Page 1 of 7 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 APR 14, 2006 MEMORANDUM: OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES SUBJECT: Initial Ethical Review of Carbofuran Human Oral Study FROM: John M. Carley TO: John Liccione, HED REF: Arnold, J. D. ( 1976) Evaluation of the Safe Exposure Levels to Carbamate, Administered Orally to Healthy Adult Normal Male Volunteers. Unpublished study prepared by Quincy Research Center. 82 p. MRID 92826.

I have performed an initial review of available information concerning the referenced document. This review characterizes the ethical conduct of the research in terms of both current ethical standards and ethical standards prevailing when the study was performed. The review applies the " Summary Framework for Ethical Assessment Using Seven Criteria of Emanuel et al." developed by the EPA Science Policy Committee's Human Studies Work Group. The completed " framework" is attached. This framework was derived from the work of Emanuel, et al. ( 2000), which summarizes seven general principles for ethical treatment of human subjects in scientific research. The Emanuel article was primarily directed at those who consider proposals for new medical research and decide which are worthy of funding or approval. These are very different decisions from those we in EPA must make when we determine whether we can ethically consider already completed human studies.

The Emanuel article reflects current standards for ethical research prevailing in the U. S. This study was conducted in the U. S. in 1976, but cites no standard of ethical research conduct. I have applied FIFRA § 12( a)( 2)( P), and assumed the Declaration of Helsinki ( 1975) to have prevailed when the research was conducted.

A. Summary Assessment of Ethical Conduct of the Research Page 2 of 7 Here is a summary of my observations about the study under the seven headings used in the Emanuel framework. Supporting details are in the attachment.

1. Value of the Research to Society: The study has never been published, suggesting that its purpose was not mainly to obtain generalizable knowledge. Its purpose is characterized differently for different audiences. It is clear from the protocol that the scientific purpose was to define a LOAEL; it was described to volunteers in terms of a " safe dosage", perhaps to make them more likely to consent to participate. The study may provide some information on the toxicity of carbofuran to humans that could help to inform EPA's assessment of human health risks.

2. Scientific Validity of the Research: I defer to others for a full review of the scientific validity of this study. If it were determined not to have scientific validity, it would also not be ethically acceptable.

3. Subject Selection: Subjects were nine healthy adult men. Restriction to men was consistent with the stated intent to explore occupational exposure patterns. Based on documentation in MRID 92829, the pool from which subjects were drawn consisted mainly of unemployed semi skilled workers.

4. Risk Benefit Ratio: Potential symptoms were accurately listed in the information for volunteers, but risks were not minimized by the study design, which committed to dose escalation until toxic signs were observed, followed by further dosing of additional subjects at the LOAEL. Volunteers were also told plainly that they would not benefit from participating. How the potential societal benefit of improved safety for production workers was weighed against the risks to subjects  either by the investigator or by the review committee  was not reported.

5. Independent Ethical Review: The protocol and related materials, including both the procedures and the information associated with informed consent, were reported to have been approved by the Community Review Committee, Inc., of Kansas City, MO.

6. Informed Consent: Both the information for subjects and the consent form itself were remarkably clear and complete for research conducted in this period. Subjects were given no indication, however, that the design of the research required dose escalation until frank toxic signs were elicited.

7. Respect for Potential and Enrolled Subjects: Subjects' privacy was not compromised. They were free to withdraw at any time.

B. Compliance with Ethical Standard Prevailing when the Research Was Conducted Page 3 of 7 No standard of ethical research conduct is cited, either by the reviewing ethics committee or by the authors. The research was conducted in the U. S. after 1972, so FIFRA § 12( a)( 2)( P) applies. In addition, as clinical research this falls within the scope of the Declaration of Helsinki. I have applied both standards in assessing the conduct of this study.

  FIFRA Sec. 12( a)( 2)( P) states: " In general, [ i] t shall be unlawful for any person . . . to use any pesticide in tests on human beings unless such human beings ( i) are fully informed of the nature and purposes of the test and of any physical and mental health consequences which are reasonably foreseeable therefrom, and ( ii) freely volunteer to participate in the test.

Although the information provided to subjects was extraordinarily complete for research from this period, subjects were not told that the design of the study required dose escalation until frank toxic effects were elicited. Instead they were told that " The purpose of the testing . . . is to find out the maximum safe dosage for human beings exposed to the test compound . . . . The nature of the test compound . . . is such that we do not expect serious complications from its use." This falls short of the requirement that they be " fully informed of . . . any physical . . . consequences which are reasonably foreseeable."

  Basic Principle # 5 of the Declaration of Helsinki ( 1975) reads " Every biomedical research project involving human subjects should be preceded by careful assessment of predictable risks in comparison to foreseeable benefits to the subject or to others. Concern for the interests of the subject must always prevail over the interest of science and society."

Societal benefits are not explicitly weighed against the risks to subjects. The same benefit could probably have been achieved through better methods of measuring ChE inhibition, without proceeding to elicitation of frank toxicity. Exposure of additional subjects to a dose which had already been shown to cause illness  notwithstanding that this was planned for in the protocol  does not indicate that the interests of the subjects prevailed over other interests.

  Basic Principle # 12 of the Declaration of Helsinki ( 1975) reads " The research protocol should always contain a statement of the ethical considerations involved and should indicate that the principles enunciated in the present Declaration are complied with."

No discussion of substantive ethical considerations appears in the protocol.

C. Standards for Judging Ethical Acceptability Page 4 of 7 On February 6, 2006, EPA published a final rule, " Protections for Subjects in Human Research," effective on April 7, 2006. Section 26.1704 of that regulation provides in pertinent part:

EPA shall not rely on data from any research initiated before [ effective date of the final rule] if there is clear and convincing evidence that the conduct of the research was fundamentally unethical ( e. g., the research was intended to seriously harm participants or failed to obtain informed consent), or was significantly deficient relative to the ethical standards prevailing at the time the research was conducted.

In addition, section 26.1703 of the final rule provides in pertinent part:

EPA shall not rely on data from any research involving intentional exposure of any human subject who is a pregnant woman ( and therefore her fetus) or child.

I have applied the standards in sections 26.1704 and 26.1703 in arriving at the conclusions below.

D. Conclusion All subjects were healthy adult males. Section 26.1703 therefore does not prohibit reliance on this study.

Although there are some gaps in the documentation of the ethical conduct of this study, it is extraordinarily well documented for research from this period. There is no clear evidence that the research was intended to harm participants, or that it was fundamentally unethical in other ways. Deficient documentation does not itself constitute evidence that the ethical conduct of this study was deficient relative to standards prevailing when it was conducted.

From the documentation available, I have identified some deficiencies relative to the standards of FIFRA § 12( a)( 2)( P) and the 1975 Declaration of Helsinki. These deficiencies do not, in my judgment, amount to " clear and convincing evidence" that this study was " fundamentally unethical." This review, however, does not take a position on either the persuasiveness of the evidence or the overall significance of the identified deficiencies relative to the prevailing ethical standards. This decision is deferred pending review of the research by the Human Studies Review Board as required by EPA regulation before EPA takes an action relying on this study.

Attachment Cited reference:

Emanuel, E.; Wender, D.; Grady, C. ( 2000) What Makes Clinical Research Ethical? JAMA 283: 2701 2711. Page 5 of 7 Framework for Ethical Assessment Using Seven Criteria of Emanuel et al. 1 April 14, 2006 Arnold, JD ( 1976) Evaluation of the Safe Exposure Levels to Carbamate, Administered Orally to Healthy Adult Normal Male Volunteers. Unpublished study prepared by Quincy Research Center. 82 p. ( MRID 92826)

1. Value: The study has never been published, suggesting that its purpose was not mainly to obtain generalizable knowledge. Its purpose is characterized differently in different places and for different audiences. It is clear from the protocol that the scientific purpose was to define a LOAEL; it may have been described to volunteers in terms of a " safe dosage" to make them more likely to consent to participate.

a. What was the stated purpose of the research? " To determine the threshold toxicity level in normal male volunteers to single oral doses of carbamate" ( protocol, p. 3) " To find out the maximum safe dosage for human beings exposed to the test compound" ( information for volunteers, p. 10) " To evaluate the toxic effect and cholinesterase inhibitive qualities of carbamate in man. [ T] o determine which of six oral doses . . . is the minimum dose necessary to induce toxic effects . . . in normal male volunteers, and to establish the cholinesterase blood levels at which symptoms occur." ( final report, p. 15)

b. Does it evaluate a diagnostic or therapeutic intervention that could lead to improvements in health or well being? No c. Does it test a hypothesis that can generate important knowledge about structure or function of human biological systems? No d. Will society benefit from the knowledge gained from this research? Will its results be disseminated? It has never been published. Subjects were told "[ Your taking the test compound] is essential to determine the levels of this test compound that are safe for the people making it as well as the people exposed to it during its use." ( p. 10)

e. What government, organization, company and/ or institution( s) funded the research? FMC 2. Scientific Validity: I defer to others for a full review of the scientific validity of this study. If it were determined not to have scientific validity, it would also not be ethically acceptable.

a. Did the research have a clear scientific objective? See responses to 1( a) above. The scientific objective was to demonstrate a LOAEL.

b. Was the research designed using accepted principles, methods, and reliable practices? I defer to the science reviewer Page 6 of 7 c. In what way were human subjects intentionally dosed in this research, and what endpoints were identified or measured? Two subjects each received oral doses of 0.05 mg/ kg, 0.1 mg/ kg, or 0.25 mg/ kg ( the LOAEL), without controls. Planned dose levels of 0.5, 1.0, and 2.0 mg/ kg were not administered after toxic signs were elicited at 0.25 mg/ kg. Although the protocol called for repeating the LOAEL dose in six additional subjects with two controls, in fact only two additional subjects and one placebo control were used. Subjects remained in the clinic for 24 hours post dose. Measures included RBC and plasma ChEI, pulse, blood pressure, pupil size, eye accommodation, and ECG.

d. Did the research design have sufficient power to definitively test the objective? I defer to the science reviewer e. To what purpose is the study used, or proposed for use, in the Agency? Informing the WOE review of carbofuran 3. Fair Subject Selection: Subjects were nine healthy adult men. Restriction to men was consistent with the stated intent to explore occupational exposure patterns. Based on documentation in MRID 92829, the pool from which subjects were drawn consisted mainly of unemployed semi skilled workers.

a. Were the groups and individuals recruited and enrolled determined solely on the basis of the scientific goals of the study? Nine healthy adult men participated in the research. Limitation to adult men was consistent with the stated intent to explore occupational exposure patterns. Exclusion factors included organic disease, use of medications before or during the study, or use of alcohol during the study. The protocol states " special attention will be paid to the use of tobacco", but does not indicate that it was controlled.

b. Were any susceptible groups used in the study, such as children, prisoners, infirm, or impoverished? Did the burden of participation fall disproportionately on a particular group? The pool from which volunteers were drawn was described in these terms: "[ V] olunteers were 19 to 58 year old men with 60% between 20 and 40 and a median age of 34. Seventeen percent were black, 80% were white, and 3% were from other ethnic groups. Fifty two percent had completed the twelfth grade, and 16 percent had attended college. Sixty percent were semi skilled workers and 8% were steadily employed." [ MRID 92829, p. 85]

4. Favorable Risk Benefit Ratio: Potential symptoms were accurately listed in the information for volunteers, but risks were not minimized by the study design, which committed to dose escalation until toxic signs were observed, followed by further dosing of additional subjects at the LOAEL. Volunteers were also told plainly that they would not benefit from participating. How the potential societal benefit of improved safety for production workers was weighed against the risks to subjects  either by the investigator or by the review committee  was not reported.

a. How were the risks to individual subjects minimized? Research was conducted in a clinic under medical supervision. Subjects were told what kinds of symptoms they might experience, and encouraged to report any complaints. Atropine was available in the clinic.

b. If the research presents no health related benefits to individual subjects, what are the societal benefits in terms of knowledge from the study, and do these justify the excess risk to individual subjects? The results of this research may have been used to improve safety of Furadan production workers.

c. What compensation was paid to the participants in the study? The volunteer information form indicates that participants were compensated. It does not say how much they received. Page 7 of 7 5. Independent Review: The protocol and related materials, including both the procedures and the information associated with informed consent, were reported to have been approved by the Community Review Committee, Inc., of Kansas City, MO.

a. Was the research asserted to have been overseen by an ethics review body? Yes, the protocol and informed consent materials were reportedly reviewed and approved by the Community Review Committee, Inc., of Kansas City, MO.

b. Was the research subject to independent review by individuals unaffiliated with the clinical research? Yes c. Was the research conducted in compliance with the Common Rule? It predates the Common Rule.

d. Does/ did the research institution ( or any institution participating in the research) hold a Federal Wide Assurance or Multi Project Assurance during the period of the study? n/ a e. Was the research conducted in compliance with another standard? What standard? No ethical standard was cited. FIFRA § 12( a)( 2)( P) applies, as does the Declaration of Helsinki ( 1975).

6. Informed Consent: Both the information for subjects and the consent form itself were remarkably clear and complete for research conducted in this period. Subjects were given no indication, however, that the design of the research required dose escalation until frank toxic signs were elicited.

a. Does the research assert that informed consent was obtained from participants? Yes b. How and under what circumstances was informed consent obtained? The " Volunteer agreement and informed consent" was read aloud, verbatim, and then the subjects were asked to sign the consent form.

7. Respect for Potential and Enrolled Subjects: Subjects' privacy was not compromised. They were free to withdraw at any time.

a. Was information about individual subjects managed so as to ensure their privacy? " The collection and submission of the medical information from this study will be accomplished with strict adherence to professional standards of confidentiality."

b. Were subjects free to withdraw from the research without penalty? " As a volunteer, I understand that I am free to withdraw and discontinue my participation at any time upon my request. Both participation in the study as well as possible withdrawal are at my own free will without coercion, duress, or intimidation of any sort."

1 Emanuel, E; Wender, D; Grady, C ( 2000) What Makes Clinical Research Ethical? JAMA 283: 2701 2711.


[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Rules and Regulations]
[Pages 50071-50073]
[FR Doc No: 2017-23491]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket No. FDA-2017-N-5685]

Medical Devices; Clinical Chemistry and Clinical Toxicology
Devices; Classification of the Acute Kidney Injury Test System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the acute kidney injury test system into class II (special controls).
The special controls that apply to the device type are identified in
this order and will be part of the codified language for the acute
kidney injury test system's classification. We are taking this action
because we have determined that classifying the device into class II
(special controls) will provide a reasonable assurance of safety and
effectiveness of the device. We believe this action will also enhance
patients' access to beneficial innovative devices, in part by reducing
regulatory burdens.

DATES: This order is effective October 30, 2017. The classification was
applicable on September 5, 2014.

FOR FURTHER INFORMATION CONTACT: Seth Olson, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4561, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the acute kidney injury test
system as class II (special controls), which we have determined will
provide a reasonable assurance of safety and effectiveness. In
addition, we believe this action will enhance patients' access to
beneficial innovation, in part by reducing regulatory burdens by
placing the device into a lower device class than the automatic class
III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (the FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act to a predicate device that does not require
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new
device is substantially equivalent to a predicate by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA

classifies a device into class I or II via the De Novo process, the
device can serve as a predicate for future devices of that type,
including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result,
other device sponsors do not have to submit a De Novo request or
premarket approval application in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the less-burdensome 510(k)
process, when necessary, to market their device.

II. De Novo Classification

    On June 5, 2013, Astute Medical, Incorporated submitted a request
for De Novo classification of the NEPHROCHECK[supreg] Test System. FDA
reviewed the request in order to classify the device under the criteria
for classification set forth in section 513(a)(1) of the FD&C Act. We
classify devices into class II if general controls by themselves are
insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to general
controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on September 5, 2014, FDA issued an order to the
requestor classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 862.1220. We have named
the generic type of device acute kidney injury test system, and it is
identified as a device intended to measure one or more analytes in
human samples as an aid in the assessment of a patient's risk for
developing acute kidney injury. Test results are intended to be used in
conjunction with other clinical and diagnostic findings, consistent
with professional standards of practice, including confirmation by
alternative methods.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

 Table 1--Acute Kidney Injury Test System Risks and Mitigation Measures
------------------------------------------------------------------------
                                            Mitigation measures/21 CFR
            Identified risks                         section
------------------------------------------------------------------------
Incorrect interpretation of test         Special controls (1), (2), and
 results.                                 (3) (21 CFR 862.1220(b)(1), 21
                                          CFR 862.1220(b)(2), and 21 CFR
                                          862.1220(b)(3)).
Incorrect test results.................  Special control (3) (21 CFR
                                          862.1220(b)(3)).
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. In order for a device to fall
within this classification, and thus avoid automatic classification in
class III, it would have to comply with the special controls named in
this final order. The necessary special controls appear in the
regulation codified by this order. This device is subject to premarket
notification requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
part 807, subpart E, regarding premarket notification submissions have
been approved under OMB control number 0910-0120; the collections of
information 21 CFR part 801, regarding labeling have been approved
under OMB control number 0910-0485; and the collections of information
in 21 CFR part 820, regarding the Quality System Regulation have been
approved under OMB control number 0910-0073.

List of Subjects in 21 CFR Part 862

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
862 is amended as follows:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

0
1. The authority citation for part 862 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  862.1220 to subpart B to read as follows:

Sec.  862.1220  Acute kidney injury test system.

    (a) Identification. An acute kidney injury test system is a device
that is intended to measure one or more analytes in human samples as an
aid in the assessment of a patient's risk for developing acute kidney
injury. Test results are intended to be used in conjunction with other
clinical and diagnostic findings, consistent with professional
standards of practice, including confirmation by alternative methods.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Premarket notification submissions must detail an appropriate
end user device training program that will be offered while marketing
the device as part of your efforts to mitigate the risk of incorrect
interpretation of test results.
    (2) As part of the risk management activities performed as part of
your 21 CFR 820.30 design controls, you must document the appropriate
end user device training program provided in your premarket
notification submission to satisfy special control 21 CFR
862.1220(b)(1) that will be offered while marketing the device as part
of your efforts to mitigate the risk of incorrect interpretation of
test results.
    (3) Robust clinical data demonstrating the positive predictive
value, negative predictive value, sensitivity and specificity of the
test in the intended use population must be submitted as part of the
premarket notification submission.

    Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23491 Filed 10-27-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 64 (Monday, April 4, 2022)]
[Notices]
[Page 19541]
[FR Doc No: 2022-07060]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-015, OMB Control No. 3235-0021]

Submission for OMB Review; Comment Request; Extension: Rule 6a-3

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for extension of the previously approved
collection of information provided for in Rule 6a-3 (17 CFR 240.6a-3)
under the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.)
(``Act'').
    Section 6 of the Act sets out a framework for the registration and
regulation of national securities exchanges. Under Rule 6a-3, one of
the rules that implements Section 6, a national securities exchange (or
an exchange exempted from registration based on limited trading volume)
must provide certain supplemental information to the Commission,
including any material (including notices, circulars, bulletins, lists,
and periodicals) issued or made generally available to members of, or
participants or subscribers to, the exchange. Rule 6a-3 also requires
the exchanges to file monthly reports that set forth the volume and
aggregate dollar amount of certain securities sold on the exchange each
month. The information required to be filed with the Commission
pursuant to Rule 6a-3 is designed to enable the Commission to carry out
its statutorily mandated oversight functions and to ensure that
registered and exempt exchanges continue to be in compliance with the
Act.
    The Commission estimates that each respondent makes approximately
12 such filings on an annual basis. Each response takes approximately
0.5 hours. In addition, respondents incur shipping costs of
approximately $20 per submission. Currently, 24 respondents (24
national securities exchanges) are subject to the collection of
information requirements of Rule 6a-3. The Commission estimates that
the total burden for all respondents is 144 hours and $5,760 per year.
    Compliance with Rule 6a-3 is mandatory for registered and exempt
exchanges. Information received in response to Rule 6a-3 shall not be
kept confidential; the information collected is public information. As
set forth in Rule 17a-1 (17 CFR 240.17a-1) under the Act, a national
securities exchange is required to retain records of the collection of
information for at least five years.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov.
    Find this particular information collection by selecting
``Currently under 30-day Review--Open for Public Comments'' or by using
the search function. Written comments and recommendations for the
proposed information collection should be sent within 30 days of
publication of this notice to (i) www.reginfo.gov/public/do/PRAMain and
(ii) David Bottom, Director/Chief Information Officer, Securities and
Exchange Commission, c/o John Pezzullo, 100 F Street NE, Washington, DC
20549, or by sending an email to: [email protected].

    Dated: March 30, 2022.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-07060 Filed 4-1-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 47 (Monday, March 11, 2013)]
[Rules and Regulations]
[Pages 15281-15283]
[FR Doc No: 2013-05196]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0909; Directorate Identifier 2011-NM-027-AD;
Amendment 39-17374; AD 2013-05-02]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for all The
Boeing Company Model DC-9-81 (MD-81), DC-9-82 (MD-82), DC-9-83 (MD-83),
DC-9-87 (MD-87), and MD-88 airplanes. This AD was prompted by reports
of cracks of the hinge bearing lugs of the center section ribs of the
horizontal stabilizer. This AD requires repetitive high frequency eddy
current (HFEC) inspections for cracking of the left and right rib hinge
bearing lugs of the aft face of the center section of the horizontal
stabilizer; measuring crack length and blending out cracks; and
replacing the horizontal stabilizer center section rib, if necessary.
We are issuing this AD to detect and correct cracking in the hinge
bearing lugs of the horizontal stabilizer center section ribs, which
could result in failure of the lugs, and consequent inability of the
horizontal stabilizer to sustain the required limit loads and loss of
control of the airplane.

DATES: This AD is effective April 15, 2013.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of April 15,
2013.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
3855 Lakewood Boulevard, MC D800-0019, Long Beach, CA 90846-0001;
telephone<PHONE_NUMBER>, extension 2; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may review copies of the referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, Washington. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; 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 address for the
Docket Office (phone:<PHONE_NUMBER>) is Document 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: Roger Durbin, Aerospace Engineer,
Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification
Office (ACO), 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone:
562-627-5233; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a supplemental notice of proposed rulemaking (SNPRM) to
amend 14 CFR part 39 to include an airworthiness directive (AD) that
would apply to the specified products. That SNPRM published in the
Federal Register on September 11, 2012 (77 FR 55773). The original NPRM
(76 FR 53346, August 26, 2011) proposed to require repetitive high
frequency eddy current (HFEC) inspections for cracking of the left and
right rib hinge bearing lugs of the aft face of the center section of
the horizontal stabilizer; measuring crack length and blending out
cracks; and replacing the horizontal stabilizer center section rib, if
necessary. The SNPRM proposed to specify the corrective actions for
airplanes on which cracking is found during the inspections of the
blendout required by paragraphs (h)(1) and (j)(1) of the SNPRM.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the proposal
(77 FR 55773, September 11, 2012) and the FAA's response to each
comment. One representative of Boeing concurred with the contents of
the proposed rule.

Request To Revise Paragraphs (h)(1)(ii) and (j)(1)(ii) of SNPRM (77 FR
55773, September 11, 2012)

    Another representative of Boeing requested that we revise
paragraphs (h)(1)(ii) and (j)(1)(ii) of the SNPRM (77 FR 55773,
September 11, 2012). Those paragraphs specify that if any cracking is
found during any inspection of the blendout to do a replacement. The
commenter requested that we specify either doing a repair or a
replacement.
    We disagree with the request To revise paragraphs (h)(1)(ii) and
(j)(1)(ii) of this AD to allow a repair as an option to the
replacement. Providing a repair option would allow a blendout repair
for cracking found in a rib with a blendout repair already
accomplished. The intent of the AD is to allow only one blendout repair
before the rib must be replaced. No change has been made to the AD in
this regard.

Request To Permit Rib Replacement Using Structural Repair Manual

    American Airlines (American) stated that paragraphs (h)(2) and
(j)(2) of the SNPRM (77 FR 55773, September 11, 2012) would require
replacing the horizontal stabilizer rib in accordance with a method
approved by the FAA. American stated that the rib replacement is not a
type design change, and this action should be allowed to be
accomplished with approved type design data and the structural repair
manual (SRM) without the need for FAA approval.
    We partially agree. Although we have determined that rib
replacement using the SRM is acceptable, we cannot refer to the SRM
without revision levels and dates as a method of compliance because
doing so violates Office of the Federal Register regulations for
approving materials that are incorporated by reference. We will
consider approving a global AMOC allowing rib replacement using the
SRM.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the 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
SNPRM (77 FR 55773, September 11, 2012) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the SNPRM (77 FR 55773, September 11, 2012).

Interim Action

    We consider this AD interim action since investigation is ongoing
and no terminating action has been developed yet. The manufacturer is
currently developing a modification that will address the unsafe
condition identified in this AD. Once this modification is developed,
approved, and available, we may consider additional rulemaking.

Costs of Compliance

    We estimate that this AD affects 668 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
             Action                        Labor cost             Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Inspection......................  6 work-hours x $85 per hour              $0             $510         $340,680
                                   = $510 per inspection
                                   cycle.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
labor cost estimates for the on-condition actions (blendout repair(s)
or replacement of center section rib(s)) specified in this AD. However,
we have been advised that replacement parts would be $14,500 per
horizontal stabilizer rib crack repair kit.

Authority for This Rulemaking

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

Regulatory Findings

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

2013-05-02 The Boeing Company: Amendment 39-17374; Docket No. FAA-
2011-0909; Directorate Identifier 2011-NM-027-AD.

(a) Effective Date

    This AD is effective April 15, 2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model DC-9-81 (MD-81), DC-
9-82 (MD-82), DC-9-83 (MD-83), DC-9-87 (MD-87), and MD-88 airplanes,
certificated in any category, as identified in Boeing Alert Service
Bulletin MD80-55A069, dated January 19, 2011.

(d) Subject

    Air Transport Association (ATA) of America Code 55, Stabilizers.

(e) Unsafe Condition

    This AD was prompted by reports of cracks of the hinge bearing
lugs of the center section ribs of the horizontal stabilizer. We are
issuing this AD to detect and correct cracking in the hinge bearing
lugs of the horizontal stabilizer center section ribs, which could
result in failure of the lugs, resulting in the inability of the
horizontal stabilizer to sustain the required limit loads and
consequent loss of control of the airplane.

(f) Compliance

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

(g) Inspection of Horizontal Stabilizer Ribs Made From 7075-T7351
Material

    For Group 1 airplanes, as identified in Boeing Alert Service
Bulletin MD80-55A069, dated January 19, 2011: Before the
accumulation of 23,000 total flight cycles, or within 4,383 flight
cycles after the effective date of this AD, whichever occurs later,
do a high frequency eddy current (HFEC) inspection for cracking of
the left and right rib hinge bearing lugs of the aft face of the
center section of the horizontal stabilizer, in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin MD80-
55A069, dated January 19, 2011. For any crack-free lug, repeat the
inspection thereafter at intervals not to exceed 8,200 flight
cycles.

(h) Repair and Replacement for Cracking of 7075-T7351 Material

    If, during any inspection required by paragraph (g) of this AD,
any crack is found: Before further flight, measure the length of the
crack between the points specified in Boeing Alert Service Bulletin
MD80-55A069, dated January 19, 2011. Do the action in accordance
with the Accomplishment Instructions of Boeing Alert Service
Bulletin MD80-55A069, dated January 19, 2011.
    (1) If the crack length between points `A' and `B' is less than
or equal to 0.15 inch and the crack length between points `C' and
`D' is less than or equal to 0.05 inch: Before further flight, blend
out the crack, in accordance with the Accomplishment Instructions of
Boeing Alert Service Bulletin MD80-55A069, dated January 19, 2011.
Within 15,600 flight cycles after doing the blendout, do an HFEC
inspection of the blendout on the center section rib hinge bearing
lug for cracking, in accordance with the Accomplishment Instructions
of Boeing Alert Service Bulletin MD80-55A069, dated January 19,
2011.
    (i) If no cracking is found, repeat the inspection thereafter at
intervals not to exceed 3,900 flight cycles.
    (ii) If cracking is found during any inspection of the blendout,
before further flight, do the replacement required by paragraph
(h)(2) of this AD, and do the inspections required by paragraph
(h)(2) of this AD at the times specified in paragraph (h)(2) of this
AD.
    (2) If the crack length between points `A' and `B' is greater
than 0.15 inch or the crack length between points `C' and `D' is
greater

than 0.05 inch: Before further flight, replace the horizontal
stabilizer center section rib with a new horizontal stabilizer
center section rib, using a method approved in accordance with the
procedures specified in paragraph (l) of this AD. Repeat the
inspection required by paragraph (g) of this AD one time before the
accumulation of 23,000 total flight cycles on the new horizontal
stabilizer center section rib, and thereafter at intervals not to
exceed 11,300 flight cycles.

(i) Inspection of Horizontal Stabilizer Ribs Made From 7050-T7451
Material

    For Group 2 airplanes, as identified in Boeing Alert Service
Bulletin MD80-55A069, dated January 19, 2011: Before the
accumulation of 23,000 total flight cycles, or within 4,383 flight
cycles after the effective date of this AD, whichever occurs later,
do an HFEC inspection for cracking of the left and right rib hinge
bearing lugs of the aft face of the center section of the horizontal
stabilizer, in accordance with the Accomplishment Instructions of
Boeing Alert Service Bulletin MD80-55A069, dated January 19, 2011.
For any crack-free lug, repeat the inspection thereafter at
intervals not to exceed 11,300 flight cycles.

(j) Repair and Replacement for Cracking of 7050-T7451 Material

    If, during any inspection required by paragraph (i) of this AD,
any crack is found: Before further flight, measure the length of the
crack between the points specified in, and in accordance, with the
Accomplishment Instructions of Boeing Alert Service Bulletin MD80-
55A069, dated January 19, 2011.
    (1) If the crack length between points `A' and `B' is less than
or equal to 0.15 inch and the crack length between points `C' and
`D' is less than or equal to 0.05 inch: Before further flight,
blendout the crack, in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin MD80-55A069, dated
January 19, 2011. Within 15,600 flight cycles after doing the
blendout, do an HFEC inspection of the blendout on the center
section rib hinge bearing lug for cracking, in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin MD80-
55A069, dated January 19, 2011.
    (i) If no cracking is found, repeat the inspection thereafter at
intervals not to exceed 5,800 flight cycles.
    (ii) If cracking is found during any inspection of the blendout,
before further flight, do the replacement required by paragraph
(j)(2) of this AD, and do the inspections required by paragraph
(j)(2) of this AD at the times specified in paragraph (j)(2) of this
AD.
    (2) If the crack length between points `A' and `B' is greater
than 0.15 inch or the crack length between points `C' and `D' is
greater than 0.05 inch: Before further flight, replace the
horizontal stabilizer center section rib with a new horizontal
stabilizer center section rib, using a method approved in accordance
with the procedures specified in paragraph (l) of this AD. Repeat
the inspection required by paragraph (i) of this AD one time before
the accumulation of 23,000 total flight cycles on the new horizontal
stabilizer center section rib, and thereafter at intervals not to
exceed 11,300 flight cycles.

(k) No Reporting Requirement

    Although Boeing Alert Service Bulletin MD80-55A069, dated
January 19, 2011, specifies to submit certain information to the
manufacturer, this AD does not include that requirement.

(l) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles Aircraft Certification Office
(ACO), 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 manager of the ACO, send it to the
attention of the person identified in the Related Information
section of this AD.
    (2) 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.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Los Angeles ACO, to
make those findings. For a repair method to be approved, the repair
must meet the certification basis of the airplane and 14 CFR 25.571,
Amendment 45, and the approval must specifically refer to this AD.

(m) Related Information

    For more information about this AD, contact Roger Durbin,
Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles
Aircraft Certification Office (ACO), 3960 Paramount Boulevard,
Lakewood, CA 90712-4137; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
(n) 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 Service Bulletin MD80-55A069, dated January 19,
2011.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
3855 Lakewood Boulevard, MC D800-0019, Long Beach, California 90846-
0001; telephone<PHONE_NUMBER>, extension 2; fax<PHONE_NUMBER>;
Internet https://www.myboeingfleet.com.
    (4) You may view this service information at FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, Washington. For
information on the availability of this material at the FAA, call
425-227-1221.
    (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 February 22, 2013.
Jeffrey E. Duven,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-05196 Filed 3-8-13; 8:45 am]
BILLING CODE 4910-13-P


MEMORANDUM DATE: April 2, 2004 TO: Effluent Guidelines Planning Record FROM: M. Ahmar Siddiqui RE: Discharge status of PBST facilities and possible reasons for the prevalence of zerodischarge of toxic wastewaters As part of the development of the 2004/ 2005 Effluent Guidelines Plan, a study of the petroleum bulk stations and terminal industry ( PBST, SIC 5171) is being conducted. PBST was identified as an industry of interest due to stakeholder comments and an expected similarity of operations and wastewater characteristics to those of the petroleum refining industry, which is being evaluated by EPA for potential future effluent guidelines revision. Moreover, depending on the outcome of EPA's study of PBSTs, a decision could be made to begin development of effluent guidelines for PBSTs as a new subcategory under the current petroleum refining rule ( 40 CFR Part 419).

Any assessment of PBSTs will begin with an examination of effluent discharge characteristics and attempt to account for the reasons that facilities choose to discharge in particular ways . Two EPA databases, the Toxic Release Inventory ( TRI) and Permit Compliance System ( PCS) databases, are being used to evaluate these wastewaters. These databases were chosen because they can identify toxic discharges on a nationwide basis ( TRI) and because they can provide information about large direct dischargers in an industry ( PCS). While it is true that there are some limitations in both databases ( e. g., PCS does not reveal much information about small direct dischargers and none about indirect dischargers; TRI also provides little information about small facilities), EPA believes that both are useful as a " first cut" examination tool.

In addition to relying on the TRI and PCS databases while developing a PBST industry profile, EPA engaged in discussions with State and Regional permitting and compliance authorities and evaluated comments to the Preliminary Plan. The Agency hoped that, using these resources, it could more readily understand local factors that drive PBSTs to operate and discharge in a particular way.

As noted in an earlier memorandum (" Discharge status of PBST facilities, as enumerated by TRI and PCS databases"), TRI data from the year 2000 suggest that two thirds of the industry is made up of zero dischargers ( only 167 of 502 reporting facilities reported discharges to surface waters). In addition, eight " major" dischargers were identified in the PCS database for the same year.

All stakeholders ( control authorities and commenters) identified stormwater as the largest portion of water discharges from PBSTs. For example, in their comments to the Preliminary Plan, the Independent Fuel Terminal Operators Association ( IFTOA) and the New England Fuel Institute ( NEFI) said that facilities, by and large, only discharge stormwater. Amerada Hess, in its comments, estimated that 95 percent of discharges from PBSTs is stormwater. In addition, the following have been identified as possible sources of toxic discharges from PBSTs, though of much smaller volumes, by these same stakeholders:

° Tank bottoms water ° Equipment wash water ° Product spills ° Ballast water It should be noted that in Massachusetts, where permits are written by EPA Region 1, the discharge of tank bottoms water without treatment is strictly prohibited. This is due to the toxic nature of tank bottoms in general: recall that tank bottoms is water that is either in the stored products itself or is water that has seeped into the tanks ( from rain or high humidity) and has settled onto the tank bottom. As a result of this prolonged contact, this water is often laden with petroleum hydrocarbons, including BTEX, MTBE, and PACs.

EPA Region 9 notes that, in some cases, tank bottoms water may also be significant in volume. This can happen at PBSTs that receive off spec products. If the products contains large quantities of water, it will settle to the bottom of the tanks and augment the tank bottoms water already being formed through stormwater infiltration.

Especially with respect to tank bottoms water, offsite treatment has been reported to be a widely used practice by several industry stakeholders. In its comments to the Preliminary Plan, ConocoPhillips states that the vast majority of its terminals send their tank bottoms water either offsite or to one of its refineries for treatment. Amerada Hess, in its comments to the Preliminary Plan, states that its terminals send their tank bottoms waters off site for treatment and disposal. The American Petroleum Institute ( API) claims that more than 50 percent of PBST facilities in close proximity to oil refineries send their tank bottoms waters to the refineries specifically for oil recovery, though EPA has not been able to verify this.

Two commenters stated outright that PBSTs do not discharge toxic wastes: in their comments, IFTOA and NEFI asserted that PBSTs do not discharge toxic pollutants at all.

Given two factors, that discharges seems to be completely dominated by stormwater and that tank bottoms waters are generally treated offsite, EPA believes it can explain the 2000 TRI data's implication that large segments of the PBST industry are zero discharge: the remaining toxic wastewater sources, by and large, are too small to trigger TRI reporting requirements for toxic discharges to surface waters.


[Federal Register Volume 81, Number 115 (Wednesday, June 15, 2016)]
[Rules and Regulations]
[Pages 38903-38906]
[FR Doc No: 2016-13740]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-7524; Directorate Identifier 2014-NM-231-AD;
Amendment 39-18554; AD 2016-12-05]
RIN 2120-AA64

Airworthiness Directives; Saab AB, Saab Aeronautics (Formerly
Known as Saab AB, Saab Aerosystems)

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

ACTION: Final rule.

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

SUMMARY: We are superseding Airworthiness Directive (AD) 2014-15-04 for
certain Saab AB, Saab Aeronautics Model SAAB 2000 airplanes. AD 2014-
15-04 required deactivating the potable water system, or alternatively
filling and activating the potable water system. This new AD requires
inspecting the in-line heater for correct brazing and corrective action
if needed, and installing a shrinkable tube on the water line and a
spray shield on the in-line heater. This AD was prompted by a report of
rudder pedal restriction which was the result of water leakage at the
inlet tubing of an in-line heater in the lower part of the forward
fuselage. This AD was also prompted by the development of a
modification that would address the unsafe condition. We are issuing
this AD to prevent rudder pedal restriction due to the pitch control
mechanism becoming frozen as the result of water spray, which could
prevent disconnection of the pitch control mechanism and normal pitch
control, and consequently result in reduced controllability of the
airplane.

DATES: This AD is effective July 20, 2016.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of July 20,
2016.
    The Director of the Federal Register approved the incorporation by
reference of certain other publications listed in this AD as of
September 9, 2014 (79 FR 45337, August 5, 2014).

ADDRESSES: For service information identified in this final rule,
contact Saab AB, Saab Aeronautics, SE-581 88, Link[ouml]ping, Sweden;
telephone +46 13 18 5591; fax +46 13 18 4874; email
<EMAIL_ADDRESS>Internet http://www.saabgroup.com.
You may view this referenced service information at the FAA, Transport
Airplane Directorate, 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-2015-7524.

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-2015-
7524; 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 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: Shahram Daneshmandi, Aerospace
Engineer, International Branch, ANM-116, Transport Airplane
Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 2014-15-04, Amendment 39-17906 (79 FR 45337,
August 5, 2014) (``AD 2014-15-04''). AD 2014-15-04 applied to certain
Saab AB, Saab Aeronautics Model SAAB 2000 airplanes. The NPRM published
in the Federal Register on December 17, 2015 (80 FR 78702) (``the
NPRM''). The NPRM was prompted by a report of rudder pedal restriction
which was the result of water leakage at the inlet tubing of an in-line
heater in the lower part of the forward fuselage. The NPRM was also
prompted by the development of a modification that would address the
unsafe condition. The NPRM proposed to continue to require deactivating
the potable water system, or alternatively filling and activating the
potable water system. The NPRM also proposed to require inspecting the
in-line heater for correct brazing and corrective action if needed, and
installing a shrinkable tube on the water line and a spray shield on
the in-line heater. We are issuing this AD to prevent rudder pedal
restriction due to the pitch control mechanism becoming frozen as the
result of water spray, which could prevent disconnection of the pitch
control mechanism and normal pitch control, and consequently result in
reduced controllability 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
Airworthiness Directive 2014-0255, dated November 25, 2014 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for certain Saab AB, Saab
Aeronautics Model SAAB 2000 airplanes. The MCAI states:

    One occurrence of rudder pedal restriction was reported on a
SAAB 2000 aeroplane. Subsequent investigation showed that this was
the result of water leakage at the inlet tubing for the in-line
heater (25HY) in the lower part of the forward fuselage (Zone 116).
The in-line heater attachment was found ruptured, which resulted in
water spraying in the area. Frozen water on the rudder control
mechanism in Zone 116 then led to the rudder pedal restriction.
    Analysis after the reported event indicated that the pitch
control mechanism (including pitch disconnect/spring unit) may also
be frozen as a result of water spray, which would prevent
disconnection and normal pitch control.
    This condition, if not corrected, could result in further
occurrences of reduced control of an aeroplane.
    To address this potential unsafe condition, SAAB issued Service
Bulletin (SB) 2000-38-10 to provide instructions to deactivate the
Potable Water System. Consequently, EASA issued [an EASA] Emergency
AD * * * to require that action. That [EASA] Emergency AD was
revised and republished as EASA AD 2013-0172R1 [(http://ad.easa.europa.eu/ad/2013-0172R1), which corresponds to FAA AD 2014-
15-04, Amendment 39-17906 (79 FR 45337, August 5, 2014)],
introducing a temporary alternative procedure for filling, which
would allow reactivation and operation of the Potable Water System.
    Since that [EASA] AD was issued, SAAB developed an in-line
heater spray shield and a water line shrink tube to eliminate the
consequences of a water spray leak in case of rupture of the in-line
heater. SAAB also issued a SB 2000-38-011, providing instructions
for inspection of the in-line heater and installation of a shrink
tube and a spray shield.
    For reasons described above, this [EASA] AD retains the
requirements of EASA AD 2013-0172R1, which is superseded, and
requires inspection [for correct brazing] of the in-line heater [and
corrective action if needed] and installation of shrink tube [on
water line] and spray shield [on in-line heater].

    Corrective actions include repairing or replacing the in-line
heater. 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-2015-7524.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    We reviewed the available data 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

    We reviewed Saab Service Bulletin 2000-38-011, dated October 22,
2014. The service information describes procedures for inspecting for
correct brazing of the in-line heater, repairing or replacing the in-
line heater, and installing a shrinkable tube on the water line and a
spray shield on the in-line heater. 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 1 airplane of U.S. registry.
    The actions required by AD 2014-15-04, Amendment 39-17906 (79 FR
45337, August 5, 2014), and retained in this AD take about 1 work-hour
per product, at an average labor rate of $85 per work-hour. Required
parts cost $0 per product. Based on these figures, the estimated cost
of the actions that are required by AD 2014-15-04 is $85 per product.
    We also estimate that it takes about 6 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Required parts will cost about $3,650 per
product. Based on these figures, we estimate the cost of this AD on
U.S. operators to be $4,160.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.

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

Regulatory Findings

    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 removing Airworthiness Directive (AD)
2014-15-04, Amendment 39-17906 (79 FR 45337, August 5, 2014), and
adding the following new AD:

2016-12-05 Saab AB, Saab Aeronautics (Formerly Known as Saab AB,
Saab Aerosystems): Amendment 39-18554. Docket No. FAA-2015-7524;
Directorate Identifier 2014-NM-231-AD.

(a) Effective Date

    This AD is effective July 20, 2016.

(b) Affected ADs

    This AD replaces AD 2014-15-04, Amendment 39-17906 (79 FR 45337,
August 5, 2014) (``AD 2014-15-04'').

(c) Applicability

    This AD applies to Saab AB, Saab Aeronautics (formerly known as
Saab AB, Saab Aerosystems) Model SAAB 2000 airplanes, certificated
in any category, serial numbers 004 through 016 inclusive, 018, 022,
023, 024, 026, 029, 031, 032, 033, 035 through 039 inclusive, 041
through 044 inclusive, 046, 047, 048, 051, and 053 through 063
inclusive.

(d) Subject

    Air Transport Association (ATA) of America Code 38, Water/Waste.

(e) Reason

    This AD was prompted by a report of rudder pedal restriction
which was the result of water leakage at the inlet tubing of an in-
line heater in the lower part of the forward fuselage. This AD was
also prompted by the development of a modification that would
address the unsafe condition. We are issuing this AD to prevent
rudder pedal restriction due to the pitch control mechanism becoming
frozen as the result of water spray, which could prevent
disconnection of the pitch control mechanism and normal pitch
control, and consequently result in reduced controllability of the
airplane.

(f) Compliance

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

(g) Retained Deactivation of Potable Water System With New Exception

    This paragraph restates the requirements of paragraph (g) of AD
2014-15-04, with a new exception. Except as provided by paragraph
(l) of this AD, within 30 days after September 9, 2014 (the
effective date of AD 2014-15-04), deactivate the potable water
system, in accordance with the Accomplishment Instructions of Saab
Service Bulletin 2000-38-010, dated July 12, 2013.

(h) Retained Alternative to Deactivation of Potable Water System With
No Changes

    This paragraph restates the requirements of paragraph (h) of AD
2014-15-04, with no changes. As an alternative, or subsequent, to
the action required by paragraph (g) of this AD, during each filling
of the potable water system after September 9, 2014, accomplish the
temporary filling procedure, in accordance with the instructions in
Saab Service Newsletter SN 2000-1304, Revision 01, dated September
10, 2013, including Attachment 1 Engineering Statement to Operator
2000PBS034334, Issue A, dated September 9, 2013.

(i) New Inspection and Installation

    At the applicable compliance times specified in paragraphs
(j)(1) and (j)(2) of this AD, concurrently accomplish the actions
specified in paragraphs (i)(1) and (i)(2) of this AD, in accordance
with the Accomplishment Instructions of Saab Service Bulletin 2000-
38-011, dated October 22, 2014.
    (1) Do a detailed inspection for correct brazing of the in-line
heater, and if any discrepancy is found, before further flight, and
before accomplishment of the modification required by paragraph
(i)(2) of this AD, accomplish all applicable corrective actions.
    (2) Install a shrink tube on the water line and a spray shield
on the in-line heater.

(j) Compliance Times for Inspection and Installation

    Do the actions specified in paragraph (i) of this AD at the
applicable times specified in paragraphs (j)(1) and (j)(2) of this
AD.
    (1) For airplanes having had the potable water system
reactivated and operated using the alternative filling procedure
specified in Saab Service Newsletter SN 2000-1304, Revision 01,
dated September 10, 2013, including Attachment 1 Engineering
Statement to Operator 2000PBS034334, Issue A, dated September 9,
2013: Within 6 months after the effective date of this AD.
    (2) For airplanes having the potable water system deactivated
using procedures specified in the Accomplishment Instructions of
Saab Service Bulletin 2000-38-010, dated July 12, 2013: Before
further flight after the reactivation of the potable water system.

(k) Terminating Actions for the Deactivation of the Potable Water
System

    Accomplishing the actions required by paragraph (i) of this AD
terminates the requirements of paragraphs (g) and (h) of this AD.

(l) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, ANM-
116, International Branch, Transport Airplane Directorate, 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 Branch, send it to ATTN: Shahram
Daneshmandi, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information
may be emailed to<EMAIL_ADDRESS>    (i) 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. The AMOC approval letter must specifically
reference this AD.
    (ii) AMOCs approved previously in accordance with AD 2014-15-04
are approved as AMOCs for the corresponding provisions of paragraphs
(g) and (h) of this AD.
    (2) Contacting the Manufacturer: As of the effective date of
this AD, 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 Branch, ANM-116, Transport Airplane Directorate, FAA;
or the European Aviation Safety Agency (EASA); or Saab AB, Saab
Aeronautics' EASA Design Organization Approval (DOA). If approved by
the DOA, the approval must include the DOA-authorized signature.

(m) Related Information

    Refer to Mandatory Continuing Airworthiness Information (MCAI)
European Aviation Safety Agency Airworthiness Directive 2014-0255,
dated November 25, 2014, 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-2015-7524.

(n) 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.
    (3) The following service information was approved for IBR on
July 20, 2016.
    (i) Saab Service Bulletin 2000-38-011, dated October 22, 2014.
    (ii) Reserved.
    (4) The following service information was approved for IBR on
September 9, 2014 (79 FR 45337, August 5, 2014).
    (i) Saab Service Bulletin 2000-38-010, dated July 12, 2013.
    (ii) Saab Service Newsletter SN 2000-1304, Revision 01, dated
September 10, 2013, including Attachment 1 Engineering Statement to
Operator 2000PBS034334, Issue A, dated September 9, 2013.
    (5) For service information identified in this AD, contact Saab
AB, Saab Aeronautics, SE-581 88, Link[ouml]ping, Sweden; telephone
+46 13 18 5591; fax +46 13 18 4874; email
<EMAIL_ADDRESS>Internet http://www.saabgroup.com.
    (6) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (7) 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 May 31, 2016.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-13740 Filed 6-14-16; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 55 (Tuesday, March 22, 2022)]
[Notices]
[Pages 16171-16172]
[FR Doc No: 2022-06027]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG22-63-000.
    Applicants: Emerald Grove Solar, LLC.
    Description: Emerald Grove Solar, LLC submits Notice of Self-
Certification of Exempt Wholesale Generator Status.
    Filed Date: 3/15/22.
    Accession Number: 20220315-5240.
    Comment Date: 5 p.m. ET 4/5/22.

    Docket Numbers: EG22-64-000.
    Applicants: Brightside Solar, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Brightside Solar, LLC.
    Filed Date: 3/15/22.
    Accession Number: 20220315-5243.
    Comment Date: 5 p.m. ET 4/5/22.

    Docket Numbers: EG22-65-000.
    Applicants: High Point Solar LLC.
    Description: High Point Solar LLC submits Notice of Self-
Certification of Exempt Wholesale Generator Status.
    Filed Date: 3/16/22.
    Accession Number: 20220316-5079.
    Comment Date: 5 p.m. ET 4/6/22.

    Take notice that the Commission received the following Complaints
and Compliance filings in EL Dockets:

    Docket Numbers: EL21-77-000.
    Applicants: Tenaska Clear Creek Wind, LLC v. Southwest Power Pool,
Inc.
    Description: Southwest Power Pool, Inc submits Results of the
Restudy for the Tenaska Clear Creek Wind Project in Response to the
December 16 Order.
    Filed Date: 3/11/22.
    Accession Number: 20220311-5274.
    Comment Date: 5 p.m. ET 4/1/22.

    Docket Numbers: EL22-42-000.
    Applicants: RENEW Northeast, Inc. and the American Clean Power
Association v. ISO New England Inc.
    Description: Complaint of RENEW Northeast, Inc. and the American
Clean Power Association v. ISO New England, Inc.

    Filed Date: 3/15/22.
    Accession Number: 20220315-5286.
    Comment Date: 5 p.m. ET 4/4/22.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER04-835-010.
    Applicants: California Independent System Operator Corporation,
Pacific Gas and Electric Company.
    Description: Refund Report of California Independent System
Operator Corporation.
    Filed Date: 3/16/22.
    Accession Number: 20220316-5113.
    Comment Date: 5 p.m. ET 4/6/22.

    Docket Numbers: ER22-1050-001.
    Applicants: DesertLink, LLC.
    Description: Tariff Amendment: DesertLinks Amended Formula Rate
Revision Filing to be effective 4/18/2022.
    Filed Date: 3/16/22.
    Accession Number: 20220316-5060.
    Comment Date: 5 p.m. ET 4/6/22.

    Docket Numbers: ER22-1354-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Amendment: Notice of Cancellation of CSA,
Service Agreement No. 5500; Queue No. AC1-216 to be effective 2/15/
2022.
    Filed Date: 3/16/22.
    Accession Number: 20220316-5031.
    Comment Date: 5 p.m. ET 4/6/22.

    Docket Numbers: ER22-1355-000.
    Applicants: Energy Harbor LLC.
    Description: Petition for Limited Waiver of Energy Harbor LLC.
    Filed Date: 3/14/22.
    Accession Number: 20220314-5316.
    Comment Date: 5 p.m. ET 4/4/22.

    Docket Numbers: ER22-1357-000.
    Applicants: Midcontinent Independent System Operator, Inc.,
American Transmission Company LLC.
    Description: Sec. 205(d) Rate Filing: Midcontinent Independent
System Operator, Inc. submits tariff filing per Sec.  35.13(a)(2)(iii):
2022-03-16_SA 2769 ATC-City of Reedsburg 2nd Rev CFA to be effective 5/
16/2022.
    Filed Date: 3/16/22.
    Accession Number: 20220316-5056.
    Comment Date: 5 p.m. ET 4/6/22.

    Docket Numbers: ER22-1358-000.
    Applicants: Midcontinent Independent System Operator, Inc.,
American Transmission Company LLC.
    Description: Sec. 205(d) Rate Filing: Midcontinent Independent
System Operator, Inc. submits tariff filing per Sec.  35.13(a)(2)(iii):
2022-03-16_SA 2800 ATC-City of Stoughton 2nd Rev CFA to be effective 5/
16/2022.
    Filed Date: 3/16/22.
    Accession Number: 20220316-5076.
    Comment Date: 5 p.m. ET 4/6/22.

    Docket Numbers: ER22-1359-000.
    Applicants: Midcontinent Independent System Operator, Inc.,
American Transmission Company LLC.
    Description: Sec. 205(d) Rate Filing: Midcontinent Independent
System Operator, Inc. submits tariff filing per Sec.  35.13(a)(2)(iii):
2022-03-16_SA 2805 ATC-Rock Energy Cooperative 2nd Rev CFA to be
effective 5/16/2022.
    Filed Date: 3/16/22.
    Accession Number: 20220316-5077.
    Comment Date: 5 p.m. ET 4/6/22.

    Docket Numbers: ER22-1360-000.
    Applicants: R-WS Antelope Valley Gen-Tie, LLC.
    Description: Compliance filing: Shared Facilities Common Ownership
Agreements and Request for Expedited Action to be effective 3/17/2022.
    Filed Date: 3/16/22.
    Accession Number: 20220316-5084.
    Comment Date: 5 p.m. ET 4/6/22.

    Docket Numbers: ER22-1361-000.
    Applicants: Georgia-Pacific Toledo LLC.
    Description: Sec. 205(d) Rate Filing: Filing of Revised MBR Tariff
Record to be effective 3/17/2022.
    Filed Date: 3/16/22.
    Accession Number: 20220316-5088.
    Comment Date: 5 p.m. ET 4/6/22.

    Docket Numbers: ER22-1362-000.
    Applicants: Georgia-Pacific Port Hudson LLC.
    Description: Tariff Amendment: Notice of Cancellation of MBR Tariff
to be effective 5/16/2022.
    Filed Date: 3/16/22.
    Accession Number: 20220316-5090.
    Comment Date: 5 p.m. ET 4/6/22.

    Docket Numbers: ER22-1363-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec. 205(d) Rate Filing: 2022-03-16_ROE Additional
Compliance Filing to be effective 9/28/2016.
    Filed Date: 3/16/22.
    Accession Number: 20220316-5106.
    Comment Date: 5 p.m. ET 4/6/22.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at https://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: March 16, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-06027 Filed 3-21-22; 8:45 am]
BILLING CODE 6717-01-P