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

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer 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. On behalf of myself, 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 my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take 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 a mere six months to comment on it. 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 stakeholders have the opportunity to provide their comments on this proposed regulation.

I am a 39 year old college graduate and father of four who has smoked since he was 8. I decided to try Vaping as I have tried every other cessatation tool with deserved skepticism. I was smoking three packs a day for the past 15 years. I have not had a cigarette nor wanted one since 01/13/2014. I can also tell you that I no longer feel the compulsion or need to run to my Vape at times of stress, my first thought of the day is where is my Vape like it was with cigarettes. I breathe easier, my children are happy I no longer gag until I spit or wake up fighting for air. I am a grown adult and I do not confuse these with vitamins. Yes there should be age restrictions. At the same time we both know as fact there are far more toxic and destructive substances in legal usage everyday. There are far more deserving threats then this that deserve the expense and resources being exhausted here.

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


[Federal Register: November 30, 2009 (Volume 74, Number 228)]
[Rules and Regulations]
[Page 62485-62487]
[DOCID:fr30no09-5]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0886 Directorate Identifier 2009-CE-045-AD;
Amendment 39-16109; AD 2009-24-15]
RIN 2120-AA64

Airworthiness Directives; SOCATA Model TBM 700 Airplanes

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

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) issued by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    It was noticed on assembly line an elongation of bolts
connecting power leads on R700 and R701 shunts. An incorrect
tightening torque value is likely to be the cause of the elongation.
    This condition, if left uncorrected could lead to heating,
electrical arcing or smokes and could result in an in-flight loss of
electrical power.

We are issuing this AD to require actions to correct the unsafe
condition on these products.

DATES: This AD becomes effective January 4, 2010.
    On January 4, 2010, the Director of the Federal Register approved
the incorporation by reference of certain publications listed in this
AD.

ADDRESSES: You may examine the AD docket on the Internet at http://
www.regulations.gov or in person at Document Management Facility, U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC
20590.

FOR FURTHER INFORMATION CONTACT: Albert Mercado, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on September 28, 2009
(74 FR 49345). That NPRM proposed to correct an unsafe condition for
the specified products. The MCAI states:

    It was noticed on assembly line an elongation of bolts
connecting power leads on R700 and R701 shunts. An incorrect
tightening torque value is likely to be the cause of the elongation.
    This condition, if left uncorrected could lead to heating,
electrical arcing or smokes and could result in an in-flight loss of
electrical power.
    For the reason described above, this Airworthiness Directive
(AD) mandates the replacement of the power lead bolts on R700 and
R701 shunts.

Comments

    We gave the public the opportunity to participate in developing
this AD. We have considered the comment received.

Comment Issue: Costs of Compliance

    Ms. Catherine H[eacute]rau, SOCATA, states the cost of the required
parts (4 bolts) is $10, not $50. Consequently, the cost of the proposed
AD on U.S. operators is $2,350 or $50 per product.
    We agree with the commenter, and we are changing the costs of
compliance in the final rule AD action to reflect the more accurate
estimated costs.

Conclusion

    We reviewed the available data, including the comment received, and
determined that air safety and the public interest require adopting the
AD as proposed.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the AD.

Costs of Compliance

    We estimate that this AD will affect 47 products of U.S. registry.
We also estimate that it will take about 0.5 work-hour per product to
comply with the basic requirements of this AD. The average labor rate
is $80 per work-hour. Required parts will cost about $10 per product.
Where the service information lists required parts costs that are
covered under warranty, we have assumed that there will be no charge or
a lower charge for these parts. As we do not control warranty coverage
for affected parties, some parties may incur costs higher than
estimated here.
    Based on these figures, we estimate the cost of this AD to the U.S.
operators to be $2,350 or $50 per product.

Authority for This Rulemaking

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

Regulatory Findings

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

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Office (telephone<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2009-24-15 SOCATA: Amendment 39-16109; Docket No. FAA-2009-0886;
Directorate Identifier 2009-CE-045-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective January
4, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to TBM 700 airplanes, serial numbers 434
through 502, and serial numbers 504 and 505, certificated in any
category.

Subject

    (d) Air Transport Association of America (ATA) Code 24: Electric
Power.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    It was noticed on assembly line an elongation of bolts
connecting power leads on R700 and R701 shunts. An incorrect
tightening torque value is likely to be the cause of the elongation.
    This condition, if left uncorrected could lead to heating,
electrical arcing or smokes and could result in an in-flight loss of
electrical power.
    For the reason described above, this Airworthiness Directive
(AD) mandates the replacement of the power lead bolts on R700 and
R701 shunts.

Actions and Compliance

    (f) Unless already done, within the next 100 hours time-in-
service after January 4, 2010 (the effective date of this AD), or
within the next 12 months after January 4, 2010 (the effective date
of this AD), whichever occurs first, replace the bolts of shunts
R700 and R701 following DAHER-SOCATA Mandatory Service Bulletin SB
70-169, dated May 2009.

FAA AD Differences

    Note: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to Attn: Albert Mercado, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>. Before using
any approved AMOC on any airplane to which the AMOC applies, notify
your appropriate principal inspector (PI) in the FAA Flight
Standards District Office (FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (h) Refer to MCAI EASA AD No.: 2009-0174, dated August 11, 2009;
and DAHER-SOCATA Mandatory Service Bulletin SB 70-169, dated May
2009, for related information.

Material Incorporated by Reference

    (i) You must use DAHER-SOCATA Mandatory Service Bulletin SB 70-
169, dated May 2009, to do the actions required by this AD, unless
the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
SOCATA, 65921--TARBES Cedex 9, France; telephone: +33 6 07 32 62 24;
or SOCATA NORTH AMERICA, INC., North Perry Airport, 7501 South
Airport Rd., Pembroke Pines, Florida 33023; telephone: (954) 893-
1400; fax:<PHONE_NUMBER>; Internet: http://mysocata.com.
    (3) You may review copies of the service information
incorporated by reference for this AD at the FAA, Central Region,
Office of the Regional Counsel, 901 Locust, Kansas City, Missouri
64106. For information on the availability of this material at the
Central Region, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information
incorporated by reference for this AD at the National Archives and
Records Administration (NARA). For information on the availability
of this material at NARA, call<PHONE_NUMBER>, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

    Issued in Kansas City, Missouri, on November 19, 2009.
Patrick R. Mullen,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-28305 Filed 11-27-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 21 (Wednesday, February 1, 2023)]
[Proposed Rules]
[Pages 6691-6695]
[FR Doc No: 2023-02073]

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

Federal Motor Carrier Safety Administration

49 CFR Chapter III

[Docket No. FMCSA-2018-0037]
RIN 2126-AC17

Safe Integration of Automated Driving Systems (ADS)-Equipped
Commercial Motor Vehicles (CMVs)

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).

ACTION: Supplemental advance notice of proposed rulemaking (SANPRM).

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

SUMMARY: FMCSA requests public comment about factors the Agency should
consider in amending the Federal Motor Carrier Safety Regulations
(FMCSRs) to establish a regulatory framework for ADS-equipped CMV
operations. FMCSA previously published an advance notice of proposed
rulemaking (ANPRM) on May 28, 2019, seeking comments on FMCSRs that may
need to be amended, revised, or eliminated to facilitate the safe
introduction of ADS-equipped CMVs onto the Nation's roadways. FMCSA
continues to consider amendments to the FMCSRs to ensure the safe
integration of ADS-equipped CMVs into interstate motor carriers'
operations and issues this SANPRM to request additional information.

DATES: Comments on this document must be received on or before March
20, 2023.

ADDRESSES: You may submit comments identified by Docket Number FMCSA-
2018-0037 using any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov/docket/FMCSA-2018-2018-0037/document. Follow the
online instructions for submitting comments.
     Mail: Dockets Operations, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building, Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: Dockets Operations, West
Building, Ground Floor, Room W12-140, 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. To be sure someone is there to help you,
please call<PHONE_NUMBER> or<PHONE_NUMBER> before visiting Dockets
Operations.
     Fax:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Mr. David Sutula, Division Chief,
Vehicle

and Roadside Operations, Office of Carrier, Driver, and Vehicle Safety
Standards, FMCSA, 1200 New Jersey Avenue SE, Washington, DC 20590-0001;
(202) 366-9209; [email protected]. If you have questions on viewing
or submitting material to the docket, contact Dockets Operations, (202)
366-9826.

SUPPLEMENTARY INFORMATION:

I. Public Participation and Request for Comments

A. Submitting Comments

    If you submit a comment, please include the docket number for this
SANPRM (FMCSA-2018-0037), indicate the specific section of this
document to which your comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online or by fax, mail, or hand delivery, but please use only one of
these means. FMCSA recommends that you include your name and a mailing
address, an email address, or a phone number in the body of your
document so FMCSA can contact you if there are questions regarding your
submission.
    To submit your comment online, go to https://www.regulations.gov/docket/FMCSA-2018-0037/document, click on this SANPRM, click
``Comment,'' and type your comment into the text box on the following
screen.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8.5 by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the facility, please enclose a stamped,
self-addressed postcard or envelope.
    FMCSA will consider all comments and material received during the
comment period.

B. Confidential Business Information

    Confidential Business Information (CBI) is commercial or financial
information that is both customarily and actually treated as private by
its owner. Under the Freedom of Information Act (5 U.S.C. 552), CBI is
exempt from public disclosure. If your comments responsive to this
SANPRM contain commercial or financial information that is customarily
treated as private, that you actually treat as private, and that is
relevant or responsive to this SANPRM, it is important that you clearly
designate the submitted comments as CBI. Please mark each page of your
submission that constitutes CBI as ``PROPIN'' to indicate it contains
proprietary information. FMCSA will treat such marked submissions as
confidential under the Freedom of Information Act, and they will not be
placed in the public docket for this rulemaking. Submissions containing
CBI should be sent electronically to Mr. Brian Dahlin, Chief,
Regulatory Evaluation Division, Office of Policy at
[email protected]. At this time, you need not send a duplicate
hardcopy of your electronic CBI submissions to FMCSA headquarters. Any
comments FMCSA receives not specifically designated as CBI will be
placed in the public docket for this rulemaking.

C. Viewing Comments and Documents

    To view any documents mentioned as being available in the docket,
go to https://www.regulations.gov/docket/FMCSA-2018-0037/document and
choose the document to review. To view comments, click this SANPRM,
then click ``Browse Comments.'' If you do not have access to the
internet, you may view the docket online by visiting Dockets Operations
in Room W12-140 on the ground floor of the DOT West Building, 1200 New
Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m.
ET, Monday through Friday, except Federal holidays. To be sure someone
is there to help you, please call<PHONE_NUMBER> or<PHONE_NUMBER>
before visiting Dockets Operations.

D. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its regulatory process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov. As described in the system
of records notice DOT/ALL 14 -FDMS, which can be reviewed at https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices, the comments are searchable by the name of the submitter.

II. Legal Basis for the Rulemaking

    This SANPRM is based on 49 U.S.C. 31502 (originally enacted as part
of the Motor Carrier Act of 1935 (1935 Act)); 49 U.S.C. chapter 311,
subchapter III (originally enacted as part of the Motor Carrier Safety
Act of 1984 (1984 Act)); and 49 U.S.C. chapter 313 (originally enacted
as part of the Commercial Motor Vehicle Safety Act of 1986 (1986 Act)).
Both 49 U.S.C. 31502 and 49 U.S.C. chapter 311, subchapter III vest
broad rulemaking authority in the Secretary of Transportation
(Secretary) to prescribe regulations on CMV safety, which includes the
authority to issue regulations governing ADS-equipped CMV operations
and operators. In this regard, section 31502(b) provides, ``The
Secretary of Transportation may prescribe requirements for--(1)
qualifications and maximum hours of service of employees of, and safety
of operation and equipment of, a motor carrier; and (2) qualifications
and maximum hours of service of employees of, and standards of
equipment of, a motor private carrier, when needed to promote safety of
operation.'' Section 31136(a) requires the Secretary of Transportation
to ``prescribe regulations on commercial motor vehicle safety. The
regulations shall prescribe minimum safety standards for commercial
motor vehicles.'' The provision further requires that: ``At a minimum,
the regulations shall ensure that--(1) commercial motor vehicles are
maintained, equipped, loaded, and operated safely; (2) the
responsibilities imposed on operators of commercial motor vehicles do
not impair their ability to operate the vehicles safely; (3) the
physical condition of operators of commercial motor vehicles is
adequate to enable them to operate the vehicles safely . . .; (4) the
operation of commercial motor vehicles does not have a deleterious
effect on the physical condition of the operators; and (5) an operator
of a commercial motor vehicle is not coerced by a motor carrier,
shipper, receiver, or transportation intermediary to operate a
commercial motor vehicle in violation of a regulation promulgated under
this section . . .'' (49 U.S.C. 31136(a)(1)-(5)). Additionally, section
31308 gives the Secretary broad authority to ``prescribe regulations on
minimum uniform standards for the issuance of commercial drivers'
licenses [CDLs] and learner's permits by the States . . . .'' This
SANPRM is based primarily on section 31502(b), which authorizes
requirements to address the safety of operations and equipment of a
motor carrier, and on section 31136(a)(1), which requires provisions to
ensure that CMVs are maintained, equipped, and operated safely.
Sections 31136(a)(2) through (5) are not immediately relevant to this
SANPRM. These statutes provide sufficient legal authority for the
Secretary to issue regulations on the operation of ADS-equipped CMVs.
Before prescribing regulations, the Secretary must consider their costs
and benefits (49 U.S.C. 31136(c)(2)(A) and 31502(d)).
    The Administrator of FMCSA is delegated authority under 49 CFR 1.87
to carry out the functions vested in the Secretary by 49 U.S.C.
chapters 311, 313, and 315 as they relate to CMV operators, programs,
and safety.

III. Executive Order (E.O.) 12866 (Regulatory Planning and Review) and
E.O. 13563 (Improving Regulation and Regulatory Review)

    This SANPRM is a not a significant regulatory action under section
3(f) of E.O. 12866, as supplemented by E.O. 13563. Accordingly, the
Office of Management and Budget has not reviewed it under these orders.
    Executive Orders 12866 and 13563 require agencies to provide a
meaningful opportunity for public participation. Accordingly, the
Agency has asked commenters to answer a variety of questions to elicit
practical information about alternative approaches, including the
associated costs and benefits of those approaches, and relevant
scientific, technical, and economic data.

IV. Background

A. FMCSA's 2019 ANPRM

    FMCSA is responsible for overseeing the safety of CMVs, their
drivers, and their operation in interstate commerce. The Agency works
with Federal, State, and local enforcement agencies, the motor carrier
industry, and interested stakeholders to reduce crashes, injuries, and
fatalities involving large trucks and buses. The FMCSRs provide rules
to support the safe operation of CMVs, and these rules apply to motor
carriers who operate ADS-equipped CMVs. Since 2017, FMCSA has engaged
in multiple stakeholder outreach activities and has taken other actions
to assist the Agency in understanding issues related to ADS-equipped
CMV operations and to consider what amendments to the FMCSRs may be
necessary to reduce safety risk associated with the operation of ADS-
equipped CMVs. In 2019, FMCSA summarized previous outreach and other
actions related to ADS-equipped CMVs in an ANPRM (84 FR 24449, 24450-
51, May 28, 2019). The ANPRM also requested public comment about which
FMCSRs may need to be amended, revised, or eliminated to facilitate the
safe introduction of ADS-equipped CMVs onto the Nation's roadways. In
this regard, the ANPRM posed specific questions on the following
topics: whether the FMCSRs require a human driver; CDL endorsements;
drivers' hours of service rules; medical qualification standards for
human operators; distracted driving and monitoring; requirements to
ensure safe driving; inspection, repair, and maintenance; roadside
inspections; cybersecurity; and confidentiality of shared information.
FMCSA extended the comment period to August 28, 2019 (84 FR 37228, Jul.
31, 2019), and the Agency received 122 comments from individuals and 59
from organizations. Interested parties can view the comments the Agency
received at https://www.regulations.gov/docket/FMCSA-2018-0037/comments.
    In the ANPRM, FMCSA explained that the Department adopted the SAE
International's definitions for the levels of driving automation set
forth in SAE J3016 (``Taxonomy and Definitions for Terms Related to
Driving Automation Systems for On-Road Motor Vehicles''). The six
levels of automation range from Level 0 (driver support features but no
driving automation) to Level 5 (full driving automation). FMCSA
continues to explore the potential risks and safety benefits of Levels
0-3 driving automation and driver assistance technologies. FMCSA,
however, does not believe there is a need to revise the FMCSRs to
address the integration of Levels 0-3 equipment because a licensed
human CMV driver must be seated behind the wheel of these vehicles at
all times to perform, or be ready to take over, dynamic driving tasks.
The focus of this notice is Level 4 and 5 ADS-equipped CMVs because it
is only at those levels that an ADS can control all aspects of the
dynamic driving task without any expectation of an intervention from a
human driver.

B. Departmental and Modal Administration Publications and Actions

    Since FMCSA's publication of the ANPRM, the Department has
continued engagement with key transportation stakeholders to develop a
national policy framework to facilitate the safe integration of ADS
technology, as well as other emerging technologies, into the
transportation system. Prioritizing safety while supporting the power
of innovation to transform transportation for the better are central to
the Department's approach, as memorialized in both the National Roadway
Safety Strategy (NRSS) and the U.S. DOT Innovation Principles, both
released in January 2022.\1\ The NRSS outlines the Department's
comprehensive approach to significantly reducing serious injuries and
deaths with a long-term goal of zero roadway fatalities. The NRSS
recognizes the Department's responsibility to use holistic approaches
to assess the safety of emerging technologies such as ADS. The NRSS
explains that the Department is actively researching test methods,
procedures, and criteria to assess long-term safety benefits of ADS, as
well as broader impacts on workers, drivers, and all people who use the
Nation's roadways.
---------------------------------------------------------------------------

    \1\ The NRSS is available at https://www.transportation.gov/sites/dot.gov/files/2022-02/USDOT-National-Roadway-Safety-Strategy.pdf.
---------------------------------------------------------------------------

    Additionally, the NRSS describes actions taken by the Department
and DOT modal administrations to enable the safe deployment of new and
emerging vehicle technologies. For example, the National Highway
Traffic Safety Administration (NHTSA) issued Standing General Order
2021-01 on June 29, 2021, amended on August 5, 2021, that requires
identified vehicle manufacturers and operators to report to NHTSA
crashes involving vehicles equipped with ADS or certain advanced driver
assistance systems.\2\ The Standing General Order, which remains in
effect until June 2024, enables NHTSA and the Department to obtain
timely and transparent notification of real-world crashes associated
with vehicles equipped with an ADS and, when appropriate, may lead DOT
modal administrations to gather additional data and information or
conduct an investigation, when warranted, into emerging safety issues
potentially arising from the on-road testing, development, use, or
deployment of new driving automation technologies.
---------------------------------------------------------------------------

    \2\ The Standing General Order, as well as crash report data, is
available at https://www.nhtsa.gov/laws-regulations/standing-
general-order-crash-
reporting#:~:text=NHTSA%20issued%20the%20General%20Order,are%20free%2
0of%20defects%20that.
---------------------------------------------------------------------------

    The U.S. DOT Innovation Principles will guide the Department's work
in supporting transportation innovation.\3\ Innovations consistent with
these principles should reduce deaths and serious injuries on the
roadways. The Department will also encourage partnerships and
collaborations through an outcomes-based approach. FMCSA's approach to
safety oversight of motor carriers operating ADS-equipped CMVs is
consistent with the Department's innovation principles and commits
FMCSA to fostering purpose-driven innovation that is technology
neutral, and protects the interests of the public, workers, and
communities.
---------------------------------------------------------------------------

    \3\ The Innovation Principles are available at https://www.transportation.gov/priorities/transformation/us-dot-innovation-principles.
---------------------------------------------------------------------------

V. Discussion and Supplemental Questions for Response

    ADS-equipped CMVs have the potential to produce measurable safety
benefits in crashes involving human error. ADS-equipped CMVs, however,
present operational characteristics and challenges that may introduce
new and complex safety risks that need to be monitored and may require
FMCSA to

modify existing and/or adopt new regulatory standards. ADS developers
are actively engaged in the development, testing, and limited
deployment of ADS-equipped CMVs, and promoting their use in commercial
motor carrier operations. Although many ADS-equipped CMVs are being
tested in manufacturer or developer owned fleets, many developers and
manufacturers are also working to integrate their ADS equipment into
existing motor carrier fleets. To mitigate potential safety risks
associated with in-service use of ADS-equipped CMVs, FMCSA is
developing an appropriate regulatory framework.
    In this SANPRM, which is a supplement to the ANPRM published May
28, 2019, FMCSA invites comment on additional questions and those
issued in the previous ANPRM, to help FMCSA assess benefits, costs, and
other impacts of any potential proposal issued later. If interested
parties have new information regarding the questions presented in the
2019 ANPRM, those comments may be submitted in response to this SANPRM.
The 2019 ANPRM is available at 84 FR 24449 or at the following link:
https://www.regulations.gov/document/FMCSA-2018-0037-0131.

A. Notification by Motor Carriers Operating Level 4 or 5 ADS-Equipped
CMVs

    To more effectively oversee Level 4 or 5 ADS-equipped CMV
operations, FMCSA is considering establishing a requirement for motor
carriers to notify FMCSA that they will operate those CMVs in
interstate commerce without a human driver behind the wheel. It may be
necessary to require motor carriers operating such vehicles to notify
the Agency to facilitate monitoring of those operations and give FMCSA
the opportunity to address any unique in-service safety issues involved
in the operations of such vehicles, and, if necessary, to target safety
interventions to correct those issues. FMCSA therefore seeks comment on
(1) regulatory approaches that would enable the Agency to obtain
relevant safety information and (2) the current and anticipated size of
the population of motor carriers operating ADS-equipped CMVs.
Questions
    1.1. Should FMCSA require motor carriers operating Level 4 or 5
ADS-equipped CMVs to notify FMCSA before operating those vehicles in
interstate commerce without a human driver behind the wheel? If so,
what potential methods or procedures should be established to notify
FMCSA of those operations?
    1.2. Before operating in interstate commerce, should motor carriers
be required to submit information, data, documentation, or other
evidence that demonstrates to FMCSA that motor carriers seeking to
operate Level 4 or 5 ADS-equipped CMVs have appropriate safety
management controls in place to operate the vehicle in accordance with
the manufacturer's specifications and with Federal requirements? If so,
please describe any recommended approaches including the information to
be provided and appropriate techniques for reviewing that information.
If available, provide cost estimates for proposed approaches.
    1.3. What data should FMCSA collect and maintain regarding Level 4
or 5 ADS-equipped CMVs engaged in interstate transportation? How would
such information be used and how would it improve FMCSA's ability to
oversee the safe operation of Level 4 or 5 ADS-equipped CMVs?
    1.4. What is the current size of the Level 4 or 5 ADS-equipped CMV
population? What is the anticipated size of the population within 5
years? What might the size of the population be in 10 years?
    1.5. On average, how many days are Level 4 or 5 ADS-equipped CMVs
expected to be operational per year?

B. Oversight for Remote Assistants

    As FMCSA explained in the ANPRM, at Level 5 driving automation, the
ADS technology will be expected, by definition, to be capable of
performing all driving functions under all conditions. For Level 4
driving automation the ADS technology would be limited to certain
operational design domains (ODD). However, when a Level 4 CMV reaches
the limit of its ODD, continued operation may require a human driver,
either seated behind the wheel or located remotely, to directly control
the CMV. (See the ANPRM for more information on operational design
domains (84 FR 24449, 24452)). Human drivers who may operate an ADS-
equipped CMV from a remote location are generally referred to as remote
drivers.\4\ FMCSA stated in the ANPRM that the FMCSRs applicable to
drivers seated behind the wheel of the CMV, such as drug and alcohol
use and testing, CDL requirements, hours of service, distracted
driving, and medical qualification standards, should continue to apply
to remote drivers who are able to take control of an ADS-equipped CMV
operating on a public road. This remains FMCSA's position.
---------------------------------------------------------------------------

    \4\ The definition of remote driver is a driver who is not
seated in a position to manually exercise in-vehicle braking,
accelerating, steering, and transmission gear selection input
devices (if any), but is able to operate the vehicle.
---------------------------------------------------------------------------

    During FMCSA's continued engagement with stakeholders, the Agency
has learned that some motor carriers' operational models may also
include the use of a person operating as a remote assistant \5\ who
would remotely monitor the Level 4 or 5 ADS-equipped CMV. On an as-
needed basis, the remote assistant would engage (via a wireless
telematics connection) with the vehicle if/when the ADS is unable to
perform the dynamic driving task and enters a minimal risk condition
due to a system fault, mechanical failure, an event that caused the
vehicle to enter into a condition or location outside its ODD, and/or
other anomalies that the ADS was unable to negotiate. In such
circumstances the remote assistant may enable the ADS to complete the
driving task but in all circumstances the on-board ADS would complete
or execute the actual vehicle control maneuvers. That is, the remote
assistant would not engage in direct control of the vehicle throttle,
steering, accelerator, turn signals, lighting, or other vehicle control
functions. The remote assistant may also engage with law enforcement
personnel, first responders and/or other public officials engaged in
traffic and CMV oversight operations. FMCSA seeks information on what
requirements, if any, should be imposed on persons performing remote
assistant duties for motor carriers operating Level 4 or 5 ADS-equipped
CMVs.
---------------------------------------------------------------------------

    \5\ The definition of remote assistance is a human who provides
remote information or advice to an ADS-equipped vehicle in
driverless operation in order to facilitate trip continuation when
the ADS encounters a situation it cannot manage.
---------------------------------------------------------------------------

Questions
    2.1. To what extent should the Federal requirements otherwise
applicable to CMV drivers (such as hours-of service limitations, drug
and alcohol testing, and physical qualifications), also apply to a
remote assistant who is not expected to take control of the dynamic
driving task of an ADS-equipped CMV operating at Level 4?
    2.2. What, if any, aspects of the remote assistant job function may
require FMCSA oversight including minimum standards and/or auditing,
e.g., training, physical qualifications, and other job-performance
related measures? Please provide rationale and evidence for the
recommended manner of oversight.
    2.3. Are there any qualification requirements that FMCSA should

consider for remote assistants, such as related experience, e.g., as a
CDL holder?
    2.4. Are there any specific limitations that should be imposed on
the working conditions of remote assistants, such as limitations on the
number of ADS-equipped CMVs that a remote assistant is simultaneously
responsible for or the number of hours that a remote assistant may
work?
    2.5. Are there any other considerations that FMCSA should be aware
of relating to individuals who may function as remote assistants?

C. Vehicle Inspection and Maintenance

    As indicated in the ANPRM, motor carriers operating Level 4 or 5
ADS-equipped CMVs must comply with existing vehicle inspection and
maintenance regulations, including the requirements for pre-trip, post-
trip, periodic, and roadside inspections, unless and until those
regulations are revised through an FMCSA final rule. Additionally, the
ANPRM noted that motor carriers operating Level 4 or 5 ADS-equipped
CMVs would necessarily require a means to ensure that the ADS equipment
is properly maintained and functioning.
    Level 4 or 5 ADS-equipped CMVs have the potential to operate almost
continuously, except for re-fueling and maintenance. FMCSA is therefore
considering whether additional inspection requirements would be
appropriate for Level 4 or 5 ADS-equipped CMVs to reduce overall safety
risk associated with this new technology and to account for their
extended periods of operation without direct human observation.
    At the same time, roadside inspections of Level 4 or 5 ADS-equipped
CMVs would be uniquely challenging in the absence of a human driver to
engage in the inspection process. For example, during a Level 1 \6\
roadside inspection, a human driver is generally required to
communicate with enforcement officers and perform tasks associated with
the inspection, such as testing the braking system, lighting functions,
and the fifth wheel movement. The Agency therefore is soliciting
comment to better inform its rulemaking proposals in the areas of
inspection and maintenance of ADS-equipped CMVs.
---------------------------------------------------------------------------

    \6\ See https://www.cvsa.org/inspections/all-inspection-levels/
for a description of inspection levels.
---------------------------------------------------------------------------

    The Commercial Vehicle Safety Alliance (CVSA) recently released a
new program and procedures on inspections of ADS-equipped CMVs, which
it developed through a multiparty working group.\7\ FMCSA requests
public comment on the CVSA document,\8\ and it welcomes information and
comment on activities of other stakeholder groups, including consensus
standards bodies, that are considering ADS technology and deployment.
---------------------------------------------------------------------------

    \7\ See https://www.cvsa.org/news/new-enhanced-cmv-inspection-program/.
    \8\ CVSA's ``Enhanced CMV Inspection Program for Automated
Vehicle Motor Carrier Operations'' can be found in the docket for
this SANPRM.
---------------------------------------------------------------------------

Questions
    3.1. Should Level 4 or 5 ADS-equipped CMVs be subject to pre-trip
inspection requirements for their mechanical and ADS components in
addition to those specified in 49 CFR 392.7, including those which
might necessitate new inspection equipment, before such CMVs are
dispatched and after a specified period of operation? If so, what
methods should be used to conduct these additional inspection items,
what equipment components should be inspected, what documentation
should be required, who should be responsible for conducting those
inspections and what qualifications or specialized training should be
required, and how frequently should the additional inspections be
conducted?
    3.2. If additional inspections, inspection equipment, or additional
qualifications for inspectors are proposed, provide an estimate of the
costs associated with such additional requirements including the
approximate time to complete the additional inspection requirements,
costs of any proposed training if additional inspector requirements are
proposed, and the paperwork burden associated with such training.
    3.3. What technical barriers exist to conducting conventional
roadside inspections (which require interactions with the human driver)
of Level 4 or 5 ADS-equipped CMVs and what approaches currently exist
or might be developed to remove those barriers?
    3.4. What, if any, pre-trip inspection requirements, documentation,
and communications capability (for making the results of such
inspections available to law enforcement personnel), should be imposed
on motor carriers operating Level 4 and 5 ADS-equipped CMVs as a
condition for by-passing conventional roadside inspection stations?
    3.5. If Level 4 or 5 ADS-equipped CMVs are not required by the
States to undergo roadside inspections during operation, what
information should be communicated by the motor carrier and CMV to the
State inspectors (e.g., the results of potential alternative pre-trip
inspections, and/or the real-time operational status and condition of
safety critical systems such as brakes, tires, lighting systems,
steering, and ADS components)? Are there other data and performance
information that would need to be made available to ensure adequate
vehicle maintenance and safe operations?
    3.6. What communication systems currently exist that would allow
roadside inspection officers to receive information regarding Level 4
or 5 ADS-equipped CMVs, and what information could be transmitted via
these systems regarding the mechanical condition of the CMV and other
operational documentation, (e.g., shipping documents and origin/
destination), while in route?
    3.7 Under what safety situations should State inspectors and/or
FMCSA receive immediate notification of an unsafe maintenance or
operational issue, if any? What data and information would need to be
provided in instances such as tow-away crashes or those that disable
key operational features of a CMV? Under such safety situations, what
return to service process would ensure any maintenance and operation
issues have been addressed?
    3.8. If Level 4 or 5 ADS-equipped CMVs are not subject to State
roadside inspections, how would law enforcement agencies and motor
carriers ensure that such CMVs are not used to engage in unlawful
activity, e.g., human trafficking, cargo theft?
    3.9. Should Level 4 or 5 ADS-equipped CMVs be subject to additional
post-trip inspection requirements for the mechanical or ADS components
of the CMV?
    Issued under authority delegated in 49 CFR 1.87.

Robin Hutcheson,
Administrator.
[FR Doc. 2023-02073 Filed 1-31-23; 8:45 am]
 BILLING CODE 4910-EX-P


To:	Jeff Telander						From:	Dave Reeves

Project File						Date:	March 17, 2008

Re:	Mineral Wool Production – Actual versus Allowable Emissions

Source Category	Emission Point	Format of Primary (MACT) Standard	Could
Possibly Calculate Allowable?	Info Needed to Calculate Allowable
Emissions

Mineral Wool	Cupolas	Emission Limits:

kg PM/ Mg melt

kg CO/ Mg melt	Yes	Amount of melt

	Curing Ovens	Emission Limit:

kg formaldehyde/Mg melt	Yes	Amount of melt

We reviewed all of the reported emissions data in NEI and TRI, as well
as the emission limits in the Mineral Wool Production MACT standard and
state operating permits.  In general, all of the emission limits are
based on production levels (e.g., mass of pollutant allowed to be
emitted per mass of material melted).  Even though production levels
could be increased at most of the currently operating facilities, there
are equipment and process limitations on how the melting furnaces
(cupolas) are operated – which limits the potential (allowable)
emissions for a given facility.  Market forces also impose production
caps on existing facilities and probably account for much of their
current excess capacity.  The cupolas are considered batch operations,
but are run on a continuous or semi-continuous basis to save time and
energy to heat up the furnace for each batch.  Because melting
operations are the production limiting process at these manufacturing
facilities, the reported emissions are representative of the current
market and are believed to at the highest level (since the overall
mineral wool market is declining).

We also reviewed data from the North American Insulation Manufacturers
Association (NAIMA) in response to a request for summary MACT compliance
test data for mineral wool production facilities.  Six facilities
reported cupola particulate matter (PM) emissions and three facilities
operating bonded lines reported formaldehyde emissions from curing ovens
– see attached summary table.

The arithmetic average PM emission rate for all cupola PM emissions data
is 0.044 pounds PM/ton melt.  (We also calculated individual facility
averages and means and came up with basically the same value.)  The
average formaldehyde emission rate for all curing oven formaldehyde
emissions data is 0.038 pounds formaldehyde/ton melt.  Allowable PM and
formaldehyde emission rates under the Mineral Wool MACT standard are 0.1
pounds PM/ton melt and 0.06 pounds/ton melt, respectively.  The
allowable PM emission rate is approximately 2.3 times higher than the
average of the reported PM emission rates (0.1/0.044).  The allowable
formaldehyde emission rate is approximately 1.6 times higher than the
average of the reported formaldehyde emission rates (0.06/0.038).

Based on these reported emission rates and the equipment and process
limitations, we are recommending that allowable emissions be estimated
to be 2 times the actual emissions for each facility for purposes of the
risk modeling.  We believe that a 2X factor applied to the most recent
reported emissions is realistic and does not grossly overstate potential
emissions.


[Federal Register Volume 86, Number 229 (Thursday, December 2, 2021)]
[Notices]
[Pages 68491-68492]
[FR Doc No: 2021-26191]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

Filings Instituting Proceedings

    Docket Numbers: RP22-344-000.
    Applicants: FP Wheeler Upstream LLC, Formentera Operations LLC.
    Description: Joint Petition for Limited Waiver of Capacity Release
Regulations, et al. of FP Wheeler Upstream LLC, et al. under RP22-344.
    Filed Date: 12/02/21.
    Accession Number: 20211124-5070.
    Comment Date: 5 p.m. ET 12/6/21.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's

Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern
time on the specified comment date. Protests may be considered, but
intervention is necessary to become a party to the proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP18-923-010.
    Applicants: Enable Mississippi River Transmission, LLC.
    Description: Compliance filing: Errata to 11.23.2021 Compliance
Filing to be effective 1/1/2022.
    Filed Date: 11/24/21.
    Accession Number: 20211124-5128.
    Comment Date: 5 p.m. ET 12/6/21.

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

    Dated: November 26, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-26191 Filed 12-1-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: August 12, 2008 (Volume 73, Number 156)]
[Notices]
[Page 46909-46911]
[DOCID:fr12au08-63]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0439 ]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Blood Establishment Registration and Product Listing,
Form FDA 2830

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
requirements relating to the blood establishment registration and
product listing requirements in the agency's regulations and Form FDA
2830.

DATES: Submit written or electronic comments on the collection of
information by October 14, 2008.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All

comments should be identified with the docket number found in brackets
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Blood Establishment Registration and Product Listing, Form FDA 2830--21
CFR Part 607 (OMB Control Number 0910-0052)--Extension

    Under section 510 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360), any person owning or operating an establishment that
manufactures, prepares, propagates, compounds, or processes a drug or
device must register with the Secretary of Health and Human Services,
on or before December 31 of each year, his or her name, place of
business, and all such establishments, and must submit, among other
information, a listing of all drug or device products manufactured,
prepared, propagated, compounded, or processed by him or her for
commercial distribution. In part 607 (21 CFR part 607), FDA has issued
regulations implementing these requirements for manufacturers of human
blood and blood products.
    Section 607.20(a), in brief, requires owners or operators of
certain establishments that engage in the manufacture of blood products
to register and to submit a list of every blood product in commercial
distribution. Section 607.21, in brief, requires the owners or
operators of establishments entering into the manufacturing of blood
products to register within 5 days after beginning such operation and
to submit a list of every blood product in commercial distribution at
the time. If the owner or operator of the establishment has not
previously entered into such operation for which a license is required,
registration must follow within 5 days after the submission of a
biologics license application. In addition, establishments are required
to register annually between November 15 and December 31 and update
their blood product listing every June and December of each year.
Section 607.22 requires the use of Form FDA 2830, Blood Establishment
Registration and Product Listing, for initial registration, for annual
registration, and for blood product listing. Section 607.25 indicates
the information required for establishment registration and blood
product listing. Section 607.26, in brief, requires certain changes to
be submitted on FDA Form 2830 as amendments to the establishment
registration within 5 days of such changes. Section 607.30(a), in
brief, indicates the information required for owners or operators of
establishments to update their blood product listing information every
June and December, or at the discretion of the registrant at the time
the change occurs. Section 607.31 requires that additional blood
product listing information be provided upon FDA request. Section
607.40, in brief, requires certain foreign blood product establishments
to register and submit the blood product listing information, and to
provide the name and address of the establishment and the name of the
individual responsible for submitting blood product listing information
as well as the name, address, and phone number of its U.S. agent.
    Among other uses, this information assists FDA in its inspections
of facilities, and its collection is essential to the overall
regulatory scheme designed to ensure the safety of the nation's blood
supply. Form FDA 2830 is used to collect this information.
    Respondents to this collection of information are human blood and
plasma donor centers, blood banks, certain transfusion services, other
blood product manufacturers, and independent laboratories that engage
in quality control and testing for registered blood product
establishments.
    FDA estimates the burden of this collection of information based
upon information obtained from FDA's Center for Biologics Evaluation
and Research's database and FDA experience with the blood establishment
registration and product listing requirements.
    FDA estimates the burden of this collection as follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                  Form FDA        No. of       Annual Frequency    Total Annual      Hours Per
21 CFR Section      2830        Respondents      per Response        Responses       Response       Total Hours
----------------------------------------------------------------------------------------------------------------
607.20(a),      Initial                  111                   1             111               1             111
 607.21,         Registratio
 607.22,         n
 607.25, and
 607.40
----------------------------------------------------------------------------------------------------------------
607.21,         Re-                    2,621                   1           2,621             0.5           1,311
 607.22,         registratio
 607.25,         n
 607.26,
 607.31, and
 607.40
----------------------------------------------------------------------------------------------------------------

607.21,         Product                  180                   1             180            0.25              45
 607.25,         Listing
 607.30(a),      Update
 607.31, and
 607.40
----------------------------------------------------------------------------------------------------------------
Total                                                                                1,467
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

    Dated: August 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-18570 Filed 8-11-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 79, Number 195 (Wednesday, October 8, 2014)]
[Notices]
[Page 60851]
[FR Doc No: 2014-24051]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0627]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; General Administrative Procedures:
Citizen Petitions; Petition for Reconsideration or Stay of Action;
Advisory Opinions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``General Administrative Procedures:
Citizen Petitions; Petition for Reconsideration or Stay of Action;
Advisory Opinions'' has been approved by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On June 12, 2014, the Agency submitted a
proposed collection of information entitled ``General Administrative
Procedures: Citizen Petitions; Petition for Reconsideration or Stay of
Action; Advisory Opinions'' to OMB for review and clearance under 44
U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0183.
The approval expires on August 31, 2017. A copy of the supporting
statement for this information collection is available on the Internet
at http://www.reginfo.gov/public/do/PRAMain.

    Dated: October 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-24051 Filed 10-7-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: April 5, 2006 (Volume 71, Number 65)]
[Proposed Rules]
[Page 17047-17050]
[DOCID:fr05ap06-29]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 51 and 93

[EPA-HQ-OAR-2004-0491; FRL-8055-4]
RIN 2060-AN60

PM2.5 De Minimis Emission Levels for General Conformity
Applicability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The EPA is proposing to amend its regulations relating to the
Clean Air Act (CAA) requirement that Federal actions conform to the
appropriate State, Tribal or Federal implementation plan for attaining
clean air (``general conformity'') to add de minimis emissions levels
for particulate matter with an aerodynamic diameter equal to or less
than 2.5 microns (PM2.5) National Ambient Air Quality
Standards (NAAQS) and its precursors.

DATES: Comments must be received by May 5, 2006.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2004-0491, by one of the following methods:
     http://www.regulations.gov: Follow the on-line

instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>attention Docket No. EPA-
HQ-OAR-2004-0491.
     Fax:<PHONE_NUMBER>.
     Mail: PM2.5 De Minimis Emission Levels for
General Conformity Applicability, Docket ID No. EPA-HQ-OAR-2004-0491,
Environmental Protection Agency Docket Center, Mail Code: 6102T, 1200
Pennsylvania Avenue, NW., Washington, DC 20460. Please include a total
of two copies, if possible. In addition, please mail a copy of your
comments on the information collection provisions to the Office of
Information and Regulatory Affairs, Office of Management and Budget
(OMB), Attn: Desk Officer for EPA, 725 17th St., NW., Washington, DC
20503.
     Hand Delivery: PM2.5 De Minimis Emission Levels
for General Conformity Applicability, Docket ID No. EPA-HQ-OAR-2004-
0491, Environmental Protection Agency Docket Center, EPA West, Room B-
102, 1301 Constitution Avenue, NW., Washington, DC. Such deliveries are
only accepted during the Docket's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information.
    Instructions: Direct comments to Docket ID No. EPA-HQ-OAR-2004-
0491. The EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site

is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be

automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm
.

    Docket: All documents in the docket are listed in the http://www.regulations.gov
 index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Docket, EPA/DC,

EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the Air
Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Mr. Thomas Coda, Office of Air Quality
Planning and Standards, U.S. Environmental Protection Agency, Mail

Code C539-02, Research Triangle Park, NC 27711, phone number (919) 541-
3037 or by e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

    Today's action applies to all Federal agencies and Federal
activities.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or e-mail. Clearly mark the part or all of

the information that you claim to be CBI. For CBI information in a disk
or CD-ROM that you mail EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments. When submitting comments
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.

II. Today's Rule

    This proposed rule and the accompanying direct final rule are
available electronically on the day of publication from EPA's Federal
Register Web site http://www.epa.gov/docs/fedrgstr/EPA-AIR/. For

further information, including the rationale, administrative
requirements, statutory authority, and regulatory text for these
amendments, please see the information provided in the direct final
action that is located in the ``Rules and Regulations'' section of this
Federal Register publication.

III. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether the regulatory action is ``significant''
and, therefore, subject to Office of Management and Budget (OMB) review
and the requirements of the Executive Order. The Order defines
``significant regulatory action'' as one that is likely to result in a
regulation that may:
    1. Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or Tribal governments or
communities;
    2. Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
    3. Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
    4. Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
    Pursuant to the terms of Executive Order 12866, it has been
determined that these revisions to the regulations are considered a
``significant regulatory action'' because they may interfere with
actions taken or planned by other Federal agencies. As such, this
action was submitted to OMB for review. Changes made in response to OMB
suggestions or recommendations can be found in the public docket.

B. Paperwork Reduction Act

    This action does not directly impose an information collection
burden under the provisions of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq., on non-Federal entities. The General Conformity
Regulations require Federal agencies to determine that their actions
conform to the SIPs or TIPs. However, depending upon how Federal
agencies implement the regulations, non-Federal entities seeking
funding or approval from those Federal agencies may be required to
submit information to that agency.
    Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements;
train personnel to be able to respond to a collection of information;
search data sources; complete and review the collection of information;
and transmit or otherwise disclose the information. An agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information unless it displays a currently valid OMB
control number. The OMB control numbers for EPA's regulations in 40 CFR
are listed in 40 CFR part 9.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act generally requires an Agency to
prepare a regulatory flexibility analysis of any regulation subject to
notice and comment rulemaking requirements under the Administrative
Procedures Act or any other statute unless the Agency certifies the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of today's proposed revisions
to the regulations on small entities, small entity is defined as:
    1. A small business that is a small industrial entity as defined in
the U.S. Small Business Administration (SBA) size standards. (See 13
CFR 121.201);
    2. A governmental jurisdiction that is a government of a city,
county, town, school district or special district with a population of
less than 50,000; and
    3. A small organization that is any not-for-profit enterprise which
is independently owned and operated and is not dominant in its field.
    Today's proposed revisions to the regulations, if promulgated will
not impose any requirements on small entities and therefore, will not
have a significant economic impact on a substantial number of small
entities. The General Conformity Regulations

require Federal agencies to conform to the appropriate State, Tribal or
Federal implementation plan for attaining clean air. We continue to be
interested in the potential impacts of the regulations on small
entities and welcome comments on issues related to such impacts.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and Tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final regulations with ``Federal mandates''
that may result in expenditures to State, local, and Tribal
governments, in the aggregate, or to the private sector, of $100
million or more in any 1 year. Before promulgating an EPA regulation
for which a written statement is needed, section 205 of the UMRA
generally requires EPA to identify and consider a reasonable number of
regulatory alternatives and to adopt the least costly, most cost-
effective or least burdensome alternative that achieves the objectives
of the regulation. The provisions of section 205 do not apply when they
are inconsistent with applicable law. Moreover, section 205 allows EPA
to adopt an alternative other than the least costly, most cost-
effective or least burdensome alternative if the Administrator
publishes with the final regulations an explanation why that
alternative was not adopted. Before EPA establishes any regulatory
requirements that may significantly or uniquely affect small
governments, including Tribal governments, it must have developed under
section 203 of the UMRA a small government agency plan. The plan must
provide for notifying potentially affected small governments, enabling
officials of affected small governments to have meaningful and timely
input in the development of EPA regulatory proposals with significant
Federal intergovernmental mandates, and informing, educating, and
advising small governments on compliance with the regulatory
requirements.
    The EPA has determined that these revisions to the regulations do
not contain a Federal mandate that may result in expenditures of $100
million or more for State, local, and Tribal governments, in the
aggregate, or the private sector in any 1 year. Thus, today's proposed
regulation revisions are not subject to the requirements of sections
202 and 205 of the UMRA.
    The EPA has determined that these proposed regulation revisions
contain no regulatory requirements that may significantly or uniquely
affect small governments, including Tribal governments.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255; August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have Federalism implications.''
``Policies that have Federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
    This action does not have Federalism implications. The regulations
will not have substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132. Previously, EPA
determined the costs to States to implement the General Conformity
Regulations to be less than $100,000 per year. Thus, Executive Order
13132 does not apply to these proposed regulation revisions.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by Tribal officials in the development of regulatory
policies that have Tribal implications.'' This determination is stated
below.
    These proposed regulation revisions do not have Tribal implications
as defined by Executive Order 13175. They do not have a substantial
direct effect on one or more Indian Tribes, since no Tribe has to
demonstrate conformity for their actions. Furthermore, these proposed
regulation revisions do not affect the relationship or distribution of
power and responsibilities between the Federal government and Indian
Tribes. The CAA and the Tribal Air Rule establish the relationship of
the Federal government and Tribes in developing plans to attain the
NAAQS, and these revisions to the regulations do nothing to modify that
relationship. Because these proposed regulation revisions do not have
Tribal implications, Executive Order 13175 does not apply.
    Although Executive Order 13175 does not apply to these regulations,
EPA encourages Tribal input and specifically solicits comment on this
regulation from Tribal officials.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    Executive Order 13045: ``Protection of Children from Environmental
Health and Safety Risks'' (62 FR 19885, April 23, 1997) applies to any
rule that (1) is determined to be ``economically significant'' as
defined under Executive Order 12866, and (2) concerns an environmental
health or safety risk that EPA has reason to believe may have
disproportionate effect on children. If the regulatory action meets
both criteria, the Agency must evaluate the environmental health or
safety effects of the planned rule on children, and explain why the
planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the Agency.
    These proposed revisions to the regulations are not subject to
Executive Order 13045 because they are not economically significant as
defined in Executive Order 12866 and because EPA does not have reason
to believe the environmental health or safety risk addressed by the
General Conformity Regulations present a disproportionate risk to
children. The General Conformity Regulations ensure that Federal
agencies comply with the SIP, TIP or FIP for attaining and maintaining
the NAAQS. The NAAQS are promulgated to protect the health and welfare
of sensitive populations, including children.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    These revisions to the regulations are not considered a
``significant energy action'' as defined in Executive Order 13211,
``Actions That Significantly Affect Energy Supply, Distribution, or
Use,'' (66 FR 28355, May 22, 2001) because it is not likely to have a
significant adverse effect on the supply, distribution, or use of
energy.

I. National Technology Transfer Advancement Act

    Section 12(d) of the National Technology Transfer Advancement Act
of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus

standards (VCS) in its regulatory activities unless to do so would be
inconsistent with applicable law or otherwise impractical. The VCS are
technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by VCS bodies. The NTTAA directs EPA to provide Congress,
through OMB, explanations when the Agency decides not to use available
and applicable VCS.
    This revision to the regulations does not involve technical
standards. Therefore, EPA is not considering the use of any VCS.
    However, EPA will encourage the Federal agencies to consider the
use of such standards, where appropriate, in the implementation of the
General Conformity Regulations.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 requires that each Federal agency make
achieving environmental justice part of its mission by identifying and
addressing, as appropriate, disproportionately high and adverse human
health environmental effects of its programs, policies, and activities
on minorities and low-income populations.
    The EPA believes that these proposed revisions to the regulations
should not raise any environmental justice issues. The proposed
revisions to the regulations would, if promulgated, revise procedures
for other Federal agencies to follow. They do not disproportionately
affect the health or safety of minority or low income populations. The
EPA encourages other agencies to carefully consider and address
environmental justice in their implementation of their evaluations and
conformity determinations.

List of Subjects

40 CFR Part 51

    Environmental protection, Administrative practice and procedures,
Air pollution control, Carbon monoxide, Intergovernmental relations,
Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and
recordkeeping requirements, Sulfur dioxide, Volatile organic compounds.

40 CFR Part 93

    Environmental protection, Administrative practice and procedures,
Air pollution control, Carbon monoxide, Intergovernmental relations,
Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and
recordkeeping requirements, Sulfur dioxide, Volatile organic compounds.

    Authority: 42 U.S.C. 7401-7671q.

    Dated: March 31, 2006.
Stephen L. Johnson,
Administrator.
[FR Doc. 06-3310 Filed 4-4-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: June 1, 2010 (Volume 75, Number 104)]
[Notices]
[Page 30388-30389]
[DOCID:fr01jn10-59]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13725-000]

Natural Currents Energy Services, LLC; Notice of Preliminary
Permit Application Accepted for Filing and Soliciting Comments, Motions
To Intervene, and Competing Applications

May 24, 2010.
    On May 6, 2010, Natural Currents Energy Services, LLC filed an
application for a preliminary permit, pursuant to section 4(f) of the
Federal Power Act, proposing to study the feasibility of the Highlands
New Jersey Tidal Energy Project, which would be located on the
Shrewsbury River, in Monmouth County, New Jersey. The sole purpose of a
preliminary permit, if issued, is to grant the permit holder priority
to file a license application during the permit term. A preliminary
permit does not authorize the permit holder to perform any land-
disturbing activities or otherwise enter upon lands or waters owned by
others without the owners' express permission.
    Natural Currents proposes to develop this project, in conjunction
with various marinas as well as private, public and commercial
properties within the project footprint, potentially including 42 South
Bay Ave, LLC, Twin Lights Marina, Barhs Marina, and other property
owners in the Highlands, NJ area. The purpose of this project is to
install and operate in-stream tidal turbines to power the office
buildings and marinas within the site. Natural Currents Red Hawk \TM\
Tidal In-Stream Energy Conversion (TISEC) modules would generate
electricity in the free flow of the tides. The initial installations
will consist of twenty in-stream 150-kilowatt (kW) turbines with an
initial peak output of 3,000 kW.
    Applicant Contact: Mr. Roger Bason, Natural Currents Energy
Services, LLC, 24 Roxanne Boulevard, Highland, NY 12561; phone (845)
691-4009.
    FERC Contact: John M. Mudre,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site (http://www.ferc.gov/docs-filing/ferconline.asp) under the
``eFiling'' link. For a simpler method of submitting text only
comments, click on ``Quick Comment.'' For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>call toll-free at
(866) 208-3676; or, for TTY, contact<PHONE_NUMBER>. Although the
Commission strongly encourages electronic filing, documents may also be
paper-filed. To paper-file, mail an original and eight copies to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http:// www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13725) in the docket number field to access
the

document. For assistance, contact FERC Online Support.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-12994 Filed 5-28-10; 8:45 am]
BILLING CODE 6717-01-P


August 1, 2003 1 ATTACHMENT 1.

RECOMMENDATION FOR A SHORT TERM EXPOSURE LIMIT ( STEL) FOR OCTAFLUOROPROPANE ( R 218)

The STEL for octafluoropropane ( R 218) was determined from information in the Background Document ( EPA, 1994). Propane was used as a surrogate compound in determining the AEL for R 218 to be 1000 ppm. Therefore, the STEL was set at 3000 ppm, which is three times the AEL set by the Background Document. This was a conservative calculation based on the relative low toxicity of octafluoropropane. A summary of the available toxicity studies was presented in the ISCEON 89 ® SNAP submission and detailed below.

As reported by the submitter, two acute inhalation studies in the rat were performed by McHale ( 1974) and 3M ( 1993a) and one in the mouse by Huntington Research Centre ( 1992) ( ISCEON ® 89, 2003). A cardiac sensitization study was performed in the dog and was described in correspondence between the submitter and 3M ( ISCEON ® 89, 2003). A repeat exposure test of 10 days duration was performed using rats and guinea pigs as performed by McHale ( 1974) ( ISCEON 89, 2003). Genetic toxicity tests ( reverse mutagenicity assay in bacteria and mouse micronucleus assay) were performed by Huntingdon Research Centre ( 1991) ( ISCEON ® 89, 2003). The results of these tests are described below as summarized by the submitter; however, the raw data were not provided.

McHale ( 1974) exposed 10 rats ( sex not specified) for one hour to 800,000 ppm octafluoropropane in 20% oxygen. No mortality was observed. Exposed rats appeared hyperactive initially, then appeared hypoactive, with hyperemia and closed eyes. Growth curves, as measured by body weight gain, of the exposed animals were comparable to the controls during the 14 day post exposure observation period.

Rhône Poulenc, the submitter, corresponded with 3M Corporation ( 1993a) and received acute inhalation toxicity data on the rat. Ten Sprague Dawley rats ( 5 males and females each) were exposed to 110,000 ppm octafluoropropane for 4 hours. No mortality was observed. Body weight gains were reduced in the females as compared to controls ( significance was not reported). Food consumption was reportedly reduced the day after exposure. Lung congestion was reported in one of the rats ( sex and time of necropsy not reported). The study authors concluded that octafluoropropane is a simple asphyxiant.

A micronucleus study was performed ( Huntingdon Research Centre 1991) in which 30 mice were exposed to 800,000 ppm octafluoropropane ( in 20% oxygen) for 6 hours. No mortality was observed. An initial onset of hyperactivity was observed. Five animals of each sex were sacrificed at 24, 48, and 72 hours. The lungs, liver, and kidneys from animals sacrificed at 72 hours were preserved and no abnormalities were noted. No increases in the number of micronucleated polychromatic or normochromatic erythrocytes were observed. August 1, 2003 2 Rhône Poulenc, the submitter, again corresponded with 3M Corporation ( 1993b) and received data on a cardiac sensitization study in the dog. Dogs were exposed by inhalation to 50,000, 100,000, 200,000, 300,000, and 400,000 ppm octafluoropropane followed by an injection of adrenaline ( concentration unspecified). Oxygen was maintained above 22% (> 100,000 ppm oxygen was added to the exposure chamber). Eight dogs were exposed to the highest dose, but 6 dogs were exposed to the remaining doses. One positive ( multiple and multifocal ectopic beats) and one questionable response were observed in the 400,000 ppm exposure group. The NOAEL was 300,000 ppm and the LOAEL was 400,000 ppm due to an increase in cardiac effects in 2/ 8 dogs.

The repeat exposure test utilized rats ( 10/ sex) and guinea pigs that were exposed to 113,000 ppm octafluoropropane continuously via inhalation ( McHale 1974). No signs of toxicity, or changes in hematological or histopathological endpoints due to octafluorpropane exposure were observed.

Intraocular injection of 0.4 mL of octafluoropropane into rabbit's eyes caused temporary haziness of the vitreous humor that cleared in an average of 28 days ( Lincoff and Kreissig 1981). No cellular damage or membrane damage was observed.

Reverse mutation tests in Salmonella strains TA98, TA100, TA1535, and TA1537 were negative at doses up to 800,000 ppm in air ( Huntingdon Research Centre 1991; 3M 1993c). E. coli ( strains unreported) exposed to octafluoropropane ( exposure was via bubbling of the gas through the bacterial culture at an unreported concentration) exhibited a change in mannitol fermentation, causing the investigators to conclude that the compound had affected gene expression by mutating the bacterial DNA ( Fuerst and Laundry 1966; Laundry and Fuerst 1967).

No subchronic, chronic, carcinogenic, developmental, or reproductive studies were identified in any animal model using octafluoropropane. Further, no exposure studies in humans have been performed ( an exception may be the NASA information referred to below, but it does not appear that they have actually done studies on their astronauts). The submitter has established an internal 8 hour TWA Occupational Exposure Limit of 1000 ppm ( 7690 mg/ m3). Perfluoropropane ( octafluoropropane) is used by the Russians in their space program with a maximum limit of 19.51 ppm ( 150 mg/ m3). The National Aeronautics and Space Administration has set a Spacecraft Maximum Allowable Concentration for a 1 hour exposure of 11,000 ppm based on the McHale ( 1974) study NOAEL of 113,000 ppm with an uncertainty factor of 10 for interspecies extrapolation and intraspecies variations ( NRC 2000). August 1, 2003 3 REFERENCES 3M 1993. 3M Correspondence with Rhône Poulenc on May 13, 1993a; July 7, 1993b; September 3, 1993c.

Fuerst R and MM Laundry 1966. Gases affecting bacterial survival. Develop Ind Microbiol. 8: 305 312.

Huntingdon Research Centre 1992. Unpublished data.

Huntingdon Research Centre 1991. Unpublished data.

ISCEON ® 89, 2003. Application to SNAP for approval of ISCEON ® 89 submitted by Fluorinated Consumer Products.

Landry MM and R Fuerst. 1967. Gas ecology of bacteria. Develop Ind Microbiol. 9: 370 380.

Lincoff A and I Kreissig 1981. Intravitreal behavior of perflourocarbons. Dev Ophthalmol. 2: 17 23.

McHale ET. 1974. Life support without combustion hazard. Fire Technology. 10: 15 24.

National Research Council. 2000. Spacecraft Maximum Allowable Concentration for Selected Airborne Contaminants. Volume 1. National Academy of Sciences, Washington, DC. pp 148.