[Federal Register Volume 86, Number 181 (Wednesday, September 22, 2021)]
[Notices]
[Pages 52670-52672]
[FR Doc No: 2021-20470]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OLEM-2019-0540; FRL-8998-01-OLEM]

Comprehensive Environmental Response, Compensation, and Liability
Act (CERCLA) or Superfund, Section 128(a); Notice of Grant Funding
Guidance for State and Tribal Response Programs for Fiscal Year 2022

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Comprehensive Environmental Response, Compensation, and
Liability Act (CERCLA), as amended, authorizes a noncompetitive $50
million grant program to establish or enhance state and tribal response
programs. These response programs generally address the assessment,
cleanup, and redevelopment of brown fields sites and other sites with
actual or perceived contamination. For Fiscal Year (FY) 2022, the
Environmental Protection Agency (EPA) will consider grant requests up
to a maximum of $1.0 million per state or tribe. This document
announces the availability of guidance that will assist states and
tribes in the development and submission of CERCLA section 128(a)
noncompetitive funding requests and utilization of these funds.

DATES: The FY 2022 CERCLA section 128(a) grant funding guidance is
applicable as of October 1, 2021, and EPA Regional offices will accept
requests for section 128(a) noncompetitive grant awards through
December 17, 2021.

FOR FURTHER INFORMATION CONTACT: Melissa Papasavvas, Office of
Brownfields and Land Revitalization, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number
(202) 566-0435.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be affected by this action if you administer a State or
Tribal response program that oversees

assessment and cleanup activities at brownfield sites across the
country. Note: the CERCLA definition of ``State'' includes US
Territories and the District of Columbia (CERCLA section 101(27)).

B. How can I get copies of the grant funding guidance and other related
information?

    1. Docket. The docket for this action, identified by docket
identification (ID) number EPA-HQ-OLEM-2019-0540, is available online
at https://www.regulations.gov.
    2. EPA Website. To access the FY22 section 128(a) grant funding
guidance on EPA's website, please go to https://www.epa.gov/brownfields/types-brownfields-grant-funding.

II. Authority

    CERCLA section 128(a) (42 U.S.C. 9628(a)) authorizes a
noncompetitive $50 million grant program to ``establish or enhance''
state and tribal response programs. CERCLA section
128(a)(1)(B)(ii)(III) authorizes a noncompetitive $1.5 million
technical assistance grant program to assist small communities, Indian
tribes, rural areas, or disadvantaged areas to carry out activities
outlined in CERCLA section 104(k)(7) (42 U.S.C. 9604(k)(7)) (i.e.,
providing training, research, and technical assistance to individuals
and organizations, as appropriate, to facilitate the inventory of
brownfields sites, site assessments, remediation of brownfield sites,
community involvement, or site preparation).

III. Background

    1. General. State and tribal response programs oversee assessment
and cleanup activities at brownfield sites across the country. The
depth and breadth of these programs vary. Some focus on CERCLA-related
activities, while others are multi-faceted, addressing sites regulated
by both CERCLA and the Resource Conservation and Recovery Act (42
U.S.C. 6901 et seq.). Many states also offer accompanying financial
incentive programs to spur cleanup and redevelopment. In enacting the
Small Business Liability Relief and Brownfields Revitalization Act
(Pub. L. 107-118, 115 Stat. 2356), which added section 128 to CERCLA,
Congress recognized the value of state and tribal response programs in
cleaning up and redeveloping brownfield sites. Section 128(a)
strengthens EPA's partnerships with states and tribes and recognizes
their response programs' critical role in overseeing cleanups.
    Section 128(a) response program grants are funded with categorical
State and Tribal Assistance Grant (STAG) appropriations. Categorical
grants are issued by Congress to fund state and local governments for
narrowly-defined purposes. This funding is intended for those states
and tribes that have the required management and administrative
capacity within their government to administer a federal grant. The
primary goal of this funding is to ensure that state and tribal
response programs include, or are taking reasonable steps to include,
certain elements of an environmental response program and that the
program establishes and maintains a public record of sites addressed.
    Section 128(a) cooperative agreements are awarded and administered
by the EPA regional offices. Generally, these response programs address
the assessment, cleanup, and redevelopment of brownfields sites and
other sites with actual or perceived contamination. Subject to the
availability of funds, EPA regional personnel will provide technical
assistance to states and tribes as they apply for and carry out section
128(a) cooperative agreements.
    2. Catalogue of Federal Domestic Assistance (CFDA) and EPA Funding
Opportunity Number (FON). The CFDA entry for the section 128(a) State
and Tribal Response Program cooperative agreements is 66.817. The FON
for FY 2022 section 128(a) funds is EPA-CEP-02. This grant program is
eligible to be included in state and tribal Performance Partnership
Grants under 40 CFR part 35 Subparts A and B, with the following
exceptions: funds used to capitalize a revolving loan fund for
brownfield remediation under CERCLA section 104(k)(3); funds received
for technical assistance under CERCLA section 128(a)(I)(B)(ii)(III);
and funds used to purchase environmental insurance or developing a risk
sharing pool, an indemnity pool, or insurance mechanism to provide
financing for response actions under a State or Tribal response
program.
    3. Application period. Requests for funding should be sent to the
appropriate Regional EPA contact and will be accepted from October 1,
2021 through December 17, 2021. Requests EPA Regional offices receive
after December 17, 2021 will not be considered for FY 2022 funding.
States or tribes that do not submit the request in the appropriate
manner may forfeit their ability to receive funds. First time
requestors are strongly encouraged to contact their respective Regional
EPA Brownfields contacts, identified in Table 1, prior to submitting
their funding request. EPA will consider funding requests up to a
maximum of $1.0 million per state or tribe for FY 2022.
    Requests submitted by the December 17, 2021 request deadline are
preliminary; final cooperative agreement work plans and budgets will be
negotiated with the EPA regional offices once final funding allocation
determinations are made. As in previous years, EPA will place special
emphasis on reviewing a cooperative agreement recipient's use of prior
section 128(a) funding in making allocation decisions, and unexpended
balances are subject to 40 CFR 35.118 and 35.518 to the extent
consistent with this guidance. EPA will also prioritize funding for
recipients establishing their response programs.

                Table 1--EPA Regional Brownfields Contacts for State and Tribal Response Programs
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                           Region                                       State                    Tribal
----------------------------------------------------------------------------------------------------------------
1--CT, ME, MA, NH, RI, VT...................................  AmyJean McKeown, 5 Post   AmyJean McKeown, 5 Post
                                                               Office Square, Suite      Office Square, Suite
                                                               100 (OSRR07-2), Boston,   100 (OSRR07-2), Boston,
                                                               MA 02109-3912, Phone      MA 02109-3912, Phone
<PHONE_NUMBER>, Fax<PHONE_NUMBER>, Fax
<PHONE_NUMBER>.<PHONE_NUMBER>.
2--NJ, NY, PR, VI...........................................  John Struble, 290         John Struble, 290
                                                               Broadway, 25th Floor,     Broadway, 25th Floor,
                                                               New York, NY 10007-       New York, NY 10007-
                                                               1866, Phone (212) 637-    1866, Phone (212) 637-
                                                               4291, Fax (212) 637-      4291, Fax (212) 637-
                                                               3083.                     3083.
3--DE, DC, MD, PA, VA, WV...................................  Mike Taurino, 1650 Arch   Mike Taurino, 1650 Arch
                                                               Street (3HS51),           Street (3HS51),
                                                               Philadelphia, PA 19103,   Philadelphia, PA 19103,
                                                               Phone<PHONE_NUMBER>,     Phone<PHONE_NUMBER>,
                                                               Fax<PHONE_NUMBER>.       Fax<PHONE_NUMBER>.
4--AL, FL, GA, KY, MS, NC, SC, TN...........................  Cindy Nolan, 61 Forsyth   Cindy Nolan, 61 Forsyth
                                                               Street, SW, 10TH FL       Street, SW, 10TH FL
                                                               (9T25), Atlanta, GA       (9T25), Atlanta, GA
                                                               30303-8960, Phone (404)   30303-8909, Phone (404)
                                                               562-8425, Fax (404)<PHONE_NUMBER>, Fax (404) 562-
                                                               8788.                     8788.

5--IL, IN, MI, MN, OH, WI...................................  Keary Cragan, 77 West     Rosita Clarke, 77 West
                                                               Jackson Boulevard (SB-    Jackson Boulevard (SB-
                                                               5J), Chicago, IL 60604-   5J), Chicago, IL 60604-
                                                               3507, Phone (312) 353-    3507, Phone (312) 886-
                                                               5669, Fax (312) 692-      7251, Fax (312) 697-
                                                               2161.                     2075.
6--AR, LA, NM, OK, TX.......................................  Ana Esquivel, 1201 Elm    Elizabeth Reyes, 1201
                                                               Street, Suite 500,        Elm Street, Suite 500,
                                                               Dallas, Texas 75270-      Dallas, Texas 75270-
                                                               2102, Phone (214) 665-    2102, Phone (214) 665-
                                                               3163, Fax (214) 665-      2194, Fax (214) 665-
                                                               6660.                     6660.
7--IA, KS, MO, NE...........................................  Susan Klein, 11201        Jennifer Morris, 11201
                                                               Renner Boulevard (LCRD/   Renner Boulevard ((LCRD/
                                                               BSPR), Lenexa, KS         BSPR), Lenexa, KS
                                                               66219, Phone (913) 551-   66219, Phone (913) 551-
                                                               7786.                     7341.
8--CO, MT, ND, SD, UT, WY...................................  Christina Wilson, 1595    Melisa Devincenzi, 1595
                                                               Wynkoop Street (8LCR-     Wynkoop Street (8LCR-
                                                               BR), Denver, CO 80202-    BR), Denver, CO 80202-
                                                               1129, Phone (303) 312-    1129, Phone (303) 312-
                                                               6706, Fax (303) 312-      6377, Fax (303) 312-
                                                               6065.                     6962.
9--AZ, CA, HI, NV, AS, GU, MP...............................  Jose Garcia, Jr., 600     Jose Garcia, Jr., 600
                                                               Wilshire Blvd., Suite     Wilshire Blvd., Suite
                                                               1460, Los Angeles, CA     1460, Los Angeles, CA
                                                               90017, Phone (213) 244-   90017, Phone (213) 244-
                                                               1811, Fax (213) 244-      1811, Fax (213) 244-
                                                               1850.                     1850.
10--AK, ID, OR, WA..........................................  Madison Sanders-Curry,    Madison Sanders-Curry,
                                                               1200 Sixth Ave., Suite    1200 Sixth Ave., Suite
                                                               155 (mail code 15-H04),   155 (mail code 15-H04),
                                                               Seattle, WA 98101,        Seattle, WA 98101,
                                                               Phone<PHONE_NUMBER>,     Phone<PHONE_NUMBER>,
                                                               Fax<PHONE_NUMBER>.        Fax<PHONE_NUMBER>.
----------------------------------------------------------------------------------------------------------------

    Authority: 42 U.S.C. 9628(a).

    Dated: September 16, 2021.
David R. Lloyd,
Director, Office of Brownfields and Land Revitalization.
[FR Doc. 2021-20470 Filed 9-21-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 92 (Friday, May 14, 2021)]
[Notices]
[Pages 26530-26532]
[FR Doc No: 2021-10177]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0408]

Modified Risk Tobacco Product Application: Application for the
IQOS 3 System Holder and Charger Submitted by Philip Morris Products
S.A.

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability for public comment of a modified risk tobacco product
application (MRTPA) for the IQOS 3 System Holder and Charger submitted
by Philip Morris Products S.A.

DATES: Electronic or written comments on the application may be
submitted beginning May 14, 2021. FDA will establish a closing date for
the comment period as described in section I.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): 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-2021-N-0408 for ``Modified Risk Tobacco Product Application:
Application for the IQOS 3 System Holder and Charger Submitted by
Philip Morris Products S.A.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     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 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: Samantha Loh Collado, Center for
Tobacco Products, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, 1-877-287-1373,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Section 911 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 387k) addresses the marketing and distribution of modified
risk tobacco products (MRTPs). MRTPs are tobacco products that are sold
or distributed for use to reduce harm or the risk of tobacco-related
disease associated with commercially marketed tobacco products. Section
911(a) of the FD&C Act prohibits the introduction or delivery for
introduction into interstate commerce of any MRTP unless an order
issued by FDA pursuant to section 911(g) of the FD&C Act is effective
with respect to such product.
    Section 911(d) of the FD&C Act describes the information that must
be included in a MRTPA, which must be filed and evaluated by FDA before
an applicant can receive an order from FDA. FDA is required by section
911(e) of the FD&C Act to make a MRTPA available to the public (except
for matters in the application that are trade secrets or otherwise
confidential commercial information) and to request comments by
interested persons on the information contained in the application and
on the label, labeling, and advertising accompanying the application.
The determination of whether an order is appropriate under section 911
of the FD&C Act is based on the scientific information submitted by the
applicant as well as the scientific evidence and other information that
is made available to the Agency, including through public comments.
    Section 911(g) of the FD&C Act describes the demonstrations
applicants must make to obtain an order from FDA under either section
911(g)(1) or (2). The applicant, Philip Morris Products S.A., is
seeking an order under section 911(g)(2) of the FD&C Act.
    FDA may issue an order under section 911(g)(2) of the FD&C Act with
respect to a tobacco product that does not satisfy the section
911(g)(1) standard. A person seeking an order under section 911(g)(2)
of the FD&C Act must show that:
     Such an order would be appropriate to promote the public
health;
     Any aspect of the label, labeling, and advertising for the
product that would cause the product to be an MRTP is limited to an
explicit or implicit representation that the tobacco product or its
smoke does not contain or is free of a substance or contains a reduced
level of a substance, or presents a reduced exposure to a substance in
tobacco smoke;
     Scientific evidence is not available and, using the best
available scientific methods, cannot be made available without
conducting long-term epidemiological studies for an application to meet
the standards for obtaining an order under section 911(g)(1) of the
FD&C Act;
     The scientific evidence that is available without
conducting long-term epidemiological studies demonstrates that a
measurable and substantial reduction in morbidity or mortality among
individual tobacco users is reasonably likely in subsequent studies;
     The magnitude of overall reductions in exposure to the
substance or substances which are the subject of the application is
substantial, such substance or substances are harmful, and the product
as actually used exposes consumers to the specified reduced level of
the substance or substances;
     The product as actually used by consumers will not expose
them to higher levels of other harmful substances compared to the
similar types of tobacco products then on the market unless such
increases are minimal and the reasonably likely overall impact of use
of the product remains a substantial and measurable reduction in
overall morbidity and mortality among individual tobacco users;
     Testing of actual consumer perception shows that, as the
applicant proposes to label and market the product, consumers will not
be misled into believing that the product is or has been demonstrated
to be less harmful or presents or has been demonstrated to present less
of a risk of disease than one or more other commercially marketed
tobacco products; and
     Issuance of the exposure modification order is expected to
benefit the health of the population as a whole taking into account
both users of tobacco products and persons who do not currently use
tobacco products.
    Section 911(g)(4) of the FD&C Act describes factors that FDA must
take into account in evaluating whether a tobacco product benefits the
health of individuals and the population as a whole.
    FDA is issuing this notice to inform the public that an MRTPA for
the IQOS 3 System Holder and Charger submitted by Philip Morris
Products S.A. has been filed and is being made available for public
comment. The applicant is seeking authorization to market a modified
version of the IQOS system holder and charger that previously

received an order under section 911(g)(2) of the FD&C Act \1\ as an
MRTP and is including information from the authorized MRTPA by cross-
reference.
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    \1\ The notice of availability for the IQOS MRTPAs that received
a modified risk granted order appeared in the Federal Register of
June 15, 2017 (82 FR 27487), and the docket containing notices and
public comments, FDA-2017-D-3001, is accessible at: https://www.regulations.gov/docket/FDA-2017-D-3001/.
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    FDA will post the application documents, including those cross-
referenced from prior submissions previously authorized and those
contained in any amendments, for public comment in batches on a rolling
basis as they are redacted in accordance with applicable laws. In this
document, FDA is announcing the availability of the first batch of
application documents for public comment. FDA intends to establish a
closing date for the comment period that is both at least 45 days after
the date this notice publishes and at least 30 days after the final
documents from the application are made available for public comment.
FDA will announce the closing date at least 30 days in advance. FDA
believes that this comment period is appropriate given the relatively
low volume of information in the MRTPA that has not already been
available for public comment as part of the previously authorized
MRTPAs for the IQOS system. FDA will notify the public about the
availability of application documents and comment period closing date
via the Agency's web page for the MRTPA (see section II) and by other
means of public communication, such as by email to individuals who have
signed up to receive email alerts. FDA does not intend to issue
additional notices in the Federal Register regarding the availability
of additional application documents, including amendments, or the
comment period for this MRTPA. To receive email alerts, visit FDA's
email subscription service management website (https://www.fda.gov/about-fda/contact-fda/get-email-updates), provide an email address,
scroll down to the ``Tobacco'' heading, select ``Modified Risk Tobacco
Product Application Update'', and click ``Submit''. To encourage public
participation consistent with section 911(e) of the FD&C Act, FDA is
making the redacted MRTPA that is the subject of this notice available
electronically (see section II).

II. Electronic Access

    Persons with access to the internet may obtain the application
documents at either https://www.fda.gov/tobacco-products/advertising-and-promotion/philip-morris-products-sa-modified-risk-tobacco-product-mrtp-applications or http://www.regulations.gov.

    Dated: May 10, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10177 Filed 5-13-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Rules and Regulations]
[Pages 34278-34280]
[FR Doc No: 2016-12720]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2016-0319]
RIN 1625-AA00

Safety Zone; Chesapeake Bay, Cape Charles, VA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a safety zone on the navigable
waters of the Chesapeake Bay in Cape Charles, Virginia. This safety
zone will restrict vessel movement in the specified area during a
fireworks display. This action is necessary to provide for the safety
of life and property on the surrounding navigable waters during the
fireworks display.

DATES: This rule is effective and enforced from 8 p.m. through 8:30
p.m. on July 2, 2016.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2016-0319 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 LCDR Barbara Wilk, Waterways Management Division Chief,
Sector Hampton Roads, 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
E.O. Executive order
FR Federal Register
NPRM Notice of proposed rulemaking
Pub. L. Public Law
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 is impracticable, because information about
the fireworks on July 2, 2016 was not received by the Coast Guard with
sufficient time to allow for an opportunity to comment on the proposed
rule. Publishing an NPRM would also be contrary to the public interest
as immediate action is needed to ensure the safety of the fireworks
participants, patrol vessels, and other vessels transiting the
fireworks display area. The Coast Guard will provide advance
notifications to users of the affected waterway via marine information
broadcasts and local notice to mariners. For the same reasons, we find
good cause, under 5 U.S.C. 553(d)(3), for making this rule effective
less than 30 days after publication in the Federal Register.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port Hampton Roads (COTP) has determine that
potential hazards associated with the fireworks display starting on
July 2, 2016 will be a safety concern for anyone within a 420-foot
radius of the fireworks barge. This rule is needed to protect the
participants, patrol vessels, and other vessels transiting the
navigable waters of the Chesapeake Bay, in the vicinity of the Sunset
Beach Resort in Cape Charles, VA from hazards associated with a
fireworks display. The potential hazards to mariners within the safety
zone include accidental discharge of fireworks, dangerous projectiles,
and falling hot embers or other debris.

IV. Discussion of the Rule

    The Captain of the Port of Hampton Roads is establishing a safety
zone on the Chesapeake Bay, in the vicinity of the Sunset Beach Resort,
in Cape Charles, VA. The safety zone will encompass all navigable
waters within a 420 foot radius of the fireworks display barge
location. This safety zone still allows for navigation on the waterway.
This safety zone will be effective and enforced from 8 p.m. through
8:30 p.m. on July 2, 2016. Access to the safety zone will be restricted
during the effective period. Except for participants and vessels
authorized by the Captain of the Port or his Representative, no person
or vessel may enter or remain in the regulated area.
    The Captain of the Port will give notice of the enforcement of the
safety zone by all appropriate means to provide the widest
dissemination of notice to the affected segments of the public. This
includes publication in the Local Notice to Mariners and Marine
Information Broadcasts.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders (E.O.s) related to rulemaking. Below we summarize our
analyses based on a number of these statutes and E.O.s, and we discuss
First Amendment rights of protestors.

A. Regulatory Planning and Review

    E.O.s 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.
E.O. 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has not been designated a ``significant
regulatory action,'' under E.O. 12866. Accordingly, it has not been
reviewed by the Office of Management and Budget.
    Although this safety zone restricts vessel traffic through the
regulated area, the effect of this rule will not be significant
because: (i) This rule will only be enforced for the limited size and
duration of the event; and (ii) the Coast Guard will make extensive
notification to the maritime community via marine information
broadcasts so mariners may adjust their plans accordingly.

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
contact 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 E.O. 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 E.O. 13132.
    Also, this rule does not have tribal implications under E.O. 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. If you believe this rule has
implications for federalism or Indian tribes, please contact the person
listed in the FOR FURTHER INFORMATION CONTACT section above.

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
Management Directive 023-01 and Commandant Instruction M16475.lD, 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 less than 2 hours that will
prohibit entry within 420 feet of the fireworks display. It is
categorically excluded from further review under paragraph 34(g) of
Figure 2-1 of the Commandant Instruction. An environmental analysis
checklist supporting this determination and a Categorical Exclusion
Determination are 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 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.

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 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: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T05-0319 to read as follows:

Sec.  165.T05-0319  Safety Zone, Chesapeake Bay; Cape Charles, VA.

    (a) Definitions. For the purposes of this section, Captain of the
Port means the Commander, Sector Hampton Roads. Representative means
any Coast Guard commissioned, warrant or petty officer who has been
authorized to act on the behalf of the Captain of the Port.
Participants mean individuals and vessels involved in explosives
training.
    (b) Locations. The following area is a safety zone:
    (1) All waters in the vicinity of the of the Sunset Beach Resort,
on the Chesapeake Bay, within a 420 foot radius of the fireworks
display barge in approximate position 37[deg]08'12'' N.,
075[deg]58'34'' W. (NAD 1983).
    (c) Regulations. (1) All persons are required to comply with the
general regulations governing safety zones in Sec.  165.23 of this
part.
    (2) With the exception of participants, entry into or remaining in
this safety zone is prohibited unless authorized by the Captain of the
Port, Hampton Roads or his designated representatives.
    (3) All vessels underway within this safety zone at the time it is
implemented are to depart the zone immediately.
    (4) The Captain of the Port, Hampton Roads or his representative
can be contacted at telephone number<PHONE_NUMBER>.
    (5) The Coast Guard and designated security vessels enforcing the
safety zone can be contacted on VHF-FM marine band radio channel 13
(165.65Mhz) and channel 16 (156.8 Mhz).
    (6) This section applies to all persons or vessels wishing to
transit through the

safety zone except participants and vessels that are engaged in the
following operations:
    (i) Enforcing laws;
    (ii) Servicing aids to navigation, and
    (iii) Emergency response vessels.
    (7) The U.S. Coast Guard may be assisted in the patrol and
enforcement of the safety zone by Federal, State, and local agencies.
    (d) Enforcement Period. This section will be enforced from 8 p.m.
through 8:30 p.m. on July 2, 2016.

    Dated: May 17, 2016.
Christopher S. Keane,
Captain, U.S. Coast Guard, Captain of the Port Hampton Roads.
[FR Doc. 2016-12720 Filed 5-27-16; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 65 (Wednesday, April 4, 2018)]
[Rules and Regulations]
[Page 14367]
[FR Doc No: 2018-06811]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2018-0271]

Drawbridge Operation Regulation; Barnegat Bay, New Jersey
Intracoastal Waterway, Seaside Heights, NJ

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the U.S. Route 37 (Mathis) Bridge
across the Barnegat Bay, New Jersey Intracoastal Waterway, mile 14.1,
at Seaside Heights, NJ. The deviation is necessary to facilitate
routine maintenance. This deviation allows the bridge to remain in the
closed-to-navigation position.

DATES: This deviation is effective without actual notice from April 4,
2018 through 8 p.m. on April 16, 2018. For the purposes of enforcement,
actual notice will be used from 12:01 a.m. on April 1, 2018 until April
4, 2018.

ADDRESSES: The docket for this deviation, [USCG-2018-0271] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH''. Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Mickey Sanders, Bridge
Administration Branch Fifth District, Coast Guard; telephone (757) 398-
6587, email [email protected].

SUPPLEMENTARY INFORMATION: The New Jersey Department of Transportation,
owner and operator of the U.S. Route 37 (Mathis) Bridge across the
Barnegat Bay, New Jersey Intracoastal Waterway, mile 14.1, at Seaside
Heights, NJ, has requested a temporary deviation from the current
operating schedule to accommodate routine maintenance. Under this
temporary deviation, the bridge will be maintained in the closed-to-
navigation position from 12:01 a.m. on April 1, 2018, to 8 p.m. on
April 16, 2018. The current operating schedule is set out in 33 CFR
117.733(c).
    The Barnegat Bay, New Jersey Intracoastal Waterway is used by a
variety of vessels including small commercial vessels, recreational
vessels and tug and barge traffic. The Coast Guard has carefully
considered the restrictions with waterway users in publishing this
temporary deviation.
    Vessels able to pass through the bridge in the closed position may
do so at any time. The bridge will not be able to open for emergencies
and there is no immediate alternate route for vessels unable to pass
through the bridge in the closed position. The Coast Guard will also
inform the users of the waterways through our Local and Broadcast
Notice to Mariners of the change in operating schedule for the bridge
so that vessel operators can arrange their transits to minimize any
impact caused by this temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of this effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: March 30, 2018.
Hal R. Pitts,
Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2018-06811 Filed 4-3-18; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 21 (Wednesday, January 31, 2018)]
[Notices]
[Pages 4479-4480]
[FR Doc No: 2018-01915]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2017-0474; FRL-9973-13-ORD]

Availability of the Integrated Risk Information System (IRIS)
Assessment Plan for Uranium

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.

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

SUMMARY: The Environmental Protection Agency (EPA) is announcing a 30-
day public comment period associated with release of the draft IRIS
Assessment Plan for Uranium. This document communicates information on
the scoping needs identified by EPA program and regional offices and
the IRIS Program's initial problem formulation activities.
Specifically, the assessment plan outlines the objectives for each
assessment and the type of evidence considered most pertinent to
address the scoping needs. EPA is releasing this draft IRIS Assessment
Plan for public comment at least 60 days in advance of a public science
webinar planned on March 22, 2018.

DATES: The 30-day public comment period begins January 31, 2018, and
ends March 2, 2018. Comments must be received on or before March 2,
2018.

ADDRESSES: The IRIS Assessment Plan for Uranium, will be available via
the internet on IRIS' website at https://cfpub.epa.gov/ncea/iris2/chemicalLanding.cfm?substance_nmbr=259 and in the public docket at
https://www.regulations.gov, Docket ID: EPA-HQ-ORD-2017-0474.

FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the ORD Docket at the EPA Headquarters Docket Center;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or email:
[email protected].
    For technical information on the draft IRIS Assessment Plan for
Uranium, contact Dr. James Avery, NCEA; telephone:<PHONE_NUMBER>; or
email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background Information on IRIS Assessment Plans

    EPA's IRIS Program is a human health assessment program that
evaluates quantitative and qualitative risk information on effects that
may result from exposure to chemicals found in the environment. Through
the IRIS Program, EPA provides the highest quality science-based human
health assessments to support the Agency's regulatory activities and
decisions to protect public health. As part of scoping and initial
problem formulation activities prior to the development of a draft
assessment, the IRIS Program carries out a broad, preliminary
literature survey to assist in identifying health effects that have
been studied in relation to the chemical or substance of interest, as
well as science issues that may need to be considered when evaluating
toxicity. This information, in conjunction with scoping needs
identified by EPA program and regional offices, is used to inform the
development of an IRIS Assessment Plan (IAP).
    The IAP communicates the plan for developing each individual
chemical assessment to the public and includes summary information on
the IRIS Program's scoping and initial problem formulation, objectives
and specific aims for the assessment, and a PECO (Populations,
Exposures, Comparators, and Outcomes) for the systematic review. The
PECO provides the framework for developing literature search strategies
and inclusion/exclusion criteria, particularly with respect to evidence
stream (i.e., human, animal, mechanistic), exposure measures and
outcome measures. The IAP serves to inform the subsequent development
of chemical-specific systematic review protocols, which will be made
publicly available.

II. Public Webinar

    In order to allow for public input, EPA is convening a public
webinar to discuss the draft IRIS Assessment Plan for Uranium March 22,
2018. Specific teleconference and webinar information regarding this
public meeting will be provided through the IRIS website (https://www.epa.gov/iris) and via EPA's Human Health Risk Assessment (HHRA) and
IRIS listservs. To register for the HHRA or IRIS listserv, visit the
IRIS website (https://www.epa.gov/iris) or visit https://www.epa.gov/iris/forms/staying-connected-integrated-risk-information-system#connect.

III. How To Submit Technical Comments to the Docket at http://www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2017-
0474 for uranium, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email: [email protected].
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Environmental Protection Agency, EPA Docket
Center (ORD Docket), Mail Code: 28221T, 1200 Pennsylvania Avenue NW,
Washington, DC 20460. The phone number is<PHONE_NUMBER>.
     Hand Delivery: The ORD Docket is located in the EPA
Headquarters Docket Center, EPA West Building, Room 3334, 1301
Constitution Avenue NW, Washington, DC 20229.
    The EPA Docket Center Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>.
Deliveries are only accepted during the docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information. If you provide comments by mail or hand delivery,
please submit three copies of the comments. For attachments, provide an
index, number pages consecutively with the comments, and submit an
unbound original and three copies.
    Instructions: Direct your comments to docket number EPA-HQ-ORD-
2017-0474 for uranium. Please ensure that your comments are submitted
within the specified comment period. Comments received after the
closing date will be marked ``late,'' and may only be considered if
time permits. It is EPA's policy to include all comments it receives in
the public docket without change and to make the comments available
online at www.regulations.gov, including any personal information
provided, unless a comment includes information claimed to be
Confidential Business Information (CBI) or other information for which
disclosure is restricted by statute. Do not submit information through
www.regulations.gov or email that you consider to be CBI or otherwise
protected. The www.regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an

email comment directly to EPA without going through
www.regulations.gov, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. 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. For additional information about EPA's public docket visit the
EPA Docket Center homepage at www.epa.gov/epahome/dockets.htm.
    Docket: Documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other materials,
such as copyrighted material, are publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the ORD Docket in the EPA
Headquarters Docket Center.

    Dated: January 8, 2018.
Tina Bahadori,
Director, National Center for Environmental Assessment.
[FR Doc. 2018-01915 Filed 1-30-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 216 (Wednesday, November 7, 2012)]
[Proposed Rules]
[Page 66791]
[FR Doc No: 2012-27156]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 67

[Docket ID FEMA-2011-0002; Internal Agency Docket No. FEMA-B-1233]

Proposed Flood Elevation Determinations for Yakima County, WA,
and Incorporated Areas

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Proposed rule; withdrawal.

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

SUMMARY: The Federal Emergency Management Agency (FEMA) is withdrawing
its proposed rule concerning proposed flood elevation determinations
for Yakima County, Washington, and Incorporated Areas.

DATES: This withdrawal is effective November 7, 2012.

ADDRESSES: You may submit comments, identified by Docket No. FEMA-B-
1233, to Luis Rodriguez, Chief, Engineering Management Branch, Federal
Insurance and Mitigation Administration, Federal Emergency Management
Agency, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
Federal Emergency Management Agency, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On November 29, 2011, FEMA published a
proposed rulemaking at 76 FR 73537, proposing flood elevation
determinations along one or more flooding sources in Yakima County,
Washington. Because FEMA has or will be issuing a Revised Preliminary
Flood Insurance Rate Map, and if necessary a Flood Insurance Study
report, featuring updated flood hazard information, the proposed
rulemaking is being withdrawn. A Notice of Proposed Flood Hazard
Determinations will be published in the Federal Register and in the
affected community's local newspaper.

    Authority: 42 U.S.C. 4104; 44 CFR 67.4.

    Dated: October 12, 2012
James A. Walke,
Acting Deputy Associate Administrator for Mitigation, Department of
Homeland Security, Federal Emergency Management Agency.
[FR Doc. 2012-27156 Filed 11-6-12; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)]
[Notices]
[Pages 8501-8502]
[FR Doc No: 2016-03461]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0310]

Guidance for Industry on Immunogenicity-Related Considerations
for Low Molecular Weight Heparin; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Immunogenicity-
Related Considerations for Low Molecular Weight Heparin.'' This
guidance discusses how applicants for low molecular weight heparin
(LMWH) products should provide information on impurities and their
potential impact on immunogenicity.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-D-0310 for ``Immunogenicity-Related Considerations for Low
Molecular Weight Heparin.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper

submission. You should submit two copies total. One copy will include
the information you claim to be confidential with a heading or cover
note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''.
The Agency will review this copy, including the claimed confidential
information, in its consideration of comments. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets
Management. If you do not wish your name and contact information to be
made publicly available, you can provide this information on the cover
sheet and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Daniela Verthelyi, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Immunogenicity-Related Considerations for Low Molecular
Weight Heparin.'' It finalizes the draft guidance entitled
``Immunogenicity-Related Considerations for the Approval of Low
Molecular Weight Heparin for New Drug Applications and Abbreviated New
Drug Applications'' that published on April 9, 2014 (79 FR 19621). FDA
has considered the comments submitted to the public docket and modified
statements and added terms for clarity.
    This guidance provides recommendations to applicants for new drug
applications (NDAs) and abbreviated new drug applications (ANDAs)
regarding impurities and their potential effect on immunogenicity for
LMWH. This guidance also includes recommendations for ANDA applicants
on meeting the requirement for active ingredient sameness, because a
demonstration of active ingredient sameness helps to address
immunogenicity considerations in this context. In addition, this
guidance discusses how to address changes in the source material or
other component, or when there are modifications to the manufacturing
process after completion of supporting clinical studies, either before
or after approval of the application.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). This guidance represents the
Agency's current thinking on immunogenicity considerations for low
molecular weight heparin. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. The Paperwork Reduction Act

    This guidance refers to a previously approved collection of
information that is subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collection of information in 21 CFR part 314 has been
approved under OMB control number 0910-0001.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: February 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03461 Filed 2-18-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 67 (Friday, April 7, 2023)]
[Notices]
[Page 20875]
[FR Doc No: 2023-07338]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas & Oil Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: PR23-33-000.
    Applicants: Bay Gas Storage Company, LLC.
    Description: Report Filing: Bay Gas Storage Supplemental LAUF
Filing to be effective N/A.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5446.
    Comment Date: 5 p.m. ET 4/21/23.

    Docket Numbers: RP23-657-000.
    Applicants: Hardy Storage Company, LLC.
    Description: Sec.  4(d) Rate Filing: RAM 2023 to be effective 5/1/
2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5273.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-658-000.
    Applicants: Northern Natural Gas Company.
    Description: Sec.  4(d) Rate Filing: 20230331 Negotiated Rate to be
effective 4/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5276.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-659-000.
    Applicants: Cheyenne Connector, LLC.
    Description: Compliance filing: CC 2023-03-31 Annual L&U Report to
be effective N/A.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5289.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-660-000.
    Applicants: Dauphin Island Gathering Partners.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Filing 3-31-
2023 to be effective 4/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5293.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-661-000.
    Applicants: Northern Border Pipeline Company.
    Description: Sec.  4(d) Rate Filing: Fuel Mechanism Implementation
to be effective 5/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5297.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-662-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: OTRA Summer 2023 to be
effective 5/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5302.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-663-000.
    Applicants: NEXUS Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Various
Releases eff 4-1-23 to be effective 4/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5308.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-664-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Compliance filing: TETLP March 2023 Penalty
Disbursement Report to be effective N/A.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5309.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-665-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Compliance filing: AGT March 2023 OFO Penalty
Disbursement Report to be effective N/A.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5331.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-666-000.
    Applicants: Tennessee Gas Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Volume No. 2--Koch Energy
Services, LLC SP385736 to be effective 4/1/2023.
    Filed Date: 3/31/23.
    Accession Number: 20230331-5438.
    Comment Date: 5 p.m. ET 4/12/23.

    Docket Numbers: RP23-667-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Various
Releases eff 4-1-23 to be effective 4/1/2023.
    Filed Date: 4/3/23.
    Accession Number: 20230403-5002.
    Comment Date: 5 p.m. ET 4/17/23.

    Docket Numbers: RP23-668-000.
    Applicants: NEXUS Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Enbridge Gas
to DTE 963130 eff 4-2-23 to be effective 4/2/2023.
    Filed Date: 4/3/23.
    Accession Number: 20230403-5009.
    Comment Date: 5 p.m. ET 4/17/23.

    Docket Numbers: RP23-669-000.
    Applicants: Equitrans, L.P.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Capacity
Release Agreements--4/1/2023 to be effective 4/1/2023.
    Filed Date: 4/3/23.
    Accession Number: 20230403-5027.
    Comment Date: 5 p.m. ET 4/17/23.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: April 3, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-07338 Filed 4-6-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 133 (Thursday, July 15, 2021)]
[Notices]
[Pages 37339-37340]
[FR Doc No: 2021-14757]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2020-0278]

Port Access Route Study: Northern New York Bight

AGENCY: Coast Guard, DHS.

ACTION: Notice of availability of draft report and public meeting;
request for comments.

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SUMMARY: From June 29, 2020, through June 28, 2021, the Coast Guard
conducted the Northern New York Bight Port Access Route Study
(NNYBPARS) and is now requesting your comments on a draft version of
the study report. The goal of the study is to evaluate the adequacy of
existing vessel routing measures and determine whether additional
vessel routing measures are necessary for port approaches to New York
and New Jersey and international and domestic transit areas in the
First District area of responsibility. To accomplish this goal, the
Coast Guard has undertaken measures to determine whether existing or
additional routing measures are necessary to improve navigation safety
due to factors such as planned or potential offshore development,
current port capabilities and planned improvements, increased vessel
traffic, existing and potential anchorage areas, changing vessel
traffic patterns, effects of weather, or navigational difficulty. We
seek your comments on the content and development of the report.

DATES: Your comments and related material must reach the Coast Guard on
or before August 30, 2021.
    Although the Coast Guard prefers and highly encourages all comments
and related material be submitted directly to the electronic docket, a
public meeting will be held via webinar and teleconference to provide
an opportunity for oral comments about the NNYBPARS draft report on
Friday, July 30, 2020, beginning at 9 a.m. EST.
    Additional public meetings dates may be added. Information as to
the date, time, and location of these in person public meetings will be
posted at https://www.navcen.uscg.gov/?pageName=PARS by July 23, 2021.

ADDRESSES: You may submit comments identified by docket number USCG-
2020-0278 using the Federal portal at https://www.regulations.gov. See
the ``Public Participation and Request for Comments'' portion of the
SUPPLEMENTARY INFORMATION section for further instructions on
submitting comments.
    A virtual public meeting on Friday, July 30, 2020, beginning at 9
a.m. EST, will be held via webinar and teleconference.
    Access information for this virtual public meeting will be posted
at https://www.navcen.uscg.gov/?pageName=PARS by July 23, 2021.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
contact Mr. Craig Lapiejko, Waterways Management at First Coast Guard
District, telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

ACPARS Atlantic Coast Port Access Route Study
AIS Automatic Identification System
COMDTINST Commandant Instruction
DHS Department of Homeland Security
EEZ Exclusive Economic Zone
IMO International Maritime Organization
MTS Marine Transportation System
NAD83 North American Datum of 1983
NNYB Northern New York Bight
PARS Port Access Route Study
PWSA Ports and Waterways Safety Act
TSS Traffic Separation Scheme
USCG United States Coast Guard

II. Background and Purpose

    The Ports and Waterways Safety Act (46 U.S.C. 70003(c)) requires
the Coast Guard to conduct a Port Access Route Study (PARS), i.e., a
study of potential traffic density and the need for safe access routes
for vessels. Through the study process, the Coast Guard coordinates
with Federal, State, local, tribal and foreign state agencies (as
appropriate) to consider the views of maritime community
representatives, environmental groups, and other interested
stakeholders. The primary purpose of this coordination is, to the
extent practicable, to reconcile the need for safe access routes with
other reasonable waterway uses such as construction and operation of
renewable energy facilities and other uses of the Atlantic Ocean in the
study area.
    In 2019, the Coast Guard announced a new study of routes used by
ships to access ports on the Atlantic Coast of the United States in the
Federal Register (84 FR 9541; March 15, 2019). This new study
supplements and builds upon the ACPARS by conducting a series of PARS
to examine ports along the Atlantic Coast that are economically
significant or support military or critical national defense operations
and related international entry and departure transit areas that are
integral to the safe and efficient and unimpeded flow of commerce to/
from major international shipping lanes. The NNYBPARS is one of several
studies being conducted.
    On June 29, 2020, the First Coast Guard District published a notice
of study and public meetings; request for comments entitled ``Port
Access Route Study (PARS): Northern New York Bight'' in the Federal
Register (85 FR 38907) to evaluate the adequacy of existing vessel
routing measures and determine whether additional vessel routing
measures are necessary for port approaches to New York and New Jersey
and international and domestic transit areas in the First District area
of responsibility.
    The public was afforded a 60-day comment period, and two virtual
public meetings were held via teleconference and webinar to receive
public input. The Coast Guard received 25 comments to this document in
response to our Federal Register Notice, public meetings and other
outreach efforts. All comments and supporting documents to this
document are available in a public

docket and can be viewed at http://www.regulations.gov.
    On April 12, 2021, we published a supplemental notice of study;
request for comments entitled ``Port Access Route Study (PARS):
Northern New York Bight'' in the Federal Register (86 FR 18996) seeking
additional information.
    The public was afforded a 30-day comment period. The Coast Guard
received five comments to this document in response to our Federal
Register Notice, and other outreach efforts. All comments and
supporting documents to this document are available in a public docket
and can be viewed at http://www.regulations.gov.
    During both comment periods a total of 30 comments were submitted
by representatives of the maritime community, wind energy developers,
non-governmental organizations, Federal and State governmental
agencies, and private citizens.
    Of the thirty comments, fourteen requested additional routing
measures be established, twelve expressed concerns that wind farm
installations will negatively affect vessel's marine radar performance,
eight requested setback/buffer zones, six requested anchorages be
designated, six requested additional meetings, three requested
alteration of existing routing measures, and three requested expanding
Vessel Traffic Services.
    A synopsis of the comments and copies of the Coast Guard's Public
outreach can be found in the report. The Coast Guard is opening this
third and final NNYBPARS comment period to facilitate transparent
public discussions on the information above as well as the draft report
findings to date.

III. Information Requested

    Do you agree or disagree with the draft report's recommendations,
propose actions, or continued actions, and if so, why?

V. Public Participation and Request for Comments

    We encourage you to comment on the content and development of the
report through the Federal eRulemaking Portal at https://www.regulations.gov.
    A. Viewing the draft version of the report: To view the draft
version of the NNYBPARS report in the docket, go to http://www.regulations.gov, and insert ``USCG-2020-0278'' in the ``search
box.'' Click ``Search''. Then scroll down looking of the document
entitled ``DRAFT REPORT Northern New York Bight PARS June 29, 2021''
under the document type ``Supporting & Related Material.''
    B. Submitting Comments: To submit your comment online, go to http://www.regulations.gov, and insert ``USCG-2020-0278'' in the ``search
box.'' Click ``Search''. Then click ``Comment.'' The ``Comment'' button
can be found on the following pages:
     Docket Details page when a document within the docket is
open for comment,
     Document Details page when the document is open for
comment, and
     Document Search Tab with all search results open for
comment displaying a ``Comment'' button.
    Clicking ``Comment'' on any of the above pages will display the
comment form. You can enter your comment on the form, attach files
(maximum of 20 files up to 10MB each), and choose whether to identify
yourself as an individual, an organization, or anonymously. Be sure to
complete all required fields depending on which identity you have
chosen. Once you have completed all required fields and chosen an
identity, the ``Submit Comment'' button is enabled. Upon completion,
you will receive a Comment Tracking Number for your comment. For
additional step by step instructions, please see the Frequently Asked
Questions page on http://www.regulations.gov or by clicking https://www.regulations.gov/faq.
    We accept anonymous comments. Comments we post to http://www.regulations.gov and will include any personal information you have
provided. For more about privacy and submissions to the docket in
response to this document, see DHS's eRulemaking System of Records
notice (85 FR 14226, March 11, 2020).
    We review all comments and materials received during the comment
period, but we may choose not to post off-topic, inappropriate, or
duplicate comments that we receive.
    C. How do I find and browse for posted comments on Regulations.gov.
On the previous version of Regulations.gov, users browse for comments
on the Docket Details page. However, since comments are made on
individual documents, not dockets, new Regulations.gov organizes
comments under their corresponding document. To access comments and
documents submitted to this draft version of the study report go to
http://www.regulations.gov, and insert ``USCG-2020-0278'' in the
``search box.'' Click ``Search''. Then scroll down to and click on the
``notice'' entitled ``Port Access Route Study: Notice of availability
of draft report and public information session; request for comments.''
This will open to the ``Document Details'' page. Then click on the
``Browse Comments'' tab. On the comment tab, you can search and filter
comments. Note: If no comments have been posted to a document, the
``Comments'' tab will not appear on the Document Details page.
    D. If you need additional help navigating the new Regulations.gov.
For additional step by step instructions to submit a comment or to view
submitted comments or other documents please see the Frequently Asked
Questions (FAQs) at http://www.regulations.gov/faqs or call or email
the person in the FOR FURTHER INFORMATION CONTACT section of this
document for alternate instructions.
    E. Privacy Act: Anyone can search the electronic form of comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review a
Privacy Act, system of records notice regarding DHS's eRulemaking in
the March 11, 2020, issue of the Federal Register (85 FR 14226).

VI. Future Actions

    Any comments received will be reviewed and considered before a
final version of the NNYBPARS is announced in the Federal Register.
    This notice is published under the authority of 46 U.S.C. 70004 and
5 U.S.C. 552(a).

    Dated: June 28, 2021.
T.G. Allan Jr.,
Rear Admiral, U.S. Coast Guard, Commander, First Coast Guard District.
[FR Doc. 2021-14757 Filed 7-13-21; 4:15 pm]
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