[Federal Register Volume 84, Number 111 (Monday, June 10, 2019)]
[Notices]
[Pages 26866-26868]
[FR Doc No: 2019-12080]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2018-0097; FRL-9991-65]

Certain New Chemicals or Significant New Uses; Statements of
Findings for November and December 2018

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: Section 5(g) of the Toxic Substances Control Act (TSCA)
requires EPA to publish in the Federal Register a statement of its
findings after its review of TSCA section 5(a) notices when EPA makes a
finding that a new chemical substance or significant new use is not
likely to present an unreasonable risk of injury to health or the
environment. Such statements apply to premanufacture notices (PMNs),
microbial commercial activity notices (MCANs), and significant new use
notices (SNUNs) submitted to EPA under TSCA section 5. This document
presents statements of findings made by EPA on TSCA section 5(a)
notices during the period from November 1, 2018 to December 31, 2018.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Greg Schweer, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. As such, the
Agency has not attempted to describe the specific entities that this
action may apply to. Although others may be affected, this action
applies directly to the submitters of the PMNs addressed in this
action.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPPT-2018-0097, is available at http://www.regulations.gov or at the Office of Pollution Prevention and Toxics
Docket (OPPT Docket), Environmental Protection Agency Docket Center
(EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 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 (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

II. What action is the Agency taking?

    This document lists the statements of findings made by EPA after
review of notices submitted under TSCA section 5(a) that certain new
chemical substances or significant new uses are not likely to present
an unreasonable risk of injury to health or the environment. This
document presents statements of findings made by EPA during the period
from November 1, 2018 to December 31, 2018.

III. What is the Agency's authority for taking this action?

    TSCA section 5(a)(3) requires EPA to review a TSCA section 5(a)
notice and make one of the following specific findings:
     The chemical substance or significant new use presents an
unreasonable risk of injury to health or the environment;
     The information available to EPA is insufficient to permit
a reasoned evaluation of the health and environmental effects of the
chemical substance or significant new use;
     The information available to EPA is insufficient to permit
a reasoned evaluation of the health and environmental effects and the
chemical substance or significant new use may present an unreasonable
risk of injury to health or the environment;
     The chemical substance is or will be produced in
substantial quantities, and such substance either enters or may
reasonably be anticipated to enter the environment in substantial
quantities or there is or may be significant or substantial human
exposure to the substance; or
     The chemical substance or significant new use is not
likely to present an unreasonable risk of injury to health or the
environment.
    Unreasonable risk findings must be made without consideration of
costs or other non-risk factors, including an unreasonable risk to a
potentially exposed or susceptible subpopulation identified as relevant
under the conditions of use. The term ``conditions of use'' is defined
in TSCA section 3 to mean ``the circumstances, as determined by the
Administrator, under which a chemical substance is intended, known, or
reasonably foreseen to be manufactured, processed, distributed in
commerce, used, or disposed of.''
    EPA is required under TSCA section 5(g) to publish in the Federal
Register a statement of its findings after its review of a TSCA section
5(a) notice when EPA makes a finding that a new chemical substance or
significant new use is not likely to present an unreasonable risk of
injury to health or the environment. Such statements apply to PMNs,
MCANs, and SNUNs submitted to EPA under TSCA section 5.
    Anyone who plans to manufacture (which includes import) a new
chemical substance for a non-exempt commercial purpose and any
manufacturer or processor wishing to engage in a use of a chemical
substance designated by EPA as a significant new use must submit a
notice to EPA at least 90 days before

commencing manufacture of the new chemical substance or before engaging
in the significant new use.
    The submitter of a notice to EPA for which EPA has made a finding
of ``not likely to present an unreasonable risk of injury to health or
the environment'' may commence manufacture of the chemical substance or
manufacture or processing for the significant new use notwithstanding
any remaining portion of the applicable review period.

IV. Statements of Administrator Findings Under TSCA Section 5(a)(3)(C)

    In this unit, EPA provides the following information (to the extent
that such information is not claimed as Confidential Business
Information (CBI)) on the PMNs, MCANs and SNUNs for which, during this
period, EPA has made findings under TSCA section 5(a)(3)(C) that the
new chemical substances or significant new uses are not likely to
present an unreasonable risk of injury to health or the environment:
     EPA case number assigned to the TSCA section 5(a) notice.
     Chemical identity (generic name, if the specific name is
claimed as CBI).
     Website link to EPA's decision document describing the
basis of the ``not likely to present an unreasonable risk'' finding
made by EPA under TSCA section 5(a)(3)(C).

------------------------------------------------------------------------
       EPA case No.           Chemical identity         Website link
------------------------------------------------------------------------
P-18-0077.................  Urea, reaction         https://www.epa.gov/
                             products with N-       reviewing-new-
                             butylphosphorothioic   chemicals-under-
                             triamide and           toxic-substances-
                             formaldehyde (CASRN:   control-act-tsca/
                             2093385-47-6).         tsca-section-5a3c-
                                                    determination-155.
P-16-0400.................  Alkanes, C11-16-       https://www.epa.gov/
                             branched and linear    reviewing-new-
                             (CASRN: 1809170-78-    chemicals-under-
                             2).                    toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-145.
J-18-0045.................  Biofuel producing      https://www.epa.gov/
                             Saccharomyces          reviewing-new-
                             cerevisiae modified,   chemicals-under-
                             genetically stable     toxic-substances-
                             (generic name).        control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-143.
J-18-0046-0047............  Genetically modified   https://www.epa.gov/
                             microorganism          reviewing-new-
                             (generic name).        chemicals-under-
                                                    toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-142.
J-19-0002-0004............  Genetically modified   https://www.epa.gov/
                             microorganism          reviewing-new-
                             (generic name).        chemicals-under-
                                                    toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-141.
P-18-0221.................  Polyglycerol reaction  https://www.epa.gov/
                             product with acid      reviewing-new-
                             anhydride,             chemicals-under-
                             etherified (generic    toxic-substances-
                             name).                 control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-139.
P-18-0324.................  Organic acid dimethyl  https://www.epa.gov/
                             ester, polymer with    reviewing-new-
                             mixed alkanediols      chemicals-under-
                             and 5-isocyanato-1-    toxic-substances-
                             (isocyanatomethyl)-    control-act-tsca/
                             1,3,3-                 tsca-section-5a3c-
                             trimethylcyclohexane   determination-138.
                             ,
                             trimethoxysilylalkyl
                             alkanamine-blocked
                             (generic name).
P-19-0006.................  Diisocyanate polymer   https://www.epa.gov/
                             blocked with           reviewing-new-
                             alkoxyamine (generic   chemicals-under-
                             name).                 toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-137.
P-17-0281.................  Polysiloxane-          https://www.epa.gov/
                             polyester polyol       reviewing-new-
                             carboxylate (generic   chemicals-under-
                             name).                 toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-136.
P-18-0007-0008............  (P-18-0007)            https://www.epa.gov/
                             Glycerides, soya       reviewing-new-
                             mono- and di-,         chemicals-under-
                             epoxidized, acetates   toxic-substances-
                             (CASRN: 2097734-14-    control-act-tsca/
                             8), (P-18-0008)        tsca-section-5a3c-
                             Glycerides, C16-18     determination-135.
                             and C18-unsatd. mono-
                              and di-,
                             epoxidized, acetates
                             (CASRN: 2097734-15-
                             9).
P-18-0212.................  Substituted            https://www.epa.gov/
                             carbomonocycle,        reviewing-new-
                             polymer with alkyl     chemicals-under-
                             alkenoate, alkenyl     toxic-substances-
                             substituted            control-act-tsca/
                             carbomonocycle,        tsca-section-5a3c-
                             substituted            determination-134.
                             alkanediol,
                             heteropolycycle,
                             alkylene glycol and
                             alkenoic acid,
                             compd. with
                             alkylamino alkanol;
                             polymer exemption
                             flag (generic name).
SN-15-0009................  Fatty acid amide       https://www.epa.gov/
                             (generic name).        reviewing-new-
                                                    chemicals-under-
                                                    toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3-
                                                    determination.
P-18-0219.................  Polythioether, short   https://www.epa.gov/
                             chain diol polymer     reviewing-new-
                             terminated with        chemicals-under-
                             aliphatic              toxic-substances-
                             diisocyanate           control-act-tsca/
                             (generic name).        tsca-section-5a3c-
                                                    determination-133.
P-18-0068.................  Metal, oxo             https://www.epa.gov/
                             alkylcarboxylate       reviewing-new-
                             complexes (generic     chemicals-under-
                             name).                 toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-132.
J-18-0042-0043............  Biofuel producing      https://www.epa.gov/
                             Saccharomyces          reviewing-new-
                             cerevisiae modified,   chemicals-under-
                             genetically stable     toxic-substances-
                             (generic name).        control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-131.
P-18-0319.................  Plant oil fatty        https://www.epa.gov/
                             acids, alkyl esters    reviewing-new-
                             (generic name).        chemicals-under-
                                                    toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-129.
P-18-0152.................  Hydrolyzed             https://www.epa.gov/
                             functionalized di-     reviewing-new-
                             amino silanol          chemicals-under-
                             polymer (generic       toxic-substances-
                             name).                 control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-128.
P-18-0147.................  Phenol, 4-ethenyl-, 1- https://www.epa.gov/
                             substituted, polymer   reviewing-new-
                             with 1-(1,1-           chemicals-under-
                             substituted)-4-        toxic-substances-
                             ethenylbenzene and     control-act-tsca/
                             ethenylbenzene, 2,     tsca-section-5a3c-
                             2'-(1,2-               determination-126.
                             diazenediyl)bis[2-
                             substituted]-
                             initiated,
                             hydrolyzed (generic
                             name).

P-18-0279.................  Substituted            https://www.epa.gov/
                             heteromonocycle,       reviewing-new-
                             polymer with           chemicals-under-
                             substituted            toxic-substances-
                             alkanediol and         control-act-tsca/
                             diisocyanate           tsca-section-5a3c-
                             substituted            determination-127.
                             carbomonocyle,
                             alkylene glycol
                             acrylate-blocked
                             (generic name).
P-18-0136.................  1-Butanaminium, N,N,N- https://www.epa.gov/
                             tributyl-, 2(or5)-     reviewing-new-
                             [[benzoyldihydrodiox   chemicals-under-
                             o[(sulfophenyl)amino   toxic-substances-
                             ]heteropolycycle]oxy   control-act-tsca/
                             ]-5(or 2)-(1,1-        tsca-section-5a3c-
                             dimethylpropyl)benze   determination-125.
                             nesulfonate (2:1)
                             (generic name).
P-17-0382.................  Amides, tallow, N,N-   https://www.epa.gov/
                             bis(2-hydroxypropyl)   reviewing-new-
                             (CASRN 1454803-04-3).  chemicals-under-
                                                    toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-124.
P-18-0054.................  2-Alkenoic acid, 2-    https://www.epa.gov/
                             alkyl-, 2-alkyl        reviewing-new-
                             ester, polymer with    chemicals-under-
                             alkyl 2-alkenoate, 2-  toxic-substances-
                             substitutedalkyl 2-    control-act-tsca/
                             alkenoate and 2-       tsca-section-5a3c-
                             substitutedalkyl 2-    determination-123.
                             alkyl-2-alkenoate,
                             esters with
                             carboxylic acids,
                             tert alkylperoxoate
                             initiated; polymer
                             exemption flag
                             (generic name).
P-18-0078.................  2-Alkenoic acid, 2-    https://www.epa.gov/
                             alkyl-, 2-alkyl        reviewing-new-
                             ester, polymer with    chemicals-under-
                             alkyl 2-alkenoate, 2-  toxic-substances-
                             substitutedalkyl 2-    control-act-tsca/
                             alkenoate and 2-       tsca-section-5a3c-
                             substitutedalkyl 2-    determination-122.
                             alkyl-2-alkenoate,
                             tert alkylperoxoate
                             initiated; polymer
                             exemption flag
                             (generic name).
P-18-0261.................  Metal,                 https://www.epa.gov/
                             alkylcarboxylate oxo   reviewing-new-
                             complexes (generic     chemicals-under-
                             name).                 toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-121.
J-18-0044.................  Saccharomyces          https://www.epa.gov/
                             cerevisiae NE095.      reviewing-new-
                                                    chemicals-under-
                                                    toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-120.
J-18-0041.................  E. coli K-12 C003,     https://www.epa.gov/
                             arsenic detecting      reviewing-new-
                             strain of E. coli      chemicals-under-
                             with extra-            toxic-substances-
                             chromosomal            control-act-tsca/
                             elements, including    tsca-section-5a3c-
                             an intergeneric        determination-119.
                             screening marker
                             (generic name).
P-18-0233.................  Alkyl alkenoic acid,   https://www.epa.gov/
                             alkyl ester, telomer   reviewing-new-
                             with alkylthiol,       chemicals-under-
                             substituted            toxic-substances-
                             carbomonocycle,        control-act-tsca/
                             substituted alkyl      tsca-section-5a3c-
                             alkyl alkenoate and    determination-118.
                             hydroxyalkyl
                             alkenoate, tert-
                             butyl alkyl
                             peroxoate-initiated
                             (generic name).
------------------------------------------------------------------------

    Authority: 15 U.S.C. 2601 et seq.

    Dated: June 3, 2019.
Leo Schweer,
Chief, New Chemicals Management Branch, Chemical Control Division,
Office of Pollution Prevention and Toxics.
[FR Doc. 2019-12080 Filed 6-7-19; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 23 (Wednesday, February 4, 2015)]
[Notices]
[Page 6073]
[FR Doc No: 2015-02116]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Commissioner and Staff Attendance at North American
Electric Reliability Corporation Meetings

    The Federal Energy Regulatory Commission (Commission) hereby gives
notice that members of the Commission and/or Commission staff may
attend the following meetings:

    North American Electric Reliability Corporation
    Member Representatives Committee and Board of Trustees Meetings
    Board of Trustees Corporate Governance and Human Resources
Committee, Finance and Audit Committee, Compliance Committee, and
Standards Oversight and Technology Committee Meetings

    The Westin San Diego, 400 West Broadway, San Diego, CA 92101.

February 11 (7:30 a.m.-5:00 p.m.) and February 12 (8:30 a.m.-12:00
p.m.), 2015

    Further information regarding these meetings may be found at:
http://www.nerc.com/Pages/Calendar.aspx.
    The discussions at the meetings, which are open to the public, may
address matters at issue in the following Commission proceedings:

Docket No. RR15-2, North American Electric Reliability Corporation
Docket No. RR15-3, North American Electric Reliability Corporation
Docket No. RR15-4, North American Electric Reliability Corporation
Docket No. RD15-1, North American Electric Reliability Corporation

    For further information, please contact Jonathan First, 202-502-
8529, or<EMAIL_ADDRESS>
    Dated: January 28, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-02116 Filed 2-3-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 196 (Thursday, October 14, 2021)]
[Notices]
[Pages 57191-57192]
[FR Doc No: 2021-22388]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4609-DR; Docket ID FEMA-2021-0001]

Tennessee; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Tennessee (FEMA-4609-DR), dated August 23, 2021, and
related determinations.

DATES: This amendment was issued August 25, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Tennessee is hereby amended to include the following
areas among the area determined to have been adversely affected by the
event declared a major disaster by the President in his declaration of
August 23, 2021.

    Dickson, Hickman, and Houston Counties for Individual
Assistance.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-22388 Filed 10-13-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 88, Number 13 (Friday, January 20, 2023)]
[Rules and Regulations]
[Pages 3634-3636]
[FR Doc No: 2023-01048]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2022-N-3255]

Medical Devices; Gastroenterology-Urology Devices; Classification
of the Computerized Behavioral Therapy Device for Treating Symptoms of
Gastrointestinal Conditions

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the computerized behavioral therapy device for treating
symptoms of gastrointestinal conditions into class II (special
controls). The special controls that apply to the device type are
identified in this order and will be part of the codified language for
the computerized behavioral therapy device for treating symptoms of
gastrointestinal conditions' classification. We are taking this action
because we have determined that classifying the device into class II
(special controls) will provide a reasonable assurance of safety and
effectiveness of the device. We believe this action will also enhance
patients' access to beneficial innovative devices.

DATES: This order is effective January 20, 2023. The classification was
applicable on November 25, 2020.

FOR FURTHER INFORMATION CONTACT: Stephanie Cole, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2536, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the computerized behavioral
therapy device for treating symptoms of gastrointestinal conditions as
class II (special controls), which we have determined will provide a
reasonable assurance of safety and effectiveness. In addition, we
believe this action will enhance patients' access to beneficial
innovation, in part by placing the device into a lower device class
than the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device
that does not require premarket approval. We determine whether a new
device is substantially equivalent to a predicate device by means of
the procedures for premarket notification under section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).

    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C
Act). As a result, other device sponsors do not have to submit a De
Novo request or premarket approval application to market a
substantially equivalent device (see section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
less-burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On April 30, 2020, FDA received Mahana Therapeutics, Inc.'s request
for De Novo classification of the Parallel. FDA reviewed the request in
order to classify the device under the criteria for classification set
forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on November 25, 2020, FDA issued an order to the
requester classifying the device into class II. In this final order,
FDA is codifying the classification of the device by adding 21 CFR
876.5960.\1\ We have named the generic type of device computerized
behavioral therapy device for treating symptoms of gastrointestinal
conditions, and it is identified as a prescription device intended to
provide a computerized version of condition-specific therapy as an
adjunct to standard of care treatments to patients with
gastrointestinal conditions.
---------------------------------------------------------------------------

    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------

    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

Table 1--Computerized Behavioral Therapy Device for Treating Symptoms of
        Gastrointestinal Conditions Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Worsening of condition due to device     Clinical data, and Labeling.
 providing ineffective treatment.
Delayed access to treatment due to       Software verification,
 device software failure.                 validation, and hazard
                                          analysis, and Labeling.
Ineffective treatment due to use error/  Usability assessment, and
 improper use of device.                  Labeling.
Treatment results in anxiety, depressed  Clinical data, and Labeling.
 mood, depression, mental disorder
 (unspecified), stress or suicidal
 ideation.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.
    At the time of classification, computerized behavioral therapy
devices for treating symptoms of gastrointestinal conditions are for
prescription use only. Prescription devices are exempt from the
requirement for adequate directions for use for the layperson under
section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR
801.5, as long as the conditions of 21 CFR 801.109 are met.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this 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.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in 21 CFR part 860, subpart D, regarding De Novo
classification have been approved under OMB control number 0910-0844;
the collections of information in 21 CFR part 814, subparts A through
E, regarding premarket approval, have been approved under OMB control
number 0910-0231; the collections of information in part 807, subpart
E, regarding premarket notification submissions, have been approved
under OMB control number 0910-0120; the collections of information in
21 CFR part 820, regarding quality system regulation, have been
approved under OMB control number 0910-0073; and the collections of
information in 21 CFR parts 801, regarding labeling, have been approved
under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 876

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
876 is amended as follows:

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
1. The authority citation for part 876 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  876.5960 to subpart F to read as follows:

Sec.  876.5960   Computerized behavioral therapy device for treating
symptoms of gastrointestinal conditions.

    (a) Identification. A computerized behavioral therapy device for
treating symptoms of gastrointestinal conditions is a prescription
device intended to provide a computerized version of condition-specific
therapy as an adjunct to standard of care treatments to patients with
gastrointestinal conditions.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Clinical data must be provided to fulfill the following:
    (i) Describe a model of therapy for the indicated gastrointestinal
conditions;
    (ii) Validate the model of therapy as implemented by the device
using a clinically defined endpoint; and
    (iii) Evaluate all adverse events.
    (2) Software must be described in detail in the software
requirements specification and software design specification. Software
verification, validation, and hazard analysis must be performed.
Software documentation must demonstrate that the device effectively
implements the behavioral therapy model.
    (3) Usability assessment must demonstrate that the intended user(s)
can safely and correctly use the device.
    (4) Labeling:
    (i) Labeling must include instructions for use, including images
that demonstrate how to interact with the device;
    (ii) Patient and physician labeling must list the minimum operating
system requirements that support the software of the device;
    (iii) Patient and physician labeling must include a warning that
the device is not intended for use in lieu of a standard therapeutic
intervention or to represent a substitution for the patient's
medication;
    (iv) Patient and physician labeling must include a warning to seek
medical care if a patient has feelings or thoughts of harming
themselves or others; and
    (v) Physician and patient labeling must include a summary of the
clinical testing with the device.

    Dated: January 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01048 Filed 1-19-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 17 (Thursday, January 25, 2018)]
[Notices]
[Pages 3461-3462]
[FR Doc No: 2018-01324]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2017-0082]

Pipeline Safety: Information Collection Activities

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice and request for comments.

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

SUMMARY: On October 18, 2017, in accordance with the Paperwork
Reduction Act of 1995, the Pipeline and Hazardous Materials Safety
Administration (PHMSA) published a notice in the Federal Register to
invite comments on an information collection under Office of Management
and Budget (OMB) Control No. 2137-0629 to revise Form PHMSA F 7100.1-1
Annual Report--Gas Distribution System, and the instructions associated
with this Form.
    During the 60-day comment period, PHMSA received five comments in
response to this information collection from the stakeholders. PHMSA is
publishing this notice to respond to the comments received and to
announce that the information collection will be submitted to OMB for
approval.

DATES: Comments must be submitted on or before February 26, 2018.

ADDRESSES: Send comments regarding the burden estimate, including
suggestions for reducing the burden, to OMB, Attention: Desk Officer
for the Office of the Secretary of Transportation, 725 17th Street NW,
Washington, DC 20503. You may also send comments by email to [email protected].

FOR FURTHER INFORMATION CONTACT: Angela Dow by telephone at 202-366-

1246, by fax at<PHONE_NUMBER>, or by mail at U.S. Department of
Transportation, PHMSA, 1200 New Jersey Avenue SE, PHP-30, Washington,
DC 20590-0001.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 1320.8(d), Title 5, Code of Federal Regulations, requires
PHMSA to provide interested members of the public and affected entities
an opportunity to comment on information collection and recordkeeping
requests. This notice identifies the proposed changes to the
information collection that PHMSA will submit to OMB for approval. In
order to improve the data collection processes, PHMSA is revising the
Gas Distribution Annual Report Form PHMSA F 7100.1-1, and the
instructions associated with this Form. PHMSA will remove ``Other'' as
a selection for Operator Type in Part A7 and add guidance for the
proper selection to the instructions. By eliminating ``Other'' as a
selection, PHMSA will obtain more accurate data about the types of gas
distribution operators.
    PHMSA is also changing the instructions for PHMSA Form 7100.1-1,
Gas Distribution System Annual Report, related to calculating the
percent of lost and unaccounted for (LAUF) gas and negative percent
values. PHMSA will calculate the percent of LAUF gas by dividing the
LAUF volume by the gas consumption volume. PHMSA will allow a negative
value to be reported for the percent of LAUF gas. These changes will
harmonize the PHMSA and Energy Information Administration (EIA)
methodologies for calculating the percent of LAUF gas.
    PHMSA received five comments in response to the revision of this
information collection. Four comments came from anonymous sources and
one comment came from The American Public Gas Association (APGA).

A. Summary of Comment

    PHMSA has proposed changing the denominator from ``volume of
input'' to ``volume consumed'' when calculating the percent of lost and
unaccounted for gas. This change would match the methodology used by
the EIA. APGA recommends no change to the methodology for calculating
the percent of lost and unaccounted for gas since a percent is not
reported to the EIA. Also, changing the denominator for calculating
percent would make analysis of multi-year trends more difficult.

B. PHMSA Response

    Each year, EIA publishes volume data in a document titled: Natural
Gas Annual. In Table A1 of the calendar year 2016 Natural Gas Annual,
the EIA calculates ``Losses and Unaccounted as a percent of Total
Consumption.'' PHMSA's proposal aligns with the EIA methodology in the
Natural Gas Annual. Regarding the impact of the methodology change on
the analysis of multi-year trends, the impact would be minimal. For
example, using calendar year 2016 EIA data for Massachusetts, the
percent using the current PHMSA methodology yields a value of 3.2
percent. When using the EIA methodology, the value is 3.3 percent.

II. Summary of Impacted Collection

    Section 1320.8(d), Title 5, Code of Federal Regulations, requires
PHMSA to provide interested members of the public and affected agencies
an opportunity to comment on information collection and recordkeeping
requests. This notice identifies an information collection request that
PHMSA will submit to OMB for revision. The changes proposed by PHMSA
would have no effect on the calendar year 2017 data collection now in
progress. The changes would be implemented when operators submit
calendar year 2018 data early in calendar year 2019.
    The following information is provided for this information
collection: (1) Title of the information collection; (2) OMB control
number; (3) Current expiration date; (4) Type of request; (5) Abstract
of the information collection activity; (6) Description of affected
public; (7) Estimate of total annual reporting and recordkeeping
burden; and (8) Frequency of collection. PHMSA will request a three-
year term of approval for this information collection activity. PHMSA
requests comments on the following information collection:
    1. Title: Annual Report for Gas Distribution Pipeline Operators.
    OMB Control Number: 2137-0629.
    Current Expiration Date: 1/31/2018.
    Type of Request: Revision.
    Abstract: PHMSA intends to revise the form and instructions for the
gas distribution annual report PHMSA F 7100.1-1.
    Affected Public: Gas distribution pipeline operators.
    Annual Reporting and Recordkeeping Burden:
    Total Annual Responses: 1,446.
    Total Annual Burden Hours: 24,582.
    Frequency of Collection: Annually.
    Comments are invited on:
    (a) The need for the renewal and revision of these collections of
information for the proper performance of the functions of the agency,
including whether the information will have practical utility;
    (b) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    (c) Ways to enhance the quality, utility, and clarity of the
information to be collected; and
    (d) Ways to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques.

    Authority:  The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended; and 49 CFR 1.48.

    Issued in Washington, DC, on January 18, 2018, under authority
delegated in 49 CFR 1.97.
Alan K. Mayberry,
Associate Administrator for Pipeline Safety.
[FR Doc. 2018-01324 Filed 1-24-18; 8:45 am]
 BILLING CODE 4910-60-P