[Federal Register Volume 83, Number 71 (Thursday, April 12, 2018)]
[Notices]
[Pages 15825-15826]
[FR Doc No: 2018-07556]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC18-12-000]

Commission Information Collection Activities (FERC-566); Comment
Request; Extension

AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice of information collection and request for comments.

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SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is soliciting public comment on the currently approved
information collection, FERC-566 (Annual Report of a Utility's 20
Largest Purchasers).

DATES: Comments on the collection of information are due June 11, 2018.

ADDRESSES: You may submit comments (identified by Docket No. IC18-12-
000) by either of the following methods:
     eFiling at Commission's Website: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance contact FERC Online Support
by email at [email protected], or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
[email protected], telephone at<PHONE_NUMBER>, and fax at (202)
273-0873.

SUPPLEMENTARY INFORMATION:
    Title: FERC-566 (Annual Report of a Utility's 20 Largest
Purchasers).
    OMB Control No.: 1902-0114.
    Type of Request: Three-year extension of the FERC-566 information
collection requirements with no changes to the current reporting
requirements.
    Abstract: The Federal Power Act (FPA), as amended by the Public
Utility Regulatory Policies Act of 1978 (PURPA), mandates federal
oversight and approval of certain electric corporate activities to
ensure that neither public nor private interests are adversely
affected. Accordingly, the FPA proscribes related information filing
requirements to achieve this goal. Such filing requirements are found
in the Code of Federal Regulations (CFR), specifically in 18 CFR
131.31, and serve as the basis for the FERC-566.
    FERC-566 implements FPA requirements that each public utility
annually publish a list of the 20 purchasers which purchased the
largest annual amounts of electric energy sold by such public utility
during any of the three previous calendar years. The public disclosure
of this information provides the information necessary to determine
whether an interlocked position is with any of the 20 largest
purchasers of electric energy. Similar to the Form 561,\1\ the FPA
identifies who must file the FERC-566 report and sets the filing
deadline.
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    \1\ FERC Form No. 561 (Annual Report of Interlocking
Directorates), OMB Control No. 1902-0099.
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    Type of Respondents: Public utility.
    Estimate of Annual Burden: \2\ The Commission estimates the annual
public reporting burden for the information collection as:
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    \2\ ``Burden'' is defined as the total time, effort, or
financial resources expended by persons to generate, maintain,
retain, or disclose or provide information to or for a Federal
agency. For further explanation of what is included in the
information collection burden, reference 5 Code of Federal
Regulations 1320.3.
    \3\ The estimates for cost per response are derived using the
following formula: Average Burden Hours per Response * $76.50 per
Hour = Average Cost per Response. The figure comes from the 2017
FERC average hourly cost (for wages and benefits) of $76.50 (and an
average annual salary of $158,754). Commission staff is using the
FERC average hourly cost because we consider any reporting completed
in response to the FERC-566 to be compensated at rates similar to
the work of FERC employees.

                                              FERC-566 (Annual Report of a Utility's 20 Largest Purchasers)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       Annual  number
                                          Number of     of  responses   Total number    Average  burden & cost     Total annual  burden      Cost per
                                         respondents         per        of responses       per response \3\       hours  & total  annual  respondent ($)
                                                         respondent                                                        cost
                                                  (1)             (2)     (1) * (2) =  (4).....................  (3) * (4) = (5)........       (5) / (1)
                                                                                (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
FERC-566.............................             300               1             300  4 hrs.; $306............  1,200 hrs.; $91,800....            $306
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.

    Dated: April 6, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-07556 Filed 4-11-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 191 (Monday, October 3, 2011)]
[Proposed Rules]
[Pages 61069-61070]
[FR Doc No: 2011-25283]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2011-0580; FRL-9468-1]

Revisions to the California State Implementation Plan, Sacramento
Metropolitan Air Quality Management District, Ventura County Air
Pollution Control District, and Placer County Air Pollution Control
District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve revisions to the Sacramento
Metropolitan Air Quality Management District (SMAQMD), Ventura County
Air Pollution Control District (VCAPCD), and Placer County Air
Pollution Control District (PCAPCD) portion of the California State
Implementation Plan (SIP). These revisions concern volatile organic
compound (VOC) emissions from organic chemical manufacturing, soil
decontamination, and polyester resin operations. We are proposing to
approve local rules to regulate these emission sources under the Clean
Air Act as amended in 1990 (CAA or the Act).

DATES: Any comments on this proposal must arrive by November 2, 2011.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2011-0580, by one of the following methods:
    1. Federal eRulemaking Portal: www.regulations.gov. Follow the on-
line instructions.
    2. E-mail<EMAIL_ADDRESS>    3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute.
Information that you consider CBI or otherwise protected should be
clearly identified as such and should not be submitted through http://www.regulations.gov or e-mail. http://www.regulations.gov is an
``anonymous access'' system, and EPA will not know your identity or
contact information unless you provide it in the body of your comment.
If you send e-mail directly to EPA, your e-mail address will be
automatically captured and

included as part of the public comment. If EPA cannot read your comment
due to technical difficulties and cannot contact you for clarification,
EPA may not be able to consider your comment. Electronic files should
avoid the use of special characters, any form of encryption, and be
free of any defects or viruses.
    Docket: Generally, documents in the docket for this action are
available electronically at http://www.regulations.gov and in hard copy
at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While
all documents in the docket are listed at http://www.regulations.gov,
some information may be publicly available only at the hard copy
location (e.g., copyrighted material, large maps), and some may not be
publicly available in either location (e.g., CBI). To inspect the hard
copy materials, please schedule an appointment during normal business
hours with the contact listed in the FOR FURTHER INFORMATION CONTACT
section.

FOR FURTHER INFORMATION CONTACT: David Grounds, EPA Region IX, (415)
972-3019<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This proposal addresses the following local
rules: SMAQMD Rule 464 (Organic Chemical Manufacturing Operations),
VCAPCD Rule 74.29 (Soil Decontamination), and PCAPCD Rule 243
(Polyester Resin Operations). In the Rules and Regulations section of
this Federal Register, we are approving these local rules in a direct
final action without prior proposal because we believe these SIP
revisions are not controversial. If we receive adverse comments,
however, we will publish a timely withdrawal of the direct final rule
and address the comments in subsequent action based on this proposed
rule. Please note that if we receive adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, we may adopt as final those provisions
of the rule that are not the subject of an adverse comment.
    We do not plan to open a second comment period, so anyone
interested in commenting should do so at this time. If we do not
receive adverse comments, no further activity is planned. For further
information, please see the direct final action.

    Dated: August 16, 2011.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2011-25283 Filed 9-30-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: October 10, 2008 (Volume 73, Number 198)]
[Notices]
[Page 60306-60307]
[DOCID:fr10oc08-98]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1796-DR]

Alaska; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Alaska (FEMA-1796-DR), dated September 26,
2008, and related determinations.

DATES: Effective Date: September 26, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated September 26, 2008, the President declared a major disaster under
the authority of the Robert T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as follows:

    I have determined that the damage in certain areas of the State
of Alaska resulting from severe storms, flooding, landslides, and
mudslides during the period of July 27 to August 6, 2008, is of
sufficient severity and magnitude to warrant a major disaster
declaration under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act).
Therefore, I declare that such a major disaster exists in the State
of Alaska.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas, Hazard Mitigation throughout the State, and any
other forms of assistance under the Stafford Act that you deem
appropriate. Consistent with the requirement that Federal assistance
be supplemental, any Federal funds provided under the Stafford Act
for Hazard Mitigation will be limited to 75 percent of the total
eligible costs. Federal funds provided under the Stafford Act for
Public Assistance also will be limited to 75 percent of the total
eligible costs, except for any particular projects that are eligible
for a higher Federal cost-sharing percentage under the FEMA Public
Assistance Pilot Program instituted pursuant to 6 U.S.C. 777. If
Other Needs Assistance under Section 408 of the Stafford Act is
later requested and warranted, Federal funding under that program
also will be limited to 75 percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
to the extent allowable under the Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Douglas G. Mayne, of FEMA is
appointed to act as the Federal Coordinating Officer for this declared
disaster.
    The following areas of the State of Alaska have been designated as

adversely affected by this declared major disaster:

    Denali Borough, Fairbanks North Star Borough, North Slope
Borough, and the Yukon-Koyukuk Regional Educational Attendance Area
for Public Assistance.
    All boroughs and Regional Educational Attendance Areas within
the State of Alaska are eligible to apply for assistance under the
Hazard Mitigation Grant Program.

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

R. David Paulison,
Administrator, Federal Emergency Management Agency.
 [FR Doc. E8-24092 Filed 10-9-08; 8:45 am]

BILLING CODE 9111-23-P


[Federal Register Volume 85, Number 212 (Monday, November 2, 2020)]
[Rules and Regulations]
[Pages 69172-69175]
[FR Doc No: 2020-24020]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2020-0600]
RIN 1625-AA00

Safety Zone; East River, New York, NY

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters of the east channel of the East River between the
Roosevelt Island Bridge (mile 6.4) and Gibbs Point approximately 800
yards northeast of the bridge. The safety zone is needed to protect
personnel, vessels, and the marine environment from potential hazards
created by the installation of one TriFrame with three attached
underwater turbines, associated cabling and 4 to 6 Private Aids to
Navigation. When enforced, entry of vessels or persons into this zone
is prohibited unless specifically authorized by the Captain of the Port
New York.

DATES: This rule is effective without actual notice from November 2,
2020 through 11:59 p.m., December 31, 2020. For the purposes of
enforcement, actual notice will be used from 7 a.m., October 22, 2020
through November 2, 2020.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2020-0600 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Jeff Yunker, Sector New York Waterways Management
Division; U. S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
PATON Private Aids to Navigation
RITE Roosevelt Island Tidal Energy Project
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the contractor did not provide enough
notice that three barges, three tugs and three work vessels will be
conducting heavy lift operations and installing 4 to

6 Private Aids to Navigation (PATON) in the east channel of the East
River, north of the Roosevelt Island Bridge while installing one
TriFrame with three underwater turbines for the RITE Project. The USACE
is issuing a permit for this installation and immediate action is
needed to respond to the potential safety hazards associated with heavy
lift operations. It is impracticable to publish an NPRM because we must
establish this safety zone by October 22, 2020. The Coast Guard is
publishing this rule to be effective through December 31, 2020 in case
the project is delayed due to unforeseen circumstances.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable because immediate action is needed to
respond to the potential safety hazards associated with multiple
construction vessels operating within a confined area of the East
River.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port New York
(COTP) has determined that potential hazards associated with
installation of the RITE Project TriFrame with three turbines and
associated PATON marking this installation on October 22, 2020, will be
a safety concern for anyone in the East River, east of Roosevelt
Island, between the Roosevelt Island Bridge (mile 6.4) and Gibbs Point.
This rule is needed to protect personnel, vessels, and the marine
environment in the navigable waters within the safety zone while nine
tugs, barges and work vessels are installing one TriFrame with three
underwater turbines and 4-6 PATON marking the RITE Project area.

IV. Discussion of the Rule

    This rule establishes a safety zone from October 22 through
December 31, 2020. The safety zone will cover all navigable waters of
the East River east of Roosevelt Island between the Roosevelt Island
Bridge (mile 6.4) and Gibbs Point being used by vessels and personnel
to install Phase 1 of the RITE Project.
[GRAPHIC] [TIFF OMITTED] TR02NO20.003

    We anticipate enforcing the safety zone during the heavy lift
operations for installation of the RITE Project TriFrame with three
turbines scheduled from approximately 7 a.m. until 11 p.m. on October
22, 2020. The duration of the zone is intended to protect personnel,
vessels, and the marine environment in these constrained navigable
waters while the project and PATON marking the project area are being
installed. When enforced no vessel or person will be permitted to enter
the safety zone without obtaining permission from the COTP or a
designated representative. The Coast Guard is publishing this rule to
be effective through December 31, 2020 in case the project is delayed
due to unforeseen circumstances.

V. Regulatory Analyses

    We developed this 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 rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule 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,
location, duration, and time-of-year of the safety zone. Vessel traffic
will be able to safely transit around this safety zone which would
impact a small designated area of

the East River for approximately 16 hours during the Fall when vessel
traffic is normally low. Moreover, the Coast Guard would issue a
Broadcast Notice to Mariners via VHF-FM marine channel 16 about the
zone, publish the zone in the Local Notice to Mariners, and the rule
would allow vessels to seek permission to enter 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 rule
will 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
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    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 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
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will 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 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 rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does 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.

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 rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, 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 determined 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 rule involves a
safety zone lasting only 16 hours that will prohibit entry between the
Roosevelt Island Bridge (mile 6.4) and Gibbs Point being used by
vessels, machinery and personnel to install Phase 1 of the RITE Project
and 4-6 PATON marking the project area. It is categorically excluded
from further review under paragraph L60(a) of Appendix A, Table 1 of
DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental
Consideration supporting this determination is available in the docket.
For instructions on locating the docket, see the ADDRESSES section of
this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email 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.

List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard amends
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.T01-0600 to read as follows:

Sec.  165.T01-0600  Safety Zone; East River, New York, NY.

    (a) Location. The following area is a safety zone: All waters of
the East River, from surface to bottom, east of Roosevelt Island,
upstream of the Roosevelt Island Bridge (mile 6.4) and downstream of a
line connecting the following points: Gibbs Point at (pa)
40[deg]46'05.12'' N, 073[deg]56'21.74'' W to Roosevelt Island at (pa)
40[deg]46'09.25'' N, 073[deg]56'29.60'' W. These coordinates are based
on NAD 83.
    (b) Definitions. As used in this section, designated representative
means a Coast Guard Patrol Commander, including a Coast Guard coxswain,
petty officer, or other officer operating a Coast Guard vessel and a
Federal, State, and local officer designated by or assisting the
Captain of the Port New York (COTP) in the enforcement of the safety
zone.
    (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.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by VHF-Channel 16 or at

718-354-4353. 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 period[s]. This section is effective from October
22 through December 31, 2020 but will only be enforced when Roosevelt
Island Tidal Energy Project heavy lift operations are in progress.

    Dated: October 20, 2020.
Jason P. Tama,
Captain, U.S. Coast Guard, Captain of the Port New York.
[FR Doc. 2020-24020 Filed 10-30-20; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 137 (Wednesday, July 19, 2017)]
[Proposed Rules]
[Pages 33030-33032]
[FR Doc No: 2017-15050]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2016-0740; FRL-9965-07-Region 9]

Approval of California Air Plan Revisions; Sacramento
Metropolitan Air Quality Management District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the Sacramento Metropolitan Air Quality Management
District (SMAQMD) portion of the California State Implementation Plan
(SIP). These revisions concern emissions of volatile organic compounds
(VOC) from organic chemical manufacturing operations. We are proposing
to approve a local rule and a rule rescission to regulate these
emission sources under the Clean Air Act (CAA or the Act). We are
taking comments on this proposal and plan to follow with a final
action.

DATES: Any comments must arrive by August 18, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2016-0740 at https://www.regulations.gov, or via email to Andrew
Steckel, Rulemaking Office Chief at<EMAIL_ADDRESS>For
comments submitted at Regulations.gov, follow the online instructions
for submitting comments. Once submitted, comments cannot be removed or
edited 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. The 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 https://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Arnold Lazarus, EPA Region IX, (415)
972-3024<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. The State's Submittal
    A. What rules did the State submit?
    B. Are there other versions of these rules?
    C. What is the purpose of the submitted rule and rule
rescission?
II. The EPA's Evaluation and Action
    A. How is the EPA evaluating the rule and rule rescission?
    B. Do the rule and rule rescission meet the evaluation criteria?
    C. Public Comment and Proposed Action
III. Incorporation by Reference
IV. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rules did the State submit?

    Table 1 lists the rules addressed by this action with the dates
that they were amended or repealed by the local air agency and
submitted by the California Air Resources Board (CARB).

                                                                Table 1--Submitted Rules
--------------------------------------------------------------------------------------------------------------------------------------------------------
                  Local agency                      Rule No.                    Rule title                    Amended        Repealed        Submitted
--------------------------------------------------------------------------------------------------------------------------------------------------------
SMAQMD.........................................             455  Pharmaceutical Manufacturing...........  ..............         4/28/16         8/22/16
SMAQMD.........................................             464  Organic Chemical Manufacturing                  4/28/16  ..............         8/22/16
                                                                  Operations.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    On September 27, 2016, the EPA determined that the submittal for
SMAQMD Rule 455 and Rule 464 met the completeness criteria in 40 CFR
part 51 Appendix V, which must be met before formal review by the EPA.

B. Are there other versions of these rules?

    We approved an earlier version of SMAQMD Rule 464 into the SIP on
October 3, 2011 (76 FR 61057), and we approved SMAQMD Rule 455 into the
SIP on January 24, 1985 (50 FR 3338).\1\
---------------------------------------------------------------------------

    \1\ EPA's approval of Rule 455 refers to the Sacramento County
Air Pollution Control District, which was then the name of the
regulatory authority for air pollution in the Sacramento area.
---------------------------------------------------------------------------

C. What is the purpose of the submitted rule and rule rescission?

    VOCs help produce ground-level ozone, also known as ``smog,'' and
particulate matter (PM), which harm human health and the environment.
Section 110(a) of the CAA requires states to submit regulations that
control VOC emissions. SMAQMD Rule 455, ``Pharmaceutical
Manufacturing,'' was approved into the SIP on January 24, 1985 (50 FR
3338). EPA re-evaluated Rule 455 as part of our review of the SMAQMD's
2006 Reasonably Available Control Technology (RACT) SIP, and concluded
that Rule 455 did not meet the requirements of Federal CAA section
110(a)(2) because it lacked test methods, recordkeeping, and monitoring
requirements that are necessary to ensure that the rule is enforceable.
81 FR 53280, 53281 (August 12, 2016). The SMAQMD subsequently repealed
Rule 455 and simultaneously amended Rule 464 to include pharmaceutical
and cosmetic manufacture. Rule 464 limits VOC emissions from organic
chemical plants and pharmaceutical and cosmetic manufacturing; its
controls for pharmaceutical manufacturing replace Rule 455. The EPA's
technical support documents (TSDs) have more information about these
rules.

II. The EPA's Evaluation and Action

A. How is the EPA evaluating the rule and rule rescission?

    SIP rules must be enforceable (see CAA section 110(a)(2)), must not
interfere with applicable requirements concerning attainment and
reasonable further progress or other CAA requirements (see CAA section
110(l)), and must not modify certain SIP control requirements in
nonattainment areas without ensuring equivalent or greater emissions
reductions (see CAA section 193).
    Generally, SIP rules in ozone nonattainment areas classified as
moderate or above must require RACT for each category of sources
covered by a control techniques guidelines (CTG) document as well as
each major source of VOCs (see CAA sections 182(b)(2)). The SMAQMD
regulates an ozone nonattainment area classified as severe
nonattainment for the 1997 and the 2008 8-hour ozone National Ambient
Air Quality Standards (NAAQS) (40 CFR 81.305). Therefore, Rule 464 must
implement RACT.
    Guidance and policy documents that we use to evaluate
enforceability, revision/relaxation and rule stringency requirements
for the applicable criteria pollutants include the following:

    1. ``State Implementation Plans; General Preamble for the
Implementation of Title I of the Clean Air Act Amendments of 1990,''
57 FR 13498 (April 16, 1992); 57 FR 18070 (April 28, 1992).
    2. ``Issues Relating to VOC Regulation Cutpoints, Deficiencies,
and Deviations,'' U.S. EPA, May 25, 1988; revised January 11, 1990
(``The Bluebook'').
    3. ``Guidance Document for Correcting Common VOC & Other Rule
Deficiencies,'' EPA Region 9, August 21, 2001 (``The Little
Bluebook'').
    4. ``Control of Volatile Organic Emissions from Manufacture of
Synthesized Pharmaceutical Products,'' EPA-450/2-78-029, December
1978.
    5. ``Control of Volatile Organic Compound Emissions from Reactor
Processes and Distillation Operations Processes in the Synthetic
Organic Chemical Manufacturing Industry,'' EPA-450/4-91-031, August
1993.

B. Do the rule and rule rescission meet the evaluation criteria?

    We believe this rule and rule rescission are consistent with CAA
requirements and relevant guidance regarding enforceability, RACT, and
SIP revisions. The TSDs have more information on our evaluation.
    The EPA partially approved and partially disapproved the RACT SIP
revisions submitted by California on July 11, 2007 and January 21, 2009
for the SMAQMD severe ozone

nonattainment area,\2\ based in part on our conclusion that the state
had not fully satisfied CAA section 182 RACT requirements for the
pharmaceuticals manufacturing CTG category and for the municipal waste
landfill category. We are separately but contemporaneously proposing
approval of submitted portions of SMAQMD Permits 24360 and 24361 for
the Kiefer Landfill, which are intended to address the deficiencies
identified in our 2016 partial disapproval of the SMAQMD's RACT SIP
regarding the municipal waste landfill category.\3\ Final approval of
Rule 464 and the submitted portions of the Kiefer Landfill permits
would satisfy California's obligation to implement RACT under CAA
section 182 for the 1997 8-hour ozone NAAQS and thereby terminate both
the sanctions clocks and the Federal Implementation Plan clock
associated with our August 12, 2016 final action.
---------------------------------------------------------------------------

    \2\ See, 81 FR 53280 (August 12, 2016).
    \3\ We are submitting these two proposed actions together for
publication, and expect the Federal Register notices to publish
around the same time.
---------------------------------------------------------------------------

C. Public Comment and Proposed Action

    As authorized in section 110(k)(3) of the Act, the EPA proposes to
fully approve the submitted rule and rule rescission because we believe
they fulfill all relevant requirements. We will accept comments from
the public on this proposal until August 18, 2017. If we take final
action to approve the submitted rule and rule rescission, our final
action will incorporate these rules into the federally enforceable SIP.

III. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference the SMAQMD rules described in Table 1 of this preamble. The
EPA has made, and will continue to make, these materials available
through https://www.regulations.gov and at the EPA Region IX Office
(please contact the person identified in the FOR FURTHER INFORMATION
CONTACT section of this preamble for more information).

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this proposed 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 Clean Air Act; and
     Does not provide the EPA with the discretionary authority
to address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the 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 and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Particulate matter,
Reporting and recordkeeping requirements, Volatile organic compounds.

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

    Dated: June 29, 2017.
Alexis Strauss,
Acting Regional Administrator, Region IX.
[FR Doc. 2017-15050 Filed 7-18-17; 8:45 am]
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[Federal Register Volume 87, Number 38 (Friday, February 25, 2022)]
[Notices]
[Pages 10800-10803]
[FR Doc No: 2022-03994]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0377]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Tobacco Health Document Submission

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 associated with
the tobacco health document submission.

DATES: Submit either electronic or written comments on the collection
of information by April 26, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 26, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 26, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-N-0377 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Tobacco Health Document
Submission.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.

Tobacco Health Document Submission

OMB Control Number 0910-0654--Extension

    On June 22, 2009, the Family Smoking Prevention and Tobacco Control
Act (Tobacco Control Act) (Pub. L. 111-31) was enacted. The Tobacco
Control Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act)
by adding, among other things, a new chapter granting FDA important
authority to regulate the manufacture, marketing, and distribution of
tobacco products to protect the public health generally and to reduce
tobacco use by minors. Additionally, section 101 of the Tobacco Control
Act amended the FD&C Act by adding, among other things, new section
904(a)(4) (21 U.S.C. 387d(a)(4)).
    Section 904(a)(4) of the FD&C Act requires each tobacco product
manufacturer or importer, or agent thereof, to submit all documents
developed after June 22, 2009, ``that relate to health, toxicological,
behavioral, or physiologic effects of current or future tobacco
products, their constituents (including smoke constituents),
ingredients, components, and additives'' (herein referred to as
``tobacco health documents'').
    The guidance document ``Health Document Submission Requirements for
Tobacco Products (Revised)'' (2017) (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/tobacco-health-document-submission) requests health documents based on statutory requirements
and compliance dates.\1\ As indicated in the guidance, all
manufacturers and importers of tobacco products are now subject to the
FD&C Act and are required to comply with section 904(a)(4), which
requires immediate and ongoing submission of health documents developed
after June 22, 2009 (the date of enactment of the Tobacco Control Act).
However, FDA generally does not intend to enforce the requirement at
this time with respect to

all such health documents, so long as a specified set of documents,
those developed between June 23, 2009, and December 31, 2009, are
provided at least 90 days prior to the delivery for introduction of
tobacco products into interstate commerce. Thereafter, manufacturers
should preserve all health documents, including those that relate to
products for further manufacturing and those developed after December
31, 2009, for future submission to FDA. All Agency guidance documents
are issued in accordance with our good guidance practice regulations in
21 CFR 10.115, which provide for public comment at any time.
---------------------------------------------------------------------------

    \1\ FDA announced the availability of a guidance on this
collection in the Federal Register on April 20, 2010 (75 FR 20606)
(revised December 5, 2016 (81 FR 87565)).
---------------------------------------------------------------------------

    FDA is planning revisions to the guidance to reflect that the
deemed tobacco product compliance period has passed. Additional
revisions include clarifying and editorial changes to promote a better
understanding of FDA's interpretation of the ``health, toxicological,
behavioral, or physiologic'' phrase, examples of health, toxicological,
behavioral, or physiologic effects documents, and minor updates to the
metadata list.
    FDA has been collecting the information submitted pursuant to
section 904(a)(4) of the FD&C Act through a facilitative electronic
form and through a paper form (Form FDA 3743) for those individuals who
choose not to use the electronic method. On both forms, FDA is
requesting the following information from firms that have not already
reported or still have documents to report:
     Submitter identification
     Submitter type, company name, address, country, company
headquarters Dun and Bradstreet D-U-N-S number, and FDA assigned
Facility Establishment Identifier (FEI) number
     Submitter point of contact
     Contact name, title, position title, email, telephone, and
Fax
     Submission format and contents (as applicable)
     Electronic documents: Media type, media quantity, size of
submission, quantity of documents, file type, and file software
     Paper documents: Quantity of documents, quantity of
volumes, and quantity of boxes
     Whether or not a submission is being provided
     Confirmation statement
     Identification and signature of submitter including name,
company name, address, position title, email, telephone, and Fax
     Document categorization (as applicable): Relationship of
the document or set of documents to the following:
    [cir] Health, behavioral, toxicological, or physiological effects
    [cir] Uniquely identified current or future tobacco product(s)
    [cir] Category of current or future tobacco product(s)
    [cir] Specific ingredient(s), constituent(s), component(s), or
additive(s)
    [cir] Class of ingredient(s), constituent(s), component(s), or
additive(s)
     Document readability and accessibility: Keywords; glossary
or explanation of any abbreviations, jargon, or internal (e.g., code)
names; special instructions for loading or compiling submission.
     Document metadata: Date document was created, document
author(s), document recipient(s), document custodian, document title or
identification number, beginning and ending Bates numbers, Bates number
ranges for documents attached to a submitted email, document type, and
whether the document is present in the University of California San
Francisco's Truth Tobacco Documents database.
    You may access the electronic form and paper form on our website,
at https://www.fda.gov/tobacco-products/manufacturing/submit-documents-ctp-portal and https://www.fda.gov/media/78652/download, respectively.
In addition to the electronic and paper forms, FDA issued the guidance
on this collection to assist persons making tobacco health document
submissions. For further assistance, FDA is providing a technical
guide, embedded hints, and a web tutorial on the electronic portal.
    FDA issued a final rule to deem products meeting the statutory
definition of ``tobacco product'' to be subject to the FD&C Act on May
10, 2016 (81 FR 28973), which became effective on August 8, 2016. The
FD&C Act provides FDA authority to regulate cigarettes, cigarette
tobacco, roll-your-own tobacco (RYO), smokeless tobacco, and any other
tobacco products that the Agency by regulation deems to be subject to
the law. This final rule extended the Agency's ``tobacco product''
authorities to all other categories of products that meet the statutory
definition of ``tobacco product'' in the FD&C Act, except accessories
of such deemed tobacco products.
    For tobacco products subject to the deeming rule, FDA understands
``current or future tobacco products'' to refer to products
commercially distributed on or after August 8, 2016, or products in any
stage of research or development at any time after August 8, 2016,
including experimental products and developmental products intended for
introduction into the market for consumer use. For cigarettes,
cigarette tobacco, RYO, and smokeless tobacco, FDA understands
``current or future tobacco products'' to refer to products
commercially distributed on or after June 23, 2009, or products in any
stage of research or development at any time after June 23, 2009,
including experimental products and developmental products intended for
introduction into the market for consumer use.
    In the guidance on this collection, FDA indicated our intent to
enforce the requirement at this time with respect to all such health
documents relating to the deemed tobacco products, so long as a
specified set of documents, those developed between June 23, 2009, and
December 31, 2009, were submitted by February 8, 2017, or in the case
of small-scale deemed tobacco product manufacturers (small-scale
manufacturers), by November 8, 2017 (81 FR 28973 at 29008 and 29009).
Additionally, FDA extended the compliance deadlines by an additional 6
months for small-scale manufacturers in the areas impacted by natural
disasters to May 8, 2018. Thereafter, FDA's compliance plan requested
deemed manufacturers provide tobacco health document submissions from
the specified period, at least 90 days prior to the delivery for
introduction into interstate commerce of tobacco products to which the
health documents relate. Manufacturers or importers of cigarettes,
cigarette tobacco, RYO, or smokeless tobacco products must provide all
health documents developed between June 23, 2009, and December 31,
2009, at least 90 days prior to the delivery for introduction of
tobacco products into interstate commerce.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tobacco Health Document Submissions and Form FDA 3743..............              10              3.2               32               50            1,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The number of documents received each year since the original
collection period has fallen to less than 5 percent of what was
received in the original collection period. FDA expects this is because
documents created within the specified period should have already been
submitted. The Agency bases this estimate on the total number of
tobacco firms it is aware of and its experience with document
production and the number of additional documents that have been
reported each year since the original estimate of the reporting burden.
    FDA estimates that a tobacco health document submission as required
by section 904(a)(4) of the FD&C Act, will take approximately 50 hours
per submission based on FDA experience. To derive the number of
respondents for this provision, FDA assumes that very few manufacturers
or importers, or agents thereof, would have health documents to submit.
We anticipate documents will be submitted on an annual basis for a
total of 10 respondents. FDA estimates the total annual reporting
burden to be 1,600 hours.
    Based on a review of the information collection of our current OMB
approval, we have made no adjustments to our burden estimate.

    Dated: February 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03994 Filed 2-24-22; 8:45 am]
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