[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Notices]
[Pages 79878-79880]
[FR Doc No: 2015-32272]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application Ready for Environmental Analysis and
Soliciting Comments, Recommendations, Terms and Conditions, and
Prescriptions

------------------------------------------------------------------------
                                                                Project
                                                                  No.
------------------------------------------------------------------------
FFP Missouri 16, LLC........................................   13753-002
FFP Missouri 15, LLC........................................   13762-002
Solia 8 Hydroelectric, LLC..................................   13771-002
FFP Missouri 13, LLC........................................   13763-002
Solia 5 Hydroelectric, LLC..................................   13766-002
Solia 4 Hydroelectric, LLC..................................   13767-002
FFP Missouri 12, LLC........................................   13755-002
FFP Missouri 5, LLC.........................................   13757-002
FFP Missouri 6, LLC.........................................   13761-002
Solia 6 Hydroelectric, LLC..................................   13768-002
------------------------------------------------------------------------

    Take notice that the following hydroelectric applications have been
filed with the Commission and are available for public inspection.
    a. Type of Application: Original Major License.
    b. Project Nos.: 13753-002; 13762-002; 13771-002; 13763-002; 13766-
002; 13767-002; 13755-002; 13757-002; 13761-002; 13768-002.
    c. Date filed: P-13753, P-13762, P-13771, P-13763, and P-13766 were
filed on February 27, 2014; P-13755 was filed on February 3, 2014; P-
13757, P-13761, and P-13768 were filed on March 14, 2014.
    d. Applicants: FFP Missouri 16, LLC; FFP Missouri 15, LLC; Solia 8
Hydroelectric, LLC; FFP Missouri 13, LLC; Solia 5 Hydroelectric, LLC;
Solia 4 Hydroelectric, LLC; FFP Missouri 12, LLC; FFP Missouri 5, LLC;
FFP Missouri 6, LLC, and; Solia 6 Hydroelectric, LLC. All applicants
are subsidiaries of FFP New Hydro, LLC.
    e. Name of Projects: Opekiska Lock and Dam Hydroelectric Project;
Morgantown Lock and Dam Hydroelectric Project; Point Marion Lock and
Dam Hydroelectric Project; Grays Landing Lock and Dam Hydroelectric
Project; Maxwell Lock and Dam Hydroelectric Project; Monongahela Lock
and Dam Number Four Hydroelectric Project; Allegheny Lock and Dam
Number Two Hydroelectric Project; Emsworth Locks and Dam Hydroelectric
Project; Emsworth Back Channel Hydroelectric Project; Montgomery
Hydroelectric Project.
    f. Location: The proposed projects would be located at U.S. Army
Corps of Engineers' (Corps) dams on the Monongahela, Allegheny, and
Ohio rivers as described in the table below. The projects would occupy
approximately 41.2 acres of federal land managed by the Corps.

----------------------------------------------------------------------------------------------------------------
                                                                                Federal land
                                                                                used by
        Project No.                 Projects           County and state          City/town            project
                                                                                (acres)
----------------------------------------------------------------------------------------------------------------
P-13753....................  Opekiska Lock and Dam  Monongalia, WV.......  Between Fairmont and            * 4.5
                                                                            Morgantown.
P-13762....................  Morgantown Lock and    Monongalia, WV.......  Morgantown...........             1.0
                              Dam.
P-13771....................  Point Marion Lock and  Fayette, PA..........  Point Marion.........             1.4
                              Dam.
P-13763....................  Grays Landing Lock     Greene, PA...........  Near Masontown.......          * 12.0
                              and Dam.
P-13766....................  Maxwell Lock and Dam.  Washington, PA.......  Downstream of                   * 1.0
                                                                            Fredericktown.
P-13767....................  Monongahela Lock and   Washington, PA.......  Charleroi............           * 1.0
                              Dam Number Four.

P-13755....................  Allegheny Lock and     Allegheny, PA........  Borough of Sharpsburg             3.2
                              Dam Number Two.
P-13757....................  Emsworth Locks and     Allegheny, PA........  Neville Township.....             9.7
                              Dam.
P-13761....................  Emsworth Back Channel  Allegheny, PA........  Neville Township.....             2.3
                              Dam.
P-13768....................  Montgomery Locks &     Beaver, PA...........  Borough of Industry..             5.1
                              Dam.
----------------------------------------------------------------------------------------------------------------
* Value is estimated from exhibit G.

    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Kellie Doherty, Vice President--
Environmental, Rye Development, LLC, 745 Atlantic Ave, 8th Floor,
Boston, MA 02111 or at<PHONE_NUMBER>.
    i. FERC Contact: Nicholas Ettema,<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. Deadline for filing comments, recommendations, terms and
conditions, and prescriptions: 60 days from the issuance date of this
notice; reply comments are due 105 days from the issuance date of this
notice.
    The Commission strongly encourages electronic filing. Please file
comments, recommendations, terms and conditions, and prescriptions
using the Commission's eFiling system at 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>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include the
applicable project name(s) and docket number(s) (e.g., Opekiska Lock
and Dam P-13753-002).
    The Commission's Rules of Practice and Procedures 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. These applications have been accepted, and are ready for
environmental analysis at this time.
    l. The proposed Opekiska Lock and Dam Hydroelectric Project would
be the most upstream project at river mile (RM) 115.4 on the
Monongahela River and would consist of the following new facilities:
(1) A 180-foot-long, 95-foot-wide intake channel directing flow to a
30-foot-long, 50-foot-high, 70-foot-wide intake structure with 3-inch
bar spacing trash racks; (2) a 120-foot-long, 60-foot-high, 70-foot-
wide reinforced concrete powerhouse on the west bank of the river; (3)
two turbine-generator units with a combined capacity of 6.0 megawatts
(MW); (4) a 280-foot-long, 64-foot-wide tailrace; (5) a 40-foot-long by
40-foot-wide substation; (6) a 3,511-foot-long, 12.5-kilovolt (kV),
overhead transmission line to connect the project substation to an
existing distribution line; and (7) appurtenant facilities.
    The proposed Morgantown Lock and Dam Hydroelectric Project would be
located at RM 102.0 on the Monongahela River and consist of the
following new facilities: (1) A 100-foot-long, 64-foot-wide intake
channel located downstream of the Corps' 6th spillway gate on the east
side of the river; (2) a pair of spill gates totaling 60 feet wide
located within the intake channel; (3) a 30-foot-long, 50-foot-high,
64-foot-wide intake structure with 3-inch bar spacing trash racks; (4)
a 120-foot-long, 60-foot-high, 70-foot-wide reinforced concrete
powerhouse; (5) two turbine-generator units with a combined capacity of
5.0 MW; (6) a 170-foot-long, 90-foot-wide tailrace; (7) a 40-foot-long
by 40-foot-wide substation; (8) a 2,162-foot-long, 12.5-kV, overhead
transmission line to connect the project substation to an existing
distribution line; and (9) appurtenant facilities.
    The proposed Point Marion Lock and Dam Hydroelectric Project would
be located at RM 90.8 on the Monongahela River and consist of the
following new facilities: (1) A 280-foot-long, 70-foot-wide intake
channel directing flow to a 30-foot-long, 50-foot-high, 70-foot-wide
intake structure with 3-inch bar spacing trash racks; (2) a 120-foot-
long, 60-foot-high, 70-foot-wide reinforced concrete powerhouse on the
east bank of the river; (3) two turbine-generator units with a combined
capacity of 5.0 MW; (4) a 215-foot-long, 84-foot-wide tailrace; (5) a
40-foot-long by 40-foot-wide substation; (6) a 3,325-foot-long, 69-kV,
overhead transmission line to connect the project substation to an
existing substation; and (7) appurtenant facilities.
    The proposed Grays Landing Lock and Dam Hydroelectric Project would
be located at RM 82.0 on the Monongahela River and consist of the
following new facilities: (1) A 300-foot-long, 130-foot-wide intake
channel directing flow to a 100-foot-long, 84-foot-wide intake
structure with 3-inch bar spacing trash racks; (2) a 576-foot-long,
2.5-foot-high adjustable crest gate on top of the existing dam crest;
(3) a 150-foot-long, 75-foot-high, 90-foot-wide reinforced concrete
powerhouse on the west bank of the river; (4) two turbine-generator
units with a combined capacity of 12.0 MW; (5) a 250-foot-long, 84-
foot-wide tailrace; (6) a 40-foot-long by 40-foot-wide substation; (7)
a 9,965-foot-long, 69-kV, overhead transmission line to connect the
project substation to an existing distribution line; and (8)
appurtenant facilities.
    The proposed Maxwell Lock and Dam Hydroelectric Project would be
located at RM 61.2 on the Monongahela River and consist of the
following new facilities: (1) A 130-foot-long, 85-foot-wide intake
channel located immediately downstream of the Corps' 5th spillway gate
on the east side of the river; (2) a pair of spill gates totaling 84
feet wide located within the proposed intake channel; (3) a 100-foot-
long, 70-foot-high, 85-foot-wide intake structure with 3-inch bar
spacing trash racks; (4) a 150-foot-long, 70-foot-high, 90-foot-wide
reinforced concrete powerhouse; (5) two turbine-generator units with a
combined capacity of 13.0 MW; (6) a 160-foot-long, 120-foot-wide
tailrace; (7) a 40-foot-long by 40-foot-wide substation; (8) a 350-
foot-long, 69/138-kV, overhead transmission line to connect the project
substation to an existing distribution line; and (9) appurtenant
facilities.
    The proposed Monongahela Lock and Dam Number Four (Charleroi)
Hydroelectric Project would be located at RM 41.5 on the Monongahela
River

and consist of the following new facilities: (1) A 140-foot-long, 90-
foot-wide intake channel located immediately downstream of the Corps'
5th spillway gate on the west side of the river; (2) a pair of spill
gates totaling 84 feet wide located within the proposed intake channel;
(3) a 100-foot-long, 65-foot-high, 90-foot-wide intake structure with
3-inch bar spacing trash racks; (4) a 150-foot-long, 70-foot-high, 90-
foot-wide reinforced concrete powerhouse; (5) two turbine-generator
units with a combined capacity of 12.0 MW; (6) a 210-foot-long, 130-
foot-wide tailrace; (7) a 40-foot-long by 40-foot-wide substation; (8)
a 45-foot-long, 69-kV, overhead transmission line to connect the
project substation to an existing distribution line; and (9)
appurtenant facilities.
    The proposed Allegheny Lock and Dam Number Two Hydroelectric
Project would be located at RM 6.7 on the Allegheny River and consist
of the following new facilities: (1) A 170-foot-wide, 120-foot-long,
70-foot-high intake structure with two 5-inch bar spacing trash racks;
(2) two 45-foot-wide, 40-foot-high spillway bays; (3) an 1,100-foot-
long, 2.5-foot-high adjustable crest gate on top of the existing dam
crest; (4) a 170-foot-wide by 180-foot-long powerhouse along the east
side of the river; (5) three Kaplan turbine-generator units with a
combined installed capacity of 17.0 MW; (6) a 50-foot-wide by 60-foot-
long substation; (7) a 1,265-foot-long, single overhead, 69-kV,
overhead transmission line to connect the project substation to an
existing distribution line owned by Duquesne Light Company; and (8)
appurtenant facilities. The average annual generation would be 81,950
MWh annually.
    The proposed Emsworth Locks and Dam Hydroelectric Project would be
located at RM 6.2 on the Ohio River and would consist of the following
new facilities: (1) A 205-foot-long, 180-foot-wide intake channel
directing flow to a 30-foot-long, 63.5-foot-high, 180-foot-wide intake
structure with 5-inch bar spacing trash racks; (2) a 180-foot-long, 77-
foot-high, 180-foot-wide reinforced concrete powerhouse on the south
bank of the river; (3) four turbine-generator units with a combined
capacity of 24 MW; (4) a 380-foot-long, 280-foot-wide tailrace; (5) a
50-foot-long by 60-foot-wide substation; (6) a 1,893-foot-long, 69-kV,
overhead transmission line to connect the project substation to an
existing substation; and (7) appurtenant facilities. The average annual
generation would be 101,300 MWh.
    The proposed Emsworth Back Channel Dam Hydroelectric Project would
be located at RM 6.8 on the Ohio River and consist of the following new
facilities: (1) A 100-foot-long, 165-foot-wide intake channel directing
flow to a 32-foot-long, 63.5-foot-high, 90-foot-wide intake structure
with 5-inch bar spacing trash racks; (2) a 150-foot-long, 77-foot-high,
90-foot-wide reinforced concrete powerhouse on the north bank of the
river; (3) two turbine-generator units with a combined capacity of 12.0
MW; (4) a 190-foot-long, 105-foot-wide tailrace; (5) a 50-foot-long by
60-foot-wide substation; (6) a 3,758-foot-long, 69-kV, overhead
transmission line to connect the project substation to an existing
substation; and (7) appurtenant facilities. The average annual
generation would be 53,500 MWh.
    The proposed Montgomery Locks and Dam Hydroelectric Project would
be located at RM 31.7 on the Ohio River and consist of the following
new facilities: (1) A 340-foot-long, 205-foot-wide intake channel
directing flow to a 150-foot-long, 90-foot-high, 205-foot-wide intake
structure with 5-inch bar spacing trash racks; (2) a 315-foot-long,
105-foot-high, 205-foot-wide reinforced concrete powerhouse on the
north bank of the river; (3) three turbine-generator units with a
combined capacity of 42 MW; (4) a 280-foot-long, 210-foot-wide
tailrace; (5) a 50-foot-long by 60-foot-wide substation; (6) a 392-
foot-long, 69-kV, overhead transmission line to connect the project
substation to an existing distribution line; and (7) appurtenant
facilities. The average annual generation would be 194,370 MWh.
    The applicants propose to operate each of the ten projects in a
``run-of-river'' mode using flows made available by the Corps. The
proposed projects would not change existing flow releases or water
surface elevations upstream or downstream of the proposed projects.
    m. A copy of each 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. Copies are also available for inspection and
reproduction at the address in item h above.
    All filings must (1) bear in all capital letters the title
``COMMENTS,'' ``REPLY COMMENTS,'' ``RECOMMENDATIONS,'' ``TERMS AND
CONDITIONS,'' or ``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 submitting the filing; 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. Each filing must be
accompanied by proof of service on all persons listed on the service
list prepared by the Commission in this proceeding, in accordance with
18 CFR 4.34(b), and 385.2010.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to these or other pending projects. For assistance, contact
FERC Online Support.
    n. Public notice of the filing of the initial development
applications, which has already been given, established the due date
for filing competing applications or notices of intent. Under the
Commission's regulations, any competing development application must be
filed in response to and in compliance with public notice of the
initial development application. No competing applications or notices
of intent may be filed in response to this notice.
    o. A license applicant must file no later than 60 days following
the date of issuance of this notice: (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: December 17, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-32272 Filed 12-22-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 96 (Monday, May 18, 2020)]
[Notices]
[Page 29711]
[FR Doc No: 2020-10574]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER20-1801-000]

Techren Solar V LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Techren Solar V LLC's application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is June 1, 2020.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: May 12, 2020.
 Nathaniel J. Davis, Sr.,
 Deputy Secretary.
[FR Doc. 2020-10574 Filed 5-15-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: April 5, 2006 (Volume 71, Number 65)]
[Notices]
[Page 17086]
[DOCID:fr05ap06-52]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP99-176-117]

Natural Gas Pipeline Company of America; Notice of Proposed
Change in FERC Gas Tariff

March 28, 2006.
    Take notice that on March 21, 2006, Natural Gas Pipeline Company of
America (Natural) tendered for filing as part of its FERC Gas Tariff,
Sixth Revised Volume No. 1, the following tariff sheets, to become
effective April 1, 2006.

First Revised Sheet No. 26W.35
First Revised Sheet No. 26W.36
First Revised Sheet No. 26W.37
First Revised Sheet No. 26W.38
First Revised Sheet No. 26W.39
First Revised Sheet No. 26W.40

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

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

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

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-4876 Filed 4-4-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: June 6, 2007 (Volume 72, Number 108)]
[Notices]
[Page 31325-31326]
[DOCID:fr06jn07-89]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-1004; FRL-8113-5]

Pesticides; Draft Guidance for Pesticide Registrants on
Antimicrobial Pesticide Products With Anthrax-Related Claims

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: The Agency is announcing the availability of, and seeking
public comment on, a draft Pesticide Registration Notice entitled,
``Guidance for Antimicrobial Pesticide Products With Anthrax-Related
Claims.'' PR notices are issued by the Office of Pesticide Programs
(OPP) to inform pesticide registrants and other interested persons
about important policies, procedures, and registration related
decisions. This particular notice would, once final, provide guidance
to prospective applicants of antimicrobial products that make labeling
claims to inactivate Bacillus anthracis (anthrax) spores (hereafter
referred to as ``anthrax-related products'').

DATES: Comments must be received on or before September 4, 2007.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-1004, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-1004. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information. If
EPA cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the OPP

Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The hours of operation of this
Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Jeff Kempter, Antimicrobials Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 305-5448; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me

    This action is directed to the public in general. Although this
action may be of particular interest to those persons who are required
to register pesticides and federal, state, and local government
agencies and private institutions or organizations who are interested
in bio-decontamination chemicals. Since other entities may also be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the information in this notice, consult the person listed
under FOR FURTHER INFORMATION CONTACT.

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

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the

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

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPPT-2006-1004. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard

copy, at the Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal
Dr., Arlington, VA. The hours of operation of this Docket Facility are
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The Docket facility telephone number is<PHONE_NUMBER>.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.

II. What Guidance Does this PR Notice Provide?

    This draft PR Notice provides guidance to the registrant concerning
antimicrobial products that make labeling claims to ``inactivate
Bacillus anthracis (anthrax) spores'' (hereafter referred to as
``anthrax-related products''). In summary, this notice specifies that
in order for a product to qualify for a claim of inactivating anthrax
spores, an anthrax-related product should be:
    1. Supported by specific sporicidal efficacy studies that are
acceptable to EPA; and
    2. Subject to specific terms and conditions of registration that
limit the use of these products to certain trained persons. Prospective
applicants are encouraged to follow the guidance in this notice and
consult with EPA prior to applying for registration or amendment of a
product when seeking such a claim. This guidance should help the United
States be better prepared to respond to the intentional, accidental or
natural introduction of anthrax spores by helping to assure that
anthrax-related products bear appropriate labeling and are effective
when used as directed.
    In October 2001, when several letters containing Bacillus anthracis
(anthrax) spores were introduced into the U.S. Postal Service mail
system causing extensive contamination to dozens of buildings, no
antimicrobial products were specifically registered for inactivating
this particular pathogen. Since that time, the EPA has conducted
extensive research and coordinated across the federal government to
determine which efficacy test methods would be appropriate for
demonstrating the effectiveness of antimicrobial products for
inactivating B. anthracis spores. Guidance on acceptable efficacy test
methods will be made available in a separate document. EPA's Office of
Pesticide Programs has also developed guidance on the terms and
conditions of registration for the labeling of these products. EPA
intends to limit the use of these products to certain groups of trained
persons. This notice is aimed primarily at applicants and registrants,
but may also be of interest to other federal, state, and local
government agencies, academic institutions, and other interested
parties.

III. Do PR Notices Contain Binding Requirements?

    The PR Notice discussed in this notice is intended to provide
guidance to EPA personnel and to pesticide registrants. While the
requirements in the statutes and Agency regulations are binding on EPA
and the applicants, this PR Notice is not binding on pesticide
registrants, and EPA may depart from the guidance where circumstances
warrant and without prior notice. Likewise, pesticide registrants may
assert that the guidance is not appropriate generally or not applicable
to a specific pesticide or situation.

List of Subjects

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Decontamination.

    Dated: May 21, 2007.
Debra Edwards,
Director, Office of Pesticide Programs.
[FR Doc. E7-10694 Filed 6-5-07; 8:45 am]

BILLING CODE 6560-50-S


From: Thomas Andersen<EMAIL_ADDRESS>
Sent: Tuesday, May 06, 2014 5:57 PM
To: Howard, Jodi
Subject: EDC/VCM test data - THC results 2011 per 114D request

Jodi

Here is the 2011 Test data  that I spoke about on the phone. Also attached are three PDFs:

*         One is an e-mail to you from James Bell showing submission of the data
*         The second is the original information request to Mark Garza
*         The last pdf is an excerpt from the stack test conducted by ETS

In reviewing the data submission, it appears there was an error in the reporting.  It appears that NMHC
results were reported versus the THC data – please see the excerpt pdf for confirmation.

I will also send the 2010 THC  data along (separate e-mail) with diagrams depicting our incinerator,
scrubber and SCR treatment process versus the standard for the industry.

Please let me know when we can discuss our situation further.

Thanks

Thomas S. Andersen
Environmental Manager
Shintech, Inc.
5618 East Hwy 332
Freeport, TX 77541
979 233 7861 ext 398
979 236 5641 (c)


[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Notices]
[Pages 6575-6578]
[FR Doc No: 2017-01012]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2285]

Medical Product Communications That Are Consistent With the Food
and Drug Administration-Required Labeling--Questions and Answers; Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Medical
Product Communications That Are Consistent With the FDA-Required
Labeling--Questions and Answers.'' This draft guidance provides
information for manufacturers, packers, and distributors and their
representatives (collectively ``firms'') of drugs and medical devices
for humans, including those that are licensed as biological products,
and animal drugs (collectively ``medical products''), about how FDA
evaluates their medical product communications, including their
promotional materials, that present information that is not contained
in the FDA-required labeling for the product but that may be consistent
with the FDA-required labeling for the product. The Agency is issuing
this draft guidance to explain FDA's current thinking on commonly asked
questions regarding such communications in order to provide clarity for
firms.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 19, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a

third party may not wish to be posted, such as medical information,
your or anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your comments, that information will be
posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-2285 for ``Medical Product Communications That Are
Consistent With the FDA-Required Labeling--Questions and Answers; Draft
Guidance for Industry; Availability.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002;
Division of Small Manufacturers, International and Consumer Assistance,
Office of Communication, Education and Radiation Programs, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002;
or to Communications Staff (HFV-12), Center for Veterinary Medicine,
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Kristin Davis, Office of Policy,
Office of the Commissioner, 10903 New Hampshire Ave., Bldg. 32, Rm.
4252, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or Catherine Gray,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51, Rm. 3203, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>; or Stephen Ripley, Center for Biologics Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
Angela Krueger, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1666,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or Thomas Moskal, Center
for Veterinary Medicine, Food and Drug Administration, 7519 Standish
Pl. (HFV-1), Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Medical Product Communications That Are Consistent With the
FDA-Required Labeling--Questions and Answers.'' This draft guidance
provides information for firms about how FDA evaluates their medical
product communications, including their promotional materials, that
present information that is not contained in the FDA-required labeling
\1\ for the product but that may be consistent with the FDA-required
labeling for the product.
---------------------------------------------------------------------------

    \1\ As used in the draft guidance, the term FDA-required
labeling includes the labeling reviewed and approved by FDA as part
of the medical product marketing application review process. For
products not subject to premarket approval, but instead subject to
premarket notification requirements or exempt from premarket review,
the term also includes the labeling relied on to provide adequate
directions for use and other information required to appear on the
label or in labeling.
---------------------------------------------------------------------------

    FDA determines whether a medical product is safe and effective for
use under the conditions prescribed, recommended, or suggested in the
proposed labeling submitted to FDA with the product's marketing
application or submission (and for devices, also during the
classification process). In making this determination, FDA evaluates
whether the conditions of use in the proposed labeling are supported by
the required levels and types of evidence of safety and effectiveness
and whether the benefits of using the product under those specific
conditions of use outweigh the risks of the product. After FDA approves
or clears a medical product, the FDA-required labeling sets forth the
conditions of use under which the product has been shown to meet the
relevant standard for marketing, and it provides directions and
information on how to use the product safely and effectively under
those conditions.
    Medical product firms have expressed interest in communicating,
including in promotional materials, data and

information that are not contained in their products' FDA-required
labeling but concern the approved/cleared uses of the products. We are
aware that firms have questions about how FDA determines when such
communications are consistent with the FDA-required labeling, and how
they are viewed by FDA.
    The draft guidance describes FDA's thinking on these topics. As
explained in the draft guidance, a firm's communication of information
that is not contained in the product's FDA-required labeling, but that
is determined to be consistent with the FDA-required labeling, is not
alone considered evidence of a new intended use. However, even if a
communication is consistent with the FDA-required labeling, the
representations or suggestions made about the product would misbrand
the product and could subject firms to enforcement action if the
representations or suggestions are false or misleading. Accordingly,
the draft guidance both describes FDA's thinking on the types of
information that are consistent with the FDA-required labeling and
provides general recommendations for how this information can be
conveyed in a truthful and non-misleading way. The draft guidance also
provides some examples to illustrate these concepts. The
recommendations provided in the draft guidance to help ensure that
communications are not false or misleading are specific to
communications that are consistent with the FDA-required labeling;
communication of information that is not consistent with the FDA-
required labeling is outside the scope of these recommendations.
    Elsewhere in this issue of the Federal Register, FDA is announcing
the availability of a draft guidance for industry entitled ``Drug and
Device Manufacturer Communications With Payors, Formulary Committees,
and Similar Entities--Questions and Answers.'' This draft guidance
provides answers to common questions regarding firms' communications of
health care economic information about their approved prescription
drugs to payers and similar entities. This draft guidance also
addresses common questions relating to firms' dissemination of
information about investigational products to payers before FDA
approval or clearance of such products.
    In addition, FDA is announcing in this issue of the Federal
Register that it is reopening the comment period for the notice of
public hearing that appeared in the Federal Register of September 1,
2016, concerning manufacturer communications regarding unapproved uses
of approved or cleared medical products. The comment period will be
reopened for 90 days, until April 19, 2017. As announced in the notice
of public hearing, FDA is engaged in a comprehensive review of its
regulations and policies governing communications by firms about
unapproved uses of approved or cleared medical products, and the
comments it receives will inform FDA's policy development in this area.
    FDA will consider the feedback it receives in all three of these
dockets as the Agency continues to review its policies on firm
communications about medical products, and interested persons may wish
to review the documents FDA has issued in all three dockets before
submitting comments to any of the relevant dockets.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on certain
commonly asked questions regarding firms' communications for their
medical products that may be consistent with the FDA-required labeling.
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    Title: Recommended Content of Medical Product Communications That
Are Consistent With the FDA-Required Labeling.
    Description of Respondents: Respondents to the proposed collection
of information are manufacturers, packers, and distributors and their
representatives (firms) of human drugs and devices, including those
licensed as biological products, and animal drugs.
    Burden Estimate: The draft guidance includes Third-Party Disclosure
recommendations regarding information that firms should include in
communications that contain information not found in the FDA-required
labeling for their medical products but that are consistent with the
FDA-required labeling (as explained in the draft guidance) if they
choose to publically disseminate such materials.
    Specifically, FDA recommends that various aspects of study design
and methodology for studies relied on in such communications be
disclosed to provide material contextual information (e.g., type of
study, study objectives, product dosage/use regimens, control(s) used,
patient population studied), and that material limitations related to
the study design, methodology, and results also be disclosed in a clear
and prominent manner to help ensure that the communications are not
false or misleading.
    Furthermore, FDA recommends that firms accurately characterize and
contextualize the relevant information about the product, including by
disclosing unfavorable or inconsistent findings. FDA also recommends
that firms disclose material contextual information from the FDA-
required labeling in these communications, such as data and information
from studies in the FDA-required labeling that are relevant to the data
or information presented in the communication (e.g., if a communication
provides post-market information about the types and rates of
occurrence of adverse events that have been observed in practice, the
communication should also include information from the FDA-required
labeling about the types and rates of occurrence of adverse reactions

observed in clinical trials to provide context).
    According to FDA data, approximately 162,000 FDA-regulated
promotional materials are prepared by approximately 500 firms annually.
Of these materials, we estimate approximately 5 percent contain unique
presentations of information consistent with FDA-required labeling, as
that term is described in the draft guidance, submitted by
approximately 64 percent (or 324) of the firms. Anticipating the number
of these FDA-regulated promotional materials will soon increase to 6
percent, we estimate the 324 firms will prepare and disseminate
annually 9,720 FDA-regulated promotional materials that contain unique
presentations of information that is consistent with FDA-required
labeling, as that term is described in the draft guidance, and that
therefore are recommended to include the proposed third party
disclosures. Based on our experience reviewing FDA-regulated
promotional materials for medical products, we estimate it will take
respondents approximately 4 hours per unique presentation to prepare
and incorporate the disclosures recommended in the draft guidance, if
they choose to disseminate this information.
    We estimate the burden of this collection of information as
follows:

                                                Table 1--Estimated Annual Third-Party Disclosure Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                        Type of information                             Number of      disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent       disclosures     per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommended information to be included when firms choose to                     324                30            9,720                4          38,880
 disseminate communications that are consistent with the FDA-
 required labeling.................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm,
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm,
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm,
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or
https://www.regulations.gov.

    Dated: January 6, 2017.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-01012 Filed 1-18-17; 8:45 am]
 BILLING CODE 4164-01-P


STATE OF RHODE ISLAND AND PROVIDENCE PLANTATIONS

DEPARTMENT OF ENVIRONMENTAL MANAGEMENT

OFFICE OF AIR RESOURCES

AIR POLLUTION CONTROL REGULATION NO. 8

SULFUR CONTENT OF FUELS

Effective 2 1 October 1971

Last Amended 19 July 2007

AUTHORITY:	These regulations are authorized pursuant to R.I. Gen. Laws
§ 42-17.1-2(s) and 23-23, as amended, and have been promulgated
pursuant to the procedures set forth in the R.I. Administrative
Procedures Act, R.I. Gen. Laws Chapter 42-35.

STATE OF RHODE ISLAND AND PROVIDENCE PLANTATIONS

DEPARTMENT OF ENVIRONMENTAL MANAGEMENT

OFFICE OF AIR RESOURCES

AIR POLLUTION CONTROL REGULATION NO. 8

SULFUR CONTENT OF FUELS

TABLE OF CONTENTS  TOC \o "1-3" \h \z \u

  HYPERLINK \l "_Toc169496714"  8.1	Definitions	  PAGEREF _Toc169496714
\h  1

  HYPERLINK \l "_Toc169496715"  8.2	General Limitations	  PAGEREF
_Toc169496715 \h  2

  HYPERLINK \l "_Toc169496716"  8.3	Exceptions	  PAGEREF _Toc169496716
\h  2

  HYPERLINK \l "_Toc169496717"  8.4	Determination of Compliance
PAGEREF _Toc169496717 \h  8

  HYPERLINK \l "_Toc169496718"  8.5	General Provisions	  PAGEREF
_Toc169496718 \h  9

	  HYPERLINK \l "_Toc169496719"  POLICY FOR INCREMENT CONSUMPTION FROM
APPLICATION UNDER SECTION 8.3.3 OF REGULATION 8 - 14 MARCH 1985
PAGEREF _Toc169496719 \h  12

RHODE ISLAND DEPARTMENT OF ENVIRONMENTAL MANAGEMENT

OFFICE OF AIR RESOURCES

AIR POLLUTION CONTROL REGULATION NO. 8

SULFUR CONTENT OF FUELS

Definitions

Unless otherwise expressly defined in this section, the terms used in
this regulation shall be defined by reference to the Rhode Island Air
Pollution Control General Definitions Regulation.. As used in this
regulation, the following terms shall, where the context permits, be
construed as follows:

"Approved stack gas cleaning process" means a process, approved by the
Director, which removes sulfur dioxide from the products of combustion
of fossil fuel.

"Effective stack height" means the sum of the physical stack height and
the plume rise as calculated according to the current practice of the
Department of Environmental Management as described in the Rhode Island
Guideline for Air Quality Modeling.

"Fuel burning device" means any device engineered to burn fuel for the
primary purpose, as determined by the Director, of producing steam, heat
or power.

"High sulfur fuel" means any fuel except fuel oil containing more than
0.55 pounds of sulfur per million Btu heat release potential or fuel oil
containing more than 1.0 percent sulfur by weight.

"Low sulfur fuel" means any fuel except fuel oil containing 0.55 pounds
or less of sulfur per million Btu heat release potential or fuel oil
containing 1.0 percent sulfur or less by weight.

"Permanent energy conservation measures" means any combination of
permanent measures designed to increase the available heat, power, or
steam output for a given fuel input or to increase the amount of heat or
steam required to produce an equivalent amount of product or heat an
equivalent amount of space.

"Significant impact" means an increase in the annual average or maximum
short-term ambient concentration of a pollutant that would exceed any of
the following:

 PRIVATE

Averaging Time (Hours)

Pollutant	Annual	24	8	3	1

SO2	1.0 ug/m3	5 ug/m3

25 ug/m3

	TSP	1.0 ug/m3	5 ug/m3

	NO2	1.0 ug/m3

CO

	0.5 mg/m3

2 mg/m3

General Limitations

Unless the Director declares in writing after a hearing that a shortage
of low sulfur  fuel exists, no person shall store for sale, offer for
sale, sell or deliver for use in  Rhode Island and no person shall use
or store high sulfur fuel except as provided in Section 8.3.

Exceptions

Limitations with Stack Gas Cleaning Process

The Director may approve the use of high sulfur fuel when combined with
an approved stack gas cleaning process, provided the sulfur compound
emissions (expressed as sulfur dioxide) from the stack do not exceed 1.1
pounds per million Btu actual heat input, and the person using such
process gives evidence satisfactory to the Director that the emissions
do not exceed the requirements of this subsection.

Emission Bubbling

The provisions of Section 8.2 shall not apply to fuels included in an
emissions bubble.  In an emissions bubble, the owner or operator of a
source with more than one fuel burning device, each of which is subject
to specific emission requirements under the applicable regulations, may
propose to meet the total emission control requirements of the
applicable regulations, for a given pollutant, through a different mix
of control technology than that mandated by existing regulations.
Sulfur compound emissions (expressed as sulfur dioxide) from such a
bubble shall not exceed 1.1 pounds per million Btu actual heat  input
and the sulfur content of any fuel used within the bubble shall not
contain  over 1.21 pounds of sulfur per million Btu heat release
potential. Particulate emissions from the bubble shall not exceed 0.10
pounds per million Btu actual heat input and particulate emissions from
any single fuel burning device within the bubble shall not exceed 0.15
pounds per million Btu actual heat input.

It is the responsibility of the owner or operator of the source to
develop a specific emission bubble.  Application for approval of an
emission bubble shall be made to the Department and must include the
following:

Certification that all fuel burning devices to be included in the
emissions bubble are at the same plant location and are under the
control of, or operated by, the same person; and

Identification of each fuel burning device and stack to be included in
the emissions bubble, including the types of fuel to be burned  in each
unit, the maximum sulfur content of each fuel, the heat input capacity
for each unit, the annual fuel use and operating hours per year for each
unit; and for each stack, the physical stack height; the exit velocity
of the stack gas, the inside diameter of the stack exit and the exit
stack gas temperature; and

Sufficient information to evaluate aerodynamic downwash effects in
accordance with all applicable federal requirements; and

Air quality modeling meeting the requirements of the Rhode Island
Guideline for Air Quality Modeling, including aerodynamic downwashing
modeling, to demonstrate that the bubble will not cause a violation of
any National Ambient Air Quality Standard, or applicable PSD increment,
and will not have a significant  impact on any nonattainment area or
Class I PSD area.  If there is no increase in actual emissions, the air
quality modeling requirement may be waived under the following
conditions:

All the fuel burning devices included in the bubble discharge through
the same stack; or

Emissions from the most polluting fuel are released at an effective
stack height within 10 percent of the greatest effective stack height
within the bubble and all stacks included in the bubble are co-located.
Co-located shall be held to mean within 100 meters of each other.

The Department shall not approve any emissions bubble without first
giving public notice and affording all interested persons opportunity to
comment on the emissions bubble.  Additionally, the Department shall
notify the public after each final approval.

An emissions bubble shall not allow a source to supersede any of the
following applicable conditions or standards:

Conditions of any Prevention of Significant Deterioration permit; or

Conditions of any nonattainment area permit; or

Federal New Source Performance Standards; or

National Emissions Standards for Hazardous Air Pollutants.

An approved bubble shall be in effect for a period of no more than three
years from the date of issuance.  At the end of such three-year period,
the Department shall review the bubble for compliance and may either
terminate or extend approval of the bubble based on consideration of air
quality, control technology innovation, and such other determinations as
the Department deems appropriate.

The provisions of any bubble shall be incorporated in a permit issued in
accordance with the provisions of Air Pollution Control Regulation 9.

Any bubble approved by the Department and incorporated into the State
Implementation Plan prior to the effective date of this regulation may
be continued at the discretion of the Department, subject to the
provisions of paragraphs (c), (d) and (e) of this subsection..

Conversion and Conservation Incentive

The Department may authorize the use of high sulfur fuel oil for a
period of up to 30 months in any fuel burning device with an energy
input capacity of less than 250 million Btu's per hour.  The use of the
high sulfur fuel oil will be contingent on the source committing to
implement permanent energy conservation measures to convert to a fuel
(other than a petroleum product such as coal, wood, coal-oil mixture,
etc.).  The savings realized from burning high sulfur fuel oil during
this period shall be used to finance the necessary modifications or
installation of pollution control equipment.

Approval for burning of high sulfur fuel oil under this section may be
granted provided that:

The applicant demonstrates by means of air quality modeling, including
aerodynamic downwash modeling meeting the requirements of the Rhode
Island Guideline for Air Quality Monitoring, that the increase in sulfur
dioxide and particulate emissions resulting from the use of the high
sulfur fuel oil will not cause a violation of any National Ambient Air
Quality Standard or any applicable PSD increment and will not have a
significant impact on any nonattainment area or Class I PSD area; and

The applicant enters into a Consent Agreement with the Department that
specifies a schedule with deadlines by which time various aspects of the
conversion and installation of pollution control equipment or the
implementation of energy conservation measures shall be completed. .In
no event shall final installation of pollution control equipment and
completion of the conversion or complete implementation of energy
conservation measures be accomplished more than 30 months from the
commencement of installation unless the Department finds good cause for
a longer time.  Financial difficulty will not be considered a good
cause; and

The applicant agrees to submit to the Department a quarterly report
stating the quantity of high sulfur fuel oil used, the cost of fuel, the
cost of an equivalent quantity of low sulfur fuel oil and the hours of
operation for the high sulfur fuel burning unit; and

The applicant, where practicable and deemed necessary by the Department,
shall have a three-day supply of low sulfur fuel oil on hand and be
prepared to convert as soon as possible after receiving notice from the
Department.  If the above is not practicable, then, at a minimum, the
company shall have a commitment from its fuel oil supplier to supply the
low sulfur fuel within a specified time; and

If the conversion does not take place or the energy conversion measures
are equivalent to the difference between the cost of the high sulfur
fuel oil used and the equivalent amount of low sulfur fuel oil.  The
applicant shall put up a bond for the amount of money estimated to be
saved during the burning of high sulfur fuel oil.  This money shall be
forfeited if the final conversion or implementation of energy
conservation measures does not take place; and

If the applicant implements permanent energy conservation measures, they
must reduce oil consumption by at least 50,000 gallons/year below
average consumption in the two calendar years immediately preceding the
30-month period. The applicant can continue to burn high sulfur fuel
after the 30-month period if, through the use of permanent energy
conservation measures, annual oil consumption has been reduced by 56
percent from the average annual consumption during the two calendar
years immediately preceding the 30- month period; and

In the case of conversion, the capacity of the unit that will be
converted or installed shall be at least equal to the estimated average
heat input rate of high sulfur fuel oil during the 30-month period.
This requirement may be waived by the Director if, in his judgment, an
increase in the efficiency of the unit due to conversion would decrease
the required capacity of the converted unit; and

Approval to burn high sulfur oil shall be granted for only one 30- month
period per facility.  Such approval may not be renewed or extended
except as provided in paragraph 8.3.3(a)(6).  After the 30- month
period, the source must meet the sulfur dioxide and particulate emission
standards which were in effect prior to the approval, except if an
applicable standard is amended during the 30-month period, in which case
the source may elect to meet the new standard; or except as may be
allowed under paragraph 8.3.3(a)(6). Additionally, the applicant must
agree to conduct stack testing of any converted unit at his expense to
verify compliance with applicable standards for sulfur dioxide and
particulates.  The Department may, where appropriate, approve fuel
testing rather than stack testing for determining compliance with sulfur
dioxide emission limits; and

The sulfur content of the high sulfur fuel oil used in this section
shall not exceed 1.21 pounds of sulfur per million Btu actual heat
input.

An application for approval under this section shall be made to the
Department and must include the following:

The required air quality modeling; and

A proposed schedule for completing conversion or for implementing
conservation measures; and

Information on any proposed modifications intended to be made at the
facility before it burns high sulfur oil; and

For conversions, information on the facility as it will exist after the
conversion; and

For conservation applications, a listing of each conservation measure
and a preliminary estimate of the fuel savings expected; and

Historical fuel usage for the facility and preliminary estimates of the
quantity of high sulfur fuel oil to be consumed and the total hours
burning of high sulfur fuel oil that will take place.

Any fuel burning device included in a plan under this section must have
been installed and in operation prior to the effective date of this
regulation.

Large Fuel Burning Devices Using Coal

Any fuel burning device with a rated energy input capacity of 250
million Btu's per hour or more may use high sulfur fuel provided that:

the high sulfur fuel is coal; and

the average sulfur content does not exceed 1.21 pounds per million Btu's
heat release potential in any 30-day period of 2.31 pounds per million
Btu's in any 24-hour period; and

the stack height, from which emissions resulting from the burning of the
high sulfur fuel exit, meets or exceeds good engineering practice; and

emissions resulting from the use of the high sulfur fuel will not cause
a violation of any National Ambient Air Quality Standard or any
applicable PSD increment and will not have a significant impact on any
nonattainment area.

It is the responsibility of the owner or operator of the facility to
provide evidence, satisfactory to the Department, and meeting the
requirements of the Rhode Island Guideline for Air Quality Modeling,
that the above conditions are met.

If any new or amended federal law requires a reduction in the total
emissions of sulfur oxides or nitrogen oxides in Rhode Island or sets a
maximum limit on such emissions, then the owner or operator of a
facility burning high sulfur fuel under the provisions of paragraph
8.3.4(a) must obtain emission offsets or emission reductions for the
increased sulfur oxide emissions due to coal burning.

The actual amount of emission offsets or emission reductions at any time
shall be the difference between the actual annual sulfur oxide emission
rate and the actual annual sulfur oxide emission rate during the
baseline period established by federal law; except that the amount of
emission offsets or reductions required shall be reduced to the extent
that the new or amended federal law does not count the increased sulfur
oxide emissions due to coal burning as part of the maximum allowable
emissions for sulfur oxides and nitrogen oxides in Rhode Island.

Such emission offsets or emission reductions must meet any conditions
specified in federal law to be creditable against Rhode Island sulfur
oxide and nitrogen oxide emissions and must be obtained within the
period established by the new or amended federal law

The Director may waive any or all of the required emission offsets or
emission reductions at his discretion, provided that the total emissions
of sulfur oxides and nitrogen oxides in Rhode Island shall not exceed
the maximum amount allowed under federal law.

Storage Facilities

Any person seeking to store for sale, sell or deliver, high sulfur fuel
for use in Rhode Island under the provisions of Subsections 8.3.1,
8.3.2, 8.3.3 and 8.3.4 or for use outside of Rhode Island shall obtain
the prior written approval of the Director.

Exemptions

The limitations of this regulation shall not apply to marine vessels or
motor vehicles.

Determination of Compliance

Compliance with the applicable limitations set forth in this regulation
shall be determined by procedures referenced below or deemed equivalent
by the Director.  Such procedures shall include but not be limited to
any of the following:

Emission testing conducted by the owner or operator of the source
according to the Reference Methods of Appendix A to 40 CFR 60; and

Laboratory analysis of fossil fuels by the owner or operator of the
source or by the supplier.  A sampling valve shall be installed in the
fuel line between the feed pump and the burner by the owner or operator
for sample collection.  Fossil fuels must be sampled and analyzed
according to ASTM methods which have the prior approval or are required
by the Director.

Residual Fuel Oil Shipments to Marine Terminals

Each shipment of residual fuel oil received at a marine terminal shall
be sampled and tested for sulfur content using methods approved by the
Director. Such sampling and testing shall be performed by a qualified
referee laboratory. Results of such tests must be reported to the
Director.  In addition, a representative sample of each shipment of oil
shall be submitted to the Rhode Island Health Laboratory or other
laboratory designated by the Director, by the close of business on the
next business day after the oil has been received at the terminal.  The
following information shall be included with each sample:

The name of the vessel delivering the oil and compartment or tank number
where applicable.

The name of the inspector taking the sample and the name of the referee
laboratory.

The name of the terminal where the oil was delivered and the name of the
owner of the oil.

The amount of oil in the shipment.

Results of tests conducted by the Rhode Island Health Laboratory or
other designated laboratory shall be reported to the owner of the oil.

Taking of Fossil Fuel Samples

The Director may require, under his supervision, the collection of
fossil fuel samples for the purpose of determining compliance with this
regulation. Sampling and analysis of fossil fuels under Subsection 8.4.2
shall not limit the collection of samples under this section.

Sulfur Variability in Coal

Coal burning devices with a rated energy input capacity of less than 250
million Btu's per hour shall be considered in compliance with sulfur
dioxide and particulate emission limitations if the average emission
rate in any 24-hour period does not exceed the applicable emission
limitation.

General Provisions

Purpose

The purpose of this regulation is to limit the sulfur content of fuels.

Authority

These regulations are authorized pursuant to R.I. Gen. Laws §
42-17.1-2(s) and 23-23, as amended, and have been promulgated pursuant
to the procedures set forth in the R.I. Administrative Procedures Act,
R.I. Gen. Laws Chapter 42-35

Application

The terms and provisions of this regulation shall be liberally construed
to permit the Department to effectuate the purposes of state law, goals
and policies.

Severability

If any provision of this regulation or the application thereof to any
person or circumstance, is held invalid by a court of competent
jurisdiction, the validity of the remainder of the regulation shall not
be affected thereby.

Effective Date

The foregoing regulation, "Sulfur Content of Fuels”, as amended, after
due notice, is hereby adopted and filed with the Secretary of State this
_29th____ day of _______June____, 2007_ to become effective twenty (20)
days thereafter, in accordance with the provisions of Chapters 23-23,
42-35, 42-17.1, 42-17.6, of the General Laws of Rhode Island of 1956, as
amended.

W. Michael Sullivan, PhD., Director

Department of Environmental Management

Notice Given on:	February 21, 2007

Public Hearing held:	  March 23, 2007

Filing Date:	June 29, 2007

Effective Date: July 19, 2007

POLICY FOR INCREMENT CONSUMPTION FROM APPLICATION UNDER SECTION 8.3.3
OF REGULATION 8 - 14 MARCH 1985

As part of an application under the Conversion and Conservation
Incentive Section of Regulation 8, the applicant must demonstrate
"...that the increase in sulfur dioxide and particulate emissions
resulting from the use of the high sulfur oil will not cause a violation
of ... any applicable PSD increment..."

Air Pollution Control Regulation 9, Section 9.15, contains the rules
governing increment consumption, and these requirements supersede those
of any other regulations.  Section 9.15.1 (c) allows for the exclusion
of certain concentrations from increment consumption.  One such
exclusion is for "...concentrations attributable to the temporary
increase in emissions of sulfur dioxide of particulate matter from
stationary sources which are affected by State Implementation Plan
revisions meeting the following criteria:

The duration of the State Implementation Plan revision shall not exceed
thirty (30) months; and

The duration of the exclusion is not renewable; and

The emissions increase from the source would not cause or contribute to
the violation of a national ambient air quality standard or impact an
area where an applicable increment is known to be violated; and

At the end of the State Implementation Plan revision, the emission
levels from the source shall not exceed those levels occurring before
the State Implementation Plan revision was approved..."

Any approval under the Conversion and Conservation Incentive Section of
Regulation 8 would satisfy all of these criteria.  Therefore, in
general, applications under Section 8.3.3 will no longer be required to
assess increment consumption as part of the application.  If, however,
an applicant will have a significant impact in either Massachusetts or
Connecticut, it will be required to assess increment consumption in that
state.

For those applications where the impacts are in Rhode Island only, the
applicant will be required to assess compliance with the applicable
NAAQS, impacts on nonattainment areas, impacts on Class I PSD areas and
impacts on any area where an increment is known to be violated.

 PAGE

Page   PAGE  11  of 12


[Federal Register Volume 84, Number 88 (Tuesday, May 7, 2019)]
[Notices]
[Pages 19923-19925]
[FR Doc No: 2019-09338]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1774]

Requests for Feedback and Meetings for Medical Device
Submissions: The Q-Submission Program; Guidance for Industry and Food
and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Requests for Feedback
and Meetings for Medical Device Submissions: The Q-Submission
Program.'' This guidance document provides an overview of the
mechanisms available to applicants through which they can request
feedback from or a meeting with FDA regarding potential or planned
medical device investigational device exemption (IDE) applications,
premarket approval applications (PMAs), humanitarian device exemption
(HDE) applications, evaluation of automatic class III designations (De
Novo requests), premarket notification (510(k)) submissions, Clinical
Laboratory Improvement Amendments (CLIA) Waiver by Applications, Dual
510(k) and CLIA Waiver by Application Submissions, Accessory
Classification Requests, and certain investigational new drug (IND)
applications and biologics license applications (BLAs).

DATES: The announcement of the guidance is published in the Federal
Register on May 7, 2019.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-1774 for ``Requests for Feedback and Meetings for Medical
Device Submissions: The Q-Submission Program.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Requests for Feedback and Meetings for Medical Device Submissions:
The Q-Submission Program'' to the Office of Policy, Guidance and Policy
Development, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002; or to the Office of Communication, Outreach and
Development, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Joshua Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The pre-IDE program was established in 1995 to provide applicants a
mechanism to obtain FDA feedback on future IDE applications prior to
their submission. Over time, the pre-IDE program evolved to include
feedback on PMA applications, HDE applications, De Novo requests, and
510(k) submissions, as well as to address whether a clinical study
requires submission of an IDE.
    To capture this evolution, the Secretary of Health and Human
Services' 2012 Commitment Letter to Congress regarding the Medical
Device User Fee Amendments of 2012 (MDUFA III) included FDA's
commitment to institute a structured process for managing these
interactions, referring to them as ``Pre-Submissions.'' The Pre-
Submission Guidance, published February 18, 2014, implemented the
broader Q-Submission (Q-Sub) Program, which includes Pre-Submissions
(Pre-Subs), as well as additional opportunities to engage with FDA.
    As part of the Medical Device User Fee Amendments of 2017 (MDUFA
IV), industry and the Agency agreed to refine the Q-Sub Program with
changes related to the scheduling of Pre-Sub meetings and a new
performance goal on the timing of FDA feedback on Pre-Subs. This
guidance reflects those changes and clarifies other elements of the Q-
Sub program.
    This guidance document provides an overview of the mechanisms
available to submitters through which they can request feedback from or
a meeting with FDA regarding potential or planned medical device IDE
applications, PMAs, HDE applications, De Novo requests, 510(k)
Submissions, CLIA Waiver by Application, Dual 510(k) and CLIA Waiver by
Application Submissions, Accessory Classification Requests, and certain
INDs and BLAs submitted to the Center for Biologics Evaluation and
Research. FDA considered comments received on the draft guidance, which
was announced in the Federal Register of June 7, 2018 (83 FR 26482).
FDA revised the guidance as appropriate in response to the comments.
This guidance supersedes the document entitled ``Requests for Feedback
on Medical Device Submissions: The Pre-Submission Program and Meetings
with Food and Drug Administration Staff,'' issued on September 29,
2017.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance

practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Requests for Feedback and Meetings for
Medical Device Submissions: The Q-Submission Program.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov or
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to
download an electronic copy of ``Requests for Feedback and Meetings for
Medical Device Submissions: The Q-Submission Program'' may send an
email request to<EMAIL_ADDRESS>to receive an electronic
copy of the document. Please use the document number 1677 to identify
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information. 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
the following FDA regulations and guidance have been approved by OMB as
listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
     21 CFR Part or guidance               Topic                No.
------------------------------------------------------------------------
``Requests for Feedback on        Q-submissions.........       0910-0756
 Medical Device Submissions: The
 Pre-Submission Program and
 Meetings with Food and Drug
 Administration Staff''.
``De Novo Classification Process  De Novo Requests......       0910-0844
 (Evaluation of Automatic Class
 III Designation)''.
``Recommendations: Clinical       CLIA Waivers..........       0910-0598
 Laboratory Improvement
 Amendments of 1988 (CLIA)
 Waiver Applications for
 Manufacturers of In Vitro
 Diagnostic Devices''.
``Medical Device Accessories--    Accessories...........       0910-0823
 Describing Accessories and
 Classification Pathways''.
312.............................  Investigational New          0910-0014
                                   Drug Application.
601.............................  Biologics License            0910-0338
                                   Application.
807, subpart E..................  Premarket Notification       0910-0120
812.............................  Investigational Device       0910-0078
                                   Exemption.
814, subparts A through E.......  Premarket Approval....       0910-0231
814, subpart H..................  Humanitarian Use             0910-0332
                                   Device; Humanitarian
                                   Device Exemption.
------------------------------------------------------------------------

    Dated: May 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09338 Filed 5-6-19; 8:45 am]
 BILLING CODE 4164-01-P