Materials Characterization Paper

In Support of the

Advanced Notice of Proposed Rulemaking –

Identification of Nonhazardous Materials That Are Solid Waste

Blast Furnace Slag - Used as ingredient in clinker manufacture

December 16, 2008

=================================================================

1.	Definition of BFS

Blast furnace slag (BFS) is a nonmetallic byproduct of the manufacture
of pig iron in a blast furnace. BFS consists primarily of silicates,
aluminosilicates, and calcium-alumina-silicates. BFS forms when slagging
agents (e.g., iron ore, coke ash, and limestone) are added to the iron
ore to remove impurities. In the process of reducing iron ore to iron, a
molten slag forms as a non-metallic liquid (consisting primarily of
silicates and aluminosilicates of calcium and other bases) that floats
on top of the molten iron.  The molten slag is then separated from the
liquid metal and cooled. Different forms of slag product are produced
depending on the method used to cool the molten slag and subsequent
processing:  (1) granulated blast furnace slag (GBFS) is produced by
quickly quenching (chilling) molten slag to produce a glassy, granular
product; (2) GBFS can further be ground to a specified fineness,
yielding ground granulated blast furnace slag (GGBFS); (3) blast furnace
slag aggregate (BFSA) is produced by allowing the molten slag to cool
and solidify slowly under ambient (atmospheric) conditions. BFSA and
GBFS are used in clinker manufacture (EPA 2008).

2.	Annual Quantities of BFS Generated and Used

Sectors that generate BFS:

Blast furnace slag is generated by NAICS industry sector 331111, Iron
and Steel Mills.

Quantities and prices of BFS generated:

In 2004, between 13 and 15 million short tons of blast furnace slag were
generated in the U.S (van Oss 2004).

In addition, approximately one million short tons of blast-furnace slag
were imported into the United States in 2005.

In 2004, average sales prices for GBFS were $55.79 per short ton, with a
reported range of $20.00 per ton for un-ground GBFS to $64.99 per ton
for GGBFS (EPA 2008).

In 2004, average sales prices of BFSA were $5.90 per short ton, with a
range of $1.40 to $15.74 per short ton (EPA 2008).

Trends in generation of BFS:

The generally declining trend in the U.S. output of iron and steel
implies future overall supply constraints from domestic sources,
especially as existing stockpiles get drawn down. This is especially
true for the long-term availability of air-cooled slag, given the
continuing decline in the number of operating blast furnaces (van Oss
2006).

2005, with no assurance of restarting. Retroﬁtting other blast
furnaces with granulators is possible and a handful of new slag grinders
are being constructed in the U.S., which will likely increase GGBFS
supply in coming years (EPA 2008).

3.	Uses of BFS

Ingredient uses of BFS:

Both BFSA and GBFS can be added to the raw material feed in clinker
manufacturing to contribute specific required elements, such as silica,
alumina, calcium, and magnesium in the final cement composition. The
primary virgin material used in clinker manufacture is limestone, with
smaller quantities of sand, clay, and shale to achieve the correct
mineral composition. Thus, BFS partially offsets these virgin raw feed
materials.

Cement kilns are represented by NAICS industry sector 327310, Cement
Manufacturing, which included 247 facilities in 2002 (U.S. Census
Bureau, 2002). EPA reports that this sector included 144 facilities in
2006 (EPA 2006).

Non-combustion uses of BFS:

Blast furnace slag aggregate is used as a substitute for virgin
aggregate in road base, concrete, asphalt concrete, rail ballast,
roofing, shingles, mineral wool, and glass making.

GGBFS can be used as a supplementary cementitious material either by
premixing the slag with portland cement or hydrated lime to produce a
blended cement (during the cement production process) or by adding the
slag to portland cement concrete as a mineral admixture.

Quantities of BFS landfilled:

No data exist on the disposal or landfilling of blast-furnace slag, but
it is likely that the utilization of blast furnace slag is nearly 100
percent of U.S. production, reflecting the high value of these materials
as cementitious materials, aggregates, or components of blended cements
(EPA 2008).

Quantities of BFS stockpiled/stored:

A preliminary sampling of three blast furnace slag processors in the
U.S. has identified approximately 100 million metric tons of stockpiled
slag as of 2006 (Connor, Martin, and Wolanske 2006). The total quantity
of stockpiled slag in the U.S. is likely significantly higher, but
additional slag processors have not been surveyed to obtain an estimate.

It is unclear what percentage of the known 100 million metric tons of
stockpiled slag is suitable for use in clinker manufacture.

 Exhibit 1:  Overview of Generation and Use of BFS in 2004

Commodity	Annual Quantity Generated 	Annual Quantity Used as Ingredient
Annual Quantity Landfilled	Annual Quantity in Other Uses	Total Quantity
Stockpiled as of 2006

Cement Kilns	Other

-------------------- Short Tons --------------------

Blast Furnace Slag 	12.0-14.0 million	0.25 million	0	0	11.58 million
>100 milliona

Sources:

Unless otherwise noted, data is from U.S. EPA, April 28, 2008, Study on
Increasing the Usage of Recovered Mineral Components in Federally Funded
Projects Involving Procurement of Cement or Concrete to Address the

Safe, Accountable, Flexible, Efficient Transportation Equity Act: A
Legacy for Users.

Notes:

a. Personal communication with Jamie Connor, Tube City IMS Corporation,
Chuck Martin, Beaver Valley Slag, Inc., and Max Wolanske, Lafarge NA,
December 5, 2006 and December 6, 2006.

4.	Management and Combustion processes for BFS

Types of units using BFS

Blast furnace slag is added to cement kilns during the clinker
manufacturing process.

Sourcing of BFS

Cement manufacturing facilities purchase blast furnace slag directly
from iron mills or from a slag processing/grinding facility.

Processing of BFS:

Once molten slag has been cooled into either BFSA or GBFS, no further
processing is required for use as a raw material in clinker manufacture.

State status of BFS use as ingredient:

At this stage, we have not identified any states that have specifically
granted beneficial use designation to the use of blast furnace slag in
clinker manufacture, but we have not performed an exhaustive
investigation of state activities and regulations.

5.	BFS Composition and Impacts

Composition of BFS:

The chemical composition of BFS includes: calcium oxide (CaO), silicon
dioxide (SiO2), aluminum oxide (Al2O3), magnesium oxide (MgO), iron (FeO
or Fe2O3), manganese oxide (MnO), and sulfur (S) (Turner-Fairbank
Highway Research Center).

When heated to high temperatures (1450 degrees Celsius) in a cement
kiln, some of the chemical constituents of slag may be volatized.

Impacts of BFS use:

In clinker manufacture, blast furnace slag partially offsets the need
for virgin materials such as limestone, sand, clay, and shale.
Substitution of slags for natural raw materials to make clinker can
reduce the unit consumption of fuel and limestone in the kiln, which may
then reduce the emissions of certain pollutants (van Oss 2006).

The specific lifecycle impacts of BFS use as a raw material in clinker
production are not evaluated here because of uncertainties in lifecycle
scenario development. For example, it is difficult to determine the
replacement ratio between BFS and other raw feed materials in clinker
production. Thus, the correct quantity of material to be modeled is
unclear. In addition, BFS may substitute for a variety of virgin raw
materials as well as other secondary materials (e.g., cement kiln dust,
CCPs, foundry sand, etc.); the choice of material often depends on
location-specific factors such as the proximity of material sources to
the cement kiln and relative availability of different materials.
Avoided upstream impacts depend heavily on the specific material being
displaced in the lifecycle scenario.

References

Personal communication with Jamie Connor, Tube City IMS Corporation,
Chuck Martin, Beaver Valley Slag, Inc., and Max Wolanske, Lafarge NA,
December 5, 2006 and December 6, 2006.

Turner Fairbank Highway Research Center and the Federal Highway
Administration. User Guidelines for Waste and Byproduct Materials in
Pavement Construction, accessed at:   HYPERLINK
"http://www.tfhrc.gov/hnr20/recycle/waste/begin.htm"
http://www.tfhrc.gov/hnr20/recycle/waste/begin.htm .

United States Census Bureau. 2002 Economic Census, Industry Snapshots
for Cement Manufacturing, accessed on August 18, 2008 at:   HYPERLINK
"http://quarterhorse.dsd.census.gov/TheDataWeb_HotReport/servlet/HotRepo
<EMAIL_ADDRESS>AICS2002=327310&forward=20071204152004.Var.NAICS2002"
http://quarterhorse.dsd.census.gov/TheDataWeb_HotReport/servlet/HotRepor
<EMAIL_ADDRESS>ICS2002=327310&forward=20071204152004.Var.NAICS2002 .

United States Environmental Protection Agency (EPA). 2006, Sector
Strategies Performance Report: Cement, accessed at:    HYPERLINK
"http://www.epa.gov/ispd/pdf/2006/cement.pdf"
http://www.epa.gov/ispd/pdf/2006/cement.pdf .

United States Environmental Protection Agency (EPA). 2008, Study on
Increasing the Usage of Recovered Mineral Components in Federally Funded
Projects Involving Procurement of Cement or Concrete to Address the
Safe, Accountable, Flexible, Efficient Transportation Equity Act: A
Legacy for Users, pgs 2-5 and 2-8.

United States Geological Survey (USGS). January 2006, Mineral Commodity
Summaries: Iron and Steel Slag, pg 2, accessed at:   HYPERLINK
"http://minerals.usgs.gov/minerals/pubs/commodity/iron_&_steel_slag/fesl
amcs06.pdf"
http://minerals.usgs.gov/minerals/pubs/commodity/iron_&_steel_slag/fesla
mcs06.pdf .

van Oss, H.G. 2003, USGS 2003 Minerals Yearbook: Slag-Iron and Steel,
accessed August 21, 2008 at:   HYPERLINK
"http://minerals.usgs.gov/minerals/pubs/commodity/iron_&_steel_slag/isla
gmyb03.pdf"
http://minerals.usgs.gov/minerals/pubs/commodity/iron_&_steel_slag/islag
myb03.pdf .

van Oss, H.G. 2004, USGS 2004 Minerals Yearbook: Volume II--Metals and
Minerals: Slag-Iron and Steel, accessed October 2, 2006, at:   HYPERLINK
"http://minerals.usgs.gov/minerals/pubs/commodity/cement/cemenmyb04.pdf"
 http://minerals.usgs.gov/minerals/pubs/commodity/cement/cemenmyb04.pdf
.

van Oss, H.G. 2006, USGS 2006 Minerals Yearbook: Slag-Iron and Steel,
accessed August 21, 2008 at:   HYPERLINK
"http://minerals.usgs.gov/minerals/pubs/commodity/iron_&_steel_slag/myb1
-2006-fesla.pdf"
http://minerals.usgs.gov/minerals/pubs/commodity/iron_&_steel_slag/myb1-
2006-fesla.pdf .

 The USGS estimates that the quantity of blast-furnace slag produced is
equivalent to 25 percent to 30 percent of crude iron (i.e., pig iron)
production (EPA 2008).

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ᔀ硨陭ᘀ䙨鹃唀Ĉ∀This range does not include old, weathered
GBFS from existing stockpiles that is sold as fine aggregate for a few
dollars per metric ton (EPA 2008). Prices were converted from a metric
ton to short ton basis.

 Prices were converted from a metric ton to short ton basis.

Blast Furnace Slag

 PAGE

 PAGE   5


[Federal Register Volume 85, Number 208 (Tuesday, October 27, 2020)]
[Rules and Regulations]
[Pages 67992-67994]
[FR Doc No: 2020-23065]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2020-0631]
RIN 1625-AA00

Safety Zone; Firestone Grand Prix of St. Petersburg, St.
Petersburg, Florida

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone for
the navigable waters of Tampa Bay, in the vicinity of the St.
Petersburg Municipal Yacht Basin, St. Petersburg, Florida during the
Firestone Grand Prix of St. Petersburg. The temporary safety zone is
needed to protect the safety of race participants, spectators, and
vessels on the surrounding waterway during the race. Persons and
vessels are prohibited from entering, transiting through, anchoring in,
or remaining within the regulated area unless authorized by the Captain
of the Port St. Petersburg or a designated representative.

DATES: This rule is effective daily from 6 a.m. until 10 p.m., on
October 23, 2020 through October 25, 2020.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2020-0631 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 Marine Science Technician First Class Michael
Shackleford, Sector St. Petersburg Prevention Department, 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
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, 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 it is impracticable. The Coast Guard
received information regarding the need for a safety zone on October 2,
2020. Insufficient time remains to publish an NPRM and to receive
public comments, as the event will occur before the rulemaking process
would be completed. Because of the potential safety hazards associated
with the race, the regulations is necessary to provide for the safety
of race participants, spectators, and other vessels navigating the
surrounding waterways. For those reasons, it would be impracticable to
publish an NPRM.
    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, for the reasons
discussed above.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under the authority in 46
U.S.C. 70034. The Captain of the Port St. Petersburg has determined
that potential hazards associated with the race, will be a safety
concern for race participants, spectators, and vessels. This rule is
needed to ensure the safety of life for vessels and persons within the
navigable waters of the safety zone during the Firestone Grand Prix of
St. Petersburg, Florida.

IV. Discussion of the Rule

    This rule establishes a safety zone daily from 6:00 a.m. until
10:00 p.m., on October 23, 2020 through October 25, 2020. The safety
zone will cover all navigable waters within a specified area of Tampa
Bay, St. Petersburg, Florida. The duration of the zone is intended to
ensure the safety of the public and designated navigable waters during
the race event. No vessel or person will be permitted to enter, transit
through, anchor in, or remain within the safety zone without obtaining
permission from the Captain of the Port St. Petersburg or a designated
representative.
    Persons and vessels may request authorization to enter, transit
through, anchor in, or remain within the regulated area by contacting
the Captain of the Port St. Petersburg by telephone at<PHONE_NUMBER>,
or a designated representative via VHF radio on channel 16. If
authorization to enter, transit through, anchor in, or remain within
the regulated area is granted by the Captain of the Port St. Petersburg
or a designated representative, all persons and vessels receiving such
authorization must comply with the instructions of the Captain of the
Port St. Petersburg or a designated representative. The Coast Guard
will provide notice of the safety zone by Local Notice to Mariners,
Broadcast Notice to Mariners, and/or on-scene designated
representatives.

IV. 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 available exceptions to the enforcement of the
safety zone. The safety zone will be enforced for a limited period of
time over the course of three days and is thus limited in duration. The
safety zone is limited to only those areas in which race events will be
occurring for the Firestone Grand Prix of St. Petersburg, Florida race
event and is thus limited in size. Although persons and vessels are
prohibited to enter, transit through, anchor in, or remain within the
regulated area without authorization from the Captain of the Port St.
Petersburg or a designated representative, they may operate in the
surrounding area during the enforcement period. The rule allows for
vessels to seek permission to enter the safety zone. The Coast Guard
will provide advance notification of the safety zone to the local
maritime community by Local Notice to Mariners and/or Broadcast Notice
to Mariners.

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
would not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
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 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. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a

State, local, or tribal government, in the aggregate, or by the private
sector of $100,000,000 (adjusted for inflation) or more in any one
year. Though this rule would not result in such an expenditure, we do
discuss the effects of this rule elsewhere in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have
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 that will prohibit
persons and vessels from entering, transiting through, anchoring in, or
remaining within the regulated area during a three day high speed grand
prix race event. It is categorically excluded from further review under
paragraph L60(a) in Table 3-1 of U.S. Coast Guard Environmental
Planning Implementing Procedures 5090.1. A Record of Environmental
Consideration supporting this determination is available in the docket
where indicated under ADDRESSES.

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:  46 U.S.C. 70034; 46 U.S.C. 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.T07-0631 to read as follows:

Sec.  165.T07  -0631 Safety Zone; Firestone Grand Prix of St.
Petersburg, St. Petersburg, FL.

    (a) Location. The following area is established as a safety zone.
All waters of the Gulf of Mexico encompassed within the following
points: 27[deg]46'18'' N, 082[deg]37'55.2'' W, thence to position
27[deg]46'18'' N, 082[deg]37'54.6'' W, thence to position
27[deg]46'9.6'' N, 082[deg]37'54.6'' W, thence to position
27[deg]46'9.6'' N, 082[deg]37'33'' W, thence to position
27[deg]46'4.2'' N, 082[deg]37'33'' W, thence to position
27[deg]45'59.4'' N, 082[deg]37'50.4'' W, thence to position
27[deg]46'6.6'' N, 082[deg]37'56.4'' W, thence to position
27[deg]46'13.8'' N, 082[deg]37'55.8'' W, thence back to the original
position 27[deg]46'18'' N, 082[deg]37'55.2'' W. All coordinates are
North American Datum 1983.
    (b) Definition. The term ``designated representative'' means Coast
Guard Patrol Commanders, including Coast Guard coxswains, petty
officers, and other officers operating Coast Guard vessels, and
Federal, state, and local officers designated by or assisting the
Captain of the Port St. Petersburg in the enforcement of the regulated
areas.
    (c) Regulations. (1) All persons and vessels are prohibited from
entering, transiting through, anchoring in, or remaining within the
regulated area unless authorized by the Captain of the Port St.
Petersburg or a designated representative.
    (2) Designated representatives may control vessel traffic
throughout the enforcement area as determined by the prevailing
conditions.
    (3) Persons and vessels may request authorization to enter, transit
through, anchor in, or remain within the regulated areas by contacting
the Captain of the Port St. Petersburg by telephone at<PHONE_NUMBER>,
or a designated representative via VHF radio on channel 16. If
authorization is granted by the Captain of the Port St. Petersburg or a
designated representative, all persons and vessels receiving such
authorization must comply with the instructions of the Captain of the
Port St. Petersburg or a designated representative.
    (d) Enforcement Period. This rule will be enforced daily from 6
a.m. until 10 p.m., on October 23, 2020 through October 25, 2020.

    Dated: October 13, 2020.
Matthew A. Thompson,
Captain, U.S. Coast Guard, Captain of the Port Saint Petersburg.
[FR Doc. 2020-23065 Filed 10-23-20; 4:15 pm]
BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 173 (Friday, September 4, 2020)]
[Notices]
[Pages 55300-55301]
[FR Doc No: 2020-19563]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1095]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Electronic Submission
Process for Voluntary Allegations to the Center for Devices and
Radiological Health

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by October 5, 2020.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0769. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Electronic Submission Process for Voluntary Allegations to the Center
for Devices and Radiological Health

OMB Control Number 0910-0769--Extension

    This information collection request collects information
voluntarily submitted to the Center for Devices and Radiological Health
(CDRH) on actual or potential health risk concerns about a medical
device or radiological product or its use. Because, prior to the

establishment of the electronic submission process for voluntary
allegations to CDRH, there had been no established guidelines or
instructions on how to submit an allegation to CDRH, allegations often
contained minimal information and were received via phone calls,
emails, or conversationally. CDRH has established a consistent format
and process for the submission of device allegations that enhances our
timeliness in receiving, assessing, and evaluating voluntary
allegations. The information provided in the allegations received by
CDRH may be used to clarify the recurrence or emergence of significant
device-related risks to the general public and the need to initiate
educational outreach or regulatory action to minimize or mitigate
identified risks.
    In the Federal Register of February 10, 2020 (85 FR 7562), we
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received two comments.
    The first comment was not relevant to the information collection.
    The second comment stated that the rule does not state whether
people submitting allegations of regulatory misconduct are required to
redact their contact information.
    We disagree with the comment. Anyone may file a complaint reporting
an allegation of regulatory misconduct. FDA encourages people
submitting allegations to include supporting information and contact
information in case additional information is needed for FDA to
understand the allegation and act on the report; however, you can
choose to submit a report anonymously. FDA will not share your identity
or contact information with anyone outside FDA unless required to do so
by law, regulation, or court order.
    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
----------------------------------------------------------------------------------------------------------------
Electronic submission of                 1,600               1           1,600  0.25 (15                     400
 voluntary allegations to CDRH.                                                  minutes).
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden for the information collection reflects an
overall increase of 225 hours and a corresponding increase of 900
responses/records. We attribute this adjustment to an increase in the
number of submissions we received over the last few years.

    Dated: August 26, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-19563 Filed 9-3-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 68 (Friday, April 8, 2022)]
[Proposed Rules]
[Pages 20798-20800]
[FR Doc No: 2022-07504]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2022-0181]
RIN 1625-AA00

Safety Zone; Demolition of Gerald Desmond Bridge; Long Beach,
California

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard is proposing to establish a temporary safety
zone for waters near Gerald Desmond Bridge during demolition. This
action is necessary to provide for the safety of life on these
navigable waters near Long Beach, CA, during period where the over-the-
water portion of the Gerald Desmond Bridge will be subject to
demolition from May 7, through May 9, 2022. This proposed rulemaking
would prohibit persons and vessels from being in the safety zone unless
authorized by the Captain of the Port (COTP), Los Angeles-Long Beach,
or a designated representative. We invite your comments on this
proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before April 25, 2022.

ADDRESSES: You may submit comments identified by docket number USCG
2022-0181 using the Federal Decision Making 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.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email LCDR Maria Wiener at Sector Los
Angeles-Long Beach Waterways Management Branch at<PHONE_NUMBER> or
email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    On March 3, 2022, the Port of Long Beach notified the Coast Guard
that it will be conducting demolition of the

Gerald Desmond Bridge from 12:01 a.m. on May 7, 2022, to 11:59 p.m. on
May 9, 2022. The demolition will take place at mile 3.3 over Long Beach
Harbor on the section of the bridge that is over the water. Hazards
from demolition include falling debris and construction work conducted
on a barge that will be moored in such a way that it blocks the entire
channel. The Captain of the Port (COTP), Los Angeles-Long Beach has
determined that potential hazards associated with the demolition of the
replacement and removal of Gerald Desmond Bridge would be a safety
concern for anyone within a 100-yard radius of the bridge.
    The purpose of this rulemaking is to ensure the safety of vessels
and the navigable waters within a 100-yard radius of the Gerald Desmond
Bridge before, during, and after the scheduled event. The Coast Guard
is proposing this rulemaking under authority in 46 U.S.C. 70034
(previously 33 U.S.C. 1231).]

III. Discussion of Proposed Rule

    The COTP is proposing to establish a safety zone from 12:01 a.m. on
May 7, 2022, to 11:59 p.m. on May 9, 2022, with a contingency date of
May 14 through May 16, 2022. The safety zone would cover all navigable
within 100-yards of the over-water portion of the Gerald Desmond
Bridge, located approximately at mile 3.3 over Long Beach Harbor, CA.
The duration of the zone is intended to ensure the safety of vessels
and these navigable waters before, during, and after the scheduled
demolition. There will be no maritime access to transit to and from
middle harbor Long Beach to inner harbor Long Beach in vicinity of the
Gerald Desmond Bridge. A contingency time window for the 48-hour
closure would start at 12:01 a.m. on May 14, 2022, and end at 11:59
p.m. on May 16, 2022, in case of an unexpected event forcing a change
in schedule. The COTP would announce the dates and times of enforcement
via local notice to mariners. No vessel or person would be permitted to
enter the safety zone without obtaining permission from the COTP or a
designated representative. The regulatory text we are proposing appears
at the end of this document.

IV. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This NPRM has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, the NPRM
has not been reviewed by the Office of Management and Budget (OMB).
    This regulatory action determination is based on potential hazards
associated with the demolition of the replacement and removal of Gerald
Desmond Bridge.

B. Impact on Small Entities

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

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this proposed 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 made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on

the human environment. This proposed rule involves a safety zone
lasting 48 hours that would prohibit entry within 100-yards of the
potential hazards associated with the demolition of the replacement and
removal of the over-water portion of the Gerald Desmond Bridge.
Normally such actions are categorically excluded from further review
under paragraph L of Appendix A, Table 1 of DHS Instruction Manual 023-
01-001-01, Rev. 1. A preliminary 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. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this proposed
rule.

G. Protest Activities

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

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    Submitting comments. We encourage you to submit comments through
the Federal Decision Making Portal at https://www.regulations.gov. To
do so, go to https://www.regulations.gov, type USCG-2022-0181 in the
search box and click ``Search.'' Next, look for this document in the
Search Results column, and click on it. Then click on the Comment
option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER
INFORMATION CONTACT section of this proposed rule for alternate
instructions.
    Viewing material in docket. To view documents mentioned in this
proposed rule as being available in the docket, find the docket as
described in the previous paragraph, and then select ``Supporting &
Related Material'' in the Document Type column. Public comments will
also be placed in our online docket and can be viewed by following
instructions on the https://www.regulations.gov Frequently Asked
Questions web page. We review all comments received, but we will only
post comments that address the topic of the proposed rule. We may
choose not to post off-topic, inappropriate, or duplicate comments that
we receive.
    Personal information. We accept anonymous comments. Comments we
post to https://www.regulations.gov 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).

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 proposes
to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.2.

0
2. Add Sec.  165.T11-0181 to read as follows:

Sec.  165.T11-0181  Safety Zone; Demolition of Gerald Desmond Bridge;
Long Beach, California.

    (a) Location. The safety zone covers all navigable waters within
100-yards of the over-the-water portion of the Gerald Desmond Bridge,
located approximately at mile 3.3 over Long Beach, CA.
    (b) Effective period. This section is effective from 12:01 a.m. on
May 7, 2022 until 11:59 p.m. on May 16, 2022.
    (c) Enforcement period. This section will be enforced from 12:01
a.m. on May 7, 2022 through 11:59 p.m. on May 9, 2022. In case of
unexpected events, a contingency enforcement time window for the 48-
hour closure starts at 12:01 a.m. on May 14, 2022, and ends at 11:59
p.m. on May 16, 2022.
    (d) Regulations. (1) In accordance with the general regulations in
Sec.  165.23, entry of vessels or persons into the zone is prohibited
unless specifically authorized by the Captain of the Port Los Angeles
Long Beach (COTP) or designated representative. A designated
representative is a commissioned, warrant, or petty officer of the U.S.
Coast Guard (USCG) assigned to units under the operational control of
the COTP.
    (2) In the event of an emergency, vessels requiring entry into the
safety zone must request permission from the COTP or a designated
representative. To seek entry into the safety zone, contact the COTP or
the COTP's representative by telephone at<PHONE_NUMBER> or on VHF-FM
channel 16. To coordinate the movement of vessel traffic, vessel
operators may contact the Jacobsen Pilot Station at<PHONE_NUMBER> or
the Water Traffic Coordinator, Andres Velasco, at<PHONE_NUMBER>.
    (3) Persons and vessels permitted to enter the safety zone must
transit at their slowest safe speed and comply with all lawful
directions issued by the COTP or the designated representative.
    (e) Information broadcasts. The COTP or a designated representative
will inform the public when the safety zone is being enforced via a
Broadcast Notices to Mariners.

    Dated: April 1, 2022.
R.E. Ore,
Captain, U.S. Coast Guard, Captain of the Port, Los Angeles Long Beach.
[FR Doc. 2022-07504 Filed 4-7-22; 8:45 am]
BILLING CODE 9110-04-P