository.
    Second, all the attendees of the meeting believed that a central
service provider, whether it be EPA, a private entity, or a public/
private combination, must be reliable and trusted if a centralized e-
manifest system is to be successful. The stakeholders expect a
trustworthy system operated with minimal downtime so that it would not
disrupt or inconvenience waste handler operations. They also noted that
a governance structure enabling regular interactions between the user
community, the IT vendor, and government interests would be necessary
to ensure that the system is developed and operated in a manner that
meets the needs and expectations of all affected interests.
    Third, stakeholders from the user community who attended the
meeting emphasized that a centralized e-manifest system should be
optional and, thus, able to accommodate those manifest users who want
to continue to use paper manifests in the future. On the other hand,
the IT vendor community would prefer to have EPA mandate that users
access the centralized e-manifest system to complete and transmit all
their manifests, particularly if the vendor community will be asked to
bid on a centralized e-manifest system development contract, so that
there would be greater certainty for the vendor attempting to price e-
manifest services, based on the size of the e-manifest market and
expected volumes of use. (Note: See discussion in Section I.D for
further explanation of this.) EPA, at this time, believes that the
savings to be realized by those users who complete significant
quantities of manifests will provide sufficient incentives for these
users to commit to the e-manifest voluntarily, without a mandate from
EPA that might be disruptive to or cause hardship for other users. EPA
recognizes that a key ingredient in any procurement process where the
vendor community will be bidding on such a task that leads to the
development and successful operation of the centralized e-manifest
system will be a dialogue between the user community and the vendors
bidding on the task. This dialogue is necessary to develop mutual
understandings about likely levels of usage and likely e-manifest
transmission volumes, so that the vendor may accurately project these
parameters and price its services accordingly. Nevertheless, the Agency
specifically solicits comments on whether the use of the e-manifest
should be mandatory or voluntary. In providing comments, we ask that
you include your rationale and any supporting data regarding this
matter. In addition, we also solicit comment from the states, as well
as other stakeholders, as to whether a centralized e-manifest system
that is voluntary will require the states to maintain two separate
manifest systems, and, if so, what concerns or problems this may raise.
    Finally, and most significantly, the user community indicated at
the May 2004 stakeholder meeting that it is willing to help fund the
establishment and operation of an e-manifest system through the payment
of reasonable service or transactional fees for e-manifest services.
Stakeholders stated that they would be willing to pay reasonable
service fees as the means to fund the establishment of a national e-
manifest system, if they could be assured that the collected fees would
be earmarked to the payment of the e-manifest system costs only, and
not deflected to other program accounts or costs. Stakeholders also
stated that they expect service fee arrangements, including the
collection of any such fees and the reporting of expenditures, to be
handled in a very transparent manner so that stakeholders can be
assured that they are receiving value for the fees they contribute to
the system. The full proceedings for this meeting have been posted on
our EPA Web site at http://www.epa.gov/epaoswer/hazwaste/gener/manifest/e-man.htm.
 Comments from stakeholders about a centralized e-

manifest system have been submitted to the RCRA docket (EPA Docket
(Docket ID No. EPA-HQ-RCRA-2001-0032)), which can be found at http://www.epa.gov/edocket
.

    Since the May 2004 stakeholder meeting, we have been exploring
whether there is a way for EPA to proceed with the development of a
nationally-centralized e-manifest system, as well as exploring in more
detail the design and performance requirements of any such system.
While the notion of a centralized e-manifest system has strong appeal
to states and industry, it would require adequate funding to build and
operate.
    In 2000 to 2002, we estimated the initial start-up cost for the
design, development and installation, plus the future annual operating
and maintenance (O&M) cost, for a ``centralized'' e-manifest IT system
procurement. This cost estimate is based on a benefit-cost analysis
conducted by Logistics Management Institute, Inc. (LMI). LMI's study is
dated September 20, 2002, and is available for public review (with
accompanying spreadsheet file) in the docket cited above in the
ADDRESSES section. This study is an expansion of LMI's October 2000
initial benefit-cost study in support of our May 22, 2001 proposed rule
for the e-manifest (http://www.epa.gov/epaoswer/hazwaste/gener/manifest/pdf/cba-rprt.pdf
). The 2002 LMI study estimated the benefits

and costs associated with three alternative e-manifest data flow
configurations (i.e., electronic system options), all involving hosting
the e-manifest on EPA's existing CDX computer hub (http://www.epa.gov/cdx
), and connecting the central e-manifest system electronically to

industrial facilities and to state governments via EPA's partnership
National Environmental Information Exchange Network (NEIEN; http://www.exchangenetwork.net
), which is operational in 38 states as of

October 2005. The estimated cost for e-manifest system start-up ranges
from $2.0 million to $7.0 million in the initial year, plus $0.8
million to $3.2 million per year for future annual operation and
maintenance (O&M). In addition to this system cost, industrial
facilities are expected to spend upwards of $60.2 million to $68.8
million, and state governments upwards of $2.3 million to $3.1 million,
in start-up costs for modifying existing IT systems to process e-
manifests (assuming 100% participation in the centralized e-manifest
system). Industrial facilities and state governments also may spend
upwards of $32.2 million to $37.0 million in annual future costs for
apportionment of a fraction of existing business IT system costs for e-
manifesting purposes. Although there appear to be substantial initial
and recurring annual costs associated with e-manifesting, the expected
average annual reduction in paperwork burden for handling the current
paper manifest forms that e-manifest will provide industrial facilities
and state governments is expected to offset these costs by a net annual
savings upwards of $103 million per year.
    While an e-manifest would lead to significant savings, EPA
recognizes, as described above, that startup and maintenance costs of a
centralized e-manifest system could require considerable funds. EPA
believes that the costs of this system should be shared by entities
that will benefit from it. Therefore, EPA has been examining various
user-fee and other IT funding alternatives within the context of OSW's

http://www.epa.gov/epaoswer/hazwaste/gener/manifest/present/funding.pdf).

D. Collaboration With GSA and Stakeholders After May 2004

    One approach the Agency explored closely as a means to fund and
implement the centralized e-manifest system was the Share-in-Savings
(SiS) contract approach that was authorized under the E-Government Act
of 2002 (E-Gov Act). We consulted with the General Services
Administration (GSA), which managed the E-Gov Act Share-in-Savings
program, on a possible procurement action that might have enabled the
centralized e-manifest system to be developed and operated for EPA by
an IT vendor under a ``Share-in-Savings'' (SiS) type contract (http://www.gsa.gov/shareinsavings
). The SiS IT contracting mechanism was

authorized under the E-Gov Act of 2002 on a provisional basis as an
innovative tool for Federal agencies to develop new IT systems with
little direct Federal investment. The premise of the SiS contracting
approach was that the IT vendor awarded an SiS contract would build the
IT system at the vendor's initial expense, and then recover its costs
and profit from the cost savings or enhanced revenue that results to
the sponsoring agency from the new IT system. With this approach, for
example, the successful e-manifest IT contractor would have incurred
the initial financial risk and outlay to build the centralized e-
manifest system to meet EPA's performance objectives, and then would
have recovered its costs and earned its agreed profit from the revenue
stream generated by the service fees paid by the users for manifest
transactions.
    GSA established an SiS contract vehicle (i.e., blanket purchase
agreement or BPA) under which GSA qualified six IT vendors to compete
for Federal IT projects during FY 2005. While EPA was very interested
in initiating a procurement action under the GSA Share-in-Savings BPA
during FY 2005, we and GSA concluded that the procurement action should
not proceed until there was in place a final rule authorizing the use
of electronic manifests. Unfortunately, the initial Congressional
authorization for the SiS program expired on September 30, 2005, and it
does not now appear that the authority for this program will be
extended. While the expiration of the SiS program introduces some
uncertainty about the funding arrangements for the national e-manifest
system, the Agency is aware that some Congressional representatives are
considering legislative proposals that would provide the Agency with
the authority, including perhaps user fee authority, to implement a
centralized e-manifest system. Thus, we are proceeding with this
regulatory action so that we can proceed in the future with the
necessary contract actions that would lead to the development of a
national e-manifest system, provided that appropriate authorizing
legislation is enacted in the interim. Should the necessary authorizing
legislation not materialize, EPA could decide to adopt a final e-
manifest rule that is based on the proposed rule approach, if we
determine that such an approach is better than no e-manifest system, or
another approach that is not dependent on new federal funding
legislation being authorized. EPA's current schedule would have its
final regulation authorizing the use of electronic manifests in place
in time to enable us to award a contract in FY 2007, assuming any
legislation needed to address the funding of e-manifest is enacted
within that timeframe.

II. The Agency's General Approach to a Centralized E-Manifest System

    Based on information provided at the May 2004 public meeting and
discussions with our stakeholders during and subsequent to this
meeting, EPA believes that the vast majority of stakeholders support an
e-manifest system. They also prefer a consistent national framework for
supplying, preparing, transmitting and maintaining e-manifests.
Stakeholders attending the public meeting also indicated that they are
willing to pay fees for their electronic manifest transactions in order
to develop and maintain a centralized e-manifest system.
    EPA agrees with the position, from commenters to the May 2001
proposal and from stakeholder participants in the May 2004 public
meeting, that a centralized e-manifest system is the preferred approach
for developing an electronic manifest system. First, we are concerned
that the user participation in the decentralized approach for an e-
manifest system is limited to some extent by the customers'
relationships to firms that elect to establish e-manifest systems.
There should not be similar concerns about user participation in the
centralized e-manifest system since it would be developed to serve all
interested users, and participation would be open to all those with
Internet access who choose to access the system or who deal with waste
handlers who provide access to the system.
    Second, our preferred approach is the more effective means to
address concerns that arise under the decentralized approach about the
potential inability of different systems to operate with each other, as
well as other concerns that arise regarding whether data from these
different systems can be exchanged and processed consistently. A final
rule adopting a decentralized e-manifest approach would require, among
other things, rigorous standards to address the consistent processing
and interoperability issues posed by multiple vendors' systems. Such an
approach would likely involve a process to evaluate the various systems
to determine if they are in compliance with our interoperability and
system security standards. In contrast, a centralized approach would
not need to address interoperability concerns, as the development of a
single, national e-manifest system would ensure the consistency of the
processing, completion, and transmission of electronic manifests.
Moreover, the centralized approach would simplify the execution of
system and data security with respect to e-manifests, as the necessary
security requirements could be addressed within the national e-manifest
procurement process, rather than as detailed regulatory standards that
would have to be met by the various vendors who might develop systems
under the decentralized approach.
    Third, other capabilities and enhancements could be realized
through a centralized e-manifest system that are not possible under a
decentralized approach. For instance, a centralized e-manifest system
could be designed to store electronic manifest data centrally in a
national data repository, so that manifest users and regulators could
extract the stored manifest data to develop analyses from that data.
Such a national data repository could collect manifest data from both
domestic and transboundary waste movements, and it could also become a
basis for easing the production of reports under RCRA biennial
reporting requirments (the Hazardous Waste Report) and other reports
that are required under authorized state programs. The manifest users
who now must incur the burden and expense of supplying paper copies of
manifest forms through the mail to individual authorized states could
instead submit their manifest copies one time electronically to one
centralized hub system, which would distribute copies as needed to
interested states through their nodes on the Exchange Network. In
addition to this one-stop submission feature, the users may be able to
maintain their official copies of

manifest records on secure storage sites on the national system, rather
than continuing to retain manifest copies locally. We believe that the
centralized collection of manifest copies by the e-manifest system
would also afford advantages to RCRA inspectors by providing a simple
and efficient means for accessing and inspecting manifest records
electronically.
    Therefore, today's notice announces that EPA's preferred approach,
at this time, for proceeding with the e-manifest rule is to develop a
centralized web-based IT system that EPA will host on its IT
architecture. This national system likely would be funded, in whole or
in part, by service fees that would be paid to EPA or its contractor.
This notice discusses a conceptual design of the nationally-centralized
e-manifest system and requests comment on our approach.
    Today, we are announcing that EPA intends to develop a final rule
to authorize the use of electronic manifests that are created and
transmitted through the use of a centralized e-manifest system. EPA
will consider the comments received pursuant to this notice, along with
comments on the e-manifest proposal in the May 2001 proposed rule and
the May 2004 Stakeholder meeting, as we prepare a final rule on the e-
manifest. The final rule would amend existing manifest regulations
which require manifests to be created only as paper forms. These
regulatory changes would be necessary to ensure that electronic
manifests are as valid as the traditional paper manifests that are
signed with ink and manually processed and transmitted. The usage of
EPA's national e-manifest system to obtain and process valid electronic
manifests would be the key component of the final rule.
    EPA believes that as a result of this change in approach for the e-
manifest system, the final regulation authorizing the use of electronic
manifests would be much simpler than the regulation suggested by the
May 2001 proposed rule. The final rulemaking will be constrained in its
scope to authorizing the use of electronic manifests created and
transmitted in the national system, and to several other key policy
issues that must be resolved prior to implementation. EPA thus expects
to limit, as far as possible, the subject matter of the final rule on
electronic manifesting to the key policy issues associated with
authorizing the use of electronic manifests and with implementing the
electronic manifest as a means of tracking hazardous waste shipments
and recording and transmitting waste shipment information. EPA believes
it is far more sensible to address the more detailed technical system
design and performance requirements for the centralized e-manifest
system within the contracting process than to codify performance
requirements and other technical matters within the rulemaking process.
We also recognize that State participation and input during the
planning stage of the e-manifest development process is critical,
because there will be significant implementation issues associated with
moving to an electronic manifest system. EPA will work closely with our
State partners as we develop both the final rulemaking and the detailed
system design and performance requirements.

A. Conceptual Design of the E-Manifest

    The centralized e-manifest system will include the necessary
applications and components to supply, complete, electronically sign,
transmit, and retain electronic manifests. The centralized e-manifest
system that will be developed initially will provide only the core
services necessary to manage the basic waste shipment tracking and
waste data collection functions of the manifest process, including
manifest creation, completion, signing, routing and communication
services (i.e., services required to create, view, update, transmit,
and close manifests) and the collection, distribution, and archiving of
official manifest records. In accordance with requests expressed by
stakeholders in the May 2004 public meeting, the system initially will
not support any more advanced reporting or business integration
services. The system would be designed with scalability so that
additional EPA reporting functions (e.g., Biennial Report integration
or transboundary waste reporting), or additional commercial services
that may be desired by users could be added as future upgrades. The
development of the e-manifest system will use a web services-oriented
architecture and will be hosted on EPA's CDX (http://www.epa.gov/cdx)

and NEIEN architecture. The CDX would act as the Agency's central
reporting hub for receiving, processing, and routing the in-bound
electronic manifests to waste shipment management entities and to state
governments. As the e-manifest would be hosted within our CDX/Exchange
Network architecture, the submission of e-manifests to the national
system would be governed by the standards and procedures included in
EPA's Cross Media Electronic Reporting Rule (CROMERR), which EPA
published in the Federal Register on October 13, 2005 (70 FR 59847).
The CROMERR Rule provides the legal and policy framework for electronic
reporting to the CDX hub, and will address such matters as user
registration, user authentication, execution of electronic signatures,
and the procedures for producing records of electronic manifest
submissions.
    We believe that the use of a services-oriented architecture
involving web services applications will enable a high level of
interoperability with users' legacy and future system investments.
Thus, EPA plans to develop the e-manifest applications in conformance
with Internet ``web services'' standards which now are supported by
CDX. Also, schemas (i.e., models for describing the structure of
information within a document to allow machine validation of document
structure) and stylesheets developed in the Extensible Mark-up Language
(XML) will be the means EPA will use for the electronic exchange of e-
manifest data, and these XML documents will conform to the data
elements of the hazardous waste manifest (EPA Form 8700-22) and
continuation sheet (EPA Form 8700-22A) that EPA recently announced in
the March 4, 2005 Form Revisions final rule (70 FR 10776).
    EPA further will develop the e-manifest applications with the
appropriate access controls to ensure that only authorized users may
enter the system, complete and sign manifests, and access manifest
data. We plan to limit access to particular manifest records and
related data to only those entities that are involved with the handling
of a waste shipment, as well as to RCRA regulators. The centralized e-
manifest system also will support, as far as possible, the provision of
reliable and uninterrupted manifest services to the user community and
will adopt necessary measures and controls that meet EPA and Federal
policies for protecting information security, privacy, and confidential
business information (CBI).
    The Federal regulations concerning CBI are found at 40 CFR Part 2.
Confidential business information obtained under the Resource
Conservation and Recovery Act is handled in accordance with 40 CFR Part
2, and will be disclosed by EPA only to the extent allowed by, and by
means of, the procedures set forth in 40 CFR Part 2. Anyone wishing to
claim that some or all of the information provided in their Uniform
Hazardous Waste Manifest is confidential business information must make
this claim at the time the manifest is transmitted electronically to
EPA. Claims of confidentiality must be specific: The generator,
transporter, or designated

facility must clearly indicate which manifest item number is being
declared confidential (e.g., Item 18a.). Any information not claimed as
confidential when being submitted will not be treated as confidential
business information.

III. Request for Comments

    EPA requests comments on the approach described in today's notice
for electronically completing and transmitting manifests through a
national, centralized e-manifest system. EPA will consider the comments
received pursuant to this notice, along with comments on the e-manifest
proposal in the May 2001 proposed rule and the May 2004 Stakeholder
meeting, as it prepares a final rule on the e-manifest.

    Dated: April 11, 2006.
Susan Parker Bodine,
Assistant Administrator, Office of Solid Waste and Emergency Response.
 [FR Doc. E6-5745 Filed 4-17-06; 8:45 am]

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