[Federal Register: November 30, 2009 (Volume 74, Number 228)]
[Notices]
[Page 62581]
[DOCID:fr30no09-62]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Pediatric Advisory Committee; Amendment of Notice; Correction

AGENCY:  Food and Drug Administration, HHS

ACTION:  Notice; correction.

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    The Food and Drug Administration (FDA) is correcting a notice that
appeared in the Federal Register of November 2, 2009 (74 FR 56652). The
document announced an amendment to the notice of meeting of the
Pediatric Advisory Committee. This meeting was announced in the Federal
Register of October 6, 2009 (74 FR 51289). The document was published
with an inadvertent error. This document corrects that error.

FOR FURTHER INFORMATION CONTACT:  Joyce A. Strong, Office of Policy
(HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20957,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:  In FR Doc. E9-26262, appearing on page
56652, in the Federal Register of Monday, November 2, 2009, the
following correction is made:
    1. On page 56652, in the first column, the heading ``[Docket No.
2009-N-0664]'' is corrected to read ``[Docket No. FDA-2009-N-0664]''.

    Dated: November 20, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-28448 Filed 11-27-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 81, Number 182 (Tuesday, September 20, 2016)]
[Notices]
[Pages 64575-64576]
[FR Doc No: 2016-22631]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2016-0098; Notice 1]

General Motors LLC, Receipt of Petition To Amend Takata DIR
Schedule

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Receipt of petition.

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SUMMARY: General Motors, LLC (GM) has petitioned the Agency to alter
the Part 573 defect information report (DIR) filing schedule set forth
in paragraph 14 of the May 4, 2016 Amendment to November 3, 2015
Consent Order between NHTSA and TK Holdings Inc. (``Takata''). More
specifically, GM has requested that NHTSA modify the DIR schedule with
respect to certain GM-branded motor vehicles from December 31, 2016 to
December 31, 2017.

DATES: The closing date for comments on the petition is October 4,
2016.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments regarding this petition. Comments must refer to
the docket and notice number cited in the title of this notice and be
submitted by one of the following methods:
     Internet: Go to http://www.regulations.gov and follow the
online instructions for submitting comments.
     Mail: Docket Management Facility, M-30, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building, Room W12-
140, Washington, DC 20590.
     Hand Delivery or Courier: U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building, Room W12-
140, Washington, DC 20590 between 9 a.m. and 5 p.m. Eastern Time,
Monday through Friday, except Federal holidays.
     Facsimile:<PHONE_NUMBER>.
    You may call the Docket at<PHONE_NUMBER>.
    Note that all comments received will be posted without change to
http://www.regulations.gov, including any personal information
provided. Thus, submitting such information makes it public. You may
wish to read the Privacy Act notice, which can be viewed by clicking on
the ``Privacy and Security Notice'' link in the footer of http://www.regulations.gov. DOT's complete Privacy Act Statement is available
for review in the Federal Register published on April 11, 2000 (65 FR
19477-78).
    The petition, supporting materials, and all comments received
before the close of business on the closing date indicated above will
be filed in the docket and will be considered. Comments and supporting
materials received after the closing date will also be filed and will
be considered to the extent possible. When the petition is granted or
denied, notice of the decision will also be published in the Federal
Register pursuant to the authority indicated at the end of this notice.

SUPPLEMENTARY INFORMATION:

I. Background

    On May 4, 2016, NHTSA issued, and Takata agreed to, an Amendment to
the November 3, 2015 Consent Order (the ``Amendment''), under which
Takata is bound to declare a defect in all driver and passenger
inflators that contain an ammonium nitrate-based propellant and do not
contain a moisture-absorbing desiccant. Such defect declarations are to
be made on a rolling basis. See Amendment at ] 14. Takata timely
submitted the first scheduled DIR on May 16, 2016. The next DIR is due
to be filed on December 31, 2016, and is expected to include passenger
inflators installed as original equipment on certain motor vehicles
manufactured by GM (the ``covered passenger inflators'').
    The Amendment sets forth the following procedure under which the
DIR schedule may be modified or amended:

    Based on the presentation of additional test data, analysis, or
other relevant and appropriate evidence, by Takata, an automobile
manufacturer, or any other credible source, NHTSA may, after
consultation with Takata, alter the schedule set forth in Paragraph
14 to modify or amend a DIR or to defer certain inflator types or
vehicles, or a portion thereof, to a later DIR filing date. Any such
evidence must be submitted to NHTSA no later than one-hundred-twenty
(120) days before the relevant DIR filing date. This paragraph
applies only to the DIRs scheduled to be issued on or after December
31, 2016 under the schedule established by Paragraph 14 of this
Amendment.

See Amendment at ] 17. On July 22, 2016, NHTSA issued Enforcement
Guidance Bulletin 2016-03 to inform the public of the process and
procedure the Agency had established in connection with Paragraph 17 of
the Amendment, as well as the standards and criteria that would guide
Agency decision-making. See 81 FR 47854.
    On September 2, 2016, GM filed a petition pursuant to Paragraph 17
of the Amendment and Enforcement Guidance Bulletin 2016-03. Therein, GM
has requested that NHTSA modify the DIR

schedule to delay the inclusion of covered GM passenger-side inflators
from December 31, 2016 to December 31, 2017. This notice of receipt of
GM's petition is published in accordance with Enforcement Guidance
Bulletin 2016-03 and does not represent any Agency decision or other
exercise of judgment concerning the merits of the petition.

II. Class of Motor Vehicles Involved

    GM's petition involves certain GMT900 vehicles that contain the
covered passenger inflators (designated as inflator types ``SPI YP''
and ``PSPI-L YD''). GMT900 is a GM-specific vehicle platform that forms
the structural foundation for a variety of GM trucks and sport utility
vehicles, including: Chevrolet Silverado 1500, GMC Sierra 1500,
Chevrolet Silverado 2500/3500, GMC Sierra 2500/3500, Chevrolet Tahoe,
Chevrolet Suburban, Chevrolet Avalanche, GMC Yukon, GMC Yukon XL,
Cadillac Escalade, Cadillac Escalade ESV, and Cadillac Escalade EXT.
    The next Takata DIR, which is due to be filed on December 31, 2016,
is expected to include the following GMT900 vehicles:
     In Zone A, model year 2012 GMT900 vehicles. Zone A
comprises the following states and U.S. territories: Alabama,
California, Florida, Georgia, Hawaii, Louisiana, Mississippi, South
Carolina, Texas, Puerto Rico, American Samoa, Guam, the Northern
Mariana Islands (Saipan), and the U.S. Virgin Islands. See Amendment at
] 7.a.
     In Zone B, certain model year 2009 GMT900 vehicles. Zone B
comprises the following states: Arizona, Arkansas, Delaware, District
of Columbia, Illinois, Indiana, Kansas, Kentucky, Maryland, Missouri,
Nebraska, Nevada, New Jersey, New Mexico, North Carolina, Ohio,
Oklahoma, Pennsylvania, Tennessee, Virginia, and West Virginia. See
Amendment at ] 7.b.
     In Zone C, certain model year 2007 and 2008 GMT900
vehicles. Zone C comprises the following states: Alaska, Colorado,
Connecticut, Idaho, Iowa, Maine, Massachusetts, Michigan, Minnesota,
Montana, New Hampshire, New York, North Dakota, Oregon, Rhode Island,
South Dakota, Utah, Vermont, Washington, Wisconsin, and Wyoming. See
Amendment at ] 7.c.

III. Summary of GM's Petition

    GM's petition states its belief that the requested modification to
the DIR schedule will not pose an unreasonable risk to motor vehicle
safety. In support of this contention, GM states that it has studied
the long-term performance of the covered passenger inflators and has
conducted an analysis of the ballistic performance of the covered
passenger inflators. Based upon this analysis, GM states that the
covered passenger inflators are not currently at risk of rupture.
According to the petition, GM's position is based upon the following:
An estimated 44,000 Takata passenger inflator deployments in GMT900
vehicles without a rupture; ballistic tests of 1055 covered passenger
inflators without a rupture or sign of abnormal deployment; deployment
of 12 inflators artificially exposed to additional humidity and
temperature cycling without a rupture or sign of abnormal deployment;
and analysis, through stress-strength interference, indicating that the
propellant in older covered passenger inflators has not degraded to a
sufficient degree to create rupture risk.
    GM further states that the covered passenger inflators are not used
by any other original equipment manufacturer and have a number of
unique design features that influence burn rates and internal ballistic
dynamics, including greater vent-area-to-propellant-mass ratios, steel
end caps, and thinner propellant wafers. In addition, GM states that
the physical environment of the GMT900 vehicles better protects the
covered passenger inflators from the temperature cycling that can cause
rupture. More specifically, GM notes that the GMT900 vehicles have
larger interior volumes than smaller passenger cars, and are equipped
with solar-absorbing windshields and side glass.
    Finally, GM states that it has retained a third-party expert to
conduct a long-term aging study that will estimate the service life
expectancy of the covered passenger inflators in the GMT900 vehicles.
GM anticipates that this study will be complete in August 2017.
    For these reasons, GM requests that NHTSA amend the DIR schedule
pursuant to Paragraph 17 of the Amendment to delay the inclusion of the
covered passenger inflators until the December 31, 2017 DIR filing.

    Authority:  49 U.S.C. 30101, et seq., 30118, 30162, 30166(b)(1),
30166(g)(1); delegation of authority at 49 CFR 1.95(a).

    Issued: September 15, 2016.
Michael Brown,
Acting Director, Office of Defects Investigation.
[FR Doc. 2016-22631 Filed 9-16-16; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 76, Number 116 (Thursday, June 16, 2011)]
[Notices]
[Pages 35201-35202]
[FR Doc No: 2011-14967]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2309-019]

Jersey Central Power and Light; PSEG Fossil LLC; Notice of
Application Accepted for Filing, Soliciting Motions To Intervene and
Protests, Ready for Environmental Analysis, and Soliciting Comments,
Recommendations, Preliminary Terms and Conditions, and Preliminary
Fishway Prescriptions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New Major License.
    b. Project No.: 2309-019.
    c. Date Filed: February 18, 2011.
    d. Applicant: Jersey Central Power and Light and PSEG Fossil LLC.
    e. Name of Project: Yards Creek Pumped Storage Project.
    f. Location: The existing project is located on Yards Creek, in the
townships of Hardwick and Blairstown, Warren County, New Jersey. No
Federal lands are involved.
    g. Filed pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Timothy Oakes, Project Manager, Kleinschmidt
Associates, 2 East Main Street, Strasburg, PA 17579; Telephone (717)
687-7211.
    i. FERC Contact: Allyson Conner,<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. Deadline for filing motions to intervene and protests, comments,
recommendations, preliminary terms and conditions, and preliminary
prescriptions: 60 days from the issuance date of this notice; reply
comments are due 105 days from the issuance date of this notice.
    Motions to intervene, protests, comments, recommendations,
preliminary terms and conditions, and preliminary fishway prescriptions
may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit
brief comments up to 6,000 characters, without prior registration,
using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the
end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and seven copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. This application has been accepted for filing and is now ready
for environmental analysis.
    l. The Yards Creek Pumped Storage Project consists of: (1) An upper
reservoir with a total usable storage capacity of 4,763 acre-feet; (2)
a lower reservoir with a total usable storage capacity of 5,452 acre-
feet; (3) an auxiliary reservoir with seasonal storage of 412 acre-feet
formed by the auxiliary reservoir dam, which is 1,000 feet long and 20
feet high; (4) a main, earthfill dam at the lower reservoir that is
1,404 feet long and 52 feet high; (5) an auxiliary dike at the lower
reservoir that is 2,091 feet long and 35 feet high; (6) a 2,116-foot,
35-foot-wide intake channel in the floor of the upper reservoir; (7) a
95-foot-high concrete intake structure with trashracks and stop logs;
(8) a 1,130-foot-long, 20-foot-diameter concrete-lined pressure tunnel;
(9) a 210-foot-long, 19-foot-diameter steel-lined pressure tunnel; (10)
a 144-foot-long, 19-foot-diameter concrete encased steel-lined
transition section; (11) a 478-foot-long, 19-foot-diameter steel
penstock; (12) an 8-foot-long reducer from a 19-foot-diameter to 18-
foot-diameter penstock; (13) a 1,582-foot-long, 18-foot-diameter steel
penstock; (14) a 325-foot-long trifurcated penstock, one penstock per
pumping-generating unit that tapers from 10-foot-diameter to 7-foot
2.5-inch-diameter; (15) 86.5-inch spherical guard valves at the
entrance to each pump-turbine spiral case; (16) three vertical shaft,
Francis-type, reversible pump-turbine engine units, each with a
nameplate generating capacity of 140 megawatts; (17) a 140-foot-long by
63.5-foot-wide underground concrete powerhouse; and (18) appurtenant
facilities.
    The licensee proposes to raise the preliminary spillway crest at
the lower reservoir by 1 foot, to 819.5 feet, to provide for additional
storage by adding wooden flashboards. The licensee also proposes
raising the upper reservoir pool elevation 2 feet, from 1,555 feet to
1,557 feet, allowing only 4 feet of freeboard to the crest elevation of
1,561 feet. As an additional precaution to existing monitors and
controls, the licensee is proposing to install an overflow structure at
the upper reservoir to prevent overtopping the non-overflow structures
(dikes) in the event of high water levels.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via e-mail of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    n. Anyone may submit comments, a protest, or a motion to intervene
in accordance with the requirements of Rules of Practice and Procedure,
18 CFR 385.210, .211, .214. In determining the appropriate action to
take, the Commission will consider all protests or other comments
filed, but only those who file a motion to intervene in accordance with
the Commission's Rules may become a party to the proceeding. Any
comments, protests, or motions to intervene must be received on or
before the specified comment date for the particular application.
    All filings must (1) bear in all capital letters the title
``PROTEST,'' ``MOTION TO INTERVENE,'' ``COMMENTS,'' ``REPLY COMMENTS,''
``RECOMMENDATIONS,'' ``PRELIMINARY TERMS AND CONDITIONS,'' or
``PRELIMINARY FISHWAY PRESCRIPTIONS;'' (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, recommendations, terms and conditions or prescriptions must
set forth their evidentiary basis and otherwise comply with the
requirements of 18 CFR 4.34(b). Agencies may obtain copies of the
application directly from

the applicant. A copy of any protest or motion to intervene must be
served upon each representative of the applicant specified in the
particular application. A copy of all other filings in reference to
this application must be accompanied by proof of service on all persons
listed in the service list prepared by the Commission in this
proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
    o. Procedural Schedule: The application will be processed according
to the following revised Hydro Licensing Schedule. Revisions to the
schedule may be made as appropriate.

------------------------------------------------------------------------
              Milestone                           Target date
------------------------------------------------------------------------
Filing of recommendations,            August 9, 2011.
 preliminary terms and conditions,
 and preliminary fishway
 prescriptions.
Commission issues Single EA.........  December 7, 2011.
Comments on EA......................  January 6, 2011.
Modified terms and conditions.......  March 5, 2012.
------------------------------------------------------------------------

    p. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of this notice.
    q. A license applicant must file no later than 60 days following
the date of issuance of the notice of acceptance and ready for
environmental analysis provided for in 5.22: (1) A copy of the water
quality certification; (2) a copy of the request for certification,
including proof of the date on which the certifying agency received the
request; or (3) evidence of waiver of water quality certification.

    Dated: June 10, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-14967 Filed 6-15-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 79 (Wednesday, April 24, 2019)]
[Proposed Rules]
[Pages 17113-17116]
[FR Doc No: 2019-08262]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 170, 177, and 189

[Docket No. FDA-2015-F-0537]

Natural Resources Defense Council et al.: Response to the
Objections and Denial of the Requests for a Public Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; response to objections and denial of public
hearing requests.

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SUMMARY: The Food and Drug Administration (FDA or we) is overruling the
objections and is denying the requests for a public hearing, submitted
by the Environmental Defense Fund, Natural Resources Defense Council,
Center for Food Safety, Clean Water Action, Center for Science in the
Public Interest, Breast Cancer Prevention Partners, Center for
Environmental Health, Environmental Working Group, and Improving Kids'
Environment.

DATES: April 24, 2019.

FOR FURTHER INFORMATION CONTACT: Hui-Chen (Anita) Chang, Center for
Food Safety and Applied Nutrition (HFS-275), Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740-3835, 240-402-
1161.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 16, 2015 (80 FR 13508), we
announced the filing of a food additive petition (FAP 4B4808)
(``petition'') submitted by the Natural Resources Defense Council, 1152
15th St. NW, Suite 300, Washington, DC 20005; the Center for Food
Safety, 303 Sacramento St., Second Floor, San Francisco, CA 94111;
Clean Water Action, 1444 I St. NW, Suite 400, Washington, DC 20005; the
Center for Science in the Public Interest, 1220 L St. NW, Suite 300,
Washington, DC 20005; Children's Environmental Health Network, 110
Maryland Ave. NE, Suite 402, Washington, DC 20002; the Breast Cancer
Fund (now known as Breast Cancer Prevention Partners), 1388 Sutter St.,
Suite 400, San Francisco, CA 94109-5400; the Center for Environmental
Health, 2201 Broadway, Suite 302, Oakland, CA 94612; Environmental
Working Group, 1436 U St. NW, Suite 100, Washington, DC 20009; and
Improving Kids' Environment, 1915 West 18th St., Indianapolis, IN 46202
(collectively, ``petitioners''). The petition asked FDA to take three
separate regulatory actions: (1) Revoke our 2005 approval of Threshold
of Regulation (TOR) exemption No. 2005-006 allowing as much as 1.2
percent sodium perchlorate monohydrate in dry food packaging; (2) issue
a new regulation under part 189 (21 CFR part 189) prohibiting the use
of perchlorate as a conductivity enhancer in the manufacture of
antistatic agents to be used in food contact articles; and (3) remove
potassium perchlorate as an allowed additive in sealing gaskets for
food containers in existing Sec.  177.1210 (21 CFR 177.1210).
    In the Federal Register of June 30, 2016 (81 FR 42585), we
announced that we filed a food additive petition (FAP 6B4816)
(``abandonment petition'') submitted on behalf of Society of the
Plastics Industry, Inc. (SPI) by Keller and Heckman LLP, 1001 G Street
NW, Suite 500 West, Washington, DC 20001. The abandonment petition
proposed to amend Sec.  177.1210 to no longer provide for the use of
potassium perchlorate as an additive in closure sealing gaskets for
food containers because the use has

been intentionally and permanently abandoned.
    In response to the abandonment petition, we issued a final rule in
the Federal Register on May 4, 2017 (82 FR 20829), to no longer provide
for the use of potassium perchlorate as an additive in closure-sealing
gaskets for food containers because this use has been abandoned. The
final rule removed the entry for ``Potassium perchlorate'' from Sec.
177.1210(b)(5), table 1.
    Additionally, in the Federal Register of May 4, 2017 (82 FR 20847),
we announced that we were denying the petition (``2017 denial''). The
2017 denial advised that objections and requests for a hearing were due
by June 4, 2017. The 2017 denial explained that the requests to revoke
TOR exemption No. 2005-006 and issue a regulation under part 189
prohibiting the use of perchlorate in the manufacture of antistatic
agents to be used in food-contact articles are not directed at
regulations issued under the food additive petition process and are not
subject to the statutory processes for food additive petitions (82 FR
20847 at 20858). Because the requests to revoke TOR exemption No. 2005-
006 and issue a regulation under part 189 are not within the scope of a
food additive petition, the provision for objections and a hearing
under section 409(f) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 348(f)) does not apply to these two requests (Id.). The
2017 denial also explained that the petitioners' request to remove
potassium perchlorate as an allowed additive in closure-sealing gaskets
for food containers in Sec.  177.1210 was moot when we amended Sec.
177.1210 to no longer authorize this use of potassium perchlorate
because it had been abandoned (see 82 FR 20847 at 20849).

II. Objections and Requests for Hearing

    Section 409(f) of the FD&C Act provides that, within 30 days after
publication of an order relating to a food additive regulation, any
person adversely affected by such order may file objections, specifying
with particularity the provisions of the order deemed objectionable,
stating reasonable grounds therefor, and requesting a public hearing
upon such objections. FDA may deny a hearing request if the objections
to the regulation do not raise genuine and substantial issues of fact
that can be resolved at a hearing (Community Nutrition Inst. v. Young,
773 F.2d 1356, 1364 (D.C. Cir. 1985)).
    Under the food additive regulations at 21 CFR 171.110, objections
and requests for a hearing are governed by part 12 (21 CFR part 12) of
FDA's regulations. Under Sec.  12.22(a), each objection must: (1) Be
submitted on or before the 30th day after the date of publication of
the final rule; (2) be separately numbered; (3) specify with
particularity the provision of the regulation or proposed order
objected to; (4) specifically state each objection on which a hearing
is requested; failure to request a hearing on an objection constitutes
a waiver of the right to a hearing on that objection; and (5) include a
detailed description and analysis of the factual information to be
presented in support of the objection if a hearing is requested;
failure to include a description and analysis for an objection
constitutes a waiver of the right to a hearing on that objection.
    Within the 30-day objection period following publication of the
2017 denial, we received one submission raising objections. The
submission, dated June 4, 2017, from most of the petitioners and the
Environmental Defense Fund, raised specific objections to the 2017
denial and requested a hearing on the issues raised by each objection.
However, as explained in this document, the provision for objections
and a hearing under section 409(f) of the FD&C Act does not apply to
all objections in the submission. As further explained in this
document, for the objections to which this provision does not apply, we
do not address the submission's arguments and we do not consider the
related requests for a hearing. For purposes of this document, our use
of the term ``objections'' does not mean that the provision for
objections and hearing under section 409(f) of the FD&C Act necessarily
applies.

III. Standards for Granting a Hearing

    Specific criteria for deciding whether to grant or deny a request
for a hearing are set out in Sec.  12.24(b). Under that regulation, a
hearing will be granted if the material submitted by the requester
shows, among other things, the following: (1) There is a genuine and
substantial factual issue for resolution at a hearing; a hearing will
not be granted on issues of policy or law; (2) the factual issue can be
resolved by available and specifically identified reliable evidence; a
hearing will not be granted on the basis of mere allegations or denials
or general descriptions of positions and contentions; (3) the data and
information submitted, if established at a hearing, would be adequate
to justify resolution of the factual issue in the way sought by the
requester; a hearing will be denied if the data and information
submitted are insufficient to justify the factual determination urged,
even if accurate; (4) resolution of the factual issue in the way sought
by the person is adequate to justify the action requested; a hearing
will not be granted on factual issues that are not determinative with
respect to the action requested (e.g., if the action would be the same
even if the factual issue were resolved in the way sought); (5) the
action requested is not inconsistent with any provision in the FD&C Act
or any FDA regulation; and (6) the requirements in other applicable
regulations, e.g., 21 CFR 10.20 and Sec. Sec.  12.21 and 12.22, and in
the document issuing the final regulation or the notice of opportunity
for hearing are met.
    A party seeking a hearing is required to meet a ``threshold burden
of tendering evidence suggesting the need for a hearing'' (Costle v.
Pac. Legal Found., 445 U.S. 198, 214 (1980), citing Weinberger v.
Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 620-21 (1973)). An
allegation that a hearing is necessary to ```sharpen the issues' and
`fully develop the facts' does not meet this test'' (Georgia-Pacific
Corp. v. U.S. EPA, 671 F.2d 1235, 1241 (9th Cir. 1982)). If a hearing
request fails to identify any factual evidence that would be the
subject of a hearing, there is no point in holding one. In judicial
proceedings, a court is authorized to issue summary judgment without an
evidentiary hearing whenever it finds that there are no genuine issues
of material fact in dispute and a party is entitled to judgment as a
matter of law (see Fed. R. Civ. P. 56). The same principle applies in
administrative proceedings (see Sec.  12.24).
    A hearing request must not only contain evidence, but that evidence
should raise a material issue of fact ``concerning which a meaningful
hearing might be held'' (Pineapple Growers Ass'n v. FDA, 673 F.2d 1083,
1085 (9th Cir. 1982)). Where the issues raised in the objection are,
even if true, legally insufficient to alter the decision, an agency
need not grant a hearing (see Dyestuffs and Chem., Inc. v. Flemming,
271 F.2d 281, 286 (8th Cir. 1959)). A hearing is justified only if the
objections are made in good faith and if they ``draw in question in a
material way the underpinnings of the regulation at issue'' (Pactra
Indus. v. CPSC, 555 F.2d 677, 684 (9th Cir. 1977)). A hearing need not
be held to resolve questions of law or policy (see Citizens for Allegan
Cnty., Inc. v. FPC, 414 F.2d 1125, 1128 (D.C. Cir. 1969); Sun Oil Co.
v. FPC, 256 F.2d 233, 240 (5th Cir. 1958)).
    Even if the objections raise material issues of fact, FDA need not
grant a hearing if those same issues were

adequately raised and considered in an earlier proceeding. Once an
issue has been so raised and considered, a party is estopped from
raising that same issue in a later proceeding without new evidence. The
various judicial doctrines dealing with finality, such as collateral
estoppel, can be validly applied to the administrative process (see
Pac. Seafarers, Inc. v. Pac. Far East Line, Inc., 404 F.2d 804, 809
(D.C. Cir. 1968)). In explaining why these principles ought to apply to
an agency proceeding, the U.S. Court of Appeals for the District of
Columbia Circuit wrote: ``The underlying concept is as simple as this:
justice requires that a party have a fair chance to present his
position. But overall interests of administration do not require or
generally contemplate that he will be given more than a fair
opportunity'' (Retail Clerks Union, Local 1401 v. NLRB, 463 F.2d 316,
322 (D.C. Cir. 1972); see also Costle v. Pac. Legal Found., 445 U.S. at
215-17).

IV. Analysis of Objections and Response to Hearing Requests

    As explained in the 2017 denial (82 FR 20847 at 20849), a food
additive petition must either propose the issuance of a regulation
prescribing the conditions under which a food additive may be safely
used or propose the amendment or repeal of an existing food additive
regulation (see section 409(b)(1) and (i) of the FD&C Act). The
petitioners' requests to revoke TOR exemption No. 2005-006 and issue a
regulation under part 189 prohibiting the use of perchlorate in the
manufacture of antistatic agents to be used in food-contact articles do
not propose the issuance of a new food additive regulation or the
amendment or repeal of an existing food additive regulation (82 FR
20847 at 20849). As the 2017denial states, the petitioners' TOR
exemption revocation request and part 189 regulation request are not
within the scope of a food additive petition and FDA's denial of these
requests is not an order under section 409(c)(1)(B) of the FD&C Act (82
FR 20847 at 20858). Therefore, the provision for objections and public
hearing under section 409(f) of the FD&C Act does not apply to the
requests to revoke TOR exemption No. 2005-006 and issue a regulation
under part 189.

A. Objections 1 and 2

    The submission's first two ``objections'' are not subject to the
objections and hearing procedure in section 409(f) of the FD&C Act.
Therefore, we will not address the arguments detailed in those
objections and we do not consider the related requests for a hearing.
    The submission's first ``objection'' asserts that we improperly
dismissed its request to revoke TOR exemption No. 2005-006 because, it
claims, we relied on a flawed interpretation of the definition of a
food additive in the TOR regulation. The submission additionally
asserts that the use of sodium perchlorate monohydrate allowed under
TOR exemption No. 2005-006 is not eligible for a TOR exemption and that
we made ``myriad errors'' in determining that it was eligible for a TOR
exemption. Because TOR exemption No. 2005-006 is not subject to the
objections and hearing procedure in section 409(f) of the FD&C Act, we
will not address the arguments detailed in ``objection'' 1.
    To the extent that any of the arguments made in ``objection'' 1 may
be construed as also pertaining to the petitioners' request to amend
Sec.  177.1210 to remove potassium perchlorate as an allowed additive
in closure-sealing gaskets for food containers, a request that is
subject to section 409(f) of the FD&C Act, this request became moot
when we amended Sec.  177.1210 to no longer authorize this use of
potassium perchlorate because it had been abandoned (see 82 FR 20847 at
20849). A hearing will not be granted on factual issues that are not
determinative with respect to the action requested (see Sec.
12.24(b)(4)). Therefore, to the extent that ``objection'' 1 pertains to
the petitioners' request to amend Sec.  177.1210, we are overruling the
submission's objection and denying the submission's request for a
hearing on this point.
    The submission's second ``objection'' challenges as ``contrary to
law'' FDA's determination that the petition's requests to revoke TOR
exemption No. 2005-006 and issue a regulation under part 189 are not
within the scope of a food additive petition. Section 409(f)(1) of the
FD&C Act permits objections and requests for a hearing only to orders
made under section 409(c) and (d) of the FD&C Act. Because FDA's denial
of the petitioners' TOR revocation request and part 189 request was not
an order under section 409(c)(1)(B) of the FD&C Act (see 82 FR 20847 at
20850), the submission's second ``objection'' is not an objection to an
order under section 409(c)(1)(B) of the FD&C Act and is not subject to
the objections and hearing procedure in section 409(f) of the FD&C Act.
Therefore, we will not address the arguments presented in ``objection''
2.

B. Objection 3

    Objection 3 challenges FDA's determination that the petitioners'
request to amend Sec.  177.1210 was moot when we issued a final rule in
response to the abandonment petition that removed potassium perchlorate
as an allowed additive in closure-sealing gaskets for food containers.
Specifically, the submission alleges that FDA's mootness determination
was ``poor public policy'' because it discourages industry to file
abandonment petitions except in the face of a petition that may find
the use no longer safe, and unfair to the petitioners, whose petition
was filed before the abandonment petition.
    In presenting objection 3, the submission fails to identify any
specific factual dispute that could be resolved by a hearing.
Accordingly, we are denying the submission's hearing request on
objection 3 because a hearing will not be granted on issues of policy
(Sec.  12.24(b)(1)). We also note that, in granting the abandonment
petition and removing potassium perchlorate as an allowed additive in
closure-sealing gaskets for food containers, we took the third action
requested in the petition. As stated in response to a similar comment
from the petitioners to the filing notice for the abandonment petition,
FDA has numerous responsibilities related to food additives, and we
receive and respond to hundreds of submissions annually under the
various petition and notification programs that we administer.
Accordingly, if a use of a food additive is no longer authorized in
response to an abandonment petition, we may determine that it is
neither necessary nor an efficient use of our limited resources to
address safety arguments related to an abandoned use (see 82 FR 20829
at 20831).

V. Summary and Conclusion

    After evaluating the objections from the submitters, we have
concluded that ``objections'' 1 and 2 are not within the scope of the
objections and hearing provision under section 409(f) of the FD&C Act.
Therefore, we do not address the arguments related to these
``objections'' and we do not address the related requests for a
hearing. To the extent that ``objection'' 1 pertains to the
petitioners' request to amend Sec.  177.1210, this request became moot
when we amended Sec.  177.1210 to no longer authorize this use of
potassium perchlorate, and therefore we are overruling the submission's
objection and denying the request for a hearing on this point.
Objection 3 does not provide any basis to reconsider our decision to

deny the petition. We also have determined that objection 3 does not
raise any genuine and substantial issue of fact that would justify an
evidentiary hearing. Therefore, we are overruling this objection and
are denying the related request for a hearing.

    Dated: April 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-08262 Filed 4-23-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 154 (Friday, August 9, 2019)]
[Notices]
[Page 39394]
[FR Doc No: 2019-17058]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA--2019-0027; Notice 3]

Withdrawal of Notice for State Notification to Consumers of Motor
Vehicle Recall Status

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Notice withdrawal.

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    On July 25, 2019, NHTSA inadvertently published, at 84 FR 35927, a
notice seeking comments on the proposed burden estimates related to a
proposed funding opportunity regarding state notification to consumers
of motor vehicle recall status. NHTSA is withdrawing the July 25, 2019
notice.

    Authority:  The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended; and 49 CFR 1:48

Stephen A. Ridella,
Director, Office of Defects Investigation Enforcement.
[FR Doc. 2019-17058 Filed 8-8-19; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register: April 15, 2010 (Volume 75, Number 72)]
[Notices]
[Page 19645]
[DOCID:fr15ap10-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR10-14-000]

Enterprise Texas Pipeline LLC; Notice of Petition for Rate
Approval

April 7, 2010.
    Take notice that on April 1, 2010, Enterprise Texas Pipeline LLC
(Enterprise Texas) filed a petition for rate approval pursuant to
section 284.123(b)(2) of the Commission's regulations. Enterprise Texas
proposes rates of $0.6090 per MMBtu for Rate Zone 1--Legacy Assets and
$0.6744 for Rate Zone 2--Sherman Extension Facilities.
    Any person desiring to participate in this rate proceeding must
file a motion to intervene or to protest this filing must file in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211 and 385.214). Protests will be considered
by the Commission in determining the appropriate action to be taken,
but will not serve to make protestants parties to the proceeding. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed on or before 5 p.m. Eastern time on the date as indicated
below. Anyone filing an intervention or protest must serve a copy of
that document on the Applicant. Anyone filing an intervention or
protest on or before the intervention or protest date need not serve
motions to intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on Wednesday April 21, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-8588 Filed 4-14-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 39 (Monday, February 29, 2016)]
[Notices]
[Page 10305]
[FR Doc No: 2016-04351]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension:
    Form SD; SEC File No. 270-647, OMB Control No. 3235-0697.

    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 collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Form SD (17 CFR 249b--400) under Securities Exchange Act of 1934
(15 U.S.C. 78a et seq.)(``Exchange Act'') pursuant to Section 13(p)(15
U.S.C. 78m(p)) of the Exchange Act is filed by issuers to provide
disclosures regarding the source and chain of custody of certain
minerals used in their products. We estimate that Form SD takes
approximately 480.61 hours per response to prepare and is filed by
approximately 864 issuers. We estimate that 75% of the 480.61 hours per
response (360.46 hours) is prepared by the issuer internally for a
total annual burden of 311,437 hours (360.46 hours per response x 864
responses).
    Written comments are invited on: (a) Whether this proposed
collection of information is necessary 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 imposed by the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
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.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Please direct your written comment to Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549 or send an email
to<EMAIL_ADDRESS>
    Dated: February 24, 2016.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-04351 Filed 2-26-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: August 25, 2010 (Volume 75, Number 164)]
[Notices]
[Page 52425-52427]
[DOCID:fr25au10-129]

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Part III

Department of Health and Human Services

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Food and Drug Administration

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Guidance for Industry; Section 4205 of the Patient Protection and
Affordable Care Act of 2010; Availability; Notices

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0370]

Draft Guidance for Industry: Questions and Answers Regarding
Implementation of the Menu Labeling Provisions of Section 4205 of the
Patient Protection and Affordable Care Act of 2010; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Guidance for Industry:
Questions and Answers Regarding Implementation of the Menu Labeling
Provisions of Section 4205 of the Patient Protection and Affordable
Care Act of 2010.'' Section 4205 of the Patient Protection and
Affordable Care Act (Affordable Care Act) requires certain chain
restaurants and similar retail food establishments with 20 or more
locations (hereinafter ``chain retail food establishments'') to provide
calorie information, and other nutrition information, for standard menu
items, food on display, and self-service food. Section 4205 also
requires vending machine operators who own or operate 20 or more
machines (hereinafter ``chain vending machine operators'') to disclose
calories for articles of food. Restaurants and similar retail food
establishments with fewer than 20 locations and vending machine
operators with fewer than 20 machines may elect to be subject to these
Federal requirements by registering every other year with the FDA.
    Section 4205 of the Affordable Care Act became effective on the
date the law was signed, March 23, 2010; however, some provisions
specifically require FDA to issue rules before FDA implements them.
Other provisions became requirements immediately upon enactment of the
law. The draft guidance, when finalized, will explain how those
provisions should be implemented.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on the
draft guidance before it begins work on the final version of the
guidance, submit electronic or written comments on the draft guidance
by October 12, 2010.

ADDRESSES: Submit electronic comments on the draft guidance to http://
www.regulations.gov. Submit written comments on the draft guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the draft guidance to the
Office of Nutrition, Labeling, and Dietary Supplements, Center for Food
Safety and Applied Nutrition (HFS-820), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Geraldine A. June, Center for Food
Safety and Applied Nutrition (HFS-820), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled
``Guidance for Industry: Questions and Answers Regarding Implementation
of the Menu Labeling Provisions of Section 4205 of the Patient
Protection and Affordable Care Act of 2010.''
    The availability of nutrition information through menu and vending
machine labeling would provide Americans with additional information to
make informed choices about their diets. Studies show that providing
nutrition information at restaurants can help people make healthier
choices (Refs. 1 and 2). Responding to this demand for information,
several States and localities have initiated a variety of legislative
or regulatory efforts for menu labeling, which has resulted in
differing requirements across jurisdictions. These differing
requirements have created logistical challenges for restaurant chains
that have locations in more than one jurisdiction (Ref. 3).
    On March 23, 2010, the President signed into law the Affordable
Care Act (Public Law 111-148), which sets up a uniform nationwide
approach to menu and vending machine labeling. Section 4205 of the
Affordable Care Act (hereinafter ``section 4205'') creates a new
subparagraph (H) within section 403(q)(5) of the Federal Food, Drug,
and Cosmetic Act (the act), to be codified at 21 U.S.C. 343(q)(5)(H),
which requires certain chain retail food establishments to provide
calorie information and other nutrition information for menu items,
food on display, and self-service food. Section 4205 also requires
chain vending machine operators to disclose calories for articles of
food. Chain retail food establishments with fewer than 20 locations (or
other restaurants or similar retail food establishments not covered by
section 4205) and vending machine operators with fewer than 20 machines
may elect to be subject to these Federal requirements by registering
every other year with the FDA.
    Section 4205 became effective on the date the law was signed, March
23, 2010; however, some provisions require FDA to issue rules before
FDA implements them. Other provisions must be implemented immediately
upon enactment of the law. FDA is required to issue a proposed rule
implementing section 4205 by March 23, 2011.
    For chain retail food establishments, the provisions that became
requirements immediately upon enactment of the law include:
    (1) Disclosing the number of calories in each standard menu item on
menus and menu boards,
    (2) Making additional written nutrition information available to
consumers upon request,
    (3) Providing a statement on menus and menu boards about the
availability of the additional nutrition information, and
    (4) Providing calorie information (per serving or per food item)
for most self-service items and food on display, on a sign adjacent to
each food item.
    In addition, the provision requiring chain vending machine
operators to disclose, in a clear and conspicuous manner, calories of
any article of food that does not permit a prospective purchaser to
examine its Nutrition Facts panel before purchasing, or does not
otherwise provide visible nutrition information at the point of
purchase, became an immediate requirement upon enactment of the law.
    FDA is issuing this draft guidance as Level 1 draft guidance
consistent with FDA's good guidance practices regulation (21 CFR
10.115). The draft guidance, when finalized, will represent the
agency's current thinking on the provisions in section 4205 related to
chain retail food establishments that became requirements immediately
upon enactment of the law. It does not create or confer any rights for
or on any person and does not operate to bind FDA or the public. An
alternate approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations. FDA is
soliciting comments from interested parties on the entire document to
better inform the agency as it develops further guidance.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. 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. 3501-3520). The
collections of information in section 4205 of the Affordable Care Act
have been approved under OMB Control No. 0910-0665 (menu labeling third
party disclosures and recordkeeping) and OMB Control No. 0910-0664
(voluntary registration program).

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding the
draft guidance. It is only necessary to send one set of comments. It is
no longer necessary to send two sets of mailed comments. Identify
comments 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at http://www.fda.gov/FoodGuidances.

V. References

    FDA has placed the following references on display in the Division
of Dockets Management (see ADDRESSES), and they may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but FDA is not responsible
for any subsequesnt changes to the Web sites after this document
publishes in the Federal Register.)
    1. Howlett, E.A., S. Burton, K. Bates, and K. Huggins, ``Coming
to a Restaurant Near You? Potential Consumer Responses to Nutrition
Information Disclosure on Menus,'' Journal of Consumer Research
36(3): 494-503, 2009. Available at http://www.journals.uchicago.edu/
doi/pdf/10.1086/598799.
    2. Tandon, P.S., J.Wright, C. Zhou, C.B. Rogers, D.A.
Christakis, ``Nutrition Menu Labeling May Lead to Lower-Calorie
Restaurant Meal Choices for Children,'' Pediatrics 125(2): 244-248,
2010.
    3. Center for Science in the Public Interest, ``Comparison of
Menu Labeling Policies,'' Available at http://cspinet.org/new/pdf/
comparison_of_ml_policies_6-9.pdf.

    Dated: August 18, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-21065 Filed 8-24-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 82, Number 90 (Thursday, May 11, 2017)]
[Notices]
[Pages 21993-21994]
[FR Doc No: 2017-09561]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2013-0677; FRL-9961-94]

Receipt of Information Under the Toxic Substances Control Act

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is announcing its receipt of information submitted
pursuant to a rule, order, or consent agreement issued under the Toxic
Substances Control Act (TSCA). As required by TSCA, this document
identifies each chemical substance and/or mixture for which information
has been received; the uses or intended uses of such chemical substance
and/or mixture; and describes the nature of the information received.
Each chemical substance and/or mixture related to this announcement is
identified in Unit I. under SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
John Schaeffer, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-8173; 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. Chemical Substances and/or Mixtures

    Information received about the following chemical substance and/or
mixture is provided in Unit IV.: 2-Butenedioic acid (2E)-, di-C8-18-
alkyl esters (CASRN 68610-90-2).

II. Authority

    Section 4(d) of TSCA (15 U.S.C. 2603(d)) requires EPA to publish a
notice in the Federal Register reporting

the receipt of information submitted pursuant to a rule, order, or
consent agreement promulgated under TSCA section 4 (15 U.S.C. 2603).

III. Docket Information

    A docket, identified by the docket identification (ID) number EPA-
HQ-OPPT-2013-0677, has been established for this Federal Register
document, which announces the receipt of the information. Upon EPA's
completion of its quality assurance review, the information received
will be added to the docket identified in Unit IV., which represents
the docket used for the TSCA section 4 rule, order, and/or consent
agreement. In addition, once completed, EPA reviews of the information
received will be added to the same docket. Use the docket ID number
provided in Unit IV. to access the information received and any
available EPA review.
    EPA's dockets are available electronically at http://www.regulations.gov or in person 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.

IV. Information Received

    As specified by TSCA section 4(d), this unit identifies the
information received by EPA.

A. 2-Butenedioic acid (2E)-, di-C8-18-alkyl esters (CASRN 68610-90-2).

    1. Chemical Use: Industrial manufacturing lubricant.
    2. Applicable Rule, Order, or Consent Agreement: Chemical testing
requirements for third group of high production volume chemicals
(HPV3), 40 CFR 799.5089.
    3. Information Received: The following listing describes the nature
of the information received. The information will be added to the
docket for the applicable TSCA section 4 rule, order, or consent
agreement and can be found by referencing the docket ID number
provided. EPA reviews of information will be added to the same docket
upon completion.

B. Water Solubility Analytical Report. The docket ID number assigned to
this information is EPA-HQ-OPPT-2009-0112.

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

    Dated: April 26, 2017.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
[FR Doc. 2017-09561 Filed 5-10-17; 8:45 am]
 BILLING CODE 6560-50-P