[Federal Register Volume 76, Number 73 (Friday, April 15, 2011)]
[Notices]
[Pages 21378-21379]
[FR Doc No: 2011-9154]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0264]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Request for Designation as Country Not Subject to the
Restrictions Applicable to Human Food and Cosmetics Manufactured From,
Processed With, or Otherwise Containing, Material From Cattle

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of existing FDA regulations regarding countries seeking to
be designated as not subject to certain bovine spongiform
encephalopathy (BSE)-related restrictions applicable to FDA-regulated
human food and cosmetics.

DATES: Submit either electronic or written comments on the collection
of information by June 14, 2011.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>.

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

Request for Designation as Country Not Subject to the Restrictions
Applicable to Human Food and Cosmetics Manufactured From, Processed
With, or Otherwise Containing, Material From Cattle--21 CFR 189.5 and
700.27 (OMB Control Number 0910-0623--Extension)
    Section 801(a) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 381(a)) provides requirements with regard to
imported food and cosmetics and provides for refusal of admission into
the United States of human food and cosmetics that appear to be
adulterated. Section 701(b) of the FD&C Act (21 U.S.C. 371(b))
authorizes the Secretaries of Treasury and Health and Human Services to
jointly prescribe regulations for the efficient enforcement of section
801 of the FD&C Act. To address the potential risk of BSE in human food
and cosmetics, FDA regulations in Sec. Sec.  189.5 and 700.27 (21 CFR
189.5 and 700.27) designate certain materials from cattle as
``prohibited cattle materials,'' including specified risk materials,
the small intestine of cattle not otherwise excluded from being a
prohibited cattle material, material from nonambulatory disabled
cattle, and mechanically separated (MS) (Beef). Under the regulations
no human food or cosmetic may be manufactured from, processed with, or
otherwise contain prohibited cattle materials. However, the Agency may
designate a country from which cattle materials inspected and passed
for human consumption are not considered prohibited cattle materials
and their use does not render a human food or cosmetic adulterated.
    Sections 189.5(e) and 700.27(e) provide that a country seeking to
be so designated must send a written request to the Director, Center
for Food Safety and Applied Nutrition (CFSAN). The information the
country is required to submit includes information about a country's
BSE case history, risk factors, measures to prevent the introduction
and transmission of BSE, and other information relevant to determining
whether specified risk materials, the small intestine of cattle not
otherwise excluded from being a prohibited cattle material, material
from nonambulatory disabled cattle, or MS (Beef) from the country
seeking designation should be considered prohibited cattle materials.
FDA uses the information to determine whether to grant a request for
designation, and whether to impose conditions if a request is granted.
    Sections 189.5 and 700.27 further state that countries that have
been designated under Sec. Sec.  189.5(e) and 700.27(e) will be subject
to future review by FDA to determine whether designation remains
appropriate. As part of this process, FDA may ask designated countries
to confirm that their BSE situation and the information submitted by
them in support of their original application remain unchanged. FDA may
revoke a country's designation if FDA determines that it is no longer
appropriate. Therefore, designated countries may respond to periodic
requests by FDA by submitting information to confirm that their
designation remains appropriate. FDA uses the information to ensure
that their designation remains appropriate.
    FDA estimates the burden of this collection of information as
follows:

                                                      Table 1--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                        21 CFR Section                              Number of       responses per     Total annual     Average burden      Total hours
                                                                   respondents       respondent         responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.  Sec.   189.5 and 700.27-- request for designation.......                 1                 1                 1                80                80
Sec.  Sec.   189.5(e) and 700.27(e)--response to request for                   1                 1                 1                26                26
 review by FDA................................................
                                                               -----------------------------------------------------------------------------------------
    Total.....................................................  ................  ................  ................  ................               106
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    This estimate is based on FDA's experience and the average number
of requests for designation under Sec. Sec.  189.5 and 700.27 received
in the past 3 years. FDA received one request for designation in 2009
and one in 2010. Based on this experience, FDA estimates the annual
number of new requests for designation will be 1. FDA estimates that
preparing the information required by Sec. Sec.  189.5 and 700.27 and
submitting it to the Agency in the form of a written request to the
Director, CFSAN will require a burden of approximately 80 hours per
request. Thus, the annual burden for new requests for designation is
estimated to be 80 hours, as shown in table 1, row 1 of this document.
    Under Sec. Sec.  189.5(e) and 700.27(e), designated countries are
subject to future review by FDA and may respond to periodic requests by
FDA by submitting information to confirm that their designation remains
appropriate. In the last 3 years, FDA has not requested any reviews.
Thus, the Agency estimates that one or fewer will occur annually in the
future. We estimate that the designated country undergoing a review in
the future will need one third the time it took preparing its request
for designation to respond to FDA's request for review, or 26 hours (80
hours x 0.33 = 26.4 hours, rounded to 26). The annual burden for
reviews is estimated to be 26 hours, as shown in table 1, row 2 of this
document. The total annual burden for this information collection is
estimated to be 106 hours.

    Dated: April 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-9154 Filed 4-14-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 78, Number 25 (Wednesday, February 6, 2013)]
[Notices]
[Pages 8684-8685]
[FR Doc No: 2013-02596]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Twelfth Meeting: RTCA Special Committee 222, Inmarsat AMS(R)S

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

ACTION: Meeting Notice of RTCA Special Committee 222, Inmarsat AMS(R)S.

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SUMMARY: The FAA is issuing this notice to advise the public of the
twelfth meeting of the RTCA Special Committee 222, Inmarsat AMS(R)S.

DATES: The meeting will be held February 20, 2013, from 1:00 p.m.--4:00
p.m.

ADDRESSES:  The meeting will be held at the RTCA Headquarters, 1150
18th Street NW., Suite 910, Washington DC 20036.

FOR FURTHER INFORMATION CONTACT: The RTCA Secretariat, 1150 18th Street
NW., Suite 910, Washington, DC, 20036, or by telephone at (202) 330-
0662/(202) 833-9339, fax<PHONE_NUMBER>, or Web site at http://www.rtca.org. In addition, Jennifer Iversen may be contacted directly
at email<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of Special Committee 222. The agenda will
include the following:

February 01, 2013

     Greetings & Attendance.
     Review summary of 11th Plenary (November 2012) meeting.
     Finalize comment resolution for new DO-xxx, Minimum
Aviation System Performance Standard for AMS(R)S Data and Voice
Communications Supporting Required Communications Performance (RCP) and
required surveillance performance (RSP) in Procedural Airspace.
     Status, update and review of SSB-specific material for DO
262A.
     Other items as appropriate.
     Review action items from 11th Plenary.
     Schedule 13th Plenary.
     Adjourn.
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC on December 14, 2012.
Paige Williams,
Management Analyst, Business Operations Group, NextGen, Management
Services, Federal Aviation Administration.
[FR Doc. 2013-02596 Filed 2-5-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 205 (Wednesday, October 23, 2019)]
[Proposed Rules]
[Pages 56731-56733]
[FR Doc No: 2019-23030]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2019-0846]
RIN 1625-AA00

Safety Zone for Fireworks Display; Spa Creek, Annapolis, MD

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard is proposing to establish a temporary safety
zone for certain waters of Spa Creek. This action is necessary to
provide for the safety of life on these navigable waters of Spa Creek
in Annapolis, MD, on December 31, 2019, during a fireworks display.
This proposed rulemaking would prohibit persons and vessels from
entering the safety zone unless authorized by the Captain of the Port
Maryland-National Capital Region or a designated representative. We
invite your comments on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before November 22, 2019.

ADDRESSES: You may submit comments identified by docket number USCG-
2019-0846 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Mr. Ron Houck, Sector Maryland-
National Capital Region Waterways Management Division, U.S. Coast
Guard; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations

COTP Captain of the Port Maryland-National Capital Region
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    Pyrotecnico, Inc., of New Castle, PA notified the Coast Guard that
it will be conducting a public fireworks display from 11:59 p.m. on
December 31, 2019, to 12:11 a.m. on January 1, 2020, sponsored by the
City of Annapolis, MD. The fireworks are to be launched from a barge
located in Spa Creek, approximately 600 feet southeast of Dock Street
in Annapolis, MD. Hazards from the fireworks display includes
accidental discharge of fireworks, dangerous projectiles, and falling
hot embers or other debris. The COTP has determined that potential
hazards associated with the fireworks to be used in this display would
be a safety concern for anyone within 400 feet of the fireworks barge.
    The purpose of this rulemaking is to ensure the safety of vessels
on the navigable waters within 400 feet of the fireworks barge on Spa
Creek before, during, and after the scheduled event. The Coast Guard
proposes this rulemaking under authority in 46 U.S.C. 70034 (previously
33 U.S.C. 1231).

III. Discussion of Proposed Rule

    The COTP is proposing to establish a safety zone in Spa Creek from
11:00 p.m. on December 31, 2019, through 1:00 a.m. on January 1, 2020.
The safety zone would cover all navigable waters within 400 feet of the
fireworks barge in Spa Creek in approximate position latitude
38[deg]58'32.48'' N, longitude 076[deg]28'57.55'' W, located at
Annapolis, MD. A ``FIREWORKS--DANGER--STAY AWAY'' sign would be posted
on the port and starboard sides of the barge on-scene near the
location. The duration and enforcement of the safety zone is intended
to ensure the safety of vessels on these navigable waters before,
during, and after the scheduled 11:59 p.m. fireworks display.
    No vessel or person would be permitted to enter the safety zone
without obtaining permission from the COTP or a designated
representative. The regulatory text we are proposing appears at the end
of this document.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive orders and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This NPRM has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, the NPRM has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
duration, time-of-day and time-of-year of the safety zone. Although
this safety zone would restrict the entire width of the waterway, it
would impact a small designated area of Spa Creek for a total of two
hours during the evening when vessel traffic is normally low. The Coast
Guard will issue a Broadcast Notice to Mariners via VHF-FM marine
channel 16 about the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
IV.A above, this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section. The Coast Guard will not retaliate against small entities that
question or complain about this proposed rule or any policy or action
of the Coast Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175 (Consultation and Coordination with Indian Tribal
Governments) because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Environmental Planning
COMDTINST 5090.1 (series), which guide the Coast Guard in complying
with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-
4370f), and have made a preliminary determination that this action is
one of a category of actions that do not individually or cumulatively
have a significant effect on the human environment. This proposed rule
involves a safety zone lasting a total of two hours that would prohibit
entry within a small designated area of Spa Creek in Annapolis, MD.
Normally such actions are categorically excluded from further review
under paragraph L60(a) in Table 3-1 of U.S. Coast Guard Environmental
Planning Implementing Procedures 5090.1. A preliminary Record of
Environmental Consideration supporting this determination is available
in the docket where indicated under ADDRESSES. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places, or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and
submissions in response to this document, see DHS's Correspondence
System of Records notice (84 FR 48645, September 26, 2018).
    Documents mentioned in this NPRM as being available in the docket,
and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that website's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard is
proposing to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
0
2. Add Sec.  165.T05-0846 to read as follows:

Sec.  165.T05-0846   Safety Zone for Fireworks Display; Spa Creek,
Annapolis, MD.

    (a) Location. The following area is a safety zone. All navigable
waters of Spa Creek within 400 feet of the fireworks barge in
approximate position latitude 38[deg]58'32.48'' N, longitude
076[deg]28'57.55'' W, located at Annapolis, MD. All coordinates refer
to datum NAD 1983.
    (b) Definitions. As used in this section:
    (1) Captain of the Port (COTP) means the Commander, U.S. Coast
Guard Sector Maryland-National Capital Region.
    (2) Designated representative means any Coast Guard commissioned,
warrant, or petty officer who has been authorized by the Captain of the
Port Maryland-National Capital Region to assist in enforcing any safety
zone described in paragraph (a) of this section.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative. All vessels underway within this
safety zone at the time it is activated are to depart the zone.
    (2) To seek permission to enter, contact the COTP or the COTP's
designated representative by telephone at<PHONE_NUMBER> or on Marine
Band Radio VHF-FM channel 16 (156.8 MHz). The Coast Guard vessels
enforcing this section can be contacted on Marine Band Radio VHF-FM
channel 16 (156.8 MHz).
    (3) Those in the safety zone must comply with all lawful orders or
directions given to them by the COTP or the COTP's designated
representative.
    (d) Enforcement officials. The U.S. Coast Guard may be assisted in
the patrol and enforcement of the safety zone by Federal, State, and
local agencies.
    (e) Enforcement. This safety zone will be enforced during the
periods described in paragraph (f) of this section. A ``FIREWORKS--
DANGER--STAY AWAY'' sign will be posted on the port and starboard sides
of the barge on-scene near the location described in paragraph (a) of
this section.
    (f) Enforcement period. This section will be enforced from 11:00
p.m. on December 31, 2019 to 1:00 a.m. on January 1, 2020.

    Dated: October 17, 2019.
Joseph B. Loring,
Captain, U.S. Coast Guard, Captain of the Port Maryland-National
Capital Region.
[FR Doc. 2019-23030 Filed 10-22-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 78, Number 216 (Thursday, November 7, 2013)]
[Notices]
[Pages 66962-66964]
[FR Doc No: 2013-26646]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2013-0006]

Advisory Committee on Construction Safety and Health (ACCSH)

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Announcement of a meeting of ACCSH and request for nominations
for membership on ACCSH.

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SUMMARY: ACCSH will meet December 5-6, 2013, in Washington, DC. OSHA
also announces the Assistant Secretary of Labor request for nominations
for membership on ACCSH.

DATES:
    ACCSH meeting: ACCSH will meet from 1 to 4 p.m., e.t., Thursday,
December 5, 2013, and Friday, December 6, 2013. Submit (postmark, send,
transmit) comments, requests to address the ACCSH meeting, speaker
presentations (written or electronic), requests for special
accommodations for the ACCSH meeting, by November 15, 2013.
    Nominations for ACCSH membership: Submit nominations for ACCSH
membership January 6, 2014.

ADDRESSES:
    Submission of comments, requests to speak, and speaker
presentations for the ACCSH meeting, and nominations for ACCSH
membership: Submit comments, requests to speak, and speaker
presentations for the ACCSH meeting, and nominations and supporting
material for ACCSH membership, using one of the following methods:
    Electronically: Submit materials, including attachments,
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the on-line instructions for submissions.
    Facsimile (Fax): If the submission, including attachments, does not
exceed 10 pages, you may fax it to the OSHA Docket Office at (202) 693-
1648.
    Regular mail, express mail, hand delivery, or messenger (courier)
service: Submit materials to the OSHA Docket Office, Docket No. OSHA-
2013-0006, Room N-2625, U.S. Department of Labor, 200 Constitution
Avenue NW., Washington, DC 20210; telephone<PHONE_NUMBER> (TTY (877)
889-5627). OSHA's Docket Office accepts deliveries (hand deliveries,
express mail, and messenger service) during normal business hours, 8:15
a.m.-4:45 p.m., e.t., weekdays.
    Instructions: Submissions must include the agency name and docket
number for this Federal Register notice (Docket No. OSHA-2013-0006).
Due to security-related procedures, submissions by regular mail may
experience significant delays. Please contact the OSHA Docket Office
for information about security procedures for making submissions. For
additional information on submitting comments, requests to speak, and
speaker presentations, see the SUPPLEMENTARY INFORMATION section of
this notice.
    OSHA will post comments, requests to speak, and speaker
presentations, including any personal information provided, without
change, at http://www.regulations.gov. Therefore, OSHA cautions you
about submitting personal information such as Social Security numbers
and birthdates.
    Location of the ACCSH meeting: ACCSH will meet in Room C-5515, 1A-
B, U.S. Department of Labor, 200 Constitution Avenue NW., Washington,
DC 20210.
    Requests for special accommodations at the ACCSH meeting: Please
submit requests for special accommodations to attend the ACCSH meeting
to Ms. Frances Owens, OSHA, Office of Communications, Room N-3647, U.S.
Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210;
telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT:
    For press inquiries: Mr. Frank Meilinger, Director, OSHA Office of
Communications, Room N-3647, U.S. Department of Labor, 200 Constitution
Avenue NW., Washington, DC 20210; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    For general information about ACCSH, the ACCSH meeting, and ACCSH
membership: Mr. Damon Bonneau, OSHA, Directorate of Construction, Room
N-3468, U.S. Department of Labor, 200 Constitution Avenue NW.,
Washington, DC 20210; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    Copies of this Federal Register notice: Electronic copies of this
Federal Register notice are available at http://www.regulations.gov.
This notice, as well as news releases and other relevant information,
also are available on the OSHA Web page at http://www.osha.gov.

SUPPLEMENTARY INFORMATION:

I. ACCSH Meeting

    Background: ACCSH will meet December 5-6, 2013, in Washington, DC.
Some ACCSH members will attend the meeting by teleconference. The
meeting is open to the public. OSHA transcribes ACCSH meetings and
prepares detailed minutes of meetings. OSHA places the transcript and
minutes in the public docket for the meeting. The docket also includes
speaker presentations, comments, and other materials submitted to
ACCSH.
    ACCSH advises the Secretary of Labor and the Assistant Secretary of
Labor for Occupational Safety and Health (Assistant Secretary) in the
formulation of standards affecting the construction industry, and on
policy matters arising in the administration of the safety and health
provisions under the Contract Work Hours and Safety Standards Act
(Construction Safety Act (CSA)) (40 U.S.C. 3701 et seq.) and the
Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 651 et
seq.) (see also 29 CFR 1911.10 and 1912.3). In addition, the OSH Act
and CSA require that OSHA consult with ACCSH before the Agency proposes
any occupational safety and health standard affecting construction
activities (29 CFR 1911.10; 40 U.S.C. 3704).

    Meeting agenda: The tentative agenda for this meeting includes:
     Assistant Secretary's Agency update and remarks;
     Directorate of Construction update on rulemaking projects;
     Directorate of Standards and Guidance update on the
Globally Harmonized System of Classification and Labeling of Chemicals
(GHS) program;
     Discussion of the OSHA 10-hour and 30-hour training
courses;
     Presentation on the draft proposed standard on
Occupational Exposure to Beryllium; and
     Public comment period.
    Attending the meeting: Individuals attending the meeting at the
U.S. Department of Labor must enter the building at the visitors'
entrance, 3rd and C Streets, NW., and pass through building security.
Attendees must have valid government-issued photo identification (such
as a driver's license) to enter the building. For additional
information about building security measures for attending ACCSH
meetings, please contact Ms. Owens (see ADDRESSES section).
    Requests to speak and speaker presentations: Attendees who want to
address ACCSH at the meeting must submit a request to speak, as well as
any written or electronic presentation, by November 15, 2013, using one
of the methods listed in the ADDRESSES section. The request must state:
     The amount of time requested to speak;
     The interest you represent (e.g., business, organization,
affiliation), if any; and
     A brief outline of your presentation.
    PowerPoint presentations and other electronic materials must be
compatible with PowerPoint 2010 and other Microsoft Office 2010
formats.
    The ACCSH Chair may grant requests to address ACCSH as time and
circumstances permit.
    Public docket of the meeting: OSHA will place comments, requests to
speak, and speaker presentations, including any personal information
you provide, in the public docket of this ACCSH meeting without change,
and those documents may be available online at http://www.regulations.gov. OSHA also places in the public docket the meeting
transcript, meeting minutes, documents presented at the ACCSH meeting,
and other documents pertaining to the ACCSH meeting. These documents
are available online at http://www.regulations.gov.
    Access to the public record of ACCSH meetings: To read or download
documents in the public docket of this ACCSH meeting, go to Docket No.
OSHA-2013-0006 at http://www.regulations.gov. The http://www.regulations.gov index also lists all documents in the public record
for this meeting; however, some documents (e.g., copyrighted materials)
are not publicly available through that Web page. All documents in the
public record, including materials not available through http://www.regulations.gov, are available for inspection and copying in the
OSHA Docket Office (see ADDRESSES section). Contact the OSHA Docket
Office for assistance in making submissions to, or obtaining materials
from, the public docket.

II. Request for Nominations for Membership on ACCSH

    The Assistant Secretary of Labor for Occupational Safety and Health
(OSHA Assistant Secretary) invites interested persons to submit
nominations for membership on ACCSH.
    Background: ACCSH is a continuing advisory committee established
under Section 107(e) of the CSA to advise the Secretary of Labor
(Secretary) in the formulation of construction safety and health
standards, as well as on policy matters arising under the CSA and the
OSH Act. In particular, 29 CFR 1911.10(a) and 1912.3(a) provide that
the Assistant Secretary shall consult with ACCSH whenever the Agency
proposes any safety or health standard that affects the construction
industry.
    ACCSH operates in accordance with the CSA, the OSH Act, the Federal
Advisory Committee Act (FACA) (5 U.S.C. App. 2), and regulations issued
pursuant to those statutes (29 CFR part 1912, 41 CFR part 102-3). ACCSH
generally meets two to four times a year.
    ACCSH membership: ACCSH consists of 15 members whom the Secretary
appoints. ACCSH members generally serve staggered two-year terms,
unless they resign, cease to be qualified, become unable to serve, or
the Secretary removes them (29 CFR 1912.3(e)). The Secretary may
appoint ACCSH members to successive terms. No member of ACCSH, other
than members who represent employers or employees, shall have an
economic interest in any proposed rule that affects the construction
industry (29 CFR 1912.6).
    The categories of ACCSH membership, and the number of new members
to be appointed to replace members whose terms have expired, are:
     Five members who are qualified by experience and
affiliation to present the viewpoint of employers in the construction
industry--two employer representatives will be appointed;
     Five members who are similarly qualified to present the
viewpoint of employees in the construction industry--two employee
representatives will be appointed;
     Two representatives of State safety and health agencies--
one representative from a State safety and health agency will be
appointed;
     Two public members, qualified by knowledge and experience
to make a useful contribution to the work of ACCSH, such as those who
have professional or technical experience and competence with
occupational safety and health in the construction industry--one public
representative will be appointed; and
     One representative designated by the Secretary of the
Department of Health and Human Services and appointed by the
Secretary--no new appointment will be made.
    The Department of Labor is committed to equal opportunity in the
workplace and seeks broad-based and diverse ACCSH membership. Any
interested person or organization may nominate one or more individuals
for membership on ACCSH. Interested persons also are invited and
encouraged to submit statements in support of nominees.
    Submission requirements: Nominations must include the following
information:
     Nominee's contact information and current employment or
position;
     Nominee's r[eacute]sum[eacute] or curriculum vitae,
including prior membership on ACCSH and other relevant organizations
and associations;
     Category of membership (employer, employee, public, State
safety and health agency) that the nominee is qualified to represent;
     A summary of the background, experience, and
qualifications that addresses the nominee's suitability for each of the
nominated membership categories;
     Articles or other documents the nominee has authored that
indicate the nominee's knowledge, experience, and expertise in
occupational safety and health, particularly as it pertains to the
construction industry; and
     A statement that the nominee is aware of the nomination,
is willing to regularly attend and participate in ACCSH meetings, and
has no conflicts of interest that would preclude membership on ACCSH.
    Member selection: The Secretary will select ACCSH members on the
basis of their experience, knowledge, and competence in the field of
occupational safety and health, particularly as it pertains to the
construction industry.

Information received through this nomination process, in addition to
other relevant sources of information, will assist the Secretary in
appointing members to ACCSH. In selecting ACCSH members, the Secretary
will consider individuals nominated in response to this Federal
Register notice, as well as other qualified individuals.
    Instructions for submitting nominations: All nominations,
supporting documents, attachments, and other materials must identify
the Agency name and the docket number for this Federal Register notice
(Docket No. OSHA-2013-0006). Submit materials electronically, by FAX,
or by hard copy. You may supplement electronic submissions by attaching
electronic files. If you supplement electronic submissions with hard-
copy documents, submit the hard copy documents to the OSHA Docket
Office and clearly identify the electronic submission by Agency name
and docket number (Docket No. OSHA-2013-0006) so the Docket Office can
attach the hard-copy documents to the appropriate electronic
submission.
    The OSHA Docket Office will post all submissions, including
personal information provided, in the docket without change. Therefore,
OSHA cautions interested parties about submitting personal information
such as Social Security numbers and birthdates. Guidance on submitting
nominations and supporting materials is available on-line at http://www.regulations.gov and from the OSHA Docket Office.
    Access to docket: The http://www.regulations.gov index lists all
submissions provided in response to this Federal Register notice;
however, some information (e.g., copyrighted material) is not publicly
available to read or download from that Web page. All submissions,
including materials not available on-line, are available for inspection
and copying at the OSHA Docket Office. For information about accessing
materials in Docket No. OSHA-2013-0006, including materials not
available on-line, contact the OSHA Docket Office.

Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, authorized the preparation of this
notice under the authority granted by 29 U.S.C. 656; 40 U.S.C. 3704; 5
U.S.C. App. 2; 29 CFR parts 1911 and 1912; 41 CFR part 102; and
Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012).

    Signed at Washington, DC, on November 1, 2013.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2013-26646 Filed 11-6-13; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 81, Number 51 (Wednesday, March 16, 2016)]
[Notices]
[Pages 14150-14151]
[FR Doc No: 2016-05878]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

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

Extension:
    Form S-6, SEC File No. 270-181, OMB Control No. 3235-0184.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') has submitted to the Office of
Management and Budget (``OMB'') a request for extension of the
previously approved collection of information discussed below.
    The title for the collection of information is ``Form S-6 (17 CFR
239.16), for Registration under the Securities Act of 1933 of
Securities of Unit Investment Trusts Registered on Form N-8B-2 (17 CFR
274.13).'' Form S-6 is a form used for registration under the
Securities Act of 1933 (15 U.S.C. 77a et seq.) (``Securities Act'') of
securities of any unit investment trust (``UIT'') registered under the
Investment Company Act of 1940 (15 U.S.C. 80a-1 et seq.) (``Investment
Company Act'') on Form N-8B-2. Section 5 of the Securities Act (15
U.S.C. 77e) requires the filing of a registration statement prior to
the offer of securities to the public and that the statement be

effective before any securities are sold. Section 5(b) of the
Securities Act requires that investors be provided with a prospectus
containing the information required in a registration statement prior
to the sale or at the time of confirmation or delivery of the
securities.
    Section 10(a)(3) of the Securities Act (15 U.S.C. 77j(a)(3))
provides that when a prospectus is used more than nine months after the
effective date of the registration statement, the information therein
shall be as of a date not more than sixteen months prior to such use.
As a result, most UITs update their registration statements under the
Securities Act on an annual basis in order that their sponsors may
continue to maintain a secondary market in the units. UITs that are
registered under the Investment Company Act on Form N-8B-2 file post-
effective amendments to their registration statements on Form S-6 in
order to update their prospectuses.
    The purpose of Form S-6 is to meet the filing and disclosure
requirements of the Securities Act and to enable filers to provide
investors with information necessary to evaluate an investment in the
security. This information collection differs significantly from many
other federal information collections, which are primarily for the use
and benefit of the collecting agency. The information required to be
filed with the Commission permits verification of compliance with
securities law requirements and assures the public availability and
dissemination of the information.
    The Commission estimates that there are approximately 1,340 initial
registration statements filed on Form S-6 annually and approximately
1,158 annual post-effective amendments to previously effective
registration statements filed on Form S-6. The Commission estimates
that the hour burden for preparing and filing an initial registration
statement on Form S-6 is 45 hours and for preparing and filing a post-
effective amendment to a previously effective registration statement
filed on Form S-6 is 40 hours. Therefore, we estimate that the total
hour burden of preparing and filing registration statements on Form S-6
for all affected UITs is 106,620 hours. We estimate that the cost
burden of preparing and filing an initial registration statement on
Form S-6 is $33,104 and for preparing and filing a post-effective
amendment is $19,862. Therefore, we estimate that the total cost burden
of preparing and filing registration statements on Form S-6 for all
affected UITs is $67,359,556.
    Estimates of average burden hours and costs are made solely for the
purposes of the Paperwork Reduction Act, and are not derived from a
comprehensive or even representative survey or study of the costs of
Commission rules and forms. Compliance with the collection of
information requirements of Form S-6 is mandatory. Responses to the
collection of information will not be kept confidential. An agency may
not conduct or sponsor, and a person is not required to respond to a
collection of information unless it displays a currently valid OMB
control number.
    The public may view the background documentation for this
information collection at the following Web site: www.reginfo.gov.
Comments should be directed to: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503, or by sending an email to:
<EMAIL_ADDRESS>and (ii) Pamela Dyson, Chief Information
Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon, 100
F Street NE., Washington, DC 20549 or by sending an email to:
<EMAIL_ADDRESS>Comments must be submitted to OMB within 30 days
of this notice.

    Dated: March 11, 2016.
Lynn M. Powalski,
Deputy Secretary.
[FR Doc. 2016-05878 Filed 3-15-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 22 (Thursday, February 1, 2018)]
[Proposed Rules]
[Pages 4621-4622]
[FR Doc No: 2018-02059]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[EPA-R03-OAR-2017-0570; FRL-9973-29-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
State of Maryland; Control of Emissions From Existing Commercial and
Industrial Solid Waste Incinerator Units

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
notify the public that it has received a negative declaration for
commercial and industrial solid waste incineration (CISWI) units within
the State of Maryland. This negative declaration certifies that CISWI
units subject to the requirements of sections 111(d) and 129 of the
Clean Air Act (CAA) do not exist within the jurisdictional boundaries
of the State of Maryland. EPA is accepting the negative declaration in
accordance with the requirements of the CAA.

DATES: Written comments must be received on or before March 5, 2018.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R03-
OAR-2017-0570 at http://www.regulations.gov, or via email to
[email protected]. For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, the EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be confidential business information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the For Further Information Contact section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Mike Gordon,<PHONE_NUMBER>, or by
email at [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Sections 111(d) and 129 of the CAA require submittal of state plans
to control certain pollutants (designated pollutants) at existing solid
waste combustor facilities (designated facilities) whenever standards
of performance have been established by EPA under section 111(b) for
new sources of the same source category and the EPA has established
emission guidelines for such existing sources. When designated
facilities are located in a state, the state must then develop and
submit a plan for the control of the designated pollutant. Subpart B of
40 CFR part 60 establishes procedures to be followed and requirements
to be met in the development and submission of state plans for
controlling designated pollutants from designated facilities under
sections 111(d) and 129 of the CAA. Also, Subpart A of 40 CFR part 62
provides the procedural framework for the submission of these plans.
    If a state fails to submit a satisfactory plan, the CAA provides
the EPA the authority to prescribe a plan for regulating the designated
pollutants at the designated facilities. The EPA prescribed plan, also
known as a federal plan, is often delegated to states with designated
facilities but no EPA approved state-specific plan. If no such
designated facilities exist within a state's jurisdiction, a state may
submit to the EPA a letter of certification to that effect (referred to
as a negative declaration) in lieu of a state plan to satisfy the
state's obligation. 40 CFR 60.23(b) and 62.06. A negative declaration
exempts the state from the requirement to submit a CAA section 111(d)/
section 129 plan for that designated pollutant and source category. 40
CFR 60.23(b).

II. Commercial and Industrial Solid Waste Incinerators

    On December 1, 2000 (60 FR 75338), the EPA promulgated new source
performance standards for new CISWI units, 40 CFR part 60, subpart
CCCC, and emission guidelines for existing CISWI units, 40 CFR part 60,
subpart DDDD. After a series of legal challenges, amendments, and
reconsiderations, the EPA promulgated the Reconsideration and Final
Amendments for CISWI units on February 7, 2013 (78 FR 9112) (providing
final standards for new and existing sources). A CISWI unit is any
distinct operating unit of any commercial or industrial facility that
combusts, or has combusted in the preceding six months, any solid
waste, as that term is defined in 40 CFR part 241, Solid Wastes Used as
Fuels or Ingredients in Combustion Units. 40 CFR 60.2875. A state plan
must address all existing CISWI units that commenced construction on or
before June 4, 2010, or for which modification or reconstruction was
commenced on or before August 7, 2013, with limited exceptions as
provided in paragraph 40 CFR 60.2555. 40 CFR 60.2550.
    As discussed above, however, if there are no designated facilities
in the state, the state may submit a negative declaration in lieu of a
state plan. The EPA will provide public notice of receipt of a state's
negative declaration with respect to CISWI. 40 CFR 60.2530. If any
subsequently identified existing CISWI unit is found in a state that
had submitted a negative declaration, the Federal plan implementing the
emission guidelines for subpart DDDD would automatically apply to that
CISWI unit until a state plan is approved. 40 CFR 60.2530.

III. State Submittals and EPA Analysis

    The State of Maryland, through the MDE, has determined that there
are no CISWI units subject to CAA 111(d)/129 requirements in its
respective air pollution control jurisdiction. Accordingly, the MDE
submitted a negative declaration letter to EPA certifying this fact on
January 20, 2017. The negative declaration letter is available in the
docket for this rulemaking and available online at www.regulations.gov.

IV. Proposed Action

    EPA's review of this material indicates that MDE has fulfilled its
obligation under CAA Sections 129 and 111(d) for submittal of a
negative declaration. EPA is proposing to approve the Maryland negative
declaration for CISWI units, which was submitted on January 20, 2017.
EPA is soliciting public comments on the issues discussed in this
document. These comments will be considered before taking final action.

IV. Statutory and Executive Order Reviews

    In reviewing section 111(d)/129 plan submissions, EPA's role is to
approve state choices, provided that they meet the criteria of the CAA.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rule for existing CISWI units within the
State of Maryland does not have tribal implications as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000), because the
section 111(d)/129 plan is not approved to apply in Indian country
located in the state, and EPA notes that it will not impose substantial
direct costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 62

    Environmental protection, Administrative practice and procedure,
Air pollution control, Commercial and industrial solid waste
incineration units, Incorporation by reference, Intergovernmental
relations, Reporting and recordkeeping requirements.

    Dated: January 11, 2018.
Cosmo Servidio,
Regional Administrator, Region III.
[FR Doc. 2018-02059 Filed 1-31-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 136 (Thursday, July 16, 2015)]
[Notices]
[Pages 42100-42101]
[FR Doc No: 2015-17449]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9926-09-OEI]

Cross-Media Electronic Reporting: Authorized Program Revision
Approval, State of Florida

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's approval of the State of Florida's
request to revise/modify certain of its EPA-authorized programs to
allow electronic reporting.

DATES: EPA's approval is effective July 16, 2015.

FOR FURTHER INFORMATION CONTACT: Karen Seeh, U.S. Environmental
Protection Agency, Office of Environmental Information, Mail Stop
2823T, 1200 Pennsylvania Avenue NW., Washington, DC 20460, (202) 566-
1175<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On October 13, 2005, the final Cross-Media
Electronic Reporting Rule (CROMERR) was published in the Federal
Register (70 FR 59848) and codified as part 3 of title 40 of the CFR.
CROMERR establishes electronic reporting as an acceptable regulatory
alternative to paper reporting and establishes requirements to assure
that electronic documents are as legally dependable as their paper
counterparts. Subpart D of CROMERR requires that state, tribal or local
government agencies that receive, or wish to begin receiving,
electronic reports under their EPA-authorized programs must apply to
EPA for a revision or modification of those programs and obtain EPA
approval. Subpart D provides standards for such approvals based on
consideration of the electronic document receiving systems that the
state, tribe, or local government

will use to implement the electronic reporting. Additionally, Sec.
3.1000(b) through (e) of 40 CFR part 3, subpart D provides special
procedures for program revisions and modifications to allow electronic
reporting, to be used at the option of the state, tribe or local
government in place of procedures available under existing program-
specific authorization regulations. An application submitted under the
subpart D procedures must show that the state, tribe or local
government has sufficient legal authority to implement the electronic
reporting components of the programs covered by the application and
will use electronic document receiving systems that meet the applicable
subpart D requirements. Once an authorized program has EPA's approval
to accept electronic documents under certain programs, CROMERR Sec.
3.1000(a)(4) requires that the program keep EPA apprised of any changes
to laws, policies, or the electronic document receiving systems that
have the potential to affect the program's compliance with CROMERR
Sec.  3.2000.
    On February 22, 2011, the Florida Department of Environmental
Protection (FDEP) submitted an amended application titled ``Electronic
Reporting System'' for revisions/modifications of its EPA-authorized
programs under title 40 CFR to allow new electronic reporting. EPA
reviewed FDEP's request to revise/modify its EPA-authorized programs
and, based on this review, EPA determined that the application met the
standards for approval of authorized program revisions/modifications
set out in 40 CFR part 3, subpart D. In accordance with 40 CFR
3.1000(d), this notice of EPA's decision to approve Florida's request
to revise/modify its following EPA-authorized programs to allow
electronic reporting under 40 CFR parts 71, and 122, is being published
in the Federal Register:
    Part 71--Federal Operating Permit Programs;
    Part 123--EPA Administered Permit Programs: The National Pollutant
Discharge Elimination System; and
    Part 239--Requirements for State Permit Program Determination of
Adequacy.
    FDEP was notified of EPA's determination to approve its application
with respect to the authorized programs listed above.

Matthew Leopard,
Director, Office of Information Collection.
[FR Doc. 2015-17449 Filed 7-15-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 61 (Thursday, April 1, 2021)]
[Notices]
[Pages 17162-17164]
[FR Doc No: 2021-06711]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1584]

Revocation of Authorization of Emergency Use of a Medical Device
During COVID-19; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of the Emergency Use Authorization (EUA) (the Authorization)
issued to NovaSterilis, Inc. for the Nova2200 using the NovaClean
decontamination process. FDA revoked the Authorization on February 12,
2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The
revocation, which includes an explanation of the reasons for the
revocation, is reprinted in this document.

DATES: The Authorization for the Nova2200 using the NovaClean
decontamination process is revoked as of February 12, 2021.

ADDRESSES: Submit written requests for a single copy of the revocation
to the Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a Fax number to which
the revocation may be sent. See the SUPPLEMENTARY INFORMATION section
for electronic access to the revocation.

FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to
strengthen the public health protections against biological, chemical,
nuclear, and radiological agents. Among other things, section 564 of
the FD&C Act allows FDA to authorize the use of an unapproved medical
product or an unapproved use of an approved medical product in certain
situations. On August 20, 2020, FDA issued the Authorization. Notice of
the issuance of the Authorization was published in the Federal Register
on November 20, 2020 (85 FR 74346), as required by section 564(h)(1) of
the FD&C Act. FDA authorized the Nova2200 using the NovaClean
decontamination process for use in decontaminating compatible N95
respirators identified in the EUA consistent with the Authorization.
Subsequent to the issuance of the Authorization, as described in the
revocation letter reprinted in this notice, FDA considered new data and
evidence, including from testing performed by the Centers for Disease
Control and Prevention (CDC) and in published literature, indicating
that the compatible N95 respirators identified in the EUA may not
maintain adequate fit and filtration efficiency following one
decontamination cycle using the authorized product.

II. EUA Criteria for Issuance No Longer Met and Other Circumstances
Make Revocation Appropriate To Protect the Public Health or Safety

    Under section 564(g)(2)(B) and (C) of the FD&C Act, the Secretary
of HHS may revoke an EUA if, among other things, the criteria for
issuance are no longer met or other circumstances make such revocation
appropriate to protect the public health or safety. On February 12,
2021, FDA revoked the Authorization because the criteria for issuance
were no longer met and other circumstances made such revocation
appropriate to protect the public health or safety. Under section
564(c)(2) of the FD&C Act, an EUA may be issued only if FDA concludes
that, based on the totality of scientific evidence available, including
data from adequate and well-controlled clinical trials, if available,
it is reasonable to believe that the product may be effective in
diagnosing, treating, or preventing such disease or condition and that
the known and potential benefits of the product, when used to diagnose,
prevent, or treat such disease or condition, outweigh the known and
potential risks of the product.
    Given the new data and evidence from CDC and recently reported in
the literature, FDA has concluded it is not reasonable to believe the
product may be effective in preventing healthcare provider exposure to
pathogenic biological airborne particulates. Additionally, based on
this new information, FDA can no longer conclude that the known and
potential benefits of the product outweigh the known and potential
risks of its emergency use. Further, based on the same information and
the risks to public health and to healthcare providers from using
decontaminated respirators with

reduced fit and filtration performance, FDA has concluded under section
564(g)(2)(C) of the FD&C Act that other circumstances make revocation
appropriate to protect the public health or safety. Accordingly, FDA
has revoked the Authorization, pursuant to section 564(g)(2)(B) and (C)
of the FD&C Act.

III. Electronic Access

    An electronic version of this document and the full text of the
revocations are available on the internet at https://www.regulations.gov/ and https://www.fda.gov/media/145913/download.

IV. The Revocation

    Having concluded that the criteria for revocation of the
Authorization under section 564(g) of the FD&C Act are met, FDA has
revoked the EUA for the Nova2200 using the NovaClean decontamination
process. The revocation in its entirety follows and provides an
explanation of the reasons for revocation, as required by section
564(h)(1) of the FD&C Act.
BILLING CODE 4164-01-P
[GRAPHIC] [TIFF OMITTED] TN01AP21.007

[GRAPHIC] [TIFF OMITTED] TN01AP21.008

    Dated: March 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06711 Filed 3-31-21; 8:45 am]
BILLING CODE 4164-01-C


[Federal Register Volume 86, Number 56 (Thursday, March 25, 2021)]
[Proposed Rules]
[Pages 15840-15844]
[FR Doc No: 2021-06082]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2020-0185; FRL-10021-61-Region 4]

Air Plan Approval; Florida; Maintenance Plan Update for the
Hillsborough County Lead Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a State Implementation Plan (SIP) revision submitted by the
State of Florida, through the Florida Department of Environmental
Protection (FDEP), on January 23, 2020. The SIP revision seeks to
update the attainment emissions inventory and the maintenance
demonstration, including the projected future emissions inventories, in
the maintenance plan for the Hillsborough County lead maintenance area
(hereinafter referred to as the ``Hillsborough Area'' or ``Area'') for
the 2008 lead national ambient air quality standards (NAAQS). The SIP
revision also seeks to incorporate recent changes to the air
construction permit for the EnviroFocus Technologies, LLC (EnviroFocus)
facility in the Area that are related to an increase in the refined
lead production limit. EPA proposes to find that this SIP revision
meets all relevant Clean Air Act (CAA or Act) statutory and regulatory
requirements, is consistent with EPA's guidance, and is in accordance
with EPA's September 11, 2018, redesignation of the Hillsborough Area
from nonattainment to maintenance.

DATES: Comments must be received on or before April 26, 2021.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-RO4-
OAR-2020-0185 at www.regulations.gov. Follow the online instructions
for submitting comments. Once submitted, comments cannot be edited or
removed from Regulations.gov. EPA may publish any comment received to
its public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Andres Febres, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number is
(404) 562-8966. Mr. Febres can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On November 12, 2008 (73 FR 66964), EPA promulgated a revised
primary and secondary lead NAAQS of 0.15 micrograms per cubic meter
([micro]g/m\3\). Under EPA's regulations at 40 CFR part 50, the 2008
lead NAAQS are met when the maximum arithmetic 3-month mean
concentration for a 3-year period, as determined in accordance with
Appendix R of 40 CFR part 50, is less than or equal to 0.15 [micro]g/
m\3\. See 40 CFR 50.16. Ambient air quality monitoring data for the 3-
year period must meet a data completeness requirement.
    EPA designated the Hillsborough Area \1\ as a nonattainment area
for the

2008 lead NAAQS on November 22, 2010 (75 FR 71033), effective December
31, 2010, using 2007-2009 ambient air quality data. This established an
attainment date of five years after the December 31, 2010, effective
date for the 2008 lead nonattainment designations pursuant to CAA
section 172(a)(2)(A). Therefore, the Hillsborough Area's attainment
date was December 31, 2015.
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    \1\ The Hillsborough Area is comprised of a portion of
Hillsborough County in Florida bounded by a 1.5 km radius centered
at Universal Transverse Mercator coordinates 364104 meters East,
30093830 meters North, Zone 17, which surrounds Envirofocus.
---------------------------------------------------------------------------

    On April 16, 2015 (80 FR 20441), EPA published a final rule that
approved a SIP revision, comprised of an attainment plan, based on
Florida's attainment demonstration for the Hillsborough Area that
included the base year emissions inventory requirements, a modeling
demonstration of attainment for the 2008 lead NAAQS, reasonably
available control measure (RACM) requirements that included reasonably
available control technology (RACT), a reasonable further progress
(RFP) plan, and CAA section 172(c)(9) contingency measures for the
Hillsborough Area.
    Subsequently, on September 11, 2018 (83 FR 45836), EPA published a
final rule that approved Florida's March 26, 2018, redesignation
request and associated SIP revision for the Hillsborough Area.
Specifically, EPA took three separate but related final actions
regarding the Hillsborough Area: (1) Determined that the Hillsborough
Area attained the 2008 lead NAAQS based on complete, quality-assured,
and certified ambient monitoring data for the 2014-2016 period, and
that the Hillsborough Area continued to attain the standard based on
complete, quality-assured, and certified ambient monitoring data for
the 2015-2017 period; (2) approved the maintenance plan for the
Hillsborough Area and incorporated it into the Florida SIP; and (3)
approved Florida's request for redesignation of the Hillsborough Area
from nonattainment to attainment for the 2008 lead NAAQS.

II. EPA's Analysis of the State's SIP Revision

    On January 23, 2020, FDEP submitted a SIP revision that seeks to
update the attainment emissions inventory and the maintenance
demonstration, including the projected future emissions inventories, in
the maintenance plan for the Area.\2\ The SIP revision also seeks to
incorporate recent changes to the air construction permit for the
EnviroFocus facility that are related to an increase in the refined
lead production limit.
---------------------------------------------------------------------------

    \2\ Florida's SIP revision does not seek changes to any other
portions of the maintenance plan. Therefore, those portions of the
plan will remain in the SIP as approved by EPA in its September 11,
2018 action (83 FR 45836) and are not open for comment.
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A. Changes to the EnviroFocus Construction Permit

    As noted above, EPA approved the attainment plan for the
Hillsborough Area on April 16, 2015. See 80 FR 20441. As part of that
approval, EPA incorporated Florida's Air Construction Permit No.
0570057-027-AC for the EnviroFocus facility into the SIP, excluding
elements of the permit not specifically related to lead emissions.\3\
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    \3\ Florida Air Permit No. 0570057-027-AC is available in the
docket for this proposed action.
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    On November 6, 2019, FDEP issued Air Construction Permit No.
0570057-037-AC that increases the refined lead production limit for the
facility from 150,000 tons per year (tpy) to 200,000 tpy and increases
the maximum capacity of the reverb furnace from 262,800 tpy to 338,400
tpy. As part of the January 23, 2020, SIP revision, FDEP requests that
EPA incorporate the following four conditions in Section 3 of Permit
No. 0570057-037-AC into the SIP thereby replacing conditions in the SIP
relating to the lead production and furnace capacity limits from Permit
No. 0570057-027-AC: (1) Subsection B, Specific Condition 2; (2)
Subsection B, Specific Condition 3a; (3) Subsection C, Specific
Condition 1; and (4) Subsection D, Specific Condition 1.\4\ All other
provisions in permit 0570057-027-AC specifically related to lead
emissions remain in the SIP.
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    \4\ See Florida Air Construction Permit No. 0570057-037-AC,
found in Appendix A of Florida's January 23, 2020, SIP revision and
included in the docket for this proposed action. See footnotes 12-15
of this notice for the text of each revised permit condition
proposed for incorporation into the SIP.
---------------------------------------------------------------------------

    These four conditions specify the new maximum refined lead
production limit of 200,000 tpy as well as the new maximum reverb
furnace capacity of 338,400 tpy. Because the emission control measures
remain the same, are federally enforceable, and all EnviroFocus process
areas at the facility are completely encapsulated with negative
pressure, the only anticipated increases in lead emissions come from
the EU036 emissions unit, which encompasses the facility grounds and
roadways.\5\ This anticipated increase is due to the increased truck
traffic that will be needed to reach the newly approved production
limit as well as the potential re-entrained dust caused by this
traffic. Section II.B, below, goes into detail regarding the effects of
these production limit increases on the overall emissions from the
EnviroFocus facility and EPA's analysis of these increases.
---------------------------------------------------------------------------

    \5\ See 80 FR 6485 (February 5, 2015) for information on the
encapsulation of the facility as part of the attainment plan for the
Area. EPA finalized this action on April 16, 2015 at 80 FR 20441.
---------------------------------------------------------------------------

B. Changes to the Maintenance Plan

(i) Attainment Emissions Inventory
    FDEP is proposing to update the attainment emissions inventory in
the maintenance plan for the Hillsborough Area to: (1) Correct an error
in the original attainment emissions inventory that was part of the
March 29, 2018, redesignation request; and (2) update the attainment
emissions inventory in order to reflect site-specific emission factors
from the EnviroFocus facility.
    In its maintenance plan, Florida selected 2014 as the attainment
year, as this was the first full year that the Area did not show any
monitored violations of the 2008 lead NAAQS. Florida provided an
attainment emissions inventory for that year. However, the 2014 lead
emissions estimates for unit EU036 (Facility Grounds and Roadways) were
incorrectly reported. The reported value was based on an incorrect
control efficiency of 50 percent, rather than 94 percent. The correct
control efficiency of 94 percent is based on the wet suppression
controls used by the EnviroFocus facility and AP-42 calculations. As
shown in Table 1 (column 3), below, by using the correct control
efficiency, the 2014 lead emissions estimates for unit EU036 are
lowered from 0.178 tpy to 0.0213 tpy.\6\ \7\ Nonetheless, Florida
explains that the emissions estimate of 0.0213 tpy (reflecting the
correct control efficiency of 94 percent) was used in the inputs for
the original modeling that demonstrated attainment and so the
attainment modeling results do not change. The error described above is
limited solely to the representation of the emissions estimate in the
attainment inventory and maintenance demonstration evaluation.
---------------------------------------------------------------------------

    \6\ For its original attainment emissions inventory, Florida
used actual emissions obtained from the facility's annual operating
report (AOR).
    \7\ Appendices B and C of Florida's January 23, 2020, SIP
revision include calculations to demonstrate the difference in the
2014 emissions for EU036. The SIP revision and all of its appendices
are located in the docket for this proposed action.
---------------------------------------------------------------------------

    Additionally, in the attainment emissions inventory, Florida used
the silt level and silt loading factors from a similar facility in
Eagan, Minnesota, to estimate the emissions for EU036 because on-site
data was not available at the time. Since then, EnviroFocus has carried
out on-site measurements for these two factors, as well as updated

vehicle weight and truck route distances within the facility. These
measured data on the conditions of the soil within the EnviroFocus
facility help to more precisely determine the possible emissions caused
by truck traffic. Using this data, EnviroFocus determined that the
levels of lead near the facility are much lower than those at the Eagan
facility. Specifically, silt loading at EnviroFocus was on average
about one-third of the amount measured in Eagan, and silt content was
about 50 percent lower than at Eagan.
    Given the newly obtained site-specific data, and accounting for the
correct control efficiency, the emissions estimates for EU036 are
lowered to 0.0026 tpy and the facility-wide emissions estimate is
lowered to 0.272 tpy as shown in Table 1 (column 7).\8\ The value for
EU036 is approximately 98 percent below the erroneous emissions
estimate of the original emissions inventory and approximately 88
percent below the emissions estimate that reflects the correct control
efficiency and non-site specific data from the Eagan facility.
---------------------------------------------------------------------------

    \8\ In addition, Table 1 of Florida's January 23, 2020, SIP
revision shows the results of on-site samples for the EnviroFocus
facility and compares them to results from the Eagan, Minnesota
facility. Additionally, Appendix D of Florida's SIP revision
includes calculations to demonstrate the difference in the 2014
emissions for EU036 when using site-specific data. These documents
can be accessed through the docket for this proposed action.

            Table 1--EU036 Emissions Comparison, Using Site-Specific and Non Site-Specific Data, as Well as 50% and 94% Control Efficiencies
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                2014 Lead emissions
                                         ---------------------------------------------------------------------------------------------------------------
                                             Non site-specific data (Eagan, MN source)                   Site-specific data (EnviroFocus)
                                         ---------------------------------------------------------------------------------------------------------------
                                           Original data      94% Control efficiency          50% Control efficiency          94% Control efficiency
                                                 *       -----------------------------------------------------------------------------------------------
                                         ----------------
                                             Emissions       Emissions     Reduction [%]     Emissions     Reduction [%]     Emissions     Reduction [%]
                                               (tpy)           (tpy)                           (tpy)                           (tpy)
--------------------------------------------------------------------------------------------------------------------------------------------------------
EU036 Emissions.........................           0.178          0.0213              88          0.0218            87.8          0.0026            98.5
Total Emissions Facility-wide...........           0.447           0.291            34.9           0.291            34.9           0.272            39.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Original Data used non site-specific data from the Eagan, MN facility, and a control efficiency of 50%.

    EnviroFocus is the only point source of lead emissions within the
Hillsborough Area, and since the removal of lead from gasoline in the
1990s, there are no on-road mobile sources that would contribute to
lead emissions. EPA proposes to approve the corrected emissions
attainment inventory because Florida is effectively correcting a
reporting error and because the new value is more representative as it
is based on site-specific factors.
(ii) Maintenance Demonstration
    In order to demonstrate maintenance through 2029, which is the end
of the first 10-year maintenance period, Florida included projected
lead emissions for the Hillsborough Area for the years 2023, 2026, and
2029 in the maintenance plan and seeks to revise those projected
emissions through its SIP revision. In the original maintenance plan,
Florida used an emissions comparison approach to demonstrate
maintenance and assumed that emissions would remain equal to the 2014
attainment year level.\9\ Due to the increase in permitted production
at the facility, Florida's SIP revision contains revised projected
emissions for 2023, 2026, and 2029.
---------------------------------------------------------------------------

    \9\ EPA determined that it was appropriate to use an emissions
comparison approach to demonstrate maintenance in the Area because
local emissions were the primary contributor to nonattainment. See
83 FR 28402 (June 19, 2018) (proposal) and 83 FR 45836 (September
11, 2018) (final). Under this approach, if future projected
emissions in an area remain at or below baseline emissions, then the
related ambient air quality standards should not be exceeded in the
future.
---------------------------------------------------------------------------

    Because the emission control measures remain the same, are
federally enforceable, and the EnviroFocus facility is completely
encapsulated with negative pressure, the only anticipated increase in
lead emissions comes from EU036, which encompasses the facility grounds
and roadways. This is due to the increased truck traffic needed to
reach the newly approved production limit and the potential re-
entrained dust caused by this traffic.
    As shown in Table 1, the adjusted 2014 emissions inventory, which
includes the correct control efficiency of 94 percent and the site-
specific data for EnviroFocus, shows that lead emissions for the EU036
unit are 0.0026 tpy. By increasing the truck traffic at the facility,
Florida estimates that future emissions for EU036 will be 0.0046 tpy
with the new production limit for the facility. The new facility-wide
total emissions would be 0.274 tpy, an increase of 0.002 tpy from the
corrected 2014 attainment year value of 0.272 tpy.\10\ Table 2, below,
identifies the 2009 base year emissions included in Florida's
attainment plan, the original and corrected attainment year emissions
for comparison, as well as the projected emissions for 2023, 2026, and
2029 that account for the new production limit.
---------------------------------------------------------------------------

    \10\ Appendix E of Florida's January 23, 2020, SIP revision
includes calculations to demonstrate the emissions increases due to
the new production limit at EnviroFocus.
    \11\ See the discussion in Section II(B)(i) of this notice for
details on the corrected 2014 attainment year emissions.

       Table 2--Actual and Projected Annual Lead Emissions (tpy) for the Hillsborough Area; Including the Corrected 2014 Attainment Year Emissions
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                                                                                Corrected 2014                                          2029
                           2009 Base year                             Original 2014   attainment year    2023 Interim     2026 Interim     Maintenance
                                                                     attainment year        \11\             year             year             year
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0.588..............................................................           0.447            0.272            0.274            0.274            0.274
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Florida has revised the projected emissions as described
previously, and these projections indicate that emissions in the Area
will increase slightly from 0.272 tpy to 0.274 tpy, a difference of
less than 1 percent, which is due to the increased potential emissions
from EU036. As EU036 represents the only unit which will have an
emissions increase as a result of the production increase, the revised
projections (in Table 2) are correct and representative of new
conditions, and it is therefore acceptable to hold these projected
values the same throughout the maintenance period.
    Although emissions have increased slightly due to the corrected
attainment year value, this increase is negligible and therefore not
enough to cause a violation of the standard throughout the maintenance
period. This is further supported by the fact that the modeling used in
the EPA-approved attainment demonstration showed attainment using the
erroneous emissions estimate of 0.291 tpy discussed in section
II.B.(i), which is higher than the updated 0.274 tpy projected value,
and the modeled controls are still permanent and enforceable. The
attainment demonstration modeled emissions that already accounted for
the corrected control efficiency of 94 percent but did not yet reflect
the site-specific data for silt loading and silt content in the
EnviroFocus facility. Therefore, the projected future emissions for the
Hillsborough Area will remain below the emissions used to demonstrate
attainment and future maintenance (through 2029) when the Area was
redesignated to attainment.
    For these reasons, EPA believes that the Hillsborough Area will
continue to maintain the lead standard at least through the year 2029
and that the increase in the production limit for the EnviroFocus
facility will not interfere with any applicable requirement concerning
attainment, RFP, or any other applicable requirement of the CAA.

III. Incorporation by Reference

    In this document, EPA is proposing to include in a final rule,
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, EPA is proposing to incorporate by
reference into Florida's SIP Air Construction Permit No. 0570057-27-AC
issued by FDEP to EnviroFocus with an effective date of December 14,
2012, except for the following: (1) Conditions not specifically related
to lead emissions, (2) Section 3, Subsection B, Specific Condition 3,
(3) Section 3, Subsection B, Specific Condition 10, (4) Section 3,
Subsection C, Specific Condition 5, and (5) Section 3, Subsection G,
Specific Condition 5. EPA is also proposing to incorporate by reference
into Florida's SIP the following conditions from Air Construction
Permit No. 0570057-37-AC, issued by FDEP to EnviroFocus with an
effective date of November 6, 2019: (1) Section 3, Subsection B,
Specific Condition 2; \12\ (2) Section 3, Subsection B, Specific
Condition 3a; \13\ (3) Section 3, Subsection C, Specific Condition 1;
\14\ and (4) Section 3, Subsection D, Specific Condition 1.\15\
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    \12\ This provision states: ``Lead Production: The maximum
refined lead production from the EFT facility shall not exceed
200,000 tons in any consecutive twelve-month period. [Application
No. 0570057-037-AC and Rule 62-210.200 (PTE), F.A.C.]''
    \13\ This provision states: ``Furnace Capacities: Any equipment
or any other changes authorized as part of this permit, shall not
result in any capacity increase of the reverb or blast furnaces. The
reverb furnace shall still be limited to a maximum charge rate of
960 tons per day (TPD) with a maximum capacity of 338,400 tons in
any twelve-month consecutive period. The blast furnace shall still
have a maximum charge rate of 180 TPD with a maximum capacity of
65,700 tons in any twelve-month consecutive period. [Application No.
0570057-037-AC; Rules 62-4.070(3) and 62-210.200(PTE), F.A.C.]''
    \14\ This provision states: ``Lead Production: The maximum
refined lead produced from the EFT facility shall not exceed 200,00
tons in any consecutive twelve-month period. [Application No.
0570057-037 and Rule 62-210.200(PTE), F.A.C.]''
    \15\ This provision states: ``Production: The maximum refined
lead produced from the enclosed facility shall not exceed 200,000
tons any consecutive twelve-month period. [Application No. 0570057-
037-AC and Rule 62.210.200(PTE), F.A.C.]''
---------------------------------------------------------------------------

    EPA has made, and will continue to make, the State Implementation
Plan generally available through www.regulations.gov and at EPA Region
4 office (please contact the person identified in the ``For Further
Information Contact'' section of this preamble for more information).

IV. Proposed Action

    EPA is proposing to approve changes regarding the Hillsborough Area
as presented in Florida's January 23, 2020, SIP revision. The proposed
changes include corrections to the attainment emissions inventory and
the maintenance demonstration, including the projected future emissions
inventories, in the maintenance plan for the Area. The SIP revision
also includes recent changes to the construction permit for the
EnviroFocus facility that authorize an increase in the refined lead
production limit at the facility.
    EPA proposes to find that the changes to the SIP will not interfere
with any applicable requirement concerning attainment, RFP, or any
other applicable requirement of the CAA. EPA therefore proposes to
incorporate the aforementioned changes to the maintenance plan and the
facility's permit into the Florida SIP.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. This action merely
proposes to approve state law as meeting Federal requirements and does
not impose additional requirements beyond those imposed by state law.
For that reason, this proposed action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe

has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it
impose substantial direct costs on tribal governments or preempt tribal
law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Lead, Reporting and
recordkeeping requirements.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: March 16, 2021.
John Blevins,
Acting Regional Administrator, Region 4.
[FR Doc. 2021-06082 Filed 3-24-21; 8:45 am]
BILLING CODE 6560-50-P