[Federal Register Volume 77, Number 99 (Tuesday, May 22, 2012)]
[Proposed Rules]
[Pages 30238-30241]
[FR Doc No: 2012-12383]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Parts 91, 119, 120, 121, 135, and 136

[Docket No. FAA-2012-0374 ]

Living History Flight Experience (LHFE)--Exemptions for Passenger
Carrying Operations Conducted for Compensation and Hire in Other Than
Standard Category Aircraft

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of public meeting.

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SUMMARY: The FAA is announcing public meetings to gather additional
technical input on the subject of exemptions relating to the LHFE.
Input gathered will aid in developing future FAA guidance for
evaluating LHFE petitions for exemption. Prior to the public meetings,
the FAA is seeking public comment on the guidance.

DATES: The public meetings will be held on June 26, 27, and 28, 2012,
from 8:00 a.m. until 4:30 p.m. Note that the meetings may be adjourned
early if scheduled speakers complete their presentations early. The
deadline to submit a request to make an oral statement is June 18,
2012. The written comment period will close on June 18, 2012.

ADDRESSES: The public meetings will be held in the FAA Headquarters
building auditorium on the third floor, 800 Independence Ave. SW.,
Washington, DC 20591. Due to limited space, attendees are required to
please reply (RSVP) to<EMAIL_ADDRESS>Seating will be on a first-
come-first-serve basis. If computer access is not possible, please RSVP
via mail, fax or hand delivery via the methods listed directly below:
     Mail or Hand Delivery: RSVP to Flight Standards Service,
General Aviation and Commercial Division, AFS-800, ATTN: LHFE (RSVP),
800 Independence Ave. SW., Washington, DC 20591.
     Fax: RSVP to AFS-800, Attn: LHFE (RSVP) at<PHONE_NUMBER>.
    Written comments (identified by docket number FAA-2012-0374) may be
submitted using any of the following methods:
    [cir] Federal eRulemaking Portal: Go to http://www.regulations.gov
and follow the instructions for sending comments electronically.
    [cir] Mail: Send comments to Docket Operations, M-30, U.S.
Department of Transportation, 1200 New Jersey Avenue SE., West Building
Ground Floor, Room W12-140, Washington, DC 20590.
    [cir] Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    [cir] Hand Delivery: Docket Operations in Room W12-140 of the West
Building Ground Floor at 1200 New Jersey Avenue SE., Washington, DC,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.
    Written comments to the docket will receive the same consideration
as statements made at the public meeting. For more information on the
rulemaking process, see the SUPPLEMENTARY INFORMATION section of this
document.
    Privacy: The FAA will post all comments it receives, without
change, to http://www.regulations.gov, including any personal
information provided by the commenter. Using the search function of the
FAA's docket Web site, anyone can find and read the comments received
into any of the agency's dockets, including the name of the individual
sending the comment (or signing the comment for an association,
business, labor union, etc.). DOT's complete Privacy Act Statement may
be reviewed in the Federal Register published on April 11, 2000 (65 FR
19477-19478) or at http://DocketsInfo.dot.gov.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time or in Docket Operations in Room
W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue
SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Requests to present a statement at the
public meetings and questions regarding the logistics of the meetings
should be directed to Ms. Keira Jones, Office of Rulemaking (ARM-101),
Federal Aviation Administration, 800 Independence Avenue SW.,
Washington, DC 20591; telephone<PHONE_NUMBER>, facsimile (202) 267-
5075.
    Technical questions should be directed to the General Aviation and
Commercial Division, AFS-800, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone (202) 385-
9600, facsimile<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The FAA has historically found an overwhelming public interest in
preserving United States (U.S.) aviation history, including former
military aircraft transferred to private individuals or organizations
for the purpose of restoring and flying these aircraft. The FAA has
further determined that, with appropriate conditions and limitations
imposed for public safety purposes, access to these aircraft can
include allowing the public to experience flight. Because the
regulations (14 CFR) do not otherwise allow such operations, the FAA
established through its mid-1990s Living History Flight Experience
(LHFE) policy that exemptions are an appropriate way to preserve
aviation history and keep historic airplanes operational when
comparable airplanes manufactured under a standard airworthiness
certificate do not exist. The LHFE policy provided a way for the
private owner/operators of historically significant, American-
manufactured large, crew-served, piston-powered, multi-engine, World
War II bomber aircraft to conduct limited passenger carrying flights,
for compensation, as a way to generate funds needed to maintain and
preserve these historically significant aircraft for future
generations.
    Because this policy generated a number of petitions for exemption,
the FAA affirmed that the regulatory scheme adopted in 14 CFR
establishes appropriate safety standards for aircraft operators and
crewmembers. Those requesting an exemption from a particular standard
or set of standards must demonstrate that: (1) The flight cannot be
performed in full compliance with regulations, (2) there is an
overriding public interest in conducting passenger flights on the
aircraft, and (3) the measures to be taken establish an appropriate
level of safety for the flight. Because of this, the FAA limited the
scope of its nostalgia flight exemption to World War II (WWII) or
earlier vintage airplanes (i.e., manufactured before December 31,
1947). The reasoning behind this limitation addressed both public
interest (e.g., the unique opportunity to experience flight in a B-

17 or B-24 while such aircraft can still be safely maintained) and
public safety (e.g., older and slower multi-engine which airplanes
allow time for appropriate corrective measures in the event of an in-
flight emergency, and crews must meet FAA qualification and training
requirements). In addition, the FAA determined that it would not be
prudent to grant exemptions from the FAA regulations to operators of
supersonic jets because the speed of supersonic jets makes it likely
that any in-flight emergency may result in serious injuries or
fatalities. The recent crash of a supersonic jet at an air show that
was piloted by two highly qualified and well-trained flight crewmembers
clearly demonstrates the need to reevaluate LHFE.
    However, even after defining the guidelines for approving LHFE
exemptions, the number of petitions for exemptions outside this scope--
e.g., for former military turbojet-powered aircraft such as the L-29,
L-39, TS-11, Alfa Jet, and others that remain in active military
service--led the FAA to issue further guidance in 2006 on Exemptions
for Passenger-Carrying Operations Conducted for Compensation and Hire
in Other Than Standard Category Aircraft (71 FR 15087). However, the
FAA also noted that in expanding requests beyond the original intent,
i.e., going from a passenger in a B-17 to manipulating the controls of
a fighter jet to conducting simulated aerial combat fights in the
interest of ``the historical experience,'' requires the agency to
reevaluate its policy. The FAA noted that the clear market orientation
of these requests undermines arguments of a public interest goal in
preserving unique historical aircraft.
    Nevertheless, the 2006 policy agreed to consider any request for
exemption for passenger-carrying flights in non-standard category
aircraft, especially former military turbine-engine-powered aircraft,
on a case-by-case basis, including consideration of non-American
manufactured aircraft. However, some petitioners are now creating
business models (as indicated above) that, if authorized by the FAA,
would offer civilians an opportunity to conduct such aerial combat
flights with hands-on flight experience in these aircraft. The FAA did
not contemplate or intend operations of this nature when it originally
developed the LHFE policy and, since issuance of the original policy
and its subsequent revisions, additional issues (e.g., airworthiness
and maintenance concerns) continue to emerge. Because of the high risks
associated with the industry's expanded business model, the FAA has
determined that a comprehensive evaluation of this policy is necessary
and seeks public input.

Purpose of the Public Meetings

    The purpose of the public meetings is for the FAA to hear the
public's views and obtain information relevant to the policy under
consideration. The FAA will consider comments made at the public
meetings (as well as comments submitted to the docket) before making a
final decision on issuance of the policy.
    Persons wishing to attend this one-time meeting are required to
register in advance. Your registration must detail whether you wish to
make a statement during the public meeting. If you do wish to make a
statement, your registration must indicate which of the following
policy topics/questions you wish to speak about and what organization
you represent. Due to limited space, attendees are required to reply
(RSVP) to<EMAIL_ADDRESS>If computer access is not possible,
please RSVP via mail, fax or hand delivery via the methods listed above
in the ADDRESSES section.
    In addition to the information sought during the public meeting,
the FAA seeks information on the following questions. In order for the
FAA to consider expansion of the policy, we must have sufficient data
that provides an equivalent level of safety, address public interest,
along with full background documentation. It is foreseen that
additional limitations will be required for any expansion to the LHFE
policy due to some additions that have been requested (i.e., replica,
turbojet and supersonic aircraft), and not previous contemplated in the
original LHFE policy. Again, the FAA requests that all comments be
accompanied by full documentation.

General Policy

    (a) If changes are made to the LHFE policy that excludes certain
aircraft which are currently allowed in an exemption, how should the
FAA possibly grandfather such operations?
    (b) If LHFE is not limited to original factor built aircraft with
operational history or if replica, reproduction, or look a like
aircraft are to be considered under an expanded LHFE, what are the
safety mitigations and limitations that should be considered and why.
    (c) Should the operational history of the model be considered?
Should the civil and public/military accident rate be considered when
reviewing petitions for LHFE?
    (d) Should the LHFE policy be limited to U.S. manufactured aircraft
(as originally intended) with significant U.S. aviation history? If the
FAA is to expand the scope of LHFE, the following issues must be
addressed:
    i. The operational history of former U.S. military aircraft is
accessible to the FAA while that of foreign aircraft may not be
accessible.
    ii. The FAA has little or no information on the ``standard'' to
which the non-U.S. aircraft were built.
    (e) Should the FAA exclude jets, turbojets and/or supersonic
aircraft? If not, the following issues must be addressed:
    i. High performance aircraft increase the level of complexity for
the operation of these aircraft.
    ii. High performance aircraft add an increased level of complexity
to the maintenance of these aircraft.
    iii. The FAA must consider the higher level of risk brought on by
the higher energy aircraft and ejection seats. What are the industry
standards for the FAA to evaluate on the inherent risks?
    iv. Should the FAA permit turboprop powered aircraft to hold LHFE
status?
    (f) Should the FAA permit single engine aircraft to hold LHFE
status considering policy was originally developed based on the
operation of large, multi-engine, crew served aircraft?
    (g) Should the FAA permit aircraft that were once operated by the
military as single seat aircraft LHFE status if a second seat has been
added? Does this configuration still meet the intent of LHFE?
    (h) The original concept of the exemptions was to permit the public
to experience something that could not be experienced in a ``standard
category'' aircraft. With that in mind, should the FAA permit LHFE in
aircraft for which a standard category aircraft is available and where
comparable experience can be obtained.
    (i) The original concept of the exemptions was to permit the public
to experience something that could not be experienced in a ``standard''
aircraft. With that in mind, should the FAA permit LHFE in aircraft for
which there is a standard version of the same? How do we phase out or
grandfather those that were inadvertently included as LHFE?
    (j) Should the FAA establish an Organizational Delegation
Authority-like process where an authorized industry entity evaluates an
organization's request (training, certification, airworthiness, etc.)
and makes recommends to the FAA.

Issuance, General

    (k) Older aircraft require a rather large commitment on the part of
the operator. Sometimes it may be more than the operator realizes.
Should the FAA require a ``fitness'' standard that considers the
following?
    i. Can the operator operate the aircraft?
    1. How much experience is enough to demonstrate the operator has
the ability to operate the specific type? Or should the FAA consider
their ability to operate a similar aircraft?
    ii. Can the operator maintain the aircraft?
    1. Have they satisfactorily maintained this or a similar aircraft?
    (l) The FAA feels that an operator's compliance history should be
considered. If the operator or its principals have a history of non-
compliance, should the FAA deny the petition?
    i. Should the FAA require a ``violation free'' time period? If so,
how long should it be? What about non-aviation history (i.e., convicted
felon)?
    (m) In part 119 operations, a new operator or one proposing to
conduct operations with a significantly different aircraft may be asked
to conduct proving or validation flights/testing to demonstrate their
ability to conduct the operations proposed.
    i. How much proving or validation flights/testing should be
required if the petitioner does not have experience with the specific
aircraft?
    ii. How much proving or validation flight/testing should be
required if the petitioner does not have experience with a similar
aircraft?
    (n) How can the FAA determine ``Operational Control''? The
exemptions are designed to permit not-for-profit organizations to
support the continued operation of LHFE aircraft. Who owns the
aircraft? Who operates the aircraft? Who is responsible for the
operation of the aircraft? Who really benefits?
    (o) Should the FAA require that LHFE holders carry insurance?

Issuance, Limitations

    (p) Should passengers be permitted to occupy a crew seat/position
considering the following current policy?
    i. The current LHFE policy states: ``No persons other than the
assigned flight crew members may be permitted on the pilot station of
the airplane during flight operations.''
    ii. The FAA has always interpreted this statement as prohibiting
the passengers from manipulating the controls of a single pilot
aircraft but several LHFE holders have complained that the FAA
misapplied the meaning as applied to single pilot aircraft.
    (q) Formation flight is already prohibited by Sec.  91.111(b) but
the FAA feels that ``air combat maneuvering'' at any distance creates
an unacceptable level of risk (formation is popularly defined as flight
within 500 feet). Considering this, should such flights be prohibited
or severely restricted to ensure the safety of the aircraft occupants
and persons and property on the ground?
    (r) Should the FAA prohibit or severely restrict aerobatics in LHFE
aircraft considering the following?
    i. Older aircraft, mitigation of risk requires that the aircraft be
operated ``gently.''
    ii. Aerobatic training and rides are available in properly
certificated aircraft.
    iii. Pilot qualification. The FAA has no clear way to qualify or
evaluate aerobatic qualifications. Is an ICAS ACE evaluation adequate?
    iv. If the FAA permits aerobatics, are the current weather minimums
adequate (1500 ft ceiling and three miles visibility) or are they too
low?
    v. Many of the aircraft manuals restrict aerobatics to much higher
altitudes such as those listed in the P-47 aircraft.
    (s) Should the FAA limit, restrict, or prohibit low passes while
conducting LHFE flights?
    (t) Should the FAA require approved seats for the pilots and
passengers?
    (u) What emergency equipment should the FAA require on LHFE
aircraft?
    (v) Should the FAA require operators to have evacuation plans and
drills?
    (w) If the FAA allows ``high performance'' jets, should the
operator be required to have arresting gear?
    i. If the FAA requires the availability of arresting gear, will the
military approve?
    (x) Considering the following, should the FAA include flight
training requirements in the LHFE exemption?
    i. Flight training is available via deviation for experimental
aircraft.
    ii. Flight training is available in limited aircraft via exemption.
    (y) In addition to the LHFE exemption, should the FAA require the
operator to obtain a 14 CFR 91 Sightseeing ride Letter of
Authorization?
    (z) In nearly every flight operation where passengers are carried
for compensation or hire, pilots are required to participate in a drug
and alcohol testing program. Should the FAA require drug and alcohol
training and testing for LHFE operators?

Weather Minimums

    (aa) Weather minimums.
    i. Should the weather minimums be raised for all LHFE flights or
should the FAA require the pilot in command (PIC) of LHFE aircraft to
be instrument rated and current?
    ii. Since Sec.  91.515 requires large aircraft to remain at least
1,000 feet above ground level, and the minimum distance below clouds in
class C, D, and E airspace is 500 feet, is a 1500 foot ceiling
appropriate or should the FAA require more appropriate weather minimums
for these aircraft?
    iii. If the FAA allows passengers to manipulate the controls of the
LHFE aircraft, what should be the minimum weather?
    iv. If the FAA allows aerobatic flight in LHFE aircraft, what
should be the minimum weather?

Pilot Qualification/Currency

    (bb) Pilot qualification/experience minimums.
    i. Is an unrestricted pilot qualification required?
    (cc) Pilot and crew training requirements.
    i. Are the current LHFE training requirements adequate?

Maintenance/Inspection

    (dd) Should the operator be required to demonstrate their ability
to maintain the aircraft?
    (ee) Are the current LHFE maintenance and inspection requirements
adequate?
    i. An experimental airworthiness certificate assumes a higher level
of risk is acceptable for the pilot. However, is the higher level of
risk acceptable for a paying passenger or should the FAA change the
conditions and limitations, or the operating limitations, to mitigate
the risks? If so, what should such changes look like?
    (ff) Should the FAA require that the interior and exterior
entrances be marked as exit doors?
    i. Should the markings be in contrasting colors?
    ii. Should the markings have a minimum legibility requirement such
as 36 inches?
    iii. Should the FAA require that the handles be marked in a
contrasting color?
    (gg) Should aircraft that have been modified by the addition of a
second seat be required to provide a means for the passenger to exit
the aircraft without the pilot exiting first?
    (hh) Safety of the public is the FAA's primary goal. Since LHFE
aircraft are all older aircraft, how should the FAA

determine which aircraft can be operated under LHFE? Some of the LHFE
aircraft range from complete restorations (from the data plate up) to
aircraft that have serious corrosion or other structural issues.
    i. How should the FAA identify which aircraft are eligible for LHFE
status?
    ii. How does the FAA or operator ensure an equal level of safety?
    (ii) Should the FAA allow aircraft that previously held a standard
certificate, but later ``decertified'' and now hold an experimental
certificate, be allowed to operate under an LHFE exemption?
    i. Aircraft that no longer conform to their type certificate data
sheet create an issue for the FAA since it can be difficult to
determine an equal level of safety for a decertified aircraft. With
this in mind, should such aircraft be allowed to operate under LHFE
status?

Participation at the Public Meetings

    Commenters who wish to present oral statements at the June 26, 27,
and 28, 2012, public meetings should submit requests to the FAA no
later than June 18, 2012.
    Requests should be submitted as described in the FOR FURTHER
INFORMATION CONTACT section of this document and should include a
written summary of oral remarks to be presented and an estimate of time
needed for the presentation. Preferably, please submit requests via
email to<EMAIL_ADDRESS>Requests received after the dates
specified above will be scheduled if there is time available during the
meetings; however, the speakers' names may not appear on the written
agendas. To accommodate as many speakers as possible, the amount of
time allocated to each speaker may be less than the amount of time
requested to ensure various views can be heard. See ``Public Meeting
Procedures'' below.
    The FAA may have available a projector and a computer capable of
accommodating Word and PowerPoint presentations from a compact disk
(CD) or USB memory device. Persons requiring any other kind of
audiovisual equipment should notify the FAA when requesting to be
placed on the agenda.
    Sign and oral interpretation can be made available at the meeting,
as well as an assistive listening device, if requested 10 calendar days
before the meeting.

Public Meeting Procedures

    A panel of representatives from the FAA and other government
agencies will be present. An FAA representative will facilitate the
meetings in accordance with the following procedures:
    (1) The meetings are designed to facilitate the public comment
process. The meetings will be informal and non-adversarial. No
individual will be subject to cross-examination by any other
participant. Government representatives on the panel may ask questions
to clarify statements and to ensure an accurate record. Any statement
made during the meetings by a panel member should not be construed as
an official position of the government.
    (2) There will be no admission fees or other charges to attend or
to participate in the public meetings. The meetings will be open to all
persons, subject to availability of space in the meeting room. The FAA
will make every effort to accommodate all persons wishing to attend.
The FAA asks that participants sign in between 7:30 and 8:00 a.m. on
the days the meetings are being attended. The FAA will try to
accommodate all speakers; however if available time does not allow
this, speakers will be scheduled on a first-come-first-served basis.
The FAA reserves the right to exclude some speakers, if necessary, to
obtain balanced viewpoints. The meetings may adjourn early if scheduled
speakers complete their statements in less time than is scheduled for
the meetings.
    (3) The FAA will prepare agendas of speakers and presenters and
make the agendas available at the meetings.
    (4) Speakers may be limited to 3-minute statements. If possible,
the FAA will notify speakers if additional time is available.
    (5) The FAA will review and consider all material presented by
participants at the public meetings. Position papers or materials
presenting views or information related to the draft policy may be
accepted at the discretion of the presiding officer and will be
subsequently placed in the public docket. The FAA requests that
presenters at the meetings provide at least 10 copies of all materials
for distribution to the panel members. Presenters may provide other
copies to the audience at their discretion.
    (6) Each person presenting comments is asked to submit data to
support the comments. The FAA will protect from disclosure all
proprietary data submitted in accordance with applicable laws.

    Issued in Washington, DC, on May 16, 2012.
John M. Allen,
Director, Flight Standards Service.
[FR Doc. 2012-12383 Filed 5-21-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: December 17, 2009 (Volume 74, Number 241)]
[Notices]
[Page 66988-66989]
[DOCID:fr17de09-61]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Food and Drug Administration Clinical Trial Requirements,
Regulations, Compliance and Good Clinical Practices; Public Workshop

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop.

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SUMMARY:  The Food and Drug Administration (FDA) Florida District, in
cosponsorship with The Society of Clinical Research Associates, Inc.
(SoCRA), is announcing a public workshop entitled ``FDA Clinical Trial
Requirements, Regulations, Compliance and GCP.'' This 2-day public
workshop is intended to provide information about FDA clinical trial
requirements to the regulated industry.
    Date and Time: The public workshop will be held on Wednesday, March
3, 2010, from 8 a.m. to 5 p.m., and Thursday, March 4, 2010, from 8
a.m. to 4:35 p.m.
    Location: The public workshop will be held at The Wyndham Orlando
Resort, 8001 International Dr., Orlando, FL 32819,<PHONE_NUMBER>.
    Attendees are responsible for their own accommodations. To make
reservations at the Wyndham Orlando Resort, at the discounted rate of
$149 per night (plus applicable taxes), contact the hotel before
February 10, 2010, citing ``SoCRA''. The hotel's Web site is: http://
www.wyndham.com/hotels/MCOWD/main.wnt. (FDA has verified the Web site
address, but is not responsible for subsequent changes to the Web site
after this document publishes in the Federal Register.)
    Contacts:
    For FDA: C. Stewart Watson, Food and Drug Administration, 555
Winderley Pl., suite 200, Maitland, FL 32751,<PHONE_NUMBER>, FAX: 407-
475-4768, e-mail<EMAIL_ADDRESS>    For SoCRA: SoCRA Administrative Office, 530 West Butler Ave., suite
109, Chalfont, PA 18914, 1-800-762-7292 or<PHONE_NUMBER>, FAX: 215-822-
8633, e-mail<EMAIL_ADDRESS>    Registration: You are encouraged to register by February 26, 2010.
Seats are limited; please submit your registration as soon as possible.
Workshop space will be filled in order of receipt of registration.
Registration will close when the workshop is filled. Those accepted
into the workshop will receive confirmation. Registration at the site
is not guaranteed but may be possible on a space available basis on the
day of the public workshop beginning at 8 a.m. The SoCRA registration
fees cover the cost of the workshop facilities, materials, breaks, and
lunches. The cost of registration is as follows:

                                              Cost of Registration
----------------------------------------------------------------------------------------------------------------
                      Affiliation                                                  Fee
----------------------------------------------------------------------------------------------------------------
FDA Employee                                                                                Fee waived
----------------------------------------------------------------------------------------------------------------
Federal Government (SoCRA Member)                                                                        $450.00
----------------------------------------------------------------------------------------------------------------
Federal Government (Non-SoCRA Member)                                                                    $525.00
----------------------------------------------------------------------------------------------------------------
Non-Federal Government (SoCRA Member)                                                                    $575.00
----------------------------------------------------------------------------------------------------------------
Non-Federal Government (Non-SoCRA Member)                                                                $650.00
----------------------------------------------------------------------------------------------------------------

    If you need special accommodations due to a disability, please
contact C. Stewart Watson at least 7 days in advance of the meeting.
    Registration instructions: To register, please submit your name,
affiliation,

mailing address, phone/fax number, and e-mail, along with a check or
money order payable to SoCRA. Please mail your payment to: SoCRA
Administrative Office, 530 West Butler Ave., suite 109, Chalfont, PA
18914. Registration may be downloaded on the SoCRA Web site at http://
www.socra.org. (FDA has verified the Web site address, but is not
responsible for subsequent changes to the Web site after this document
publishes in the Federal Register.)
    Other payment forms accepted are major credit cards (VISA,
MasterCard, or American Express only). For more information on the
meeting, or for questions on registration, contact the SoCRA
Administrative Office (see Contact).

SUPPLEMENTARY INFORMATION: The public workshop helps fulfill the
Department of Health and Human Services' and FDA's important mission to
protect the public health. The public workshop will provide those
engaged in FDA-regulated (human) clinical trials with information on a
number of topics concerning FDA requirements related to informed
consent, clinical investigation requirements, institutional review
board investigations, electronic record requirements, and investigator
initiated research. Topics for discussion include the following: (1)
What FDA Expects in a Pharmaceutical Clinical Trial, (2) Adverse Event
Reporting, (3) Part 11 Compliance--electronic signatures, (4) Informed
Consent Regulations, (5) IRB Regulations and FDA Inspections, (6)
Keeping Informed and Working Together, (7) FDA Conduct of Clinical
Investigator Inspections, (8) Meetings with the FDA, (9) Investigator
Initiated Research, (10) Medical Device Aspects of Clinical Research,
(11) Working with FDA's Center for Biologics Evaluation and Research,
(12) Ethical Issues in Subject Enrollment, (13) The Inspection is
Over--What Happens Next? Possible FDA Compliance Actions.
    FDA has made education of the drug and device manufacturing
community a high priority to help ensure the quality of FDA-regulated
drugs and devices. The public workshop helps to achieve objectives set
forth in section 406 of the FDA Modernization Act of 1997 (21 U.S.C.
393) which includes working closely with stakeholders and maximizing
the availability and clarity of information to stakeholders and the
public. The public workshop also is consistent with the Small Business
Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), as
outreach activities by Government agencies to small businesses.

    Dated: December 10, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-30017 Filed 12-16-09; 8:45 am]

BILLING CODE 4160-01-S


Inhalation Risk Modeling Results

Acute Inhalation Risks

          Table 3. Maximum Predicted Acute Inhalation Risks (HEM-3)
                                Facility FRS ID
                                   Pollutant
                          Maximum Hazard Quotient[1]

                                    HQ_REL
                                   HQ_AEGL1
                                   HQ_AEGL2
                                   HQ_ERPG1
                                   HQ_ERPG2
<PHONE_NUMBER>2818745
                                   Chlorine
                                      42
                                       6
                                       2
                                       3
                                       1
<PHONE_NUMBER>0380061
                                   Chlorine
                                      33
                                       5
                                       1
                                       2
                                      0.8
<PHONE_NUMBER>0380061
                               Hydrochloric acid
                                       9
                                       7
                                      0.5
                                       4
                                      0.6
<PHONE_NUMBER>3266849
                                   Chlorine
                                       5
                                      0.6
                                      0.2
                                      0.3
                                      0.1
<PHONE_NUMBER>0961965
                                   Chlorine
                                       4
                                      0.6
                                      0.2
                                      0.3
                                      0.1
<PHONE_NUMBER>2818745
                               Hydrochloric acid
                                       4
                                       3
                                      0.3
                                       2
                                      0.3
<PHONE_NUMBER>7408296
                                   Chlorine
                                       4
                                      0.5
                                      0.1
                                      0.3
                                     0.09
<PHONE_NUMBER>0597373
                                   Chlorine
                                       2
                                      0.3
                                     0.07
                                      0.1
                                     0.05
<PHONE_NUMBER>0582003
                                   Chlorine
                                       2
                                      0.3
                                     0.07
                                      0.1
                                     0.05
<PHONE_NUMBER>0324435
                                   Chlorine
                                       2
                                      0.3
                                     0.07
                                      0.1
                                     0.04
<PHONE_NUMBER>0961965
                               Hydrochloric acid
                                       2
                                       1
                                      0.1
                                      0.7
                                      0.1
Notes:
[1] BOLD indicates an HQ value greater than 1.

                    Table 7. Refined Acute Modeling Results
                                Facility FRS ID
                                   Pollutant
                                   Criteria
                       Original Acute Hazard Quotient[1]
                       Off-site Acute Hazard Quotient[1]
                                     Notes
<PHONE_NUMBER>2818745
                                   Chlorine
                                     AEGL2
                                       2
                                      0.1
                                   Figure 1
<PHONE_NUMBER>2818745
                                   Chlorine
                                     AEGL1
                                       6
                                      0.6
                                   Figure 2
<PHONE_NUMBER>2818745
                                   Chlorine
                                     ERPG1
                                       3
                                    <0.6
                                      [2]
<PHONE_NUMBER>2818745
                                   Chlorine
                                      REL
                                      42
                                       4
                                   Figure 3
<PHONE_NUMBER>2818745
                               Hydrochloric acid
                                     AEGL1
                                       3
                                      0.5
                                   Figure 4
<PHONE_NUMBER>2818745
                               Hydrochloric acid
                                     ERPG1
                                       2
                                    <0.5
                                      [2]
<PHONE_NUMBER>2818745
                               Hydrochloric acid
                                      REL
                                       4
                                      0.6
                                   Figure 5
<PHONE_NUMBER>0380061
                               Hydrochloric acid
                                     AEGL1
                                       7
                                      0.5
                                   Figure 6
<PHONE_NUMBER>0380061
                               Hydrochloric acid
                                     ERPG1
                                       4
                                    <0.5
                                      [2]
<PHONE_NUMBER>0380061
                               Hydrochloric acid
                                      REL
                                       9
                                      0.7
                                   Figure 7
<PHONE_NUMBER>0380061
                                   Chlorine
                                     AEGL1
                                       5
                                     0.07
                                   Figure 8
<PHONE_NUMBER>0380061
                                   Chlorine
                                     ERPG1
                                       2
                                   <0.07
                                      [2]
<PHONE_NUMBER>0380061
                                   Chlorine
                                      REL
                                      33
                                      0.6
                                   Figure 9
<PHONE_NUMBER>3266849
                                   Chlorine
                                      REL
                                       5
                                      0.6
                                   Figure 10
<PHONE_NUMBER>0961965
                                   Chlorine
                                      REL
                                       4
                                      0.6
                                   Figure 11
<PHONE_NUMBER>0961965
                               Hydrochloric acid
                                      REL
                                       2
                                      0.2
                                   Figure 12
<PHONE_NUMBER>7408296
                                   Chlorine
                                      REL
                                       4
                                     <1
                                   Figure 13
<PHONE_NUMBER>0597373
                                   Chlorine
                                      REL
                                       2
                                       2
                                   Figure 14
<PHONE_NUMBER>0582003
                                   Chlorine
                                      REL
                                       2
                                      0.9
                                   Figure 15
<PHONE_NUMBER>0324435
                                   Chlorine
                                      REL
                                       2
                                      0.3
                                   Figure 16
Notes:
[1] BOLD indicates an HQ value greater than 1.
[2] Figures for HQ_ERPG1s were not created because in these situations the unrefined HQ_ERPG1 values are less than the HQ_AEGL1 values and after refinement all the HQ_AEGL1 values were less than 1 so the HQ_ERPG1 values would also be less than 1.

Figure 1  -  Aerial photo of Facility<PHONE_NUMBER>45 and corresponding acute HQs using the AEGL2 value for chlorine at HEM-3 polar receptor locations.

Figure 2  -  Aerial photo of Facility<PHONE_NUMBER>45 and corresponding acute HQs using the AEGL1 value for chlorine at HEM-3 polar receptor locations.

Figure 3  -  Aerial photo of Facility<PHONE_NUMBER>45 and corresponding acute HQs using the REL for chlorine at HEM-3 polar receptor locations.

Figure 4  -  Aerial photo of Facility<PHONE_NUMBER>45 and corresponding acute HQs using the AEGL1 value for hydrochloric acid at HEM-3 polar receptor locations.

Figure 5  -  Aerial photo of Facility<PHONE_NUMBER>45 and corresponding acute HQs using the REL value for hydrochloric acid at HEM-3 polar receptor locations.

Figure 6  -  Aerial photo of Facility<PHONE_NUMBER>61 and corresponding acute HQs using the AEGL1 value for hydrochloric acid at HEM-3 polar receptor locations.

Figure 7  -  Aerial photo of Facility<PHONE_NUMBER>61 and corresponding acute HQs using the REL value for hydrochloric acid at HEM-3 polar receptor locations.

Figure 8  -  Aerial photo of Facility<PHONE_NUMBER>61 and corresponding acute HQs using the AEGL1 value for chlorine at HEM-3 polar receptor locations.

Figure 9  -  Aerial photo of Facility<PHONE_NUMBER>61 and corresponding acute HQs using the REL value for chlorine at HEM-3 polar receptor locations.

Figure 10  -  Aerial photo of Facility<PHONE_NUMBER>49 and corresponding acute HQs using the REL for chlorine at HEM-3 polar receptor locations.

Figure 11  -  Aerial photo of Facility<PHONE_NUMBER>65 and corresponding acute HQs using the REL value for chlorine at HEM-3 polar receptor locations.

Figure 12  -  Aerial photo of Facility<PHONE_NUMBER>65 and corresponding acute HQs using the REL for hydrochloric acid at HEM-3 polar receptor locations.

Figure 13  -  Aerial photo of Facility<PHONE_NUMBER>96 and corresponding acute HQs using the REL value for chlorine at HEM-3 polar receptor locations.

Figure 14  -  Aerial photo of Facility<PHONE_NUMBER>73 and corresponding acute HQs using the REL for chlorine at HEM-3 polar receptor locations.

Figure 15  -  Aerial photo of Facility<PHONE_NUMBER>03 and corresponding acute HQs using the REL value for chlorine at HEM-3 polar receptor locations.

Figure 16  -  Aerial photo of Facility<PHONE_NUMBER>35 and corresponding acute HQs using the REL value for chlorine at HEM-3 polar receptor locations.


[Federal Register: September 30, 2008 (Volume 73, Number 190)]
[Notices]
[Page 56858]
[DOCID:fr30se08-84]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1793-DR]

Arkansas; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Arkansas (FEMA-1793-DR), dated September 18,
2008, and related determinations.

DATES: Effective Date: September 18, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated September 18, 2008, the President declared a major disaster under
the authority of the Robert T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as follows:

    I have determined that the damage in certain areas of the State
of Arkansas resulting from severe storms and flooding during the
period of September 2-8, 2008, and continuing, is of sufficient
severity and magnitude to warrant a major disaster declaration under
the Robert T. Stafford Disaster Relief and Emergency Assistance Act,
42 U.S.C. 5121-5207 (the Stafford Act). Therefore, I declare that
such a major disaster exists in the State of Arkansas.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas, Hazard Mitigation throughout the State, and any
other forms of assistance under the Stafford Act that you deem
appropriate. Direct Federal assistance is authorized. Consistent
with the requirement that Federal assistance be supplemental, any
Federal funds provided under the Stafford Act for Hazard Mitigation
will be limited to 75 percent of the total eligible costs. Federal
funds provided under the Stafford Act for Public Assistance also
will be limited to 75 percent of the total eligible costs, except
for any particular projects that are eligible for a higher Federal
cost-sharing percentage under the FEMA Public Assistance Pilot
Program instituted pursuant to 6 U.S.C. 777. If Other Needs
Assistance under Section 408 of the Stafford Act is later requested
and warranted, Federal funding under that program also will be
limited to 75 percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
to the extent allowable under the Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Kenneth M. Riley of FEMA is
appointed to act as the Federal Coordinating Officer for this declared
disaster.
    The following areas of the State of Arkansas have been designated
as adversely affected by this declared major disaster:

    Ashley, Bradley, Calhoun, Chicot, Clark, Cleveland, Conway,
Dallas, Drew, Garland, Grant, Hot Spring, Lincoln, Montgomery,
Perry, Prairie, Saline, and Van Buren Counties for Public
Assistance. Direct Federal assistance is authorized.
    All counties within the State of Arkansas are eligible to apply
for assistance under the Hazard Mitigation Grant Program.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-22950 Filed 9-29-08; 8:45 am]

BILLING CODE 9110-10-P