[Federal Register: August 13, 2008 (Volume 73, Number 157)]
[Notices]
[Page 47162-47164]
[DOCID:fr13au08-68]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-Docket ID No. ORD-2008-0597; FRL-8703-4]

Guidance on the Development, Evaluation and Application of
Environmental Models

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.

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SUMMARY: EPA is announcing a 30-day public comment period for an
external review of its Guidance Document on the

Development, Evaluation and Application of Regulatory Environmental
Models (hereinafter Guidance Document). The EPA's Council on Regulatory
Environmental Modeling (CREM) has developed the Guidance Document and
its companion product, the Models Knowledge Base, to improve the
quality, consistency and transparency of EPA models. These products
were produced in draft form in November 2003 and have undergone a
rigorous process of internal and external peer review. This revised
draft of the Guidance Document builds on the recommendations of the
Science Advisory Board review panel and the National Research Council
report on Models in Environmental Regulatory Decision Making.
    This Federal Register Notice is intended to solicit public comment
on the Guidance Document. EPA is releasing this external review draft
document solely for the purpose of public comment under applicable
information quality guidelines. The guidance document has not been
formally disseminated by EPA. It does not represent and should not be
construed to represent any Agency policy or determination. EPA will
consider any public comments submitted in accordance with this notice
when revising the document.

DATES: Comments may be submitted in writing by September 12, 2008.

ADDRESSES: The Guidance Document may be downloaded from the CREM Web
site: http://www.epa.gov/crem. Submit your comments, identified by
Docket ID No. EPA-HQ-ORD-2008-0597, by one of the following methods:
http://www.regulations.gov. Follow the on-line instructions for
submitting comments.
     E-mail<EMAIL_ADDRESS>     Mail: ORD Docket, Environmental Protection Agency,
Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
     Hand Delivery: EPA Docket Center (EPA/DC), Room 3334, EPA
West Building, 1301 Constitution Avenue, NW., Washington, DC 20460,
Attention Docket ID No. EPA-HQ-ORD-2008-0597. Deliveries are only
accepted from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. Special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2008-0597. 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 by statute 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
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.
    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 ORD Docket, EPA/
DC, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC
20460. 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 ORD Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Dr. Noha Gaber, Council for Regulatory
Environmental Modeling, Office of the Science Advisor, 1200
Pennsylvania Ave, NW., Mail Code: 8105R, Washington, DC 20460; by
telephone/voice mail at<PHONE_NUMBER>; Fax:<PHONE_NUMBER>; or via e-
mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: To achieve its mission of protecting human
health and safeguarding the natural environment, the U.S. Environmental
Protection Agency (EPA) often employs mathematical models to study
environmental systems and processes and to inform regulatory decision
making. The EPA established the Council for Regulatory Environmental
Modeling (CREM) in 2000 in an effort to improve the quality,
consistency and transparency of EPA models. At the request of the EPA
Administrator, the CREM developed the Draft Guidance Document on the
Development, Evaluation and Application of Regulatory Environmental
Models (hereinafter Draft Models Guidance, http://www.epa.gov/ord/crem/
library/CREM%20Guidance%20Draft%2012_03.pdf) and the Models Knowledge
Base (hereinafter Models KBase, http://cfpub.epa.gov/crem/knowledge_
base/knowbase.cfm)
    While the Draft Models Guidance does not impose legally binding
requirements on EPA or the public, it provides recommendations on the
principles of good modeling practice, stressing the importance of model
quality, documentation and transparency with the aim of helping to
determine when and how a model can be used to inform a decision. The
Draft Models Guidance was developed in close collaboration with members
of the CREM, who represent the different EPA program and regional
offices, and as such, the document represents the consensus view among
EPA offices. The Draft Models Guidance was also evaluated and approved
by the EPA's Science Policy Council, the Agency's forum for senior
level policy deliberation and coordination on significant science
issues.
    Both the Draft Models Guidance and the Models KBase were issued in
draft form in November 2003. By providing access to its tools and
methods, the EPA increases transparency and can improve the public's
understanding of how sound science is used to make environmental
decisions. In short, these products are intended to help foster a
culture of transparency in developing models.
    In addition to internal review within Agency offices and regions,
the CREM products have undergone an external review process. EPA's
Science Advisory Board (SAB) formed a CREM Guidance Advisory Panel
(hereinafter ``the Panel'') to review the Draft Models Guidance and the
Models KBase. Specifically, the Panel was given seven charge questions
(which can be found at this URL: http://www.epa.gov/fedreg/EPA-SAB/
2003/August/Day-06/sab20034.htm). The Panel concluded its review in
2006

(the report may be found at http://www.epa.gov/sab/panels/
cremgacpanel.html).
    The CREM also commissioned the National Academy of Science (NAS) to
assess evolving scientific and technical issues related to the
selection and use of computational and statistical models in decision
making processes at the EPA. The NAS report which provides advice on
the management, evaluation and use of models at the EPA was released in
2007 (the report may be found at http://www.nap.edu/
catalog.php?record_id=11972).
    This revised draft of the Guidance Document builds on the
recommendations of the Science Advisory Board review panel and the
National Research Council report on Models in Environmental Regulatory
Decision Making.

    Dated: August 6, 2008.
George Gray,
EPA Science Advisor.
[FR Doc. E8-18740 Filed 8-12-08; 8:45 am]

BILLING CODE 6560-50-P


                           Served: August 16, 2004

         UNITED STATES OF AMERICA

   DEPARTMENT OF TRANSPORTATION

           OFFICE OF THE SECRETARY

                  WASHINGTON, D.C.

Issued by the Department of Transportation

on the 11th day of August, 2004

Essential Air Service at

ALAMOGORDO/HOLLOMAN AIR FORCE BASE, NEW MEXICO

under 49 U.S.C. 41731 et seq.

 		Docket OST-1996-1901

Notice of Extension

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

By Order 2004-6-23, served June 30, 2004, the Department requested
proposals on an emergency basis from air carriers interested in
providing essential air service at Alamogordo/Holloman Air Force Base,
New Mexico.  Four air carriers submitted a total of nine proposal
options in response to this order.  By letter dated July 26, 2004, we
requested comments on the air carrier selection from the Mayor of
Alamogordo, the Base Commander of Holloman Air Force Base, the Airport
Manager of White Sands Regional Airport, and the Director of the New
Mexico Department of Transportation, Aviation Division.  We requested
that these comments be submitted by August 13, 2004.

We have received a request dated August 4, 2004, from the Mayor of
Alamogordo, requesting an extension until September 17, 2004, for
submitting the civic parties’ comments.  In support of his request,
the Mayor states that questions have arisen that have required
additional research by the City of Alamogordo.

We will grant this request, and in so doing, will grant all of the
civic parties until September 17, 2004, to submit their comments on the
service proposals for Alamogordo/Holloman Air Force Base.

This action is effective immediately.

Action taken by:	Dennis DeVany, Chief

					EAS and Domestic Analysis Division, X-53

					Office of Aviation Analysis

					Office of the Secretary

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

  HYPERLINK "http://dms.dot.gov/"  http://dms.dot.gov/

 PAGE

-  PAGE   2  -


NAICS: 325300

Pesticide Registrants

Labor Category: Formula                                   Managerial                                    Technical                                    Clerical

Unloaded Hourly Rate[1]  = W                                     $57.42                                      $28.32                                      $17.02

Benefits Percentage[2] Lb = B/W                                       44%                                       44%                                       44%

Benefits per hour B = W*Lb                                     $25.31                                      $12.49                                      $7.50

Loaded Hourly Rate Wb = W + B = W(1+Lb)                                     $82.73                                      $40.81                                      $24.52

Overhead Percentage[3] Lo = OH/Wb                                       50%                                       50%                                       50%

Overhead per hour OH = Wb*Lo                                     $41.37                                      $20.40                                      $12.26

Fully Loaded Hourly Rate Wf = Wb + OH  = W + B + OH                                      $124.10                                      $61.21                                      $36.79

1.  Data Source:  BLS http://www.bls.gov/oes/current/naics4_325300.htm May 2011 data

     NAICS 325300 - Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing

     Standard Occupational Codes:

       Management:    11-0000, Management Occupations

       Technical:    19-0000, Life, Physical, and Social Science Occupations

       Clerical:    43-0000, Office and Administrative Support Occupations

2. Fringe benefits/wage per hour.  The average for non farm, non federal civilian workers.

3. U. S. Environmental Protection Agency, EPA Air Pollution Control Cost Manual, Sixth Edition, EPA-452-02-001, January 2002, pg. 2-34.  The loading for indirect costs is within the range of 20-70% of the load labor rate (wage + benefits) suggested in EPA guidance.

NAICS: 999100

EPA or Federal Government

Labor Category: Formula                                   Managerial                                    Technical                                    Clerical

Unloaded Hourly Rate[1]  = W                                     $55.67                                      $36.02                                      $20.38

Benefits Percentage[2] Lb = B/W                                       44%                                       44%                                       44%

Benefits per hour B = W*Lb                                     $24.54                                      $15.88                                      $8.98

Loaded Hourly Rate Wb = W + B = W(1+Lb)                                     $80.21                                      $51.90                                      $29.36

Overhead Percentage[3] Lo = OH/Wb                                       50%                                       50%                                       50%

Overhead per hour OH = Wb*Lo                                     $40.11                                      $25.95                                      $14.68

Fully Loaded Hourly Rate Wf = Wb + OH  = W + B + OH                                      $120.32                                      $77.85                                      $44.05

1.  Data Source:  BLS http://www.bls.gov/oes/current/naics4_999100.htm  May 2011 data

     NAICS 999100 - Federal Executive Branch

     Standard Occupational Codes:

       Management:    11-0000, Management Occupations

       Technical:    19-0000, Life, Physical, and Social Science Occupations

       Clerical:    43-0000, Office and Administrative Support Occupations

2. Fringe benefits/wage per hour.  The average for non farm, non federal civilian workers.

3. U. S. Environmental Protection Agency, EPA Air Pollution Control Cost Manual, Sixth Edition, EPA-452-02-001, January 2002, pg. 2-34.  The loading for indirect costs is within the range of 20-70% of the load labor rate (wage + benefits) suggested in EPA guidance.


Comment Info: =================

General Comment:I use e-cigarettes.  They don't look like a cigarette.  They contain none of the known carcinogens of cigarettes.
The liquid is vaporized, not burned, and it contains 2 compounds that appear to be harmless (vegetable glycerin and propylene glycol) plus a little bit of FDA-approved food flavoring.  And some Nicotine.
I spent a lot of time researching the devices and liquids - AFTER I tried one and almost immediately stopped smoking.
That was about 18 months ago.
I've reduced the use of nicotine - because it was easy to do so, rather than because I really had any other motivation.
I'm quite healthy and happy "vaping".

It is clear from the proposed rule changes that there is a LACK OF UNDERSTANDING of the use of these products, and a lack of scientific evidence regarding any potential harm.  This ruling seems to be reacting to external influences, including some misinformed media regarding the products.

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491.

I am requesting that the comment period for the Proposed Rule be extended by the FDA for AT LEAST an additional 100 days, if not a year while further studies are completed that may impact the rules.

The Proposed Rule includes SO MANY unanswered questions, that most consumers will not be able to properly voice their concerns and responses in the timeframe currently scheduled.

The FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments.

Thanks Sincerely,
T2


  SEQ CHAPTER \h \r 1 ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2010-0011; FRL __________]

Approval and Promulgation of Implementation Plan; State of Iowa

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Proposed rule.

SUMMARY:  EPA proposes to approve revisions to the Iowa State
Implementation Plan (SIP) submitted by the State on April 28, 2009.  The
purpose of these revisions is to update existing air quality rules; make
corrections, clarifications and improvements; and to add information
with regard to the application of permit exemptions.  EPA is proposing
to approve the SIP revisions pursuant to section 110 of the Clean Air
Act.

DATES:  Comments on this proposed action must be received in writing by
[insert date 30 days from the date of publication in the Federal
Register].

ADDRESSES:    SEQ CHAPTER \h \r 1 Submit your comments, identified by
Docket ID No. EPA-R07-OAR-2010-0011, by mail to Tracey Casburn,
Environmental Protection Agency, Air Planning and Development Branch,
901 North 5th Street, Kansas City, Kansas 66101.  Comments may also be
submitted electronically or through hand delivery/courier by following
the detailed instructions in the ADDRESSES section of the direct final
rule located in the rules section of this Federal Register.

FOR FURTHER INFORMATION CONTACT:  Tracey Casburn at<PHONE_NUMBER>, or
by e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:  In the final rules section of the Federal
Register, EPA is approving the state’s revision as a direct final rule
without prior proposal because the Agency views this as a
noncontroversial revision amendment and anticipates no relevant adverse
comments to this action.  A detailed rationale for the approval is set
forth in the direct final rule.  If no relevant adverse comments are
received in response to this action, no further activity is contemplated
in relation to this action.  If EPA receives relevant adverse comments,
the direct final rule will be withdrawn and all public comments received
will be addressed in a subsequent final rule based on this proposed
action.  EPA will not institute a second comment period on this action.
Any parties interested in commenting on this action should do so at this
time.  Please note that if EPA receives adverse comment on part of this
rule and if that part can be severed from the remainder of the rule, EPA
may adopt as final those parts of the rule that are not the subject of
an adverse comment.  For additional information, see the direct final
rule which is located in the rules section of this Federal Register.

Dated:  __February 23, 2010._____	_/s/ Karl Brooks    ____

							Karl Brooks,

							Regional Administrator,

							Region 7.

  PAGE  2

  PAGE  2


1 Hydrogen Cyanide/

Hydrogen Cyanide/ Amygdalin Amygdalin Charge to the HSRB Charge to the HSRB When sodium cyanide is used as a fumigant,

hydrogen cyanide is generated by acidification.

Because residues of HCN may remain on fumigated citrus, the Agency is conducting an acute dietary risk assessment of hydrogen cyanide. 2 Hydrogen Cyanide/

Hydrogen Cyanide/ Amygdalin Amygdalin Charge to the HSRB Charge to the HSRB 1. Scientific considerations:

The Agency's WOE document describes a lack of data appropriate for developing an acute dietary risk assessment for hydrogen cyanide. The WOE and DER present the results from a clinical trial with amygdalin and the usefulness of this clinical trial in the acute dietary risk assessment for hydrogen cyanide. The Agency has concluded that the clinical trial is appropriate for establishing a point of departure in the acute dietary risk assessment for hydrogen cyanide.

Please comment on the scientific evidence that supports this conclusion. 3 2. Ethical considerations:

In its ethics review of this research, EPA did not identify any deficiencies with respect to the ethical conduct of this research. The Agency asks that the Board provide comment on the following, taking into account all that is known about the ethical conduct of this study:

 OPP's conclusion that there is not clear and convincing evidence that the conduct of the research was fundamentally unethical; and  whether there is clear and convincing evidence that the conduct of the study was significantly deficient relative to the ethical standards prevailing when the study was conducted.

Hydrogen Cyanide/

Hydrogen Cyanide/ Amygdalin Amygdalin Charge to the HSRB Charge to the HSRB


[Federal Register Volume 79, Number 106 (Tuesday, June 3, 2014)]
[Rules and Regulations]
[Page 31865]
[FR Doc No: 2014-12812]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2014-0401]

Drawbridge Operation Regulation; Tennessee River, Decatur, AL

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulations.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Southern Railroad Drawbridge across
the Tennessee River, mile 304.4, at Decatur, Alabama. The deviation is
necessary to allow the bridge owner time to replace and adjust the down
haul operating ropes that are essential to the continued safe operation
of the drawbridge. This deviation allows the bridge to remain in the
closed-to-navigation position and not open to vessel traffic.

DATES: This deviation is effective from 8 a.m. to 10 p.m., June 17,
2014.

ADDRESSES: The docket for this deviation, (USCG-2014-0401) 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 Eric A. Washburn, Bridge
Administrator, Western Rivers, 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<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Norfolk Southern Railroad requested a
temporary deviation for the Southern Railroad Drawbridge, across the
Tennessee River, mile 304.4, at Decatur, Alabama to remain in the
closed-to-navigation position for 14 hours from 8 a.m. to 10 p.m. on
June 17, 2014, in order to replace and adjust the down haul operation
ropes.
    The Southern Railroad Drawbridge currently operates in accordance
with 33 CFR 117.5, which states the general requirement that drawbridge
shall open promptly and fully for the passage of vessels when a request
to open is given in accordance with the subpart.
    There are no alternate routes for vessels transiting this section
of the Tennessee River.
    The Southern Railroad Drawbridge, in the closed-to-navigation
position, provides a vertical clearance of 10.52 feet above normal
pool. Navigation on the waterway consists primarily of commercial tows
and recreational watercraft and will not be significantly impacted.
This temporary deviation has been coordinated with waterway users. No
objections were received.
    In accordance with 33 CFR 117.35(e), the drawbridge 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: May 22, 2014.
Eric A. Washburn,
Bridge Administrator, Western Rivers.
[FR Doc. 2014-12812 Filed 6-2-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 138 (Tuesday, July 19, 2011)]
[Notices]
[Pages 42707-42709]
[FR Doc No: 2011-18161]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OEI-2011-0349; FRL-9441-3]

Amendment of OIG Hotline Allegation System (EPA-30)

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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

SUMMARY: Pursuant to the provisions of the Privacy Act of 1974 (5
U.S.C. 552a), the Office of Inspector General (OIG) is giving notice
that it proposes to amend an existing system of records by changing the
name of the system from the Office of Inspector General (OIG) Hotline
Allegation System (EPA-30) to the Inspector General Enterprise
Management System (IGEMS) Hotline Module.

DATES: Effective Dates: Persons wishing to comment on this system of
records notice must do so by August 29, 2011.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OEI-2011-0349, by one of the following methods:
     http://www.regulations.gov: Follow the online instructions
for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: OEI Docket, Environmental Protection Agency,
Mailcode: 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-
2011-0349. 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 for which
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov. 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
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 http://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 http://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: Chris Han,<PHONE_NUMBER>

SUPPLEMENTARY INFORMATION:

I. General Information

    The OIG Hotline Allegation System (EPA-30) will be changed to the
Inspector General Enterprise Management System (IGEMS) Hotline Module.
This system fulfills our responsibilities under Section 7 of the
Inspector General Act, that is to receive and investigate complaints of
information concerning the possible existence of activities
constituting a violation of law, rules, or regulations, mismanagement,
gross waste of funds, abuse of authority or a substantial and specific
danger to the public health or safety, and the subject of the
complaints. The privacy of individuals is protected through user
authentication and system roles, permissions and privileges. The system
is operated and maintained by the Office of Inspector General, Office
of Mission Systems.

    Dated: July 8, 2011.
Malcolm D. Jackson,
Assistant Administrator and Chief Information Officer.
EPA-30

System Name:
    Inspector General Enterprise Management System (IGEMS) Hotline
Module.

System Location:
    Office of Inspector General, Environmental Protection Agency, 1200
Pennsylvania Avenue NW., Washington, DC 20460.

Categories of Individuals Covered by the System:
    Persons who report information to the Office of Inspector General
(OIG) concerning the possible existence of activities constituting a
violation of law, rules, or regulations, mismanagement gross waste of
funds, abuse of authority, or a substantial and specific danger to the
public health or safety and the subject of the complaints; persons
about whom complaints are made; and possible witnesses identified.

Categories of Records in the System:
    Complainants who report indications of wrongdoing, name and address
of the complainant (except for anonymous complainants), date complaint
received, program area, nature and subject of complaint, any additional
contacts and specific comments provided by the complainant, information
on the OIG disposition of the complaint, including investigative case
number, preliminary inquiry number, dates of referral, reply and
follow-up, status and disposition code of the complaint.

Authority for Maintenance of the System (includes any revisions or
amendments):
    Inspector General Act of 1978, 5 U.S.C. app. 3.

Purpose(s):
    Fulfills OIG's responsibilities under Section 7 of the Inspector
General Act, that is to receive and investigate complaints of
information concerning the possible existence of activities
constituting a violation of law, rules or regulations, mismanagement,
gross waste of funds, abuse of authority or a substantial and specific
danger to the public health or safety, and the subject of the
complaints.

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. Records may also be disclosed:
    1. To a Federal agency responsible for considering suspension or
debarment action where such record would be relevant to such action.
    2. To the Department of Justice to obtain its advice on Freedom of
Information Act matters.
    3. In response to a lawful subpoena issued by a Federal agency.

Policies and Practices for Storing, Retrieving, Accessing, Retaining,
and Disposing of Records in the System:
Storage:
    Hard copy files and a computer database.

Retrievability:
    By case number, complainant or subject name, and subject matter.

Safeguards:
    Computer records are maintained in a secure, password protected
computer system. Paper records are maintained in lockable file
cabinets. All records are maintained in secure, access-controlled areas
or buildings.

Retention and Disposal:
    Records stored in this system are subject to EPA Schedule 703.

System Manager(s) and Address:
    Assistant Inspector General for Mission Systems, Office of
Inspector General, Environmental Protection Agency, 1200 Pennsylvania
Avenue NW., Washington, DC 20460.

Notification Procedures:
    Requests to determine whether this system of records contains a
record pertaining to you must be sent to the Agency's Freedom of
Information Office. The address is: U.S. Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Room 6416 West, Washington, DC
20460;<PHONE_NUMBER>; E-mail: (hq.foia@epa.gov); Attn: Privacy Act
Officer.

Record Access Procedure:
    To the extent permitted under the Privacy Act of 1974, 5 U.S.C.
552a(k)(2), this system has been exempted from the provisions of the
Privacy Act of 1974 that permit access and correction. However, EPA
may, in its discretion, fully grant individual requests for access and
correction if it determines that the exercise of these rights will not
interfere with an interest that the exemption is intended to protect.
The exemption from access is limited in some instances by law to
information that would reveal the identity of a confidential source.
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 Procedure:
    Requests for correction or amendment must identify the record to be
changed and the corrective action sought. Complete EPA Privacy Act
procedures are set out in 40 CFR Part 16.

Record Source Categories:
    Complainants who are employees of EPA; employees of other Federal
agencies; employees of state and local agencies; and private citizens.
Records in the system come from complainants through the telephone,
mail, personal interviews, and Internet Web Site. Because security
cannot be guaranteed on the Internet site, complainants are advised
that information they provide through the Internet site may not be
confidential.

Systems Exempted From Certain Provisions of the Act:
    Pursuant to 5 U.S.C. 552a(k)(2), this system is exempt from the
following provisions of the Privacy Act of 1974, subject to the
limitations set forth in that subsection: 5 U.S.C. 552a (c)(3); (d);
(e)(1); (e)(4)(G); (e)(4)(H); and (f)(2) through (5).

[FR Doc. 2011-18161 Filed 7-18-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 37 (Friday, February 24, 2012)]
[Notices]
[Pages 11142-11145]
[FR Doc No: 2012-4268]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2012-0010; OMB No. 1660-0062]

Agency Information Collection Activities: Proposed Collection;
Comment Request, State/Local/Tribal Hazard Mitigation Plans

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on a proposed revision of a currently approved information
collection. In accordance with the Paperwork Reduction Act of 1995,
this notice seeks comments concerning State, Local and Tribal
mitigation plan requirements. While there has been no change to the
information being collected, this proposed adjustment is due to a
change in methodology used to estimate burden.

DATES: Comments must be submitted on or before April 24, 2012.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at www.regulations.gov under Docket ID
FEMA-2012-0010. Follow the instructions for submitting comments.
    (2) Mail. Submit written comments to Regulatory Affairs Division,
Office of Chief Counsel, DHS/FEMA, 500 C Street, SW., Room 835,
Washington, DC 20472-3100.
    (3) Facsimile. Submit comments to<PHONE_NUMBER>.
    (4) Email. Submit comments to<EMAIL_ADDRESS>Include Docket
ID FEMA-2012-0010 in the subject line.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available via the link in the footer of
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Frederick Sharrocks, Branch Chief,
Assessment and Planning Branch, Risk Analysis Division, Federal
Insurance and Mitigation Administration, FEMA,<PHONE_NUMBER> for
additional information. You may contact the Records Management Division
for copies of the proposed collection of information at facsimile
number<PHONE_NUMBER> or email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Section 322 of the Robert T. Stafford
Disaster Relief and Emergency Assistance Act (Stafford Act), 42 U.S.C.
5165, as amended by the Disaster Mitigation Act of 2000 (DMA 2000),
Public Law 106-390, provides new and revitalized approaches to
mitigation planning. The Stafford Act provides a framework for linking
pre-and post-disaster mitigation planning and initiatives with public
and private interests to ensure an integrated, comprehensive approach
to disaster loss reduction. Title 44 CFR part 201 provides the
mitigation planning requirements for State, local and Indian Tribal
governments to identify the natural hazards that impact them, to
identify actions and activities to reduce any losses from hazards, and
to establish a coordinated process to implement the plan, taking
advantage of a wide-range of resources.

Collection of Information

    Title: State/Local/Tribal Hazard Mitigation Plans.
    Type of Information Collection: Revision of a currently approved
information collection.
    OMB Number: OMB No. 1660-0062.
    Form Titles and Numbers: None.
    Abstract: The purpose of State, Local and Tribal Hazard Mitigation
Plan requirements is to support the administration of the Federal
Emergency Management Agency Mitigation grant programs, and contemplate
a significant State, Local and Tribal commitment to mitigation
activities, comprehensive mitigation planning, and strong program
management. Implementation of plans, pre-identified cost-effective
mitigation measures will streamline the disaster recovery process.
Mitigation plans are the demonstration of the goals, priorities to
reduce risks from natural hazards.
    Affected Public: State, local, or Tribal Government.
    Estimated Total Annual Burden Hours: 781,152 hours.

                                                                           Estimated Annualized Burden Hours and Costs
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                No. of                        Avg. burden    Total annual                    Total annual
              Type of respondent                     Form name/ form number           No. of      responses  per   Total No. of    per response     burden  (in     Avg. hourly     respondent
                                                                                respondents      respondent      responses      (in hours)        hours)         wage rate         cost
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Local or Tribal Government....................  New Plan (Local and Tribal).....              56               5             280           2,080         582,400          $44.44     $25,881,856
Local or Tribal Government....................  Plan Updates (Local and Tribal).              56               9             504             320         161,280           44.44       7,167,283
State Government..............................  State Reviews of Local and                    56              14             784               8           6,272           44.44         278,728
                                                 Tribal plans.
State Government..............................  Standard State Plan Updates.....              16               1              16           1,560          24,960           44.44       1,109,222
State Government..............................  Enhanced State Plan Updates.....               3               1               3           2,080           6,240           44.44         277,306
                                                                                ---------------------------------------------------------------------------------------------------------------
    Total.....................................  ................................              56  ..............           1,587  ..............         781,152  ..............      34,714,395
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Note: Contract support from the private sector in developing, updating, and reviewing the plans is not captured in this table.
Note: The ``Avg. Hourly Wage Rate'' for each respondent includes a 1.4 multiplier to reflect a fully-loaded wage rate.
Note: This table assumes that no grant dollars are paying for the Mitigation Plans. Mitigation Plans may be paid for using FEMA mitigation grant programs, which usually has a 75 percent
  Federal cost share.
Note: The No. of Responses per Respondent is based on estimates, which are rounded to whole plans.
Note: The No. of Respondents is based on the number of governments preparing State-level mitigation plans and is inclusive of States, U.S. Territories, and the District of Columbia.

    Estimated Cost: The estimated annual cost to respondents for the
hour burden is $34,714,395. There are no operations and maintenance
costs for technical services. There are no annual start-up or capital
costs. The estimated annual cost to the Federal Government is
$1,506,562.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) Evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

    Dated: February 14, 2012.
John G. Jenkins, Jr.,
Acting Director, Records Management Division, Mission Support Bureau,
Federal Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2012-4268 Filed 2-23-12; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register: October 8, 2008 (Volume 73, Number 196)]
[Notices]
[Page 58970-58972]
[DOCID:fr08oc08-73]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0521]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Clinical Trial Sponsors: Establishment
and Operation of Clinical Trial Data Monitoring Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the collection of information
concerning the establishment and operation of clinical trial data
monitoring committees.

DATES: Submit written or electronic comments on the collection of
information by December 8, 2008.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance for Clinical Trial Sponsors: Establishment and Operation of
Clinical Trial Data Monitoring Committees--(OMB Control Number 0910-
0581)--Extension

    Sponsors are required to monitor studies evaluating new drugs,
biologics, and devices (21 CFR 312.50 and 312.56 for drugs and
biologics, and 21 CFR 812.40 and 812.46 for devices). Various
individuals and groups play different roles in clinical trial
monitoring. One such group is a Data Monitoring Committee (DMC),
appointed by a sponsor to evaluate the accumulating outcome data in
some trials. A clinical trial DMC is a group of individuals with
pertinent expertise that reviews on a regular basis accumulating data
from an

ongoing clinical trial. The DMC advises the sponsor regarding the
continuing safety of current participants and those yet to be
recruited, as well as the continuing validity and scientific merit of
the trial.
    FDA's guidance document is intended to assist sponsors of clinical
trials in determining when a DMC is needed for monitoring a study, and
how such committees should operate. The guidance addresses the roles,
responsibilities, and operating procedures of DMCs, describes certain
reporting and recordkeeping responsibilities, including the following:
(1) Sponsor notification to the DMC regarding waivers, (2) DMC reports
of meeting minutes to the sponsor, (3) sponsor reports to the FDA on
DMC recommendations related to safety, (4) standard operating
procedures (SOPs) for DMCs, and (5) DMC meeting records.
1. Sponsor Notification to the DMC Regarding Waivers
    The sponsor must report to FDA serious unexpected adverse events in
drugs and biologics trials (Sec.  312.32 (21 CFR 312.32)) and
unanticipated adverse events in the case of device trials under (Sec.
812.150(b)(1) (21 CFR 812.150(b)(1))). The agency recommends in the
guidance that sponsors notify DMCs about any waivers granted by FDA for
expedited reporting of certain serious events.
2. DMC Reports of Meeting Minutes to the Sponsor
    The agency recommends in the guidance that the DMC issue a written
report to the sponsor based on the DMC meeting minutes. Reports to the
sponsor should include only those data generally available to the
sponsor. The sponsor may convey the relevant information in this report
to other interested parties, such as study investigators. Meeting
minutes or other information that include discussion of confidential
data would not be provided to the sponsor.
3. Sponsor Reporting to FDA on DMC Recommendations Related to Safety
    The requirement of the sponsor to report DMC recommendations
related to serious adverse events in an expedited manner in clinical
trials of new drugs (Sec.  312.32(c)) would not apply when the DMC
recommendation is related to an excess of events not classifiable as
serious. Nevertheless, the agency recommends in the guidance that
sponsors inform FDA about all recommendations related to the safety of
the investigational product whether or not the adverse event in
question meets the definition of ``serious.''
4. Standard Operating Procedures for DMCs
    In the guidance, we recommend that sponsors establish procedures to
do the following things:
     Assess potential conflicts of interest of proposed DMC
members;
     Ensure that those with serious conflicts of interest are
not included in the DMC;
     Provide disclosure to all DMC members of any potential
conflicts that are not thought to impede objectivity and, thus, would
not preclude service on the DMC;
     Identify and disclose any concurrent service of any DMC
member on other DMCs of the same, related or competing products;
     Ensure separation, and designate a different statistician
to advise on the management of the trial, if the primary study
statistician takes on the responsibility for interim analysis and
reporting to the DMC; and
     Minimize the risks of bias that arise when the primary
study statistician takes on the responsibility for interim analysis and
reporting to the DMC, if it appears infeasible or highly impractical
for any other statistician to take over responsibilities related to
trial management.
5. DMC Meeting Records
    The agency recommends in the guidance that the DMC or the group
preparing the interim reports to the DMC maintain all meeting records.
This information should be submitted to FDA with the clinical study
report (Sec.  314.50(d)(5)(ii) (21 CFR 314.50(d)(5)(ii))).
    Description of Respondents: The submission and data collection
recommendations described in this document affect sponsors of clinical
trials and DMCs.
    Burden Estimate: Table 1 of this document provides the burden
estimate of the annual reporting burden for the information to be
submitted in accordance with the guidance. Table 2 of this document
provides the burden estimate of the annual recordkeeping burden for the
information to be maintained in accordance with the guidance.

Reporting and Recordkeeping Burdens

    Based on information from FDA review divisions, FDA estimates there
are approximately 740 clinical trials with DMCs regulated by the Center
for Biologics Evaluation and Research, the Center for Drug Evaluation
and Research, and the Center for Devices and Radiological Health. FDA
estimates that the average length of a clinical trial is 2 years,
resulting in an annual estimate of 370 clinical trials. Because FDA has
no information on which to project a change in the use of DMCs, FDA
estimates that the number of clinical trials with DMCs will not change
significantly in the next few years. For purposes of this information
collection, FDA estimates that each sponsor is responsible for
approximately 10 trials, resulting in an estimated 37 sponsors that are
affected by the guidance annually.
    Based on information provided to FDA by sponsors that have
typically used DMCs for the kinds of studies for which this guidance
recommends them, FDA estimates that the majority of sponsors have
already prepared SOPs for DMCs, and only a minimum amount of time is
necessary to revise or update them for use for other clinical studies.
FDA receives very few requests for waivers regarding expedited
reporting of certain serious events; therefore, FDA has estimated one
respondent per year to account for the rare instance a request may be
made. FDA estimates that the DMCs would hold two meetings per year per
clinical trial resulting in the issuance of two DMC reports of meeting
minutes to the sponsor. One set of both of the meeting records should
be maintained per clinical trial. Based on FDA's experience with
clinical trials using DMCs, FDA estimates that the sponsor on average
would issue two interim reports per clinical trial to the DMC. FDA
estimates that the DMCs would hold two meetings per year per clinical
trial resulting in the issuance of two DMC reports of meeting minutes
to the sponsor. One set of both meeting records should be maintained
per clinical trial.
    The ``Hours per Response'' and ``Hours per Record'' are based on
FDA's experience with comparable recordkeeping and reporting provisions
applicable to FDA regulated industry. The ``Hours per Response''
include the time the respondent would spend reviewing, gathering, and
preparing the information to be submitted to the DMC, FDA, or the
sponsor. The ``Hours per Record'' include the time to record, gather,
and maintain the information.
    The information collection provisions in the guidance for
Sec. Sec.  312.30 (21 CFR 312.30), 312.32, 312.38 (21 CFR 312.38),
312.55 (21 CFR 312.55), and 312.56 have been approved under OMB Control
No. 0910-0014; Sec.  314.50 has been approved under OMB Control No.
0910-0001; and Sec. Sec.  812.35 (21 CFR 812.35) and 812.150 have been
approved under OMB Control No. 0910-0078.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of       Annual Frequency per     Total Annual        Hours Per
        Section of Guidance/Reporting Activity             Respondents            Response           Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
<IP_ADDRESS>. Sponsor notification to the DMC regarding                      1                     1                  1                .25                .25
 waivers
--------------------------------------------------------------------------------------------------------------------------------------------------------
<IP_ADDRESS>. DMC reports of meeting minutes to the sponsor                370                     2                740                  1                740
--------------------------------------------------------------------------------------------------------------------------------------------------------
5. Sponsor reporting to FDA on DMC recommendations                     37                     1                 37                 .5               18.5
 related to safety
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                758.75
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual
                Recordkeeping Activity                    Recordkeepers      per Recordkeeping        Records       Hours Per  Record     Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
4.1. and 6.4 SOPs for DMCs                                             37                     1                 37                  8                296
--------------------------------------------------------------------------------------------------------------------------------------------------------
<IP_ADDRESS>. DMC meeting records                                          370                     1                370                  2                740
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                1,036
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

    Dated: September 29, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-23833 Filed 10-7-08; 8:45 am]

BILLING CODE 4160-01-S