[Federal Register Volume 86, Number 61 (Thursday, April 1, 2021)]
[Notices]
[Page 17159]
[FR Doc No: 2021-06722]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-P-1881]

Determination That SERENTIL (Mesoridazine Besylate) Tablets, 10
Milligrams, 25 Milligrams, 50 Milligrams, and 100 Milligrams, Were Not
Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) has
determined that SERENTIL (mesoridazine besylate) tablets, 10 milligrams
(mg), 25 mg, 50 mg, and 100 mg, were not withdrawn from sale for
reasons of safety or effectiveness. This determination will allow FDA
to approve abbreviated new drug applications (ANDAs) for mesoridazine
besylate tablets, 10 mg, 25 mg, 50 mg, and 100 mg, if all other legal
and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Ayako Sato, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6206, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    SERENTIL (mesoridazine besylate) tablets, 10 mg, 25 mg, 50 mg, and
100 mg, are the subject of NDA 16774, held by Norvartis Pharmaceuticals
Corporation, and initially approved on February 27, 1970. SERENTIL is
indicated for the management of schizophrenic patients who fail to
respond adequately to treatment with other antipsychotic drugs.
    In a letter dated September 9, 2008, Novartis Pharmaceuticals
Corporation requested withdrawal of NDA 16774 for SERENTIL
(mesoridazine besylate) tablets, 10 mg, 25 mg, 50 mg, and 100 mg. In
the Federal Register of February 22, 2018 (83 FR 7738), FDA announced
that it was withdrawing approval of NDA 16774, effective March 26,
2018.
    The Weinberg Group submitted a citizen petition dated September 15,
2020 (Docket No. FDA-2020-P-1881), under 21 CFR 10.30, requesting that
the Agency determine whether SERENTIL (mesoridazine besylate) tablets,
10 mg, 25 mg, 50 mg, and 100 mg, were withdrawn from sale for reasons
of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that SERENTIL (mesoridazine besylate) tablets, 10
mg, 25 mg, 50 mg, and 100 mg, were not withdrawn for reasons of safety
or effectiveness. The petitioner has identified no data or other
information suggesting that SERENTIL (mesoridazine besylate) tablets,
10 mg, 25 mg, 50 mg, and 100 mg, were withdrawn for reasons of safety
or effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of SERENTIL (mesoridazine besylate) tablets,
10 mg, 25 mg, 50 mg, and 100 mg, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have reviewed the available evidence and determined
that this drug product was not withdrawn from sale for reasons of
safety or effectiveness.
    Accordingly, the Agency will continue to list SERENTIL
(mesoridazine besylate) tablets, 10 mg, 25 mg, 50 mg, and 100 mg, in
the ``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' delineates, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness. ANDAs that refer to SERENTIL
(mesoridazine besylate) tablets, 10 mg, 25 mg, 50 mg, and 100 mg, may
be approved by the Agency as long as they meet all other legal and
regulatory requirements for the approval of ANDAs. If FDA determines
that labeling for this drug product should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.

    Dated: March 29, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06722 Filed 3-31-21; 8:45 am]
BILLING CODE 4164-01-P


Reporting Accounting Framework for 2005 Essential Uses United States of America Essential Use Authorization for 2005: 1,902 metric tonnes Essential Use Allocation for 2005: 1,821 metric tonnes Essential Use Allocation after Trades in 2005: 1,781 metric tonnes Essential Use Allowances Expended in 2005: 1,705 metric tonnes A B C D E ( C+ D) F ( B E) G H ( G+ E) I J K L ( H I K) M Year of Essential Use Amount Exempted for year of Essential Use* Amount Acquired by Production Amount Acquired for Essential Uses by Import and Country( s)

of Manufacture Total Acquired for Essential Use Authorised but not Acquired On Hand at Start of Year Available for Use in Current Year Used for Essential Use Quantity Contained in Products Exported Destroyed or Recycled On Hand at End of Year** Pre 1996 CFCs***

Amount Country 2005 1,781 157 1,548 EU 1,705 76 1,600 3,305 1,171 0 176 1,911 398.6 * net of international trades ** allowances were issued late in 2005 which did not allow some companies to execute all of their 2005 MDI production thus over inflating the " on hand at year end" amount to make it appear that more is available for 2006 production than is the case.

*** This amount reflects the quantity of CFCs owned by companies that received 2005 essential use exemptions. As per Decisions XVI/ 12 and XVII/ 5, the United States takes these amounts into account when conducting our domestic allocation process to ensure that a company does not have a stockpile that exceeds a 12 month operational supply.


[Federal Register: April 8, 2009 (Volume 74, Number 66)]
[Rules and Regulations]
[Page 15841-15842]
[DOCID:fr08ap09-4]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-1324; Directorate Identifier 2008-NM-101-AD;
Amendment 39-15875; AD 2009-08-02]
RIN 2120-AA64

Airworthiness Directives; McDonnell Douglas Model DC-8-50 Series
Airplanes; Model DC-8F-54 and DC-8F-55 Airplanes; Model DC-8-60 Series
Airplanes; Model DC-8-60F Series Airplanes; Model DC-8-70 Series
Airplanes; and Model DC-8-70F Series Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for all
McDonnell Douglas airplanes identified above. This AD requires revising
the airplane flight manual to provide the flightcrew with procedures to
preclude dry running of the fuel pumps. This AD results from fuel
system reviews conducted by the manufacturer. We are issuing this AD to
prevent pump inlet friction (i.e., overheating or sparking) when the
fuel pumps are continually run as the center wing fuel tank becomes
empty, and/or electrical arc burnthrough, which could result in a fuel
tank fire or explosion.

DATES: This AD is effective May 13, 2009.

ADDRESSES:

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (telephone<PHONE_NUMBER>) is the 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: William Bond, Aerospace Engineer,
Propulsion Branch, ANM-140L, FAA, Los Angeles Aircraft Certification
Office, 3960 Paramount Boulevard, Lakewood, California 90712-4137;
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 airworthiness directive (AD) that would apply to
all McDonnell Douglas Model DC-8-50 series airplanes; Model DC-8F-54
and DC-8F-55 airplanes; Model DC-8-60 series airplanes; Model DC-8-60F
series airplanes; Model DC-8-70 series airplanes; and Model DC-8-70F
series airplanes. That NPRM was published in the Federal Register on
December 23, 2008 (73 FR 78678). That NPRM proposed to require revising
the airplane flight manual to provide the flightcrew with procedures to
preclude dry running of the fuel pumps.

Comments

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

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting the AD as proposed.

Costs of Compliance

    We estimate that this AD will affect 156 airplanes of U.S.
registry. We also estimate that it will take about 1 work-hour per
product to comply with this AD. The average labor rate is $80 per work-
hour. Based on these figures, we estimate the cost of this AD to the
U.S. operators to be $12,480, or $80 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

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

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, 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:

2009-08-02 McDonnell Douglas: Amendment 39-15875. Docket No. FAA-
2008-1324; Directorate Identifier 2008-NM-101-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective May 13, 2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to all McDonnell Douglas airplanes
identified in Table 1 of this AD, certificated in any category.

                         Table 1--Applicability
------------------------------------------------------------------------
                                  Model
-------------------------------------------------------------------------
(1) DC-8-51, DC-8-52, DC-8-53, and DC-8-55 airplanes.
(2) DC-8F-54 and DC-8F-55 airplanes.

(3) DC-8-61, DC-8-62, and DC-8-63 airplanes.
(4) DC-8-61F, DC-8-62F, and DC-8-63F airplanes.
(5) DC-8-71, DC-8-72, and DC-8-73 airplanes.
(6) DC-8-71F, DC-8-72F, and DC-8-73F airplanes.
------------------------------------------------------------------------

Unsafe Condition

    (d) This AD results from fuel system reviews conducted by the
manufacturer. We are issuing this AD to prevent pump inlet friction
(i.e., overheating or sparking) when the fuel pumps are continually
run as the center wing fuel tank becomes empty, and/or electrical
arc burnthrough, which could result in a fuel tank fire or
explosion.

Compliance

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

Airplane Flight Manual (AFM) Revision

    (f) Within 14 days after the effective date of this AD, revise
the Certificate Limitations Section of the Boeing DC-8 AFM to
include the following procedures that preclude dry running of fuel
pumps and/or electrical arc burnthrough (this may be done by
inserting a copy of this AD into the AFM):

    ``During level flight, the applicable alternate or center wing
auxiliary tank boost pump switch must be placed in the OFF position
no more than 5 minutes after the auto fill light is continuously
illuminated.
    DO NOT reset any tripped fuel pump circuit breakers.''

Alternative Methods of Compliance (AMOCs)

    (g)(1) The Manager, Los Angeles Aircraft Certification Office
(ACO), FAA, has the authority to approve AMOCs for this AD, if
requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: William Bond, Aerospace Engineer, Propulsion
Branch, ANM-140L, FAA, Los Angeles ACO, 3960 Paramount Boulevard,
Lakewood, California 90712-4137; telephone<PHONE_NUMBER>; fax (562)
627-5210.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
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.

Material Incorporated by Reference

    (h) None.

    Issued in Renton, Washington, on March 30, 2009.
Steve Boyd,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-7791 Filed 4-7-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: February 8, 2008 (Volume 73, Number 27)]
[Proposed Rules]
[Page 7498-7503]
[DOCID:fr08fe08-20]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 880

[Docket No. 2007N-0484]

Devices: General Hospital and Personal Use Devices;
Reclassification of Medical Device Data System

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to
reclassify, on its own initiative, the Medical Device Data System
(MDDS) from class III (premarket approval) to class I (general
controls). This action does not include medical device data systems
with new diagnostic or alarm functions. FDA is also proposing that the
MDDS be exempt from the premarket notification requirements when it is
indicated for use only by a healthcare professional and does not
perform irreversible data compression.

DATES: Submit written or electronic comments on the proposed rule by
May 8, 2008. Submit comments regarding information collection by March
10, 2008, to the Office of Management and Budget (OMB) (see ADDRESSES).
FDA proposes that any final regulation based on this proposal become
effective 60 days after its date of publication in the Federal
Register. See section VIII of the SUPPLEMENTARY INFORMATION section of
the preamble for further information about the effective date.

ADDRESSES: You may submit comments, identified by Docket No. 2007N-
0484, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the followings ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (For paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described previously, in
the ADDRESSES portion of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name
and Docket No.(s) and Regulatory Information Number (RIN) (if a RIN
number has been assigned) for this rulemaking. All comments received
may be posted without change to http://www.regulations.gov, including

any personal information provided. For additional information on
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the

docket number(s), found in brackets in the heading of this document,
into the

``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Information Collection Provisions: Submit written comments on the
information collection provisions to the Office of Information and
Regulatory Affairs, OMB. To ensure that comments on the information
collection are received, OMB recommends that written comments be faxed
to the Office of Information and Regulatory Affairs, OMB, Attn: FDA
Desk Officer, FAX:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Anthony D. Watson, Center for Devices
and Radiological Health (HFZ-480), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background (Regulatory Authorities)

    The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301
et seq.), as amended by the Medical Device Amendments of 1976 (the 1976
amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990
(SMDA) (Public Law 101-629), and the Food and Drug Administration
Modernization Act of 1997 (FDAMA) (Public Law 105-115), established a
comprehensive system for the regulation of medical devices intended for
human use. Section 513(a)(1) of the act (21 U.S.C. 360c) established
three categories (classes) of devices, depending on the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are:
     Class I (general controls),
     Class II (special controls), and
     Class III (premarket approval).
    FDA refers to devices that were in commercial distribution before
May 28, 1976 (the date of enactment of the 1976 amendments), as
``preamendment devices.'' FDA classifies these devices after it:
    1. Receives a recommendation from a device classification panel (an
FDA advisory committee);
    2. Publishes the panel's recommendation for comment, along with a
proposed regulation classifying the device; and
    3. Publishes a final regulation classifying the device.
    FDA has classified most preamendments devices under these
procedures.
    The agency determines whether new devices are substantially
equivalent to predicate devices by means of premarket notification
procedures in section 510(k) of the act (21 U.S.C. 360(k)) and part 807
of the regulations (21 CFR part 807).
    Reclassification of postamendment devices is governed by section
513(f)(3) of the act, formerly section 513(f)(2) of the act. This
section provides that FDA may initiate the reclassification of a device
classified into class III under section 513(f)(1) of the act, or the
manufacturer or importer of a device may petition the Secretary of
Health and Human Services for the issuance of an order classifying the
device in class I or class II. FDA's regulations in 21 CFR 860.134 set
forth the procedures for the filing and review of a petition for
reclassification of such class III devices. In order to change the
classification of the device, it is necessary that the proposed new
classification have sufficient regulatory controls to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use.
    FDAMA added section 510(l) to the act. Section 510(l) of the act
provides that a class I device is exempt from the premarket
notification requirements under section 510(k) of the act, unless the
device is intended for a use which is of substantial importance in
preventing impairment of human health or it presents a potential
unreasonable risk of illness or injury. FDA refers to the criteria that
designate a class I device as not exempt from premarket notification as
``reserved criteria.'' An exemption permits manufacturers to introduce
into commercial distribution generic types of devices without first
submitting a premarket notification to FDA.

II. Regulatory History of the Device

    Computer-based and software-based products are subject to
regulation as devices when they meet the definition of a device
contained in section 201(h) of the act (21 U.S.C. 321(h)). In 1989, FDA
prepared a general policy statement on how it planned to determine
whether a computer-based product and/or software based product is a
device and, if so, how FDA intended to regulate it. This document
became known as the ``Draft Software Policy.'' The scope and intention
of the 1989 policy were based on the existing state of computer and
software technology at that time. That policy included the principle
that the level of FDA oversight of software should depend primarily on
the risk to the patient should the software fail to perform in
accordance with its specifications.
    Since 1989, the use of computer-based products and software-based
products as medical devices has grown exponentially. In addition,
device interconnectivity and complexity have grown in ways that could
not have been predicted in 1989. This growth and expansion have created
new considerations for elements of risk that did not previously exist.
FDA realized that the Draft Software Policy was not adequate to address
all of the issues related to the regulation of computer-based and
software-based medical devices. Based on this history and the
complexity and diversity of computer software, FDA decided it would be
impractical to prepare one ``software'' or ``computer'' policy that
would be able to address all the issues related to the regulation of
computer- and software-based medical devices. Nonetheless, the
principle that the level of FDA oversight of software should depend
primarily on the risk to the patient should the software fail to
perform in accordance with its specifications remains important. Many
software classifications reflect this principle, including:
     FDA has classified software used in computer aided
detection of cancerous lesions in the breast in class III;
     FDA has classified software used in computer tomography
(CT) and X-ray systems to provide images to assist in clinical
decisionmaking in class II; and
     FDA has classified laboratory information systems in class
I.
    This principle also informs this proposed reclassification, in
which FDA is focusing on a category of post amendment computer- and
software-based devices that present a low risk and should not be
subject to premarket review that have not been classified elsewhere. An
examination of modern medical device networks and computer
infrastructure helped FDA to identify a category of computer based and
software products that meet the definition of a device, which the FDA
would consider to pose minimal risks, and that should not be Class III
and should not require premarket submission. This medical device has
been named a ``Medical Device Data System.''

III. Device Description

    A medical device data system (MDDS) is a device intended to provide
one or more of the following uses:
     The electronic transfer or exchange of medical device data
from a medical device, without altering the function or parameters of
any connected devices. For example, this would include software that
interrogates a ventilator every 15 minutes and transfers information
about patient CO\2\ levels to a central patient data repository;

     The electronic storage and retrieval of medical device
data, without altering the function or parameters of connected devices.
For example, this would include software that stores historical blood
pressure information for later review by a healthcare provider;
     The electronic display of medical device data, without
altering the function or parameters of connected devices. For example,
this would include software that displays the previously stored
electrocardiogram for a particular patient;
     The electronic conversion of medical device data from one
format to another format in accordance with a preset specification. For
example, this would include software that converts digital data
generated by a pulse oximeter into a digital format that can be
printed.
     Examples of medical device data systems that would be used
in the home are systems that periodically collect data from glucose
meters or blood pressure devices for later review by a healthcare
provider.
    Medical device data consist of numerical or other information
available from a medical device in a form suitable for processing by
computer. Medical device data can represent many types of information
(e.g., clinical values, alarm conditions, error messages). MDDS are not
intended or designed to provide any real time, active, or online
patient monitoring functions. Medical device data systems can deliver
and store alarm data but do not have the capability to display, create,
or detect alarm conditions, or to actually sound an alarm. In
particular, a MDDS can record the fact that an alarm sounded, but
cannot by itself sound an alarm in response to patient information.
Medical device data systems cannot create alarms that are not already
present from the connected medical devices. By themselves, MDDS do not
provide any diagnostic or clinical decision making functions. Medical
device data systems can transmit, exchange, store, or retrieve data in
its original format or can be used to convert the medical device data
from one format to another so that the arrangement or organization of
the medical device data is in accordance with preset specifications.
    In developing its current regulatory strategy for MDDS, FDA
considered how the risks presented by an MDDS compare to existing
manual processes for managing these data. Hospitals, clinics, and other
healthcare facilities are well-aware of the shortcomings of manual
functions and have introduced other manual oversight to reduce their
effects, such as audits of records and multiple-person checks of
paperwork prior to treatments. These facilities have also introduced
electronic systems to help reduce the human element in these errors.
However, when data are being stored, retrieved, transferred, exchanged,
or displayed electronically, an additional element of risk is
introduced. This element of risk would not be present for a manual
transfer of files or information because the information is readily
apparent to the healthcare provider.
    When manual data is converted to electronic form, data can be
altered in such a way as to not be transparent to the user and pose a
risk to the patient. In effect, even though manual functions have their
risks (e.g., illegible handwriting, wrong charts, etc.), when these
functions are automated, users tend to rely entirely on the technology
because the technology is assumed to alleviate those risks. This is
especially true when software systems are designed to interface with a
number of unspecified medical devices. Thus, regulatory oversight of
MDDS is critical to ensuring that there is an adequate expectation of
performance.
    It is FDA's long-standing practice to not regulate those manual
office functions that are simply automated for the ease of the user
(e.g., office automation) and that do not include MDDS as described
previously. For example, the report-writing functions of a computer
system that allow for the manual (typewriter like) input of data by
practitioners would not be considered as a MDDS, because these systems
are not directly connected to a medical device. In addition, software
that merely performs library functions, such as storing, indexing, and
retrieving information not specific to an individual patient, is not
considered to be a medical device. Examples include medical texts or
the Physician's Desk Reference on CD-ROM that are indexed and cross-
referenced for ease of use. This proposed regulation does not address
software that allows a doctor to enter or store a patient's health
history in a computer file.

IV. Proposed Reclassification

    Because MDDS that are subject to the rulemaking are new post
amendment devices, they are deemed to be class III by operation of the
statute (section 513(f) of the act (21 U.S.C. 360c(f)). FDA believes
that classification in class I, with appropriate application of the
Quality System Regulation (part 820 (21 CFR part 820)), will provide
reasonable assurance of the safety and effectiveness of this device.
FDA is proposing that the Medical Device Data System be reclassified
from class III to class I. In addition, FDA is proposing that when the
device is indicated for use only by a healthcare professional and does
not perform irreversible data compression, in accordance with section
510(l) of the act (21 U.S.C. 360(l)), it would be exempt from the
premarket notification procedures in subpart E of part 807, subject to
the limitations in Sec.  880.9 (21 CFR 880.9). For purposes of this
regulation, ``healthcare professional'' is any practitioner licensed by
the law of the State in which he or she practices to use or order the
use of the device. When the device is indicated for use by a lay user,
or performs irreversible data compression, FDA believes that the device
presents a potential for unreasonable risk of illness or injury. FDA is
proposing that MDDS devices indicated for lay use or that perform
irreversible data compression not be exempt from premarket notification
requirements.

V. Risks to Health

    FDA believes that general controls, including the Quality System
regulation and the requirements for Design Controls as per Sec.
820.30, will provide a reasonable assurance of safety and effectiveness
for a MDDS. Risks to health from this device would be caused by
inadequate software quality. Specifically, the risk to health would be
that incorrect medical device data is stored, retrieved, transferred,
exchanged, or displayed, resulting in incorrect treatment or diagnosis
of the patient. As explained below, FDA believes the risk related to
inadequate software quality can be mitigated through application of the
Quality System Regulation.

VI. Summary of Reasons for Reclassification

    FDA believes that the MDDS should be reclassified into class I
because general controls would provide reasonable assurance of safety
and effectiveness and special controls and premarket approval are not
necessary to provide such assurance. FDA believes that the application
of the Quality System Regulation (part 820), particularly the design
control provisions, would significantly reduce the risk of errors from
these devices that might cause incorrect treatment or diagnosis of the
patient. The design controls section (Sec.  820.30) of the QS
regulation (Sec.  820.30) applies to the design of devices including
class I devices with software. FDA does not intend to apply design
controls retroactively to currently legally

marketed MDDS devices. However, changes to existing designs or to
currently marketed devices must be made in accordance with design
control requirements, even if the original design was not subject to
these requirements, Sec.  820.30. This approach to implementing design
controls for MDDS is consistent with the way FDA implemented design
controls after the issuance of the Quality System Regulation in 1996.

VII. Summary of Data Upon Which the Reclassification is Based

    FDA is basing this proposed rule upon the history of use of this
type of device in clinical practice as well as the substantial
knowledge of FDA staff about this device type. These types of systems
provide no new or unique clinical algorithms or clinical functions that
have not already been reviewed and cleared in existing medical devices;
therefore, no new pre-market review or evaluation should be required.
Further, FDA believes that the proper application of a Quality System
approach to the design and development of MDDS devices will ensure
their quality. FDA believes that this is the least burdensome approach
to the regulation of these medical devices.

VIII. Effective Date

    FDA intends that this rule, if finalized, will become effective 60
days after the date of publication of the final rule. However, FDA
intends to continue to exercise enforcement discretion after
publication of any final rule so that manufacturers who are already on
the market with MDDS devices may have sufficient time to come into
compliance as follows: FDA expects manufacturers who are already
marketing a MDDS device before publication of a final rule and who meet
the criteria for exemption from premarket notification to register and
list under part 807 within 60 days after publication of the final rule.
If a premarket notification is required, FDA expects manufacturers who
are marketing an MDDS device without FDA clearance to submit a
premarket notification within 90 days of the effective date of a final
rule and to obtain final clearance of a premarket notification within
180 days after publication of a final rule. FDA expects manufacturers
who are required to obtain clearance of a premarket notification to
register and list within 30 days after receiving a substantial
equivalence order for their device. Manufacturers who are not already
marketing an MDDS device will be required to comply with any final rule
as of the effective date.

IX. Environmental Impact

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

X. Analysis of Impact

    FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is not a significant regulatory action as defined by
the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this action is deregulatory and imposes no
new burdens, the agency certifies that the proposed rule will not have
a significant economic impact on a substantial number of small
entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $127 million, using the most current (2006) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.

Background

    An MDDS is a device that electronically stores, transfers,
displays, or reformats patient medical data. It does not provide any
diagnostic or clinical decision making functions. A MDDS could, for
example, store alarm data being generated by a connected medical
device, but would not be able to generate alarms on its own. The MDDS
device is currently classified into class III, the highest level of
regulatory oversight. The MDDS was initially placed in this
classification by default. MDDS manufacturers, as makers of class III
devices, bear all costs associated with premarket approval, including
the cost of submitting the premarket approval application (PMA) and
payment of user fees. The costs associated with the submission of the
PMA are substantial, potentially reaching $1,000.000.
    Although we can identify several MDDS devices and device
manufacturers, we nevertheless do not know the size of the affected
industry because FDA has not been enforcing registration and listing
requirements for manufacturers of MDDS devices. We welcome comment on
the size and other characteristics of the affected industry.
    FDA is proposing to reclassify MDDS devices from class III to class
I. Based on the history of use of this type of device in clinical
practice and on the experience of FDA reviewers, the agency concludes
that in the hands of a healthcare professional, a MDDS is safe and
effective under general controls. The application of general controls,
including the software design controls in part 820, would be consistent
with the principle of applying the least degree of regulatory control
necessary to provide reasonable assurance of safety and effectiveness.
The application of this lowest level of regulatory oversight would be
consistent with the treatment of other devices with similar risk
profiles. Software used to store, transmit, and communicate patient
medical data, such as Laboratory Information Systems and Medical Image
Communication Systems, is typically classified into class I.
    FDA has already recognized that the class III requirements are not
necessary for ensuring the safety and effectiveness of MDDS devices and
has been exercising enforcement discretion with MDDS device
manufacturers. These firms have not been required to submit PMAs or
meet other requirements typically required of manufacturers of class
III devices, but the agency believes that all or nearly all firms in
this industry have in place good business practices, including quality
systems. If FDA were to discontinue enforcement discretion, most firms
would continue to comply with the class I provisions.

Cost of the Proposed Regulation

    This proposed regulation is deregulatory. Device manufacturers
currently subject to class III requirements would be subject to the

less burdensome requirements for makers of class I devices. Of course,
changing the device classification may not have an impact on the
practices of MDDS device manufacturers as long as FDA continues its
practice of enforcement discretion. For the purpose of this analysis,
however, we assume that enforcement discretion would not be permanent.
The regulatory alternatives are therefore class III, II, or I controls,
enforced by the agency. This proposed rule would re-classify MDDS
devices as class I, which would reduce the applicable regulatory
requirements.
    Manufacturers of class I devices are required to: (1) Register and
list their MDDS devices with the agency, (2) conform to applicable
medical device current good manufacturing practice requirements (part
820), (3) comply with Medical Device Reporting (MDR) requirements (21
CFR part 803), and (4) submit a premarket notification for the device
unless it is exempt. This proposed rule proposes to exempt MDDS devices
unless they are indicated for use by someone other than a healthcare
professional, perform irreversible data compression, or exceed the
limitations in Sec.  880.9. MDDS devices indicated for use solely by a
healthcare professional, are exempt from the premarket notification
requirements.
    Registration and listing. The majority of manufacturers of MDDS
devices would incur a cost to register and list their devices with the
agency. We estimate this burden to be less than 1 hour per year for
manufacturers familiar with this requirement, and up to 2 hours of time
for manufacturers not currently producing any FDA-regulated devices.
Manufacturers would also face user fees of $1,708 in fiscal year (FY)
2008 to register and list their devices with the agency. These fees
would rise to $2,364 in 2012.
    Current Good Manufacturing Practices (CGMP)/Quality System
Regulation (QSR) compliance/Medical Device Reporting. Based on
experience with this and similar devices, FDA believes that most
manufacturers of these devices already have quality systems in place as
part of good business practices. Good quality systems would include
complaint-handling procedures. FDA's QSR (part 820) requirements are
very flexible and FDA believes that these manufacturers will be able to
conform their systems to FDA requirements with little difficulty or
cost. Manufacturers are already required to report to FDA whenever they
learn that their device may have caused or contributed to a death or
serious injury to a patient. The cost of complying with these
requirements would be small, but would vary depending on the number and
nature of the devices manufactured and the nature of the firm's current
quality system. Firms with existing quality systems should be able to
adapt their complaint procedures to incorporate MDR reporting with
little difficulty. Based on our understanding of the industry and that
it has in place measures to ensure quality, we believe most firms would
be able to adapt their systems to meet FDA's QSR and MDR regulations
for no more than $20,000. Again, this would not be a cost imposed by
this proposed rule, but the cost of an existing burden manufacturers
may not have incurred because FDA's practice of enforcement discretion
with manufacturers of MDDS devices.
    Premarket notification. If FDA finalizes the classification of MDDS
devices into class I, a manufacturer of a MDDS device that is indicated
for use solely in a health care facility would not need to comply with
the PMA requirement that applies to class III devices or submit a
premarket notification. FDA is unaware of any MDDS devices that are not
intended for use solely by healthcare professionals, so we believe all
or nearly all MDDS devices will be exempt from premarket review. A
manufacturer of a MDDS device that is indicated for use by anyone other
than a healthcare professional or that performs irreversible data
compression would need to submit a premarket notification, but the
burden of submitting a premarket notification is substantially less
than that of submitting a PMA. A premarket notification for a MDDS
device would be far less complex than a PMA. The cost of preparing and
submitting such a notification would be several thousand dollars. The
user fees for a premarket notification would be $3,404 for FY 2008,
increasing to $4,717 in 2012. In contrast, the cost of submitting a PMA
can reach $1,000,000, plus user fees of an additional $185,000 in FY
2008, increasing to $256,384 in 2012.
    In summary, this device reclassification would substantially reduce
an existing burden on the manufacturers of MDDS devices. The regulatory
burden of compliance with the general controls provisions applicable to
the manufacturers of all class I devices is attributable to statutory
requirements that already apply but have not been enforced. Assuming
that continued enforcement discretion is not a viable long-term
regulatory alternative, the proposed rule would reduce the regulatory
burden for manufacturers of MDDS devices. Considering the cost of
submitting a PMA plus the relevant user fees, the reduction could be
$1,000,000 per device.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because reclassification of the affected devices
from class III to class I would relieve manufacturers of the cost of
complying with the premarket approval requirements of section 515 of
the act (21 U.S.C. 360e), the agency does not believe that this
proposed rule would have a significant economic impact on a substantial
number of small entities. FDA requests comment on this issue.

XI. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that
are subject to review by OMB under the Paperwork Reduction Act of 1995
(the PRA) (44 U.S.C. 3501-3520). The collections of information
addressed in the proposed rule have been approved by OMB in accordance
with the PRA under the QSR (part 820, OMB Control No. 0910-0073) and
the regulations governing premarket notification submissions (21 CFR
part 807, subpart E, OMB Control No. 0910-0120).

XII. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule, if finalized, would not contain policies that would
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.
Accordingly, the agency tentatively concludes that the proposed rule
does not contain policies that have federalism implications as defined
in the Executive order and, consequently, a federalism summary impact
statement has not been prepared.

XIII. Submission of Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division

of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.

List of Subjects in 21 CFR Part 880

    Medical devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, FDA proposes
to amend 21 CFR part 880 as follows:

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

    1. The authority citation for 21 CFR part 880 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    2. Part 880 is amended in subpart G by adding Sec.  880.6310 to
read as follows:

Sec.  880.6310  Medical Device Data System.

    (a) Identification. (1) A medical device data system (MDDS) is a
device intended to provide one or more of the following uses:
    (i) The electronic transfer or exchange of medical device data from
a medical device, without altering the function or parameters of any
connected devices.
    (ii) The electronic storage and retrieval of medical device data
from a medical device, without altering the function or parameters of
connected devices.
    (iii) The electronic display of medical device data from a medical
device, without altering the function or parameters of connected
devices.
    (iv) The electronic conversion of medical device data from one
format to another format in accordance with a preset specification.
    (2) Medical device data consists of numerical or other information
available from a medical device in a form suitable for processing by
computer. Medical device data can represent any type of information or
knowledge, e.g., clinical values, alarm conditions, error messages.
This identification does not include a device that creates diagnostic,
decision support, or alarm functions. It also does not include the
report-writing functions of a data system that allows for the manual
input of data by practitioners. This identification does not include
devices with any real time, active, or online patient monitoring.
    (b) Classification. Class I (general controls). When the device is
indicated for use only by a healthcare professional and does not
perform irreversible data compression, it is exempt from the premarket
notification procedures in subpart E of part 807, subject to the
limitations in Sec.  880.9. When the device is indicated to be
prescribed by a healthcare professional for use by a lay user, or
performs irreversible data compression, or for over-the-counter use by
a lay user, the device requires the submission and clearance of a
premarket notification.

    Dated: January 25, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-2325 Filed 2-7-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 76, Number 243 (Monday, December 19, 2011)]
[Notices]
[Pages 78717-78718]
[FR Doc No: 2011-32444]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket Nos. FMCSA-2006-26367 and FMCSA-2011-0131]

Public Meeting of a Joint Subcommittee of the Motor Carrier
Safety Advisory Committee and the Medical Review Board; Obstructive
Sleep Apnea

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

ACTION: Notice of Joint Subcommittee of the Meeting of Motor Carrier
Safety Advisory Committee (MCSAC) and Medical Review Board (MRB).

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SUMMARY: FMCSA announces that MCSAC and MRB will hold a joint
subcommittee meeting on Wednesday- Thursday, January 4-5, 2012. Both
days of the meeting will be open to the public.
    Time and Dates: The joint MCSAC-MRB subcommittee meeting will be
held on Wednesday-Thursday, January 4-5, 2012, from 8:30 a.m. to 5
p.m., Eastern Time (E.T.). The meeting will be held at the Hilton
Alexandria Old Town, 1767 King Street, Alexandria, VA 22314 in the
Washington and Jefferson Rooms on the 2nd floor. The Hilton Alexandria
Old Town is located across the street from the King Street Metro
station.
    Matters To Be Considered: The MCSAC-MRB subcommittee will consider
ideas and concepts the Agency should consider for potential regulatory
changes to the current physical qualifications standards to address the
medical certification process for truck and bus drivers that have been
diagnosed with OSA or are believed to suffer from the disease but have
not been diagnosed at the time of the medical examination. The
subcommittee will make its recommendations to the MCSAC and MRB for
their deliberation at a joint meeting of the two bodies in February
2012. Upon approval by the MCSAC and MRB, the recommendations will be
submitted to FMCSA for consideration. Copies of Task Statement 11-05
and an agenda for the 2-day meeting will be made available on the MCSAC
and MRB Web sites at http://mcsac.fmcsa.dot.gov and http://mrb.fmcsa.dot.gov, respectively.

FOR FURTHER INFORMATION CONTACT: Ms. Shannon L. Watson, Senior Advisor
to the Associate Administrator for Policy, Federal Motor Carrier Safety
Administration, U.S. Department of Transportation, 1200 New Jersey
Avenue SE., Washington, DC 20590,<PHONE_NUMBER><EMAIL_ADDRESS>
Services for Individuals with Disabilities:

    For information on facilities or services for individuals with
disabilities or to request special assistance at the meeting, contact
Elizabeth Turner at<PHONE_NUMBER><EMAIL_ADDRESS>by
Wednesday, December 28, 2011.

SUPPLEMENTARY INFORMATION:

I. Background

MCSAC

    Section 4144 of the Safe, Accountable, Flexible, Efficient
Transportation Equity Act: A Legacy for Users (SAFETEA-LU, Public Law
109-59, 119 Stat. 1144, August 10, 2005) required the Secretary of
Transportation to establish the MCSAC. The MCSAC provides advice and
recommendations to the FMCSA Administrator on motor carrier safety
programs and regulations, and operates in accordance with the Federal
Advisory Committee Act (FACA, 5 U.S.C. App 2).

MRB

    Section 4116 of the SAFETEA-LU requires the Secretary of
Transportation, with the advice of the MRB, to ``establish, review, and
revise medical standards for operators of CMVs that will ensure that
the physical condition of operators of CMVs is adequate to enable them
to operate the vehicles safely.'' On November 2, 2010, the Secretary of
Transportation announced the five medical experts who serve on the MRB.
FMCSA is planning revisions to the physical qualification regulations
of CMV drivers, and the MRB will provide the necessary science-based
guidance to establish realistic and responsible medical standards. The
MRB operates in accordance with FACA.

Obstructive Sleep Apnea

    The MCSAC and the MRB met jointly on December 7, 2011, to discuss
ideas and concepts the Agency should consider for regulatory guidance
and, potentially, for future rulemaking on OSA. The MCSAC and MRB
completed their joint recommendation on regulatory guidance on OSA and
issued a letter report at the end of the meeting. As a result of these
discussions, a joint subcommittee was formed to develop ideas and
concepts the Agency should consider for a potential notice-and-comment
rulemaking to address the issue of OSA.

II. Meeting Participation

    Oral comments from the public will be heard during the last half-
hour of the meeting on Wednesday and Thursday. Members of the public
may submit written comments on the topics to be considered during the
meeting by Wednesday, December 28, 2011, to Federal Docket Management
System (FDMC) Docket Number FMCSA-2006-26367 using any of the following
methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building, Room W12-
140, Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, 1200 New
Jersey Avenue SE., Room W12-140, Washington, DC, between 9 a.m. and 5
p.m., E.T. Monday through Friday, except Federal holidays.

    Issued on: December 13, 2011.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2011-32444 Filed 12-16-11; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 77, Number 128 (Tuesday, July 3, 2012)]
[Notices]
[Page 39529]
[FR Doc No: 2012-16224]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 17Ad-15; OMB Control No. 3235-0122; SEC File No. 270-154.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) the Securities and Exchange Commission
(``Commission'') is soliciting comments on the existing collection of
information provided for in the following rule: Rule 17Ad-15 (17 CFR
240.17Ad-15) under the Securities Exchange Act of 1934 (15 U.S.C. 78a
et seq.). The Commission plans to submit this existing collection of
information to the Office of Management and Budget (``OMB'') for
extension and approval.
    Rule 17Ad-15 (17 CFR 240.17Ad-15) under the Securities Exchange Act
of 1934 (15 U.S.C. 78a et seq.) (the ``Act'') requires approximately
477 transfer agents to establish written standards for the acceptance
or rejection of guarantees of securities transfers from eligible
guarantor institutions. Transfer agents are required to establish
procedures to ensure that those standards are used by the transfer
agent to determine whether to accept or reject guarantees from eligible
guarantor institutions. Transfer agents must maintain, for a period of
three years following the date of a rejection of transfer, a record of
all transfers rejected, along with the reason for the rejection,
identification of the guarantor, and whether the guarantor failed to
meet the transfer agent's guarantee standard. These recordkeeping
requirements assist the Commission and other regulatory agencies with
monitoring transfer agents and ensuring compliance with the rule.
    There are approximately 477 registered transfer agents. The staff
estimates that every transfer agent will spend about 40 hours annually
to comply with Rule 17Ad-15. The total annual burden for all transfer
agents is 19,080 hours (477 times 40 hours). The average cost per hour
is approximately $50. Therefore, the total cost of compliance for all
transfer agents is $954,000 (19,080 hours times $50).
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information on
respondents; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    The Commission may not conduct or sponsor a collection of
information unless it displays a currently valid control number. No
person shall be subject to any penalty for failing to comply with a
collection of information subject to the PRA that does not display a
valid Office of Management and Budget (OMB) control number.
    Please direct your comments to Thomas Bayer, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik/Simon, 6432 General Green Way, Alexandria, VA 22312 or send an
email to<EMAIL_ADDRESS>
    Dated: June 27, 2012.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-16224 Filed 7-2-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 33 (Thursday, February 17, 2011)]
[Notices]
[Pages 9348-9349]
[FR Doc No: 2011-3621]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Docket No. EL11-19-000]

Southern California Edison Company, Pacific Gas and Electric
Company, San Diego Gas & Electric Company; Notice of Petition

    Take notice that on January 31, 2011, pursuant to section 210(h)(2)
of the Public Utility Regulatory Policies Act of 1978 (PURPA),\1\
Southern California Edison Company (SCE), Pacific Gas and Electric
Company (PG&E), and San Diego Gas & Electric Company (SDG&E) filed a
petition requesting that the Federal Energy Regulatory Commission
(Commission) enforce the requirements of PURPA against the Public
Utilities Commission of the State of California (CPUC), and find that
the CPUC's AB 1613 Decisions \2\ violate PURPA and the Commission's
Regulations implementing PURPA.
---------------------------------------------------------------------------

    \1\ 16 U.S.C. 824a-3(h)(2) (2006).
    \2\ The AB 1613 Decisions consist of the following CPUC
decisions issued in rulemaking docket R.08-06-024: (1) Decision
Adopting Policies and Procedures for Purchase of Excess Electricity
Under Assembly Bill 1613, D.09-12-042 (Dec. 21, 2009), (2) Order
Dismissing Motion for Stay of Decision (D.) 09-12-042, Modifying
D.09-12-042, and Denying Rehearing of D.09-12-042, as Modified,
D.10-04-055 (Apr. 26, 2010), and (3) Decision Granting, in Part, and
Denying in Part, Joint Petition of Pacific Gas and Electric Company,
Southern California Edison Company, and San Diego Gas & Electric
Company for Modification of Decision 09-12-042, D.10-12-055 (Dec.17,
2010), rehearing pending. Page citations to CPUC Decisions are to
the .pdf versions posted on the CPUC Web site.
---------------------------------------------------------------------------

    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the

Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Any person
wishing to become a party must file a notice of intervention or motion
to intervene, as appropriate. The Respondent's answer and all
interventions, or protests must be filed on or before the comment date.
The Respondent's answer, motions to intervene, and protests must be
served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on February 22, 2011.

    Dated: February 10, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-3621 Filed 2-16-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 189 (Tuesday, September 30, 2014)]
[Notices]
[Page 58851]
[FR Doc No: 2014-23148]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2014-77]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before October 20, 2014.

ADDRESSES: You may send comments identified by Docket Number FAA-2014-
0664 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Jake Troutman,<PHONE_NUMBER>, 800
Independence Avenue SW., Washington, DC 20951.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on September 24, 2014.
Lirio Liu,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2014-0664
    Petitioner: Industrial Aerobotics, LLC.
    Section of 14 CFR: parts 21 Subpart H, 27, 45.23(b), 45.27(a),
61.113(a) and (b), 91.7(a), 91.9(b)(2) and (c), 91.103, 91.109(a),
91.119, 91.121, 91.151(a), 91.203(a) and (b), 91.405(a), 91.407(a)(1),
91.409(a)(2), and 91.417(a) and (b).
    Description of Relief Sought: The petitioner is seeking an
exemption to commercially operate their SD02 small unmanned aircraft
systems (sUAS), with a maximum weight of 26 lbs., to perform precision
aerial surveys that consist of still photographs and moving images
taken by onboard cameras for inspection data to be evaluated by clients
working in industries that include agriculture, power utility, and
professional surveying.
[FR Doc. 2014-23148 Filed 9-29-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: April 3, 2007 (Volume 72, Number 63)]
[Notices]
[Page 15874]
[DOCID:fr03ap07-49]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-182-001]

Honeoye Storage Corporation; Notice of Proposed Substitute Change
in FERC Gas Tariff

March 28, 2007.
    Take notice that on March 26, 2007, Honeoye Storage Corporation
(Honeoye) tendered for filing as part of its FERC Gas Tariff, First
Revised Volume 1A, four (4) substitute revised tariff sheets to be
effective April 1, 2007. The substitute revised tariff sheets are
designated as:

Substitute First Revised Sheet No. 74
Substitute Original Sheet No. 99A
Substitute First Revised Sheet No. 100
Substitute Second Revised Sheet No. 106

    Honeoye states that copies of the filing are being mailed to those
parties who have filed motions to intervene in this proceeding.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed in accordance with the provisions of Section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing a protest
must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible online at http://www.ferc.gov, using the

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

TTY, call<PHONE_NUMBER>.

Philis J. Posey,
Acting Secretary.
[FR Doc. E7-6104 Filed 4-2-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 79 (Wednesday, April 24, 2019)]
[Notices]
[Pages 17173-17174]
[FR Doc No: 2019-08261]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1281]

General and Plastic Surgery Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: The meeting will be held on May 30, 2019, from 10 a.m. to 4 p.m.
and on May 31, 2019, from 8 a.m. to 4 p.m.

ADDRESSES: The meeting will be held at the Gaithersburg Holiday Inn,
Grand Ballroom, Two Montgomery Village Ave., Gaithersburg, MD 20879.
The hotel's telephone number is<PHONE_NUMBER>; additional information
available online at: https://www.reservations.com/hotel/holiday-inn-gaithersburg?rmcid=rcc4&msclkid=8cda4d308856180123cc11aeb932c40b&utm_source=bing&utm_medium=cpc&utm_campaign=Top%20Hotels&utm_term=Holiday%20Inn%20Gaithersburg&utm_content=Holiday%20Inn%20Gaithersburg_1736466.
Answers to commonly asked questions including information regarding
special accommodations due to a disability, visitor parking, and
transportation may be accessed at: https://www.fda.gov/

AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Patricio Garcia, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G610, Silver Spring, MD 20993,
[email protected],<PHONE_NUMBER>, or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: On May 30, 2019, the committee will discuss and make
recommendations regarding the reclassification of surgical stapler
devices for internal use from Class I (general controls) to Class II
(special controls). On May 31, 2019, the committee will discuss and
make recommendations regarding the reclassification of certain
absorbable hemostatic agents from Class III to Class II (special
controls).
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/default.htm. Scroll down to the appropriate
advisory committee meeting link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before May
20, 2019. Oral presentations from the public will be scheduled on May
30 and 31, 2019, between approximately 1 p.m. and 2 p.m. Those
individuals interested in making formal oral presentations should
notify the contact person (see FOR FURTHER INFORMATION CONTACT) and
indicate which session they would like to present. The notification
should include a brief statement of the general nature of the evidence
or arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before May 10, 2019. Time allotted for
each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
sessions. The contact person will notify interested persons regarding
their request to speak by May 13, 2019.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact AnnMarie Williams at [email protected] or 301-796-
5966 at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: April 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-08261 Filed 4-23-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 107 (Monday, June 7, 2021)]
[Notices]
[Pages 30371-30372]
[FR Doc No: 2021-11494]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-98-3599; PD-19(R)]

Hazardous Materials: The New York State Department of
Environmental Conservation Requirements on Gasoline Transport Vehicles

AGENCY: Pipeline and Hazardous Materials Safety Administration,
Department of Transportation (DOT).

ACTION: Dismissal of petition for reconsideration of an administrative
determination of preemption.

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

SUMMARY: This proceeding was initiated in February 1998, when the
National Tank Truck Carriers, Inc. (NTTC) applied to the Pipeline and
Hazardous Materials Safety Administration \1\ (PHMSA) for a
determination that the HMTA preempted certain marking and record
keeping requirements of the New York State Department of Environmental
Conservation (NYSDEC). PHMSA found that the HMTA preempted the NYSDEC
requirements because the requirements were not substantively the same
as requirements in the HMR on the marking, maintaining, repairing, or
testing of a package or container that is represented, marked,
certified, or sold as qualified for transporting hazardous material.
NYSDEC's petition for reconsideration of that decision is dismissed on
the grounds of mootness. NYSDEC has made significant revisions to its
regulations, and the revised rules do not appear to impose the same
requirements on regulated entities as the previous version of the rules
that were challenged in this proceeding. It therefore does not appear
that reconsidering PHMSA's preemption determination regarding the now-
superseded NYSDEC rules would have any practical effect.
---------------------------------------------------------------------------

    \1\ At the time of NTTC's application, PHMSA did not exist.
PHMSA was created on February 20, 2005, when the Secretary of
Transportation redelegated hazardous materials safety functions from
the Research and Special Programs Administration (RSPA) to PHMSA's
Administrator. For consistency, the terms ``PHMSA,'' ``the agency,''
and ``we'' are used throughout this decision, regardless of whether
an action was taken by RSPA before February 20, 2005, or by PHMSA
after that date.

FOR FURTHER INFORMATION CONTACT: Vincent Lopez, Office of Chief
Counsel, Pipeline and Hazardous Materials Safety Administration, U.S.
Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC
---------------------------------------------------------------------------
20590; Telephone No.<PHONE_NUMBER>; Facsimile No.<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

    Petitioner: New York State Department of Environmental
Conservation.
    Local Law Affected: New York Codes, Rules and Regulations (NYCRR),
Chapter 6, Sections 230.4(a)(3), 230.6(b) & (c).\2\
---------------------------------------------------------------------------

    \2\ The NYSDEC repealed and replaced Part 230, with an effective
date of February 11, 2021. The marking requirement in 6 NYCRR
230.4(a)(3), as amended, was recodified in 6 NYCRR 230.6(a)(2). The
recordkeeping and retention requirements of 6 NYCRR 230.6(b) and
(c), as amended, were recodified in 6 NYCRR 230.7(a)(1) and (a)(2),
respectively.
---------------------------------------------------------------------------

    Applicable Federal Requirements: Federal Hazardous Material
Transportation Law (HMTA), 49 U.S.C. 5101 et seq., and the Hazardous
Materials Regulations (HMR), 49 CFR parts 171-180.
    Mode Affected: Highway.

I. Background

    This proceeding was initiated in February 1998, when NTTC applied
to PHMSA for a determination that the HMTA preempted certain marking
and record keeping requirements of NYSDEC.
    After NTTC filed its application, two key rulemakings occurred that
delayed PHMSA's decision on NTTC's claims. The rulemakings, one
initiated by PHMSA, and the other by the United States Environmental
Protection Agency (EPA), although not related, addressed many of the
issues raised in NTTC's application. The agencies' rulemaking
activities spanned several years and culminated in December 2009, when
EPA issued a rule change and clarification of its rules.\3\
---------------------------------------------------------------------------

    \3\ Final Rule, 73 FR 1916 (January 10, 2008); corrections, 73
FR 12275 (March 7, 2008); Final Rule with amendments and
clarifications, 76 FR 4156 (January 24, 2011).

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

    Earlier in 2009, and subsequent to the publication of final rules
in each of the PHMSA and EPA rulemakings, but before EPA's
clarification of its rules, PHMSA issued its decision on NTTC's
application. On January 23, 2009, PHMSA published in the Federal
Register its determination of NTTC's application in Preemption
Determination No. 19(R) (PD-19(R)), 74 FR 4291.\4\ PHMSA found that the
HMTA preempted the following NYSDEC requirements because the
requirements were not substantively the same as requirements in the HMR
on the marking, maintaining, repairing, or testing of a package or
container that is represented, marked, certified, or sold as qualified
for transporting hazardous material:
---------------------------------------------------------------------------

    \4\ As published in the Federal Register, the agency's January
23, 2009 determination in PD-19(R) indicated an incorrect docket
number (99-3559, instead of 98-3559).
---------------------------------------------------------------------------

     6 NYCRR 230.4(a)(3)--requirement that the marking must be
a minimum two inches and contain ``NYS DEC'';
     6 NYCRR 230.6(b)--requirement for maintaining a copy of
the most recent pressure-vacuum test results with the gasoline
transport vehicle; and
     6 NYCRR 230.6(c)--requirement to retain pressure-vacuum
test and repair results for two years.
    Within the 20-day time period provided in 49 CFR 107.211(a), NYSDEC
submitted a petition for reconsideration of PHMSA's decision in PD-
19(R). NYSDEC asked PHMSA to rescind its preemption determination and
dismiss the application by NTTC. In April 2009, PHMSA extended the
period for comments on NYSDEC's petition due to the unusually long
period it took for the agency to issue PD-19(R). This action was
followed by another extended period of inactivity until August 26,
2010, when PHMSA reopened the period for comments on NYSDEC's petition
for reconsideration to receive comments on EPA's rule changes. The
matter has remained dormant since that time based on PHMSA's
understanding that NYSDEC was planning to revise its regulations.
    On February 12, 2020, NYSDEC proposed a rulemaking to repeal and
replace 6 NYCRR Part 230 Gasoline Dispensing Sites and Transport
Vehicles. Volume XLII, Issue 6, N.Y. Reg, 8 (February 12, 2020). The
adopted requirements in 6 NYCRR Part 230, sections 230.6 and 230.7,
became effective on February 11, 2021. These provisions contain revised
versions of the requirements that were at issue in this proceeding for
marking gasoline transport vehicles and recordkeeping and reporting
requirements.

II. Dismissal on Grounds of Mootness

    NYSDEC's legislative changes to its rules have rendered moot
NYSDEC's petition for reconsideration of PHMSA's 2009 preemption
determination.
    NYSDEC, in its February 12, 2020, rulemaking proposal, required
pressure-vacuum cargo tank testing and markings that align with DOT's
testing and marking requirements. NYSDEC indicated that the proposed
amendments would make the requirements consistent on the state and
federal level. Furthermore, NYSDEC proposed to revise the gasoline
transport vehicle recordkeeping retention requirements from 2 years to
5 years in order to align with the current version of the EPA's
recordkeeping requirement located at 40 CFR part 63 subpart CCCCCC.
    The recently adopted requirements in 6 NYCRR Part 230, sections
230.6 and 230.7, became effective on February 11, 2021. These
provisions contain the requirements that were at issue in this
proceeding for marking gasoline transport vehicles and recordkeeping
and reporting requirements. The provision for the marking of gasoline
transport vehicles states:

    (a) No owner or operator of a gasoline transport vehicle may
transport gasoline or allow the vehicle to be filled or emptied in
New York State unless the gasoline transport vehicle meets:
    (1) the federal Department of Transportation (DOT) requirements
for leak testing as required by 49 CFR 180.407(h) (see Table 1,
Section 200.9 of this Title); and
    (2) the federal DOT requirements for test markings as required
by 49 CFR 180.415 (see Table 1, Section 200.9 of this Title).

6 NYCRR 230.6.

    The recordkeeping and reporting provision states:

    (a) The owner of any gasoline transport vehicle subject to the
leak testing requirements outlined in section 230.6(a) of this Part
shall keep:
    (1) leak testing records with information as prescribed by 49
CFR 180.417(b)(1) and (2) (see Table 1, Section 200.9 of this Title)
for 5 years; and
    (2) a copy of the most recent leak testing results with the
gasoline transport vehicle.

6 NYCRR 230.7.

    In light of the facts and circumstances described above, it is
apparent the NYSDEC rules that PHMSA found were preempted under the
HMTA--and subject of NYSDEC's petition for reconsideration--have been
significantly revised. On their face, the revised rules do not appear
to impose the same requirements on regulated entities as the previous
version of the rules that were challenged in this proceeding.
Consequently, it would be inappropriate for PHMSA to render a decision
on a petition for reconsideration that was filed more than a decade
ago, for relief from the agency's preemption determination that was
based on a previous version of NYSDEC's pressure-vacuum cargo tank
testing and markings requirements when those requirements have recently
undergone significant revisions. It appears that issuing a decision on
the petition for reconsideration would have no practical effect on any
party.

III. Ruling

    For the reasons set forth above, NYSDEC's petition for
reconsideration is dismissed because the issues raised in the petition
are moot.
    Going forward, any person directly affected by the revised NYSDEC
rules (including a State, political subdivision of a State, or Indian
tribe) may apply to PHMSA for a decision on whether the revised rules
are preempted by the HMTA. 49 U.S.C. 5125(d); 49 CFR 107.203.
Similarly, any person who thinks there is a practical reason for PHMSA
to revisit its preemption decision regarding the now-superseded rules
may apply to PHMSA for a new decision on that question.

    Issued in Washington, DC, on May 26, 2021.
Vasiliki Tsaganos,
Acting Chief Counsel.
[FR Doc. 2021-11494 Filed 6-4-21; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 81, Number 91 (Wednesday, May 11, 2016)]
[Notices]
[Page 29321]
[FR Doc No: 2016-11106]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2016-63]

Petition for Exemption; Summary of Petition Received; Drone
Consultants LLC

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Title 14 of the Code of Federal
Regulations. The purpose of this notice is to improve the public's
awareness of, and participation in, the FAA's exemption process.
Neither publication of this notice nor the inclusion or omission of
information in the summary is intended to affect the legal status of
the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before May 31, 2016.

ADDRESSES: Send comments identified by docket number FAA-2015-5557
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Dan Ngo,<PHONE_NUMBER>, 800
Independence Avenue SW., Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on May 2, 2016.
Lirio Liu,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2015-5557.
    Petitioner: Drone Consultants LLC.
    Section(s) of 14 CFR Affected: Part 21 subpart H and Sec. Sec.
45.23(b), 61.113(a) & (b), 91.7(a), 91.9(b)(2), 91.103, 91.109,
91.119(c), 91.121, 91.151(a), 91.203(a) & (b), 91.205(c), 91.209,
91.405(a), 91.407(a)(1), 91.409(a)(2), 91.417(a) & (b).
    Description of Relief Sought: The petitioner is requesting relief
for the following:
    1. Commercially Operate the DJI F550, DJI S-800, DJIS-900 and DJI
Phantom 3 for the aerial photography/videography/inspection, and
conducting sUAS operator training, qualification and demonstrations.
    2. Night operations of DJI Phantom 3 under VFR conditions up to 200
feet AGL without having to request permission to fly each time from the
FAA FSDO closest to the proposed area of operations.

[FR Doc. 2016-11106 Filed 5-10-16; 8:45 am]
BILLING CODE 4910-13-P