[Federal Register Volume 76, Number 24 (Friday, February 4, 2011)]
[Notices]
[Pages 6477-6478]
[FR Doc No: 2011-2458]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Industry Exchange Workshop on Food and Drug Administration Drug
and Device Requirements; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) Southwest Regional
Office, in co-sponsorship with the Association of Food and Drug
Officials (AFDO), the Mid-Continental Association of Food and Drug
Officials (MCAFDO), and the FDA Medical Device Industry Coalition, is
announcing a public workshop entitled ``The Future of Medical Products
Regulation: Ensuring Safety and Integrity in a Global Market''. This 2-
day public workshop is intended to provide information about FDA drug
and device regulation to the regulated industry.
    Date and Time: The public workshop will be held on June 20 and 21,
2011, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Marriott Dallas/
Plano at Legacy Town Center, Plano, Texas, 7120 Dallas Pkwy., Plano,
Texas 75024,<PHONE_NUMBER>, or toll-free<PHONE_NUMBER>.
    Attendees are responsible for their own accommodations. To make
reservations at the Marriott Dallas/Plano at Legacy Town Center, at the
reduced conference rate, contact the Marriott Dallas/Plano at Legacy
Town Center before May 20, 2011, citing meeting code ``AFDO
Conference''.
    Contact: David Arvelo, Food and Drug Administration, 4040 North
Central Expressway, suite 900, Dallas, Texas 75204,<PHONE_NUMBER>, FAX:
214-253-4970, e-mail<EMAIL_ADDRESS>    Registration: You are encouraged to register by May 24, 2011. The
AFDO registration fees cover the cost of facilities, materials, and
breaks. Seats are limited; therefore, please submit your registration
as soon as possible. Course space will be filled in order of receipt of
registration. Those accepted into the course will receive confirmation.
Registration will close after the course is filled. Registration at the
site is not guaranteed but may be possible on a space available basis
on the day of the public workshop beginning at 7:30 a.m. The cost of
registration follows:

                          Cost of Registration
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------------------------------------------------------------------------
Government (AFDO/Mid-Continental AFDO Member)...........         $425.00
Government (Non-Member):................................          525.00
Non-Government (AFDO/MCAFDO Member).....................          425.00
Non-Government (Non-Member).............................          525.00
To be added to registration fee for public workshop               100.00
 registration postmarked after May 24, 2011.............
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    If you need special accommodations due to a disability, please
contact David Arvelo (see Contact) at least 21 days in advance of the
workshop.
    Registration instructions: To register, please complete and submit
an AFDO Conference Registration Form, along with a check or money order
payable to ``AFDO''. Please mail your completed registration form and
payment to: AFDO, 2550 Kingston Rd., suite 311, York, PA 17402. To
register online, please visit http://www.afdo.org. (FDA has verified
the Web site address, but is not responsible for subsequent changes to
the Web site after this document publishes in the Federal Register.)
    The registrar will also accept payment through Visa and MasterCard
credit cards. For more information on the public workshop, or for
questions about registration, please contact AFDO at

717-757-2888, FAX:<PHONE_NUMBER>, or e-mail<EMAIL_ADDRESS>
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 FDA-regulated drug
and device entities with information on a number of topics concerning
FDA requirements related to the production and marketing of drugs and/
or devices. Topics for discussion include the following:
     Globalization, Imports, and Supplier Controls,
     Medical Product Theft and Criminal Investigations,
     Proposed Changes to the 510(K) Review Process,
     Health Fraud,
     Streamlining the FDA Enforcement Process,
     The Future of Medical Products Regulation,
     Medical Devices in Canada,
     The Freedom of Information Act,
     Medical Product Complaint Investigations,
     Writing Corrective and Preventive Actions Procedures and
Documents to Reflect Compliance Initiatives, and
     Top Ten FDA-483 Objectionable Observations.
    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 workshop helps to achieve objectives set forth
in section 406 of the Food and Drug Administration 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 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 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-2458 Filed 2-3-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 87, Number 158 (Wednesday, August 17, 2022)]
[Notices]
[Page 50621]
[FR Doc No: 2022-17684]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER22-2536-000]

Kossuth County Wind, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Kossuth County Wind, LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is August 31, 2022.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: August 11, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-17684 Filed 8-16-22; 8:45 am]
BILLING CODE 6717-01-P


Summary of Conference Presentation

Conference:	Campus Safety Health and Environmental Management
Association (CSHEMA) Conference, Boston, MA

Date: 		July 25, 2007

Presented by:	 Kristin Fitzgerald, U.S. EPA, Office of Solid Waste

Title:		Update on EPA’s Laboratories Rule

EPA spoke at the annual CSHEMA Conference to provide an update on the
status of the final rule for laboratory waste from colleges and
universities.  Approximately 40 college and university representatives
attended the presentation.  Kristin Fitzgerald provided an overview of
the public comments EPA received on the proposed rule and corrected some
misunderstandings about specific provisions of the proposed rule.  She
summarized the main issues under discussion within the Agency, but
indicated that no decisions about the final rule had been made at this
time.  She also discussed the process of finalizing and implementing a
final rule and indicated where OSW is in the process.


[Federal Register Volume 77, Number 38 (Monday, February 27, 2012)]
[Notices]
[Pages 11521-11522]
[FR Doc No: 2012-4416]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP12-56-000]

ANR Pipeline Company; Notice of Application

    Take notice that on February 3, 2012, ANR Pipeline Company (ANR),
717 Texas Street, Houston, Texas 77002-2761 filed with the Federal
Energy Regulatory Commission (Commission) an application under section
7(b) of the Natural Gas Act for permission and approval to abandon its
present and any future obligation to perform transportation service
through approximately 7.0 miles of 20-inch pipeline extending from High
Island Block A-552 to High Island Block A-539, located in federal
waters, offshore Texas, all as more fully set forth in the application
which is on file with the Commission and open to public inspection.
This filing is available for review at the Commission in the Public
Reference Room or may be viewed on the Commission's Web site at http://www.ferc.gov using the ``eLibrary'' link. Enter the docket number
excluding the last three digits in the docket number field to access
the document. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    Any questions regarding the application should be directed to Rene
Staeb, Manager, Project Determinations & Regulatory Administration, ANR
Pipeline Company, 717 Texas Street, Houston, Texas 77002-2761, or
telephone<PHONE_NUMBER> or fax<PHONE_NUMBER> or by email<EMAIL_ADDRESS>    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete

its environmental assessment (EA) and place it into the Commission's
public record (eLibrary) for this proceeding; or issue a Notice of
Schedule for Environmental Review. If a Notice of Schedule for
Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit seven copies of filings made in the proceeding with the
Commission and must mail a copy to the applicant and to every other
party. Only parties to the proceeding can ask for court review of
Commission orders in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
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 seven copies of the protest or intervention to
the Federal Energy regulatory Commission, 888 First Street NE.,
Washington, DC 20426.
    Comment Date: 5 p.m. Eastern Time on March 9, 2012.

    Dated: February 17, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-4416 Filed 2-24-12; 8:45 am]
BILLING CODE 6717-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON D.C., 20460
                                   OFFICE OF
                              CHEMICAL SAFETY AND
                             POLLUTION PREVENTION
                                   OFFICE OF
                              CHEMICAL SAFETY AND
                             POLLUTION PREVENTION

                                                               PC Code:  104601
                                                             DP Barcode: 456087
                                                            Date: June 18, 2020
MEMORANDUM

SUBJECT:	Response to Public Comment on the Draft Risk Ecological Risk Assessment of Fenbutatin- Oxide

FROM:		Karen Milians, Ph.D., Chemist
		Thomas Steeger, Ph.D., Senior Science Advisor
      Environmental Risk Branch IV
		Environmental Fate and Effects Division (7507P)
REVIEWED
BY:		Ideliz Negron-Encarnacion, Ph.D., Risk Assessment Process Leader
		Cheryl Sutton, Ph.D., Environmental Scientist
		Environmental Risk Branch IV
		Environmental Fate and Effects Division (7507P)

THROUGH:	Jean Holmes, D.V.M., Branch Chief
		Environmental Risk Branch IV
		Environmental Fate and Effects Division (7507P)

TO:	Lauren Weissenborn, Chemical Review Manager
Melanie Biscoe, Team Leader
Cathryn Britton, Branch Chief
Risk Management and Implementation Branch V
Pesticide Re-evaluation Division (7508P)

The Environmental Fate and Effects Division (EFED) completed its review of public comments received on the Draft Ecological Risk Assessment (DRA; USEPA 2019) for the acaracide fenbutatin-oxide (PC Code 104601; CAS No: 13356-08-6) as part of Registration Review. The fenbutatin-oxide DRA was published in the docket on September 30, 2019 (Docket Number:  EPA-HQ-OPP-2009-0841). Below is a summary of the comments received and EFED's responses.

Comment:

Writing on behalf of the  U.S. Department of Agriculture Office of Pest Management Policy, Dr. Sheryl Kunickis (EPA-HQ-OPP-2009-0814-0032) noted that while fenbutatin-oxide is no longer a primary mite control tool for most crops, "significant usage is still reported on citrus" for which there are registered uses in Arizona, California, Florida and Texas. Dr. Kunickis indicated that fenbutatin-oxide kills by contact only and that the compound has no systemic activity; therefore, adequate foliar coverage is "critically important for efficacy." USDA also noted that based on EPA's screening-level usage analysis (SLUA), strawberries, and caneberries are also important agricultural uses.  According to USDA, although raspberries in Washington and Oregon are the only caneberries with labeled uses for fenbutatin-oxide, overall use estimates for caneberries may misrepresent (underestimate) actual usage as the acaracide continues to be important for mite control in raspberries in the Pacific Northwest.  USDA also noted that although additional mite control products have become available for other crops, fenbutatin-oxide remains an important component of integrated pest management (e.g., Christmas trees; strawberries) and resistance management (e.g., apples) efforts.

With respect to the ecological risk assessment, USDA agreed with EPA's conclusions regarding potential risks of concern for aquatic taxa and believes that the restricted use classification of the compound in combination with application setbacks/buffers from water bodies have historically addressed such risks.  USDA encouraged EPA to focus on practical and feasible measures to minimize off-site movement while retaining the efficacy/utility of the compound. Given that fenbutatin-oxide acts through contact, USDA stressed the importance of uniform coverage on treated plants and expressed concern regarding the implementation of overly stringent restrictions on spray droplet sizes to reduce risk, in that it may lead to the use of "increased application rates...to compensate for decreased efficacy."  USDA encouraged EPA to "explore the potential for prohibiting aerial applications" given that the registered uses for which fenbutatin-oxide remains important typically rely on ground equipment to maximize foliar coverage.  Similar to their comments regarding risks of concern for aquatic taxa, USDA indicated that risks of concern for terrestrial taxa are addressed through the restricted use classification; however, USDA noted that EPA default assumptions used in modeling terrestrial animal exposure (e.g., 100% of the diet treated) may "significantly over-estimate" foraging activity and subsequent exposure. It was noted that the use of rate reductions as a mitigation option "may pose significant challenges for both efficacy and resistance management, as sub-lethal/non-effective doses can exacerbate selection pressure for miticide resistance." With respect to terrestrial invertebrates, USDA recognized the uncertainty from data gaps but noted that since fenbutatin-oxide is not systemic in plants, exposure is likely limited to contact and direct contamination of pollen/nectar from spraying the blooms themselves.  USDA noted that although that growers/applicators attempt to be "judicious about avoiding applications to bee-pollinated crops during bloom," as spider mite outbreaks that occur rapidly could require applications during bloom, particularly in crops (e.g., citrus, berries) with indeterminant bloom periods.

EFED response:

EFED appreciates the comments provided by Dr. Kunickis and the acknowledgement that the ecological risk assessment bracketed risk estimates by examining variability in toxicity as well as exposure estimates and that the assessment provided helpful risk characterization information. EPA also appreciates the willingness of USDA to provide additional information on usage and assessing the benefits of fenbutatin-oxide.  EFED concurs with USDA comments that the restricted use classification of fenbutatin-oxide in combination with buffers/setbacks help to mitigate exposure; however, the aquatic exposure assessment took setbacks/buffers into consideration when assessing risk. As noted in the "Risk Conclusions Summary" of the assessment, "Buffers stipulated for use in aerial (125-ft) and ground applications (25-ft) to citrus reduce EECs; however, the EECs as a result of the buffers are not reduced sufficiently to drop RQ values below acute or chronic risk LOC [Level of Concern] for aquatic organisms."  Additionally, the monitoring data provide evidence that even with such restrictions in place, the compound can move off-site and potentially pose risk to aquatic communities.

EFED also appreciates USDA comments with respect to restricting aerial applications. Based on EFED's analysis of labeled use patterns, citrus and Christmas trees were the only uses for which aerial applications were identified.  However, in follow-up discussion with the Biological and Economic Analysis Division (BEAD) of the Office of Pesticide Programs, aerial applications are conducted for other uses (e.g. almonds).  Therefore, the ecological risk assessment does not fully and accurately reflect potential risks to aquatic communities from such applications.

Comment:

The National Agricultural Aviation Association (NAAA) provided comments regarding default assumptions in the Tier 1 AgDrift(TM) model used to assess risk from spraydrift as a result of aerial applications.  According to NAAA, aerial applicators routinely use large droplet sizes and the NAAA recommends medium droplet size as a default (vs. EFED's default of fine to medium) when modeling drift as this size is the most commonly observed at clinics where aerial applicators have their spray systems tested for droplet efficiency and drift prevention.  Surveys conducted by the National Agricultural Aviation Research and Education Foundation's (NAAREF) Professional Aerial Application Support System (PAASS) indicated that 49% of the respondents primarily used flat fan nozzles which typically produce medium droplet sizes, whereas 17% utilize straight stream nozzles that provide coarse droplet sizes, and 22% used deflector-type nozzles which can produce medium or coarse droplets.

The NAAA indicated that the Tier 1 default assumptions do not account for the effect of lowered spray boom and nozzles in reducing off-target deposition. NAAA also noted that the default conditions regarding swath displacements and standard 10 mile per hour crosswind conditions improperly bias spray drift estimates and do not account for aviator standard practices.  According to NAAA, surveys of aerial applicators indicated that >90% of the aerial operators account for swath offset during applications.

The NAAA also noted that the Tier 1 model assumes neutral air stability and that this assumption can include negative stability ratios which can occur during atmospheric inversions; however, training provided by NAAREF and the pesticide label itself prohibit applications during inversions.  Therefore, NAAA recommended changes to some of the AgDrift(TM) input values used by EFED in assessing spray drift along with modifications to label language regarding temperature inversions (i.e., "to not apply
product if an inversion is present at or near the ground level.")

Response:

EFED appreciates the information provided by NAAA on standard practices used by aerial applicators, along with the published articles that NAAA cited, to support their comments/recommendations.  The
AgDRIFT(TM) model, a modified version of the Agricultural DISPersal (AGDISP(TM)) model, was developed as a collaborative effort between EPA, the USDA Forest Service and the Spray Drift Task Force.  The model is used to estimate downwind deposition of spray drift from aerial, ground and airblast applications.  NAAA is correct in noting that at Tier 1, EPA relies on conservative assumptions which are intended to be protective, i.e., representative of worst-case scenarios.  While applicator standard practice may include more conservative practices in terms of spray droplet sizes, swath off-sets, and applications during atmospheric inversions, the survey data provided by NAAA indicate that those measures are not ubiquitously practiced; therefore, it would be inappropriate for EFED to utilize less conservative assumptions when modeling spray drift.  However, based on the information provided by NAAA, it is clear that the organization and its affiliates are attempting to promote methods to reduce spray drift, and risk managers can consider these efforts along with the other reference materials provided by NAAA. The concerns raised by NAAA are consistent with those expressed by USDA regarding potential restrictions on droplet size leading to increases in application rate to retain the same level of efficacy given the need to ensure that foliar surfaces are properly treated.  EFED will consider the information provided by NAAA in future risk assessments; however, risk assessments will continue to rely on conservative assumptions to ensure that such assessments are protective for a broad range of application practices.