[Federal Register: February 4, 2010 (Volume 75, Number 23)]
[Rules and Regulations]
[Page 5684-5685]
[DOCID:fr04fe10-3]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0066; Directorate Identifier 2009-SW-52-AD;
Amendment 39-16190; AD 2009-23-51]
RIN 2120-AA64

Airworthiness Directives; Sikorsky Aircraft Corporation Model S-
92A Helicopters

AGENCY: Federal Aviation Administration, DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: This document publishes in the Federal Register an amendment
adopting Airworthiness Directive (AD) 2009-23-51, which was sent
previously to all known U.S. owners and operators of Sikorsky Aircraft
Corporation (Sikorsky) Model S-92A helicopters by individual letters.
This AD requires cleaning and inspecting each main gearbox (MGB)
assembly mounting foot pad and rib for a crack and corrosion. If you do
not find a crack, the AD requires applying a corrosion preventive
compound. If you find a crack, the AD requires replacing the MGB before
further flight. If you find corrosion, bubbled paint, or paint
discoloration, the AD also requires you to repair the MGB before
further flight. This amendment is prompted by reports of cracks in the
MGB mounting foot pads and foot ribs. This condition, if not detected,
could result in loss of the MGB and subsequent loss of control of the
helicopter.

DATES: Effective February 19, 2010, to all persons except those persons
to whom it was made immediately effective by Emergency AD 2009-23-51,
issued on October 29, 2009, which contained the requirements of this
amendment.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of February 19, 2010.
    Comments for inclusion in the Rules Docket must be received on or
before April 5, 2010.

ADDRESSES: Use one of the following addresses to submit comments on
this AD:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    You may get the service information identified in this AD from
Sikorsky Aircraft Corporation, Attn: Manager, Commercial Technical
Support, mailstop s581a, 6900 Main Street, Stratford, CT, telephone
(203) 383-4866, e-mail address<EMAIL_ADDRESS>or at http://
www.sikorsky.com.
    Examining the Docket: You may examine the docket that contains the
AD, any comments, and other information on the Internet at http://
www.regulations.gov, or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The Docket Operations office (telephone<PHONE_NUMBER>) is
located in Room W12-140 on the ground floor of the West Building at the
street address stated in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Michael Schwetz, Aviation Safety
Engineer, Boston Aircraft Certification Office, 12 New England
Executive Park, Burlington, MA 01803, telephone<PHONE_NUMBER>, fax
(781) 238-7170.

SUPPLEMENTARY INFORMATION: On October 29, 2009, the FAA issued
Emergency AD 2009-23-51 for the Sikorsky Model S-92A helicopters, which
requires cleaning and inspecting each MGB assembly mounting foot pad
and rib for a crack and corrosion. If you do not find a crack, the AD
requires applying a corrosion preventive compound. If you find a crack,
the AD requires replacing the MGB before further flight. If you find
corrosion, bubbled paint, or paint discoloration, the AD also requires
you to repair the MGB before further flight. This amendment is prompted
by reports of cracks in the MGB mounting foot pads and foot ribs. The
manufacturer is investigating the root cause of these cracks.
Contributing factors may include corrosion and the bushing press fit in
the mounting foot bolt hole. This condition, if not detected, could
result in loss of the MGB and subsequent loss of control of the
helicopter.
    We have reviewed Sikorsky Alert Service Bulletin No. 92-63-020,
dated September 11, 2009 (ASB), which describes procedures for visually
inspecting the MGB assembly mounting foot pads and foot ribs for a
crack and corrosion. The ASB specifies a 10-hour recurring visual
inspection. If you suspect a crack, the ASB specifies a fluorescent
penetrant inspection (FPI) or a dye penetrant inspection (DPI). If you
find a crack, the ASB specifies replacing the MGB before further
flight. Also, the ASB specifies treating any corrosion.
    This unsafe condition is likely to exist or develop on other
helicopters of the same type design. Therefore, this AD requires within
10 hours time-in-service (TIS), unless accomplished previously, and
thereafter at intervals not to exceed 10 hours TIS, cleaning and
inspecting each MGB assembly mounting foot pad and rib for a crack and
corrosion. If you do not find a crack, the AD requires applying a
corrosion preventive compound. If you find a crack, the AD requires
replacing the MGB before further flight. If you find corrosion, bubbled
paint, or paint discoloration, this AD also requires you to repair the
MGB before further flight. The actions specified in this AD are interim
actions until the root cause of the cracking is determined. After that
determination, we anticipate further rulemaking.
    Since it was found that immediate corrective action was required,
notice and opportunity for prior public comment thereon were
impracticable and contrary to the public interest, and good cause
existed to make the AD effective immediately by individual letters
issued on October 29, 2009, to all known U.S. owners and operators of
Sikorsky Model S-92A helicopters. These conditions still exist, and the
AD is hereby published in the Federal Register as an amendment to 14
CFR 39.13 to make it effective to all persons.
    The FAA estimates that this AD will affect 44 helicopters of U.S.
registry, and inspecting the MGB assembly mounting foot pads and foot
ribs for corrosion or a crack will take about:
     2 work hours to do the visual inspection, assuming 2,200
(50 x 44 helicopters) inspections per year for commercial and part 91
operators; and
     24 work hours to remove and replace an MGB.

The average labor rate is $80 per work hour and required parts will
cost about $590,000 per helicopter. Based on these figures, we estimate
the total cost impact of the AD on U.S. operators to be $5,087,360,
assuming 8 helicopters will require an MGB replacement.

Comments Invited

    This AD is a final rule that involves requirements that affect
flight safety and was not preceded by notice and an opportunity for
public comment;

however, we invite you to submit any written data, views, or arguments
regarding this AD. Send your comments to an address listed under
ADDRESSES. Include ``Docket No. FAA-2010-0066; Directorate Identifier
2009-SW-52-AD'' at the beginning of your comments. We specifically
invite comments on the overall regulatory, economic, environmental, and
energy aspects of the AD. We will consider all comments received by the
closing date and may amend the AD in light of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this AD. Using the search function of our
docket Web site, you can find and read the comments to any of our
dockets, including the name of the individual who sent the comment. You
may review the DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19477-78).

Regulatory Findings

    We have 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 the regulation:
    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); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this AD. See the AD docket to examine the economic evaluation.

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.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration amends part 39 of
the Federal Aviation Regulations (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. Section 39.13 is amended by adding a new airworthiness directive to
read as follows:

2009-23-51 Sikorsky Aircraft Corporation: Amendment 39-16190. Docket
No. FAA-2010-0066; Directorate Identifier 2009-SW-52-AD.

    Applicability: Model S-92A helicopters, with main gearbox (MGB)
assembly, part number (P/N) 92351-15000-042 or -043, with MGB
housing, P/N 92351-15110-042, -043, -044, or -045, installed,
certificated in any category.
    Compliance: Required as indicated.
    To prevent loss of an MGB and subsequent loss of control of the
helicopter, do the following:
    (a) Within 10 hours time-in-service (TIS), unless accomplished
previously, and thereafter at intervals not to exceed 10 hours TIS,
clean and inspect each MGB assembly mounting foot pad and rib for a
crack and corrosion in the area depicted in Figure 1; as shown in
the examples in Figures 2, 3, and 4; of Sikorsky Alert Service
Bulletin No. 92-63-020, dated September 11, 2009 (ASB). If no crack
is found, apply the corrosion preventive compound to each foot pad
and rib area.

    Note 1: When conducting a visual inspection, use a bright, non-
LED light.
    (1) If you find a crack, replace the MGB before further flight.
    (2) If you find corrosion, bubbled paint, or paint
discoloration, before further flight, repair the affected area.

    Note 2: Following the ASB Accomplishment Instructions
accomplishes the intent of this AD.

    (b) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Contact the Manager, Boston Aircraft Certification Office, ATTN:
Michael Schwetz, Aviation Safety Engineer, 12 New England Executive
Park, Burlington, MA 01803, telephone<PHONE_NUMBER>, fax (781) 238-
7170, for information about previously approved alternative methods
of compliance.
    (c) The Joint Aircraft System/Component (JASC) Code is 6320:
Main Rotor Gearbox.
    (d) Do the inspections by following the specified portions of
Sikorsky Alert Service Bulletin No. 92-63-020, dated September 11,
2009. The Director of the Federal Register approved this
incorporation by reference under 5 U.S.C. 552(a) and 1 CFR part 51.
Copies may be obtained from Sikorsky Aircraft Corporation, Attn:
Manager, Commercial Technical Support, mailstop s581a, 6900 Main
Street, Stratford, CT, telephone<PHONE_NUMBER>, e-mail address
<EMAIL_ADDRESS>or at http://www.sikorsky.com. Copies may
be inspected at the FAA, Office of the Regional Counsel, Southwest
Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas, or 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/code_of_federal_
regulations/ibr_locations.html.
    (e) This amendment becomes effective on February 19, 2010, to
all persons except those persons to whom it was made immediately
effective by Emergency AD 2009-23-51, issued October 29, 2009, which
contained the requirements of this amendment.

    Issued in Fort Worth, Texas, on December 18, 2009.
Mark R. Schilling,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2010-1723 Filed 2-3-10; 8:45 am]
BILLING CODE 4910-13-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: Laura Nollen,<PHONE_NUMBER>

Interregional Research Project Number 4 (IR-4)

PP# 9E7594

	EPA has received a pesticide petition (9E7594) from Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540, proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.466, by establishing a tolerance for residues of the insecticide fenpropathrin, alpha-cyano-3-phenoxy-benzyl 2,2,3,3-tetramethylcyclopropanecarboxylate, in or on the following raw agricultural commodities:  guava, acerola, feijoa, jaboticaba, passionfruit, starfruit and wax jambu at 1.5 parts per million (ppm); lychee, longan, Spanish lime, pulasan and rambutan at 3.0 ppm; sugar apple, atemoya, biriba, cherimoya, custard apple, ilama, and soursop at 1.0 ppm; and tea at 2.0 ppm.    EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism.  The plant metabolism of fenpropathrin has been studied in five different crop plant species: Cotton, apple, tomato, cabbage, and bean. Each of the studies involved foliar treatment of the plants under either greenhouse or field conditions. In all studies the total toxic residue is best defined as parent, fenpropathrin. The primary metabolic pathway for fenpropathrin in plants is similar to that in mammals. There are no qualitatively unique plant metabolites.

	2. Analytical method. Adequate analytical methodology is available to detect and quantify fenpropathrin at residue levels in numerous matrices. The methods use solvent extraction and partition and/or column chromatography clean-up steps, followed by separation and quantitation using capillary gas liquid chromatography (GLC) with FID.  The extraction efficiency has been validated using radiocarbon samples from the plant and animal metabolism studies. The enforcement methods have been validated at independent laboratories and by EPA. The limit of quantification (LOQ) for fenpropathrin in raw agricultural commodity samples is usually 0.01 ppm.

	3. Magnitude of residues. Residue data has been submitted for Guava, Lychee, and Sugar Apple and the requested tolerances are adequately supported.

B. Toxicological Profile

Additional toxicological studies have been completed and have been submitted to reduce the uncertainty factor associated with fenpropathrin.

	1. Acute toxicity.  An assessment of the toxic effects caused by fenpropathrin is discussed in III. A. and III. B. of the Federal Register dated September 23, 2005 (OPP-2005-0133) (FRL-7738-7).

	2. Genotoxicty. An assessment of the toxic effects caused by fenpropathrin is discussed in III. A. and III. B. of the Federal Register dated September 23, 2005 (OPP-2005-0133) (FRL-7738-7).

	3. Reproductive and developmental toxicity. An assessment of the toxic effects caused by fenpropathrin is discussed in III. A. and III. B. of the Federal Register dated September 23, 2005 (OPP-2005-0133) (FRL-7738-7).

	4. Subchronic toxicity. An assessment of the toxic effects caused by fenpropathrin is discussed in III. A. and III. B. of the Federal Register dated September 23, 2005 (OPP-2005-0133) (FRL-7738-7).

	5. Chronic toxicity. An assessment of the toxic effects caused by fenpropathrin is discussed in III. A. and III. B. of the Federal Register dated September 23, 2005 (OPP-2005-0133) (FRL-7738-7).

	6. Animal metabolism. Four metabolites were found in the urine of rats dosed with alcohol labeled fenpropathrin. The major metabolites were the sulfate conjugate of 3-(4'-hydroxyphenoxy)benzoic acid and 3-phenoxybenzoic acid (22-44% and 3-9% of the administered dose, respectively). The major urinary metabolites of the acid-labeled fenpropathrin were TMPA-glucuronic acid and TMPA-CH2OH (11-26% and 6-10% of the administered dose, respectively). None of the parent chemical was found in urine.

The major elimination products in the feces included the parent chemical (13-34% of the administered dose) and four metabolites. The fecal metabolites (percentage of administered dose) included CH2OH-fenpropathrin (9-20%), 4'-OH-fenpropathrin (4-11%), COOH-fenpropathrin (2-7%), and 4'-OH-CH2OH-fenpropathrin (2-7%). There are no qualitatively unique plant metabolites. The primary aglycones are identical in both plants and animals; the only difference is in the nature of the conjugating moieties employed.

	7. Metabolite toxicology. The metabolism and potential toxicity of the small amounts of terminal plant metabolites have been tested on mammals. Glucoside conjugates of 3-phenoxy-benzyl alcohol and 3-phenoxybenzoic acid, administered orally to rats, were absorbed as the corresponding aglycones following cleavage of the glycoside linkage in the gut. Normal metabolic pathways rapidly and completely eliminated the free or reconjugated aglycones. The glucose conjugates of 3-phenoxybenzyl alcohol and 3-phenoxy-benzoic acid are less toxic to mice than the corresponding aglycones.

	8. Endocrine disruption. No special studies to investigate the potential for estrogenic or other endocrine effects of fenpropathrin have been performed. However, as referenced above (see toxicological profile), a large and detailed toxicology database exists for the compound including studies acceptable to the Agency in all required categories. These studies include evaluations of reproduction and reproductive toxicity and detailed pathology and histology of endocrine organs following repeated or long-term exposure. These studies are considered capable of revealing endocrine effects and no such effects were observed.

C. Aggregate Exposure

	1. Dietary exposure. Chronic and acute dietary exposure analyses were performed for fenpropathrin using anticipated residues, and accounting for proportion of the crop treated. The crops included in the analyses are the raw agricultural commodities cottonseed, currants, peanuts, strawberries, soybeans, lingonberry, juneberry, salal, and grapes, and the crop groupings succulent shelled pea (6B), head and stem brassica (5A), fruiting vegetables (8), cucurbit vegetables (9), citrus fruits (10), bushberry (13B) and pome fruits (11); processed products from these crops; and the resulting secondary residues in meat, milk, and eggs. Soybeans (and soybean products) were entered into the analyses using tolerance-level residues and 1% of the crop treated for chronic assessments, and 2% of the crop treated for acute assessments.  Proportion of crop treated was assumed to be equal for all crops in a crop grouping.

Based on the minimal dietary intake of olives and caneberries, the magnitude of uses currently registered, and current aPAD and cPAD levels, it is not necessary to complete an additional dietary analysis to include these uses.  Also, additional toxicological studies have been completed and will be submitted to reduce the uncertainty factor associated with fenpropathrin.  None of the studies lowered the endpoints utilized in the risk assessment.

        i. Food. a.  Acute. Acute dietary exposure was calculated for the U.S. population, females (13+), males (20+ years) and five children subgroups. At the 99.9th percentile of exposure, the acute population adjusted dose (aPAD) of 0.06 milligrams/kilogram body weight/day (mg/kg bwt/day) is not exceeded.

  		  b. Chronic. Chronic dietary exposure was calculated for the U.S. 		population and 25 population subgroups. Chronic dietary exposure  		was at or below 0.6% of the chronic population adjusted dose (cPAD)  		of 0.025 mg/kg bwt/day, with apples being the commodity  		contributing the most to chronic exposure. Generally speaking, the  		Agency has no cause for concern if total residue contribution for  		published and proposed tolerances is less than 100% of the cPAD.

	ii. Drinking water. Since fenpropathrin is applied outdoors to growing agricultural crops, the potential exists for fenpropathrin to reach ground water or surface water that may be used for drinking water. To further quantify exposure from drinking water, potential surface water and ground water concentrations for fenpropathrin were estimated using First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Groundwater (SCI-GROW) modeling. Use on citrus, the most intense field use, was modeled. SCI-GROW modeling indicated that fenpropathrin would not be detected in ground water. FIRST modeling of potential surface water concentrations of fenpropathrin yielded annual average parts per billion (0.833 ppb) and peak day (1.030 ppb) concentrations. These estimated drinking water environmental concentrations (DWEC) could be used for chronic and acute exposures, respectively.

	2. Non-dietary exposure. No endpoints of concern were identified by the Health Effects Division, Hazard Identification Assessment Review Committee for dermal or inhalation exposures of any duration. Thus, no risk assessment is needed.

D. Cumulative Effects

	     There are numerous other pesticidal compounds, pyrethroids and the natural pyrethrins, that are structurally related to fenpropathrin and may have similar effects on animals. In consideration of potential cumulative effects of fenpropathrin and other substances that may have a common mechanism of toxicity, there are currently no available data or other reliable information indicating that any toxic effects produced by fenpropathrin would be cumulative with those of other chemical compounds, or other pyrethroids. Thus, only the potential risks of fenpropathrin have been considered in this assessment of aggregate exposure and effects.

     Valent will submit information for EPA to consider concerning potential cumulative effects of fenpropathrin consistent with the schedule established by EPA at 62 FR 42020 (August 4, 1997) (FRL-5734-6) and other EPA publications pursuant to the Food Quality Protection Act.

E. Safety Determination

	1. U.S. population. i. Acute. The potential acute exposure from food to the U.S. population and various non-child/infant population subgroups provide values well below the aPAD. In a conservative policy, the Agency has no cause for concern if total acute exposure calculated for the 99.9th percentile is less than 100% of the aPAD.  Acute DWLOC values are not exceeded by modeled DWEC values. It can be concluded that there is a reasonable certainty that no harm will result to the overall U.S. population and many non-child/infant subgroups from aggregate, acute exposure to fenpropathrin residues.

    ii. Chronic. Using the dietary exposure assessment procedures, the calculated chronic dietary exposure resulting from residue exposure from existing and proposed uses of fenpropathrin is minimal. The estimated chronic dietary exposure from food for the overall U.S. population and many non-child/infant subgroups ranges from 0.6% (children 1-6 years old, 0.000155 mg/kg bwt/day) to 0.1% (several groups) of the cPAD. Generally, the Agency has no cause for concern if total residue contribution is less than 100% of the cPAD. Chronic drinking water levels of concern (DWLOC) values are not exceeded by modeled drinking water estimated concentration (DWEC) values. It can be concluded that there is a reasonable certainty that no harm will result to the overall U.S. population and many non-child/infant subgroups from aggregate, chronic dietary exposure to fenpropathrin residues

	2. Infants and children. The estimated chronic dietary exposure from food to infant and child subgroups ranges from 0.6% children 1-6 years old, 0.000155 mg/kg bwt/day to 0.1% nursing infants, 0.000026 mg/kg bwt/day of the cPAD. Generally, the Agency has no cause for concern if total residue contribution is less than 100% of the cPAD. Chronic DWLOC values are not exceeded by modeled DWEC values. It can be concluded that there is a reasonable certainty that no harm will result to infant and child subgroups of the U.S. population from aggregate, chronic exposure to fenpropathrin residues.

F. International Tolerances

The following are the existing Codex MRLs for Fenpropathrin:

There are small differences between the Section 408 tolerances and the Codex MRL values for secondary residues in animal products. These minor differences are mainly caused by differences in the methods used to calculate animal feed dietary exposure. The only substantial difference between the US tolerance and the Codex MRL value is for tomatoes. The JMPR reviewer required that the MRL exceed the highest field residue value rounded up to unit value. The EPA reviewer agreed with Valent that one set of field residue samples was possibly compromised by the presence of a high rate processing treatment nearby. High outliers were ignored, and the tolerance was set at 0.6 ppm.


[Federal Register Volume 84, Number 176 (Wednesday, September 11, 2019)]
[Notices]
[Pages 47967-47968]
[FR Doc No: 2019-19675]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2019-0702]

Proposed Termination of U.S. Coast Guard Medium Frequency (MF)
Broadcast of Navigational Telex (NAVTEX) and Shift to Satellite

ACTION: Notice and request for comments.

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

SUMMARY: The U.S. Coast Guard may cease broadcasting Navigational Telex
(NAVTEX) over Medium Frequency (MF) after first ensuring the
information contained in NAVTEX broadcasts is available via
International Maritime Organization (IMO) recognized satellite
services. This notice requests public comment on the possibility of
terminating the MF NAVTEX broadcast.

DATES: Comments must be submitted to the online docket via http://www.regulations.gov, on or before November 12, 2019.

ADDRESSES: You may submit comments identified by docket number USCG-
2019- 0702 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: For information about this document,
please call or email Derrick Croinex, Chief, Spectrum Management and
Telecommunications, U.S. Coast Guard (Commandant CG-672); telephone:
202-475-3551; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Abbreviations

GMDSS Global Maritime Distress and Safety System
IMO International Maritime Organization
MF Medium Frequency
NAVTEX Navigational Telex

Public Participation and Request for Comments

    We encourage you to submit comments (or related material) on the
possible termination of the U.S. Coast Guard's broadcast of MF NAVTEX.
We will consider all submissions received before the comment period
closes. If you submit a comment, please include the docket number for
this notice, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at http://www.regulations.gov and
can be viewed by following that website's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).

Discussion

    Navigation Telex (NAVTEX) is an international automated service for
radio broadcast delivery of navigational and meteorological warnings
and forecasts, as well as urgent maritime safety information. NAVTEX
provides a low-cost, automated means of receiving this information
aboard ships at sea out to approximately 100 nautical miles off shore.
NAVTEX is part of the Global Maritime Distress and Safety System
(GMDSS) which has been incorporated into the Safety of Life at Sea
(SOLAS) treaty to which the U.S. is a party. The U.S. Coast Guard
operates this system nationwide. For more information on MF NAVTEX in
the U.S., please see the USCG Navigation Center website at https://www.navcen.uscg.gov/?pageName=NAVTEX.
    The U.S. Coast Guard is proposing to cease operating MF NAVTEX and,
instead making this information available via IMO recognized satellite
services in waters under U.S. responsibility. The current MF NAVTEX
equipment is in dire need of replacement. The equipment is antiquated
and essential replacement parts are difficult to find and expensive,
placing overall operation of MF NATEX at risk. Any approved GMDSS
satellite terminal will be able to receive this information. We would
like comments on this proposal to make the NAVTEX information available
over satellite.
    We believe the transition from terrestrial broadcast to satellite
will provide for more reliable delivery of NAVTEX information and allow
better, more cost-effective products in the future. We also believe
this change will have a low impact on the maritime public as satellite
receivers have become more prevalent onboard vessels. However, we would
like your comments on how you would be affected if we did provide the
NAVTEX information via satellite, particularly if you use MF NAVTEX and
do not currently have a GMDSS satellite terminal onboard your vessel.
We would also like your comments on what types of Maritime Safety
Information products you would like to see added in the future if we
did provide the NAVTEX information via satellite.
    Before terminating the broadcast, we will consider comments from
the public. After considering any comments received, the Coast Guard
will issue a notice in the Federal Register indicating how the matter
will be resolved.
    This notice is issued under the authority of 14 U.S.C. 93(a)(16)
and 5 U.S.C. 552(a).

    Dated: September 5, 2019.
Derrick J. Croinex,
Chief, Spectrum Management and Telecommunication.
[FR Doc. 2019-19675 Filed 9-10-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 76 (Monday, April 21, 2014)]
[Rules and Regulations]
[Pages 22018-22020]
[FR Doc No: 2014-08725]

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

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1917

[Docket ID: OSHA-2012-0028]
RIN 1218-AC72

Vertical Tandem Lifts

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Final rule; remand.

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

SUMMARY: OSHA is implementing a court-ordered remand of certain
portions of the standard for vertical tandem lifts (VTLs). This final
rule implements the remand by: Limiting the application of the corner-
casting and interbox-connector inspection requirements to shore-to-ship
VTLs; and removing the tandem lifts of platform containers from the
scope of the VTL standard.

DATES: The final rule becomes effective on July 21, 2014.

ADDRESSES: In accordance with 28 U.S.C. 2112(a), the Agency designates
Joseph Woodward, the Associate Solicitor of Labor for Occupational
Safety and Health, Office of the Solicitor of Labor, Room S4004, U.S.
Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210,
to receive petitions for review of the final rule.

FOR FURTHER INFORMATION CONTACT:
    General information and press inquiries: Frank Meilinger, Director,
OSHA Office of Communications, U.S. Department of Labor, Room N-3647,
200 Constitution Avenue NW., Washington, DC 20210; telephone: (202)
693-1999; email<EMAIL_ADDRESS>    Technical Information: Mrs. Amy Wangdahl, Director, Office of
Maritime and Agriculture, OSHA, U.S. Department of Labor, Room N-3609,
200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-
2086 or email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Copies of this Federal Register notice: Electronic copies of this
Federal Register notice are available at http://www.regulations.gov.
This notice, as well as news releases and other relevant information,
are also available at OSHA's Web site at http://www.osha.gov.
    Since the 1970s, intermodalism (the containerization of cargo) has
become the dominant mode of cargo transport in the maritime industry,
replacing centuries-old, break-bulk cargo handling. In the marine cargo
handling industry, intermodalism typically involves three key
components: Standardized containers with uniform corner castings;
interbox connectors (such as semiautomatic twistlocks) to secure the
containers (to each other at the four corners, to the deck of the ship,
to a railroad car, or to a truck chassis); and a type of crane called a
container gantry crane that has specialized features for rapid loading
and unloading of containers. Because intermodalism is highly dependent
on standardized containers and connecting gear, several international
organizations have developed standards for equipment and practices to
facilitate intermodal freight operations. This helps ensure that
containers and interbox connectors are sized and operate properly so
that containers and connectors from different manufacturers will fit
together.
    On a ship, containers above deck are secured, by interbox
connectors, to each other and to the deck of the ship. In the
conventional loading and unloading process, the container gantry crane
lifts one container (either 6.1 or 12.2 meters long) at a time, using
the crane's specially developed spreader beam. A VTL is the practice of
a container crane lifting two or more intermodal containers, one on top
of the other, connected by a particular type of interbox connector,
known as a semiautomatic twistlock.
    On December 10, 2008, OSHA published a final rule [73 FR 75245]
adopting new requirements relating to VTLs (73 FR 75246). The final
standard permitted VTLs of no more than two empty containers provided
that certain safeguards are followed. The final rule required, among
other safeguards, inspections of each container, interbox connector,
and corner casting immediately before use in a VTL (29

CFR 1917.71(i)(9)). The final rule also prohibited lifting platform
containers as part of a VTL unit (29 CFR 1917.71(i)(10)).
    The National Maritime Safety Association (NMSA), a trade
association representing marine terminal operators, petitioned the U.S.
Court of Appeals for the District of Columbia Circuit for review of the
VTL standard, arguing, in part, that two of the Standard's
requirements--the interbox connector inspection requirement in Sec.
1917.71(i)(9) and the ban on VTLs of platform containers in Sec.
1917.71(i)(10)--were not technologically feasible.\1\ The Court found
that there was insufficient evidence supporting OSHA's determination of
technological feasibility with respect to those two provisions.
Accordingly, the Court vacated and remanded the inspection requirement
at Sec.  1917.71(i)(9), as applied to ship-to-shore VTLs, and the total
ban on platform container VTLs at Sec.  1917.71(i)(10). National
Maritime Safety Ass'n v. OSHA, 649 F.3d 743, 753-54 (DC. Cir. 2011).
---------------------------------------------------------------------------

    \1\ NMSA also argued that (1) OSHA failed to demonstrate that
VTLs pose a significant risk to worker safety; (2) the Standard was
not reasonably necessary or appropriate in light of the safe work
zone requirement; (3) OSHA's authority is limited to requiring, not
prohibiting, workplace practices; and (4) if the standard is
otherwise valid, in granting OSHA standard-setting authority under
the Occupational Safety and Health Act (29 U.S.C. 651-678) Congress
unconstitutionally delegated its legislative power to the executive
branch. However, the Court denied those parts of NMSA's petition.
---------------------------------------------------------------------------

    OSHA is revising Sec.  1917.71 to effectuate the Court's ruling.
First, the Agency is removing paragraph (i)(10) of that section which
prohibited the lifting of platform containers as part of a VTL. In
addition, it is revising the scope of the VTL standard in the
introductory text to paragraph (i) of that section to make clear that
vertical tandem lifts of platform containers are not covered. Neither
the proposed nor the final rule contemplated that platform containers
would be covered under the requirements included in paragraph (i), and
there is nothing in the Court's decision indicating that it intended
such a result. Consequently, OSHA believes that the only reasonable way
to implement the Court's decision vacating the provision banning VTLs
of platform containers is to exempt VTLs of such containers from the
scope of Sec.  1917.71(i) in addition to removing existing Sec.
1917.71(i)(10).
    Second, OSHA is adding a new paragraph in Sec.  1917.71(i)(9) to
make the inspection requirements in Sec.  1917.71(i)(9) inapplicable to
ship-to-shore VTLs. The addition, which appears in paragraph
(i)(9)(vii), states that the requirements of paragraph (i)(9) of Sec.
1917.71 do not apply to ship-to-shore VTLs.
    For the hazards addressed by the portions of the VTL standard
vacated by the DC Circuit, OSHA is reverting to its prior
interpretative positions. For inspections of ship-to-shore VTLs, OSHA's
position is set forth in the September 2, 1993 letter from Roy Gurnham
to Michael Bohlman (the ``Gurnham letter''), which indicates that:

    The containers must be inspected for visible defects prior to
hoisting and damaged containers shall not be hoisted in tandem.
Ref.-29 C.F.R. 1918.85(d).

(R. Doc. OSHA-S025A-2006-0658-0003.) Any other requirements
referenced in the Gurnham letter that are not required by an applicable
standard are superceded by the VTL standard.
    For the hazards arising from lifts of multiple platform (flatrack)
containers, the letter of January 16, 2004 from Richard E. Fairfax to
Larry Hansen applies. That letter states that:

    When connected by semi-automatic twistlocks (i.e., liftlocks
that are not built-in), only two empty flatrack containers with
their end frames folded may be lifted as a vertical tandem lift
(VTL). When connected with internal mechanisms (i.e., built-in
connectors that are designed for lifting), the number of empty
flatrack containers with their end frames folded that may be lifted
cannot exceed the manufacturers' recommendations. Empty flatrack
containers with their end frames in the upright position are not
allowed to be lifted as a VTL because of strength and stability
considerations. The provisions listed in the [Gurnham letter] apply
to VTL lifts of two empty containers connected by semi-automatic
twistlocks. Although the Gurnham letter does not specifically
mention VTL lifts of flatrack containers, OSHA concluded that the
provisions listed in the letter also apply to VTL lifts of two empty
flatrack containers with their end frames folded and connected by
semi-automatic twistlocks.

(R. Doc. OSHA-S025A-2006-0658-0183.)

Final Economic Analysis and Regulatory Flexibility Act Certification

    The Agency concludes that the revisions will not impose any
additional costs on employers as it merely implements the order of the
Court remanding two provisions of the VTL standard at Sec.  1917.71(i).
As a result of the Court's action, employers have not needed to comply
with the inspection requirements in Sec.  1917.71(i)(9), with respect
to ship-to-shore VTLs, or with the ban on VTLs of platform containers
in Sec.  1917.71(i)(10). By removing workplace requirements, the
Court's decision reduces rather than increases compliance costs. This
final rule simply codifies the Court's action. Therefore, the final
rule does not impose significant additional costs on any private-sector
or public-sector entity and does not meet any of the criteria for a
significant rule specified by Executive Order 12866 or 13563. Because
this final rule has no significant additional costs, OSHA certifies
that it will not have a significant economic impact on a substantial
number of small entities. Accordingly, the Agency is not preparing a
regulatory flexibility analysis under the Regulatory Flexibility Act.
See 5 U.S.C. 605. In addition, the requirements of the Regulatory
Flexibility Act do not apply because a general notice of proposed
rulemaking was not published for this final rule. See 5 U.S.C. 601(2).
Likewise, the rule is not a ``major rule'' for purposes of the
Congressional Review Act. See 5 U.S.C. 804.

Federalism

    OSHA reviewed this final rule in accordance with the Executive
Order on Federalism (Executive Order 13132, 64 FR 43255, Aug. 10,
1999), which requires that Federal agencies, to the extent possible,
refrain from limiting State policy options, consult with States prior
to taking any actions that would restrict State policy options, and
take such actions only when clear constitutional authority exists and
the problem is national in scope.
    Section 18 of the Occupational Safety and Health Act of 1970 (the
OSH Act; U.S.C. 651 et seq.) allows States to adopt, with Federal
approval, a plan for the development and enforcement of occupational
safety and health standards; OSHA refers to States that obtain Federal
approval for such a plan as ``State Plan States'' (29 U.S.C. 667).
Occupational safety and health standards developed by State Plan States
must be at least as effective in providing safe and healthful
employment and places of employment as the Federal standards. Subject
to these requirements, State Plan States are free to develop and
enforce their own requirements for occupational safety and health
standards. Section 18(c)(2) of the OSH Act permits State Plan States
and Territories to develop and enforce their own standards for VTL
operations provided they are at least as effective in providing safe
and healthful employment and places of employment as the requirements
specified in this final rule.
    In summary, this final rule complies with Executive Order 13132. In
States without OSHA-approved State Plans, this final rule would limit
State policy

options in the same manner as every standard promulgated by OSHA. In
States with OSHA-approved State Plans, this rulemaking would not
significantly limit State policy options.

State Plan States

    When Federal OSHA promulgates a new standard or a more stringent
amendment to an existing standard, the 27 States or U.S. Territories
with their own OSHA-approved occupational safety and health plans must
amend their standards to reflect the new standard or amendment or show
OSHA why such action is unnecessary (by showing, for example, that an
existing State standard covering this area is already ``at least as
effective'' as the new Federal standard or amendment). (See 29 CFR
1953.5(a).) The State standard must be ``at least as effective'' as the
final Federal rule and must be adopted within 6 months of the
publication date of the final Federal rule (29 CFR 1953.5(a)). When
OSHA promulgates a new standard or amendment that does not impose
additional or more stringent requirements than the existing standard,
as is the case in this final rule, State Plan States are not required
to amend their standards, although OSHA may encourage them to do so.
    The 27 States and territories with OSHA-approved State Plans are:
Alaska, Arizona, California, Connecticut, Hawaii, Illinois, Indiana,
Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada, New Mexico, New
Jersey, New York, North Carolina, Oregon, Puerto Rico, South Carolina,
Tennessee, Utah, Vermont, Virginia, Virgin Islands, Washington, and
Wyoming. Connecticut, Illinois, New Jersey, New York, and the Virgin
Islands have OSHA-approved State Plans that apply to State and local
government employees only.

Unfunded Mandates Reform Act of 1995

    OSHA reviewed this final rule in accordance with the Unfunded
Mandates Reform Act of 1995 (2 U.S.C. 1501 et seq.) and Executive Order
12875 (58 FR 58093 (Oct. 28, 1993)). As discussed earlier in this
notice, the Agency determined that this final rule will not impose
additional costs on any private-sector or public-sector entity.
Accordingly, this final rule requires no additional expenditures by
either public or private employers.
    Further, as noted earlier in this notice, the Agency's standards do
not apply to State and local governments except in States that have
elected voluntarily to adopt a State Plan approved by the Agency.
Consequently, this final rule does not meet the definition of a
``Federal intergovernmental mandate'' (see Section 421(5) of the
Unfunded Mandates Reform Act (2 U.S.C. 658(5)). Therefore, for the
purposes of the Unfunded Mandates Reform Act, the Agency certifies that
this final rule does not mandate that State, local, or tribal
governments adopt new, unfunded regulatory obligations, or increase
expenditures by the private sector of more than $100 million in any
year. In addition, the requirements of UMRA do not apply because a
general notice of proposed rulemaking was not published for this final
rule. See 2 U.S.C. 1532(a).

List of Subjects in 29 CFR Part 1917

    Freight, Longshore and harbor workers, Occupational safety and
health.

Authority and Signature

    This document was prepared under the direction of David Michaels,
Ph.D., MPH Assistant Secretary of Labor for Occupational Safety and
Health, 200 Constitution Avenue NW., Washington, DC 20210. It is issued
pursuant to sections 4, 6, and 8 of the Occupational Safety and Health
Act of 1970, Public Law 91-596, 84 Stat. 1590 (29 U.S.C. 653, 655,
657), section 41 of the Longshore and Harbor Workers' Compensation Act
(33 U.S.C. 941), the judgment of the court in National Maritime Safety
Association v. OSHA, 649 F.3d 743 (D.C. Cir. 2011), and Secretary of
Labor's Order No. 1-2012 (77 FR 3912).

    Signed at Washington, DC on April 8, 2014.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.

    Accordingly, 29 CFR part 1917 is amended as follows:

PART 1917--MARINE TERMINALS

0
1. The authority citation for part 1917 is revised to read as follows:

    Authority: 33 U.S.C. 941; 29 U.S.C. 653, 655, 657; Secretary of
Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48
FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR
50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31160), 4-2010 (75 FR
55355), or 1-2012 (77 FR 3912), as applicable; and 29 CFR part 1911.
    Section 1917.28 also issued under 5 U.S.C. 553.
    Section 1917.29 also issued under 49 U.S.C. 1801-1819 and 5
U.S.C. 553.

0
2. Section 1917.71 is amended by revising paragraph (i) introductory
text, adding paragraph (i)(9)(vii), and removing paragraph (i)(10) to
read as follows:

Sec.  1917.71  Terminals handling intermodal containers or roll-on
roll-off operations.

* * * * *
    (i) Vertical tandem lifts. The following requirements apply to
operations involving the lifting of two or more intermodal containers
by the top container (vertical tandem lifts or VTLs). These
requirements do not apply to operations involving the lifting of two or
more interconnected platform containers.
* * * * *
    (9) * * *
    (vii) The requirements of paragraph (i)(9) of this section do not
apply to ship-to-shore VTLs.
* * * * *
[FR Doc. 2014-08725 Filed 4-18-14; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 87, Number 97 (Thursday, May 19, 2022)]
[Notices]
[Page 30477]
[FR Doc No: 2022-10777]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

Filings Instituting Proceedings

    Docket Numbers: RP22-922-000.
    Applicants: Viking Gas Transmission Company.
    Description: Sec.  4(d) Rate Filing: Amendment to Non-Conforming
Agreement AF0360 with NSP to be effective 11/1/2022.
    Filed Date: 5/13/22.
    Accession Number: 20220513-5049.
    Comment Date: 5 p.m. ET 5/25/22.

    Docket Numbers: RP22-923-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Compliance filing: REX 2022-05-13 2022 Annual Penalty
Charge Reconciliation to be effective N/A.
    Filed Date: 5/13/22.
    Accession Number: 20220513-5062.
    Comment Date: 5 p.m. ET 5/25/22.

    Docket Numbers: RP22-924-000.
    Applicants: Tallgrass Interstate Gas Transmission, LLC.
    Description: Compliance filing: TIGT 2022-05-13 2022 Annual Penalty
Charge Reconciliation to be effective N/A.
    Filed Date: 5/13/22.
    Accession Number: 20220513-5064.
    Comment Date: 5 p.m. ET 5/25/22.

    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.

Filings in Existing Proceedings

    Docket Numbers: RP20-1060-005.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Refund Report: Settlement Refund Report--RP20-1060 et
al. to be effective N/A.
    Filed Date: 5/13/22.
    Accession Number: 20220513-5068.
    Comment Date: 5 p.m. ET 5/25/22.

    Docket Numbers: RP21-388-000.
    Applicants: Gulf South Pipeline Company, LLC.
    Description: Report Filing: Compliance Activity Report Filing in
Docket No. RP21-388-000 to be effective N/A.
    Filed Date: 5/12/22.
    Accession Number: 20220512-5088.
    Comment Date: 5 p.m. ET 5/24/22.

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

    Dated: May 13, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-10777 Filed 5-18-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 31 (Wednesday, February 15, 2012)]
[Notices]
[Pages 8886-8887]
[FR Doc No: 2012-3553]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Food and Drug Administration Clinical Trial Requirements,
Regulations, Compliance, and Good Clinical Practice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration (FDA) Detroit District
Office, in co-sponsorship with the Society of Clinical Research
Associates (SoCRA) is announcing a public workshop. The public workshop
on FDA's clinical trial requirements is designed to aid the clinical
research professional's understanding of the mission, responsibilities,
and authority of FDA and to facilitate interaction with FDA
representatives. The program will focus on the relationships among FDA
and clinical trial staff, investigators, and institutional review
boards (IRB). Individual FDA representatives will discuss the informed
consent process and informed consent documents; regulations relating to
drugs, devices, and biologics; as well as inspections of clinical
investigators, IRB, and research sponsors.
    Date and Time: The public workshop will be held on May 9 and 10,
2012, from 8 a.m. to 5 p.m.

    Location: The public workshop will be held at the Marriott Ann
Arbor Ypsilanti at Eagle Crest, 1275 S. Huron St., Ypsilanti, MI 48197,
800-606-7044.
    Contact: Society of Clinical Research Associates (SoCRA), 530 West
Butler Ave., Suite 109, Chalfont, PA 18914, 1-800-762-7292 or 215-822-
8644, FAX:<PHONE_NUMBER>, email<EMAIL_ADDRESS>Web site: http://www.SoCRA.org. (FDA has verified the Web site addresses throughout this
document, but we are not responsible for any subsequent changes to the
Web sites after this document publishes in the Federal Register.); or
Nancy Bellamy, Food and Drug Administration, Detroit District Office,
300 River Pl., Suite 5900, Detroit, MI 48207,<PHONE_NUMBER>, Fax: 313-
393-8139, email<EMAIL_ADDRESS>    Accommodations: Attendees are responsible for their own
accommodations. Please mention SoCRA to receive the hotel room rate of
$119 plus applicable taxes (available until April 17, 2012 or until the
SoCRA room block is filled).

                          Cost of Registration
------------------------------------------------------------------------

------------------------------------------------------------------------
SoCRA member...............................................         $575
SoCRA nonmember (includes membership)......................          650
Federal Government member..................................          450
Federal Government nonmember...............................          525
FDA Employee...............................................            *
------------------------------------------------------------------------
* (Free) Fee Waived.

    If you need special accommodations due to a disability, please
contact SoCRA (see Contact) at least 21 days in advance. Extended
periods of question and answer and discussion have been included in the
program schedule. SoCRA designates this educational activity for a
maximum of 13.3 Continuing Education Credits for SoCRA CE and Nurse
CNE. SoCRA designates this live activity for a maximum of 13.3 AMA PRA
Category 1 Credit(s) TM. Physicians should claim only the
credit commensurate with the extent of their participation. CME for
Physicians: SoCRA is accredited by the Accreditation Council for
Continuing Medical Education to provide continuing medical education
for physicians. CNE for Nurses: SoCRA is an approved provider of
continuing nursing education by the Pennsylvania State Nurses
Association (PSNA), an accredited approver by the American Nurses
Credentialing Center's Commission on Accreditation (ANCC). ANCC/PSNA
Provider Reference Number: 205-3-A-09.
    Registration Instructions: To register, please submit a
registration form with your name, affiliation, mailing address,
telephone, fax number, and email, along with a check or money order
payable to ``SoCRA''. Mail to: SoCRA (see Contact for address). To
register via the Internet, go to http://www.socra.org/html/FDA_Conference.htm. Payment by major credit card is accepted (Visa/
MasterCard/AMEX only). For more information on the meeting
registration, or for questions on the workshop, contact SoCRA (see
Contact).

SUPPLEMENTARY INFORMATION: The public workshop helps fulfill the
Department of Health and Human Services' and FDA's important mission to
protect the public health. The workshop will provide those engaged in
FDA-regulated (human) clinical trials with information on a number of
topics concerning FDA requirements related to informed consent,
clinical investigation requirements, IRB inspections, electronic record
requirements, and investigator initiated research. Topics for
discussion include the following: (1) What FDA Expects in a
Pharmaceutical Clinical Trial; (2) Adverse Event Reporting--Science,
Regulation, Error, and Safety; (3) Part 11 Compliance--Electronic
Signatures; (4) Informed Consent Regulations; (5) IRB Regulations and
FDA Inspections; (6) Keeping Informed and Working Together; (7) FDA
Conduct of Clinical Investigator Inspections; (8) Meetings With FDA:
Why, When, and How; (9) Investigator Initiated Research; (10) Medical
Device Aspects of Clinical Research; (11) Working With FDA's Center for
Biologics Evaluation and Research; (12) The Inspection is Over--What
Happens Next? Possible FDA Compliance Actions; (13) Ethical Issues in
Subject Enrollment; (14) Medical Device Aspects of Clinical Research;
(15) Are We There Yet? An Overview of the FDA GCP Program.
    FDA has made education of the drug and device manufacturing
community a high priority to help ensure the quality of FDA-regulated
drugs and devices. The public workshop helps to achieve objectives set
forth in section 406 of the FDA Modernization Act of 1997 (21 U.S.C.
393) which includes working closely with stakeholders and maximizing
the availability and clarity of information to stakeholders and the
public. The public workshop also is consistent with the Small Business
Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121) as
outreach activities by Government Agencies to small businesses.

    Dated: February 9, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3553 Filed 2-14-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 80, Number 32 (Wednesday, February 18, 2015)]
[Notices]
[Pages 8636-8637]
[FR Doc No: 2015-03261]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL15-44-000]

Sage Grouse Energy Project, LLC v. PacificCorp; Notice of
Complaint

    Take notice that on February 9, 2015, pursuant to section 206 of
the Federal Energy Regulatory Commission's (Commission) Rules of
Practice and Procedure, 18 CFR 385.206, Sage Grouse Energy Project, LLC
(Complainant) filed a formal complaint against the PacificCorp
(Respondent) alleging that PacifiCorp has implemented actions and
activities to: (1) Ignore the Commission's regulatory authority; (2)
circumvent the Commission's December 16, 2013 Order in Docket No. EL-
14-1-000; \1\ (3) violate the Respondent's Open Access Transmission
Tariff, FERC Electric Tariff, Volume No. 11 (OATT); (4) violate FERC
Orders for the Standardization of Generator Interconnection Agreements
and Procedures, including FERC Order 2003; (5) engage in trickery
including the submission of subtle misrepresentations of tariff
language sufficient to alter and change the original meaning and intent
of the tariff; (6) engage in activities and practices that include acts
against individuals in protected classes such as race, color, religion,
sex and even citizenship and immigration status as defined in Civil
Rights and Anti-Discrimination Laws; (7) disparaging treatment with
respect to the Respondent requiring the Complainant to produce
additional information in excess of the mandated requirements in order
to process the Complainants' Interconnection Request; (8) the
processing of an invalid Interconnection Request for a Respondent
favored Interconnection Customer, Blue Mountain Power Partners, LLC on
parcels of land whereby the developmental rights for said parcels of
land belong to the Complainant; and (9) the processing of an invalid
Interconnection Request for a Respondent favored Interconnection
Customer, Latigo Wind Park, LLC on land where a transmission cable from
the Interconnection Customer's Generating Facility Collector Substation
to the Point of Interconnection, Pinto Substation crosses land whereby
the developmental rights belong to the Complainant, as more fully
explained in the complaint.
---------------------------------------------------------------------------

    \1\ Pioneer Wind Park I, LLC, 145 FERC ] 61,215 (2013).
---------------------------------------------------------------------------

    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, 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 electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
``eSubscription'' link on the Web site 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<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on March 11, 2015.

    Dated: February 11, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-03261 Filed 2-17-15; 8:45 am]
BILLING CODE 6717-01-P