NAT and serology testing.
DR. MIED:  Now if you do have an automation
problem or an invalid test or some type of error in
performing the NAT test and you're releasing all
products, including platelets, based on NAT in addition
to serology, you do have to go back and reform those
pools.  Does that take release of platelets out of the
question entirely?
DR. GAMMON:  No, not entirely.  We've been
able to do it.  If we can't do it that day, we'd have to
do it the next day and you're right, it would cut a day
off of the -- it would cut a day off of the release of
the components, but the general agreement with the AABC
members is to hold off in releasing those components, so
the NAT tests are available.  Now of course, all the
members do have built into place an emergency release

190
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
form.  If there would be an emergency that the
hospital's physician could sign for an emergency release
of components not fully tested.
DR. MIED:  Sue, has that been a problem for
the Red Cross?
DR. STRAMER:  Again, we're releasing
platelets based on serology, but to address the question
of invalids and what happens.  Firstly, as pools are
created they're stored with their constituent donations.
So
if there was a reactive pool the individual
donations are immediately accessible.  If repooling
needs to be done, let me say the only reason we would do
repooling other than an inadvertent accident which
hasn't happened, is because we do gravimetric checks in
our pools and if they're not within the correct weight
range, then the pool is considered invalid and then the
samples will be repooled.  But once the pooling is done
and the pooled samples move to testing, if we have an
invalid, those are added on immediately the next run.
So they really shouldn't be a problem for platelets.
Let me say this also, and I don't know how
logistically possible it is, we don't make platelets
from each collection.  So clearly there are other ways
to overcome the issues of the small number of invalid

191
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
runs we've had, etcetera.
Dr. Tabor has a question.
DR. TABOR:  Could we try to nail down the
answer to that question a bit more concretely?  Is AIBC
already in Phase II for both HCV and HIV?  Is the Red
Cross hoping to have Phase II in place early next year
for both HCV and HIV?  And is ABC not going to have
Phase II completely for both HVC and HIV until there's
a licensed test?
DR. GAMMON:  Okay, AIBC is in Phase II.
We've been in Phase II since we began testing on April
1st and we test for HIV and HCV.
DR. STRAMER:  The Red Cross tests all
consenting donors for HCV and HIV.  However, we're still
in Phase I.  A time line for Phase II has not yet been
completely developed for implementation.  We hope to do
that, let me say, perhaps by first quarter.
DR. TABOR:  You're referring to both tests?
DR. STRAMER:  Yes.  We do both tests
because we run the Multiplex test, so we don't have a
choice.
DR. TABOR:  Okay.
DR. STRAMER:  But we again, don't have a
definite time line.  It is our goal to be in Phase II,

192
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
obviously, as quickly as possible.
DR. TABOR:  And ABC -- did I understand
that correctly?
DR. BIANCO:  You heard correctly two
different answers and it's -- I think that what we have
-- Mike Strong not too long ago said we are all in Phase
II on a good day.
(Laughter.)
We have to recognize that those systems
were put together as -- they were not final tests that
a manufacturer had put together, had tested internally
and all that.  Those things have been evolving.  And
particularly, I think there are two major issues that we
still have to resolve.  One is logistics.  If you saw
the --
DR. TABOR:  Celso, excuse me, I mean the
reasons -- we've heard the list of reasons.  I'm just
trying to nail down the numbers.
DR. BIANCO:  The numbers will come as we
improve this software for the Roche systems and as the
logistic issues are resolved for centers that have to
travel a lot to get there.  And so I believe that the
prediction that Mike made of six months to get there is
correct.  I think that what Sally was trying to tell us

193
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
is that the inducement of a licensure would be a great
motive for everybody to be in Phase II.
DR. TABOR:  Obviously, if you were forced
to do it, you have to do it.  But that almost leads
right into one of the other questions.  We've now talked
about 99 percent of the supply.  Are the tests available
to everyone and to what extent can someone who is not a
part of your system obtain testing?
DR. BIANCO:  To my knowledge, and I think I
can respond the same for all the organizations that are
sitting here, the tests have been available to everyone
and at least, for instance, the example that I have in
New York, hospitals that collect and have not used the
system is because they did not finish going through
their IRB or they didn't have enough encouragement to
just move fast enough.
DR. TABOR:  We still get letters or at
least some letters at FDA from small outfits complaining
that they are at a competitive disadvantage.  Should we
just send them the addresses of the large IND holders?
That's good because that's what we've been doing.
DR. BIANCO:  Definitely.
(Laughter.)
DR. JACOBS:  We asked the question: has

194
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
contamination been an issue?  I think we've had speakers
address that, so I think now we'd like to ask the
question what have you learned from looking at your data
about contamination or other types of errors, and could
you briefly comment on any changes in procedures,
etcetera, and Sally, could you speak first?
DR. CAGLIOTI:  I'm the ring leader of this.
I think it's real clear, at least in the system that we
use and I think the Red Cross has come to find since
they've started to include seropositives in the pools
and in the test system itself, but the contamination is
coming at the individual test level within the test
system within the run.  We don't seem to get pools
contaminating other pools and we don't seem to see a lot
of pooling contamination of sample to sample within the
pooling system.  This all happens intra-run.  So I think
what we need to do is look at ways to separate the
seropositive samples when we're doing the resolution
testing, i.e., when we find a positive pool, perhaps
look at the seroreactive samples and take those out of
the run.  So yes, we are looking for ways to try to
reduce that.  But it is an issue and it seems to only be
occurring with the individual sample level, not within
the pooling system itself which is I think what we were

195
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
concerned about before we started testing.
DR. JACOBS:  Thanks.  Sue?
DR. BIANCO:  Actually, Mary Beth, just a
comment.  If we compare to the predictions that we had
in the early days of NAT testing, we were very scared
and actually I think that every one of these systems in
the centers took a large number of precautions in terms
of separating environments and engineering and all that,
that have prevented those disasters from occurring.
DR. STRAMER:  I'd like to reiterate what
Celso said.  As I presented this morning, our pool
reactive rate or initially reactive rate for our
pre-Phase II is only .17 percent.  And that's comparable
to the lowest test we do today for serology.  So our
initial rates are very low.  Our repeat rates, that is,
rates now to a single donation level, are only 1 in
30,000.  That is clearly lower than any serological test
we do and I'd like to think it is because as Celso also
said, we've taken the precaution to really isolate and
have a linear work flow.  But since we -- the challenge
did come when we included seroreactives.  So until we're
in a Phase II program, what we are doing now is
obtaining the serological results from the NTLs and
segregating, removing the seroreactives, testing them

196
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
singly, not even bothering to pool them and we've
isolated those on isolated runs.  So clearly, separation
of seroreactives out of the pooling and during
resolution also will help prevent contamination.
DR. JACOBS:  Good, thanks very much.  And I
wonder if either Dr. Gammon or Dr. Strong would want to
comment on that?
DR. STRONG:  I'd be happy to.  One of the
things that we've learned is that you have to be careful
when you walk across a room with a plateful of samples,
that you don't trip and drop them and cross contaminate
that you've got everything in your hands.
I
think a second thing is automation is clearly going to
be a big improvement to this process.  Any kind of
manual steps, any kind of manual pipepetting will
increase the chance of contamination.  I think that a
lot of these contamination aspects have been because of
pipepetting problems.  The texts have gotten very good,
to be more careful, and that the learning curve has
clearly been important in that.  So there's still a lot
to be learned, but the more we move toward automation,
I think the better off we're going to be.
DR. GAMMON:  And I just wanted to emphasize
that I think minimizing contamination, a proper training

197
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
of staff.  We have a unidirectional work flow and
strictly adhere to that, when we have doors marked "do
not enter", move in one direction and strict adherence
to the manufacturer's insert all help to minimize
contamination issues.
DR. MIED:  Chris, you asked a question what
is an appropriate look back period.  I think we heard
from Mike Busch this morning about his experience with
look back.  I'd like to direct this question, first of
all, to you, Chris and then secondly, maybe to Celso and
Sue.
Going back to prior collections, how far
back are you going, how many cases have you done and
what have you found?
MR. HEALEY:  Paul, I don't have any direct
data on the INDs and perhaps others in the audience can
comment on that, but I think you heard from Chuck
Heldebrant and Alpha this morning that 100 percent of
all implicated units were retrieved under the industry
60-day hold and we've rolled that data out before,  that
the 60-day hold really affords an adequate opportunity
to hold back all those implicated units with the NAT and
the shortened window period makes that hold even more
robust, so we're really able to get 100 percent of all

198
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
the implicated units.  I hope that addresses what you're
asking.
DR. MIED:  Now there's prior collections.
Some had not been, perhaps, previously NAT tested.
Have you found NAT positives among those?
MR. HEALEY:  I'm not sure I understand your
question.  The look back units, in other words, have
they not been NAT tested?  I can't answer that.  I don't
know what the individual IND holders have done with the
units they have retrieved, whether they've gone back and
eventually performed that on those, and what the results
are.
DR. MIED:  All right, Celso and Sue, how
far back are you going, and how many cases do you have,
and what have you found?
DR. STRAMER:  Okay, I can go first.  First,
the IND, the simplest approach we took was to take what
the FDA is already using, so for look back for HIV we
used p24 antigen, since NAT is a marker of virus and so
is p24 antigen.  So we do look back for three months.
For HCV, we do look back for a year.
That's the current guidance, correct me if I'm wrong,
but that we are just applying what the FDA has already
chosen as the most logical method.

199
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
From our 12 cases that I discussed, our
index cases, our yield cases, six were from repeat
donors.  I don't have memorized all the collection
dates, but interestingly enough, most of them did not
fall into the look back period.  Of the one that did, we
were, knock on whatever, it was incredible luck that we
could retrieve that plasma, that the plasma was sitting
on the hospital shelf.  We could call the hospital, get
the plasma and have it tested.  And that was 60 days
prior to the index NAT reactive unit and that tested
stone cold negative on every test we could throw at it,
although there is a red cell recipient and that red cell
recipient will be notified to be tested with
encouragement with the consignee giving them the plasma
results so that that recipient shouldn't be unduly
alarmed.  We had additional data that they're likely not
infected.
DR. BIANCO:  Yes, I don't know exactly all
our numbers, but I believe whatever they are, they're
very small.  And I don't think that they have been
published at the present time.  We are using the same
algorithm for HIV these three months, or eight weeks
actually, use the p24.  Algorithm for HCV, we are doing
one year.  I think there is a big difference between

200
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
what is done with source plasma versus our donors.  Our
donors come at bigger intervals, and so the look back
has less meaning.  Within the source plasma, the donor
comes regularly, the plasma is there and there is --
they can collect the data and they can hold back those
units more effectively.  Now I don't think that we are
ready in whole blood collection, at least I'm not ready
to accept a certain look back period except for the
numbers that Mike was showing us and that were, in
essence, faulty.
DR. JACOBS:  I think we could take just a
few questions from the floor if there are any.  While
we're waiting to see if someone comes to the microphone,
I'd like to thank all of our speakers.  I think it's
been a very interesting session and we appreciate your
directly dealing with the questions that people are
concerned about and I think we've gotten some very clear
information.  So if there's anyone who would like to
raise an additional question, if you'd go to the
microphone.
Well, I guess you've maybe anticipated --
is this someone coming?  Well, he's going to a chair.
Okay.
Please identify yourself when you ask the

201
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
question.
MR. SHERMAN:  I'm Larry Sherman from the
CAP.  I would echo Kay's hospital perspective and from
that standpoint ask if there have been any blood centers
who have exchanged post-NAT implementation frozen
product for pre-NAT product still out on shelves?
DR. CAGLIOTI:  Larry, yes, Blood Systems
did that.
MR. SHERMAN:  Blood Systems has done that.
Anybody else?  The reason I ask is from a hospital
perspective and patient perspective, it's intriguing.
The hospital, let's say a patient is transfused right
now, that wasn't done, that patient gets red cells and
plasma will get tested -- red cells for which they pay,
but the FFP from that donation for which they have paid
for the testing probably is going to Europe for
fractionation and the FFP that they've received was
probably drawn by spring or winter and wasn't NAT
tested.
DR. BIANCO:  I'd like to make just one
comment, Larry.  We all did that with p24 antigen.  This
was a licensed test.  We knew the outcome.  We knew what
was going to happen.  In this case, we are in a IND mode
and while the results here are very encouraging, I think

202
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
that we are all --
MR. SHERMAN:  I agree fully and I agree NAT
should be tested, but I'm simply saying that patient
paid for the whole nine yards to be tested.
MR. TEGMEIER:  Gary Tegmeier, Community
Blood Center, Kansas City.
Sue, I have a question for you.  You
indicated that Red Cross is testing for HIV and for HCV
for all consenting donors.  I wondered what percentage
of donor who are declining to be tested?
DR. STRAMER:  From data we collected when
we first implemented, it varied from one to two percent,
but current estimates are probably one percent or less.
MR. TEGMEIER:  So are you discarding the
blood from donors who do not consent to be tested?
DR. STRAMER:  Currently, we don't, but very
shortly we will go to a policy of, if you consent to
donate, you consent to the test and then everything we
collect will be tested other than autologous.
MR. TEGMEIER:  Thanks.
DR. JACOBS:  Thank you again to our
speakers.
(Applause.)
DR. TABOR:  The next session will be on NAT

203
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
testing for Parvovirus B19.  The moderators are Dr. Mei-
Ying Yu from the Division of Hematology at CBER and Dr.
Thomas Lynch, also from the Division of Hematology.  The
first speaker is Dr. Thomas Lynch.
DR. YU:  I just want to introduce to you,
Dr. -- probably everybody knows about him, but anyway,
Dr. Thomas Lynch is our Deputy Director of Division of
Hematology, CBER.
DR. LYNCH:  Thanks, Mei-Ying.  Good
afternoon, everyone.  This session actually raises an
interesting contrast to some of the prior sessions in
that we're now talking about a virus that is generally
less clinically significant than viruses such as
hepatitis C, but have a far greater prevalence in the
general population and among donors.
As you may know -- the first slide, please
-- as you may know, the Agency in considering NAT
testing for B19, recently reached the conclusion that
insofar as testing plasma for further manufacturing
went, there would be no need to demonstrate the clinical
effectiveness of such tests, i.e., no need for clinical
trials under INDs as are being conducted for the more
significant viruses.
We thought instead the testing could be

204
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
implemented as an in-process control and validated as an
analytical method and that we could control the quality
of such testing and the impact to the products through
the licensing mechanism.  Well, this left us with a need
to establish some reasonable and objective standards for
evaluating license applications covering nucleic acid
testing for B19 and we've gotten together a discussion
group among those who have been involved in the NAT
testing for the other viruses, within the Agency, to
come up with some guidelines in that respect.
Next slide.  What I want to focus my
remarks on today are aspects of the clinical,
pre-clinical assay evaluation.  There are other aspects
to licensing a nucleic acid test such as facilities
issues, control of your reagents, sample handling,
shipping, storage and so forth.  Those, I think, are all
very much generic GNP issues that will apply across the
board whether the nucleic acid test is being performed
for hepatitis C or B19.
The clinical evaluation is out, as I
mentioned, and this leaves us with the sequence of
events that take place in order to evaluate the
performance of the assay.  Our internal conclusions are
that analytical specificity, analytical sensitivity and

205
S A G  CORP.S A G  CORP.


[Federal Register Volume 77, Number 182 (Wednesday, September 19, 2012)]
[Notices]
[Page 58124]
[FR Doc No: 2012-23021]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14436-000]

Kaweah River Power Authority; Errata Notice

    On August 22, 2012, the Commission issued a Notice in the above-
referenced proceeding. Notice of Preliminary Permit Application
Accepted For Filing And Soliciting Comments, Motions To Intervene, And
Competing Applications, August 22, 2012. (August 22, 2012). The county
location of the project was incorrectly identified as Tulare County,
Nevada. The correct county location of the project is Tulare County,
California.

    Dated: September 11, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-23021 Filed 9-18-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 69 (Tuesday, April 10, 2012)]
[Notices]
[Pages 21620-21621]
[FR Doc No: 2012-8633]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2012-0033]

Notice of the Buy America Waiver Request for Vossloh 101-LV
Concrete Ties

AGENCY: Federal Railroad Administration (FRA), United States Department
of Transportation (DOT).

ACTION: Notice of Buy America waiver request and request for comment.

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

SUMMARY: FRA is issuing this notice to advise the public that the
Burlington Northern Santa Fe Railway Co. (``BNSF'') has submitted to
FRA through or with the support of the Washington Department of
Transportation (``WSDOT''), the Illinois Department of Transportation
(``IDOT''), the Texas Department of Transportation (``TxDOT''), and the
California Department of Transportation (``Caltrans'') a waiver request
from FRA's Buy America Act requirements for the purchase of Vossloh
101-LV concrete ties, which contain certain components not manufactured
in the United States. In furtherance of four FRA High-Speed Intercity
Passenger Rail (``HSIPR'') grants, BNSF, as the railroad infrastructure
owner, will construct certain rail project elements that consist of the
installation of Vossloh 101-LV concrete ties. FRA has received this
request from the four States for the following projects: (a) The
Pacific Northwest Rail Corridor Program (b) the Amtrak Quad Cities to
Chicago Service Initiation Project, (c) the Tower 55 At-Grade
Improvement Project, and (d) the LA to Fullerton Triple Track--Segment
7 Project.

DATES: Written comments should be provided on or before April 25, 2012.

ADDRESSES: Comments: Comments related to Docket No. FRA-2012-0033 may
be submitted by any of the following methods:
    (1) Web Site: http://www.regulations.gov. Follow the instructions
for submitting comments on the U.S. Government electronic docket site;
    (2) Fax:<PHONE_NUMBER>;
    (3) Mail: U.S. Department of Transportation, 1200 New Jersey Avenue
SE., Docket Operations, M-30, Room W12-140, Washington, DC 20590-0001;
or
    (4) Hand Delivery: Room W12-140 on the first floor of the West
Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    Instructions: All submissions must make reference to the ``Federal
Railroad Administration'' and include docket number FRA-2012-0033. Note
that all submissions received, including any personal information
therein, will be posted without change or alteration to http://www.regulations.gov. For more information, you may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477), or you may visit http://www.dot.gov/privacy.html.
    Docket: For access to the docket to read comments received, go to
http://www.regulations.gov at anytime, or to the Docket Management
Facility, U.S. Department of Transportation, West Building Ground
Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC,
between 9 a.m. and 5 p.m. ET, Monday through Friday, except Federal
holidays. Follow the online instructions for accessing the dockets.

FOR FURTHER INFORMATION CONTACT: For questions about this notice,
please contact Ms. Linda Martin, Attorney-Advisor, FRA Office of Chief
Counsel, Mail Stop 10, West Building 3rd Floor, Room W31-304, 1200 New
Jersey Avenue SE., Washington, DC 20590 (telephone<PHONE_NUMBER>) or via
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FRA projects funded through the American
Recovery and Reinvestment Act of 2009 and the Transportation, Housing
and Urban Development and Related Agencies Appropriations Act for 2010
(Div. A of the Consolidated Appropriations Act, 2010 (Pub. L. 111-117)
(``FY 2010 DOT Appropriations Act''), must comply with the Passenger
Rail Investment and Improvement Act of 2008 (``PRIIA'') Buy America
provisions (49 U.S.C. 24405(a)). Section 24405(a)(1) authorizes the
Secretary of Transportation (``Secretary'') to obligate grant funds
only if the steel, iron, and manufactured goods used in the project are
produced in the United States. However, sec. 24405(a)(2) also permits
the Secretary to waive the Buy America requirements if he finds that:
(A) Applying paragraph (1) would be inconsistent with the public
interest; (B) the steel, iron, and goods manufactured in the United
States are not produced in sufficient and reasonably available amount
or are not of a satisfactory quality; (C) rolling stock or power train
equipment cannot be bought or delivered to the United States within a
reasonable time; or (D) including domestic material will increase the
cost of the overall project by more than 25 percent.
    Before determining whether it is appropriate to waive the Buy
America provision, sec. 24405(a)(4) requires that the Secretary first
provide the public with an opportunity to comment. If after receiving
public comment, the Secretary decides to grant the waiver, a detailed
written justification for the decision must be published in the Federal
Register. The purpose of this notice is to inform the public that FRA
has received a waiver request for the Vossloh 101-LV concrete tie
system, which contains certain components not manufactured in the
United States, and to solicit public comments on the request. BNSF as
the owner of the infrastructure that will be improved by the HSIPR
grants proposes to install approximately 171,000 Vossloh 101-LV
concrete ties for the following projects: (a) The Pacific Northwest
Rail Corridor Program (b) the Amtrak Quad Cities to Chicago Service
Initiation Project, (c) the Tower 55 At-Grade Improvement Project, and
(d) the LA to Fullerton Triple Track--Segment 7 Project. Transmittals
in furtherance of this request have been submitted to FRA by WSDOT,
IDOT, TxDOT, and Caltrans.
    The foreign components of the concrete tie are limited to the dowel
inserts and SKL-30 tension clamps. The function of the dowel insert is
to provide housing for the lag screw that fastens the SKL-30 tension
clamps to the tie. The SKL-30 tension clamps hold the rail to the tie
and prevent lateral and longitudinal movement of the rail. BNSF and the
identified States seek the waiver pursuant to sec. 24405(a)(2)(B)
because they believe that for the reasons set forth in the request,
that suitable materials are not reasonably available in the United
States and therefore a waiver from FRA's Buy America requirement is
appropriate.
    The request in its entirety is available on FRA's Web site at
http://www.fra.dot.gov/Pages/251.shtml. In order to completely
understand the facts surrounding the request, FRA seeks comment from
all interested parties regarding the availability of suitable
domestically manufactured products, any public interest concerns, or
the potential Buy America waiver.

    Issued in Washington, DC on April 4, 2012.
Corey Hill,
Director, Rail Project Development and Delivery, Federal Railroad
Administration.
[FR Doc. 2012-8633 Filed 4-9-12; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 87, Number 111 (Thursday, June 9, 2022)]
[Notices]
[Page 35195]
[FR Doc No: 2022-12440]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 4784-106]

Topsham Hydro Partners Limited Partnership (L.P.); Notice of
Availability of Draft Environmental Assessment

    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's (Commission)
regulations, 18 CFR part 380, the Office of Energy Projects has
reviewed the application for license for the Pejepscot Hydroelectric
Project, located on the Androscoggin River in Sagadahoc, Cumberland,
and Androscoggin Counties in the village of Pejepscot and the town of
Topsham, Maine and has prepared a Draft Environmental Assessment (DEA)
for the project. No federal land is occupied by project works or
located within the project boundary.
    The DEA contains staff's analysis of the potential environmental
impacts of the project and concludes that licensing the project, with
appropriate environmental protective measures, would not constitute a
major federal action that would significantly affect the quality of the
human environment.
    The Commission provides all interested persons with an opportunity
to view and/or print the EA via the internet through the Commission's
Home Page (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. At this time, the Commission has
suspended access to the Commission's Public Reference Room, due to the
proclamation declaring a National Emergency concerning the Novel
Coronavirus Disease (COVID-19), issued by the President on March 13,
2020. For assistance, contact FERC Online Support at
[email protected], or toll-free at<PHONE_NUMBER>, or for TTY,
(202) 502-8659.
    You may also register online at https://ferconline.ferc.gov/eSubscription.aspx to be notified via email of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    Any comments should be filed within 30 days from the date of this
notice.
    The Commission strongly encourages electronic filing. Please file
comments using the Commission's eFiling system at https://ferconline.ferc.gov/FERCOnline.aspx. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at https://ferconline.ferc.gov/Quick Comment.aspx. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support. In lieu
of electronic filing, you may submit a paper copy. Submissions sent via
the U.S. Postal Service must be addressed to: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Room 1A, Washington, DC 20426. Submissions sent via any other carrier
must be addressed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852.
The first page of any filing should include docket number P-4784-106.
    Any questions regarding this notice may be directed to Ryan Hansen
at<PHONE_NUMBER> or [email protected].

    Dated: June 3, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-12440 Filed 6-8-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: March 3, 2010 (Volume 75, Number 41)]
[Rules and Regulations]
[Page 9515]
[DOCID:fr03mr10-1]

========================================================================
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.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-1107; Directorate Identifier 2009-NM-138-AD;
Amendment 39-16202; AD 2010-04-09]
RIN 2120-AA64

 Airworthiness Directives; Airbus Model A330-200 Series Airplanes
and Model A340-200 and -300 Series Airplanes

Correction

    In rule document 2010-3119 beginning on page 7940 in the issue of
February 23, 2010, make the following correction:
    On page 7941, in the second column, under the header
``Applicability,'' item (1) should read: ``(1) Airbus Model A330-201, -
202, -203, -223, and -243 airplanes, all manufacturer serial numbers.''

[FR Doc. C1-2010-3119 Filed 3-2-10; 8:45 am]
BILLING CODE 1505-01-D


[Federal Register Volume 88, Number 102 (Friday, May 26, 2023)]
[Rules and Regulations]
[Pages 34081-34084]
[FR Doc No: 2023-11305]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-1312; Project Identifier AD-2022-00551-T;
Amendment 39-22420; AD 2023-08-05]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain The Boeing Company Model 777 airplanes. This AD was prompted by
reports of cracks found in the pivot bulkhead forward outer chord of a
certain station. Analysis revealed higher bending stresses across the
chord than originally assessed. This AD requires repetitive detailed
and high frequency eddy current (HFEC) inspections of the pivot
bulkhead forward outer chord of a certain station and longeron fitting
for cracking and applicable on-condition actions. The FAA is issuing
this AD to address the unsafe condition on these products.

DATES: This AD is effective June 30, 2023.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of June 30,
2023.

ADDRESSES:
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2022-1312; 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 final rule, any comments received, and other
information. The address for Docket Operations is U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
    Material Incorporated by Reference:
     For service information identified in this final rule,
contact Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA
90740-5600; telephone<PHONE_NUMBER>; website myboeingfleet.com.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available at
regulations.gov under Docket No. FAA-2022-1312.

FOR FURTHER INFORMATION CONTACT: Luis Cortez-Muniz, Aerospace Engineer,
Airframe Sections, FAA, Seattle ACO Branch, 2200 South 216th St., Des
Moines, WA 98198; phone:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain The Boeing
Company Model 777 airplanes. The NPRM published in the Federal Register
on December 8, 2022 (87 FR 75179). The NPRM was prompted by reports of
cracks found in the station (STA) 2370 pivot bulkhead forward outer
chord. Analysis revealed higher bending stresses across the chord than
originally assessed. In the NPRM, the FAA proposed to require
repetitive detailed and HFEC inspections of the STA 2370 pivot bulkhead
forward outer chord and longeron fitting for cracking and applicable
on-condition actions. The FAA is issuing this AD to address cracking in
the STA 2370 pivot bulkhead forward outer chord. Such cracking, if not
detected and corrected, could result in a severed pivot bulkhead outer
chord, loss of horizontal stabilizer control, and loss of
controllability of the airplane.

Discussion of Final Airworthiness Directive

Comments

    The FAA received comments from Boeing and the Air Line Pilots
Association, International (ALPA), who supported the NPRM without
change.
    The FAA received additional comments from three commenters,
including Air France (AFA), Federal Express (FedEx) and United Airlines
(UAL). The following presents the comments received on the NPRM and the
FAA's response to each comment.

Request To Change Estimated and On-Condition Cost Sections

    FedEx requested a change to the Estimated and On-Condition Costs
tables in the proposed AD. FedEx noted that, based on the estimates in
Boeing Alert Service Bulletin 777-53A0098, dated April 5, 2022, the
detailed and HFEC inspections require parts totaling $3,540, as well as
62 work-hours for replacement for the on-condition requirements. FedEx
added that the proposed AD states $0 parts cost for detailed and HFEC
inspections and 7 work-hours for replacement if on-condition
requirements are met.
    The FAA agrees with revising the parts cost and labor hours because
the cost estimates provided in the proposed AD inadvertently excluded
the parts costs for the inspections and the on-condition costs
inadvertently omitted access and close-up costs. However, the FAA notes
that the labor hours listed in Boeing Alert Service Bulletin 777-
53A0098, dated April 5, 2022, estimate 28 hours for the detailed and
open hole HFEC inspection and 38 hours for the replacement (each
estimate is for one side of the airplane). The FAA has revised the
Costs of Compliance section of this AD accordingly.

Request To Change Work-Hour Estimates

    AFA suggested that Boeing Alert Service Bulletin 777-53A0098, dated
April 5, 2022, greatly underestimates the total manpower hours required
to perform the modification, which could lead to a maintenance program
disruption if not taken into account by operators. AFA noted in its
experience performing similar pivot bulkhead inspections and
modification using similar service information, it took 1,200 work-
hours to complete the modification on both sides of the airplane. AFA
added that, due to the time indicated to complete these service
bulletins, resources were not available and the airplane was grounded
for 3 weeks. AFA noted that it contacted two other operators, who
confirmed they also spent between 900 and 1,100 hours to complete the
modification on both sides of the airplane. AFA requested that the
proposed AD highlight this work-hour discrepancy so operators can plan
accordingly.
    The FAA acknowledges there may be discrepancies between the
operator labor hours and the hours listed in Boeing Alert Service
Bulletin 777-53A0098, dated April 5, 2022. Based on the best data
available, the manufacturer provided the number of work hours necessary
to do the required actions.

This number represents the time necessary to perform only the actions
actually required by this AD. The FAA recognizes that, in doing the
actions required by an AD, operators might incur incidental costs in
addition to the direct costs. The cost analysis in AD rulemaking
actions, however, typically does not include incidental costs such as
the time necessary for planning or time necessitated by other
administrative actions. Those incidental costs, which might vary
significantly among operators, are almost impossible to calculate. In
this case, the FAA has no way of knowing how much of the time estimates
AFA provided are ``incidental'' costs. Further, as previously noted,
the cost estimates in this AD have been revised to match those
specified in the service information and are estimates for performing
those actions on one side of the airplane. Therefore, the FAA has not
revised this AD regarding this issue.

Request To Change Special Tooling Requirements

    AFA noted that Boeing Alert Service Bulletin 777-53A0098, dated
April 5, 2022, paragraph 2.E advises no special tooling is needed,
while paragraph 2.F advises that certain maintenance and overhaul tools
are required. AFA explained that during similar modification they
discovered that special big diameter reamers, drill bits and guides are
required, which led to delays in work being performed because required
reamers and drill bits were not available. AFA stated that Boeing
advised that the tooling required is part of standard [maintenance,
repair, and overhaul] MRO tools. However, AFA indicated these range of
reamers and drill bit diameters are not common and not part of the
standard available tools for an MRO. AFA requested that the proposed AD
be revised to highlight the incomplete tooling information for
operators to take into account before accomplishing the proposed
requirements.
    The FAA acknowledges that additional tooling required may not be
standard available tools for an MRO. However, the FAA has no definitive
data regarding the standard MRO tools or what additional tools might be
required. Further, the FAA notes that paragraphs 2.E. and 2.F. in
Boeing Alert Service Bulletin 777-53A0098, dated April 5, 2022, are
informational, and not required for compliance with this AD. The FAA
has not changed this AD regarding this issue.

Request for Detailed Access Instructions

    AFA requested the proposed AD highlight that Chapter 3.B access and
preparation instructions in Boeing Alert Service Bulletin 777-53A0098,
dated April 5, 2022, are not detailed enough. AFA claimed a similar
modification using different service information required removal of
multiple systems and structural parts to get access to the damaged
area. This required AFA to develop task cards on a daily basis and at
mechanics' requests. AFA noted that it spent 300 work-hours after
modification to restore access and perform tests. AFA stated that the
additional work was not identified in the bulletin and caused delays
completing the corresponding AD.
    The FAA acknowledges the commenters concerns, but notes that the
access instructions are not required for compliance for this AD.
Further, Boeing, as the design approval holder (DAH), is responsible
for the development of these instructions. The FAA has no definitive
guidance to provide access and preparation instructions. The FAA has
not changed this AD regarding this issue.

Request To Allow Simultaneous Inspections of Both Sides of Aircraft

    UAL requested the proposed AD be revised to allow simultaneous
inspections of both sides of the aircraft. UAL noted that paragraph 3.B
of Boeing Alert Requirements Bulletin 777-53A0098 RB, dated April 5,
2022, states ``Do all actions on one side before you do any action on
the opposite side.'' UAL stated that it finds the restriction to be
inconsistent with related service information requiring similar actions
on other airplanes. UAL claimed that other service information stated
that removal of structure (for repair or modification) simultaneously
on both sides of the aircraft was unacceptable, but that removal of
skin panels (for inspection) simultaneously on both sides of the
aircraft was acceptable. UAL noted that the repair or replacement work
is involved and lengthy, with the horizontal stabilizer immobilized and
internally jacked, likely precluding other maintenance work in the
area. UAL added that the repair process therefore disrupts the
maintenance check, forcing the rescheduling of other planned
maintenance action. UAL explained that inspecting both sides of the
aircraft early and simultaneously would allow it to know the full scope
of the project and plan accordingly. UAL noted that it asked Boeing to
edit the service information to include this allowance, and Boeing
agreed to incorporate the allowance in a proposed revision. For these
reasons, UAL requested allowing the detailed and HFEC inspections
simultaneously on both sides of the aircraft; or simultaneously with
applicable on-condition actions on the opposite side of the aircraft;
provided any on-condition repairs or replacements are not performed
simultaneously on both sides of the aircraft.
    The FAA acknowledges the commenter's concern and the impact on
maintenance planning. However, UAL has not provided substantiation in
support of these exceptions. The FAA requires substantiation to support
that no structural concerns are introduced with the requested
exceptions and will consider their approval via alternative method of
compliance (AMOC) request in accordance with paragraph (i) of this AD,
provided an acceptable level of safety is maintained.

Request To Refer to Revised Service Information

    UAL requested that the FAA revise the proposed AD to refer to
Revision 1 of Boeing Requirements Bulletin 777-53A0098 RB. UAL noted
that it received a preliminary copy of the revised requirements
bulletin for review, and that the revision corrects elements of the
illustrations, step tables, and fastener code tables in the
Accomplishment Instructions, including to figures which are Required
for Compliance (RC). UAL stated that Revision 1 is expected to be
published later this year, and mandating it would prevent operators
from having to obtain AMOCs to use the corrected instructions.
    The FAA acknowledges the commenter's request. However, the FAA has
not reviewed and approved Revision 1 of Boeing Requirements Bulletin
777-53A0098 RB and notes that UAL did not request any specific changes
to be able to comply with this AD. Further, the FAA may not refer to
any document that does not yet exist in an AD. In general terms, the
FAA is required by Office of the Federal Register (OFR) regulations for
approval of materials incorporated by reference, as specified in 1 CFR
51.1(f), to either publish the service document contents as part of the
actual AD language; or submit the service document to the OFR for
approval as referenced material, in which case the FAA may only refer
to such material in the text of an AD. The AD may refer to the service
document only if the OFR approved it for incorporation by reference.
See 1 CFR part 51.

    Given the urgency of the identified unsafe condition, the FAA has
determined that delaying this AD while the revised service information
is developed, reviewed, and approved would be inappropriate. However,
once the revised service information is approved, the FAA may consider
granting an AMOC to allow the use of the revised service information.

Conclusion

    The FAA reviewed the relevant data, considered any comments
received, and determined that air safety requires adopting this AD as
proposed. Accordingly, the FAA is issuing this AD to address the unsafe
condition on these products. Except for minor editorial changes, and
any other changes described previously, this AD is adopted as proposed
in the NPRM. None of the changes will increase the economic burden on
any operator.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Boeing Alert Requirements Bulletin 777-53A0098 RB,
dated April 5, 2022. This service information specifies procedures for
repetitive detailed and HFEC inspections of the STA 2370 pivot bulkhead
forward outer chord and longeron fitting for cracking and applicable
on-condition actions. On-condition actions include replacing the pivot
bulkhead forward outer chord and splice angle; a detailed inspection of
the upper aft longeron extension fittings at STA 2370 to STA 2380 and
open hole HFEC inspection of the STA 2370 pivot bulkhead web, aft outer
chord, upper and lower outer chord, and skin for any crack; and repair.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in ADDRESSES.

Costs of Compliance

    The FAA estimates that this AD affects 223 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                   Labor cost          Parts cost       Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Detailed and HFEC inspections...  10 work-hours x     $3,540 per          $4,390 per          $978,970
                                   $85 per hour =      inspection cycle.   inspection cycle.   inspection cycle.
                                   $850 per
                                   inspection cycle.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary
replacements or inspections that would be required based on the results
of the required inspection. The agency has no way of determining the
number of aircraft that might need these replacements or inspections:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replacement (one side of airplane)............  38 work-hours x $85 per hour =           $37,720         $40,950
                                                 $3,230.
Detailed and open hole HFEC inspections (one    28 work-hours x $85 per hour =                 0           2,380
 side of airplane).                              $2,380.
----------------------------------------------------------------------------------------------------------------

    The FAA has received no definitive data on which to base the cost
estimates for the on-condition repairs specified in this AD.
    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some or all of the costs of
this AD may be covered under warranty, thereby reducing the cost impact
on affected operators.

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.
    The FAA is 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) Will not affect intrastate aviation in Alaska, and
    (3) 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.

List of Subjects in 14 CFR Part 39

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

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:

2023-08-05 The Boeing Company: Amendment 39-22420; Docket No. FAA-
2022-1312; Project Identifier AD-2022-00551-T.

(a) Effective Date

    This airworthiness directive (AD) is effective June 30, 2023.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 777-200, -200LR, -
300, -300ER, and 777F airplanes, certificated in any category, as
identified in Boeing Alert Requirements Bulletin 777-53A0098 RB,
dated April 5, 2022.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by reports of cracks found in the station
(STA) 2370 pivot bulkhead forward outer chord. Analysis revealed
higher bending stresses across the chord than originally assessed.
The FAA is issuing this AD to address cracking in the STA 2370 pivot
bulkhead forward outer chord. Such cracking, if not detected and
corrected, could result in a severed pivot bulkhead outer chord,
loss of horizontal stabilizer control, and loss of controllability
of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    Except as specified by paragraph (h) of this AD: At the
applicable times specified in the ``Compliance'' paragraph of Boeing
Alert Requirements Bulletin 777-53A0098 RB, dated April 5, 2022, do
all applicable actions identified in, and in accordance with, the
Accomplishment Instructions of Boeing Alert Requirements Bulletin
777-53A0098 RB, dated April 5, 2022.
    Note 1 to paragraph (g): Guidance for accomplishing the actions
required by this AD can be found in Boeing Alert Service Bulletin
777-53A0098, dated April 5, 2022, which is referred to in Boeing
Alert Requirements Bulletin 777-53A0098 RB, dated April 5, 2022.

(h) Exceptions to Service Information Specifications

    (1) Where the Compliance Time columns of the tables in the
``Compliance'' paragraph of Boeing Alert Requirements Bulletin 777-
53A0098 RB, dated April 5, 2022, use the phrase ``the original issue
date of Requirements Bulletin 777-53A0098 RB,'' this AD requires
using ``the effective date of this AD.''
    (2) Where Boeing Alert Requirements Bulletin 777-53A0098 RB,
dated April 5, 2022, specifies contacting Boeing for repair
instructions: This AD requires doing the repair using a method
approved in accordance with the procedures specified in paragraph
(i) of this AD.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or responsible Flight Standards Office,
as appropriate. If sending information directly to the manager of
the certification office, send it to the attention of the person
identified in paragraph (j)(1) of this AD. Information may be
emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the responsible Flight Standards Office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by The Boeing Company Organization Designation
Authorization (ODA) that has been authorized by the Manager, Seattle
ACO Branch, FAA, to make those findings. To be approved, the repair
method, modification deviation, or alteration deviation must meet
the certification basis of the airplane, and the approval must
specifically refer to this AD.

(j) Related Information

    (1) For more information about this AD, contact Luis Cortez-
Muniz, Aerospace Engineer, Airframe Sections, FAA, Seattle ACO
Branch, 2200 South 216th St., Des Moines, WA 98198; phone: 206-231-
3958; email: [email protected].
    (2) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (k)(3) and (4) of this AD.

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Alert Requirements Bulletin 777-53A0098 RB, dated
April 5, 2022.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; website myboeingfleet.com.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on April 18, 2023.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-11305 Filed 5-25-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: September 30, 2005 (Volume 70, Number 189)]
[Notices]
[Page 57308]
[DOCID:fr30se05-114]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-3256-EM]

Maine; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, Emergency Preparedness and
Response Directorate, Department of Homeland Security.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of an
emergency for the State of Maine (FEMA-3256-EM), dated September 19,
2005, and related determinations.

DATES: Effective September 19, 2005.

FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal
Emergency Management Agency, Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated September 19, 2005, the President declared an emergency
declaration under the authority of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford
Act), as follows:

    I have determined that the emergency conditions in the State of
Maine, resulting from the influx of evacuees from states impacted by
Hurricane Katrina beginning on August 29, 2005, and continuing, is
of sufficient severity and magnitude to warrant an emergency
declaration under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act).
Therefore, I declare that such an emergency exists in the State of
Maine.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act to save lives and protect public health and safety, or
to lessen or avert the threat of a catastrophe in the designated
areas. Specifically, you are authorized to provide emergency
protective measures (Category B), including direct Federal
assistance, under the Public Assistance program, at 100 percent
Federal funding. This assistance excludes regular time costs for
subgrantees' regular employees. In addition, you are authorized to
provide such other forms of assistance under Title V of the Stafford
Act as you may deem appropriate.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal emergency assistance and
administrative expenses.
    Further, you are authorized to make changes to this declaration
to the extent allowable under the Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Acting Under Secretary for
Emergency Preparedness and Response, Department of Homeland Security,
under Executive Order 12148, as amended, Kenneth L. Horak, of FEMA is
appointed to act as the Federal Coordinating Officer for this declared
emergency.
    I do hereby determine the following areas of the State of Maine to
have been affected adversely by this declared emergency:

    All 16 counties in the State of Maine for Public Assistance
Category B (emergency protective measures), including direct Federal
assistance, at 100 percent Federal funding.

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

R. David Paulison,
Acting Under Secretary, Emergency Preparedness and Response, Department
of Homeland Security.
[FR Doc. 05-19627 Filed 9-29-05; 8:45 am]

BILLING CODE 9110-10-P


[Federal Register Volume 78, Number 192 (Thursday, October 3, 2013)]
[Notices]
[Pages 61407-61408]
[FR Doc No: 2013-24222]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. IC--30738]

Notice of Applications for Deregistration Under Section 8(f) of
the Investment Company Act of 1940

September 27, 2013.
    The following is a notice of applications for deregistration under
section 8(f) of the Investment Company Act of 1940 for the month of
September 2013. A copy of each application may be obtained via the
Commission's Web site

by searching for the file number, or for an applicant using the Company
name box, at http://www.sec.gov/search/search.htm or by calling (202)
551-8090. An order granting each application will be issued unless the
SEC orders a hearing. Interested persons may request a hearing on any
application by writing to the SEC's Secretary at the address below and
serving the relevant applicant with a copy of the request, personally
or by mail. Hearing requests should be received by the SEC by 5:30 p.m.
on October 22, 2013, and should be accompanied by proof of service on
the applicant, in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, the reason for the request, and the issues
contested. Persons who wish to be notified of a hearing may request
notification by writing to the Secretary, U.S. Securities and Exchange
Commission, 100 F Street NE., Washington, DC 20549-1090.
    For Further Information Contact: Diane L. Titus at<PHONE_NUMBER>,
SEC, Division of Investment Management, Exemptive Applications Office,
100 F Street NE., Washington, DC 20549-8010.

Claymore China Strategy Fund

[File No. 811-22124]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. Applicant has
never made a public offering of its securities and does not propose to
engage in any business activity other than those necessary for winding
up it affairs.
    Filing Date: The application was filed on September 17, 2013.
    Applicant's Address: 2455 Corporate West Drive, Lisle, IL 60532.

Dominion Funds, Inc.

[File No. 811-6727]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On June 27, 2013, applicant made a
liquidating distribution to its shareholders, based on net asset value.
Expenses of $2,970 incurred in connection with the liquidation were
paid by applicant and its investment adviser.
    Filing Date: The application was filed on September 11, 2013.
    Applicant's Address: c/o Fairfax Global Markets, LLC, 2 West
Washington St., Middleburg, VA 20118.

Grosvenor Registered Multi-Strategy Fund (TE), LLC

[File No. 811-22354]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. Applicant
transferred its assets to Grosvenor Registered Multi-Strategy Fund
(TI2), LLC, and on January 1, 2013, made a distribution to its
shareholders based on net asset value. Applicant has retained $24,109
in outstanding assets to pay off its outstanding liabilities. Expenses
of $152,274 incurred in connection with the reorganization were paid by
Grosvenor Registered Multi-Strategy Master Fund, LLC, applicant's
master fund.
    Filing Date: The application was filed on September 13, 2013.
    Applicant's Address: 900 North Michigan Ave., Suite 1100, Chicago,
IL 60611.

RiverSource Dimensions Series Inc.

[File No. 811-1629]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. Applicant has transferred its assets to
corresponding series of Columbia Funds Series Trust and Columbia Funds
Series Trust I, and, on May 31, 2011, made a distribution to its
shareholders based on net asset value. Expenses of $82,382 incurred in
connection with the reorganization were paid by applicant and
applicant's investment adviser, Columbia Management Investment
Advisers, LLC.
    Filing Dates: The application was filed on March 8, 2013, and
amended on July 17, 2013, and September 11, 2013.
    Applicant's Address: 901 Marquette Ave. South, Suite 2810,
Minneapolis, MN 55402-3268.

Seligman Growth Fund, Inc.

[File No. 811-229]

Seligman LaSalle Real Estate Fund Series, Inc.

[File No. 811-21365]

    Summary: Each applicant seeks an order declaring that it has ceased
to be an investment company. Applicants transferred their assets to
corresponding series of Columbia Fund Series Trust I, and on or prior
to April 5, 2011, made final distributions to their shareholders based
on net asset value. Expenses of $729,844 and $77,689, respectively,
incurred in connection with the reorganization were paid by applicants
and Columbia Management Investment Advisers, LLC, applicants'
investment adviser.
    Filing Date: The applications were filed on September 10, 2013.
    Applicants' Address: 901 Marquette Avenue South, Suite 2810,
Minneapolis, MN 55402-3268.

International Equity Portfolio/MA

[File No. 811-21867]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On April 21, 2011, applicant made a
liquidating distribution to its shareholders, based on net asset value.
Applicant incurred no expenses in connection with the liquidation.
    Filing Dates: The application was filed on November 30, 2012, and
amended on September 20, 2013.
    Applicant's Address: Two International Place, Boston, MA 02110.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-24222 Filed 10-2-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: June 18, 2008 (Volume 73, Number 118)]
[Notices]
[Page 34720-34721]
[DOCID:fr18jn08-49]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP95-35-001]

EcoEl[eacute]ctrica, L.P.; Notice of Intent To Prepare an
Environmental Assessment for the Proposed Ecoel[eacute]ctrica Terminal
Modification Project and Request for Comments on Environmental Issues

June 11, 2008.
    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental assessment (EA) that will
discuss the potential environmental impacts of the EcoEl[eacute]ctrica
Terminal Modification Project (Project) involving construction and
operation of natural gas pipeline facilities by EcoEl[eacute]ctrica,
L.P. (EcoEl[eacute]ctrica) in Pe[ntilde]uelas, Puerto Rico. The EA will
be used by the Commission in its decision-making process to determine
whether the project is in the public convenience and necessity.
    This notice announces the opening of the scoping process the
Commission will use to gather input from the public and interested
agencies on the project. Your input will help determine which issues
need to be evaluated in the EA. Please note that the scoping period
will close on July 11, 2008. Details on how to submit comments are
provided in the Public Participation section of this notice.
    This notice is being sent to affected landowners; federal, state,
and local government agencies; elected officials; other interested
parties; and newspapers. State and local government representatives are
asked to notify their constituents of this proposed project and to
encourage them to comment on their areas of concern.
    A fact sheet prepared by the FERC entitled ``An Interstate Natural
Gas Facility On My Land? What Do I Need To Know?'' addresses a number
of typically asked questions, including the use of eminent domain and
how to participate in the Commission's proceedings. It is available for
viewing on the FERC Internet Web site (http://www.ferc.gov).

Summary of the Proposed Project

    EcoEl[eacute]ctrica's Terminal Modification Project would provide
up to 186 million cubic feet per day of natural gas to the Puerto Rico
Electric Power Authority (PREPA). To accomplish this,
EcoEl[eacute]ctrica proposes to:
     Utilize a previously constructed natural gas pipeline at
the existing EcoEl[eacute]ctrica liquefied natural gas (LNG) terminal
that extends to the facility fence line where it would interconnect
with PREPA's facilities; and
     Construct two additional vertical shell and tube heat
exchanger vaporizers within its existing 36-acre site.
    Other required facilities associated with the vaporizers include:
     Two fixed speed, in-tank LNG sendout pumps (one
operational, one in-tank spare);
     Three seawater heat exchangers (plate and frame type, one
operational, and two spare);
     Three water/glycol circulation pumps (one operational, two
spare);
     One water/glycol expansion tank at 1,800 gallons;
     One seawater supply pump (warehouse spare) at 6,000
gallons per minute; and
     Three seawater circulation pumps (one operational, two
spare).
    All construction would take place within the existing LNG facility
fence lines. These modifications would increase LNG ship traffic by one
ship per month. The general location of the proposed facilities is
shown in appendix 1.\1\
---------------------------------------------------------------------------

    \1\ The appendices referenced in this notice are not being
printed in the Federal Register. Copies of all appendices are
available on the Commission's Web site (http://www.fer.gov) at the
``eLibrary'' link or from the Commission's Public Reference Room,
888 First Street, NE., Washington, DC 20426, or call<PHONE_NUMBER>.
For instructions on connecting to eLibrary, refer to the
``Additional Information'' section of this notice. Copies of the
appendices were sent to all those receiving this notice in the mail.
Requests for detailed maps of the proposed facilities should be made
directly to EcoEl[eacute]ctrica.
---------------------------------------------------------------------------

Land Requirements for Construction

    The construction of the proposed Terminal Modification Project
would be entirely within previously disturbed and currently maintained
portions of the existing EcoEl[eacute]ctrica LNG terminal site.
Construction of the Project would affect a total of 0.64 acre, of which
0.12 acre would be permanently changed with the installation of the new
equipment. Following construction, 0.52 acre would be restored to pre-
construction condition. No clearing of vegetation would be required for
the Project.

The EA Process

    We \2\ are preparing this EA to comply with the National
Environmental Policy Act of 1969 (NEPA), which requires the Commission
to take into account the environmental impact that could result if it
authorizes EcoEl[eacute]ctrica's proposal. By this notice, we are also
asking federal, state, and local agencies with jurisdiction and/or
special expertise with respect to environmental issues to formally
cooperate with us in the preparation of the EA. Agencies that would
like to request cooperating status should follow the instructions for
filing comments provided below.
---------------------------------------------------------------------------

    \2\ ``We'', ``us'', and ``our'' refer to the environmental staff
of the FERC's Office of Energy Projects.
---------------------------------------------------------------------------

    NEPA also requires the FERC to discover and address concerns the
public may have about proposals. This process is referred to as
``scoping.'' The main goal of the scoping process is to focus the
analysis in the EA on important environmental issues. By this Notice,
we are requesting public comments on the scope of the issues to address
in the EA. All comments received are considered during the preparation
of the EA.
    The EA will discuss impacts that could occur as a result of the
construction and operation of the proposed project under these general
headings:
     Geology and soils
     Land use and visual quality
     Cultural resources
     Vegetation and wildlife (including threatened and
endangered species)
     Air quality and noise
     Reliability and safety
    We will also evaluate possible alternatives to the proposed project
or portions of the project, where necessary, and make recommendations
on how to lessen or avoid impacts on the various resource areas.
    Our independent analysis of the issues will be presented in the EA.
Depending on the comments received during the scoping process, the EA
may be published and mailed to federal, state, and local agencies;
public interest groups; interested individuals; affected landowners;
local libraries and newspapers; and the Commission's official service
list for this proceeding. A comment period will be allotted for review
if the EA is published. We will consider all comments on the EA before
we make our recommendations to the Commission.
    To ensure your comments are considered, please carefully follow the

instructions in the Public Participation section below.

Public Participation

    You can make a difference by providing us with your specific
comments or concerns about the project. By becoming a commentor, your
concerns will be addressed in the EA and considered by the Commission.
You should focus on the potential environmental effects of the
proposal, alternatives to the proposal, and measures to avoid or lessen
environmental impact. The more specific your comments, the more useful
they will be. Please carefully follow these instructions to ensure that
your comments are received in time and properly recorded:
     Send an original and two copies of your letter to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First St., NE., Room 1A, Washington, DC 20426;
     Label one copy of the comments for the attention of Gas
Branch 1, PJ-11.1;
     Reference Docket No. CP95-35-001; and
     Mail your comments so that they will be received in
Washington, DC on or before July 11, 2008.
    Please note that the Commission strongly encourages electronic
filing of any comments. See Title 18 of the Code of Federal Regulations
(CFR), Part 385.2001(a)(1)(iii) and the instructions on the
Commission's Internet Web site at http://www.ferc.gov under the link to
``Documents and Filings'' and ``eFiling.'' eFiling is a file attachment
process and requires that you prepare your submission in the same
manner as you would if filing on paper, and save it to a file on your
computer's hard drive. New eFiling users must first create an account
by clicking on ``Sign up'' or ``eRegister.'' You will be asked to
select the type of filing you are making. This filing is considered a
``Comment on Filing.'' In addition, there is a ``Quick Comment'' option
available, which is an easy method for interested persons to submit
text only comments on a project. The Quick-Comment User Guide can be
viewed at http://www.ferc.gov/docs-filing/efiling/quick-comment-
guide.pdf. Quick Comment does not require a FERC eRegistration account;
however, you will be asked to provide a valid e-mail address. All
comments submitted under either eFiling or the Quick Comment option are
placed in the public record for the specified docket. If you want to be
kept on our environmental mailing list, you must provide an address
along with your comment.

Becoming an Intervenor

    In addition to involvement in the scoping process, you may want to
become an official party to the proceeding known as an ``intervenor.''
Intervenors play a more formal role in the Commission's process. Among
other things, intervenors have the right to receive copies of case-
related Commission documents and filings by other intervenors.
Likewise, each intervenor must send one electronic copy (using the
Commission's eFiling system) or 14 paper copies of its filings to the
Secretary of the Commission and must send a copy of its filings to all
other parties on the Commission's service list for this proceeding. If
you want to become an intervenor, you must file a motion to intervene
according to Rule 214 of the Commission's Rules of Practice and
Procedure (18 CFR 385.214) (see appendix 2).\3\ Only intervenors have
the right to seek rehearing of the Commission's decision.
---------------------------------------------------------------------------

    \3\ Interventions may also be filed electronically via the
Internet in lieu of paper. See the previous discussion on filing
comments electronically.
---------------------------------------------------------------------------

    Affected landowners and parties with environmental concerns may be
granted intervenor status upon showing good cause by stating that they
have a clear and direct interest in this proceeding which would not be
adequately represented by any other parties. You do not need intervenor
status to have your environmental comments considered.

Environmental Mailing List

    As described above, we may mail the EA for comment. If you are
interested in receiving an EA for review and/or comment, please return
the Environmental Mailing List Mailer (appendix 3). If you do not
return the Environmental Mailing List Mailer, you will be taken off the
mailing list. All individuals who provide written comments will remain
on our environmental mailing list for this project.

Additional Information

    Additional information about the project is available from the
Commission's Office of External Affairs, at 1-866-208-FERC or on the
FERC Internet Web site (http://www.ferc.gov) using the ``eLibrary''
link. Click on the eLibrary link, then on ``General Search'' and enter
the docket number excluding the last three digits in the Docket Number
field. Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at 1-866-208-3676, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission now offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries and direct links to
the documents. Go to http://www.ferc.gov/esubscribenow.htm.
    Finally, any public meetings or site visits will be posted on the
Commission's calendar located at http://www.ferc.gov/EventCalendar/
EventsList.aspx along with other related information.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-13683 Filed 6-17-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 187 (Wednesday, September 28, 2022)]
[Notices]
[Pages 58802-58803]
[FR Doc No: 2022-21007]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-2059]

Providing Over-the-Counter Monograph Submissions in Electronic
Format; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Providing
Over-the-Counter Monograph Submissions in Electronic Format.'' This
guidance provides information on providing electronic submissions to
FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

DATES: Submit either electronic or written comments on the draft
guidance by November 28, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2022-D-2059 for ``Providing Over-the-Counter Monograph Submissions
in Electronic Format.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-

0002. Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Providing Over-the-Counter Monograph Submissions in
Electronic Format.'' This guidance provides information on providing
electronic submissions to FDA under section 505G of the FD&C Act (21
U.S.C. 355h) (hereafter referred to as over-the-counter (OTC) monograph
submissions). This guidance is intended to assist submitters by
describing the electronic OTC monograph submissions requirement in
section 505G(j) of the FD&C Act and providing recommendations and other
information on how to send such OTC monograph submissions to FDA in
electronic format.
    Section 505G of the FD&C Act was added by the Coronavirus Aid,
Relief, and Economic Security Act (CARES Act), Public Law 116-136,
which was enacted on March 27, 2020. Section 505G(j) of the FD&C Act
requires that all OTC monograph submissions must be in electronic
format. As required by section 505G(l)(3) of the FD&C Act, this draft
guidance, when finalized, specifies the format of electronic
submissions under section 505G of the FD&C Act.
    In support of the CARES Act, FDA agreed to specific performance
goals and procedures described in the document entitled ``Over-the-
Counter Monograph User Fee Program Performance Goals and Procedures--
Fiscal Years 2018-2022,'' commonly referred to as the OMUFA commitment
letter (the document can be accessed at https://www.fda.gov/media/106407/download and the document with updated goal dates for fiscal
years 2021 to 2025 can be accessed at https://www.fda.gov/media/146283/download). In the OMUFA commitment letter, FDA committed to issuing
this draft guidance under specific timelines.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Providing
Over-the-Counter Monograph Submissions in Electronic Format.'' 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

    Under section 505G(o) of the FD&C Act, the Paperwork Reduction Act
of 1995 does not apply to collections of information made under section
505G of the FD&C Act. This guidance is being issued to implement the
provisions of section 505G(l)(3) of the FD&C Act, which specifies the
format of electronic submissions to FDA under section 505G of the FD&C
Act. Therefore, clearance by the Office of Management and Budget under
the Paperwork Reduction Act of 1995 is not required.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: September 23, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21007 Filed 9-27-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 224 (Friday, November 20, 2015)]
[Rules and Regulations]
[Page 72561]
[FR Doc No: 2015-29624]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2015-3367; Special Conditions No. 25-596-SC]

Special Conditions: Flight Structures, Inc., Boeing Model 777-200
Dynamic Test Requirements for Single-Occupant, Oblique (Side-Facing)
Seats With Airbag Devices

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments; correction.

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

SUMMARY: This document corrects an error that appeared in Docket No.
FAA-2015-3367, Special Conditions No. 25-596-SC, which was published in
the Federal Register on September 30, 2015 (80 FR 58597). The error is
in a reference to Boeing in a note preceding a section titled,
Inflatable Lap Belt Special Conditions. It is being corrected herein.

DATES: The effective date of this correction is November 20, 2015.

FOR FURTHER INFORMATION CONTACT: John Shelden, FAA, Airframe and Cabin
Safety Branch, ANM-115, Transport Airplane Directorate, Aircraft
Certification Service, 1601 Lind Avenue SW., Renton, Washington 98057-
3356; telephone<PHONE_NUMBER>; facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The document designated as ``Docket No. FAA-
2015-3367, Special Conditions No. 25-596-SC'' was published in the
Federal Register on September 30, 2015 (80 FR 58597). The document
issued special conditions pertaining to dynamic test requirements for
single-occupant, oblique (side-facing) seats with airbag devices on
Boeing Model 777-200 airplanes.
    As published, the document contained one error in a note that
refers to Boeing rather than Flight Structures, Inc.
    Because no other part of the regulatory information has been
changed, the Special Conditions are not being re-published.

Correction

    In the Final Special Conditions, Request for Comments document [FR
Doc. 2015-24727 filed 9-29-15; 8:45 a.m.] published on September 30,
2015 (80 FR 58597), make the following correction:
    On page 58599, column 3, the paragraph marked ``Note:'' should
read:

    Note: Flight Structures, Inc., must demonstrate that the
installation of seats via plinths or pallets meets all applicable
requirements. Compliance with the guidance contained in FAA Policy
Memorandum PS-ANM-100-2000-00123, dated February 2, 2000, titled
``Guidance for Demonstrating Compliance with Seat Dynamic Testing
for Plinths and Pallets,'' is acceptable to the FAA.

    Issued in Renton, Washington, on November 11, 2015.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-29624 Filed 11-19-15; 8:45 am]
 BILLING CODE 4910-13-P