[Federal Register: January 26, 2010 (Volume 75, Number 16)]
[Notices]
[Page 4064-4066]
[DOCID:fr26ja10-52]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2006-0369; FRL-9107-1]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; National Estuary Program
(Renewal); EPA ICR No. 1500.07, OMB Control No. 2040-0138

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA)(44 U.S.C.
3501 et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR, which is abstracted below, describes the
nature of the information collection and its estimated burden and cost.

DATES: Additional comments may be submitted on or before February 25,
2010.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OW-
2006-0369, to (1) EPA online using

www.regulations.gov (our preferred method), by e-mail to ow-
<EMAIL_ADDRESS>or by mail to: EPA Docket Center, Environmental
Protection Agency, Water Docket (Mail Code: 28221T), 1200 Pennsylvania
Ave., NW., Washington, DC 20460, and (2) OMB by mail to: Office of
Information and Regulatory Affairs, Office of Management and Budget
(OMB), Attention: Desk Officer for EPA, 725 17th Street, NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Nell Orscheln, Oceans and Coastal
Protection Division, Office of Wetlands, Oceans, and Watersheds, Mail
Code 4504T, Environmental Protection Agency, 1200 Pennsylvania Ave.,
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On October 8, 2009 (74 FR 51849), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OW-2006-0369, which is available for online viewing at
www.regulations.gov, or in person viewing at the Water Docket in the
EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC 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 Reading Room is<PHONE_NUMBER>,
and the telephone number for the Water Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at www.regulations.gov as EPA receives
them and without change, unless the comment contains copyrighted
material, confidential business information (CBI), or other information
whose public disclosure is restricted by statute. For further
information about the electronic docket, go to www.regulations.gov.
    Title: National Estuary Program (Renewal).
    ICR numbers: EPA ICR No. 1500.07, OMB Control No. 2040-0138.
    ICR Status: This ICR is scheduled to expire on January 31, 2010.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information, unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, are displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract:
    Annual Workplans: The National Estuary Program (NEP) involves
collecting information from the state or local agency or
nongovernmental organizations that receive funds under Sec. 320 of the
Clean Water Act (CWA). The regulation requiring this information is
found at 40 CFR Part 35. Prospective grant recipients seek funding to
develop or oversee and coordinate implementation of Comprehensive
Conservation Management Plans (CCMPs) for estuaries of national
significance. In order to receive funds, grantees must submit an annual
workplan to EPA. The workplan consists of two parts: (a) Progress on
projects funded previously; and (b) new projects proposed with dollar
amounts and completion dates. The workplan is reviewed by EPA and also
serves as the scope of work for the grant agreement. EPA also uses
these workplans to track performance of each of the 28 estuary programs
currently in the NEP.
    Program Evaluations: EPA provides funding to NEPs to support long-
term implementation of CCMPs if such programs pass a program evaluation
process. The primary purpose of the program evaluation process is to
help EPA determine whether the 28 programs included in the National
Estuary Program (NEP) are making adequate progress implementing their
CCMPs and therefore merit continued funding under Sec. 320 of the Clean
Water Act. Continued funding for each NEP under Sec. 320 of the CWA is
contingent upon Congress appropriating sufficient funds to the EPA for
the purpose of implementing the NEP. The program evaluation process
also is useful for highlighting environmental results; highlighting
strengths and challenges in program management; demonstrating continued
stakeholder commitment; assessing the progress of the NEP as a national
program; and transferring lessons learned within EPA, among NEPs, and
with other watershed programs. For this ICR cycle, program evaluations
will be required for nine programs in FY2010, nine programs in FY2011,
and ten programs in 2012.
    Government Performance Results Act: EPA requests that each of the
28 NEPs receiving Sec. 320 funds report information that can be used in
the GPRA reporting process. This reporting is done on an annual basis
and is used to show environmental results that are being achieved
within the overall NEP Program. This information is ultimately
submitted to Congress along with GPRA information from other EPA
programs.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 100
hours per response for annual workplans, 250 hours per response for
program evaluations, and 25 hours per response for GPRA reporting.
Burden means the total time, effort, or financial resources expended by
persons to generate, maintain, retain, or disclose or provide
information to or for a Federal agency. This includes the time needed
to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements
which have subsequently changed; train personnel to be able to respond
to a collection of information; search data sources; complete and
review the collection of information; and transmit or otherwise
disclose the information.
    Respondents/Affected Entities: States with National Estuary
Programs.
    Estimated Number of Respondents: 28.
    Frequency of Response: Annual.
    Estimated Total Annual Hour Burden: 5,833.
    Estimated Total Annual Cost: $241,558, this includes no annualized
capital or O&M costs.
    Changes in the Estimates: There is no change in the total estimated
burden currently identified in the OMB Inventory of Approved ICR
Burdens.

    Dated: January 20, 2010.

John Moses,
Director, Collection Strategies Division.
[FR Doc. 2010-1469 Filed 1-25-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 160 (Tuesday, August 19, 2014)]
[Notices]
[Pages 49076-49078]
[FR Doc No: 2014-19689]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9915-14-OARM; EPA-HQ-OEI-2012-0836]

Notification of a New System of Records Notice for the EPA
Personnel Access and Security System (EPASS)

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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SUMMARY: The U.S. Environmental Protection Agency's (EPA) Office of
Administration and Resource Management, Office of Administration,
Security Management Division is giving notice that it proposes to
create a new system of records pursuant to the provisions of the
Privacy Act of 1974 (5 U.S.C. 552a). The EPA Personnel Access and
Security System (EPASS) is being created to comply with the Homeland
Security Presidential Directive-12 (HSPD-12), which was issued on
August 12, 2004 and signed on August 27, 2004. HSPD-12 mandates a
government-wide federal standard for ensuring that identification cards
issued to government employees and contractors are reliable and secure.
EPASS complies with the federal requirements and will enhance security,
increase efficiency, reduce identity fraud, and protect personal
privacy.

DATES: Persons wishing to comment on this new system of records notice
must do so by September 29, 2014.

ADDRESS: Submit your comments, identified by Docket ID No. EPA-HQ-2012-
0836, by mail:
     www.regulations.gov: Follow the online instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: OEI Docket, Environmental Protection Agency, Mail
code: 2822T, 1200 Pennsylvania Ave. NW., Washington, DC 20460.
     Hand Delivery: OEI Docket, EPA/DC, EPA West Building, Room
3334, 1301 Constitution Ave. 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-OEI-
2012-0836. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information

claimed to be Confidential Business Information (CBI) or other
information for which disclosure is restricted by statute. Do not
submit information that you consider to be CBI or otherwise protected
through www.regulations.gov. The 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 email comment directly to EPA without
going through www.regulations.gov your email address will be
automatically captured 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
www.regulations.gov index. Although listed in the index, some
information is not publicly available (e.g., CBI or other information
for which 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 www.regulations.gov or in hard copy at the OEI
Docket, EPA/DC, EPA West Building, Room 3334, 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<PHONE_NUMBER>, and the
telephone number for the OEI Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Kelly Glazier, Security Management
Division (SMD) Acting Director,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

General Information

    The U.S. Environmental Protection Agency (EPA) plans to create a
Privacy Act system of records for the EPA Personnel Access and Security
System (EPASS). This system is being created for the purpose of issuing
credentials to EPA employees and its contractors that meet the
requirements of Homeland Security Presidential Directive 12 (HSPD-12)
issued on August 12, 2004. The Directive requires the development of a
mandatory, government-wide standard for issuing secure and reliable
forms of identification to executive branch employees and federal
contractors for access to federally controlled facilities and networks.
    The National Institute of Standards and Technology (NIST) further
defined the issuance standards in Federal Information Processing (FIP)
Standards Publication 201which describes the minimum requirements for a
federal personal identification verification (PIV) system. EPA's
identification system, EPASS, complies with all HSPD-12 requirements.
It is designed to link a person's identity to an identification
credential and link the credential to a person's ability to physically
and logically access federally-controlled buildings and information
systems.
    EPASS will contain information on all Agency employees,
contractors, consultants, volunteers and other workers who require
long-term, regular access, as required by their position, to federal
facilities, systems and networks. The personal information collected in
the personnel enrollment process consists of data elements necessary to
verify the identity of the individual and to perform background or
other investigations. EPASS will collect the applicant's name, date of
birth, Social Security Number, organizational affiliations,
fingerprints, work email address and phone number(s), other
verification and demographic information, and the applicant's
photograph.

    Dated: June 24, 2014.
Renee P. Wynn,
Acting Assistant Administrator, and Acting Chief Information Officer.
EPA-62

System Name:
    EPA Personnel Access and Security System (EPASS)

System Location:
    Environmental Protection Agency, Office of Administration and
Resource Management (OARM), Office of Administration (OA), Ariel Rios
Building, MC3201A, 1200 Pennsylvania Ave. NW., Washington, DC 20460.

Categories of Individuals Covered by the System:
    The System will collect and maintain information on individuals who
require long-term, regular access as required by their position, to
EPA-controlled facilities and information technology systems, including
federal employees, contractors, grantees, students, interns,
volunteers, other non-federal employees and individuals formerly in any
of these positions. The System does not collect information on
occasional visitors or short-term guests to whom the Agency may issue
temporary identification.

Categories of Records in the System:
    Enrollment records: full name and history of name changes, social
security number, applicant ID number, date of birth, gender, race,
height, weight, hair color, eye color, digital color photograph,
fingerprints, biometric template (two fingerprints), employee
affiliation, work email address, work telephone number(s), office
location and organizational unit, employee status, foreign national
status, federal emergency response official status, National Agency
Check with Inquiries (NACI) status (permanent or provisional),
citizenship status, government agency code, computer login name/user
principal name (UPN), and personal identification verification (PIV)
card issuance location. Records in EPASS's Identity Management System
(IDMS) and Card Management System (CMS) are needed for credential
management of enrolled individuals and include PIV card serial number,
digital certificate serial number, PIV card issuance and expiration
dates, PIV card personal identification number (PIN), cardholder unique
identifier (CHUID), and card management keys. All sponsored individuals
enrolled within EPASS may be issued a PIV card. The PIV card contains
the following mandatory information: name, photograph, individual's
affiliation, organizational affiliation, PIV card expiration date,
Agency card serial number, and color-coding for employee affiliation.
The card also contains an integrated circuit chip which is encoded with
the following data elements: cardholder unique identifier (CHUID), PIV
authentication digital certificate, and two fingerprint biometric
minutiae templates.

Authority for Maintenance of the System:
    Government Organization and Employees (5 U.S.C. 301); Public
Buildings under the control of Administrator of General Services (40
U.S.C. 3101); Federal Information Security Management Act of 2002 (44
U.S.C. 3541); E-Government Act of 2002 (44 U.S.C. 101); Paperwork
Reduction Act of 1995 (44 U.S.C. 3501); Executive Order 9347 (Nov. 22,
1943); and

Homeland Security Presidential Directive 12 (HSPD-12) (August 27,
2004).

Purpose(s):
    The primary purposes of the System are to: (1) Ensure the safety
and security of Federal facilities, systems, or information, and of
facility occupants and users; (2) provide for interoperability and
trust in allowing physical access to individuals entering Federal
facilities; and (3) allow logical access to Federal information
systems, networks, and resources on a government-wide basis.

Routine Uses of Records Maintained in the System, Including Categories
of Users and the Purposes of Such Uses:
    General routine uses A, B, C, D E, F, G, H, I, J, K, and L apply to
this System.

Policies and Practices for Storing, Retrieving, Accessing, Retaining,
and Disposing of Records in the System:
     Storage: Records are stored on a secure server within the
EPASS sub-system Fingerprint Transmission System (FTS) and can be
accessed over the Web using encryption software. The records are kept
for 120 days and are either manually or automatically deleted.
     Retrievability: Records can only be retrieved within the
System database, which requires authorized user login/password
credentials and administrative privileges to retrieve personal data
within a Web instance of the system by using a combination of first
name and last name.
     Safeguards: Consistent with the requirements of the
Federal Information Security Management Act and associated OMB
policies, standards and guidance from the National Institute of
Standards and Technology, EPA protects all records from unauthorized
access through appropriate administrative, physical, and technical
safeguards. Buildings have security guards and secured doors. All
entrances are monitored through electronic surveillance equipment.
Physical security controls include indoor and outdoor security
monitoring and surveillance, badge and picture ID access screening and
biometric access screening. Personally identifiable information (PII)
is safeguarded and protected in conformance with all Federal statutes
and Office of Management and Budget (OMB) requirements. All access has
role-based restrictions. Individuals granted access privileges must be
screened for proper credentials. EPA maintains an audit trail and
performs random periodic reviews to identify any unauthorized access.
Persons given roles in the EPASS HSPD-12 process must be screened and
complete training specific to their roles to ensure they are
knowledgeable about how to protect PII.
     Retention and Disposal: Records are retained and disposed
of in accordance with EPA's records schedule 089.

System Manager(s) and Address:
    Director, Office of Administration and Resources Management (OARM),
Office of Administration (OA), Environmental Protection Agency, 1200
Pennsylvania Avenue NW., Washington, DC 20460.

Notification Procedures:
    Any individual who wants to know whether this System of records
contains a record about him or her, who wants access to his or her
record, or who wants to contest the contents of a record, should make a
written request to the EPA FOIA Office, Attn: Privacy Act Officer,
MC2822T, 1200 Pennsylvania Avenue NW., Washington, DC 20460.

Record Access Procedure:
    Requests for access must be made in accordance with the procedures
described in EPA's Privacy Act regulations at 40 CFR part 16.
Requesters will be required to provide adequate identification, such as
a driver's license, employee identification card, or other identifying
document. Additional identification procedures may be required in some
instances.

Contesting Records Procedure:
    Requests for correction or amendment must identify the record to be
changed and the corrective action sought. Complete EPA Privacy Act
procedures are described in EPA's Privacy Act regulations at 40 CFR
part 16.

Record Source Categories:
    The sources for information in the system are the individuals about
whom, the records are maintained, the supervisors of those individuals,
existing EPA systems, the sponsoring agency, the former sponsoring
agency, other Federal agencies, the contract employer, the former
contract employer and the U.S. Office of Personnel Management (OPM).

Systems Exempted From Certain Provisions of the Act:
    None.

[FR Doc. 2014-19689 Filed 8-18-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 119 (Wednesday, June 20, 2012)]
[Notices]
[Pages 37093-37098]
[FR Doc No: 2012-15011]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA--2012-0081]

Amendments to Highway Safety Program Guidelines

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Request for comments, highway safety program guidelines.

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SUMMARY: Section 402 of title 23 of the United States Code requires the
Secretary of Transportation to promulgate uniform guidelines for State
highway safety programs. The National Highway Traffic Safety
Administration (NHTSA) is seeking comments on proposed amendments to
five (5) guidelines and one (1) new guideline that reflect program
methodologies and approaches that have proven to be successful and are
based on sound science and program administration. The guidelines the
agency proposes to revise are: Guideline No. 1 Periodic Motor Vehicle
Inspection, Guideline No. 2 Motor Vehicle Registration, Guideline No. 6
Codes and Laws, Guideline No. 16 Management of Highway Incidents
(formerly Debris Hazard Control and Cleanup), and Guideline No. 18
Motor Vehicle Crash Investigation and Incident Reporting (formerly
Accident Investigation and Reporting). The new guideline is No. 13
Older Driver Safety. NHTSA believes the proposed amendments and new
guideline will provide more accurate, current and effective guidance to
the States. The guidelines will be made publicly available on the NHTSA
Web site.

DATES: Comments must be received on or before July 20, 2012.

ADDRESSES: You may submit comments to the docket number identified in
the heading of this document by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility, M-30, U.S. Department of
Transportation, West Building, Ground Floor, Rm. W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m. Eastern
Time, Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Instructions: For detailed instructions on submitting comments and
additional information on the rulemaking process, see the Public
Participation heading of the SUPPLEMENTARY INFORMATION section of this
document. Note that all comments received will be posted without change
to http://www.regulations.gov, including any personal information
provided.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act

Statement in the Federal Register at 65 FR 19477 FR 19477, April 11,
2000, or you may visit http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or the street
address listed above. Follow the online instructions for accessing the
dockets.

FOR FURTHER INFORMATION CONTACT: Ms. Susan Kirinich<PHONE_NUMBER>,
Office of Governmental Affairs, Policy and Strategic Planning, NHTSA,
U.S. Department of Transportation, 1200 New Jersey Avenue SE.,
Washington, DC 20590. Email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Section 402 of title 23 of the United States Code requires the
Secretary of Transportation to promulgate uniform guidelines for State
highway safety programs. As the highway safety environment changes, it
is necessary for NHTSA to update the guidelines to provide current
information on effective program content for States to use in
developing and assessing their traffic safety programs. These
guidelines reflect the best available science and the real-world
experience of NHTSA and the States in developing and managing traffic
safety program content. NHTSA will update the guidelines periodically
to address new issues and to emphasize program methodologies and
approaches that have proven to be effective in these program areas.
    The guidelines offer direction to States in formulating their
highway safety plans for highway safety efforts that are supported with
section 402 grant funds, as well as safety activities funded from other
sources. The guidelines provide a framework for developing a balanced
highway safety program and serve as benchmarks by which States can
assess the effectiveness of their own programs. NHTSA encourages States
to use these guidelines and build upon them to optimize the
effectiveness of highway safety programs conducted at the State and
local levels.
    The guidelines emphasize areas of nationwide concern and highlight
effective countermeasures. As each guideline is updated or created, it
will include the date of its revision or development.
    NHTSA has developed a new guideline on older drivers, No. 13, to
address this growing segment of the population. This new guideline will
help States develop plans to address the particular needs of older
drivers and address the emerging challenges from the increasing
population of older drivers in their States. Because of the unique
issues related to older driver safety, this guideline also includes
recommendations related to Medical Providers and Social Services
Providers.
    It is important that States begin to address the safety of older
road users now because the population of people 65 and older will
increase dramatically in the coming years. These population changes
will result in a disproportionate increase in deaths and injuries among
older people if no actions are taken. This guideline is also designed
to help policymakers with decisions about how best to address the real
and growing problem of older driver safety.
    All the highway safety guidelines are on the NHTSA Web site, in the
Highway Safety Grant Management Manual, and on the Traffic Safety page
at http://www.nhtsa.dot.gov/nhtsa/whatsup/tea21/tea21programs/.
    The five (5) guidelines NHTSA plans to revise along with one (1)
new guideline represent the last in a series of three sets of revisions
to the guidelines. For the first set of revisions, the agency revised
six (6) guidelines on November 7, 2006 (71 FR 65172): Guideline No. 3
Motorcycle Safety, Guideline No. 8 Impaired Driving, Guideline No. 14
Pedestrian and Bicycle Safety, Guideline No. 15 Traffic Enforcement,
Guideline No. 19 Speed Management, and Guideline No. 20 Occupant
Protection. The following five (5) guidelines were revised on April 1,
2009: Guideline No. 4 Driver Education, Guideline No. 5 Non-Commercial
Driver Licenses, Guideline No. 7, Judicial and Court Services,
Guideline No. 10 Traffic Records, and Guideline No. 17 Pupil
Transportation. A new guideline was also added at that time: Guideline
No. 12, Prosecutor Training.

II. Public Participation

How do I prepare and submit written comments?

    Your comments must be written and in English. To ensure that your
comments are correctly filed in the Docket, please include the docket
number of this document in your comments.
    Your primary comments cannot exceed 15 pages. (49 CFR 553.21). We
established this limit to encourage you to write your primary comments
in a concise fashion. However, you may attach necessary additional
documents to your primary comments. There is no limit on the length of
the attachments. Please submit your comments to the Docket by any of
the methods outlined under ADDRESSES.

How can I be sure that my comments were received?

    If you submit your comments by mail and wish the Docket Management
to notify you upon its receipt of your comments, enclose a self-
addressed, stamped postcard in the envelope containing your comments.
Upon receiving your comments, the Docket Management will return the
postcard by mail.

How do I submit confidential business information?

    If you wish to submit any information under a claim of
confidentiality, you should submit three copies of your complete
submission, including the information you claim to be confidential
business information, to the Chief Counsel, NHTSA, at the address given
above under FOR FURTHER INFORMATION CONTACT. In addition, you should
submit two copies, from which you have deleted the claimed confidential
business information, to Docket Management at the address given above
under ADDRESSES. When you send a comment containing information claimed
to be confidential business information, you should include a cover
letter setting forth the information specified in our confidential
business information regulation. (49 CFR part 512).

Will the agency consider late comments?

    We will consider all comments that Docket Management receives
before the close of business on the comment closing date indicated
above under DATES. To the extent possible, we will also consider
comments that Docket Management receives after that date. If Docket
Management receives a comment too late for us to consider in developing
a final guideline (assuming that one is issued), we will consider that
comment as an informal suggestion for future guideline action.

How can I read the comments submitted by other people?

    You may read the comments received by Docket Management at the
Docket Management Facility by going to the street address given above
under ADDRESSES. The Docket Management Facility is open between 9 a.m.
and 5 p.m. Eastern Time, Monday through Friday, except Federal
holidays. You may also read the materials placed in the docket for this
document (e.g., the comments submitted in response to this document by
other interested persons)

at any time by going to http://www.regulations.gov. Follow the online
instructions for accessing the dockets.
    Please note that even after the comment closing date, we will
continue to file relevant information in the Docket as it becomes
available. Further, some people may submit late comments. Accordingly,
we recommend that you periodically check the Docket for new material.
    In consideration of the foregoing, NHTSA proposes to amend
Guidelines 1, 2, 6, 16, and 18, and proposes new Guideline 13, to read
as follows.

Highway Safety Program Guideline No. 1

Periodic Motor Vehicle Inspection

    Each State should have a program for periodic inspection of all
registered vehicles to reduce the number of vehicles with existing or
potential conditions that may contribute to crashes or increase the
severity of crashes that do occur, and should require the owner to
correct such conditions.
    I. An inspection program would provide, at a minimum, that:
    A. Every vehicle registered in the State is inspected at the time
of initial registration and on a periodic basis thereafter as
determined by the State based on evidence of the effectiveness of
inspection programs.
    B. The inspection is performed by competent personnel specifically
trained to perform their duties and certified by the State.
    C. The inspection covers systems, subsystems, and components having
substantial relation to safe vehicle performance.
    D. Each inspection station maintains records in a form specified by
the State, which includes at least the following information:
     Class of vehicle.
     Date of inspection.
     Make of vehicle.
     Model year.
     Vehicle identification number.
     Defects by category.
     Identification of inspector.
     Mileage or odometer reading.
    E. The State publishes summaries of records of all inspection
stations at least annually, including tabulations by make and model of
vehicle.
    II. The program should be periodically evaluated by the State and
the National Highway Traffic Safety Administration should be provided
with an evaluation summary.

Highway Safety Program Guideline No. 2

Motor Vehicle Registration

    Each State should have a motor vehicle registration program.
    I. A model registration program would require that every vehicle
operated on public highways is registered and that the following
information is readily available for each vehicle:
     Make.
     Model year.
     Vehicle Identification Number.
     Type of body.
     License plate number.
     Name of current owner.
     Current address of owner.
     Registered gross laden weight of every commercial vehicle.
    II. Each program should have a records system that provides at
least the following services:
     Rapid entry of new data into the records or data system.
     Controls to eliminate unnecessary or unreasonable delay in
obtaining data.
     Rapid audio or visual response upon receipt at the records
station of any priority request for status of vehicle possession
authorization.
     Data available for statistical compilation as needed by
authorized sources.
     Identification and ownership of vehicle sought for
enforcement or other operation needs.
    III. This program should be periodically evaluated by the State and
the National Highway Traffic Safety Administration should be provided
with an evaluation summary.

Highway Safety Program Guideline No. 6

Codes and Laws

    Each State should strive to achieve uniformity of traffic codes and
laws throughout the State. The State Highway Safety Office should
maintain a list of all relevant traffic codes and laws, and serve as a
resource to State and local jurisdictions on any proposed changes.
    Each State should utilize all available sources, such as Federal or
State legislative databases or Web sites, to ensure that its traffic
codes and laws reflect the most current evidence-based and peer-
reviewed research.

Highway Safety Program Guideline No. 13

Older Driver Safety

    Each State, in cooperation with its political subdivisions, tribal
governments and other stakeholders, should develop and implement a
comprehensive highway safety program, reflective of State demographics,
to achieve a significant reduction in traffic crashes, fatalities, and
injuries on public roads. The highway safety program should include a
comprehensive older driver safety program that aims to reduce older
driver crashes, fatalities, and injuries. To maximize benefits, each
State older driver safety program should address driver licensing and
medical review of at-risk drivers, medical and law enforcement
education, roadway design, and collaboration with social services and
transportation services providers. This guideline recommends the key
components of a State older driver safety program, and criteria that
the program components should meet.
    In this guideline, there are recommendations regarding specific
partner groups. However, it is likely that there are other State,
local, and non-government organizations that could help in achieving
goals related to older driver safety because their missions are related
to the safe mobility of older people. When older people can no longer
drive safely, their mobility needs are often met by alternative means
such as ride programs or transit services. Federal highway safety funds
can be used for highway safety purposes--which might include programs
to facilitate older persons' decisions about when to stop driving by
increasing awareness of other transportation options. However, NHTSA
funds cannot be used to provide services--such as transit services--
whose primary purpose is not to improve highway safety. For details on
recommended practices, please see Countermeasures that Work (6th
Edition, 2011) (Countermeasures that Work.pdf).

I. Program Management

    Each State should have centralized data analysis and program
planning, implementation, and coordination to identify the nature and
extent of its older driver safety problems, to establish goals and
objectives for the State's older driver safety program and to implement
projects to reach the goals and objectives. State older driver programs
should:
     Designate a lead organization for older driver safety;
     Develop resources;
     Collect and analyze data on older driver crashes,
injuries, and fatalities;
     Identify and prioritize the State's older driver safety
problems;
     Encourage and facilitate regular collaboration among
agencies and organizations responsible for or impacted by older driver
safety issues (e.g., the State Unit on Aging, State Injury Prevention
Director, NGO's

related to aging or aging-related diseases);
     Develop programs and specific projects to address
identified problems;
     Coordinate older driver safety projects with other highway
safety projects;
     Increase awareness of older driver transportation options,
such as ride programs or transit services;
     Integrate older driver safety into the State strategic
highway safety plans and other related activities, including impaired
driving, occupant protection, and especially driver licensing programs;
and
     Routinely evaluate older driver safety programs and
services and use the results in program planning.

II. Roadway Design for Older Driver Safety

    Traffic engineering and roadway design can challenge or ease a
driver's mobility in any community. It is possible and desirable to
accommodate normal aging through the application of design,
operational, and traffic engineering countermeasures. The needs of
older road users must be considered in new construction, as well as in
spot improvements, to keep older drivers safe. The Federal Highway
Administration (FHWA) has developed guidelines (FHWA Highway Design
Handbook for Older Drivers and Pedestrians) for accommodating older
road users, and the guidelines need to be implemented on State and
local roadways. Each State also has a process by which it seeks user
input for its Strategic Highway Safety Plans. It is reasonable for
State DOTs to collaborate and seek partnerships and funding through
other sources, such as the Highway Safety Plans, which come from the
Highway Safety Office, or from the State Units on Aging. State DOTs
should:
     Consider Older Driver safety as an emphasis area in the
Strategic Highway Safety Plan (SHSP) if data analysis identifies this
as an area of concern;
     Develop and implement a plan for deploying the guidelines
and recommendations to accommodate older drivers and pedestrians; and
     Develop and implement a communications and educational
plan for assisting local entities in the deployment of the guidelines
and recommendations to accommodate older drivers and pedestrians.

III. Driver Licensing

    Driver licensing is a critical element in the oversight of public
safety as it relates to older drivers. The driver licensing authority
(DMV) can legally restrict or suspend an individual's license, and for
that reason, it is the primary audience for these recommendations.
There are three areas within driver licensing that are important to
driving safety: policies; practices; and, communications.
    Recommended driver licensing policies that each State should
implement to address older driver safety are:
     In-person renewal should be required of individual drivers
over a specified age that the State determines based on an analysis of
their individual crash records;
     Medical review policies should align with the Driver
Fitness Medical Guidelines (Driver Fitness Medical Guidelines)
published by NHTSA and the American Association of Motor Vehicle
Administrators (AAMVA); and
     Medical providers of all kinds who provide a referral
regarding a driver in good faith to the driver licensing authority
should be provided immunity from civil liability.
    Recommended driver licensing practices that each State should
implement to address older driver safety are:
     Establish a Medical Advisory Board (MAB), consisting of a
range of medical professionals, to provide policy guidance to the
driver licensing agency to implement;
     The medical review function of the DMV should include
staff with medical expertise in the review of medically-referred
drivers;
     The DMV should regularly conduct analyses and evaluation
of the referrals that come through the medical review system to
determine whether procedures are in place to appropriately detect and
regulate at-risk drivers;
     Train DMV staff, including counter-staff, in the
identification of medically at-risk drivers and the referral of those
drivers for medical review; and
     Provide a simple and fast way for individuals to convert
their driver licenses to identification cards.
    To be effective in identification of medically at-risk drivers, the
State should implement a communications program, through the DMV to:
     Make medical referral information and forms easy to find
on the DMV Web site;
     Provide outreach to and training for medical providers
(e.g., physicians, nurses, etc.) in making referrals of medically at-
risk drivers and in finding resources on functional abilities and
driving;
     Provide outreach to and training for law enforcement in
successfully identifying medically at-risk drivers and in making
referrals of medically at-risk drivers to the DMV; and
     Provide information on transportation options and
community resources to drivers who are required to submit to medical
review of their licenses.

IV. Medical Providers

    State older driver safety programs rely on the identification of
medically at-risk drivers by their medical providers, with the aim of
limiting the impact of changes in functional abilities on the safe
operation of a motor vehicle. Medical providers should know how to
counsel the at-risk driver, and when confronted by a driver who refuses
to heed advice to stop driving, to make a referral to the driver
licensing authority. To facilitate this process, State older driver
safety programs should:
     Establish and implement a communications plan for reaching
medical providers;
     Disseminate educational materials for medical providers.
Providers should include physicians, nurses, occupational therapists,
and other medical professionals who treat or deal with older people
and/or their families;
     Facilitate the provision of Continuing Medical Education
(CME) credits for medical providers in learning about driving safety;
and
     Facilitate referrals of medically at-risk drivers to the
driver licensing authority for review.

V. Law Enforcement

    Law Enforcement plays an important role in identifying at-risk
drivers on the road. States should ensure that State and local older
driver safety programs include a law enforcement component. Essential
elements of the law enforcement component include:
     A communications plan for reaching law enforcement
officers with information on medically at-risk drivers;
     Training and education for law enforcement officers that
includes emphasis on ``writing the citation'' for older violators,
identifying the medically at-risk driver, and making referrals of the
medically at-risk driver to the driver licensing authority; and
     An easy way for law enforcement officers who are in the
field to make referrals of medically at-risk drivers to the driver
licensing authority.

VI. Social and Aging Services Providers

    At the State-level, there are agencies that are responsible for
coordinating aging services. These agencies should be collaborating
with the State DOT-Transit offices in the planning for and provision of
transportation services for

older residents. State Highway Safety Offices should:
     Collaborate with State Units on Aging and other social
services providers on providing support related to older drivers who
are transitioning from driving;
     Collaborate with State DOT-Transit offices to provide
information at the local level on how individuals can access
transportation services for older people; and
     Develop joint communications strategies and messages
related to driver transitioning.

VII. Communication Program

    States should develop and implement communication strategies
directed at specific high-risk populations as identified by crash and
population-based data. Communications should highlight and support
specific policies and programs underway in the States and communities.
The programs and materials should be culturally-relevant, multi-lingual
as necessary, and appropriate to the target audience. To achieve this,
States should:
     Establish a working group of State and local agencies and
organizations that have an interest in older driver safety and mobility
with the goal of developing common message themes; and
     Focus the communication efforts on the support of the
overall policy and program.

VIII. Program Evaluation And Data

    Both problem identification and continual evaluation require
effective record-keeping by State and local governments. The State
should identify the frequency and types of older driver crashes. After
problem identification is complete, the State can identify appropriate
countermeasures. The State can promote effective evaluation by:
     Supporting detailed analyses of police accident reports
involving older drivers;
     Encouraging, supporting, and training localities in
process, impact, and outcome evaluation of local programs;
     Conducting and publicizing statewide surveys of public
knowledge and attitudes about older driver safety;
     Evaluating the use of program resources and the
effectiveness of existing countermeasures for the general public and
high-risk populations;
     Ensuring that evaluation results are used to identify
problems, plan new programs, and improve existing programs; and
     Maintaining awareness of trends in older driver crashes at
the national level and how this might influence activities statewide.

Highway Safety Program Guideline No. 16

Management of Highway Incidents (Formerly Debris Hazard and Control and
Cleanup)

    Each State in cooperation with its political subdivisions should
have a program which provides for rapid, orderly, and safe removal from
the roadway of wreckage, spillage, and debris resulting from motor
vehicle accidents, and for otherwise reducing the likelihood of
secondary and chain-reaction collisions, and conditions hazardous to
the public health and safety.
    I. The program should provide at a minimum that:
    A. Traffic Incident Management programs are effective and
understood by emergency first responders.
    B. Operational procedures are established and implemented to:
    1. Define responsibilities of all first responders;
    2. Certify and classify all rescue and salvage responders and
equipment;
    3. Enable rescue and salvage equipment personnel to get to the
scene of accidents rapidly and to operate effectively and safely on
arrival--
    a. On heavily traveled freeways and other limited access roads;
    b. In other types of locations where wreckage or spillage of
hazardous materials on or adjacent to highways endangers the public
health and safety;
    4. Extricate trapped persons from wreckage with reasonable care-to
avoid injury or aggravating existing injuries;
    5. Warn approaching drivers and detour them with reasonable care
past hazardous wreckage or spillage;
    6. Ensure safe handling of spillage or potential spillage of
materials that are --
    a. Radioactive
    b. Flammable
    c. Poisonous
    d. Explosive
    e. Otherwise hazardous; and
    7. Expeditiously remove wreckage or spillage from roadways or
otherwise ensure the resumption of safe, orderly traffic flow.
    C. All rescue and salvage personnel are properly trained and
retrained in the latest accident cleanup techniques.
    D. An interoperable communications system is provided, adequately
equipped and manned, to provide coordinated efforts in incident
detection and the notification, dispatch, and response of appropriate
services.
    II. The program should be periodically evaluated by the State to
ensure adherence to the principles and concepts of the National
Incident Management System using the Federal Highway Administration's
Traffic Incident Management State Self-Assessment (http://ops.fhwa.dot.gov/eto_tim_pse/preparedness/tim/self.htm). The National
Highway Traffic Safety Administration should be provided with an
evaluation summary.

Highway Safety Program Guideline No. 18

Motor Vehicle Crash Investigation And Incident Reporting (Formerly
Accident Investigation and Reporting)

    Each State should have a highway safety program for the
investigation and reporting of all motor vehicle crashes and incidents,
and the associated deaths, injuries and reportable property damage that
occur within the State.
    I. A uniform, comprehensive crash investigation and incident
reporting program would provide for gathering information--who, what,
when, where, why, and how--on all motor vehicle crashes and incidents,
and the associated deaths, injuries, and property damage within the
State and entering the information into the traffic records system for
use in planning, evaluating, and furthering highway safety program
goals.
    II. For the purpose of this guideline, the definitions adhere to
D16.1-2007, the Manual on Classification of Motor Vehicle Traffic
Accidents (http://downloads.nsc.org/pdf/D16.1_Classification_Manual.pdf).
    III. A model crash investigation and incident reporting program
would be structured as follows:
    A. Administration.
    1. There should be a State agency having primary responsibility for
the collection, storing, processing, administration and supervision of
crash investigation and incident reporting information and for
providing this information upon request to other user agencies.
    2. At all levels of government, there should be adequate staffing
(not necessarily limited to law enforcement officers) with the
knowledge, skills and ability to conduct crash investigations and
incident reporting and to process the collected information.
    3. Procedures should be established to assure coordination,
cooperation, and exchange of information among local, State, and
Federal agencies having responsibility for the investigation of motor
vehicle crashes and incidents, and processing of collected data.
    4. Each State should establish procedures for entering crash

investigation and incident information into the statewide traffic
records system (established pursuant to Highway Safety Program
Guideline No. 10 Traffic Records) and for assuring uniformity and
compatibility of this data with the requirements of the system,
including at a minimum:
    a. Use of uniform definitions and classifications as denoted in the
Model Minimum Uniform Crash Criteria Guideline (MMUCC) (http://www.mmucc.us); and
    b. A guideline format for input of data into a statewide traffic
records system.
    B. Crash investigation and incident reporting. Each State should
establish procedures that require the reporting of motor vehicle
crashes and incidents to the responsible State agency within a
reasonable time after the occurrence.
    C. Driver reports.
    1. In motor vehicle crashes involving only property damage, and
where the motor vehicle can be safely driven away from the scene, the
drivers of the motor vehicles involved should be required to submit a
written report consistent with State reporting requirements, to the
responsible State agency. A motor vehicle should be considered capable
of being normally and safely driven if it does not require towing and
can be operated under its own power, in its customary manner, without
further damage or hazard to itself, other traffic elements, or the
roadway. Each driver report should include, at a minimum, the following
information relating to the crash:
    a. Location.
    b. Date.
    c. Time.
    d. Identification of drivers.
    e. Identification of the owner.
    f. Identification of any pedestrians, passengers, and pedal-
cyclists.
    g. Identification of the motor vehicles.
    h. Direction of travel of each motor vehicle involved.
    i. Other property involved.
    j. Environmental conditions existing at the time of the accident.
    k. A narrative description of the events and circumstances leading
up to the time of the crash and immediately after the crash.
    2. In all other motor vehicle crashes or incidents, the drivers of
the motor vehicles involved should be required to immediately notify
and report the motor vehicle crash or incident to the nearest law
enforcement agency of the jurisdiction in which the motor vehicle crash
or incident occurred. This includes, but is not limited to, motor
vehicle crashes or incidents involving: (1) Fatal or nonfatal personal
injury or (2) damage to the extent that any motor vehicle involved
cannot be driven under its own power, and therefore requires towing.
    D. Motor vehicle crash investigation and incident reporting. Each
State should establish a plan for motor vehicle crash investigation and
incident reporting that meets the following criteria:
    1. A law enforcement agency investigation should be conducted of
all motor vehicle crashes and incidents identified in section III.C.2.
of this guideline. Information collected should be consistent with the
law enforcement mission of detecting and apprehending violators of any
criminal or traffic statute, regulation or ordinance, and should
include, as a minimum, the following:
    a. Violation(s), if any occurred, cited by section and subsection,
numbers and titles of the State code, that contributed to the motor
vehicle crash or incident or for which the driver was arrested or
cited.
    b. Information supporting each of the elements of the offenses for
which the driver was arrested or cited.
    c. Information (collected in accordance with the program
established under Highway Safety Program Guideline No. 15, Traffic Law
Enforcement Services), relating to human, vehicular, and roadway
factors causing individual motor vehicle crashes and incidents,
injuries, and deaths, including failure to use seat belts.
    2. Multidisciplinary motor vehicle crash investigation teams should
be established, with representatives from appropriate interest areas,
such as law enforcement, prosecutorial, traffic, highway and automotive
engineering, medical, behavioral, and social sciences. Data gathered by
each member of the investigation team should be consistent with the
mission of the member's agency, and should be for the purpose of
determining the causes of motor vehicle crashes, injuries, and deaths.
These teams should conduct investigations of an appropriate sampling of
motor vehicle crashes in which there were one or more of the following
conditions:
    a. Locations that have a similarity of design, traffic engineering
characteristics, or environmental conditions, or that have a
significantly large or disproportionate number of crashes.
    b. Motor vehicles or motor vehicle parts that are involved in a
significantly large or disproportionate number of motor vehicle
crashes, or fatal or injury-producing crashes or incidents.
    c. Drivers, pedestrians, and motor vehicle occupants of a
particular age, sex, or other grouping, who are involved in a
significantly large or disproportionate number of fatal or injury
producing motor vehicle crashes or incidents.
    d. Motor vehicle crashes in which the causation or the resulting
injuries and property damage are not readily explainable in terms of
conditions or circumstances that prevailed.
    e. Other factors that concern State and national emphasis programs.
    IV. Evaluation. The program should be evaluated at least annually
by the State. The National Highway Traffic Safety Administration should
be provided with a copy of the evaluation.

    Authority:  23 U.S.C. Section 402.

    Issued on: June 14, 2012.
Jeff Michael,
Associate Administrator for Research and Program Development.
[FR Doc. 2012-15011 Filed 6-19-12; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register: August 27, 2010 (Volume 75, Number 166)]
[Notices]
[Page 52755-52756]
[DOCID:fr27au10-63]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0433]

Draft Guidance for Industry on Acute Bacterial Skin and Skin
Structure Infections: Developing Drugs for Treatment; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Acute
Bacterial Skin and Skin Structure Infections: Developing Drugs for
Treatment.'' The purpose of this draft guidance is to assist clinical
trial sponsors and investigators in the development of antimicrobial
drugs for the treatment of acute bacterial skin and skin structure
infections (ABSSSI), impetigo, and minor cutaneous abscesses. FDA's
thinking in this area has evolved in recent years, and this draft
guidance, when finalized, will inform sponsors of the changes in the
definitions of ABSSSI and the recommendations for clinical drug
development.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 26, 2010.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://
www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Joseph G. Toerner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6244, Silver Spring, MD 20993-0002, 301-
796-1300.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Acute Bacterial Skin and Skin Structure Infections:
Developing Drugs for Treatment.'' The purpose of this draft guidance is
to assist clinical trial sponsors and investigators in the development
of antimicrobial drugs for the treatment of ABSSSI, impetigo, and minor
cutaneous abscesses. This guidance revises the draft guidance regarding
uncomplicated and complicated skin and skin structure infections
published in 1998. The guidance also addresses the clinical development
of new drugs to treat drug-resistant bacterial pathogens implicated in
ABSSSI, such as methicillin-resistant Staphylococcus aureus.
    The definitions of ABSSSI and the designs of ABSSSI clinical trials
were discussed at a meeting of the Anti-Infective Drugs Advisory
Committee on November 18, 2008. In addition, other advisory committee
meetings have focused on the development of specific drugs for this
indication. As a result of these public discussions, as well as review
of applications at FDA, the agency's thinking in this area has evolved
in recent years and this draft guidance informs sponsors of the changes
in our recommendations. Specifically, the guidance defines the clinical
disease entities and provides a justification for a noninferiority
margin for the design of active-controlled clinical trials that can be
used to provide evidence of efficacy for the treatment of ABSSSI. The
guidance describes a new responder efficacy endpoint for noninferiority
trials that is based on the historical studies used to justify the
noninferiority margin. Currently, there are ongoing efforts in the
scientific community to develop and evaluate new efficacy endpoints for
ABSSSI. The guidance also defines the clinical disease entities of skin
infections for which a superiority trial is recommended.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on developing
drugs for the treatment of ABSSSI. It does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
The collections of information in 21 CFR part 312 have been approved
under OMB control number 0910-0014 and the collections of information
in 21 CFR part 314 have been approved under OMB control number 0910-
0001.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http:/
/www.regulations.gov.

    Dated: August 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-21328 Filed 8-26-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register: April 6, 2006 (Volume 71, Number 66)]
[Notices]
[Page 17463]
[DOCID:fr06ap06-63]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-279-000]

Eastern Shore Natural Gas Company; Notice of Proposed Changes in
FERC Gas Tariff

March 30, 2006.
    Take notice that on March 27, 2006 Eastern Shore Natural Gas
Company (Eastern Shore) tendered for filing revised tariff sheets,
proposed to be effective April 1, 2006.

Sixtieth Revised Sheet No. 7
Sixtieth Revised Sheet No. 8

    Eastern Shore states that copies of its filing are available for
public inspection at 417 Bank Lane, Dover, Delaware and a copy has been
mailed to its customers and interested state commissions.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible online at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-4964 Filed 4-5-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 47 (Tuesday, March 11, 2014)]
[Notices]
[Page 13728]
[FR Doc No: 2014-05342]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

In The Matter Of Global Earth Energy, Inc.; Order of Suspension
of Trading

March 7, 2014.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Global Earth Energy, Inc. (``Global Earth'') because, among other
things, of questions regarding the accuracy and completeness of Global
Earth's representations to investors and prospective investors in
Global Earth's public filings with the Commission and Global Earth's
publicly-available press releases and other public statements. In
particular, there are questions regarding the accuracy and completeness
of Global Earth's public assertions relating to its business
transactions with Hawk Manufacturing Corp. Based on Global Earth's most
recent Form 10-K annual report filed for the company's fiscal year
ended August 31, 2013, Global Earth is a Nevada corporation based in
Wilmington, North Carolina. As of March 5, 2014, the company's common
stock was quoted on OTC Link operated by OTC Markets Group, Inc. under
the symbol ``GLER.''
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of Global Earth.
    Therefore, it is ordered, pursuant to Section 12(k) of the
Securities Exchange Act of 1934, that trading in the securities of
Global Earth is suspended for the period from 9:30 a.m. EST on March 7,
2014, through 11:59 p.m. EDT on March 20, 2014.

    By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2014-05342 Filed 3-7-14; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 59 (Monday, March 28, 2016)]
[Rules and Regulations]
[Page 17061]
[FR Doc No: 2016-06835]

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Rules and Regulations
                                                Federal Register
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This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

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Prices of new books are listed in the first FEDERAL REGISTER issue of each
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Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Rules
and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2015-7485; Airspace Docket No. 15-AGL-25]

Amendment of Class D and Class E Airspace; Minot, ND

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule, correction.

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SUMMARY: This action further corrects a final rule published in the
Federal Register of February 4, 2016, and corrected in the Federal
Register of March 3, 2016, amending the Class D and E airspace areas at
Minot International Airport, Minot, ND. This correction adds part-time
Notice to Airmen (NOTAM) language inadvertently removed to the Class E
surface area description, and removes duplicative Class E extension
airspace boundary information language from the Class E surface area
description.

DATES: Effective 0901 UTC, March 31, 2016. The Director of the Federal
Register approves this incorporation by reference action under Title 1,
Code of Federal Regulations, part 51, subject to the annual revision of
FAA Order 7400.9 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.9Z, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone:<PHONE_NUMBER>.
The Order is also available for inspection at the National Archives and
Records Administration (NARA). For information on the availability of
FAA Order 7400.9Z at NARA, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.9, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On February 4, 2016, the FAA published a final rule in the Federal
Register amending the Class E surface area and Class E extension
airspace areas at Minot International Airport, Minot, ND (81 FR 5903)
Docket No. FAA-2015-7485. A final rule correction was published in the
Federal Register to include Class D and Class E airspace extending
upward from the surface (81 FR 11103, March 3, 2016). Subsequent to
publication, the FAA determined the part-time NOTAM language in the
Class E surface area description was inadvertently removed in error,
and the Class E extension airspace boundary information that is
contained in the Class E surface area description should be removed.
Potential safety concerns were identified due to the possibility for
confusion in determining the operating rules and equipment requirements
in the Minot International Airport terminal area. The concerns were
based on the opportunity for part-time Class D surface area airspace
and continuous Class E surface area airspace to be active at the same
time, as well as having the same Class E extension airspace boundary
information published in both the Class E surface area and the Class E
extension airspace descriptions.
    To resolve these concerns, the FAA is keeping the part-time NOTAM
language in the Class E surface area description to retain it as part-
time airspace supplementing the existing part-time Class D surface area
airspace at Minot International Airport, and removing the Class E
extension airspace boundary information from the Class E surface area
description. The regulatory text is rewritten for clarity. These are
administrative corrections and do not affect the controlled airspace
boundaries or operating requirements supporting operations in the Minot
International Airport terminal area.

Correction to Final Rule

0
Accordingly, pursuant to the authority delegated to me, in the Federal
Register of February 4, 2016 (81 FR 5903) FR Doc. 2016-02036, and
corrected in the Federal Register of March 3, 2016 (81 FR 11103) FR
Doc. No. 2016-04482, Amendment of Class D and Class E Airspace, Minot,
ND, is corrected as follows:

Sec.  71.1  [Amended]

AGL ND E2 Minot, ND [Corrected]

    On page 5904, column 3, beginning on line 29, remove the following
text: ``Within a 4.2-mile radius of Minot International Airport and
within 3.5 miles each side of the Minot VORTAC 129 [deg] radial,
extending from the 4.2-mile radius of the airport to 7 miles southeast
of the VORTAC, and within 3.5 miles each side of the Minot VORTAC 260
[deg] radial, extending from the 4.2-mile radius of the airport to 7
miles west of the VORTAC, and within 3.5 miles each side of the Minot
VORTAC 327 [deg] radial, extending from the 4.2-mile radius of the
airport to 7 miles northwest of the VORTAC, and within 3.5 miles each
side of the Minot VORTAC 097 [deg] radial, extending from the 4.2-mile
radius to 7 miles east of the VORTAC, excluding the portion which
overlies the Minot AFB, ND, Class D airspace area''; and add in its
place the following text:
    ``Within a 4.2-mile radius of Minot International Airport. This
Class E airspace area is effective during the specific dates and times
established in advance by a Notice to Airman. The effective date and
time will thereafter be continuously published in the Airport/Facility
Directory.''

    Issued in Fort Worth, Texas, on March 16, 2016.
Walter Tweedy,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2016-06835 Filed 3-25-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 14 (Thursday, January 22, 2015)]
[Notices]
[Pages 3308-3309]
[FR Doc No: 2015-01007]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2012-0337]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

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SUMMARY: FMCSA announces its decision to renew the exemptions from the
vision requirement in the Federal Motor Carrier Safety Regulations for
13 individuals. FMCSA has statutory authority to exempt individuals
from the vision requirement if the exemptions granted will not
compromise safety. The Agency has concluded that granting these
exemption renewals will provide a level of safety that is equivalent to
or greater than the level of safety maintained without the exemptions
for these commercial motor vehicle (CMV) drivers.

DATES: This decision is effective February 11, 2015. Comments must be
received on or before February 23, 2015.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) numbers: Docket No. [Docket No. FMCSA-2012-
0337], using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and
5 p.m., Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number for this notice. Note that DOT posts all comments
received without change to http://www.regulations.gov, including any
personal information included in a comment. Please see the Privacy Act
heading below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The Federal Docket Management System (FDMS) is
available 24 hours each day, 365 days each year. If you want
acknowledgment that we received your comments, please include a self-
addressed, stamped envelope or postcard or print the acknowledgement
page that appears after submitting comments on-line.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Charles A. Horan, III, Director,
Office of Carrier, Driver and Vehicle Safety,<PHONE_NUMBER>,
<EMAIL_ADDRESS>FMCSA, Department of Transportation, 1200 New
Jersey Avenue SE., Room W64-224, Washington, DC 20590-0001. Office
hours are from 8:30 a.m. to 5 p.m. Monday through Friday, except
Federal holidays.

SUPPLEMENTARY INFORMATION:

I. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption
from the vision requirements in 49 CFR 391.41(b)(10), which applies to
drivers of CMVs in interstate commerce, for a two-year period if it
finds ``such exemption would likely achieve a level of safety that is
equivalent to or greater than the level that would be achieved absent
such exemption.'' The procedures for requesting an exemption (including
renewals) are set out in 49 CFR part 381.

II. Exemption Decision

    This notice addresses 13 individuals who have requested renewal of
their exemptions in accordance with FMCSA procedures. FMCSA has
evaluated these 13 applications for renewal on their merits and decided
to extend each exemption for a renewable two-year period. They are:

Joseph Colecchi (PA)
William A. Donovan (WA)
Douglas Eamens (NY)
Brian Knust (IL)
James W. Long (AR)
Dean L. Price (WA)
Roberto A. Ramos (TX)
Johnie Reed (VA)
Sammie Q. Soles, Jr. (MI)
Joseph Stenberg (MT)
Karl H. Strangfeld (UT)
Grover C. Taylor (VA)
Donald L. Weston (PA)

    The exemptions are extended subject to the following conditions:
(1) That each individual has a physical examination every year (a) by
an ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the requirements in 49 CFR 391.41(b)(10),
and (b) by a medical examiner who attests that the individual is
otherwise physically qualified under 49 CFR 391.41; (2) that each
individual provides a copy of the ophthalmologist's or optometrist's
report to the medical examiner at the time of the annual medical
examination; and (3) that each individual provide a copy of the annual
medical certification to the employer for retention in the driver's
qualification file and retains a copy of the certification on his/her
person while driving for presentation to a duly authorized Federal,
State, or local enforcement official. Each exemption will be valid for
two years unless

rescinded earlier by FMCSA. The exemption will be rescinded if: (1) The
person fails to comply with the terms and conditions of the exemption;
(2) the exemption has resulted in a lower level of safety than was
maintained before it was granted; or (3) continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315.

III. Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application for additional two year periods. In accordance with 49
U.S.C. 31136(e) and 31315, each of the 13 applicants has satisfied the
entry conditions for obtaining an exemption from the vision
requirements (77 FR 70534; 78 FR 9772). Each of these 13 applicants has
requested renewal of the exemption and has submitted evidence showing
that the vision in the better eye continues to meet the requirement
specified at 49 CFR 391.41(b)(10) and that the vision impairment is
stable. In addition, a review of each record of safety while driving
with the respective vision deficiencies over the past two years
indicates each applicant continues to meet the vision exemption
requirements.
    These factors provide an adequate basis for predicting each
driver's ability to continue to drive safely in interstate commerce.
Therefore, FMCSA concludes that extending the exemption for each
renewal applicant for a period of two years is likely to achieve a
level of safety equal to that existing without the exemption.

IV. Public Participation and Request for Comments

    FMCSA encourages you to participate by submitting comments and
related materials.

Submitting Comments

    If you submit a comment, please include the docket number for this
notice (FMCSA-2012-0337), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online or by fax, mail, or hand delivery, but please use only one of
these means. FMCSA recommends that you include your name and a mailing
address, an email address, or a phone number in the body of your
document so the Agency can contact you if it has questions regarding
your submission.
    To submit your comment online, go to http://www.regulations.gov and
put the docket number, ``FMCSA-2012-0337'' in the ``Keyword'' box, and
click ``Search.'' When the new screen appears, click on ``Comment
Now!'' button and type your comment into the text box in the following
screen. Choose whether you are submitting your comment as an individual
or on behalf of a third party and then submit. If you submit your
comments by mail or hand delivery, submit them in an unbound format, no
larger than 8\1/2\ by 11 inches, suitable for copying and electronic
filing. If you submit comments by mail and would like to know that they
reached the facility, please enclose a stamped, self-addressed postcard
or envelope. FMCSA will consider all comments and material received
during the comment period and may change this notice based on your
comments.

Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble as being available in the docket, go to http://www.regulations.gov and in the search box insert the docket number,
``FMCSA-2012-0337'' in the ``Keyword'' box and click ``Search.'' Next,
click ``Open Docket Folder'' button choose the document listed to
review. If you do not have access to the Internet, you may view the
docket online by visiting the Docket Management Facility in Room W12-
140 on the ground floor of the DOT West Building, 1200 New Jersey
Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., e.t.,
Monday through Friday, except Federal holidays.

    Issued on: January 12, 2015.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2015-01007 Filed 1-21-15; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 79, Number 226 (Monday, November 24, 2014)]
[Rules and Regulations]
[Page 69760]
[FR Doc No: 2014-27811]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2014-0988]

Drawbridge Operation Regulation; Three Mile Creek, Mobile, AL

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the CSX Transportation Railroad Swing
Span Bridge across Three Mile Creek, mile 0.3, at Mobile, Baldwin
County, Alabama. This deviation is necessary to conduct maintenance to
the bridge. This deviation allows the bridge to remain temporarily
closed to navigation for twelve hours during one day and then operate
during daylight hours only for eight consecutive days within a span of
nine days.

DATES: This deviation is effective from 7:00 a.m. on Thursday, November
27, 2014, through 6:00 p.m. on Friday, December 5, 2014.

ADDRESSES: The docket for this deviation, [USCG-2014-0988] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Geri Robinson, Bridge Administration
Branch, Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Cheryl F. Collins, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION: CSX Transportation requested a temporary
deviation to repair the center bearing and rack circle, which affects
the opening and closing of the swing span bridge across Three Mile
Creek at mile 0.3 at Mobile, Baldwin County, Alabama. This maintenance
is essential for the continued operation of the bridge and is expected
to guard against frequent breakdowns resulting in emergency bridge
closures. The bridge owner plans to replace the center bearing and
rehabilitate the rack circle. To accomplish the necessary repairs, the
bridge owner requested that the bridge be allowed to remain closed to
navigation for twelve consecutive hours on Thursday, November 27, 2014
from 7 a.m. until 7 p.m. to replace the center bearing. Immediately
following this closure, the bridge owner will open the bridge to allow
all vessels to clear the queue. After clearing the queue, the bridge
will be closed to navigation until Friday, November 28, at 8 a.m. At
that time, the bridge will open on signal from 8 a.m. until 6 p.m. for
eight consecutive days. During evening and nighttime hours, between 6
p.m. and 8 a.m., the bridge will open at midnight for the passage of
vessels if at least two hours advanced notice is given. During this
temporary deviation, the bridge owner will rehabilitate and reinstall
the rack circle. During this time period, the bridge will be opened by
use of an assist tug and operations may take longer than normal. At 6
p.m. on Friday, December 5, 2014, the bridge will return to normal
operation.
    The swing span bridge has a vertical clearance of 10 feet above
mean high water and 12 feet above mean low water in the closed-to-
navigation position. Navigation on the waterway is primarily
commercial, consisting of tugs with tows and fishing vessels. There is
no recreational boat traffic at the bridge site. These closures have
been discussed with waterway users and facilities and no objections to
the closure have been expressed. In accordance with 33 CFR 117.5, the
draw of the bridge opens on signal. No alternate routes are available.
    In accordance with 33 CFR 117.35(e), this bridge must return to its
regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: November 10, 2014.
David M. Frank,
Bridge Administrator, Eighth Coast Guard District.
[FR Doc. 2014-27811 Filed 11-21-14; 8:45 am]
BILLING CODE 9110-04-P