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BROWN ET AL.
130
TRANSFUSION
Volume 41, January 2001
www.transfusion.org
H
uman B19 parvovirus (B19), a pathogenic hu-
man virus first identified in 1975,/is a common
1
contaminant of pooled plasma or plasma de-
rivatives. Solvent/detergent-treated (SD) plas-
ma, factor VIII concentrates, and rarely, single-donor blood
components have induced B19 viremia in recipients.To
further explore the clinical implications of B19 in blood
components, the National Heart, Lung, and Blood Institute
(NHLBI) convened a workshop on December 16, 1999. The
workshop included presentations on the structure of B19
and the pathophysiology of B19 infections, as well as the
epidemiology, immunology, and clinical manifestations of
the virus. Also discussed were the frequency of B19 viremia
in blood donors, potential clinical consequences of trans-
fusion-associated B19 infection, and issues surrounding
screening of blood supply and individual donors for B19.
The conference concluded with a summaryof suggestions
for further basic and clinical research with respect to B19.
The full affiliations of the speakers and organizers are listed
at the end of this report.
PARVOVIRUS B19
Structural and biochemical features
K
evin Brown, MD,and Neal Young, MD,began the meeting
with an overview of the structural and biochemical features
of B19, as well as the pathology, epidemiology, and clinical
manifestations of infection (a more comprehensive review
is presented in Anderson and Young).
2
B19 is a small nonenveloped virus with a single-
stranded DNA genome (approx. 5500 nucleotides) with ter-
minal hairpins./The virus is difficult to clone because of the
3
long, 176-nucleotide hairpins at each end of the genome.
The small genome and the lack of membrane contribute to
the heat and detergent resistance of the virus.Itis classi-
fied as an erythrovirus because it is highly tropic for eryth-
roid progenitor cells and because complete replication of
B19 has been found only in these cells.Studies of viral in-
fectivity have utilized erythroid progenitor cells derived
from bone marrow, peripheral blood, or fetal liver. Some
other cell lines allow for replication,
4,5
but the process is not
efficient. Inproductive infection, two capsid proteins, the
minor capsid protein VP1 and the major capsid protein VP2,
are synthesized./The expression of VP2 alone or of VP1 and
6
VP2 in combination leads to self-assembly of virus-like
particles./The infection of susceptible cells and the expres-
7
sion of the nonstructural protein cause apoptosis,/prob-
8
ably through induction of the caspase cascade. Nonstruc-
tural protein production is cytotoxic, even in cells in which
the viral capsid proteins are not produced./Thus, cell death
9
can occur even without virus replication.
The cellular receptor for B19 has been identified as
globoside,
10
also known as blood group P antigen. Globo-
side is also responsible for the phenomenon of B19 hemag-
glutination, and the addition of globoside antibody or ex-
cess globoside to bone marrow/cultures inhibits B19
infection. Furthermore,individuals who lack blood group
P antigen on their erythroid cells arenot susceptible to in-
fection with B19.
11
Globoside is also found on cells in the
bone marrow, especially erythroid precursors and mega-
karyocytes, and on cells in the placenta and the fetal myo-
cardium. Although fetal malformations due to B19 in preg-
nancy have not been described (apart from one case
report/), fetal myocarditis almost certainly contributes to
12
B19-induced hydrops fetalis. Globoside is also expressed on
HPCs of the liver, as well as on cells in the kidney and thy-
roid. The concentration of globoside on nonhematopoietic
tissues does not appear sufficient for activeinfection, and
other factors may be required for virus internalization and
virus replication.
Parvovirus B19: implications for transfusion medicine.
Summary of a workshop
Kevin E. Brown, Neal S. Young, Barbara M. Alving, and Luiz H. Barbosa
ABBREVIATIONS:
B19 = human B19 p\rvovirCs; NHLBI = Na-
tion\l He\rt, LCng, \nd Blood InstitCte; SCD = sickle cell dise\se;
SD =solvent/detergent-tre\ted; SPV = simian parvovirus.
From the National Heart, Lung, and Blood Institute, National
Institutes of Health, Bethesda, Maryland.
Address reprint requests to:
Luiz H. Barbosa, DVM, NHLBI,
Rockledge II, Room 10146, 6701 Rockledge Drive, Bethesda, MD
20892; e-mail<EMAIL_ADDRESS>Received for publication March 28, 2000; revision received
June 23, 2000, and accepted July 10, 2000.
TRANSFUSIO
2001;41:130-135.
CONFERENCE   R E P O R T

PARVOVIRUS B19 IN TRANSFUSION MEDICINE
Volume 41, January 2001
TRANSFUSION
131
www.transfusion.org
Epidemiology and experimental infection
The seroconversion rate has been calculated as about 1.5
percent per year for women of childbearing age./ Around
13
the world, the seroprevalence is about 50 percent in adults,
in part because of the infection of adult family members by
school-age children. There is seasonal variation in infec-
tion, and the major mode of transmission is thought to be
respiratory.
Inone study in the United Kingdom of the time course
of infection, virus was administered intranasally to healthy
adult volunteers.
14
Six days later, a peak in viremia was de-
tected, which correlated with fever, chills, headache, and
myalgia (Fig. 1). This was followed byan antibody response,
with IgM anti-B19 appearing around the 10th day. IgG anti-
B19 was detected a few days later;this was concurrent with
the appearance of the classic B19 rash, which was mani-
fested on the face as slapped-cheek rash and on the ex-
tremities as a lacy reticular pattern. Reticulocytopenia with-
out anemia occurred even in the healthy volunteers.
Clinical manifestations of infection
The clinical manifestations of B19 infection range from
chills, headache, and rash in children to fetal hydrops in
pregnant women infected in the first half of pregnancy.
15
Because B19 is tropic for erythroid progenitor cells, indi-
viduals who have a shortened RBC survival time, such as
those with sickle cell disease (SCD) and other hemolytic
anemias, are at risk for B19-induced anemia due to RBC
aplasia. Individuals who are immunosuppressed are also at
risk for severe chronic anemia. Many of these patients re-
spond well to IVIG.
16
Inchildren, B19 may initially cause chills, headache,
myalgia, and gastrointestinal disturbance, and then a
slapped-cheek rash, but usually patients feel remarkably
w
ell./One to 2 days later, a rash develops on arms and legs.
17
The cutaneous eruption is generally not apparent in older
patients infected with B19, but in adults, especially women,
up to 50 percent complain of arthropathy, usually in a sym-
metrical and peripheral distribution. Studies have at-
tempted to determine if B19 infection is associated with
rheumatoid arthritis, but most have not shown a link. In one
series, B19 DNA was found in the synovial tissue of 28 per-
cent of the patients, but the virus was also found in the
synovium of half of normal adults.
18
M
aternal B19 infection during the first half of preg-
nancy can result in a hydropic fetus./If a woman is infected
19
during Weeks 9 to 20 of pregnancy, there is about a10-per-
cent incidence of fetal loss.
20
If infection occurs later than
Week 20, fetal loss is rare.B19 infection of fetal cardiac tis-
sue may lead to myocarditis and heart failure, which con-
tribute to the development of hydrops. There may also be
cases of neurologic fetal abnormalities associated with in-
trauterine infection.
21,22
In addition, three cases of congeni-
tal anemia following confirmed B19 in pregnancy have been
described.
23
A
ll the fetuses developed hydrops, two were
treated with intrauterine transfusion, and one was delivered
prematurely and treated with IVIG. In all, B19 DNA was
detected in the bone marrow byPCR. However, treatment
with immunoglobulin did not lead to symptomatic im-
provement.
The first disease associated with B19 infection was
transient aplastic crisis, which occurred in children with
SCD who wereimmigrants from the Caribbean living in
London.
24
Further confirmation of the role of B19 in aplas-
tic crisis c\;e fro; \ stCdy in Clevel\nd of \n oCtbreak of
aplastic crisis in persons with SCD at the time of aconcur-
rent epidemic of fifth disease in otherwise healthy chil-
dren.
25
Chronic severe anemia can be due to persistent B19
infection./The first patient recognized to have this condi-
26
tion had an underlying combined B- and T-cell immuno-
deficiency with low immunoglobulin levels (Nezlof’s syn-
drome). The patient’s/blood contained B19 DNA at a
concentration of 10/genome copies per mL, as measured
6
bydot-blot hybridization. This high viral titer continued to
occur over months. Inaddition, the patient experienced
iron overload due to frequent transfusions. After the patient
received a 10-day course of commercial IVIG, the viral ti-
ters fell and a marked reticulocytosis occurred. Intermittent
infusions of IVIG over the next few months led to the reso-
lution of the parvovirCs infection \nd the RBC \pl\si\.
P
atients with HIV infection can present with pure RBC
aplasia due to B19 infection; in these persons, B19 titers can
be as high as 10/genome copies per mL./The anemia can
12
16
be resolved if the patients receive IVIG treatments, which
may need to be given repeatedly because of recurrence of
the parvovirus infection.
Fig.1. Clinical, hematologic, and viral course after B19 infec-

tion in immunocompetent individuals (data modified from
Anderson et al. ).
14

BROWN ET AL.
132
TRANSFUSION
Volume 41, January 2001
www.transfusion.org
Pathogenesis
As
shown in experimental infection of volunteers, B19 in-
fection has two phases.
14
The first is associated with vire-
mia that results in bone marrowsuppression because of
direct cytotoxicity to erythroid precursors. In patients with
shortened RBC survival, such as those with hemolytic ane-
mias or SCD, the consequences may be catastrophic. The
second phase starts when the infection is terminated bythe
production of specific antibodies. Aresponse by T-lympho-
cytes has not been well established, but the humoral re-
sponse is easily measured. This humoral response leads to
the second part of the illness, fifth disease, which is almost
certainly immune complex-mediated and due to the depo-
sition of immune complexes in skin, joints, and other or-
gans, which causes the specific syndromes.
Individuals at risk for prolonged B19 infection are those
who do not develop neutralizing antibodies to VP1, as mea-
sured in erythroid progenitor assays.
27
P
atients with AIDS
usually have no anti-B19 at all, as they have the most severe
formof immunodeficiency. Inother patients, there may be
VP2 binding but an absence of anti-VP1. Co;;ercial IVIG
from avariety of sources have high titers of antibody against
VP1 and VP2, as determined byimmunoblot. These prod-
ucts can neutralize the virus and lead to its clearance from
the blood and the bone marrow,allowing marrow erythro-
poiesis to recover.One of the unanswered questions in
parvovirus pathophysiology is whether the virus persists in
a form that allows the activation of latent infection and if
so, in which cells.
IMMUNOLOGY OF B19 AND POTENTIAL
FOR A VACCINE
The virus has only two capsid proteins, the major capsid
protein VP2, which makes up most of the capsid protein,
and a second protein, VP1, which makes up 5 percent or less
of the total capsid structure.VP1 is identical to VP2, except
that it has an additional 226 amino acids at the aminoter-
;in\l; this unique region is crucial for an adequate immune
response.
28
Capsid formation can occur with VP2 expressed recom-
binantly in the baculovirus syste;; VP1 is not an absolute
requirement for capsid formation./These baculovirus-
7
derived B19 antigens have been used to develop IgG and
IgM assays, eliminating the requirement for the natural vi-
rus,which is difficult to obtain. Crystallization studies of the
empty capsids have been successfully done in collaboration
with Rossmann at Purdue University (West Layfayette, IN)
and have shown that B19 is structurally quite distinct from
canine parvovirus./These studies have been useful in de-
29
termining binding sites for MoAbs, but they have not de-
fined the unique VP1 region, which cannot be detected in
structural studies.
Preclinical in vivo/experiments suggest that VP1 is
needed to induce an effective immune response: capsids
composed of VP2 alone are not sufficient to do so. A B19
vaccine antigen has been produced byengineering capsids
that were structurally sound and that contain 20 to 40 per-
cent VP1 instead of the 5 percent or less usually found in
the B19 virion. These VP1-enhanced capsids should be use-
ful, with an appropriate adjuvant, as a vaccine to protect
susceptible children and women of gestational age. A VP1-
enhanced vaccine is in commercial development, and ex-
periments are being conducted in normal volunteers with
an adjuvant that should stimulate the production of high
titers of neutralizing antibodies without toxicity. Inaddi-
tion, an RT-PCR assay utilizing the semipermissivecell line
UT7/Epo to measure the neutralization response to the
vaccine has been developed.
30
AN ANIMAL MODEL FOR B19
An animal model for B19 infection has been developed by
using a parvovirus originally isolated from anemic cyno-
molgus monkeys.
31
The virus,simian parvovirus (SPV), is
very similar at the genomic level to parvovirus B19. Cyno-
molgus monkeys, when inoculated with this virus, have
transient high titers of virus and reticulocytopenia, which
are followed by the development of an antibody response.
Inimmunosuppressed monkeys, life-threatening anemia
can occur with prolonged viremia. When monkeys are in-
oculated in the first half of pregnancy, hydrops also occurs
in their fetuses.
32
TESTING AND DIAGNOSIS
Bernard Cohen, PhD, and Larry Anderson, MD,gave an
update of current methods for diagnosing B19 infection and
pointed out that diagnostic methods for B19 infection are
usually determined bythe clinical perspective (for a review,
see Erdman/). IgM antibodies have been the core of B19
33
diagnosis for acute infection, while the appearance of IgG
antibodies is indicative of past infection, either resolved or
chronic.The virus can be visualized byelectron microscopy.
Histopathologic findings suggestive of B19, such as giant
pronormoblast formation, and antigen detection or DNA
detection byin situ hybridization are also diagnostic tools.
M
orerecently, B19 NAT has been used to detect the
virus in acute disease. Insome instances, lowlevels of B19
DNA persist in the serum in the presence of antibody with-
out any clear link to transmissibility or evidence of disease.
The induction of effective neutralizing antibody depends
upon a strong response to VP1, but in ELISAs, there is no
appreciable difference in the sensitivity of the assay when
VP1 rather than VP2 antigens are used. The use of whole-
virus antigen in ELISA appears to increase sensitivity in the
detection of IgM antibodies, but it does not influence the
sensitivity of detection of IgG. The ELISA format is impor-
tant, particularly for the IgM assay; the capture antibody
format increases both the sensitivity and specificity for IgM,
whereas an indirect assay is better for IgG.

PARVOVIRUS B19 IN TRANSFUSION MEDICINE
Volume 41, January 2001
TRANSFUSION
133
www.transfusion.org
B19 AND TRANSFUSION MEDICINE
Testing with several methods indicates that parvovirus is
present in the blood of 1in 20,000 to 1in 50,000 donors.
During epidemic periods, the incidence can increase to as
high as 1 in 260 donors. Naomi Luban, MD, and Roger
Dodd, PhD, pointed out that plasma pools usually contain
B19 as detected byDNA \n\lysis; the components derived
from them are usually administered to potentially vulner-
able recipients, such as males with hemophilia who are al-
ready infected with HIV. The medical literature has several
reports of B19 transmission by these components.
34
Con-
versely,only three transmissions due to single-donor com-
ponents have been described.
35-37
Joan Pehta, MD,presented a summary of the recent
postmarketing studies of SD plasma prepared byVITEX
(Melville, NY). The SD plasma contains antibodies to B19,
and all plasma pools contain B19 DNA. Of 19 normal recipi-
ents of lots of SD plasma that contained high titers of B19
DNA (10/-10
7.5
8.5
genome copies/mL), 7seroconverted at 7
to 10 days.Bythe end of 3months, 18 of the 19 recipients
had seroconverted and 14 of the 18 showed evidence of vi-
rus replication (increased level of viremia byPCR). The pres-
ence of anti-B19 in the plasma pools therefore was not pro-
tectiveagainst the large virus load. It is interesting that 58
recipients of lots with virus titers between 10
0.5
and 10
3.5
genome copies per mL remained seronegative and had
negative tests for B19 DNA.
Dodd and Cohen addressed the best methods to screen
for B19 in donor plasma, with the latter suggesting that
perhaps the receptor-mediated hemagglutination test de-
veloped in Japan could be considered for screening blood
donors. This assay is simple and economic and has shown
quite promising results in astudy of over 250,000 subjects.
38
DNA studies usually are used to detect the presence of the
virus,with the assumption that the presence of B19 DNA
correlates with infectious virus particles. Sensitive detec-
tion systems are capable of revealing low levels of B19 DNA,
but it is difficult to interpret these results from aclinical
perspective.Current nucleic acid assays for B19 havea
range of sensitivity that varies by10,000-fold; therefore, if
blood units are to be screened, the level of sensitivity would
have to be established for determining the infectivity of
PCR-positive specimens.The data derived from studies of
SD plasma suggest that a B19 concentration of at least 10
3.5
genome copies per mL is necessary to transmit viremia.
THE FDA’S PERSPECTIVE
Thomas Lynch, JD,PhD, discussed the FDA’sposition re-
garding NAT of plasma for further manufacture.The con-
servative approach taken by the FDA in regard to NAT for
transfusion-associated viruses such as HIV and HCV can-
not be applied to B19, and the FDA does not currently man-
date screening for B19. The disease is of short duration and
has a mild clinical coCrse; persistence of the virus andchronic
infections are extremely rare, except in immunocomprom-
ised patients. In addition, the illness does not have a win-
dow period, because the acute phase is veryshort.Thus, the
posture adopted bythe FDA is to use its licensing author-
ity to control the testing as an analytical tool. Manufactur-
ers of plasma products would be required to validate the
B19 NAT in terms of specificity, sensitivity, and reproduc-
ibility.However, because the aim of the testing is to reduce
the potential infectivity of the manufacturing pool, the FDA
does not requirethe manufacturer to show a correlation of
test results with any particular clinical outcome. Onthe
basis of the VITEX experience, the FDA is currently propos-
ing that a manufacturer’sscreening process, regardless of
its inherent sensitivity, should be capable of achieving
manufacturing pools that have plasma B19 DNA levels con-
sistently below10/genome copies per mL. There is no need
4
to identify individual positive units or the individual do-
nors.During the validation of the test, however, it is impor-
tant to actually identify the individual positive unit to con-
firm the positive result. The FDA proposes that any
candidate B19 NAT be evaluated in 20 known-positive do-
nations with a determination of the titer of each. Further-
more, several minipools would be tested (yielding a total of
100,000 donations). Positive results would be traced to the
individual positive unit, and the titer would be determined.
UNRESOLVED CLINICAL ISSUES
Our understanding of the role of B19 in SCD is still incom-
plete.The NHLBI is sponsoring a seroprevalence study in
patients with SCD to examine seroconversion rates for B19
and to determine the correlation of infection with illnesses,
not only transient aplastic crisis, but also acute chest syn-
dro;e \nd other co;plic\tions of SCD.
B19 DNA can be detected in many organs bysensitive
assays such as PCR, but it is not known if the B19 in tissues
of an asymptomatic person can be reactivated, especially
if the person becomes immunosuppressed. The role of B19
in diseases such as hepatitis, myocarditis, and rheumatoid
arthritis is still unclear. For example,most of the studies do
not address whether the DNA found byPCR is full-length
or is capable of RNA transcription and cell infection.
The prevalence of B19 and its role in anemia have not
been determined in many at-risk patient populations, such
as those with chronic lymphocytic leukemia or childhood
leukemias.One of the few systematic studies that has been
performed involved patients with HIV and AIDS.
Recently,B19 variants have been described/; these
39


[Federal Register Volume 80, Number 48 (Thursday, March 12, 2015)]
[Rules and Regulations]
[Pages 12933-12934]
[FR Doc No: 2015-05628]

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DEPARTMENT OF HOMELAND SECURITY

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33 CFR Part 117

[Docket No. USCG-2015-0151]

Drawbridge Operation Regulation; Columbia River, Vancouver, WA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulations.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
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DATES: This deviation is effective from 5 p.m. on April 27, 2015, until
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ADDRESSES: The docket for this deviation, [USCG-2015-0151] is available
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    Dated: March 5, 2015.
Steven M. Fischer,
Bridge Administrator, Thirteenth Coast Guard District.
[FR Doc. 2015-05628 Filed 3-11-15; 8:45 am]
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Proposed Information Collection Request; Comment Request;
Chesapeake Bay Program Citizen Stewardship Index, Diversity Profile,
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track it progress under the Stewardship goal of the 2014 Agreement. The
Stewardship goal includes three outcomes: (1) Citizen stewardship, (2)
local leadership, and (3) diversity. Three surveys under this ICR each
address one of the outcomes and contributes to EPA's Government
Performance and Results Act (GPRA) goals (EPA Goal 1, A Cleaner,
Healthier Environment; Objective 1.2: Provide for Clean and Safe
Water).
    Each of the surveys under this ICR were funded and implemented by
other partners in the Chesapeake Bay area in prior years. The Program
determined that the best approach for continued implementation of these
surveys would be for the EPA assume the responsibility for implementing
these surveys; thus, EPA is seeking approval for implementing these
surveys under this ICR.
    Collecting these data and publishing them for public review will
allow the public to track how well the Agreement is working to preserve
and protect the Chesapeake Bay region from the standpoint of the
Stewardship goal outlined in the Agreement. Overall, the Agreement
contains 10 goals and their associated outcomes; data for the other
nine goals are collected through other means. Combining the data for
Stewardship goal outcomes from these surveys with the data for the
other nine goals will provide the public will have a comprehensive
picture of the progress being made to preserve and protect Chesapeake
Bay watershed.
    Form Numbers: None.
    Respondents/affected entities: Stewardship survey: members of the
general public; Local Leaders survey: individuals in local government
leadership roles; Diversity Profile survey: individuals working at
organizations to conserve/restore the Chesapeake Bay watershed.
    Respondent's obligation to respond: voluntary.
    Estimated number of respondents: 6,430 (total).
    Frequency of response: once.
    Total estimated burden: 2,298 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $0 (per year), includes $0 annualized capital
or operation & maintenance costs.
    Changes in Estimates: This is a new collection.

    Dated: April 22, 2021.
Michelle Price-Fay,
Acting Director, Chesapeake Bay Program Office.
[FR Doc. 2021-09247 Filed 4-30-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 184 (Monday, September 25, 2017)]
[Notices]
[Pages 44639-44640]
[FR Doc No: 2017-20450]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4336-DR; Docket ID FEMA-2017-0001]

Puerto Rico; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the Commonwealth of Puerto Rico (FEMA-4336-DR), dated
September 10, 2017, and related determinations.

DATES: The declaration was issued September 10, 2017.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated September 10, 2017, the President issued a major disaster
declaration under the authority of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''), as follows:

    I have determined that the damage in certain areas of the
Commonwealth of Puerto Rico resulting from Hurricane Irma beginning
on September 5, 2017, and continuing, is of sufficient severity and
magnitude to warrant a major disaster declaration under the Robert
T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C.
5121 et seq. (the ``Stafford Act''). Therefore, I declare that such
a major disaster exists in the Commonwealth of Puerto Rico.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Individual Assistance and Public
Assistance in the designated areas and Hazard Mitigation throughout
the Commonwealth. Consistent with the requirement that Federal
assistance be supplemental, any Federal funds provided under the
Stafford Act for Hazard Mitigation and Other Needs Assistance will
be limited to 75 percent of the total eligible costs. Federal funds
provided under the Stafford Act for Public Assistance also will be
limited to 75 percent of the total eligible costs, with the
exception of projects that meet the eligibility criteria for a
higher Federal cost-sharing percentage under the Public Assistance
Alternative Procedures Pilot Program for Debris Removal implemented
pursuant to section 428 of the Stafford Act.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The time period prescribed for the implementation of section
310(a), Priority to Certain Applications for Public Facility and Public
Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed
six months after the date of this declaration.
    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Alejandro DeLaCampa, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the Commonwealth of Puerto Rico have been
designated as adversely affected by this major disaster:

    The municipalities of Culebra and Vieques for Individual
Assistance.
    The municipalities of Culebra and Vieques for Public Assistance.
    All areas within the Commonwealth of Puerto Rico are eligible
for assistance under the Hazard Mitigation Grant Program.
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households in Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2017-20450 Filed 9-22-17; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register: April 9, 2009 (Volume 74, Number 67)]
[Notices]
[Page 16200]
[DOCID:fr09ap09-48]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13353-000]

Riverbank Sparta, LLC; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

April 2, 2009.
    On January 21, 2009, Riverbank Sparta, LLC, filed an application
pursuant to section 4(f) of the Federal Power Act, proposing to study
the feasibility of the Sparta Pumped Storage Project No. 13353-000, to
be located at the Limecrest Quarry in Sparta Township, Sussex County,
New Jersey.
    The proposed Sparta Pumped Storage Project would consists of: (1)
The existing Limecrest Quarry (upper reservoir); (2) four new 13-foot-
diameter vertical penstocks leading to a powerhouse 2,000 feet
underground; (3) a new powerhouse containing four 250-megawatt (MW)
generating units with a total installed capacity of 1,000 MW; (4) water
leaving the turbines, would temporarily be stored in six new
underground storage galleries (lower reservoir); (5) a new 5.7-mile-
long, 500 kV double circuit transmission line; and (6) appurtenant
facilities. The estimated average annual energy production is 2,190
gigawatt-hours.
    Applicant Contact: Mr. John Douglas, President and CEO; c/o
Riverbank Power Corporation; Royal Bank Plaza; South Tower, Box 166;
200 Bay Street, Suite 3110; Toronto, Ontario; M5J2J4 Canada; 416-861-
0092 ext. 156.
    FERC Contact: Patrick Murphy,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance date of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp.
    More information about this project can be viewed or printed on the
``eLibrary'' link of Commission's Web site at http://www.ferc.gov/docs-
filing/elibrary.asp. Enter the docket number (P-13353) in the docket
number field to access the document. For assistance, call toll-free 1-
866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-8050 Filed 4-8-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 241 (Monday, December 18, 2017)]
[Rules and Regulations]
[Pages 59960-59963]
[FR Doc No: 2017-26837]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0627; Product Identifier 2017-NM-037-AD; Amendment
39-19127; AD 2017-25-13]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all
Airbus Model A330-200 Freighter, -200, and -300 series airplanes; and
Airbus Model A340-200, -300, -500, and -600 series airplanes. This AD
was prompted by a report that the trimmable horizontal stabilizer
actuator (THSA) might not function as intended after failure of the
primary load path. This AD requires repetitive detailed visual
inspections for discrepancies of the THSA upper attachments and no-back
housing. We are issuing this AD to address the unsafe condition on
these products.

DATES: This AD is effective January 22, 2018.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of January 22,
2018.

ADDRESSES: For service information identified in this final rule,
contact Airbus SAS, Airworthiness Office--EAL, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone: +33 5 61 93 36 96;
fax: +33 5 61 93 45 80; email: [email protected];
internet: http://www.airbus.com. You may view this referenced service
information at the FAA, Transport Standards Branch, 1601 Lind Avenue
SW, Renton, WA. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>. It is also available on the internet at
http://www.regulations.gov by searching for and locating Docket No.
FAA-2017-0627.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0627; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Office (telephone:
800-647-5527) is Docket Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 1601 Lind
Avenue SW, Renton, WA 98057-3356; telephone:<PHONE_NUMBER>; fax: 425-
227-1149.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to all Airbus Model A330-200
Freighter, -200, and -300 series airplanes; and Airbus Model A340-200,
-300, -500, and -600 series airplanes. The NPRM published in the
Federal Register on June 30, 2017 (82 FR 29795) (``the NPRM''). The
NPRM was prompted by a report that the THSA might not function as
intended after failure of the primary load path. The NPRM proposed to
require repetitive detailed visual inspections for discrepancies of the
THSA upper attachments and no-back housing. We are issuing this AD to
detect and correct discrepancies of the THSA upper attachments and no-
back housing, which could lead to THSA upper attachment failure and
consequent disconnection of the THSA from the airplane structure,
possibly resulting in loss of control of the airplane.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2017-0044, dated March 9, 2017 (referred to after this as the Mandatory
Continuing Airworthiness Information, or ``the MCAI''), to correct an
unsafe condition for all Airbus Model A330-200 Freighter, -200 and -300
series airplanes; and Airbus Model A340-200, -300, -500, and -600
series airplanes. The MCAI states:

    The Trimmable Horizontal Stabilizer Actuator (THSA), as
installed on A330 and A340 aeroplanes, was initially designed to
stall when engaging on the upper secondary load path (SLP) after
primary load path (PLP) failure. Such stall triggers system
monitoring detection. New mission profile analysis revealed that in
some cases, the THSA could be operated while engaged on the upper
SLP without stalling [i.e., the THSA might not function as intended
after failure of the primary load path]. The partial engagement of
the SLP at upper attachment level does not trigger any indication to
the flight crew.
    This condition, if not detected and corrected, could lead to
THSA upper attachment failure and consequent disconnection of the
THSA from the aeroplane structure, possibly resulting in loss of
control of the aeroplane.
    For the reasons described above, this [EASA] AD requires
repetitive detailed [visual] inspections (DET) of the upper THSA
attachments parts and the PLP and SLP fuselage attachment points,
and, depending on findings (which include, but are not limited to,
failure of the primary load path), accomplishment of applicable
[additional inspections for discrepancies and] corrective action(s).

    The additional inspections include a detailed visual inspection for
discrepancies of the upper attachment fitting of the airplane and a
detailed visual inspection for discrepancies of the removed THSA.
Corrective actions include repair and replacement of the THSA. You may
examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0627.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the NPRM and
the FAA's response.

Support for the NPRM

    The Air Line Pilots Association, International (ALPA), expressed
its support for the NPRM.

Request To Delay Publication of the Final Rule or Note Discrepancy in
Service Information

    Delta Airlines (DAL) requested that we delay publication of the
final rule or include information regarding a

discrepancy found in Airbus Service Bulletin A330-27-3218, Revision 01,
dated December 5, 2016, which specifies to use Aircraft Maintenance
Manual (AMM) task 27-44-00-210-805. However, AMM task 27-44-00-210-805
is missing from the A330 AMM revision dated July 1, 2017. DAL preferred
to avoid the need for an alternative method of compliance (AMOC) to
accomplish the tasks required by Airbus Service Bulletin A330-27-3218,
Revision 01, dated December 5, 2016. DAL also contacted Airbus
regarding this issue.
    We disagree with the request to delay this final rule. We also
disagree that information regarding the discrepancy should be
specifically included. Although Airbus Service Bulletin A330-27-3218,
Revision 01, dated December 5, 2016, specifies to use AMM task 27-44-
00-210-805, the service information also includes information to
perform a detailed visual inspection using SUBTASK 273218-832-001-001
if AMM task 27-44-00-210-805 is unavailable. Therefore, no changes to
this AD are necessary regarding this issue.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD as proposed except for minor editorial changes. We have
determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    Airbus has issued the following service information.
     Airbus Service Bulletin A330-27-3218, Revision 01, dated
December 5, 2016.
     Airbus Service Bulletin A340-27-4203, Revision 01, dated
December 5, 2016.
     Airbus Service Bulletin A340-27-5067, Revision 01, dated
December 5, 2016.
    This service information describes procedures for detailed visual
inspections for discrepancies of the THSA upper attachments and no-back
housing, additional inspections for discrepancies, and corrective
actions. These documents are distinct since they apply to different
airplane models. 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 the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 102 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
           Action                  Labor cost         Parts cost       Cost per product          operators
----------------------------------------------------------------------------------------------------------------
Inspection.................  3 work-hours x $85                 $0  $255 per inspection    $26,010 per
                              per hour = $255 per                    cycle.                 inspection cycle.
                              inspection cycle.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary replacements
that would be required based on the results of the required inspection.
We have no way of determining the number of aircraft that might need
these replacements:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                   Action                                 Labor cost                Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replacement................................  20 work-hours x $85 per hour =             $734,661        $736,361
                                              $1,700.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for other on-condition actions specified in this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes to
the Director of the System Oversight Division.

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2017-25-13 Airbus: Amendment 39-19127; Docket No. FAA-2017-0627;
Product Identifier 2017-NM-037-AD.

(a) Effective Date

    This AD is effective January 22, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Model A330-201, -202, -203, -223, -
223F, -243, -243F, -301, -302, -303, -321, -322, -323, -341, -342
and -343 airplanes; and Airbus Model A340-211, -212, -213, -311, -
312, -313, -541, and -642 airplanes; certificated in any category,
all manufacturer's serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 27, Flight
Controls.

(e) Reason

    This AD was prompted by a report that the trimmable horizontal
stabilizer actuator (THSA) might not function as intended after
failure of the primary load path. We are issuing this AD to detect
and correct discrepancies of the THSA upper attachments and no-back
housing, which could lead to THSA upper attachment failure and
consequent disconnection of the THSA from the airplane structure,
possibly resulting in loss of control of the airplane.

(f) Compliance

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

(g) Repetitive Detailed Visual Inspections

    Before exceeding the threshold in Table 1 to paragraph (g) of
this AD, as applicable, or within 3 months after the effective date
of this AD, whichever occurs later; and thereafter at intervals not
to exceed the inspection interval values defined in Table 1 to
paragraph (g) of this AD; accomplish a detailed visual inspection
for discrepancies of the THSA upper attachments and no-back housing,
in accordance with the Accomplishment Instructions of Airbus Service
Bulletin A330-27-3218, Revision 01, A340-27-4203, Revision 01, or
A340-27-5067, Revision 01, all dated December 5, 2016, as
applicable. Where the ``Threshold'' column of table 1 to paragraph
(g) of this AD specifies compliance times in ``FH'' (flight hours)
or ``FC'' (flight cycles), those compliance times are flight hours
or flight cycles since the first flight of the airplane, or since
the last accomplishment of Airbus Model A330 or A340 Maintenance
Review Board Report task 27.40.00/07, or since the last detailed
visual inspection of the THSA done in accordance with the
Accomplishment Instructions of Airbus Service Bulletin A330-27-3218,
Revision 00, A340-27-4203, Revision 00, or A340-27-5067, Revision
00, all dated July 1, 2016, as applicable.

   Table 1 to Paragraph (g) of This AD--THSA Upper Attachments/No-Back
                           Housing Inspections
------------------------------------------------------------------------
                                    Compliance times (whichever occurs
                                    first, flight hours (FH) or flight
                                               cycles (FC))
       Affected airplanes        ---------------------------------------
                                                          Inspection
                                       Threshold       interval (not to
                                                            exceed)
------------------------------------------------------------------------
A330, A340-200 and A340-300.....  Before 4,000 FH or  4,000 FH or 1,000
                                   1,000 FC.           FC
A340-500 and A340-600...........  Before 4,000 FH or  4,000 FH or 800 FC
                                   800 FC.
------------------------------------------------------------------------

(h) Additional Inspections and Corrective Actions

    (1) If, during any inspection required by paragraph (g) of this
AD, any discrepancy identified in the Accomplishment Instructions of
Airbus Service Bulletin A330-27-3218, Revision 01, A340-27-4203,
Revision 01, or A340-27-5067, Revision 01, all dated December 5,
2016, as applicable, is detected, before further flight, remove the
THSA, and accomplish a detailed visual inspection for discrepancies
of the upper attachment fitting of the airplane and a detailed
visual inspection for discrepancies of the removed THSA, in
accordance with the Accomplishment Instructions of Airbus Service
Bulletin A330-27-3218, Revision 01, A340-27-4203, Revision 01, or
A340-27-5067, Revision 01, all dated December 5, 2016, as
applicable. As an alternative to the removed THSA inspections
required by this paragraph, before further flight, replace the THSA
with a serviceable part (as defined in paragraph (i) of this AD).
    (2) If, during any inspection of the upper attachment fitting of
the airplane required by paragraph (h)(1) of this AD, any
discrepancy identified in the Accomplishment Instructions of Airbus
Service Bulletin A330-27-3218, Revision 01, A340-27-4203, Revision
01, or A340-27-5067, Revision 01, all dated December 5, 2016, as
applicable, is detected, before further flight, repair using a
method approved in accordance with the procedures specified in
paragraph (k)(2) of this AD.
    (3) If, during any inspection of the removed THSA required by
paragraph (h)(1) of this AD, no discrepancy specified in the
Accomplishment Instructions of Airbus Service Bulletin A330-27-3218,
Revision 01, A340-27-4203, Revision 01, or A340-27-5067, Revision
01, all dated December 5, 2016, as applicable, is detected, before
further flight, reinstall the THSA, in accordance with the
Accomplishment Instructions of Airbus Service Bulletin A330-27-3218,
Revision 01, A340-27-4203, Revision 01, or A340-27-5067, Revision
01, all dated December 5, 2016, as applicable.
    (4) If, during any inspection of the removed THSA required by
paragraph (h)(1) of this AD, any discrepancy specified in the
Accomplishment Instructions of Airbus Service Bulletin A330-27-3218,
Revision 01, A340-27-4203, Revision 01, or A340-27-5067, Revision
01, all dated December 5, 2016, as applicable, is detected, before
further flight, replace the THSA with a serviceable part (as defined
in paragraph (i) of this AD), in accordance with the Accomplishment
Instructions of Airbus Service Bulletin A330-27-3218, Revision 01,
A340-27-4203, Revision 01, or A340-27-5067, Revision 01, all dated
December 5, 2016, as applicable.

(i) Definition of Serviceable THSA

    For the purpose of this AD, a serviceable THSA is a part that
has accumulated less than 4,000 FH or 1,000 FC (for Airbus Model
A330, A340-200, or A340-300 airplanes) or 4,000 FH or 800 FC (for
Airbus Model A340-500 or A340-600 airplanes), whichever occurs first
since the first flight of the airplane, or since the last overhaul
of the THSA, or since the last detailed visual inspection of the
THSA in accordance with the Accomplishment Instructions of Airbus
Service Bulletin A330-27-3218, Revision 01, A340-27-4203, Revision
01, or A340-27-5067, Revision 01, all dated December 5, 2016, as
applicable.

(j) Credit for Previous Actions

    This paragraph provides credit for actions required by
paragraphs (g), (h)(1), (h)(3), and (h)(4) of this AD, if those
actions were performed before the effective date of this AD using
the service information specified in

paragraph (j)(1), (j)(2), or (j)(3) of this AD, as applicable.
    (1) Airbus Service Bulletin A330-27-3218, Revision 00, dated
July 1, 2016.
    (2) Airbus Service Bulletin A340-27-4203, Revision 00, dated
July 1, 2016.
    (3) Airbus Service Bulletin A340-27-5067, Revision 00, dated
July 1, 2016.

(k) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards 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 local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (l)(2) of this AD. Information
may be emailed to: [email protected]. Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or the European Aviation
Safety Agency (EASA); or Airbus's EASA Design Organization Approval
(DOA). If approved by the DOA, the approval must include the DOA-
authorized signature.
    (3) Required for Compliance (RC): Except as required by
paragraph (h)(2) of this AD: If any service information contains
procedures or tests that are identified as RC, those procedures and
tests must be done to comply with this AD; any procedures or tests
that are not identified as RC are recommended. Those procedures and
tests that are not identified as RC may be deviated from using
accepted methods in accordance with the operator's maintenance or
inspection program without obtaining approval of an AMOC, provided
the procedures and tests identified as RC can be done and the
airplane can be put back in an airworthy condition. Any
substitutions or changes to procedures or tests identified as RC
require approval of an AMOC.

(l) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA AD 2017-0044, dated March 9, 2017, for related
information. This MCAI may be found in the AD docket on the internet
at http://www.regulations.gov by searching for and locating Docket
No. FAA-2017-0627.
    (2) For more information about this AD, contact Vladimir
Ulyanov, Aerospace Engineer, International Section, Transport
Standards Branch, FAA, 1601 Lind Avenue SW, Renton, WA 98057-3356;
telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.
    (3) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (m)(3) and (m)(4) of this AD.

(m) 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 this AD specifies otherwise.
    (i) Airbus Service Bulletin A330-27-3218, Revision 01, dated
December 5, 2016.
    (ii) Airbus Service Bulletin A340-27-4203, Revision 01, dated
December 5, 2016.
    (iii) Airbus Service Bulletin A340-27-5067, Revision 01, dated
December 5, 2016.
    (3) For service information identified in this AD, contact
Airbus SAS, Airworthiness Office--EAL, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone: +33 5 61 93 36 96;
fax: +33 5 61 93 45 80; email: [email protected];
internet: http://www.airbus.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 1601 Lind Avenue SW, Renton, 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, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on December 5, 2017.
Dionne Palermo,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2017-26837 Filed 12-15-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 95 (Monday, May 18, 2015)]
[Notices]
[Pages 28259-28261]
[FR Doc No: 2015-11922]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP15-132-000]

Kern River Gas Transmission Company; Notice of Intent To Prepare
an Environmental Assessment for the Proposed Summerlin Pipe Replacement
Project and Request for Comments on Environmental Issues

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental assessment (EA) that will
discuss the environmental impacts of the Summerlin Pipe Replacement
Project involving construction and operation of facilities by Kern
River Gas Transmission Company (Kern River) in Clark County, Nevada.
The Commission will use this EA 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. You can make a difference by providing us with
your specific comments or concerns about the project. Your comments
should focus on the potential environmental effects, reasonable
alternatives, and measures to avoid or lessen environmental impacts.
Your input will help the Commission staff determine what issues they
need to evaluate in the EA. To ensure that your comments are timely and
properly recorded, please send your comments so that the Commission
receives them in Washington, DC on or before June 11, 2015.
    If you sent comments on this project to the Commission before the
opening of this docket on March 26, 2015, you will need to file those
comments in Docket

No. CP15-132-000 to ensure they are considered as part of this
proceeding.
    This notice is being sent to the Commission's current environmental
mailing list for this project. State and local government
representatives should notify their constituents of this proposed
project and encourage them to comment on their areas of concern.
    If you are a landowner receiving this notice, a pipeline company
representative may contact you about the acquisition of an easement to
construct, operate, and maintain the proposed facilities. The company
would seek to negotiate a mutually acceptable agreement. However, if
the Commission approves the project, that approval conveys with it the
right of eminent domain. Therefore, if easement negotiations fail to
produce an agreement, the pipeline company could initiate condemnation
proceedings where compensation would be determined in accordance with
state law.
    Kern River provided landowners with a fact sheet prepared by the
FERC entitled ``An Interstate Natural Gas Facility On My Land? What Do
I Need To Know?'' This fact sheet addresses a number of typically asked
questions, including the use of eminent domain and how to participate
in the Commission's proceedings. It is also available for viewing on
the FERC Web site (www.ferc.gov).

Public Participation

    For your convenience, there are three methods you can use to submit
your comments to the Commission. The Commission encourages electronic
filing of comments and has expert staff available to assist you at
(202) 502-8258 or<EMAIL_ADDRESS>Please carefully follow these
instructions so that your comments are properly recorded.
    (1) You can file your comments electronically using the eComment
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. This is an easy method for submitting brief,
text-only comments on a project;
    (2) You can file your comments electronically by using the eFiling
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. With eFiling, you can provide comments in a
variety of formats by attaching them as a file with your submission.
New eFiling users must first create an account by clicking on
``eRegister.'' If you are filing a comment on a particular project,
please select ``Comment on a Filing'' as the filing type; or
    (3) You can file a paper copy of your comments by mailing them to
the following address. Be sure to reference the project docket number
(CP15-132-000) with your submission: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE., Room 1A,
Washington, DC 20426.

Summary of the Proposed Project

    Kern River proposes the Summerlin Pipe Replacement Project to
replace a 1.56-mile-long segment of its existing 36-inch-diameter A-
line pipeline from milepost 543.63 to 545.19 in Clark County, Nevada.
When originally constructed, this portion of the A-line was designed as
pipeline located in a Class I location. This pipe segment must be
upgraded with thicker-walled pipe to satisfy U.S. Department of
Transportation safety regulations for a Class 3 location as a result of
a planned residential development in the vicinity of the existing
pipeline.
    In order to maintain delivery to Kern River's customers, the
pipeline segment would remain in service until the new pipeline segment
is constructed and placed into service, after which the old segment
would be removed. Due to a crossover of two existing pipelines, the new
pipeline segment would be installed at a 25-foot offset from another
existing Kern River line (B-line) for 1.15 miles and at a 25-foot
offset from the existing A-line for 0.41 mile. To allow for
uninterrupted service during the project, Kern River would install a
new 24-inch-diameter crossover valve near milepost 0 of the project by
hot tapping the 36-inch-diameter A-line and installing crossover piping
to the 24-inch-diameter B-line crossover piping. An existing 0.22-acre
valve and pig \1\ launcher yard would be expanded by 0.37 acre to
accommodate the new crossover valve and crossover piping. The general
location of the project facilities is shown in appendix 1.\2\
---------------------------------------------------------------------------

    \1\ A ``pig'' is a tool that the pipeline company inserts into
and pushes through the pipeline for cleaning the pipeline,
conducting internal inspections, or other purposes.
    \2\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of appendices were sent to all those
receiving this notice in the mail and are available at www.ferc.gov
using the link called ``eLibrary'' or from the Commission's Public
Reference Room, 888 First Street NE., Washington, DC 20426, or call
(202) 502-8371. For instructions on connecting to eLibrary, refer to
the last page of this notice.
---------------------------------------------------------------------------

    Pipeline facilities are proposed to be installed and removed
between October 2015 and December 2015. Kern River expects the new
pipeline segment to be placed into service by December 29, 2015.

Land Requirements for Construction

    Construction of the proposed facilities would disturb about 39.30
acres of land, which includes 9.74 acres of permanent right-of-way,
22.23 acres of construction right-of-way (i.e., additional temporary
workspace, contractor staging yards), and 7.33 acres of access roads.
Kern River proposes to use a 100-foot-wide construction right-of-way to
install the replacement pipeline and remove the existing pipeline
segment. Of the 31.97 acres used for construction along the pipeline
route, 26.12 acres was previously disturbed by construction of the
existing A-line and B-line.
    Following construction, Kern River would maintain 9.74 acres for
permanent operation of the project's facilities with only 1.10 acres of
new disturbance, accounting for overlapping rights-of-way with A-line
and B-line and previously disturbed land. The remaining acreage used
during construction would be restored according to Kern River's
project-specific Reclamation Plan and revert to former uses.
    The proposed pipeline crosses 0.44 mile (9.22 acres) of land owned
and managed by the Bureau of Land Management (BLM), 1.06 miles (27.34
acres) of private property, and 0.06 mile (2.74 acres) owned by Clark
County.

The EA Process

    The National Environmental Policy Act (NEPA) requires the
Commission to take into account the environmental impacts that could
result from an action whenever it considers the issuance of a
Certificate of Public Convenience and Necessity. NEPA also requires us
\3\ 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 the important
environmental issues. By this notice, the Commission requests public
comments on the scope of the issues to address in the EA. We will
consider all filed comments during the preparation of the EA.
---------------------------------------------------------------------------

    \3\ ``We,'' ``us,'' and ``our'' refer to the environmental staff
of the Commission's Office of Energy Projects.
---------------------------------------------------------------------------

    In the EA we 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;
     water resources, fisheries, and wetlands;
     cultural resources;
     vegetation and wildlife;

     air quality and noise;
     endangered and threatened species;
     public safety; and
     cumulative impacts.
    We will also evaluate reasonable alternatives to the proposed
project or portions of the project, and make recommendations on how to
lessen or avoid impacts on the various resource areas.
    The EA will present our independent analysis of the issues. The EA
will be available in the public record through eLibrary. Depending on
the comments received during the scoping process, we may also publish
and distribute the EA to the public for an allotted comment period. We
will consider all comments on the EA before making our recommendations
to the Commission. To ensure we have the opportunity to consider and
address your comments, please carefully follow the instructions in the
Public Participation section, beginning on page 2.
    With this notice, we are asking agencies with jurisdiction by law
and/or special expertise with respect to the environmental issues of
this project to formally cooperate with us in the preparation of the
EA.\4\ Agencies that would like to request cooperating agency status
should follow the instructions for filing comments provided under the
Public Participation section of this notice. Currently, the BLM has
expressed its intention to participate as a cooperating agency in the
preparation of the EA to satisfy its NEPA responsibilities related to
this project.
---------------------------------------------------------------------------

    \4\ The Council on Environmental Quality regulations addressing
cooperating agency responsibilities are at Title 40, Code of Federal
Regulations, Part 1501.6.
---------------------------------------------------------------------------

Consultations Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for section 106 of the National Historic
Preservation Act, we are using this notice to initiate consultation
with the applicable State Historic Preservation Office (SHPO), and to
solicit their views and those of other government agencies, interested
Indian tribes, and the public on the project's potential effects on
historic properties.\5\ We will define the project-specific Area of
Potential Effects (APE) in consultation with the SHPO as the project
develops. On natural gas facility projects, the APE at a minimum
encompasses all areas subject to ground disturbance (examples include
construction right-of-way, contractor/pipe storage yards, compressor
stations, and access roads). Our EA for this project will document our
findings on the impacts on historic properties and summarize the status
of consultations under section 106.
---------------------------------------------------------------------------

    \5\ The Advisory Council on Historic Preservation's regulations
are at Title 36, Code of Federal Regulations, Part 800. Those
regulations define historic properties as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register of Historic
Places.
---------------------------------------------------------------------------

Currently Identified Environmental Issues

    We have already identified issues that we think deserve attention
based on a preliminary review of the proposed facilities and the
environmental information provided by Kern River, namely the impact on
federally listed threatened and endangered species as well as BLM
identified species. Other issues may be added based on your comments
and our analysis.

Environmental Mailing List

    The environmental mailing list includes federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American Tribes; other
interested parties; and local libraries and newspapers. This list also
includes all affected landowners (as defined in the Commission's
regulations) who are potential right-of-way grantors, whose property
may be used temporarily for project purposes, or who own homes within
certain distances of aboveground facilities, and anyone who submits
comments on the project. We will update the environmental mailing list
as the analysis proceeds to ensure that we send the information related
to this environmental review to all individuals, organizations, and
government entities interested in and/or potentially affected by the
proposed project.
    If we publish and distribute the EA, copies of the EA will be sent
to the environmental mailing list for public review and comment. If you
would prefer to receive a paper copy of the document instead of the CD
version or would like to remove your name from the mailing list, please
return the attached Information Request (appendix 2).

Becoming an Intervenor

    In addition to involvement in the EA scoping process, you may want
to become an ``intervenor'' which is an official party to the
Commission's proceeding. Intervenors play a more formal role in the
process and are able to file briefs, appear at hearings, and be heard
by the courts if they choose to appeal the Commission's final ruling.
An intervenor formally participates in the proceeding by filing a
request to intervene. Instructions for becoming an intervenor are in
the User's Guide under the ``e-filing'' link on the Commission's Web
site.

Additional Information

    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site at www.ferc.gov using the ``eLibrary'' link. Click on the
eLibrary link, click on ``General Search'' and enter the docket number,
excluding the last three digits in the Docket Number field (i.e., CP15-
132). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, 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 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 www.ferc.gov/docs-filing/esubscription.asp.
    Finally, public meetings or site visits will be posted on the
Commission's calendar located at www.ferc.gov/EventCalendar/EventsList.aspx along with other related information.

    Dated: May 12, 2015.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2015-11922 Filed 5-15-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 180 (Tuesday, September 17, 2019)]
[Notices]
[Page 48923]
[FR Doc No: 2019-20059]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL19-96-000]

Cimarron Windpower II, LLC v. Southwest Power Pool, Inc.; Notice
of Complaint

    Take notice that on September 10, 2019, pursuant to sections 206,
306, and 309 of the Federal Power Act (FPA), 16 U.S.C. 824e, 825e, and
825h (2018) and Rule 206 of the Federal Energy Regulatory Commission's
(Commission) Rules of Practice and Procedure, 18 CFR 385.206 (2019),
Cimarron Windpower II, LLC (Complainant), filed a formal complaint
against Southwest Power Pool, Inc. (SPP or Respondent) alleging that
SPP violated its tariff and contractual obligations by failing to
properly implement Attachment Z2 of its tariff, all as more fully
explained in the complaint.
    Complainant certifies that the complaint was served on the
Respondent as listed on the Commission's list of Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE, Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
eLibrary link and is available for review in the Commission's Public
Reference Room in Washington, DC. There is an eSubscription link on the
website that enables subscribers to receive email notification when a
document is added to a subscribed docket(s). For assistance with any
FERC Online service, please email<EMAIL_ADDRESS>or call
(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on October 10, 2019.

    Dated: September 11, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-20059 Filed 9-16-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Notices]
[Pages 49542-49543]
[FR Doc No: 2021-19113]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0536]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Device User
Fee Cover Sheet, Form FDA 3601 and Device Facility User Fee Cover
Sheet, Form FDA 3601a

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by October 4, 2021.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0511 Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Facility
User Fee Cover Sheet, Form FDA 3601a

OMB Control Number 0910-0511--Revision

    The Federal Food, Drug, and Cosmetic Act, as amended by the Medical
Device User Fee and Modernization Act of 2002 (Pub. L. 107-250), and
the Medical Device User Fee Amendments of 2007 (Title II of the Food
and Drug

Administration Amendments Act of 2007), authorizes FDA to collect user
fees for certain medical device applications. Under this authority,
companies pay a fee for certain new medical device applications or
supplements submitted to the Agency for review. Because the submission
of user fees concurrently with applications and supplements is
required, the review of an application cannot begin until the fee is
submitted. Form FDA 3601, the ``Medical Device User Fee Cover Sheet,''
is designed to provide the minimum necessary information to determine
whether a fee is required for review of an application, to determine
the amount of the fee required, and to account for and track user fees.
The form provides a cross-reference between the fees submitted for an
application with the actual submitted application by using a unique
number tracking system. The information collected is used by FDA's
Center for Devices and Radiological Health and FDA's Center for
Biologics Evaluation and Research to initiate the administrative
screening of new medical device applications and supplemental
applications.
    We are revising the information collection to add Form FDA 3601a,
the ``Device Facility User Fee Cover Sheet.'' Owners or operators of
places of business (also called establishments or facilities) that are
involved in the production and distribution of medical devices intended
for use in the United States are required to register annually with
FDA, a process known as establishment registration (21 CFR part 807,
subparts A through D). (The information collection for medical device
establishment registration and listing is approved under OMB control
number 0910-0625.) All establishments required to register must pay a
user fee. Form FDA 3601a, the ``Device Facility User Fee Cover Sheet,''
is designed to collect payments for the annual establishment
registration fee for medical device establishments.
    The total number of annual responses for Form FDA 3601 is based on
the average number of cover sheet submissions received by FDA in recent
years. The number of received annual responses includes cover sheets
for applications that were qualified for small businesses and fee
waivers or reductions. The estimated hours per response are based on
past FDA experience with the various cover sheet submissions and range
from 5 to 30 minutes. For this analysis, we estimate 18 minutes per
coversheet.
    The total number of annual responses for Form FDA 3601a is based on
the average number of cover sheet submissions received by FDA in recent
years. Based on past FDA experience with various cover sheet
submissions, we estimate 10 minutes per response.
    In the Federal Register of June 12, 2020 (85 FR 35939), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although two comments were received, only
one was responsive to the four collection of information topics
solicited.
    FDA's response to the comment is that the establishment
registration fee is not eligible for a reduced small business fee. This
can be found on our website at: https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden 1 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                FDA Form No.                     Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
3601........................................           6,182               1           6,182  0.30 (18 minutes).........................           1,855
3601a.......................................          24,086               1          24,086  0.17 (10 minutes).........................           4,095
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............          30,268  ..........................................           5,950
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.

    Our estimated burden for the information collection reflects an
overall increase of 4,036 hours and a corresponding increase of 23,889
responses/records. We attribute these increases to two factors: We have
revised the burden estimate to include Form FDA 3601a and we have
adjusted the number of respondents for Form FDA 3601 to reflect our
current data.

    Dated: August 31, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19113 Filed 9-2-21; 8:45 am]
BILLING CODE 4164-01-P