[Federal Register Volume 80, Number 156 (Thursday, August 13, 2015)]
[Proposed Rules]
[Pages 48471-48472]
[FR Doc No: 2015-19884]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2015-F-2712]

Adisseo France S.A.S.; Filing of Food Additive Petition (Animal
Use)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that
Adisseo France S.A.S. has filed a petition proposing that the food
additive regulations be amended to provide for the safe use of
selenomethionine hydroxy analogue as a source of selenium in feed for
chickens, turkeys, swine, dairy cattle, and beef cattle.

DATES: Submit either electronic or written comments on the petitioner's
request for categorical exclusion from preparing an environmental
assessment or environmental impact statement by September 14, 2015.

ADDRESSES: Submit electronic comments to: http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Isabel Pocurull, Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl.,

Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic
Act (section 409(b)(5) (21 U.S.C. 348(b)(5)), notice is given that a
food additive petition (FAP 2291) has been filed by Adisseo France
S.A.S., Immeuble Antony Parc II, 10 Place du G[eacute]n[eacute]ral de
Gaulle, 92160 Antony, France. The petition proposes to amend Title 21
of the Code of Federal Regulations (CFR) in part 573 Food Additives
Permitted in Feed and Drinking Water of Animals (21 CFR part 573) to
provide for the safe use of selenomethionine hydroxy analogue as a
source of selenium in feed for chickens, turkeys, swine, dairy cattle,
and beef cattle. The petitioner has requested a categorical exclusion
from preparing an environmental assessment or environmental impact
statement under 21 CFR 25.32(r).
    Interested persons may submit either electronic or written comments
regarding this request for categorical exclusion to the Division of
Dockets Management (see DATES and ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: August 7, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-19884 Filed 8-12-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 106 (Tuesday, June 2, 2020)]
[Proposed Rules]
[Pages 33592-33595]
[FR Doc No: 2020-11853]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2020-0148]
RIN 1625-AA08

Special Local Regulation; Chesapeake Bay, Between Sandy Point and
Kent Island, MD

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard is proposing to establish special local
regulations for certain waters of the Chesapeake Bay. This action is
necessary to provide for the safety of life on these navigable waters
located between Sandy Point, Anne Arundel County, MD, and Kent Island,
Queen Anne's County, MD, during a paddling event on September 27, 2020.
This proposed rulemaking would prohibit persons and vessels from
entering the regulated area unless authorized by the Captain of the
Port Maryland-National Capital Region or the Coast Guard Patrol
Commander. We invite your comments on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before July 2, 2020

ADDRESSES: You may submit comments identified by docket number USCG-
2020-0148 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

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

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
PATCOM Coast Guard Patrol Commander
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    ABC Events, Inc. of Arnold, MD, has notified the Coast Guard that
it will be conducting the Bay Bridge Paddle from 8 a.m. to 12:30 p.m.
on September 27, 2020. The fifth annual canoe, kayak and stand up
paddle board event for elite and intermediate paddlers includes up to
500 paddlers in two classes operating on two race courses in the
Chesapeake Bay, under and between the north and south bridges that
consist of the William P. Lane, Jr. (US-50/301) Memorial Bridges,
located between Sandy Point, Anne Arundel County, MD and Kent Island,
Queen Anne's County, MD. The first course, for elite paddlers, is a 9-
statute mile/14.5-kilometer race course that starts at the east beach
area of Sandy Point State Park at Annapolis, MD, proceeds southerly
along the shoreline to a point on the course located between north
bridge piers 13 and 13A, then easterly along and between the bridges
toward the eastern shore at Kent Island and turns around upon reaching
a point near Kent Island, then proceeds westerly along and between the
bridges toward the western shore, turns upon reaching a point on the
course located between north bridge piers 24 and 25, proceeds northerly
to the Sandy Point Shoal Lighthouse, and proceeds westerly to a finish
at the east beach area of Sandy Point State Park. The second course,
for intermediate paddlers, is a 3.1-statute mile/5-kilometer course
that starts at the east beach area of Sandy Point State Park at
Annapolis, MD, and follows the elite paddlers to the north bridge, then
easterly along and between the bridges toward the eastern shore at Kent
Island and turns northerly upon reaching a point on the course located
between north bridge piers 24 and 25, and proceeds to a finish at the
east beach area of Sandy Point State Park. Hazards from the paddle
races include numerous event participants crossing designated
navigation channels and interfering

with vessels intending to operate within those channels, as well as
operating within approaches to the Sandy Point State Park public boat
launch facility and marina. The Captain of the Port (COTP) Maryland-
National Capital Region has determined that potential hazards
associated with the paddle races would be a safety concern for anyone
intending to participate in this event or for vessels that operate
within specified waters of the Chesapeake Bay between Sandy Point and
Kent Island, MD.
    The purpose of this rulemaking is to protect event participants,
non-participants and transiting vessels on certain waters of the
Chesapeake Bay 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 Maryland-National Capital Region is proposing to establish
special local regulations from 7 a.m. on September 27, 2020. The
special local regulations would be enforced from 7 a.m. to 1:30 p.m. on
September 27, 2020. The regulated area would cover all navigable waters
of the Chesapeake Bay, adjacent to the shoreline at Sandy Point State
Park and between and adjacent to the spans of the William P. Lane Jr.
Memorial Bridges, from shoreline to shoreline, bounded to the north by
a line drawn from the western shoreline at latitude 39[deg]01'05.23''
N, longitude 076[deg]23'47.93'' W; thence eastward to latitude
39[deg]01'02.08'' N, longitude 076[deg]22'40.24'' W; thence
southeastward to eastern shoreline at latitude 38[deg]59'13.70'' N,
longitude 076[deg]19'58.40'' W; and bounded to the south by a line
drawn parallel and 500 yards south of the south bridge span that
originates from the western shoreline at latitude 39[deg]00'17.08'' N,
longitude 076[deg]24'28.36'' W; thence southward to latitude
38[deg]59'38.36'' N, longitude 076[deg]23'59.67'' W; thence eastward to
latitude 38[deg]59'26.93'' N, longitude 076[deg]23'25.53'' W; thence
eastward to the eastern shoreline at latitude 38[deg]58'40.32'' N,
longitude 076[deg]20'10.45'' W, located between Sandy Point and Kent
Island, MD.
    The proposed special local regulations duration and size of the
regulated area are intended to ensure the safety of life on these
navigable waters before, during, and after the paddle races, scheduled
from 8 a.m. to 12:30 p.m. on September 27, 2020. The COTP and the Coast
Guard Patrol Commander (PATCOM) would have the authority to forbid and
control the movement of all vessels and persons, including event
participants, in the regulated area.
    Except for Bay Bridge Paddle participants and vessels already at
berth, a vessel or person would be required to get permission from the
COTP or PATCOM before entering the regulated area. Vessel operators can
request permission to enter and transit through the regulated area by
contacting the PATCOM on VHF-FM channel 16. Vessel traffic would be
able to safely transit the regulated area once the PATCOM deems it safe
to do so. A person or vessel not registered with the event sponsor as a
participant or assigned as official patrols would be considered a non-
participant. Official Patrols are any vessel assigned or approved by
the Commander, Coast Guard Sector Maryland-National Capital Region with
a commissioned, warrant, or petty officer on board and displaying a
Coast Guard ensign.
    If permission is granted by the COTP or PATCOM, a person or vessel
would be allowed to enter the regulated area or pass directly through
the regulated area as instructed. Vessels would be required to operate
at a safe speed that minimizes wake while within the regulated area.
Official patrol vessels will direct non-participants while within the
regulated area. Vessels would be prohibited from loitering within the
navigable channel. Only participant vessels and official patrol vessels
would be allowed to enter the paddle races area.
    The regulatory text we are proposing appears at the end of this
document.

IV. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This NPRM has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, the NPRM has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on size and duration
of the regulated area, which would impact a small designated area of
the Chesapeake Bay for 6.5 hours. The Coast Guard would issue a
Broadcast Notice to Mariners via VHF-FM marine channel 16 about the
status of the regulated area. Moreover, the rule would allow vessels to
seek permission to enter the regulated area, and vessel traffic would
be able to safely transit the regulated area once the PATCOM deems it
safe to do so.

B. Impact on Small Entities

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

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security 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
implementation of regulations within 33 CFR part 100 applicable to
organized marine events on the navigable waters of the United States
that could negatively impact the safety of waterway users and shore
side activities in the event area lasting for 6.5 hours. Normally such
actions are categorically excluded from further review under paragraph
L[61] of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01,
Rev. 01. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this proposed
rule.

G. Protest Activities

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

V. Public Participation and Request for Comments

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

List of Subjects in 33 CFR Part 100

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

    For the reasons discussed in the preamble, the Coast Guard is
proposing to amend 33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority: 46 U.S.C. 70041; 33 CFR 1.05-1.

0
2. Add Sec.  100.T05-0148 to read as follows:

Sec.  100.T05-0148   Bay Bridge Paddle, Chesapeake Bay, Between Sandy
Point and Kent Island, MD.

    (a) Regulated area. The regulations in this section apply to the
following area: All navigable waters of the Chesapeake Bay, adjacent to
the shoreline at Sandy Point State Park and between and adjacent to the
spans of the William P. Lane Jr. Memorial Bridges, from shoreline to
shoreline, bounded to the north by a line drawn from the western
shoreline at latitude 39[deg]01'05.23'' N, longitude 076[deg]23'47.93''
W; thence eastward to latitude 39[deg]01'02.08'' N, longitude
076[deg]22'40.24'' W; thence southeastward to eastern shoreline at
latitude 38[deg]59'13.70'' N, longitude 076[deg]19'58.40'' W; and
bounded to the south by a line drawn parallel and 500 yards south of
the south bridge span that originates from the western shoreline at
latitude 39[deg]00'17.08'' N, longitude 076[deg]24'28.36'' W; thence
southward to latitude 38[deg]59'38.36'' N, longitude 076[deg]23'59.67''
W; thence eastward to latitude 38[deg]59'26.93'' N, longitude
076[deg]23'25.53'' W; thence eastward to the eastern shoreline at
latitude 38[deg]58'40.32'' N, longitude 076[deg]20'10.45'' W, located
between Sandy Point and Kent Island, MD. These coordinates are based on
datum NAD 1983.
    (b) Definitions. As used in this section--
    Captain of the Port (COTP) Maryland-National Capital Region means
the Commander, U.S. Coast Guard Sector Maryland-National Capital Region
or any Coast Guard commissioned, warrant or petty officer who has been
authorized by the COTP to act on his behalf.
    Coast Guard Patrol Commander (PATCOM) means a commissioned,
warrant, or petty officer of the U.S. Coast Guard who has been
designated by the Commander, Coast Guard Sector Maryland-National
Capital Region.
    Official Patrol means any vessel assigned or approved by Commander,

Coast Guard Sector Maryland-National Capital Region with a
commissioned, warrant, or petty officer on board and displaying a Coast
Guard ensign.
    Participant means all persons and vessels registered with the event
sponsor as participating in the Bay Bridge Paddle or otherwise
designated by the event sponsor as having a function tied to the event.
    (c) Regulations. (1) Except for vessels already at berth, all non-
participants are prohibited from entering, transiting through,
anchoring in, or remaining within the regulated area described in
paragraph (a) of this section unless authorized by the COTP Maryland-
National Capital Region or PATCOM.
    (2) To seek permission to enter, contact the COTP Maryland-National
Capital Region at telephone number<PHONE_NUMBER> or on Marine Band
Radio, VHF-FM channel 16 (156.8 MHz) or the PATCOM on Marine Band
Radio, VHF-FM channel 16 (156.8 MHz). Those in the regulated area must
comply with all lawful orders or directions given to them by the COTP
Maryland-National Capital Region or PATCOM.
    (3) The COTP Maryland-National Capital Region will provide notice
of the regulated area through advanced notice via Fifth Coast Guard
District Local Notice to Mariners, broadcast notice to mariners, and
on-scene official patrols.
    (d) Enforcement officials. The Coast Guard may be assisted with
marine event patrol and enforcement of the regulated area by other
Federal, State, and local agencies.
    (e) Enforcement period. This section will be enforced from 7 a.m.
to 1:30 p.m. on September 27, 2020.

    Dated: May 18, 2020.
Joseph B. Loring,
Captain, U.S. Coast Guard, Captain of the Port Maryland-National
Capital Region.
[FR Doc. 2020-11853 Filed 6-1-20; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: November 13, 2008 (Volume 73, Number 220)]
[Notices]
[Page 67186-67187]
[DOCID:fr13no08-48]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0574]

Interim Safety and Risk Assessment of Melamine and Its Analogues
in Food for Humans; Availability

AGENCY: Food and Drug Administration, HHS

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a document entitled ``Interim Safety and Risk
Assessment of Melamine and Its Analogues in Food for Humans.'' The
interim safety/risk assessment evaluated exposure to melamine and its
analogues (cyanuric acid, ammelide and ammeline) in infant formula and
other foods to identify, where possible, a level of exposure that would
not raise public health concerns. FDA is seeking public comment on the
interim safety/risk assessment.

DATES: Comments on the interim safety/risk assessment must be submitted
by January 12, 2009.

ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Annette McCarthy, Center for Food
Safety and Applied Nutrition (HFS-205), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>, FAX:
301-436-2973, or e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The purpose of the interim safety/risk assessment is to identify
the level of melamine and melamine-related compounds in food which
would not raise public health concerns. On September 11, 2008, FDA
learned that melamine may be contained in an infant formula
manufactured by a firm in China. As of September 21, 2008, FDA learned
that a total of 52,857 cases of nephrolithiasis (and, in some
instances, renal failure) had been reported in China linked to
consumption of this contaminated powdered formula. There have been
approximately 13,000 hospitalizations, and at least 3 deaths have been
confirmed to date. The results of an investigation conducted in China
indicated that Chinese-produced powdered infant formula was linked to
these illnesses; no cases were associated with liquid infant formula.
Test results conducted in China on samples of the powdered infant
formula showed that they contained a wide range of concentrations (0.1
parts per million (ppm) to greater than 2,500 ppm melamine). In
addition, other countries have reported detection of melamine in other
product categories, such as confections and beverages.
    The interim safety/risk assessment concludes that, based on
currently available data and information, there is too much uncertainty
for FDA to establish a level of melamine and its analogues in infant
formula that does not raise public health concerns. In foods other than
infant formula, FDA concludes that levels of melamine and

melamine-related compounds below 2.5 ppm do not raise public health
concerns. This interim safety/risk assessment was developed rapidly due
to the extremely time-sensitive need to understand the nature of the
potential risk. We are seeking public comment on this interim safety/
risk assessment. In addition, it will undergo expert peer review.

II. Safety/Risk Assessment

    A human health safety/risk assessment is a scientifically-based
methodology used to estimate risk to human health from exposure to
specific compounds such as contaminant(s) in food. The interim safety/
risk assessment of melamine and its analogues builds upon the 2007
Melamine Safety/Risk Assessment and considers the toxicological profile
of melamine and its analogues, including the observed results from
controlled animal studies conducted with melamine.
    For infant formula, there are gaps in our scientific knowledge
about the toxicity of melamine and its analogues in infants, including:
    1. The consequences of the continuous use of infant formulas as the
sole source of nutrition;
    2. The uncertainties associated with the possible presence and co-
ingestion of more than one melamine analogue; and
    3. For premature infants with immature kidney function, the
possibility that they may be fed these formulas as the sole source of
nutrition and thus on a body weight basis experience greater levels of
intake for a longer time than is experienced by term infants. For these
reasons, there is too much uncertainty for FDA to establish a level of
melamine and its analogues in infant formula that does not raise public
health concerns. However, it is important to understand that this does
not mean that any exposure to any detectable level of melamine and
melamine-related compounds in formula will result in harm to infants.
    In food products other than infant formula, to estimate the level
of melamine that does not raise public health concerns, FDA used a
worst case exposure scenario in which one-half of a person's total
daily dietary intake (Tolerable Daily Intake (TDI), an estimate of the
maximum amount of an agent to which an individual could be exposed on a
daily basis over the course of a lifetime without appreciable health
risk) is contaminated with melamine and its analogues. The TDI used,
0.63 milligrams/kilogram (mg/kg) body weight/day (bw/d), was developed
in 2007 in collaboration with the Food Safety and Inspection Service of
the Department of Agriculture and in consultation with the Centers for
Disease Control and Prevention, the Environmental Protection Agency,
and the Department of Homeland Security.\1\ In the present interim
safety/risk assessment, we estimated that if 50 percent of the diet
were contaminated at a level of 2.5 ppm of melamine and its analogues,
a person's daily intake would equal 0.063 mg/kg bw/d --a level 10-fold
below the TDI. Therefore, FDA concludes that levels of melamine and
melamine-related compounds below 2.5 ppm do not raise public health
concerns in food other than infant formula.
---------------------------------------------------------------------------

    \1\Interim Melamine and Analogues Safety/Risk Assessment, May
25, 2007 (http://www.cfsan.fda.gov/~dms/melamra.html).
---------------------------------------------------------------------------

    Recognizing the time-sensitive need for the safety/risk assessment,
FDA invites comments concerning:
    1. The assessment approach used;
    2. The assumptions made;
    3. The data used; and
    4. The transparency and clarity of the report.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

IV. Electronic Access

    The interim safety/risk assessment is available electronically at
http://www.cfsan.fda.gov/~dms/melamra3.html.

    Dated: November 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-26869 Filed 11-12-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 87, Number 195 (Tuesday, October 11, 2022)]
[Notices]
[Page 61418]
[FR Doc No: 2022-21955]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-069, OMB Control No. 3235-0069]

Submission for OMB Review; Comment Request; Extension: Industry
Guide

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

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget this requests for extension of the previously approved
collection of information discussed below.
    Industries Guides are used by registrants in certain industries as
disclosure guidelines to be followed in presenting information to
investors in registration statements and reports under the Securities
Act (15 U.S.C. 77a et seq.) and Exchange Act (15 U.S.C. 78a et seq.).
The paperwork burden from the Industry Guides is imposed through the
forms that are subject to the disclosure requirements in the Industry
Guides and is reflected in the analysis of these documents. To avoid a
Paperwork Reduction Act inventory reflecting duplicative burdens and
for administrative convenience, the Commission estimates the total
annual burden imposed by the Industry Guides to be one hour. The
information required by the Industry Guides is filed on occasion and is
mandatory. All information is provided to the public. The Industry
Guides do not directly impose any disclosure burden.
    An agency may conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
Written comments and recommendations for the proposed information
collection should be sent within 30 days of publication of this notice
by November 10, 2022 to (i) www.reginfo.gov/public/do/PRAMain and (ii)
David Bottom, Director/Chief Information Officer, Securities and
Exchange Commission, c/o John Pezzullo, 100 F Street NE, Washington, DC
20549, or by sending an email to: [email protected].

    Dated: October 4, 2022.
J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-21955 Filed 10-7-22; 8:45 am]
BILLING CODE 8011-01-P