[Federal Register Volume 76, Number 53 (Friday, March 18, 2011)]
[Notices]
[Pages 14959-14960]
[FR Doc No: 2011-6334]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12778-004]

Fall Creek Hydro, LLC; Notice of Application Tendered for Filing
With the Commission and Establishing Procedural Schedule for Licensing
and Deadline for Submission of Final Amendments

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Original major license.
    b. Project No.: 12778-004.
    c. Date Filed: February 28, 2011.
    d. Applicant: Fall Creek Hydro, LLC.
    e. Name of Project: Fall Creek Dam Hydroelectric Project.
    f. Location: The proposed project would be constructed at the
existing U.S. Army Corps of Engineers' (Corps) Fall Creek Dam located
on Fall Creek near the towns of Springfield and Eugene in Lane County,
Oregon. The project would occupy 6.53 acres of Federal lands managed by
the Corps.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Brent L. Smith, Chief Operating Officer;
Symbiotics LLC; 371 Upper Terrace, Suite 2; Bend, OR 97702; Telephone
(541) 330-8779.
    i. FERC Contact: Lee Emery;<PHONE_NUMBER> or<EMAIL_ADDRESS>

    j. This application is not ready for environmental analysis at this
time.
    k. Project Description: The proposed project would consist of the
following new facilities: (1) An intake structure located on the face
of the Corps dam and installed directly above one of the existing
intake structures; (2) two 8-foot-diameter by 110-foot-long steel
penstocks that would bifurcate the existing south regulating outlet to
deliver flow to a powerhouse and a fish bypass system; (3) a 60-foot by
75-foot concrete powerhouse that would be located downstream from the
toe of the dam and would house two Francis generating units and one
Kaplan generating unit with a total installed capacity of 10 megawatts;
(4) a fish bypass system (to provide downstream fish passage) that
would include, among other things, Eicher fish screens, steel pipes,
multi-level release ports, open channels, a fish counting station, and
a discharge culvert; (5) one 442-foot-long, 12.5-kilovolt (kV), single-
circuit transmission line that would be buried and extend from the
powerhouse to an existing power line at the base of the dam; and (6)
appurtenant facilities.
    l. Locations of the Application: A copy of the application is
available for review at the Commission in the Public Reference Room or
may be viewed on the Commission's Web site at http://www.ferc.gov using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, contact FERC Online Support at<EMAIL_ADDRESS>or toll-free at 1-866-208-3676, or for TTY,<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above.
    m. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via e-mail of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    n. Procedural Schedule: The application will be processed according
to the preliminary licensing schedule below. Revisions to the schedule
may be made as appropriate.

------------------------------------------------------------------------
               Milestone                           Target date
------------------------------------------------------------------------
Notice of Acceptance/Notice of Ready     May 2011.
 for Environmental Analysis.
Filing of recommendations, preliminary   July 2011.
 terms and conditions, and fishway
 prescriptions.
Commission issues Draft EA or EIS......  January 2012.
Comments on Draft EA or EIS............  February 2012.
Modified Terms and Conditions..........  April 2012.
Commission Issues Final EA or EIS......  July 2012.
------------------------------------------------------------------------

    o. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of the notice
of ready for environmental analysis.

    Dated: March 11, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-6334 Filed 3-17-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: March 1, 2010 (Volume 75, Number 39)]
[Notices]
[Page 9272-9273]
[DOCID:fr01mr10-120]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61559; File No. SR-NYSE-2010-08]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by New York Stock Exchange LLC
Amending the Provisions of NYSE Rules 116 and 123C To Repeal the
Temporary Provision That Allows the Exchange To Report Multiple Closing
Prints to the Consolidated Tape When a Closing Transaction Exceeds
99,999,999 Shares

February 22, 2010.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on February 18, 2010, New York Stock Exchange LLC (``NYSE''
or the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I
and II below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the provisions of NYSE Rules 116
(``Stop'' Constitutes Guarantee) and 123C (Market On The Close Policy
And Expiration Procedures) to repeal the temporary provision that
allows the Exchange to report multiple closing prints to the
Consolidated Tape when a closing transaction exceeds 99,999,999 shares.
The text of the proposed rule change is available at the Exchange, the
Commission's Public Reference Room, and http://www.nyse.com.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    New York Stock Exchange LLC (``NYSE'' or the ``Exchange'') proposes
to amend the provisions of NYSE Rules 116 (``Stop'' Constitutes
Guarantee) and 123C (Market On The Close Policy And Expiration
Procedures) to repeal the temporary provision that allows the Exchange
to report multiple closing prints to the Consolidated Tape when a
closing transaction exceeds 99,999,999 shares.
    The Exchange amended NYSE Rules 116.40(C) and 123C(3) to report
multiple closing prints to the Consolidated Tape last sale reporting
system in order to compensate for a temporary size limitation in a new
market data distribution system.\4\ At that time, Exchange's market
data distribution system was unable to support prints greater than
99,999,999 shares. Executions of greater than 99,999,999 shares had to
be sent to the Consolidated Tape in multiple prints. The multiple
prints reflected the cumulative volume of the single closing
transaction.
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    \4\ See Securities Exchange Act Release No. 61235 (December 23,
2009), 75 FR 168 (January 4, 2010) (SR-NYSE-2009-126). The Exchange
represented that it anticipated correction of the limitation no
later than the end of February 2010. Id. at Footnote 3.
---------------------------------------------------------------------------

    The Exchange's market data distribution system is now capable of
reporting in a single transaction, executions that exceed 99,999,999
shares to the Consolidated Tape last sale reporting system in a single
print.\5\ The Exchange therefore seeks to remove the temporary
amendments to Rules 116.40(C) and 123C(3) and once again require all
closing transactions to be reported in a single print.
---------------------------------------------------------------------------

    \5\ The size limitation was corrected as of January 25, 2010.
---------------------------------------------------------------------------

    The Exchange also proposes to add an inadvertently omitted
parenthesis in the second paragraph of Rule 123C(3)(A).
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Securities Exchange Act of 1934 (the ``Act''),\6\ in
general, and furthers the objectives of Section 6(b)(5) of the Act,\7\
in particular, in that it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
of a free and open market and a national market system, and, in
general, to protect investors and the public interest. The Exchange
believes the proposed rule change will facilitate the timely and
efficient reporting of the closing transaction on the Exchange and thus
ultimately serve to protect investors and the public interest.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The proposed rule change is effective upon filing pursuant to
Section 19(b)(3)(A) of the Act \8\ and Rule 19b-4(f)(5).\9\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(5).
---------------------------------------------------------------------------

    The Exchange submits that the proposed rule change qualifies for
immediate effectiveness in that it effects a change in an existing
order-entry or trading system of a self-regulatory organization that
does not (i) significantly affect the protection of investors or the
public interest; (ii) impose any significant burden on competition; and
(iii) have the effect of limiting the access to or availability of the
system. This proposed rule change simply seeks to remove a temporary
amendment that was implemented to compensate for a systemic limitation
in its market data distribution system. The resolution of the systemic
limitation obviates the need for the work-around implemented by the
temporary rule. The instant filing simply reinstates provisions for
printing the closing transactions to their original state now that the
market data system is functioning correctly.
    At any time within 60 days of the filing of such proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2010-08 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSE-2010-08. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission,\10\ all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of the filing will also be
available for inspection and copying at the principal office of the
self-regulatory organization. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NYSE-2010-08 and should be submitted on or before March
22, 2010.
---------------------------------------------------------------------------

    \10\ The text of the proposed rule change is available on the
Commission's Web site at http://www.sec.gov.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-4165 Filed 2-26-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 209 (Friday, October 28, 2016)]
[Notices]
[Pages 75134-75136]
[FR Doc No: 2016-26044]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0796]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Testing Communications on Medical Devices and
Radiation-Emitting Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on communication studies
involving medical devices and radiation-emitting products regulated by
FDA. This information will be used to explore concepts of interest and
assist in the development and modification of communication messages
and campaigns to fulfill the Agency's mission to protect the public
health.

DATES: Submit either electronic or written comments on the collection
of information by December 27, 2016.

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-2013-N-0796 for ``Agency Information Collection Activities;
Proposed

Collection; Comment Request; Testing Communications on Medical Devices
and Radiation-Emitting Products.'' 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.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Testing Communications on Medical Devices and Radiation-Emitting
Products--OMB Control Number 0910-0678--Extension

    FDA is authorized by section 1003(d)(2)(D) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)) to conduct educational
and public information programs relating to the safety of regulated
medical devices and radiation-emitting products. FDA must conduct
needed research to ensure that such programs have the highest
likelihood of being effective. Improving communications about medical
devices and radiation emitting products will involve many research
methods, including individual in-depth interviews, mall-intercept
interviews, focus groups, self-administered surveys, gatekeeper
reviews, and omnibus telephone surveys.
    The information collected will serve three major purposes. First,
as formative research it will provide critical knowledge needed about
target audiences to develop messages and campaigns about medical device
and radiation-emitting product use. Knowledge of consumer and health
care professional decision making processes will provide the better
understanding of target audiences that FDA needs to design effective
communication strategies, messages, and labels. These communications
will aim to improve public understanding of the risks and benefits of
using medical devices and radiation-emitting products by providing
users with a better context in which to place risk information more
completely.
    Second, as initial testing, it will allow FDA to assess the
potential effectiveness of messages and materials in reaching and
successfully communicating with their intended audiences. Testing
messages with a sample of the target audience will allow FDA to refine
messages while still in the developmental stage. Respondents will be
asked to give their reaction to the messages in either individual or
group settings.
    Third, as evaluative research, it will allow FDA to ascertain the
effectiveness of the messages and the distribution method of these
messages in achieving the objectives of the message campaign.
Evaluation of campaigns is a vital link in continuous improvement of
communications at FDA.
    Annually, FDA projects about 30 studies using a variety of research
methods and lasting an average of 0.17 hours each (varying from 0.08 to
1.5 hours). FDA estimates the burden of this collection of information
based on prior recent experience with the various types of data
collection methods described earlier. FDA is requesting this burden so
as not to restrict the Agency's ability to gather information on public
sentiment for its proposals in its regulatory and communications
programs.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1.--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per  response
----------------------------------------------------------------------------------------------------------------
Individual in-depth interviews             360               1             360  .75 (45 minutes)             270
General public focus group                 144               1             144  1.5 hours.......             216
 interviews.
Intercept interviews: Central              200               1             200  .25 (15 minutes.              50
 location.
Intercept interviews:                    4,000               1           4,000  .08 (5 minutes).             320
 Telephone.
Self-administered surveys.....           2,400               1           2,400  .25 (15 minutes)             600
Gatekeeper reviews............             400               1             400  .5 (30 minutes).             200
Omnibus surveys...............           1,200               1           1,200  .17 (10 minutes)             204
                               ---------------------------------------------------------------------------------
    Total (general public)....           8,704  ..............  ..............  ................           1,860
----------------------------------------------------------------------------------------------------------------
Physician focus group                      144               1             144  1.5 hours.......             216
 interviews.
                               ---------------------------------------------------------------------------------
    Total (physician).........             144  ..............  ..............  ................             216
                               ---------------------------------------------------------------------------------
        Total (overall).......           8,848  ..............  ..............  ................           2,076
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: October 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26044 Filed 10-27-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 79 (Wednesday, April 24, 2019)]
[Rules and Regulations]
[Pages 17062-17064]
[FR Doc No: 2019-08157]

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

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0522; Product Identifier 2015-SW-068-AD; Amendment
39-19621; AD 2019-07-10]
RIN 2120-AA64

Airworthiness Directives; Northrop Grumman LITEF GmbH LCR-100
Attitude and Heading Reference System Units

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for
Northrop Grumman LITEF GmbH LCR-100 Attitude and Heading Reference
System (AHRS) units installed on various aircraft. This AD requires
removing certain LCR-100 AHRS units from service. This AD was prompted
by test results showing loss of or invalid data. The actions of this AD
are intended to prevent an unsafe condition on these products.

DATES: This AD is effective May 29, 2019.

ADDRESSES: For service information identified in this final rule,
contact Northrop Grumman LITEF GmbH, Customer Service--Commercial
Avionics, Loerracher Str. 18, 79115 Freiburg, Germany; telephone +49
(761) 4901-142; fax +49 (761) 4901-773; email [email protected].
You may review the referenced service information at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-
321, Fort Worth, TX 76177.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0522; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this AD, the European Aviation Safety Agency (EASA) AD, the economic
evaluation, any comments received, and other information. The street
address for Docket Operations (phone:<PHONE_NUMBER>) is U.S. Department
of Transportation, Docket Operations Office, M-30, West Building Ground
Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Nick Rediess, Aviation Safety
Engineer, Boston ACO Branch, Compliance and Airworthiness Division,
1200 District Avenue, Burlington, Massachusetts 01803; telephone (781)
238-7763; email [email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    On June 5, 2017, at 82 FR 25742, the Federal Register published our
notice of proposed rulemaking (NPRM), which proposed to amend 14 CFR
part 39 by adding an AD that would apply to airplanes and helicopters
with a Northrop Grumman LITEF GmbH LCR-100 AHRS unit part number (P/N)
145130-2000,<PHONE_NUMBER>,<PHONE_NUMBER>,<PHONE_NUMBER>, or<PHONE_NUMBER>
installed that uses analog outputs for primary flight information
display or autopilot functions without automatic output comparison. A
primary flight information display includes any device that displays to
the pilot primary flight information such as attitude, airspeed, and
altitude. Such displays include primary flight displays, standby
instruments, and multifunction displays that provide a secondary
display of primary flight information. The NPRM proposed to require
removing these LCR-100 AHRS units from service and to prohibit
installing them on any aircraft.
    These units are often used to supply attitude and heading data to
Primary Flight Displays (PFDs), autopilots, and other avionics.
Northrop Grumman LITEF GmbH discovered erroneous behavior of an AHRS
unit when the unit's continuous built-in test detects a failure and
then does not correctly reset. When this occurs, the analog outputs of
attitude and heading data freeze and the transmission of digital
outputs of attitude and heading stops. The effect of the errors
(display of misleading information, providing an alert if the attitude
and heading data is frozen) depends on how the AHRS unit outputs are
used in a particular installation. For instance, if the AHRS unit
analog outputs are used by a PFD without any automatic comparison with
another source of data, the PFD will display misleading information,
which could lead to loss of control of the aircraft. Other
installations using the analog outputs might include an automatic
comparison feature that detects and provides an alert if the attitude
and heading data is frozen. A similar situation would occur in
installations that use the digital outputs since the erroneous behavior
would be detected. The NPRM proposed to only apply to installations of
the AHRS units using analog outputs for the display of

primary flight information or for input to an autopilot without
automatic output comparison since these installations do not provide
any warning indication of the erroneous behavior.
    The proposed requirements were intended to prevent an AHRS unit's
analog outputs of attitude and heading data freezing without detection
or warning, which could result in misleading attitude and heading
information, anomalous autopilot behavior, and loss of control of the
aircraft.
    The NPRM was prompted by AD No. 2015-0093, dated May 27, 2015,
issued by EASA, which is the Technical Agent for the Member States of
the European Union, to correct an unsafe condition for the Northrop
Grumman LITEF GmbH LCR-100 AHRS units. EASA advises that laboratory
tests of the AHRS units discovered that when the built-in test detects
failures and resets the system, the units are not executing the system
reset properly, which results in a freeze of analog attitude and
heading output data without detection or warning to the pilot. EASA
states that installations vary, but if there is no automatic comparison
of analog output to detect unit failure, this condition, if not
corrected, could lead to undetected attitude and heading errors,
possibly resulting in loss of control of the aircraft.
    The NPRM also advised that the proposed AD would affect AD 2010-26-
09 (75 FR 81424, December 28, 2010) (``AD 2010-26-09''), which applies
to Sikorsky Model S-76A, B, and C helicopters with an AHRS unit P/N
145130-7100 installed. Since the NPRM proposed to require the removal
of P/N<PHONE_NUMBER>, compliance with the proposed would make AD 2010-26-
09 no longer valid for those Sikorsky helicopters.
    Since the NPRM was issued, the FAA's Aircraft Certification Service
has changed its organizational structure. The new structure replaces
product directorates with functional divisions. We have revised some of
the office titles and nomenclature throughout this Final rule to
reflect the new organizational changes. Additional information about
the new structure can be found in the Notice published on July 25, 2017
(82 FR 34564).

Comments

    After our NPRM was published, we received comments from one
commenter.

Request

    The commenter suggested we made an error in the Discussion section
where it states, ``A similar situation would occur in installations
that use the digital outputs since the erroneous behavior would be
detected.'' The commenter states the loss of digital data would be
detected, and therefore the sentence should state instead that a
similar situation would not occur.
    We disagree. The commenter is correct that an installation that
uses digital outputs would detect the erroneous behavior and provide an
alert. The ``similar situation'' referred to is the alert provided by
installations that use analog outputs with automatic comparison, which
also detect the attitude and heading data becoming frozen. Because both
types of installations detect the erroneous behavior, they result in a
similar situation. We did not change the AD based on this comment.

FAA's Determination

    We have reviewed the relevant information, considered the comment
received, and determined that an unsafe condition exists and is likely
to exist or develop on other products of these same type designs and
that air safety and the public interest require adopting the AD
requirements as proposed.

Differences Between This AD and the EASA AD

    This AD only applies to certain part-numbered AHRS units that use
analog outputs for primary flight information display or autopilot
functions without automatic output comparison. The EASA AD applies to
all of these part-numbered units regardless of the type of
installation. The EASA AD requires inserting a temporary revision into
the flight manual for analog without automatic output comparison
installations until the AHRS unit is replaced with a modified unit.
This AD does not require temporarily revising the flight manual. The
EASA AD requires replacing the AHRS units with particular part-numbered
modified units, while this AD requires removing the AHRS units from
service instead.

Related Service Information

    We reviewed Northrop Grumman LITEF GmbH Service Bulletin No.
145130-0017-845, Revision D, dated April 1, 2015 (SB<PHONE_NUMBER>-845).
SB<PHONE_NUMBER>-845 specifies returning the applicable part numbered
AHRS units to certain repair stations for modification. The modified
AHRS units, which have new part numbers, have an additional watchdog
circuit in the electronic board that eliminates frozen analog outputs
and digital output interruptions.

Costs of Compliance

    We estimate that this AD affects 50 aircraft of U.S. Registry. We
estimate that operators may incur the following costs in order to
comply with this AD. Labor costs are estimated at $85 per work-hour,
and typical installations consist of two AHRS units. Replacing two AHRS
units takes about 4 work-hours and $62,630 for required parts, for a
total cost of $62,970 per aircraft and $3,148,500 for the U.S. fleet.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979);
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction; and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

    We prepared an economic evaluation of the estimated costs to comply
with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2019-07-10 Northrop Grumman LITEF GmbH LCR-100 Attitude and Heading
Reference System: Amendment 39-19621; Docket No. FAA-2017-0522;
Product Identifier 2015-SW-068-AD.

(a) Applicability

    This AD applies to airplanes and helicopters, certificated in
any category, with a Northrop Grumman LITEF GmbH LCR-100 Attitude
and Heading Reference System (AHRS) unit part number (P/N) 145130-
2000,<PHONE_NUMBER>,<PHONE_NUMBER>,<PHONE_NUMBER>, or<PHONE_NUMBER>
installed using analog outputs for primary flight information
display or autopilot functions without automatic output comparison.
Aircraft known to have the subject AHRS units installed include but
are not limited to the following:
    (1) Dornier Luftfahrt GmbH Model 228-100, 228-101, 228-200, 228-
201, 228-202, and 228-212 airplanes;
    (2) Learjet Inc. Model 31A airplanes;
    (3) Pilatus Aircraft Ltd. Model PC12, PC-12/45, and PC-12/47
airplanes;
    (4) Polskie Zaklady Lotnicze Sp. z o.o. Model PZL M28 05
airplanes;
    (5) Textron Aviation Inc. (type certificate previously held by
Cessna Aircraft Company) Model 560XL airplanes;
    (6) Bell Helicopter Textron Canada Limited Model 407
helicopters;
    (7) Bell Helicopter Textron Inc. Model 412 and 412EP
helicopters; and
    (8) Sikorsky Aircraft Corporation Model S-76A, S-76-B, and S-76C
helicopters.

(b) Unsafe Condition

    This AD defines the unsafe condition as the AHRS unit's analog
outputs of attitude and heading data freezing without detection or
warning. This condition could result in misleading attitude and
heading information, anomalous autopilot behavior, and loss of
control of the aircraft.

(c) Affected ADs

    This AD affects AD 2010-26-09, Amendment 39-16548 (75 FR 81424,
December 28, 2010) (``AD 2010-26-09''). Accomplishing a certain
requirement of this AD terminates the requirements of AD 2010-26-09.

(d) Effective Date

    This AD becomes effective May 29, 2019.

(e) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(f) Required Actions

    (1) Within 25 hours time-in-service (TIS), remove the AHRS unit
from service.
    (2) Removal from service of P/N<PHONE_NUMBER> terminates the
requirements of AD 2010-26-09 (75 FR 81424, December 28, 2010).
    (3) Do not install an AHRS unit P/N<PHONE_NUMBER>,<PHONE_NUMBER>,
145130-7000,<PHONE_NUMBER>, or<PHONE_NUMBER> on any aircraft.

(g) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Boston ACO Branch, FAA, may approve AMOCs for
this AD. Send your proposal to: Nick Rediess, Aviation Safety
Engineer, Boston ACO Branch, Compliance and Airworthiness Division,
1200 District Avenue, Burlington, Massachusetts 01803; telephone
(781) 238-7763; email [email protected].
    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office, before operating any aircraft
complying with this AD through an AMOC.

(h) Additional Information

    (1) Northrop Grumman LITEF GmbH Service Bulletin No. 145130-
0017-845, Revision D, dated April 1, 2015, which is not incorporated
by reference, contains additional information about the subject of
this AD. For service information identified in this AD, contact
Northrop Grumman LITEF GmbH, Customer Service--Commercial Avionics,
Loerracher Str. 18, 79115 Freiburg, Germany; telephone +49 (761)
4901-142; fax +49 (761) 4901-773; email [email protected].
You may review a copy of the service information at the FAA, Office
of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy.,
Room 6N-321, Fort Worth, TX 76177.
    (2) The subject of this AD is addressed in European Aviation
Safety Agency (EASA) AD No. 2015-0093, dated May 27, 2015. You may
view the EASA AD on the internet at http://www.regulations.gov in
Docket No. FAA-2017-0522.

(i) Subject

    Joint Aircraft Service Component (JASC) Code: 3420, Attitude and
Directional Data System.

    Issued in Fort Worth, Texas, on April 16, 2019.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2019-08157 Filed 4-23-19; 8:45 am]
BILLING CODE 4910-13-P


VIA E-MAIL

April 13, 2010

Mr. Jeffrey A. Telander

Sector Policies and Programs Division

Metals and Minerals Group (D243-02)

Office of Air Quality Planning and Standards

U.S. Environmental Protection Agency

109 TW Alexander Drive

Research Triangle Park, NC  27711

Mr. William Neuffer

Sector Policies and Programs Division

Metals and Minerals Group (D243-02)

Office of Air Quality Planning and Standards

U.S. Environmental Protection Agency

109 TW Alexander Drive

Research Triangle Park, NC  27711

RE:	Representativeness of Wool Fiberglass and Mineral Wool Data

Dear Messrs. Telander and Neuffer:

INTRODUCTION

In the draft Information Collection Requests (“ICRs”) for both the
wool fiberglass and mineral wool insulation manufacturing industries’
residual risk review, the Environmental Protection Agency (“EPA”)
states that “[i]n lieu of new testing, existing and well documented
test data from your current operations that you consider representative
. . . can be submitted.”  This statement is repeated in the “Summary
of Test Procedures, Methods, and Reporting Requirements” for each ICR.

This letter sets forth the wool fiberglass and mineral wool insulation
manufacturing industries’ proposal to provide both existing test data
and new test data to respond to the draft ICR.  Specifically this letter
provides the details of the existing data that will be used to respond
to the ICR and the bases for our position that such test data should
constitute representative industry data.  This letter also identifies
where we propose that new testing be conducted and the bases for our
position that such test data for the selected point sources should
constitute representative industry data.

As we stated in our March 27, 2010 letter concerning the use of
alternative test methods for responding to the draft ICRs, EPA’s
acceptance of such alternative test methods will enable us to provide
EPA the emissions data it needs while both expediting the information
collection process and leveraging the use of existing emissions data.
The industry recommended these alternative test methods not only because
it has extensive data collected by these alternative methods that are
relevant to EPA’s requests, but also because every company is
operating at reduced production due to the significant economic downturn
in the building industry.  New data could not be collected from the many
production lines that are not in operation, even though they are
currently permitted.  Use of existing data will be essential for
providing EPA with the requisite data for all point sources.

Moreover, we appreciate EPA’s willingness to accept as responsive the
test data generated by many of the alternative test methods we
identified.  However, the use of such data necessarily requires EPA’s
acceptance of at least some, if not all, such data that was generated
pursuant to tests run for the length of time prescribed by the
applicable test methods, not for some longer period of time.  For
example, one hour should be more than sufficient for all the organics to
be measured.  The majority of these test methods have a one-hour length;
detection limits are set to work within the designated timeframes.  If
the detected amount of the pollutant is one or two orders of magnitude
above the detection limit, extending the time and reducing the detection
limit does not provide any additional substantive or meaningful
information because the pollutant in question has already been detected
and measured.  We understand that it is our responsibility to make sure
sampling times are long enough to obtain results that are greater than
minimum detection limits (unless the EPA-recommended sampling times and
volumes are implemented where no-detect results will be accepted).

By this letter, the North American Insulation Manufacturers Association
(“NAIMA”) requests EPA’s approval of the selection of data below
as representative industry data so that we can prepare a plan and
schedule for the collection of the data and other information responsive
to both draft ICRs.

DESCRIPTION OF GLASS AND MINERAL WOOL MANUFACTURING PROCESSES

Fiber glass insulation starts with raw materials such as sand, soda, and
lime.  Broken or recycled glass, known as cullet, is added to the
mixture of raw materials to accelerate the melting process.  These
ingredients are mixed in the batch house and then transferred to and
melted in refractory-lined furnaces, or in some cases, special large
pots.  The heat from the furnace converts these raw materials into a
homogenous molten liquid.  The melting of glass and forming it into a
fiber consists of two distinct stages.  The first involves the chemical
reaction between the ingredients and results in a sticky molten mass
with many bubbles.  In the second stage, the glass is cooled until it
has the required viscosity for fiberization.  The molten glass flows
from the furnace through the channel to the forehearth, where, after
losing a good deal of heat along the way, the glass drains through
bushings into the fiberizing equipment.

Mineral wool follows a similar process, with the raw materials being
different.

EXISTING AND REPRESENTATIVE DATA

To identify and organize the data to be supplied to EPA, this letter
arranges by MACT Standard the point sources and pollutants for which we
will supply existing test data or newly collected data and our bases for
concluding that such data should be deemed representative.

	Wool Fiberglass

Furnaces

Process Unit:	Oxy Fuel

Pollutants Testing Requested:	PM2.5 (Filterable and Condensable), Total
PM (Filterable), Metal HAPs, Hex Chrome, HF, HC1

Data To Be Supplied:	There are 12 oxy fuel furnaces permitted in the
industry.  PM2.5, total PM, metal HAPs, hex chrome, and hydrogen
fluoride data will be collected from Owens Corning’s Kansas City,
Kansas, facility (K5 Line).  As described below, the data collected at
this plant will be representative of all 12 oxy fuel furnaces.  It is
critical that newly-collected data be accepted as representative data
because at least 6 of the 12 oxy fuel furnaces are idle.  A survey of
fiber glass companies indicates that there would be no possible source
for HC1.

Location/Lines Represented:	Knauf – Lanett, Alabama (621 Furnace (with
DEP) and 622 Furnace (with DEP))

	CertainTeed – Athens, Georgia (A2 Furnace); Chowchilla, California
(A1 Furnace); Kansas City, Kansas (K1 Furnace and K2 Furnace); Mountain
Top, Pennsylvania (M1 Furnace and M2 Furnace)

	Johns Manville – Cleburne, Texas (1902 Marble Furnace (has Scrubber
and ESP)); Defiance, Ohio (2601 & 2603 Marble Furnaces (have common ESP
and Baghouse in series and do not have oxy firing))

	Owens Corning – Delmar, New York (DM1 Furnace (with DEP) and DM2
Furnace (with DEP)); Kansas City, Kansas (J6/U3 Furnace (with Electric
Boost and DEP) and K5 Furnace (with DEP)); Waxahachie, Texas (VI Furnace
(with DEP)); Newark, Ohio (F6 Furnace (with Electric Boost and
Baghouse), A3 Furnace (with DEP))

Bases For Representativeness:	The data collected would be representative
to the extent the method of operation is the same, all oxy fuel furnaces
are powered by natural gas, all of the oxy fuel furnaces use a dry
electrostatic precipitator or similar control, all of the oxy fuel
furnaces are making borosilicate glass using essentially the same raw
materials, all of the oxy fuel furnaces are the same class size of
furnaces, and the Kansas City plant is at the midpoint of the range.

Process Unit:	Cold Top Electric – With Baghouse

Pollutants Testing Requested:	PM2.5 (Filterable and Condensable), Total
PM (Filterable), Metal HAPs, Hex Chrome, HF, HC1

Data To Be Supplied:	Heavy metal and hex chrome data will be collected
from Knauf’s Shasta Lake, California facility using EPA Method 29 and
the accepted test method for hex chrome, and this data will be
representative of all cold top furnaces with baghouses.  PM2.5 and Total
PM will be provided from Knauf’s Shasta Lake, California, facility’s
existing data.  This data will be representative of all cold top
furnaces with baghouses, as described below.  A survey of fiber glass
companies indicates that there appears to be no possible source for HF
or HC1 from this group of facilities.

Location/Lines Represented:	Knauf – Shelbyville, Indiana (611 Furnace
and 602 Furnace); Shasta Lake, California (641 Furnace)

	CertainTeed – Athens, Georgia (A1 Furnace)

	FiberTEK – Lakeland, Florida (Middle Melter and West Melter); Nephi,
Utah (Middle Melter and West Melter)

	Johns Manville – Richmond, Indiana (Melter); Defiance, Ohio (3
Melters, Lines 801-806)

Bases For Representativeness:	The data collected would be representative
to the extent the method of operation is the same, all of the furnaces
are operated with electricity, all of the furnaces are the same brand,
all of the furnaces are making borosilicate glass using essentially the
same material, and all of the furnaces have a baghouse.

Process Unit:	Cold Top Electric – Without Baghouse

Pollutants Testing Requested:	PM2.5 (Filterable and Condensable), Total
PM (Filterable), Metal HAPs, Hex Chrome, HF, HC1

Data To Be Supplied:	Heavy metal, hex chrome, and hydrogen fluoride data
will be collected from Owens Corning’s Kansas City, Kansas, facility
(70 furnace) using EPA Method 29 and the accepted test method for hex
chrome, and that data will be representative of all cold top furnaces
without baghouses.  New emissions tests for PM2.5 and Total PM will also
be conducted.  This data will be representative of all cold top furnaces
without baghouses, as described below.  A survey of fiber glass
companies indicates that there appears to be no possible source for HC1.

Location/Lines Represented:	Owens Corning – Fairburn, Georgia (FG1,
FG2, FG3 Furnaces (With Batch Wetting)); Newark, Ohio (C4 and B4
Furnaces (With Batch Wetting)); Kansas City, Kansas (70 Furnace (With
Batch Wetting)); Waxahachie, Texas (V2 Furnace, V3 Furnace (With Batch
Wetting)); Santa Clara, California (M and O Furnaces (With Batch
Wetting))

Bases For Representativeness:	The data collected would be representative
to the extent the method of operation is the same, all of the furnaces
are operated with electricity, all of the furnaces are the same basic
design, all of the furnaces are making borosilicate glass using
essentially the same material, all furnaces are operated without a
baghouse, and the capacity is at the midpoint of the range.

Process Unit:	Electric Steel Shell Melter – With Baghouse

Pollutants Testing Requested:	PM2.5 (Filterable and Condensable), Total
PM (Filterable), Metal HAPs, Hex Chrome, HF, HC1

Data To Be Supplied:	Existing PM2.5, total PM, and heavy metal data from
Johns Manville’s Willows, California, facility will be used as
representative data for all electric steel shell melters in the
industry.  Data for hex chrome will be collected at Johns Manville’s
Willows, California, facility and will be used representative data for
all electric steel shell melters in the industry.

Location/Lines Represented:	Guardian – Albion, Michigan (Line 1
Furnace, Line 2 Furnace, Line 3 Furnace, Line 4 Furnace); Kingman,
Arizona (Line 1 Furnace); Inwood, West Virginia (Line 1 Furnace, Line 2
Furnace); Winnsboro, South Carolina (Line 1 Furnace); Mineral Wells,
Mississippi (Line 1 Furnace, Line 2 Furnace)

	Johns Manville – Penbryn,  New Jersey (L58 Melter); Winder, Georgia
(Line 105 and 106 Melters); McPherson, Kansas (Line 122 and 123
Melters); Willows, California (Line 132 and 133 Melters); Cleburne,
Texas (Lines 91, Melter); Defiance, Ohio (Line 89 Melter)

	Owens Corning – Eloy, Arizona (Two Furnaces); Salt Lake City, Utah
(Two Furnaces); Mount Vernon, Ohio (Three Furnaces)

Bases For Representativeness:	The data collected would be representative
to the extent the method of operation is the same, all of the furnaces
are operated with electricity, all of the furnaces are steel shell
pot-type containers with refractory liners, all of the furnaces use a
baghouse, and all of the furnaces are making borosilicate glass using
essentially the same raw materials.

Process Unit:	Pot & Marble Flame Attenuated

Pollutants Testing Requested:	PM2.5 (Filterable and Condensable), Total
PM (Filterable), Metal HAPs, Hex Chrome, HF, HC1

Data To Be Supplied:	Johns Manville is the only member in NAIMA with a
Pot & Marble melting process.  They melt glass marbles in very small
pots using small gas burners (not electric).  It is a completely
different process than rotary and was subcategorized in the original
MACT standard.  Johns Manville will provide heavy metal, hex chrome,
PM2.5 and Total PM data from existing data.  A survey of fiber glass
companies indicates that there would be no possible source for HF or HC1
from this group of facilities.

Location/Lines Represented:	Johns Manville – Defiance, Ohio (Lines 81,
82, 84, 85, 86, 87, 88, 21, 23, 24, 25); Cleburne, Texas (L92, 93);
Waterville, Ohio (pot and marble lines (no binder)).

Bases For Representativeness:	The data collected would be representative
to the extent the method of operation is the same, all furnaces are
making borosilicate glass using essentially the same material, and all
are pot & marble flame attenuation.

Forming, Curing, and Cooling

For purposes of identifying representative data responsive to EPA’s
request, NAIMA has combined the forming, curing, and cooling sources
together into one source.  These three sources are more often than not
exhausted through one stack or common exhaust system, not separately and
individually.  Where a common stack or exhaust is not used, NAIMA will
combine the emissions data from the three sources into one data set.
This is consistent with prior practices and eliminates a lot of
confusion in treating forming, curing, and cooling in separate
categories that ultimately undertake the same discussion and analysis
for each source.

Process Unit:		Forming, Curing, and Cooling

Pollutants Testing Requested:		Formaldehyde, Phenol, Methanol

Data To Be Supplied:	All plants with bonded lines using formaldehyde
will use existing data from Owens Corning’s Kansas City, Kansas,
facility for formaldehyde, phenol, and methanol with appropriate factors
to account for different control devices, LOI, and/or pounds per ton of
melt, as applicable, because this facility’s forming, curing and
cooling sources have no voc controls.  Formaldehyde, phenol, and
methanol data are from testing done in accordance with Method 316 for
formaldehyde, Method 308 for methanol, and Lab 8, BAAQMD Method ST-16
for phenol.  No formaldehyde, phenol, or methanol data will be supplied
for plants with bonded lines using a non-Phenol/Formaldehyde (“P/F”)
binder.  The data that will be provided to EPA is not representative of
these unbonded lines, and no data has been collected for these unbonded
lines as agreed upon by EPA.

Location/Lines Represented:	The following company facilities that use
phenolic/ formaldehyde binders for which data from Owens Corning’s
Kansas City facility will serve as representative data on formaldehyde,
phenol, and methanol are:

	CertainTeed – Athens, Georgia (All Lines); Chowchilla, California
(C11 Line); Kansas City, Kansas (K11 Line, K21 Line); Mountain Top,
Pennsylvania (M1 and M2 Lines)

	FiberTEK – Lakeland, Florida (BL Line); Nephi, Utah (BL Line)

	Guardian – Albion, Michigan (Line 1, Line 3); Kingman, Arizona (Line
1); Inwood, West Virginia (Lines 1 and 2); Winnsboro, South Carolina
(Line 1); Mineral Wells, Mississippi (Line 1)

	Johns Manville – Cleburne, Texas (Lines 91, L92, L93 Lines);
Defiance, Ohio (Lines 89, 801-806, 807, 81-88, 21-25)

	Knauf – Shelbyville, Indiana (Bonded Line)

	Owens Corning – Delmar, New York (DM1 and DM2 Lines); Fairburn,
Georgia (FG1, FG2, FG3 Lines); Newark, Ohio (C4, F6, B4, A4, A5 Lines);
Kansas City, Kansas (70, J6, K5 Lines); Waxahachie, Texas (V1, V2, V3
Lines); Santa Clara, California (M, O Lines); Eloy, Arizona (1 Bonded
Line); Salt Lake City, Utah (1 Bonded Line)

	The following member company facilities that do not use
phenolic/formaldehyde binders or use no binders (unbonded lines) for
which no such test data will be provided are:

	CertainTeed – Athens, Georgia (A12 and A23 Lines); Chowchilla,
California (C12 Line); Kansas City, Kansas (K11 and K21 Lines)

	FiberTEK – Lakeland, Florida (UL Line); Nephi, Utah (UL Line)

	Guardian – Albion, Michigan (Lines 2 and 4); Mineral Wells,
Mississippi (Line 2)

	Johns Manville – Penbryn, New Jersey (Line 58); Richmond, Indiana
(Lines 2 and 3); Waterville, Ohio (Pot/Marble Production); Winder,
Georgia (Lines 105 and 106); McPherson, Kansas (Lines 122 and 123);
Willows, California (Lines 132 and 133)

	Knauf – Shasta Lake, California (100% Non-P/F); Lanett, Alabama (100%
Non-P/F); Shelbyville, Indiana (Approximately 75% Non-P/F)

	Owens Corning – Kansas City, Kansas (U3 Line); Salt Lake City, Utah
(SL2 Line); Mount Vernon, Ohio (3 Unbonded Lines)

Bases For Representativeness:  	The data collected being provided would
be representative of forming, curing, and cooling sources at facilities
suing formaldehyde/phenolic binder because the method of manufacture is
the same, of the all products are being formed from borosilicate glass
using essentially the same raw materials, all of the products are
bonded, all of the binders are phenolic, and essentially the same
process controls are used.

Mineral Wool

Process Unit:	Cupola – With Baghouse and Incinerator

Pollutants Testing Requested:	Carbon Monoxide, Carbonyl Sulfide

Data To Be Supplied:	Existing carbonyl sulfide and carbon monoxide data
from a USG Interiors facility will be used as representative data for
all mineral wool cupolas with baghouses and incinerators as described
below.  The carbonyl sulfide data has been collected with EPA Method 10,
and the carbon monoxide data has been collected with EPA Method 320.

Location/Lines Represented:	Based on the bases/assumptions identified
below, this data is representative of all lines at the following plants
and locations:

	Industrial Insulation Group – Phenix City, Alabama

	Thermafiber – Wabash, Indiana (Bonded #2, Granulated #4)

	USG Interiors – Red Wing, Minnesota; Walworth, Wisconsin

Bases For Representativeness:	This data is representative to the extent
each cupola is coke-fired, melting almost identical raw material mix,
producing rock and slag wool products, and using controls of an
incinerator or baghouse.

Process Unit:	Cupola – With Baghouse Only

Pollutants Testing Requested:	Carbon Monoxide, Carbonyl Sulfide

Data To Be Supplied:	Existing carbonyl sulfide and carbon monoxide data
from the Amerrock Products, Nolanville, Texas facility will be used as
representative data for all mineral wool cupolas with baghouses and no
incinerators.  The carbonyl sulfide data has been collected with EPA
Method 15, and the carbon monoxide data has been collected with EPA
Method 10.

Location/Lines Represented:	Based on the bases/assumptions identified
below, this data is representative of all lines at the following plants
and locations:

	Amerrock Products – Nolanville, Texas

	Isolatek International – Huntington, Indiana (Cupola #1, Cupola #2
– common baghouse/combined point source)

	Rock Wool Manufacturing – Leeds, Alabama (1 Cupola, Line #2)

Bases For Representativeness:	This data is representative to the extent
each cupola is coke-fired, melting almost identical raw material mix,
producing rock and slag wool products, and using controls of a baghouse.

Process Unit:	Cupola

Pollutants Testing Requested:	PM 2.5 (Filterable and Condensable), Total
PM (Filterable), Metal HAPs, Hex Chrome, HF, HC1

Data To Be Supplied:	Existing metal HAPs data from a USG Interiors
facility will be used as representative data for the entire industry, as
described below.  The data has been collected pursuant to EPA Method 29.
 Specific data on hexavalent chromium, mercury, and HF and HC1 need not
be provided to EPA.  Hex Chrome is identified in the wool fiber glass
industry because glass furnaces are lined with chrome refractories that
contain hexavalent chromium.  Mineral wool companies do not use chrome
refractories to line their cupolas.  To the extent that hex chrome may
appear in raw materials, NAIMA will provide data for the industry.  A
survey of mineral wool companies indicates that there would be only a
limited possibility for a source for HF emissions and apparently no
possible basis for HC1 emissions.  PM2.5 (filterable and condensable)
and Total PM filterable will have to be collected from new emissions
testing.  This data will be collected pursuant to EPA Method 27 or 28 at
one of the USG Interiors facilities.  The data collected from USG
Interiors will be used as representative data for the entire mineral
wool industry.

Location/Lines Represented:	Based on the bases/assumptions identified
below, this data is representative of all lines at the following plants
and locations:

	Amerrock Products – Nolanville, Texas

	Industrial Insulation Group – Phenix City, Alabama

	Isolatek International – Huntington, Indiana

	Rock Wool Manufacturing – Leeds, Alabama

	Thermafiber – Wabash, Indiana

	USG Interiors – Red Wing, Minnesota; Walworth, Wisconsin

Bases For Representativeness:	This data is representative to the extent
that all of the cupolas are coke-fired, melting almost identical raw
material mix, producing rock and slag wool products, and using controls
of an incinerator or baghouse.

Process Unit:	Collection Operation

Pollutants Testing Requested:	Formaldehyde, Phenol, Methanol

Data To Be Supplied:	Existing formaldehyde data will be supplied from
Thermafiber, Industrial Insulation Group, and Rock Wool Manufacturing.
New methanol and phenol data will be collected from Thermafiber pursuant
to one the EPA approved methods (EPA Method 318 or 308 for methanol and
EPA Method 318 or Method 8270D for phenol) and be used as representative
for all three companies as described below.  The remaining companies,
USG Interiors, Amerrock Products, and Isolatek International, operate
unbonded lines, and, therefore, use no binder is applied during the
manufacturing of mineral wool.  In addition, Thermafiber line –
Granulated #4 is unbonded.  The data that will be provided to EPA is not
representative of these unbonded lines, and no data has been collected
for these unbonded lines as agreed upon with EPA.

Location/Lines Represented:	As noted above, the data supplied will be
for existing or representative data for:

	Industrial Insulation Group – Phenix City, Alabama

	Thermafiber (Bonded #2) – Wabash, Indiana

	Rock Wool Manufacturing (Bonded Line #2) – Leeds, Alabama

Bases For Representativeness:	This data is representative to the extent
that all of the cupolas are coke-fired, melting almost identical raw
material mix, producing rock and slag wool products, and using controls
of an incinerator or baghouse.

Process Unit:	Curing Oven

Pollutants Testing Requested:	Formaldehyde, Phenol, Methanol

Data To Be Supplied:	Existing formaldehyde data will be supplied from
Thermafiber, Industrial Insulation Group, and Rock Wool Manufacturing.
New methanol and phenol data will be collected from Thermafiber pursuant
to one the EPA approved methods (EPA Method 318 or 308 for methanol and
EPA Method 318 or Method 8270D for phenol) and be used as representative
for all three companies as described below.  The remaining companies,
USG Interiors, Amerrock Products, and Isolatek International, operate
unbonded lines, and, therefore, no binder is applied during the
manufacturing of mineral wool.  In addition, Thermafiber line –
Granulated #4 is unbonded.  The data that will be provided to EPA is not
representative of these unbonded lines, and no data has been collected
for these unbonded lines as agreed upon with EPA.

Location/Lines Represented:	As noted above, the data supplied will be
for existing or representative data for:

	Industrial Insulation Group – Phenix City, Alabama

	Thermafiber (Bonded #2) – Wabash, Indiana

	Rock Wool Manufacturing (Bonded Line #2) – Leeds, Alabama

Bases For Representativeness:	This data is representative to the extent
that each cupola is coke-fired, melting almost identical raw material
mix, producing rock and slag wool products, and using controls of an
incinerator or baghouse.

Process Unit:	Cooling Operation

Pollutants Testing Requested:	Formaldehyde, Phenol, Methanol

Data To Be Supplied:	New formaldehyde, methanol, and phenol data will be
collected from Thermafiber pursuant to one of the EPA approved methods
(EPA Method 318 or 308 for methanol and EPA Method 318 or Method 8270D
for phenol) and be used as representative for all three companies as
described below.  The remaining companies, USG Interiors, Amerrock
Products, and Isolatek International, operate unbonded lines, and,
therefore, no binder is applied during the manufacturing of mineral
wool.  In addition, Thermafiber line – Granulated #4 is unbonded.  The
data that will be provided to EPA is not representative of these
unbonded lines, and no data has been collected for these unbonded lines
as agreed upon with EPA.

Location/Lines Represented:	As noted above, the data supplied will be
for existing or representative data for:

	Industrial Insulation Group – Phenix City, Alabama

	Thermafiber (Bonded #2) – Wabash, Indiana

	Rock Wool Manufacturing (Bonded Line #2) – Leeds, Alabama

Bases For Representativeness:	This data is representative to the extent
that all of the cupolas are coke-fired, melting almost identical raw
material mix, producing rock and slag wool products, and using controls
of an incinerator or baghouse.

Sincerely,

Angus E. Crane

Angus E. Crane, Executive Vice President, General Counsel

 F.J. Terence Maloney, Glass in the Modern World, at 74 (New York:
Doubleday, 1968).

Messrs. Jeffrey A. Telander and William Neuffer

April 13, 2010

Page   PAGE  12

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▪  Suite 310  ▪  Alexandria, Virginia  22314  ▪  Tel: (703)
684-0084  ▪  Fax:<PHONE_NUMBER>


[Federal Register Volume 76, Number 74 (Monday, April 18, 2011)]
[Notices]
[Pages 21752-21753]
[FR Doc No: 2011-9261]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0214]

Guidance for Industry on How To Write a Request for Designation;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``How to Write a
Request for Designation (RFD).'' This guidance is intended to clarify
the type of information the Office of Combination Products (OCP)
recommends that a sponsor include in a Request for Designation (RFD).
This final guidance supersedes the previous RFD guidance document
issued August 2005.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of this guidance
to the Office of Combination Products, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, rm. 5129, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kristina Lauritsen, Office of
Combination Products, Food and Drug Administration, Bldg. 32, rm. 5132,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``How to Write a Request for Designation (RFD).'' This
guidance addresses 21 CFR 3.7 and is intended to clarify the type of
information OCP recommends that a sponsor include in an RFD. The goal
of this guidance is to help a sponsor understand what information FDA
needs to determine the regulatory identity or classification of a
product as a drug, device, biological product, or combination product,
and to assign the product to the appropriate Agency component for
review and regulation. This final guidance supersedes the previously
issued RFD guidance document which was published on FDA's Web site on
August 2005.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on how to write an RFD. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.

II. 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 21 CFR part 3 have been approved under
OMB control number 0910-0523.

III. Comments

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

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/RegulatoryInformation/Guidances/ucm122047.htm
or http://www.regulations.gov.

    Dated: April 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-9261 Filed 4-15-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 30 (Monday, February 14, 2011)]
[Notices]
[Pages 8372-8373]
[FR Doc No: 2011-3338]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2011-0070]

Commercial Fishing Safety Advisory Committee; Meeting

AGENCY: Coast Guard, DHS.

ACTION: Notice of meeting.

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

SUMMARY: The Commercial Fishing Safety Advisory Committee (CFSAC) will
meet in Portsmouth, Virginia to discuss various issues relating to
safety in the commercial fishing industry. This meeting will be open to
the public.

DATES: The Committee will meet on March 1-3, 2011, from 8 a.m. to 5
p.m. This meeting may close early if all business is finished. Written
material and requests to make oral presentations should reach the Coast
Guard on or before February 23, 2011.

ADDRESSES: The Committee will meet at the Renaissance Portsmouth Hotel
and Waterfront Conference Center, 425 Water Street, Portsmouth,
Virginia 23705.
    Please send written material, comments, and requests to make oral
presentations to Mr. Jack Kemerer, Assistant to the Designated Federal
Official (DFO) of CFSAC, by one of the submission methods described
below. All materials, comments, and requests must be identified by
docket number [USCG-2011-0070].
    Submission Methods: Please use only one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>Include the docket number
in the subject line of the message.
     Fax:<PHONE_NUMBER>.
     Mail: Mr. Jack Kemerer, COMDT (CG-54221), 2100 2nd Street,
SW., Stop 7581, Washington, DC 20593.
    Instructions: All submissions received must include the words
``U.S. Coast Guard'' and docket number [USCG-2011-0070]. All
submissions received will be posted without alteration at
www.regulations.gov, including any personal information provided.
Anyone can search the electronic form of comments received into any of
our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.) You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008 issue of the
Federal Register (73 FR 3316).
    Docket: For access to the docket to read background documents or
submissions received by the CFSAC, go to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Mr. Jack Kemerer, Assistant to DFO of
CFSAC, by telephone at<PHONE_NUMBER>, fax<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act, 5 U.S.C. App. (Pub. L. 92-463). The
CFSAC is authorized by 46 U.S.C. 4508 and the Committee's purpose is to
provide advice and recommendations to the U.S. Coast Guard and the
Department of Homeland Security on matters relating to the safety of
commercial fishing industry vessels.

Agenda of Meeting

    The agenda for the CFSAC meeting is as follows:
    (1) Review of Fishing Vessel Safety Requirements changes from the
Coast Guard Authorization Act of 2010.
    (2) Status of Commercial Fishing Vessel Safety Rulemaking.
    (3) Commercial Fishing Vessel Safety District Coordinators updates.
    (4) Industry Representatives updates.
    (5) Presentation on research and safety related projects by the
National Institute for Occupational Safety and Health.
    (6) Presentation on safety standards by the National Oceanic and
Atmospheric Administration, National Marine Fisheries Service.
    (7) Subcommittee sessions on: Communications and outreach; risk
management; operator training; vessel construction and standards;
safety and survival equipment; safety examinations; and safety program
strategies, future plans, and long range goals.
    (8) Opportunity for public to comment will be provided each day.

Procedural

    This meeting is open to the public. Please note that the meeting
may close early if all business is finished. Members of the public may
make oral presentations during the meeting. If you would like to make
an oral presentation at the meeting, please notify the Designated
Federal Officer no later than February 23, 2011. Written material for
distribution at the meeting should reach the Coast Guard no later than
February 18, 2011. Copies of all material that is received will be
distributed to each member of the committee in advance of the meeting.
Please submit a copy to the DFO for distribution to committee members
no later than February 23, 2011.

Information on Services for Individuals With Disabilities

    For information on facilities or services for individuals with
disabilities or to request special assistance at a meeting, contact the
Designated Federal Officer as soon as possible, but no later than
February 23, 2011.

    Dated: February 9, 2011.
J. G. Lantz,
Director of Commercial Regulations and Standards.
[FR Doc. 2011-3338 Filed 2-10-11; 11:15 am]
BILLING CODE 9110-04-P