[Federal Register: November 10, 2005 (Volume 70, Number 217)]
[Notices]
[Page 68430-68431]
[DOCID:fr10no05-99]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP00-426-025]

Texas Gas Transmission, LLC; Notice of Negotiated Rates

November 4, 2005.
    Take notice that on November 1, 2005, Texas Gas Transmission, LLC,
(Texas Gas) tendered for filing as part of its FERC Gas Tariff, Second
Revised Volume No. 1, the following tariff sheets, to become effective
November 1, 2005:

Second Revised Sheet No. 53
Fifth Revised Sheet No. 56

    Texas Gas states that the purpose of this filing is to submit to
the Commission a Revised Negotiated Rate Agreement between Texas Gas
and Atmos Energy Marketing, LLC (AEM), dated October 1, 2005, to be
effective November 1, 2005.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to

become a party must file a notice of intervention or motion to
intervene, as appropriate. Such notices, motions, or protests must be
filed in accordance with the provisions of Section 154.210 of the
Commission's regulations (18 CFR 154.210). Anyone filing an
intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    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 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E5-6222 Filed 11-9-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 18 (Tuesday, January 28, 2020)]
[Notices]
[Page 4969]
[FR Doc No: 2020-01364]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER20-780-000]

Sooner 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
Sooner 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 February 10, 2020.
    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 should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: January 21, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-01364 Filed 1-27-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Notices]
[Pages 4353-4354]
[FR Doc No: 2017-00695]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-4460]

Multiple Endpoints in Clinical Trials; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Multiple
Endpoints in Clinical Trials.'' This draft guidance provides sponsors
and review staff with the Agency's thinking about the problems posed by
multiple endpoints in the analysis and interpretation of study results
and how these problems can be managed in clinical trials for human
drugs, including drugs subject to licensing as biological products.
Most clinical trials performed in drug development contain multiple
endpoints to assess the effects of the drug and to document the ability
of the drug to favorably affect one or more disease characteristics.
The purpose of this guidance is to describe various strategies for
grouping and ordering endpoints for analysis and applying some well-
recognized statistical methods for managing multiplicity within a study
to control the chance of making erroneous conclusions about a drug's
effects.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 14, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-4460 for ``Multiple Endpoints in Clinical Trials; Draft
Guidance for Industry; Availability.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper

submission. You should submit two copies total. One copy will include
the information you claim to be confidential with a heading or cover
note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.''
The Agency will review this copy, including the claimed confidential
information, in its consideration of comments. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets
Management. If you do not wish your name and contact information to be
made publicly available, you can provide this information on the cover
sheet and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Scott Goldie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 21, Rm. 3557, Silver Spring, MD 20993-0002, 301-
796-2055; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Multiple Endpoints in Clinical Trials.'' This guidance
describes various strategies for grouping and ordering endpoints for
analysis and applying some well-recognized statistical methods for
managing multiplicity within a study. FDA's International Conference on
Harmonization (ICH) guidance for industry ``E9 Statistical Principles
for Clinical Trials'' is a broad-ranging guidance that includes
discussion of multiple endpoints. This draft guidance provides greater
detail on the topic of multiple endpoints. The issuance of this draft
guidance represents partial fulfillment of an FDA commitment under the
Food and Drug Administration Amendments Act of 2007. (Title I of the
Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85)).
Under section XI (Expediting Drug Development) of the Prescription Drug
User Fee Act (PDUFA) Performance Goals, FDA agreed to develop and
publish for comment draft guidance on ``Multiple Endpoints in Clinical
Trials,'' and to complete the final guidance within one year of the
close of the public comment period of the PDUFA Performance Goals (see
http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119243.htm).
    Failure to account for multiplicity when there are several clinical
endpoints evaluated in a study can lead to false positive conclusions
regarding the effects of the drug. The regulatory concern regarding
multiplicity arises principally in the evaluation of clinical trials
intended to demonstrate effectiveness and support drug approval;
however, this issue is important throughout the drug development
process.
    The focus of this draft guidance is control of the Type 1 error
rate for the planned primary and secondary endpoints of a clinical
trial so that the major findings are well supported. Multiplicity
adjustments provide a means for controlling Type 1 error when there are
multiple analyses of the drug's effects. The issues of multiplicity and
methods to address them are illustrated in the draft guidance with
examples of different study endpoints. Both the issues and methods that
apply to multiple endpoints also apply to other sources of
multiplicity, including multiple doses, time points, or study
population subgroups.
    Once a trial is successful (demonstrates effectiveness or ``wins''
on the primary endpoint(s)), there are many other attributes of a
drug's effects that may be described. Analyses that describe these
other attributes of a drug can be informative and are often included in
physician labeling. Such descriptive analyses are not the subject of
this draft guidance and are not addressed in detail.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on multiple
endpoints in clinical trials. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.regulations.gov.

    Dated: January 10, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00695 Filed 1-12-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 224 (Wednesday, November 20, 2013)]
[Notices]
[Page 69694]
[FR Doc No: 2013-27771]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Changing Regulatory and Reimbursement Paradigms for Medical
Devices in the Treatment of Obesity and Metabolic Diseases: How To
Estimate and Reward True Patient-Centric Value in Innovation; Public
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Changing Regulatory and Reimbursement Paradigms for
Medical Devices in the Treatment of Obesity and Metabolic Diseases: How
to Estimate and Reward True Patient-Centric Value in Innovation.'' FDA
is cosponsoring the workshop with the American Gastroenterological
Association (AGA). The purpose of the workshop is to facilitate
discussion between FDA, AGA, and other interested parties of the
development of medical devices for the treatment of morbid obesity and
other metabolic diseases and evolving approaches for the regulation and
reimbursement of minimally invasive procedures. The public workshop is
being rescheduled due to the government shutdown. The title of the
workshop has also been changed.

Dates amd Times:  The public workshop will be held on December 19,
2013, from 8:30 a.m. to 5 p.m. and on December 20, 2013, from 8:30 a.m.
to 12:15 p.m.
    Location: The public workshop will be held at the Grand Hyatt
Washington, DC, 1000 H St. NW., Washington, DC 20001,<PHONE_NUMBER>.
    Contact Person: Herbert Lerner, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. G114, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    Registration: Registration is limited and is available on a first-
come, first-served basis. Persons interested in attending this public
workshop must register online by 4 p.m. (EDT), December 10, 2013.
Onsite registration will be available after this date. To register for
the public workshop, please visit the American Gastroenterological
Association (AGA) Web site: http://www.gastro.org/education-meetings/live-meetings/aga-fda-regulation-and-reimbursement-workshop. For more
information on the workshop, please see the FDA's Medical Devices News
& Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select
this public workshop from the posted events list.)
    The AGA will collect a registration fee to cover its share of the
expenses associated with the public workshop, which is included in the
registration information on the AGA Web site.
    If you need special accommodations due to a disability, please
contact Herbert Lerner (see Contact Person) at least 7 days before the
public workshop.

SUPPLEMENTARY INFORMATION:

I. Background

    The purpose of the public workshop is to facilitate discussion
between FDA, the AGA and other interested parties on the issues of
device development, public and private payer reimbursement, venture
capital, and regulatory pathways for device innovation and marketing.
The workshop will provide a forum for discussing new approaches for the
treatment of morbid obesity and other metabolic diseases as well as
evolving approaches for the regulation and reimbursement of minimally
invasive procedures.

II. Topics for Discussion at the Public Workshop

    Topics to be discussed at the public workshop include, but are not
limited to:
     Challenges to MedTech Innovation in the United States;
     Evolving Approaches for the Regulation of Minimally
Invasive Procedures: The FDA Benefit/Risk Paradigm;
     Evolving Approaches for the Reimbursement of Minimally
Invasive Procedures: How to Put a Price on Value;
     Obesity as a Disease: Redefining the Regulatory and
Reimbursement Context; and
     The ``Process''--Investigational Device Exemption Review.

    Dated: November 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27771 Filed 11-19-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: November 15, 2005 (Volume 70, Number 219)]
[Notices]
[Page 69332-69333]
[DOCID:fr15no05-48]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

November 7, 2005.
    Take notice that the Commission received the following electric
rate filings.

    Docket Numbers: ER01-316-018.
    Applicants: ISO New England Inc.
    Description: ISO New England, Inc submits its Index of Customers
for the third quarter of 2005.
    Filed Date: November 1, 2005.
    Accession Number: 20051103-0038.
    Comment Date: 5 p.m. eastern time on Tuesday, November 22, 2005.

    Docket Numbers: ER04-445-013.
    Applicants: California Independent System Operator Corporation.
    Description: The California Independent System Operator Corp
submits its long-term Standard Large Generator Interconnection
Procedures etc. pursuant to FERC's June 16, 2005 Order.
    Filed Date: November 1, 2005.
    Accession Number: 20051103-0065.
    Comment Date: 5 p.m. eastern time on Tuesday, November 22, 2005.

    Docket Numbers: ER04-445-014; ER04-435-018; ER04-441-010; ER04-443-
010.
    Applicants: California Independent System Operator; Pacific Gas and
Electric Company, San Diego Gas & Electric Company; Southern California
Edison Company.
    Description: California Independent System Operator Corp, Pacific
Gas & Electric Co et al. submit a long-term Standard Large Generator
Interconnection Agreement for approval as a pro forma agreement per
FERC's July 1, 2005 Order.
    Filed Date: November 1, 2005.
    Accession Number: 20051103-0096.
    Comment Date: 5 p.m. eastern time on Tuesday, November 22, 2005.

    Docket Numbers: ER05-1326-002.
    Applicants: Cornerstone Energy General Partners, LLC.
    Description: CornerStone Energy General Partners, LLC submits
Revised Sheet No. 2 to FERC Electric Tariff, Original Volume No. 1.
    Filed Date: October 31, 2005.
    Accession Number: 20051104-0300.
    Comment Date: 5 p.m. eastern time on Monday, November 21, 2005.

    Docket Numbers: ER05-718-004.
    Applicants: California Independent System Operator.
    Description: California Independent System Operator submits
compliance filing to clarify CAISO's authority to settle intertie
transactions.
    Filed Date: November 1, 2005.
    Accession Number: 20051103-0095.
    Comment Date: 5 p.m. eastern time on Tuesday, November 22, 2005.

    Docket Numbers: ER06-5-001.
    Applicants: CBK Group, LTD.
    Description: Petition of CBK Group Ltd for acceptance of amended
rate schedule, waivers and blanket authority.
    Filed Date: October 28, 2005.
    Accession Number: 20051104-0318.
    Comment Date: 5 p.m. eastern time on Friday, November 18, 2005.

    Docket Numbers: ER91-569-030; EL04-123-004; EL05-105-002; ER01-666-
006; ER02-862-006; ER01-1675-004; ER01-1804-005.
    Applicants: Entergy Services, Inc.
    Description: Entergy Services Inc on behalf of EWO Marketing LP et
al. submits a compliance filing pursuant to FERC's December 17, 2004
order.
    Filed Date: November 1, 2005.
    Accession Number: 20051104-0299.
    Comment Date: 5 p.m. eastern time on Tuesday, November 22, 2005.

    Docket Numbers: ER91-569-031; EL04-123-005; EL05-105-003.

    Applicants: Entergy Services, Inc.
    Description: Entergy Services, Inc. on behalf of Entergy Operating
Companies submits a compliance filing pursuant to FERC's 12/17/04
Order.
    Filed Date: November 1, 2005.
    Accession Number: 20051104-0322.
    Comment Date: 5 p.m. eastern time on Tuesday, November 22, 2005.

    Docket Numbers: ER99-3168-005; ER00-1463-005.
    Applicants: Astoria Generating Company Acquisitions; Orion Power
MidWest, LP.
    Description: Astoria Generating Co, LP & Orion Power MidWest, LP
submit revised tariff sheets to modify the prohibited transactions
section of their tariffs to state that they will not make sales or
purchases.
    Filed Date: November 1, 2005.
    Accession Number: 20051103-0098.
    Comment Date: 5 p.m. eastern time on Tuesday, November 22, 2005.

    Docket Numbers: ER99-3491-007; ER00-2184-005; ER00-2185-005; EL05-
124-002.
    Applicants: PP&L Montana, LLC.
    Description: PPL Montana, LLC et al. submits the Delivered Price
Test analyses in accordance with FERC's order issued September 1, 2005
in the triennial market-based rate update proceeding.
    Filed Date: October 31, 2005.
    Accession Number: 20051104-0325.
    Comment Date: 5 p.m. eastern time on Monday, November 21, 2005.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. 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. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    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 should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for 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 e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-6270 Filed 11-14-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 52 (Friday, March 17, 2023)]
[Notices]
[Pages 16515-16516]
[FR Doc No: 2023-05434]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No.: FAA-2022-1186; Summary Notice No.--2023-04]

Petition for Exemption; Summary of Petition Received; Faith
Lutheran Oder Family Flight Academy

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

ACTION: Notice.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, the FAA's exemption process. Neither publication of
this notice nor the inclusion nor omission of information in the
summary is intended to affect the legal status of the petition or its
final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before April 6, 2023.

ADDRESSES: Send comments identified by docket number FAA-2022-1186
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue SE, Room W12-140,
West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Nia Daniels,<PHONE_NUMBER>, Office of
Rulemaking, Federal Aviation Administration, 800 Independence Avenue
SW, Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC.
Angela O. Anderson,
Director, Regulatory Support Division, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2022-1186.
    Petitioner: Faith Lutheran Oder Family Flight Academy.
    Section of 14 CFR Affected: Sec. Sec.  61.123(a), 61.213(a)(1).
    Description of Relief Sought: The Faith Lutheran Oder Family Flight

Academy seeks an exemption from Title 14 Code of Federal Regulations
Sec. Sec.  61.123(a) and 61.213(a)(1) that would allow their students
who hold a private pilot certificate and are 17 years of age to be
eligible for a commercial pilot certificate and a ground instructor
certificate.

[FR Doc. 2023-05434 Filed 3-16-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: May 26, 2010 (Volume 75, Number 101)]
[Notices]
[Page 29560-29561]
[DOCID:fr26my10-63]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0237]

Identifying Unmet Public Health Needs and Facilitating Innovation
in Medical Device Development; Notice of Public Workshop; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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

    The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Identifying Unmet Public Health Needs and
Facilitating Innovation in Medical Device Development.'' The purpose of
the workshop is to obtain public input on what are the most important
unmet public health needs and what are the barriers to the development
of medical devices that can cure, significantly improve, or prevent
these illnesses and injuries.
    Dates and Times: This workshop will be held on June 24, 2010, from
8 a.m. to 5 p.m. Persons interested in attending the meeting must
register by 5 p.m. on June 10, 2010. Submit electronic or written
comments by July 23, 2010.
    Location: The public workshop will be held at Hilton Washington DC/
North Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877.
    Contact Person: Melanie Fleming, Office of the Center Director,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5407, Silver
Spring, MD 20993,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Registration and Requests for Oral Presentations: Interested
persons may register at http://www.fda.gov/MedicalDevices/NewsEvents/
WorkshopsConferences/default.htm (select the appropriate meeting from
the list). Registrants must provide the following information: (1)
name, (2) title, (3) company or organization (if applicable), (4)
mailing address, (5) telephone number, and (6) e-mail address. There is
no registration fee for the public workshop. Early registration is
recommended because seating is limited. Registration on the day of the
public workshop will be provided on a space available basis beginning
at 7:30 a.m.
    If you wish to make an oral presentation during any of the open
comment sessions at the meeting (see section II of this document), you
must indicate this at the time of registration. FDA requests that
presentations focus on the areas defined in section III of this
document. You should also identify which discussion topic you wish to
address in your presentation and you must submit a brief statement that
describes your experience and/or expertise relevant to your proposed
presentation. In order to keep each open session focused on the
discussion topic at hand, each oral presentation should address only
one discussion topic. FDA will do its best to accommodate requests to
speak.
    If you need special accommodations due to a disability, please
contact Melanie Fleming (see Contact Person) at least 7 days in
advance.
    Comments: FDA is holding this public workshop to obtain information
on a number of specific questions regarding unmet public health needs
and steps the Federal Government can take to reduce barriers to the
development of medical devices that can cure, significantly improve, or
prevent these illnesses and injuries. The deadline for submitting
comments regarding this public workshop is July 23, 2010.
    Regardless of attendance at the public workshop, interested persons
may submit electronic comments to http://www.regulations.gov, or
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. In addition, when responding to specific questions as
outlined in section III of this document, please identify the question
you are addressing. Received comments may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA's Center for Devices and Radiological Health (CDRH) has
undertaken an initiative to proactively facilitate medical device
innovation to address unmet public health needs defined as illnesses
and injuries that meet the following criteria: (1) Are serious or have
moderate adverse impact on health, but affect many individuals; (2)
could be cured, significantly improved, or prevented by the development
or redesign of a device; and (3) the device(s) is not being developed
or redesigned due to barriers that the Federal Government can directly
or indirectly remove or minimize, where those barriers are out of
proportion to what is warranted based on the public health needs.
    Medical device development and/or redesign is responsible for
significant public health benefits, including the prevention,
treatment, diagnosis, and monitoring of serious or life-threatening
diseases and improved quality of life. However, unnecessary barriers to
market may exist either due to market failures or regulatory
inefficiencies. For example, payment practices can affect financial
incentives for manufacturers to develop a new or improved technology. A
predictable and consistent regulatory pathway can encourage would-be
innovators to invest in the development of an innovative device.
    As part of this initiative, CDRH established a Council on Medical
Device Innovation composed of participants from federal agencies.
Agencies represented include the National Institutes of Health, the
Centers for Disease Control and Prevention, the Centers for Medicare
and Medicaid Services, the Agency for Healthcare Research and Quality,
the Department of Defense, the Defense Advanced Research Projects
Agency, and the Department of Veterans Affairs. The purpose of the
Council is to identify the most important unmet public health needs,
the barriers to innovative medical device development or redesign that
could address those needs, and actions the Federal Government can

take to reduce those barriers while assuring the safety, effectiveness,
and quality of medical devices marketed in the United States.
    The Council seeks input from a wide range of constituencies to
include but not be limited to industry, academia, patient/consumer
advocacy groups, professional organizations, and other State and
Federal bodies under aligned public health missions, to address the
issues outlined in this document.
    During the public workshop, there will be an open dialogue between
Federal Government Council members and experts from the private and
public sectors regarding the topics described in this document.
Workshop participants will not be expected to develop consensus
recommendations, but rather to provide their perspectives on priority
areas in which medical device innovations can have the highest positive
impact on public health. Participants will also be encouraged to
comment on devices not being developed or redesigned due to barriers
that the Federal Government can and should directly or indirectly
remove or minimize.
    Additional information on the public workshop, including an agenda,
will be made available in advance of June 24, 2010, at http://
www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm
(select the appropriate meeting from the list).

II. Public Participation

    If you wish to make an oral presentation during the public
workshop, you must indicate this at the time of registration. There are
two types of opportunities for participation planned for the public
workshop. In one, formal presentations will address one of the two
topics (see section III of this document) that will be limited to 15
minutes and require submission of the presentation in advance of the
meeting. The other will be time-limited, based on the number of
requests, as part of the public comment period. When registering, you
will be required to identify the title of the topic you wish to address
in your presentation and answer all the related questions on the web
registration form. FDA will do its best to accommodate requests to
present and will focus discussions to the topics described in this
document (see section III of this document). Individuals and
organizations with common interests are urged to consolidate or
coordinate their presentations, and to request time for joint
presentations. FDA will determine the amount of time allotted to each
presenter and the approximate time that each oral presentation is to
begin.

III. Issues for Discussion

    The workshop will focus on three topics: (1) Identification of the
most important unmet public health needs; (2) delineation of the
barriers to the development, redesign, and patient and healthcare
professional access to medical devices that can cure, significantly
improve, or prevent these illnesses or injuries; and (3) identification
of the actions the Federal Government can take to remove or minimize
these barriers. The discussion of these general topics should not be
limited by current statutes or regulations and will include, but not be
limited to, discussion of the following questions:
    1. Identifying areas of public health need:
    a. Which unmet public health needs could be most effectively
addressed by the development of new, or the redesign of existing,
medical devices?
    b. How should the Council set priorities amongst the identified
public health needs? Are there specific factors that should be
considered? If so, which and why?
    2. Addressing barriers to development and/or redesign of medical
devices:
    a. What are the significant barriers facing innovators, academics,
and/or industry that limit the availability and clinical use of medical
devices that have the potential to improve public health?
    b. How should any perceived or actual barriers be evaluated to
determine whether federal intervention is appropriate?
    c. How should federal agencies--including those present and others
not represented--address those barriers that are out of proportion to
what is warranted based on the public health needs?

IV. Transcripts

    Please be advised that as soon as a transcript is available, it can
be obtained in either hardcopy or on CD-ROM, after submission of a
Freedom of Information request. Written requests are to be sent to
Division of Freedom of Information (HFI-35), Office of Management
Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30,
Rockville, MD 20857. A transcript of the public workshop will be
available on the Internet at http://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/default.htm (select the appropriate
meeting from the list).

    Dated: May 20, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-12588 Filed 5-25-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 88, Number 118 (Wednesday, June 21, 2023)]
[Notices]
[Pages 40253-40254]
[FR Doc No: 2023-13163]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER23-2130-000]

Glover Creek Solar, 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
Glover Creek Solar, 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 July 5, 2023.
    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>.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: June 14, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-13163 Filed 6-20-23; 8:45 am]
BILLING CODE 6717-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but due to the short time period to file my response; my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching these issues, but it takes time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public six months to comment on it, not just 75 days. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all people this will affect have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


[Federal Register Volume 82, Number 8 (Thursday, January 12, 2017)]
[Notices]
[Pages 3798-3799]
[FR Doc No: 2017-00496]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]

Joint Meeting of the Ophthalmic Devices Panel of the Medical
Devices Advisory Committee and the Risk Communication Advisory
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Ophthalmic Devices Panel of
the Medical Devices Advisory Committee and the Risk Communication
Advisory Committee. The general function of the committee is to provide
advice and recommendations to the Agency on FDA's regulatory issues.
The meeting will be open to the public.

DATES: The meeting will be held on March 17, 2017, from 7:30 a.m. to 4
p.m.

ADDRESSES: Hilton Washington, DC North/Gaithersburg, Salons A, B, C,
and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's phone
number is<PHONE_NUMBER>. Answers to commonly asked questions including
information regarding special accommodations due to a disability,
visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Aden S. Asefa, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G642, Silver Spring, MD 20993-0002,
<EMAIL_ADDRESS>301-796-0400, or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: On March 17, 2017, the committee will discuss and make
recommendations regarding the potential risks of misuse of peroxide-
based contact lens products. Specific issues to be discussed include
adequate labeling and packaging of these over-the-counter products.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
March 2, 2017. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before February 22, 2017. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by February 23, 2017.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact AnnMarie Williams at<EMAIL_ADDRESS>or 301-796-
5966 at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/

ucm111462.htm for procedures on public conduct during advisory
committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: January 6, 2017.
Janice M. Soreth,
Associate Commissioner, Special Medical Programs.
[FR Doc. 2017-00496 Filed 1-11-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 69 (Thursday, April 10, 2014)]
[Notices]
[Page 19959]
[FR Doc No: 2014-08068]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Notice of Applications for Certificates of Public Convenience and
Necessity and Foreign Air Carrier Permits Filed Under Subpart B
(Formerly Subpart Q) During the Week Ending March 29, 2014

    The following Applications for Certificates of Public Convenience
and Necessity and Foreign Air Carrier Permits were filed under Subpart
B (formerly Subpart Q) of the Department of Transportation's Procedural
Regulations (See 14 CFR 301.201 et. seq.). The due date for Answers,
Conforming Applications, or Motions to Modify Scope are set forth below
for each application. Following the Answer period DOT may process the
application by expedited procedures. Such procedures may consist of the
adoption of a show-cause order, a tentative order, or in appropriate
cases a final order without further proceedings.
    Docket Number: DOT-OST-2014-0038.
    Date Filed: March 25, 2014.
    Due Date for Answers, Conforming Applications, or Motion to Modify
Scope: April 15, 2014.
    Description: Application of Grossmann Jet Service spol. s.r.o.
requesting a foreign air carrier permit and corresponding exemption
authority to the full extent authorized by the Air Transport Agreement
by the United States and the European Community and its Member States
to enable it to engage in: (i) Foreign charter air transportation of
persons, property and mail from any point or points behind any Member
State of the European Union via any point or points in any Member State
and via intermediate points to any point or points in the United States
and beyond; (ii) foreign charter air transportation of persons,
property and mail between any point or points in the United States and
any point or points in any member of the European Common Aviation Area
(``ECAA''); (iii) other charters; and (iv) transportation authorized by
any additional route rights made available to European Community
carriers in the future.

    Docket Number: DOT-OST-2014-0041.
    Date Filed: March 28, 2014.
    Due Date for Answers, Conforming Applications, or Motion to Modify
Scope: April 18, 2014.
    Description: Application of Qatar Executive requesting a foreign
air carrier permit and related exemption that would enable it to
provide charter foreign air transportation of persons, property and
mail between any point or points in Qatar and any point or points in
the United States; and between any point or points in the United States
and any point or points in a third country or countries, provided that,
except with respect to cargo charters, such service constitutes part of
a continuous operation, with or without a change of aircraft, that
includes service to Qatar for the purposes of carrying local traffic
between Qatar and the U.S.

Barbara J. Hairston,
Supervisory Dockets Officer, Docket Operations, Federal Register
Liaison.
[FR Doc. 2014-08068 Filed 4-9-14; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 81, Number 186 (Monday, September 26, 2016)]
[Notices]
[Page 66006]
[FR Doc No: 2016-23023]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER16-2601-000]

Summit Farms Solar, 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
Summit Farms Solar, 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 October 11, 2016.
    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 should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also 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>.

    Dated: September 19, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-23023 Filed 9-23-16; 8:45 am]
 BILLING CODE 6717-01-P


September 22, 2003

MEMORANDUM

TO:		Kristina Meson

FROM:	Earl Harris, Maribelle Rodríguez, and Steven Tom

SUBJECT:	Revised Draft Comparative Analysis of the OSHA Laboratory
Standard and the RCRA Hazardous Waste Generator Regulations;

Task 3, Work Assignment Number 1-19, Contract Number 68-W-02-006

This memorandum presents ICF’s comparative analysis of the OSHA
Laboratory Standard at 29 CFR 1910.1450 and the RCRA hazardous waste
generator regulations at 40 CFR part 262 as they pertain to
laboratories.  The memorandum is organized into the following sections:

Section 1 presents an overview of regulatory programs applicable to
laboratories.

Section 2 presents an overview of the OSHA Lab Standard.

Section 3 discusses the applicability of the Lab Standard and RCRA
generator requirements to laboratories.

Section 4 examines the potential overlap between the Lab Standard and
RCRA generator requirements.

Section 5 discusses enforcement capabilities and difficulties of  the
OSHA Lab Standard.

Section 6 summarizes the findings of the comparative analysis.

In reviewing our analysis, it is important to keep in mind the
differences between the two regulatory programs.  For example, the goal
of the OSHA Laboratory Standard is to protect employees from workplace
safety and health hazards.  The goal of the RCRA generator regulations
is to protect human health and the environment from the threats of
hazardous waste.  Hence, these two programs differ in scope and
objectives and any discussion of a regulatory “gap” or “overlap”
should be interpreted in this context.

Please do not hesitate to contact Earl Harris at<PHONE_NUMBER> or
Maribelle Rodríguez at<PHONE_NUMBER> with questions or comments.

1.	Overview of Federal Regulatory Programs Applicable to Laboratories

Laboratories may be subject to a number of Federal regulatory programs,
depending on the types of activities performed, materials handled, and
impacts to human health and the environment.  Examples of EPA programs
include:

Subtitle C of the Resource Conservation and Recovery Act, as amended
(RCRA).  Laboratories that generate, transport, treat, store, or dispose
of hazardous waste are subject to RCRA, as specified.  In particular,
laboratories generating more than 100 kilograms of hazardous waste in a
calendar month are subject to the hazardous waste generator standards at
40 CFR part 262.

Clean Air Act (CAA).  Laboratories may be subject to regulation under
the CAA for fugitive emissions (e.g., solvents, volatile organics, or
emissions from other chemicals that evaporate from their work areas).
In addition, some laboratories also may be subject to a Title V
operating permit if they are located in facilities that qualify as major
sources.

Clean Water Act (CWA).  Laboratories that discharge to public treatment
works may need to treat their effluent before discharging it (e.g.,
flammable or explosive pollutants, solids and viscous pollutants that
may cause an obstruction of flow).  Laboratories that discharge to
surface water may be required to obtain a National Pollutant Discharge
Elimination System (NPDES) permit.

Toxic Substances Control Act (TSCA).  Laboratories who import
TSCA-covered chemicals must comply with import certification
requirements and may be subject to export notification requirements if
exporting TSCA chemicals.  In addition, laboratories may be using
polychlorinated byphenils (PCB)-containing equipment (e.g.,
transformers) and PCB-containing materials that must be labeled, stored,
and disposed of in accordance with TSCA.

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  In support
of pesticide registration requirements, manufacturers may require labs
to conduct analysis on pesticides ranging from product chemistry and
performance to environmental fate and transport.  Labs testing
pesticides are subject to FIFRA Good Laboratory Practice Standards at 40
CFR part 160.

Emergency Response and Community Right-to-Know Act (EPCRA).
Laboratories required to have material safety data sheets (MSDSs) for
hazardous chemicals under OSHA regulations may be required to submit
copies of their MSDSs and an annual inventory report of these chemicals
to the State Emergency Response Commission (SERC), the Local Emergency
Planning Committee (LEPC), and the local fire department.  In addition,
they must report accidental releases of these chemicals to emergency
planning authorities.  Laboratories also may be subject to Toxic Release
Inventory (TRI) reporting.

Other Federal agencies implementing regulatory programs that may apply
to laboratories include:

OSHA.  Laboratories may be subject to a number of different OSHA
regulations, including:

-	“Laboratory Standard” at 29 CFR 1910.1450.

-	“Recording and Reporting Occupational Injuries and Illnesses” at
29 CFR part 1904.

-	“Personal Protective Equipment” at 29 CFR part 1910, subpart I.

-	“Access to Employee Exposure and Medical Records” at 29 CFR
1910.1020.

-	“Hazard Communication” at 29 CFR 1910.1200.  The basic goal of the
Hazard Communication Standard is to ensure that employers and employees
know about health and physical hazards posed by chemicals at the
workplace.  The standard applies to all employers with hazardous
chemicals at their workplace, except as otherwise specified.  This has
important implications for employees and activities associated with a
lab. For example, in some instances, a lab worker might be covered by
both the Hazard Communication Standard and the Lab Standard.  The Hazard
Communication Standard would apply while outside the laboratory (e.g.,
transferring a hazardous chemical to another lab).  The Lab Standard
would apply while inside the laboratory.  In addition, some laboratories
(e.g., production laboratories) are subject to the Hazard Communication
Standard, not the Lab Standard.

-	“Hazardous Waste Operations and Emergency Response” (HAZWOPER) at
29 CFR 1910.120.  The HAZWOPER Standard applies to employees who are
exposed or potentially exposed to hazardous substances, including
hazardous waste, and who are engaged, among other things, in operations
involving the storage of hazardous waste.  Laboratories that generate
and accumulate hazardous waste in the laboratory may be subject to the
emergency response program requirement at 29 CFR 1910.120(p)(8).

U.S. Nuclear Regulatory Commission (NRC).  Laboratories using gas
chromatographs, which contain 63Nickel, may be subject to NRC licensing.
 Laboratories using radiation-producing devices (e.g., X-ray equipment,
electron microscopes) also may be subject to NRC regulations.

U.S. Department of Health and Human Services (DHHS).  DHHS regulates the
handling and disposal of human pathogens used in laboratories.  DHHS
also is responsible for regulating the possession, use, and transfer of
select biological agents and toxins (i.e., select agents) that could
pose a threat to public health and safety.

U.S. Department of Agriculture (USDA).  USDA restricts the handling and
disposal of animal pathogens.  USDA also is responsible for regulating
the possession, use, and transfer of select agents that could pose a
threat to animal and plant health.

U.S. Department of Transportation (DOT).  DOT regulates activities
associated with the transportation of hazardous materials.  For example,
DOT regulates the transport of lab packs, a type of container used to
ship laboratory waste to treatment or disposal facilities.

2.	Overview of OSHA Laboratory Standard

OSHA promulgated the Laboratory Standard after recognizing that
laboratories typically differ from industrial operations in the use and
handling of hazardous chemicals and that a different approach than that
found in OSHA’s General Industry Standards was warranted to protect
workers.  The Lab Standard applies to employers engaged in the
“laboratory use of hazardous chemicals” as defined at 29 CFR
1910.1450(b).  Put another way, the standard defines a “laboratory”
as any facility that meets the definition of “laboratory use of
hazardous chemicals.”  OSHA further clarifies that a “lab” is a
workplace where relatively small quantities of hazardous chemicals are
used on a non-production basis (e.g., a room in which chemical
manipulation and/or experimentation occurs).

If a facility does not satisfy the definition of “laboratory use of
hazardous chemicals,” it is not considered a “laboratory” under
the standard and is not covered by it.  Laboratories not meeting the
definition of “laboratory use of hazardous chemicals” are covered
under the Hazard Communication Standard at 29 CFR 1910.1200.

Employees are covered by the Lab Standard if they may be exposed to
hazardous chemicals in a laboratory in the course of their assignments.
Refer to Section 3 of this memorandum for a fuller discussion of the
applicability criteria of the Lab Standard.

The Lab Standard lays out a number of performance-based requirements
applicable to laboratories.  These are shown in Exhibit 1.  Laboratories
covered by the standard must maintain employee exposures at or below the
permissible exposure limits (PELs) specified in 29 CFR part 1910,
subpart Z.  They also must develop and implement a Chemical Hygiene Plan
(CHP).  The CHP must include the necessary work practices, procedures,
and policies to ensure that employees are protected from all potentially
hazardous chemicals in use in their work area.  It is used to implement
the requirements under the standard.  Laboratories must comply with
inspection, employee information and training, medical consultation and
examinations, hazard identification, respirator use, and recordkeeping
requirements.  Refer to Section 4 of this memorandum for a fuller
description of these requirements.

In addition, the Lab Standard lays out recommended practices that
laboratories may use in developing their CHPs.  Laboratories incorporate
recommendations into their CHP at their discretion.  The recommendations
cover aspects of laboratory operations such as general rules for working
with laboratory chemicals, proper housekeeping, and waste disposal.
Once a recommendation is incorporated into the CHP, it is expected that
the laboratory will follow it.  If an OSHA compliance inspector
performing an inspection finds that a recommendation is not being
followed, the laboratory may face enforcement action.  It appears that
OSHA’s authority to enforce the recommendation may derive from the
mandatory elements of the standard, rather than the voluntary inclusion
of a recommended practice.  For example, if a laboratory’s CHP
contains a recommended provision for proper housekeeping and an OSHA
compliance inspector finds that an employee’s work area is unclean and
cluttered with chemicals and equipment, the laboratory may be cited
under the training requirement at 29 CFR 1910.1450(f) for not providing
proper training on housekeeping.  In addition, a compliance inspector
may indicate the need for the CHP to be revised to include additional
provisions.

Exhibit 1

Elements of the OSHA Laboratory Standard

Elements of the OSHA Laboratory Standard

Regulatory Citation at 29 CFR

Mandatory Requirements

Monitoring of employees’ chemical exposure

1910.1450(c) and (d)

Chemical Hygiene Plan

1910.1450(e)

-	Standard operating procedures

1910.1450(e)(3)(i)

-	Measures to reduce employee exposure to hazardous chemicals

1910.1450(e)(3)(ii) and (i)

-	Inspection

1910.1450(e)(3)(iii)

-	Information sharing with employees

1910.1450(e)(3)(iv) and 1910.1450(f)

-	Training

1910.1450(e)(3)(iv) and 1910.1450(f)

-	Medical consultation and examinations

1910.1450(e)(3)(vi) and 1910.1450(g)

-	Other CHP elements

1910.1450(e)(3)(v), (vii), (viii)

Labeling

1910.1450(h)(1)(i)

Hazard identification

1910.1450(h)(2)

Recordkeeping

1910.1450(e), (h)(1)(ii), and (j)

Recommended Practices for Inclusion in the CHP (Not Mandatory) a

Procedures/methods to assure that minimal harm to people, other
organisms, and the environment will result from the disposal of waste
laboratory chemicals.

1910.1450, Appendix A

Procedures on how waste is to be collected, segregated, stored, and
transported and consideration of what materials can be incinerated.
Transportation must be in accordance with DOT regulations.

1910.1450, Appendix A

Procedures for the prompt disposal of unlabeled containers.

1910.1450, Appendix A

Frequency of disposal, e.g., procedures for weekly removal of waste from
laboratories to a central consolidation area; and prompt removal from
the central area.

1910.1450, Appendix A

Method of disposal, e.g., recommendation for using incineration as an
environmentally acceptable manner of disposal for combustible laboratory
waste; and recycling or chemical decontamination as a preferred method
of disposal.

1910.1450, Appendix A

a  “Recommended Practices” in this table includes examples of
recommendations on proper waste disposal.

3.	Applicability of the OSHA Laboratory Standard and the RCRA Generator
Regulations to Laboratories

In this section, we compare the applicability criteria of the Lab
Standard and the RCRA generator regulations to laboratories.  The
purpose of the comparison is to identify the extent to which the Lab
Standard and the RCRA generator regulations apply to the same universe
of laboratories.

To determine whether a laboratory is subject to the OSHA Lab Standard,
it is necessary to refer to at least two sets of applicability criteria.
 The Occupational Safety and Health Act of 1970 (the “OSH Act”)
defines the general applicability criteria that determine whether an
employer is subject to OSHA’s regulatory jurisdiction.  If an employer
is in fact subject to OSHA’s regulatory jurisdiction, the next
question is whether it is subject to the Lab Standard.

Section 3.1 describes the general applicability criteria of the OSH Act.
 Section 3.2 describes the applicability criteria of the Lab Standard to
laboratories.  Section 3.3 compares the applicability criteria of the
Lab Standard and RCRA generator regulations to laboratories.  Section
3.4 describes the applicability of the OSHA Laboratory Standard to the
primary types of personnel associated with laboratory operations.

3.1	General Applicability Criteria of the OSH Act

The OSH Act establishes a Federal program to protect employees against
workplace safety and health hazards.  It also created OSHA, an agency of
the U.S. Department of Labor whose sole responsibility is worker safety
and health protection.  As shown in Exhibit 2, there are a number of
questions that need to be asked to determine whether an employer is
subject to OSHA’s regulatory jurisdiction:

Are you an employer in the private or public sector?  OSHA has
regulatory jurisdiction over private sector employers, except in limited
circumstances.  OSHA has limited jurisdiction over employers in the
public sector.

Are you a Federal or State/local employer?

-	Federal employers.  OSHA has regulatory jurisdiction over Federal
employers and employees, except for the military, pursuant to Executive
Order 12196 (February 26, 1980).  The Department of Defense is
responsible for prescribing and enforcing standards affecting the
working conditions of military personnel.

-	State/local government employers.  State and local government workers
are excluded from Federal coverage under the OSH Act.  However, States
operating their own State workplace safety and health programs under
plans approved by OSHA are required to extend their coverage to public
sector (State and local government) workers in the State.  There are
currently 26 States with OSHA-approved programs.

Exhibit 2

Who is Subject to OSHA’s Regulatory Jurisdiction? a

a  Includes Federal OSHA and States with approved plans.

b  Includes a few exceptions (e.g., the self-employed are not regulated
by OSHA).

c  Note that the OSHA standards do not apply to the working conditions
of employees if these working conditions are

covered under occupational safety and health standards of other Federal
agencies.

Based on the above discussion, Exhibit 3 identifies employers that are
and are not subject to OSHA’s regulatory jurisdiction.

Exhibit 3

Employers Subject to OSHA’s Regulatory Jurisdiction a

Sector

Subject to OSHA’s Regulatory Jurisdiction?

Private b

In

Public b

Military

Out

Federal, non-military

In

State/local government employers in States with OSHA-approved plans

In

State/local government employers in States without OSHA-approved plans

Out

a  Includes Federal OSHA and States with approved plans.

b  There are exceptions.  For example, the OSHA standards do not apply
to the working

conditions of employees if these working conditions are covered under
occupational safety

and health standards of other Federal agencies.

3.2	Applicability Criteria of the OSHA Laboratory Standard to
Laboratories

As shown in Exhibit 4, there are certain criteria that need to be met to
be covered under the Lab Standard:

The employer must be subject to OSHA’s regulatory jurisdiction (as
described above); and

The employer must meet the definition of “laboratory use of hazardous
chemicals” as defined at 29 CFR 1910.1450(b).  Specifically, the
employer must meet the following criteria:

-	Chemical manipulations are carried out on a “laboratory scale.”
As defined in the standard, the term “laboratory scale” means work
with substances in which the containers used for reactions, transfers,
and other handling of substances are designed to be easily and safely
manipulated by one person.  It excludes those workplaces whose function
is to produce commercial quantities of materials;

-	Multiple chemical procedures or chemicals are used; and

-	The procedures involved are not part of a production process, nor in
any way simulate a production process.  The term “production” means
an operation where a product is produced (e.g., refineries,
utility-generating companies, manufacturing plants).  OSHA has
indicated, for example, that most quality control laboratories are not
expected to meet the “lab use” definition.  OSHA reasoned that
quality control laboratories are usually adjuncts of production
operations which typically perform repetitive procedures for the purpose
of assuring reliability of a product or a process.  As another example,
OSHA indicated that pilot plant operations are typically closely
connected with production processes.  Such operations would fall outside
the scope of the standard because they fail to meet the “lab use”
definition which precludes laboratory operations that are part of a
production process or in any way simulate a production process.  OSHA
noted, however, that there could be exceptions wherein both quality
control or pilot scale labs do, in fact, qualify for the Lab Standard
(e.g., in cases where their operations are solely dedicated to research
unconnected to production).

Exhibit 4 presents a simple flow diagram to identify who is subject to
the OSHA Laboratory Standard.

Exhibit 4

Who is Subject to the OSHA Laboratory Standard?

Based on the above discussion and flow diagram, the following
observations can be reached:

Laboratories meeting the definition of “lab use of hazardous
chemicals,” as defined at 29 CFR 1910.1450(b), qualify as a
“laboratory” under the Lab Standard and are covered by it.
Examples of these labs include:

-	Laboratories which monitor for environmental compliance (e.g., air
emissions, waste water quality) from a manufacturing or other process.

-	Research labs that otherwise meet the “lab use” definition.

-	Bench-scale operations that look at substitutes for processes.  Note
that OSHA has pointed out that, in most cases, these operations are
considered research and not quality control related to production;
therefore, they are within the scope of coverage of the Laboratory
Standard if all of the criteria for coverage are met.

Laboratories that do not meet the definition of “lab use of hazardous
chemicals,” as defined at 29 CFR 1910.1450(b), do not qualify as a
“laboratory” under the Lab Standard and are thus not covered by it.
Examples of laboratories that do not meet the “lab use” definition
include:

-	Laboratories involved in the production of a chemical for commercial
use.

-	Laboratories that use various hazardous chemicals to perform routine,
standardized tests which monitor and support production processes (e.g.,
metal analyses on steel and cast iron samples or concentration
measurements of coolants for machining).

-	Because they are producing a product (i.e., electricity), an
electrical power generation facility’s water treatment laboratories
that conduct quality assurance monitoring used for process control
information.

-	Small medical labs that solely draw blood, so long as the labs are
just drawing blood and are not performing other activities, since
biological hazards are not within the scope of 29 CFR 1910.1450.

-	Labs that use toxic materials just for calibration.  If the
calibration is performed for the purpose of quality control of
production processes, then the labs are not within the scope of
coverage.

3.3	Applicability of the OSHA Laboratory Standard and the RCRA Generator
Regulations to Laboratories

Sections 3.1 and 3.2 lay out the criteria for determining whether an
employer is covered under the OSHA Lab Standard.  This involves
basically a two-step process of first determining if it is subject to
OSHA jurisdiction and then whether it is subject to the OSHA Lab
Standard in particular.  As described in Section 3.1, OSHA’s
regulatory jurisdiction extends to private sector organizations with few
exceptions, but it exercises limited jurisdiction over certain Federal
(e.g., military entities) and State/local organizations as specified.
Further, Section 3.2 indicates that employers subject to OSHA regulatory
jurisdiction that meet the definition of “lab use” are considered
“labs” for purposes of the OSHA standard and are thus covered by it.
 Labs that do not meet the “lab use” definition (e.g., labs involved
in quality control of a production process) are not covered by the
Laboratory Standard.  These laboratories are covered under the Hazard
Communication Standard at 29 CFR 1910.1200.

Under the RCRA program, EPA’s and authorized States’ regulatory
jurisdiction extends to potentially any organization (e.g., government,
business, not-for-profit institution) that generates, transports,
treats, stores, or disposes of hazardous waste as defined at 40 CFR
261.3, regardless of sector.  Further, any laboratory that generates
such hazardous waste in quantities exceeding EPA’s quantity generation
thresholds is subject to regulation as a hazardous waste generator under
40 CFR part 262.  40 CFR 261.5 and 262.34 lay out the quantity
thresholds that determine whether an entity qualifies as a conditionally
exempt small quantity generator (CESQG), small quantity generator (SQG),
or large quantity generator (LQG) for purposes of part 262 regulation.
In general, a laboratory in the public or private sector that generates
hazardous waste in a quantity exceeding 100 kilograms in a calendar
month is subject to the generator standards of part 262.

In view of the above discussion, it can be concluded that the OSHA Lab
Standard and RCRA generator standards apply to a number of the same
types of laboratories.  However, their coverage is not identical.
Exhibit 5 summarizes and contrasts the coverage of the two programs in
regard to labs.  Specifically, it indicates whether a lab would be
subject to the OSHA Lab Standard, RCRA generator standards, both, or
neither, based on (1) its sector; (2) whether it meets the definition of
“lab use” under the standard; and (3) whether it is a non-generator
or a CESQG, SQG, or LQG as defined by RCRA.  Following are examples of
what the exhibit indicates:

A laboratory in the private sector that meets the definition of “lab
use” (e.g., a lab using OSHA hazardous chemicals that is involved
solely in environmental compliance testing) and qualifies as a SQG or
LQG is regulated under both sets of regulations.

A laboratory operated by only military personnel is not subject to the
OSHA Lab Standard, but is subject to RCRA if it qualifies as a SQG or
LQG.

A laboratory that is part of a State government with an OSHA-approved
Plan, meets the “lab use” definition, and qualifies as a SQG or LQG
is subject to both sets of regulations.

A laboratory that does not meet the definition of “lab use” (e.g., a
lab that performs quality control as part of a production process) is
not subject to the OSHA Lab Standard under any circumstances, but would
be subject to RCRA if it qualifies as a SQG or LQG.

A laboratory in a State-owned university in a State without an
OSHA-approved plan is not subject to OSHA’s regulatory jurisdiction,
but is subject to RCRA if it qualifies as a SQG or LQG.

.

Exhibit 5

Applicability of the OSHA Laboratory Standard and the RCRA Generator
Regulations to Laboratories

Sector

Meets “Lab Use” Definition

Does Not Meet “Lab Use” Definition

Non-Generator

CESQG

SQG

LQG

Non-Generator

CESQG

SQG

LQG

Private a

Lab Standard

Lab Standard

Both

Both

Neither

Neither

RCRA

Generator Regulations

RCRA

Generator Regulations

Public a

Military

Neither

Neither

RCRA

Generator Regulations

RCRA

Generator Regulations

Neither

Neither

RCRA

Generator Regulations

RCRA

Generator Regulations

Federal, non-military

Lab Standard

Lab Standard

Both

Both

Neither

Neither

RCRA

Generator Regulations

RCRA

Generator Regulations

State/local government employers in States with OSHA-approved plans

Lab Standard

Lab Standard

Both

Both

Neither

Neither

RCRA

Generator Regulations

RCRA

Generator Regulations

State/local government employers in States without OSHA-approved plans

Neither

Neither

RCRA

Generator Regulations

RCRA

Generator Regulations

Neither

Neither

RCRA

Generator Regulations

RCRA

Generator Regulations

a  There are exceptions.  For example, the OSHA standards do not apply
to the working conditions of employees if these working conditions are
covered under occupational safety and health standards of other Federal
agencies.

3.4	Applicability of the OSHA Laboratory Standard to Personnel in a
Laboratory

Based on our review of the OSH Act, OSHA regulations, the preamble to
the Lab Standard Final Rule (55 FR 3300; January 31, 1990), and
interpretative memoranda, as well as conversations with OSHA enforcement
staff, we have identified examples of personnel who are potentially
subject to the Lab Standard.  Exhibit 6 identifies these personnel and
whether each would be covered under the Lab Standard.

Note that OSHA has clarified that, under the Lab Standard, an
“employee” is an individual employed in a laboratory workplace who
may be exposed to hazardous chemicals in the course of his or her
assignments.  Such individuals may actually work in the lab or because
of their work assignments may be required to enter a laboratory where
potential exposures may occur.  In the latter category, OSHA considers
maintenance and custodial personnel as meeting the definition of
employee.  The definition of employee would not include occasional
visitors to the laboratory such as guests or sales personnel.

Exhibit 6

Types of Personnel Covered under the OSHA Laboratory Standard a

Type of Personnel

Who Is Covered under the Lab Standard?

Comment

Lab worker

(

Employees who may be exposed to hazardous chemicals in a laboratory in
the course of their work assignments are covered under the Lab Standard

Contracted lab workers

(

Contracted individuals who may be exposed to hazardous chemicals in a
laboratory in the course of their work assignments are covered under the
Lab Standard.  The individual’s employer is responsible for complying
with the standard for his employees

Paid students working in a lab

(

If the student is an employee who may be exposed to hazardous chemicals
in a laboratory in the course of his work assignments, he is covered
under the Lab Standard

Unpaid students working in a lab

Unpaid students are not considered “employees” and hence are not
covered under OSHA’s jurisdiction

Office staff

	Depends.  See Comment

If the staff are employees who may be exposed to hazardous chemicals in
a laboratory in the course of his work assignments, they are covered
under the Lab Standard

Waste management staff

Depends.  See Comment

If the staff are employees who may be exposed to hazardous chemicals in
a laboratory in the course of their work assignments, they are covered
under the Lab Standard

a  Assumes the laboratory meets the definition of “laboratory use of
hazardous chemicals” at 29 CFR 1910.1450(b).

4.	Overlap Between the OSHA Laboratory Standard and the RCRA Hazardous
Waste Generator Regulations

In this section, we examine potential overlap and conflicts between the
OSHA Laboratory Standard and the RCRA generator regulations.  In
developing the analysis, we first identified the basic activities
associated with the use and management of laboratory chemicals and
waste, the location of these activities, and the employees potentially
conducting them.  We then identified the OSHA Lab Standard and RCRA
requirements that apply to each activity and employee.  We then
summarized this information in Exhibit 7.  The exhibit is helpful in
identifying the potential for conflict or overlap between the two sets
of regulations.  Note that the Laboratory Standard sets forth
performance-based requirements that employers must meet, whereas the
RCRA generator regulations are prescriptive.  Hence, it is difficult to
conclude whether conflict or duplication exists between the two sets of
regulations.

Exhibit 7 shows the basic sequence of activities involved in the use and
management of laboratory chemicals and waste.  First, the lab employee
(e.g., chemical researcher) uses hazardous chemicals in the lab (e.g.,
chemical manipulations in a room) (Activity 1).  Once the lab employee
finishes his chemical procedures, he determines the spent chemicals are
hazardous waste.  He then conducts satellite accumulation in the lab
(Activity 2).  Following this, the lab worker or a waste management
staff person picks up the waste from the lab and delivers it to the
90/180-day accumulation area (Activity 3).  Finally, the waste is
accumulated in the 90/180-day accumulation area, in accordance with RCRA
(40 CFR 262.34(a) or (d)), until shipment off site (Activity 4).

Exhibit 7

Activities Involved in the Use and Management of Laboratory Chemicals
and Waste

Employee Activities and Requirements

Applicable Regulations

  Pesticides are regulated under FIFRA until they are disposed, after
which they are regulated under RCRA.

  Laboratories subject to the Lab Standard are also potentially subject
to other OSHA regulations, such as those at 29 CFR parts 1904 and 1910.

  55 FR 3315; January 31, 1990.

  Based on a conversation with Amber Hogan of OSHA’s Enforcement
Program on February 6, 2003.

  Throughout this memorandum, the term “OSHA regulatory
jurisdiction” refers to the authority of OSHA and States with
OSHA-approved Plans to administer the OSH Act and regulations.  Note
that certain entities (e.g., military) do not follow the OSHA
regulations at 29 CFR; rather, they follow and enforce their own worker
health and safety standards.  Hence, they are outside the scope of our
analysis.

  Note that, pursuant to 29 CFR 1910.5, the OSHA standards do not apply
to the working conditions of employees if these working conditions are
covered under occupational safety and health standards of other Federal
agencies.

  The 26 States with OSHA-approved programs include:  Alaska, Arizona,
California, Connecticut, Hawaii, Indiana, Iowa, Kentucky, Maryland,
Michigan, Minnesota, Nevada, New Jersey, New Mexico, North Carolina, New
York, Oregon, Puerto Rico, South Carolina, Tennessee, Utah, Vermont,
Virgin Islands, Virginia, Washington, and Wyoming.

  As defined at 29 CFR 1910.1450(b), “hazardous chemicals” are those
chemicals that present health threats to workers.

  29 CFR 1910.1450(b) sets forth four criteria for defining
“laboratory use of hazardous chemicals.”  Amber Hogan of OSHA’s
Enforcement Program indicated that one of the criteria (i.e., the
requirement for protective equipment) does not serve as a condition for
qualifying for “lab use.”  Hence, this requirement is not reflected
in our list of criteria or in Exhibit 4.

  55 FR 3311-3312; January 31, 1990.

  Lab Standard Interpretations and Compliance Letters can be found at:
http://www.osha.gov/SLTC/laboratories/index.html.

  Based on conversations with Amber Hogan of OSHA’s Enforcement
Program on January 27, 2003 and February 6, 2003.

  55 FR 3315; January 31, 1990.

  Other sequences and activities can occur besides the one shown.
However, we believe it serves as a useful model for purposes of
discussion.

((((( PAGE  21

Exhibit 6 (continued)

Types of Personnel Covered under the OSHA Laboratory Standard a