[Federal Register Volume 81, Number 148 (Tuesday, August 2, 2016)]
[Notices]
[Pages 50708-50710]
[FR Doc No: 2016-18183]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2071]

Determining Donor Eligibility for Autologous Donors of Blood and
Blood Components Intended Solely for Autologous Use--Compliance Policy;
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency or we) is
announcing the availability of a document titled ``Determining Donor
Eligibility for Autologous Donors of Blood and Blood Components
Intended Solely for Autologous Use--Compliance Policy; Guidance for
Industry.'' This guidance addresses the regulatory requirements for
determining donor

eligibility that apply to establishments that collect blood and blood
components (blood establishments) intended solely for autologous use.
On May 22, 2015, in order to better assure the safety of the nation's
blood supply and to help protect donor health, FDA finalized its
revision of the applicable requirements for blood establishments to
test donors for infectious disease, and to determine that donors are
eligible to donate and that donations are suitable for transfusion or
further manufacture (``Requirements for Blood and Blood Components
Intended for Transfusion or for Further Manufacturing Use'' (donor
eligibility rule)). The donor eligibility rule includes requirements
related to current good manufacturing practice, donation testing, donor
eligibility, and donation suitability. It became effective on May 23,
2016.
    FDA has developed this guidance in response to questions from blood
establishments concerning the applicability of the donor eligibility
rule to autologous donations. The guidance explains the conditions
under which FDA does not intend to take regulatory action for a blood
establishment's failure to comply with certain donor eligibility
determination requirements in collecting blood and blood components
intended solely for autologous use.

DATES: The Agency is soliciting public comment, but is implementing
this guidance immediately because the Agency has determined that prior
public participation is not feasible or appropriate. Submit either
electronic or written comments on Agency guidances at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-2071 for ``Determining Donor Eligibility for Autologous
Donors of Blood and Blood Components Intended Solely for Autologous
Use--Compliance Policy; Guidance for Industry.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist the office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

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

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled
``Requirements for Determining Donor Eligibility for Autologous Donors
of Blood and Blood Components Intended Solely for Autologous Use--
Compliance Policy; Guidance for Industry.'' We are implementing this
guidance without prior public comment because we have determined that
prior public participation is not feasible or appropriate (Sec.
10.115(g)(2)). Although this guidance document is immediately in
effect, it remains subject to comment in accordance with FDA's good
guidance practices regulation.
    This guidance addresses the regulatory requirements for determining
donor eligibility that apply to blood establishments that collect blood
and blood components intended solely for autologous use described in
the final

rule entitled, ``Requirements for Blood and Blood Components Intended
for Transfusion or for Further Manufacturing Use,'' 80 FR 29842 (donor
eligibility rule)) that became effective on May 23, 2016.
    A small proportion of collections of blood and blood components are
intended for autologous transfusion. In those instances, the autologous
donor presents with a physician's prescription for the collection of
the donor's blood for the donor's own upcoming medical (e.g., surgical)
procedure. If the donor ultimately does not need the blood, blood
establishments may, in some instances, use these donations for
allogeneic (i.e. intended for transfusion to a recipient other than the
donor) transfusions. This is referred to as ``cross-over.''
    Blood establishments have requested clarification on certain
requirements of the donor eligibility rule and the applicability of
certain sections of the donor eligibility rule to the collection of
blood and blood components intended for autologous use. To address
these questions, FDA has developed this guidance to clarify the
Agency's policy with respect to the requirements for autologous donors
of blood and blood components intended solely for autologous use,
(i.e., not subject to cross-over). Specifically, the guidance describes
FDA's policy with respect to the following: The requirements in 21 CFR
630.10 related to screening autologous donors for relevant transfusion-
transmitted infections; the requirement in 21 CFR 630.15(a)(1)(ii) that
the responsible physician examine the autologous donor to permit more
frequent collections; and, the requirement in 21 CFR 630.20(a) that the
responsible physician determine and document that the autologous
donor's health permits the collection of blood and blood components
intended for autologous use.
    Autologous donors have long been permitted to donate blood for
their own use even if they do not meet certain donor eligibility
criteria that apply to allogeneic donors because autologous donors are
not exposed to new transfusion-transmitted infections in receiving
their own blood. For example, FDA does not require testing of
autologous donations for Relevant Transfusion-Transmitted Infection
(RTTI) unless the donations are used for allogeneic transfusion or
shipped to another establishment (21 CFR 610.40(d)). Consistent with
this approach to testing autologous donations, FDA does not believe it
is necessary to assess autologous donors for risks for RTTI as required
in certain provisions in Sec.  630.10 if the donation is intended
solely for autologous use.
    Sections 630.15(a) and 630.20(a) describe conditions for which a
responsible physician must examine and determine and document that the
autologous donor's health permits a collection procedure. Autologous
donors are under the care of the physician who prescribes the
autologous donation. In light of the medical oversight provided by the
autologous donor's physician, FDA believes blood establishments can
appropriately protect autologous donors' health by following standard
operating procedures that are approved by the responsible physician of
the blood establishment and that define criteria for when the
autologous donation may proceed and the conditions under which the
responsible physician must be consulted.
    The guidance explains the conditions under which FDA does not
intend to take regulatory action for a blood establishment's failure to
comply with the donor eligibility determination requirements in
collecting blood and blood components intended solely for autologous
use.
    The guidance represents the current thinking of the FDA on this
topic. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in part 630 have been approved under OMB
control number 0910-0795.

III. Electronic Access

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

    Dated: July 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18183 Filed 8-1-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 170 (Wednesday, September 3, 2014)]
[Notices]
[Page 52316]
[FR Doc No: 2014-20850]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP14-1195-000.
    Applicants: Sierrita Gas Pipeline LLC.
    Description: Compliance filing per 154.203: Tariff Implementation
and Compliance Filing to be effective 12/31/9998.
    Filed Date: 8/21/14.
    Accession Number: 20140821-5081.
    Comments Due: 5 p.m. ET 9/2/14.

    Docket Numbers: RP14-1197-000.
    Applicants: Midcontinent Express Pipeline LLC.
    Description: Sec.  4(d) rate filing per 154.204: Enable Energy
Negotiated Rate to be effective 8/1/2014.
    Filed Date: 8/22/14.
    Accession Number: 20140822-5110.
    Comments Due: 5 p.m. ET 9/3/14.

    Docket Numbers: RP14-1198-000.
    Applicants: Eastern Shore Natural Gas Company.
    Description: Compliance filing per 154.203: White Oak Lateral DLFT
and DLIT Tariff Revisions to be effective 8/22/2014.
    Filed Date: 8/22/14.
    Accession Number: 20140822-5122.
    Comments Due: 5 p.m. ET 9/3/14.

    Docket Numbers: RP14-1199-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Sec.  4(d) rate filing per 154.204: Neg Rate Amendment
2014-08-20 MFNs to be effective 7/1/2014.
    Filed Date: 8/22/14.
    Accession Number: 20140822-5147.
    Comments Due: 5 p.m. ET 9/3/14.

    Docket Numbers: RP14-1200-000.
    Applicants: Destin Pipeline Company, L.L.C.
    Description: Petition for Approval of Stipulation and Agreement of
Settlement of Destin Pipeline Company, L.L.C.
    Filed Date: 8/25/14.
    Accession Number: 20140825-5072.
    Comments Due: 5 p.m. ET 9/8/14.

    Docket Numbers: RP14-1201-000.
    Applicants: Kinder Morgan Louisiana Pipeline LLC.
    Description: Sec.  4(d) rate filing per 154.204: Removal of
Terminated Agreement to be effective 8/16/2014.
    Filed Date: 8/25/14.
    Accession Number: 20140825-5147.
    Comments Due: 5 p.m. ET 9/8/14.
    The filings are accessible in the Commission's eLibrary system by
clickling on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified date(s). Protests may be considered,
but intervention is necessary to become a party to the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: August 26, 2014.
 Nathaniel J. Davis, Sr.,
 Deputy Secretary.
[FR Doc. 2014-20850 Filed 9-2-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 106 (Thursday, June 2, 2011)]
[Rules and Regulations]
[Pages 31838-31839]
[FR Doc No: 2011-13643]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2011-0442]

Drawbridge Operation Regulation; Nanticoke River, Seaford, DE

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, Fifth Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
SR 13 Bridge across the Nanticoke River, mile 39.6, at Seaford, DE. The
deviation is necessary to accommodate the cleaning and painting of the
bridge. This deviation restricts the availability to open the bridge
during the approximate seven week project.

DATES: This deviation is effective from 12:01 a.m. on June 10, 2011 to
11:59 p.m. on July 24, 2011.

ADDRESSES: Documents mentioned in this preamble as being available in
the

docket are part of docket USCG-2011-0442 and are available online by
going to http://www.regulations.gov, inserting USCG-2011-0442 in the
``Keyword'' box and then clicking ``Search''. They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 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 rule,
call or e-mail Lindsey Middleton, Bridge Management Specialist, Coast
Guard; telephone<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>If
you have questions on viewing the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Marinis Bros. Inc., on behalf of Delaware
Department of Transportation, has requested a temporary deviation from
the current operating regulation of the SR 13 Bridge across the
Nanticoke River, mile 39.6, at Seaford, DE. The requested deviation is
to accommodate painting and cleaning of the bridge. The vertical
clearance of this single-leaf bascule bridge is three feet at mean high
water (MHW) in the closed position and unlimited in the open position.
During this deviation period, the vertical clearance will be limited to
one foot at MHW due to the scaffolding that will be used for the
maintenance of the bridge. Monday through Friday from 7 a.m. until 6
p.m. the bridge is able to open if at least four hours of notice is
given and from 6 p.m. to 7 a.m. the bridge will be left in the closed-
to-navigation position. On Saturdays and Sundays and on July 4, 2011
the bridge will be left in the open position and vessels will be able
to pass through at any time. The bridge will be able to open for
emergencies if at least four hours of notice is given. There are no
alternate routes available to vessels.
    The current operating schedule for the bridge is set out in 33 CFR
117.243(b). In the months of June and July the regulation requires the
bridge to open on signal, except from 6 p.m. to 8 a.m., if at least
four hours notice is given.
    Logs from June and July 2010 have shown that most of the openings
were on the weekends and on July 4th and all of the openings were
between the hours of 7 a.m. and 6 p.m. This deviation will have no
impact for mariners traveling through the bridge on the weekends and on
July 4th because the bridge will be left in the open position on these
days. Mariners transiting through the bridge on weekdays should have
minimal delay given that the bridge can open for vessels if at least
four hours notice is given. The majority of the vessel traffic is
recreational boaters. The Coast Guard will inform the users of the
waterway through our Local and Broadcast Notices to Mariners so that
mariners can arrange their transits to minimize any impact caused by
the temporary deviation. The Coast Guard will also require the bridge
owner to post signs on either side of the bridge notifying mariners of
the temporary regulation change.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: May 23, 2011.
Waverly W. Gregory, Jr.,
Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2011-13643 Filed 6-1-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Rules and Regulations]
[Pages 30525-30528]
[FR Doc No: 2018-13999]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

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

The Code of Federal Regulations is sold by the Superintendent of Documents.

========================================================================

Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Rules
and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2018-0320; Special Conditions No. 25-731-SC]

Special Conditions: Bombardier Model BD-500-1A10 and BD-500-1A11
Airplanes, Installation of Inflatable Lap Belts on Seats

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

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SUMMARY: These special conditions are issued for the Bombardier Inc.
(Bombardier) Model BD-500-1A10 and BD-500-1A11 airplanes. These
airplanes will have a novel or unusual design feature when compared to
the state of technology envisioned in the airworthiness standards for
transport category airplanes. This design feature is installation of
inflatable lap belts on seats. The applicable airworthiness regulations
do not contain adequate or appropriate safety standards for this design
feature. These special conditions contain the additional safety
standards that the Administrator considers necessary to establish a
level of safety equivalent to that established by the existing
airworthiness standards.

DATES: This action is effective on Bombardier on June 29, 2018. Send
comments on or before August 13, 2018.

ADDRESSES: Send comments identified by Docket No. FAA-2018-0320 using
any of the following methods:
     Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending
your comments electronically.
     Mail: Send comments to Docket Operations, M-30, U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to 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.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://www.regulations.gov/, including any personal
information the commenter provides. Using the search function of the
docket website, anyone can find and read the electronic form of all
comments received into any FAA docket, 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 can be found in the Federal Register published on April 11,
2000 (65 FR 19477-19478).
    Docket: Background documents or comments received may be read at
http://www.regulations.gov/ at any time. Follow the online instructions
for accessing the docket or go to 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: Alan Sinclair, Airframe and Cabin
Section, AIR-675, Transport Standards Branch, Policy and Innovation
Division, Aircraft Certification Service, Federal Aviation
Administration, 2200 South 216th Street, Des Moines, Washington 98198;
telephone and fax<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION: The substance of these special conditions
previously has been published in the Federal Register for public
comment. These special conditions have been derived without substantive
change from those previously issued. It is unlikely that prior public
comment would result in a significant change from the substance
contained herein. Therefore, the FAA has determined that prior public
notice and comment are unnecessary, and finds that, for the same
reason, good cause exists for adopting these special conditions upon
publication in the Federal Register.

Comments Invited

    We invite interested people to take part in this rulemaking by
sending written comments, data, or views. The most helpful comments
reference a specific portion of the special conditions, explain the
reason for any recommended change, and include supporting data.
    We will consider all comments we receive by the closing date for
comments. We may change these special conditions based on the comments
we receive.

Background

    On December 6, 2017, Bombardier applied for an amendment to Type
Certificate No. T00008NY to include the new Model BD-500-1A10 and BD-
500-1A11 airplanes. These airplanes, which are a derivative of the
Model BD-500 currently approved under Type Certificate No. T00008NY,
are transport-category, twin-engine airplanes. The BD-500-1A10 has
seating for 110 to 130 passengers and an estimated maximum take-off
weight of 129,000 lbs. The BD-500-1A11 has seating for 130-150
passengers and an estimated maximum take-off weight of 144,000 lbs.

Type Certification Basis

    Under the provisions of title 14, Code of Federal Regulations (14
CFR) 21.101, Bombardier must show that the Model BD-500-1A10 and BD-
500-1A11 airplanes meet the applicable provisions of the regulations
listed in Type Certificate No. T00008NY, or the applicable regulations
in effect on the date of application for the change except for earlier
amendments as agreed upon by the FAA.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the Bombardier Model BD-500-1A10 and
BD-500-1A11 airplanes because of a novel or unusual design feature,
special conditions are prescribed under the provisions of Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same novel or
unusual design feature, or should any other model already included on
the same

type certificate be modified to incorporate the same novel or unusual
design feature, these special conditions would also apply to the other
model under Sec.  21.101.
    In addition to the applicable airworthiness regulations and special
conditions, the Bombardier Model BD-500-1A10 and BD-500-1A11 airplanes
must comply with the fuel-vent and exhaust-emission requirements of 14
CFR part 34, and the noise-certification requirements of 14 CFR part
36.
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type
certification basis under Sec.  21.101.

Novel or Unusual Design Features

    The Bombardier Model BD-500-1A10 and BD-500-1A11 airplanes will
incorporate the following novel or unusual design feature:
    Installation of inflatable lap belts on seats.

Discussion

    The inflatable lap belt has two potential advantages over other
means of head-impact protection. First, it can provide significantly
greater protection than would be expected with energy-absorbing pads,
and second, it can provide essentially equivalent protection for
occupants of all stature. These are significant advantages from a
safety standpoint, because such devices will likely provide a level of
safety that exceeds the minimum standards of part 25. Conversely,
inflatable lap belts in general are active systems and must be relied
upon to activate properly when needed, as opposed to an energy-
absorbing pad or upper torso restraint that is passive and always
available. Therefore, the potential advantages must be balanced against
this and other potential disadvantages to develop standards for this
design feature.
    The FAA has considered the installation of inflatable lap belts to
have two primary safety concerns: First, that they perform properly
under foreseeable operating conditions; and second, that they do not
perform in a manner or at such times as would constitute a hazard to
the airplane or occupants. This latter point has the potential to be
the more rigorous of the requirements, owing to the active nature of
the system.
    The inflatable lap belt will rely on electronic sensors for
signaling, and will employ an automatic inflation mechanism for
activation, so that it is available when needed. These same devices
could be susceptible to inadvertent activation, causing deployment in a
potentially unsafe manner. The consequences of such deployment must be
considered in establishing the reliability of the system. The applicant
must substantiate that the effects of an inadvertent deployment in
flight are either not a hazard to the airplane, or that such deployment
is an extremely improbable occurrence (less than 10-9 per
flight hour). The effect of an inadvertent deployment on a passenger or
crewmember that might be positioned close to the inflatable lap belt
should also be considered. The person could be either standing or
sitting. A minimum reliability level will have to be established for
this case, depending upon the consequences, even if the effect on the
airplane is negligible.
    The potential for an inadvertent deployment could be increased as a
result of conditions in service. The installation must take into
account wear and tear so that the likelihood of an inadvertent
deployment is not increased to an unacceptable level. In this context,
an appropriate inspection interval and self-test capability are
considered necessary. Other outside influences are lightning and high-
intensity radiated fields (HIRF). Existing regulations regarding
lightning, Sec.  25.1316, and HIRF, Sec.  25.1317, are applicable. For
compliance with those conditions, if inadvertent deployment could cause
a hazard to the airplane, the inflatable lap belt is considered a
critical system; if inadvertent deployment could cause injuries to
persons, the inflatable lap belt should be considered an essential
system. Finally, the inflatable lap-belt installation should be
protected from the effects of fire, so that an additional hazard is not
created by, for example, a rupture of a pyrotechnic squib.
    To function as an effective safety system, the inflatable lap belt
must function properly and must not introduce any additional hazards to
occupants as a result of its functioning. The inflatable lap belt
differs variously from traditional occupant-protection systems and
requires special conditions to ensure adequate performance.
    Because the inflatable lap belt is essentially a single-use device,
it could potentially deploy under crash conditions that are not
sufficiently severe as to require head-injury protection from the
inflatable lap belt. And because an actual crash is frequently composed
of a series of impacts before the airplane comes to rest, this could
render the inflatable lap belt useless if a larger impact follows the
initial impact. This situation does not exist with energy-absorbing
pads or upper-torso restraints, which tend to provide continuous
protection regardless of severity or number of impacts in a crash
event. Therefore, the inflatable lap-belt installation should be such
that the inflatable lap belt will provide protection when it is
required, by not expending its protection during a less-severe impact.
Also, it is possible to have several large impact events during the
course of a crash, but there will be no requirement for the inflatable
lap belt to provide protection for multiple impacts.
    Given that each occupant's restraint system provides protection for
that occupant only, the installation must address unoccupied seats. It
will be necessary to show that the required protection is provided for
each occupant regardless of the number of occupied seats, and that
unoccupied seats may have lap belts that are active.
    The inflatable lap belt should be effective for a wide range of
occupants. The FAA has historically considered the range from the 5th
percentile female to the 95th percentile male as the range of occupants
that must be taken into account. In this case, the FAA is proposing
consideration of a broader range of occupants due to the nature of the
lap-belt installation and its close proximity to the occupant. In a
similar vein, these persons could have assumed the brace position for
those accidents where an impact is anticipated. Test data indicate that
occupants in the brace position do not require supplemental protection,
so it would not be necessary to show that the inflatable lap belt will
enhance the brace position. However, the inflatable lap belt must not
introduce a hazard when it is deployed into a seated, braced occupant.
    Another area of concern is the use of seats so equipped by
children, whether they are lap-held, sitting in approved child-safety
seats, or occupying the seat directly. Although specifically prohibited
by FAA operating regulations, the use of the supplementary loop belt
(``belly belt'') may be required by other civil aviation authorities,
and should also be considered with the purpose of meeting those
regulations. Similarly, if the seat is occupied by a pregnant woman,
the installation needs to address such usage, either by demonstrating
that it will function properly, or by adding appropriate limitation on
usage.
    The inflatable lap belt will be electrically powered. Likewise, the
system could possibly fail due to a separation in the fuselage. Because
this system is intended as crash/post-crash protection means, failure
due to fuselage separation is not acceptable. As with emergency
lighting, the restraint system should function properly if such a

separation occurs at any point in the fuselage.
    Because the inflatable lap belt is likely to have a large volume
displacement, the inflated bag could potentially impede egress of
passengers. However, the lap-belt bag deflates to absorb energy, so it
is likely that an inflatable lap belt would be deflated by the time
passengers begin to leave their seats. Nonetheless, it is appropriate
to specify a time interval after which the inflatable lap belt may not
impede rapid egress. The maximum time allowed for an exit to open fully
after actuation is 10 seconds, according to Sec.  25.809(b)(2).
Therefore, the FAA has established 10 seconds as the time interval that
the inflatable lap belt must not impede rapid egress from the seat
after it is deployed. In actuality, it is unlikely that a flight
attendant would prepare an exit this quickly in an accident severe
enough to warrant deployment of the inflatable lap belt. The inflatable
lap belt will likely deflate much more quickly than 10 seconds.
    This potential impediment to rapid egress is even more critical at
the seats installed in the emergency-exit rows. Installation of
inflatable restraints at the Type III exit rows presents different
egress concerns as compared with front-row seats. However, the need to
address egress is already part of the special conditions, so the
special conditions are not changed at this time. As noted below, the
method of compliance with the special conditions may involve specific
considerations when an inflatable restraint is installed at Type III
exits. Section 25.813 clearly requires access to the exit from the main
aisle in the form of an unobstructed passageway, and no interference in
opening the exit. The restraint system must not create an impediment to
the access to, and the opening of, the exit. These lap belts should be
evaluated in the exit row under existing regulations (Sec. Sec.  25.809
and 25.813) and guidance material. The inflatable lap belts must also
be evaluated in post-crash conditions, and should be evaluated using
representative restraint systems in the bag-deployed condition.
    This evaluation would include reviewing the access to, and opening
of, the exit, specifically for obstructions in the egress path; and any
interferences in opening the exit. Each unique interior configuration
must be considered, e.g., passageway width, single or dual passageways
with outboard seat removed, etc. If the restraint creates any
obstruction or interference, it is likely that it could impede rapid
egress from the airplane. In some cases, the passenger is the one who
will open the exit, such as a Type III over-wing hatch. Project-
specific means-of-compliance guidance is likely necessary if these
restraint systems are installed at the Type III exit rows.
    Note that the special conditions are applicable to the inflatable
lap-belt system as installed. The special conditions are not an
installation approval. Therefore, while the special conditions relate
to each such system installed, the overall installation approval is
separate, and must consider the combined effects of all such systems
installed.
    Bombardier will install inflatable lap belts, a novel design
feature, on certain seats of their Model BD-500-1A10 and BD-500-1A11
airplanes, to reduce the potential for head injury if an accident
occurs. The inflatable lap belt works similar to an automotive
inflatable air bag, except that the air bag in the applicant's design
is integrated into the lap belt of the restraint system.
    The performance criteria for head-injury protection in objective
terms is stated in Sec.  25.562. However, none of these criteria are
adequate to address the specific issues raised concerning seats with
inflatable lap belts. The FAA therefore has determined that, in
addition to the requirements of part 25, special conditions are needed
to address requirements particular to the installation of seats with
inflatable lap belts.
    Accordingly, in addition to the passenger-injury criteria specified
in Sec.  25.785, these special conditions are for Bombardier Model BD-
500-1A10 and BD-500-1A11 airplanes equipped with inflatable lap belts.
Other conditions may be developed, as needed, based on further FAA
review and discussions with the manufacturer and civil-aviation
authorities.
    Part I of part 25, appendix F specifies the flammability
requirements for interior materials and components. There is no
reference to inflatable restraint systems in appendix F, because such
devices did not exist at the time the flammability requirements were
written. The existing requirements are based on material types as well
as use, and have been specified in light of state-of-the-art materials
available to perform a given function. Without a specific reference,
the default requirement would apply to the type of material used in
making the inflatable restraint, which is a fabric in this case.
However, in writing special conditions, the FAA must also consider the
use of the material, and whether the default requirement is
appropriate. In this case, the specialized function of the inflatable
restraint means that highly specialized materials are needed. The
standard normally applied to fabrics is a 12-second vertical ignition
test. However, materials that meet this standard do not perform
adequately as inflatable restraints. Because the safety benefit of the
inflatable restraint is significant, the flammability standard
appropriate for these devices should not screen out suitable materials
and thereby effectively eliminate the use of inflatable restraints. The
FAA must establish a balance between the safety benefit of the
inflatable restraint and its flammability performance. Presently, the
2.5-inch-per-minute horizontal test is considered to provide that
balance. As the state-of-the-art in materials progresses (which is
expected), the FAA may change this standard in subsequent special
conditions to account for improved materials.
    These special conditions contain the additional safety standards
that the Administrator considers necessary to establish a level of
safety equivalent to that established by the existing airworthiness
standards.

Applicability

    As discussed above, these special conditions are applicable to
Bombardier Model BD-500-1A10 and BD-500-1A11 airplanes. Should
Bombardier apply at a later date for a change to the type certificate
to include another model incorporating the same novel or unusual design
feature, these special conditions would apply to that model as well.

Conclusion

    This action affects only a certain novel or unusual design feature
on one model series of airplanes. It is not a rule of general
applicability.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

Authority Citation

    The authority citation for these special conditions is as follows:

    Authority:  49 U.S.C. 106(f), 106(g), 40113, 44701, 44702,
44704.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for Bombardier Model BD-500-1A10 and BD-
500-1A11 airplanes.
    1. The inflatable lap belt must be shown to deploy and provide
protection under crash conditions where it is necessary to prevent
serious head

injury. The means of protection must take into consideration a range of
stature from a two-year-old child to a 95th percentile male. The
inflatable lap belt must provide a consistent approach to energy
absorption throughout that range of occupants. In addition, the
following situations must be considered.
    The seat occupant is:

 Holding an infant
 a child in a child-restraint device
 a child not using a child-restraint device
 a pregnant woman

    2. The inflatable lap belt must provide adequate protection for
each occupant regardless of the number of occupants of the seat
assembly, considering that unoccupied seats may have an active airbag
system in the lap belt.
    3. The design must prevent the inflatable lap belt from being
either incorrectly buckled or incorrectly installed such that the
inflatable lap belt would not properly deploy. Alternatively, it must
be shown that such deployment is not hazardous to the occupant, and
will provide the required head-injury protection.
    4. The inflatable lap-belt system must be shown not to be
susceptible to inadvertent deployment as a result of wear and tear, or
inertial loads resulting from in-flight or ground maneuvers (including
gusts and hard landings), likely to be experienced in service.
    5. Deployment of the inflatable lap belt must not introduce injury
mechanisms to the seated occupant, nor result in injuries that could
impede rapid egress. This assessment should include an occupant who is
in the brace position when it deploys, and an occupant whose inflatable
lap belt is loosely fastened.
    6. An inadvertent deployment that could cause injury to a standing
or sitting person must be shown to be improbable.
    7. It must be shown that inadvertent deployment of the airbag
system in the lap belt, during the most critical part of the flight,
either will not cause a hazard to the airplane or its occupants, or
meets the requirement of Sec.  25.1309(b).
    8. The inflatable lap belt must be shown to not impede rapid egress
of occupants 10 seconds after its deployment.
    9. The inflatable lap-belt system must be protected from lightning
and HIRF. The threats specified in existing regulations regarding
lightning, Sec.  25.1316, and HIRF, Sec.  25.1317, are incorporated by
reference for the purpose of measuring lightning and HIRF protection.
For the purposes of complying with HIRF requirements, the inflatable
lap-belt system is considered a ``critical system'' if its deployment
could have a hazardous effect on the airplane; otherwise it is
considered an ``essential'' system.
    10. The inflatable lap belt must function properly after loss of
normal airplane electrical power, and after a transverse separation of
the fuselage at the most critical location. A separation at the
location of the lap belt does not have to be considered.
    11. The inflatable lap belt must be shown to not release hazardous
quantities of gas or particulate matter into the cabin.
    12. The inflatable lap-belt installation must be protected from the
effects of fire such that no hazard to occupants will result.
    13. A means must be available for a crewmember to verify the
integrity of the inflatable-lap-belt-activation system prior to each
flight, or it must be demonstrated to reliably operate between
inspection intervals.
    14. The inflatable material may not have an average burn rate of
greater than 2.5 inches per minute when tested using the horizontal-
flammability test as defined in 14 CFR part 25, appendix F, section
I(b)(5).
    15. The airbag system in the lap belt, once deployed, must not
adversely affect the emergency-lighting system (i.e., block floor-
proximity lights to the extent that the lights no longer meet their
intended function).

    Issued in Des Moines, Washington, on June 25, 2018.
Victor Wicklund,
Manager, Transport Standards Branch, Policy and Innovation Division,
Aircraft Certification Service.
[FR Doc. 2018-13999 Filed 6-28-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 182 (Wednesday, September 21, 2022)]
[Notices]
[Page 57692]
[FR Doc No: 2022-20409]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP21-113-000]

Alliance Pipeline, L.P.; Notice Suspending Environmental Review
Schedule of the Proposed Three Rivers Interconnection Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) is suspending the environmental review schedule of the
Three Rivers Interconnection Project (Project) involving construction
and operation of facilities by Alliance Pipeline, L.P. (Alliance) in
Grundy County, Illinois. The Notice of Intent to Prepare an
Environmental Impact Statement for the Proposed Three Rivers
Interconnection Project, Request for Comments on Environmental Issues,
and Schedule for Environmental Review, issued on February 10, 2022,
identified a September 16, 2022 final Environmental Impact Statement
(EIS) issuance date. As stated in the notice, the Project would be
located in the vicinity of a facility regulated by the Nuclear
Regulatory Commission which could require the completion of a safety
analysis, and additional time may be necessary to consider the results
of that analysis.
    In its most recent response to FERC staff's request concerning the
status of this safety analysis, Alliance stated that it anticipated
that the operator of the nearby nuclear facility (Constellation Energy
Generation, LLC) would finalize the required safety analysis by the end
of August 2022. However, to date, the safety analysis remains
outstanding.
    Therefore, the Commission will suspend the environmental review
schedule for the Project. Once Alliance provides the outstanding
information, the Commission will issue a revised schedule for the final
EIS. This is not a suspension of the Commission staff's review of the
Project. Staff will continue to process Alliance's proposal to the
extent possible based upon the information filed to date while awaiting
the remaining information.

Additional Information

    Additional information about the Project are available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC website at www.ferc.gov using the eLibrary link. Click on the
eLibrary link, click on ``General Search'' and enter the docket number
in the ``Docket Number'' field (i.e., CP21-113-000). Be sure you have
selected an appropriate date range. For assistance, please contact FERC
Online Support at [email protected] or<PHONE_NUMBER>, or for
TTY, contact<PHONE_NUMBER>. The eLibrary link also provides access to
the texts of all formal documents issued by the Commission, such as
orders, notices, and rulemakings.
    Public sessions or site visits will be posted on the Commission's
calendar located at https://www.ferc.gov/news-events/events along with
other related information.

    Dated: September 15, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-20409 Filed 9-20-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: April 27, 2007 (Volume 72, Number 81)]
[Notices]
[Page 21006-21008]
[DOCID:fr27ap07-38]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2007-0157; FRL-8306-8]

Inquiry To Learn Whether Businesses Assert Business
Confidentiality Claims

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; request for comment.

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SUMMARY: The Environmental Protection Agency receives from time to time
Freedom of Information Act (FOIA) requests for documents contained in
the EPA Waste International Tracking System (``WITSnet'') pertaining to
the export and import of Resource Conservation and Recovery Act (RCRA)
hazardous waste from/to the United States, the export of Cathode Ray
Tubes (CRTs) from the United States, and the export and import of RCRA
universal waste from/to the United States. These documents may identify
or reference multiple parties, and describe transactions involving the
movement of specified materials in which they propose to participate or
have participated. The purpose of this notice is to contact affected
businesses about the documents sought by these types of FOIA requests
in order to provide the businesses with the opportunity to assert
claims that any of the information sought that pertains to them is
entitled to treatment as confidential business information (CBI), and
to send comments to EPA supporting their claims for such treatment.
Certain businesses, however, do not meet the definition of ``affected
business,'' and are not covered by today's notice. They consist of any
business regulated by RCRA that actually submitted to EPA any document
at issue pursuant to applicable regulatory requirements and did not
assert a CBI claim as to information that pertains to that business in
the document at the time of its submission; they have waived their
right to do so at a later time. Nevertheless, other businesses
identified or referenced in the documents that were submitted to EPA by
the submitting business have not waived their own right to assert a CBI
claim concerning information that pertains to them and may do so in
response to this notice.

DATES: Comments must be received on or before May 29, 2007. The period
for submission of comments may be extended if, before the comments are
due, you make a request for an extension of the comment period and it
is approved by the EPA legal office. Except in extraordinary
circumstances, the EPA legal office will not approve such an extension
without the consent of any person whose request for release of the
information under the FOIA is pending.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OECA-2007-0157, by one of the following methods:
     http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
     E-mail<EMAIL_ADDRESS>     Address: Eva Kreisler, International Compliance Assurance
Division, Office of Federal Activities, Office of Enforcement and
Compliance Assurance, Environmental Protection Agency, Mailcode: 2254A,
1200 Pennsylvania Ave., NW., Washington, DC 20460.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OECA-
2007-0157. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information provided,

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

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

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

your e-mail address will be 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. Please include your name and other contact information
with any disk or CD-ROM you submit by mail. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.

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

    Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket materials are available either electronically in
http://www.regulations.gov or in hard copy at the HQ EPA Docket Center, EPA/

DC, EPA West, 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
docket for the Inquiry to Learn Whether Businesses Assert Business

Confidentiality Claims Regarding the Following Information: (1) Export
of Hazardous Waste Documentation; (2) Import of Hazardous Waste
Documentation; (3) Notifications of Intent to Export Cathode Ray Tubes;
Notice of Opportunity to Comment is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Eva Kreisler, International Compliance
Assurance Division, Office of Federal Activities, Office of Enforcement
and Compliance Assurance, Environmental Protection Agency, Mailcode:
2254A, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Regarding the Following Information: (1)
Documents Related to the Export of Resource Conservation and Recovery
Act (RCRA) Hazardous Waste Under 40 CFR part 262, Subparts E and H; (2)
Documents Related to the Import of RCRA Hazardous Waste Under 40 CFR
part 262, Subpart F; (3) Documents Related to the Export of Cathode Ray
Tubes Under 40 CFR part 261, Subpart E; and (4) Documents Related to
the Export and Import of RCRA Universal Waste Under 40 CFR part 273,
Subparts B, C, D, and F.

I. General Information

    EPA has previously published a notice in the Federal Register, at
67 FR 71962, December 3, 2002, that addresses issues similar to those
raised by today's notice. The Agency did not receive any comments on
the 2002 notice. Since the publication of the 2002 notice, the Agency
has continued to receive FOIA requests for documents contained in the
EPA Waste International Tracking System (``WITSnet'') database.

II. Issues Covered by This Notice

    EPA receives FOIA requests from time to time for documents that may
identify or reference multiple parties, and describe transactions
involving the movement of specified materials in which they propose to
participate or have participated. This notice informs ``affected
businesses,'' \1\ which could include, among others, specific
``transporters'' \2\ and consignees,'' \3\ of the requests for
information contained in one or more of the following documents: (1)
Documents related to the export of Resource Conservation and Recovery
Act (RCRA) hazardous waste under 40 CFR part 262, subparts E and H,
including but not limited to the ``notification of intent to export'',
``manifest,'' \4\ ``annual report,'' ``acknowledgements of consent,''
``exception reports,'' ``transit notifications,'' and
``renotification;'' (2) documents related to the import of hazardous
waste under 40 CFR part 262, subpart F, including but not limited to
notifications of intent to import hazardous waste into the U.S. from
foreign countries; (3) documents related to the export of Cathode Ray
Tubes (CRTs) under 40 CFR part 261, subpart E, including but not
limited to notifications of intent to export CRTs; and (4) documents
related to the export and import of RCRA universal waste under 40 CFR
part 273, subparts B, C, D, and F.
---------------------------------------------------------------------------

    \1\ The term ``affected business'' is defined at 40 CFR
2.201(d), and is set forth in this notice, below.
    \2\ The term ``transporter'' is defined at 40 CFR 260.10.
    \3\ The term consignee is defined, for different purposes, at 40
CFR 262.51 and 262.81(c).
    \4\ The term ``manifest'' is defined at 40 CFR 260.10.
---------------------------------------------------------------------------

    Certain businesses, however, do not meet the definition of
``affected business,'' and are not covered by today's notice. They
consist of any business that actually submitted any of the documents
sought in the FOIA requests that EPA has received, and did not assert a
claim of business confidentiality covering any of that information at
the time of submission. As set forth in the RCRA regulations at 40 CFR
260.2(b), ``if no such [business confidentiality] claim accompanies the
information when it is received by EPA, it may be made available to the
public without further notice to the person submitting it.'' Thus, for
purposes of this notice and as a general matter under 40 CFR 260.2(b),
a business that submitted to EPA the documents at issue, pursuant to
applicable regulatory requirements, and that failed to assert a claim
as to information that pertains to it at the time of submission, cannot
later make a confidentiality claim. Nevertheless, other businesses
identified or referenced in the same documents that were submitted to
EPA by the submitting business have not waived their own right to
assert a CBI claim concerning information that pertains to them and may
do so in response to this notice.
    In accordance with 40 CFR 2.204(c) and (e), this notice inquires
whether any affected business asserts a claim that any of the requested
information constitutes CBI, and affords such business an opportunity
to comment to EPA on the issue. This notice also informs affected
businesses that, if a claim is made, EPA would determine under 40 CFR
part 2, subpart B, whether any of the requested information is entitled
to confidential treatment.

1. Affected Businesses

    EPA's FOIA regulations at 40 CFR 2.204(c)(1) require an EPA office
that is responsible for responding to a FOIA request for the release of
business information (``EPA office'') ``to determine which businesses,
if any, are affected businesses * * *.'' ``Affected business'' is
defined at 40 CFR 2.201(d) as, ``* * * with reference to an item of
business information, a business which has asserted (and not waived or
withdrawn) a business confidentiality claim covering the information,
or a business which could be expected to make such a claim if it were
aware that disclosure of the information to the public was proposed.''

2. The Purposes of This Notice

    This notice encompasses two distinct steps in the process of
communication with affected businesses prior to EPA's making a final
determination concerning the confidentiality of the information at
issue: the preliminary inquiry and the notice of opportunity to
comment.
a. Inquiry To Learn Whether Affected Businesses (Other Than Those
Businesses That Previously Asserted a CBI Claim) Assert Claims Covering
Any of the Requested Information
    Section 2.204(c)(2)(i) provides, in relevant part:
    If the examination conducted under paragraph (c)(1) of this section
discloses the existence of any business which, although it has not
asserted a claim, might be expected to assert a claim if it knew EPA
proposed to disclose the information, the EPA office shall contact a
responsible official of each such business to learn whether the
business asserts a claim covering the information.
b. Notice of Opportunity To Submit Comments
    Sections 2.204(d)(1)(i) and 2.204(e)(1) require that written notice
be provided to businesses that have made claims of business
confidentiality for any of the information at issue, stating that EPA
is determining under 40 CFR part 2, subpart B, whether the information
is entitled to confidential treatment, and affording the businesses an
opportunity to comment as to the reasons why they believe that the
information deserves confidential treatment.

3. The Use of Publication in the Federal Register

    Section 2.204(e)(1) requires that this type of notice be furnished
by certified

mail (return receipt requested), by personal delivery, or by other
means which allows verification of the fact and date of receipt. EPA,
however, has determined that in the present circumstances the use of a
Federal Register notice is the only practical and efficient way to
contact affected businesses and to furnish the notice of opportunity to
submit comments. The Agency's determination to follow this course was
made in recognition of the large number of businesses included in the
pertinent universe. Publication in the Federal Register also dispenses
with the requirement of orally informing a responsible representative
of the business that it should expect to receive a written notice, and
requesting the business to contact the EPA office if the written notice
has not been received within a few days, so that EPA may furnish a
duplicate notice. 40 CFR 2.204(e)(3).

4. Submission of Your Response in the English Language

    All responses to this notice must be in the English language.

5. The Effect of Failure To Respond to This Notice

    In accordance with 40 CFR 2.204(e)(1) and 2.205(d)(1), EPA will
construe your failure to furnish timely comments in response to this
notice as a waiver of your business's claim(s) of confidentiality for
any information in the documents identified in this notice.

6. What To Include in Your Comments

    If you believe that some or all of the information contained in the
types of documents which are described in this notice and which are
currently, or may become, subject to FOIA requests, is entitled to
confidential treatment, please specify which portions of the
information you consider confidential. Information not specifically
identified as subject to a confidentiality claim will be disclosed to
the requestor without further notice to you.
    For each item or class of information that you identify as being
subject to your claim, please answer the following questions, giving as
much detail as possible:
    1. For what period of time do you request that the information be
maintained as confidential, e.g., until a certain date, until the
occurrence of a specified event, or permanently? If the occurrence of a
specific event will eliminate the need for confidentiality, please
specify that event.
    2. Information submitted to EPA becomes stale over time. Why should
the information you claim as confidential be protected for the time
period specified in your answer to question no. 1?
    3. What measures have you taken to protect the information claimed
as confidential? Have you disclosed the information to anyone other
than a governmental body or someone who is bound by an agreement not to
disclose the information further? If so, why should the information
still be considered confidential?
    4. Is the information contained in any publicly available material
such as the Internet, publicly available data bases, promotional
publications, annual reports, or articles? Is there any means by which
a member of the public could obtain access to the information? Is the
information of a kind that you would customarily not release to the
public?
    5. Has any governmental body made a determination as to the
confidentiality of the information? If so, please attach a copy of the
determination.
    6. For each category of information claimed as confidential,
explain with specificity why release of the information is likely to
cause substantial harm to your competitive position. Explain the
specific nature of those harmful effects, why they should be viewed as
substantial, and the causal relationship between disclosure and such
harmful effects. How could your competitors make use of this
information to your detriment?
    7. Do you assert that the information is submitted on a voluntary
or a mandatory basis? Please explain the reason for your assertion. If
the business asserts that the information is voluntarily submitted
information, whether and why disclosure of the information would tend
to lessen the availability to EPA of similar information in the future.
    8. Any other issue you deem relevant.
    Please note that you bear the burden of substantiating your
confidentiality claim. Conclusory allegations will be given little or
no weight in the determination. If you wish to claim any of the
information in your response as confidential, you must mark the
response ``CONFIDENTIAL'' or with a similar designation, and must
bracket all text so claimed. Information so designated will be
disclosed by EPA only to the extent allowed by, and by means of, the
procedures set forth in, 40 CFR part 2, subpart B. If you fail to claim
the information as confidential upon submission, it may be made
available to the public without further notice to you.

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

    1. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or e-mail. Please submit this information by mail

to the address identified in the ADDRESSES section of today's notice.
Clearly mark the part or all of the information that you claim to be
CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark
the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is claimed as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2, subpart B. In
addition to one complete version of the comment that includes
information claimed as CBI, a copy of the comment that does not contain
the information claimed as CBI must be submitted for inclusion in the
public docket.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the notice by docket number and other identifying
information (subject heading, Federal Register date and page number).
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.

    Dated: April 20, 2007,
Anne Norton Miller,
Director, Office of Federal Activities.
[FR Doc. E7-8120 Filed 4-26-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: May 5, 2010 (Volume 75, Number 86)]
[Notices]
[Page 24730-24731]
[DOCID:fr05my10-114]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2010-0026]

Agency Information Collection Activities: Proposed Collection;
Comment Request, 1660-0046; FEMA/EMI Independent Study Course
Enrollment and Test Answer Sheet

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice; 60-day notice and request for comments; revision of a
currently approved information collection; OMB No. 1660-0046; FEMA Form
064-0-9 (formerly 95-23), FEMA/EMI Independent Study Course Enrollment
and Test Answer Sheet (paper and electronic).

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

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 the collection of information
necessary to allow students to enroll in online independent study
courses and take the tests after study is complete.

DATES: Comments must be submitted on or before July 6, 2010.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at http://www.regulations.gov under
docket ID FEMA-2010-0026. Follow the instructions for submitting
comments.
    (2) Mail. Submit written comments to Office of Chief Counsel,
Regulation and Policy Team, DHS/FEMA, 500 C Street, SW., Room 835,
Washington, DC 20472-3100.
    (3) Facsimile. Submit comments to<PHONE_NUMBER>.
    (4) E-mail. Submit comments to<EMAIL_ADDRESS>Include docket
ID FEMA-2010-0026 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 on the Privacy and Use Notice link on the
Administration Navigation Bar of http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Contact Mollie Herrick, Systems
Specialist, FEMA/EMI/Distance Learning Branch at<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 e-mail address: FEMA-Information-Collections-
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FEMA's Emergency Management Institute (EMI)
provides a wide variety of training to emergency management personnel
throughout the country. The EMI Independent Study (IS) Program is part
of the FEMA training program authorized under the Robert T. Stafford
Disaster Relief and Emergency Act, 42 U.S.C. 5121-5207, Public Law 93-
288 as amended. These courses are offered online by the Emergency
Management Institute (EMI). The IS Program provides valuable training
to Federal, State, local and Tribal emergency management personnel and
the general citizenry of the United States without having to attend a
resident course at EMI, or at a State-sponsored course. The National
Incident Management System (NIMS) is our nation's incident management
system. Homeland Security Presidential Directive 5, ``Management of
Domestic Incidents'' requires the adoption of NIMS by all Federal
departments and agencies. This directive also requires that Federal
preparedness assistance funding for States, Territories, local
jurisdictions and Tribal entities be dependent on being NIMS
compliance.

Collection of Information

    Title: FEMA/EMI Independent Study Course Enrollment and Test Answer
Sheet.
    Type of Information Collection: Revision of a currently approved
information collection.
    OMB Number: 1660-0046.
    Form Titles and Numbers: FEMA Form 064-0-9 (formerly 95-23), FEMA/
EMI Independent Study Course Enrollment and Test Answer Sheet (paper
and electronic).
    Abstract: The Independent Study (IS) program offers self-paced
courses designed for people who have emergency management
responsibilities and the general public. All are offered free-of-charge
to those who qualify for enrollment. Those who wish to participate
select the course(s) they want to take, review the material and then
complete an examination covering coursework. Successful completion
results in a certificate that can be used to obtain continuing learning
credit or even college credit.
    Affected Public: Individuals and households, business or other for-
profit, not for profit institutions, farms, Federal government, State,
local or Tribal government.
    Estimated Total Annual Burden Hours: 3,925,204 Hours.

                                                                           Estimated Annualized Burden Hours and Costs
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                      Avg. burden    Total annual                    Total annual
              Type of respondent                       Form name/Form No.            Number of     responses per   Total number    per response     burden  (in     Avg. hourly     respondent
                                                                                respondents     respondent     of responses     (in hours)        hours)         wage rate         cost
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
State, local or Tribal Government; Business or  FEMA/EMI Independent Study             1,682,231               4       6,728,924             0.5       3,364,462          $28.45     $95,718,944
 other for-profit; Not-for-profit                Course Enrollment and Test
 institutions; Individuals or households;        Answer Sheet/FEMA Form 064-0-9
 farms.                                          (Electronic).
State, local or Tribal Government; Business or  FEMA/EMI Independent Study               186,914               4         747,656            0.75         560,742           28.45      15,953,110
 other for-profit; Not-for-profit                Course Enrollment and Test
 institutions; Individuals or households;        Answer Sheet/FEMA Form 064-0-9
 farms.                                          (Paper).
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    Total.....................................  ................................       1,869,145  ..............       7,476,580  ..............       3,925,204  ..............     111,672,054
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    Estimated Cost: There are no annual capital, start-up, operation or
maintenance costs associated with this collection.

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: April 28, 2010.
Samuel C. Smith,
Acting Director, Records Management Division, Mission Support Bureau,
Federal Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2010-10525 Filed 5-4-10; 8:45 am]
BILLING CODE 9111-72-P