[Federal Register Volume 87, Number 45 (Tuesday, March 8, 2022)]
[Notices]
[Pages 13024-13025]
[FR Doc No: 2022-04796]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-291, OMB Control No. 3235-0328]

Proposed Collection; Comment Request

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

Extension:
    Form ID

    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'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Form ID (OMB Control No. 3235-0328; SEC File No. 270-291) is used
by companies and other entities to apply for identification numbers and
passwords used in conjunction with the EDGAR electronic filing system.
The information provided on Form ID is

essential to the security of the EDGAR system. Form ID must be filed
every time a registrant or other person obtains or changes an
identification number. Form ID is filed by individuals, companies or
other for-profit organizations that are required to file
electronically. We estimate approximately 48,493 registrants file Form
ID and it takes approximately an estimated 0.15 hours per response for
a total annual burden of 7,274 hours.
    Written comments are invited on: (a) Whether this proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden imposed by the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication by May 8, 2022.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Please direct your written comment to David Bottom, Director/Chief
Information Officer, Securities and Exchange Commission, c/o John
Pezzullo, 100 F Street NE, Washington, DC 20549 or send an email to:
[email protected].

    Dated: March 2, 2022.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-04796 Filed 3-7-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)]
[Notices]
[Pages 15148-15152]
[FR Doc No: 2018-07147]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0545]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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: Fax written comments on the collection of information by May 9,
2018.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0256.
Also include the FDA docket number found in brackets in the heading of
this document.

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

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Infant Formula Requirements--21 CFR parts 106 and 107

OMB Control Number 0910-0256--Extension

    This information collection supports FDA regulations regarding
infant formula requirements. Statutory requirements for infant formula
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) are intended
to protect the health of infants and include a number of reporting and
recordkeeping requirements. Among other things, section 412 of the FD&C
Act (21 U.S.C. 350a) requires manufacturers of infant formula to
establish and adhere to quality control procedures, notify us when a
batch of infant formula that has left the manufacturers' control may be
adulterated or misbranded, and keep records of distribution. We also
regulate the labeling of infant formula under the authority of section
403 of the FD&C Act (21 U.S.C. 343). The purpose of the labeling
requirements is to ensure that consumers have the information they need
to prepare and use infant formula appropriately. The regulations for
infant formula requirements are codified in 21 CFR parts 106 and 107.
    To assist respondents with applicable reporting provisions found in
the regulations, we have developed an electronic Form FDA 3978 that
allows infant formula manufacturers to electronically submit reports
and notifications in a standardized format. Form FDA 3978 prompts
respondents to include information in a standardized format and helps
respondents organize submissions to include only the information needed
for our review. Draft screenshots of Form FDA 3978 and instructions are
available at https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/InfantFormula/default.htm. Form FDA 3978 was
deployed in 2017 as a pilot by FDA and, while informal feedback
regarding its use has been favorable, we continue to invite comment. If
manufacturers prefer, however, FDA continues to accept paper
submissions.

    In the Federal Register of November 15, 2017, we published a notice
inviting public comment on the proposed collection of information. No
comments were received. We therefore retain our original burden
estimate for the information collection, which is as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of        Total
         FD&C act or 21 CFR section             Number of      responses per      annual            Average burden  per response            Total hours
                                               respondents      respondent      responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reports; Section 412(d) of the FD&C Act....               5                13           65  10                                                       650
Notifications; Sec.   106.120(b)...........               1                 1            1  4                                                          4
Reports for Exempt Infant Formula; Sec.                   3                 2            6  4                                                         24
 107.50(b)(3) and (4).
Notifications for Exempt Infant                           1                 1            1  4                                                          4
 Formula;Sec.   107.50(e)(2).
Requirements for Quality Factors Growth                   4                 9           36  20                                                       720
 Monitoring Study Exemption; Sec.
 106.96(c).
Requirements for Quality Factors--PER                     1                34           34  12                                                       408
 Exemption; Sec.   106.96(g).
New Infant Formula Registration; Sec.                     4                 9           36  0.50 (30 minutes)                                         18
 106.110.
New Infant Formula Submission; Sec.                       4                 9           36  10                                                       360
 106.120.
                                            ------------------------------------------------------------------------------------------------------------
    Total..................................  ..............  ................  ...........  ............................................           2,188
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with the information collection.

    In compiling these estimates, we consulted our records of the
number of infant formula submissions we received under the information
collection. All infant formula submissions may be provided to us in
electronic format. Our estimate of the time needed per response is
based on our experience with similar programs and informal feedback we
have received from industry.
    We assume that we will receive 13 reports from 5 manufacturers
under section 412(d) of the FD&C Act, for a total of 65 reports
annually. We assume each report takes 10 hours to compile for a total
of 650 hours annually. We also assume that we will receive one
notification under Sec.  106.120(b) and 4 hours is needed per response,
for a total of 4 hours annually.
    For exempt infant formula, we assume we will receive two reports
from three manufacturers under Sec.  107.50(b)(3) and (4), for a total
of six reports annually. We assume each report takes 4 hours to compile
for a total burden of 24 hours annually. We also assume we will receive
one notification annually under Sec.  107.50(e)(2) and that it takes 4
hours to prepare.
    We assume that 4 firms will submit 36 exemptions under Sec.
106.96(c) and that each exemption will take 20 hours to assemble for a
total burden of 720 hours annually, as reflected in row 5 of table 1.
    We assume that the infant formula industry annually submits 35
protein efficiency ratio (PER) submissions. For the submission of the
PER exemption, we estimate that the infant formula industry submits 34
exemptions per year and that each exemption takes supporting staff 12
hours to prepare. Therefore, we calculate 34 exemptions x 12 hours per
exemption = 408 hours to fulfill the requirements of Sec.  106.96(g),
as shown in row 6 of table 1.
    We estimate that four firms each use one senior scientist or
regulatory affairs professional who needs 30 minutes to gather and
record the required information for an infant formula registration
under Sec.  106.110. We estimate that the industry annually registers
35 new infant formulas, or an average of 9 registrations per firm.
Therefore, we calculate the annual burden as 36 registrations x 0.5
hour per registration = 17.5 (rounded to 18) hours, as shown in row 7
of table 1.
    We estimate that four firms each use one senior scientist or
regulatory affairs professional who needs 10 hours to gather and record
information needed for infant formula submissions under Sec.  106.120.
This estimate includes the time needed to gather and record the
information the manufacturer uses to request an exemption under Sec.
106.91(b)(1)(ii), which provides that the manufacturer includes the
scientific evidence that the manufacturer is relying on to demonstrate
that the stability of the new infant formula will likely not differ
from the stability of formula with similar composition, processing, and
packaging for which there are extensive stability data. We estimate
that 4 firms make submissions for 36 new infant formulas, or an average
of 9 submissions per firm. Therefore, to comply with Sec.  106.120, we
calculate the annual burden as 36 submissions x 10 hours per submission
= 360 hours, as shown in row 8 of table 1. Thus, the total annual
reporting burden is 2,188 hours.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                               Number of
         Activity; 21 CFR section              Number of      records per    Total  annual        Average burden  per recordkeeping        Total  hours
                                             recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Controls to prevent adulteration caused by              21               1              21  1.5 (90 minutes)                                          32
 facilities--testing for radiological
 contaminants; \3\ Sec.   106.20(f)(3)
Controls to prevent adulteration caused by              21               1              21  0.08 (5 minutes)                                           2
 facilities--recordkeeping of testing for
 radiological contaminants; \2\ Sec.  Sec.
   106.20(f)(4) and 106.100(f)(1)
Controls to prevent adulteration caused by               5              52             260  0.08 (5 minutes)                                          21
 facilities--testing for bacteriological
 contaminants Sec.   106.20(f)(3)
Controls to prevent adulteration caused by               5              52             260  0.08 (5 minutes)                                          21
 facilities--recordkeeping of testing for
 bacteriological contaminants Sec.  Sec.
 106.20(f)(4) and 106.100(f)(1)
Controls to prevent adulteration by                      5              52             260  0.22 (13 minutes)                                         57
 equipment or utensils; Sec.  Sec.
 106.30(d) and 106.100(f)(2)
Controls to prevent adulteration by                      5              52             260  0.22 (13 minutes)                                         57
 equipment or utensils; Sec.  Sec.
 106.30(e)(3)(iii) and 106.100(f)(3)

Controls to prevent adulteration by                      5              52             260  0.20 (12 minutes)                                         52
 equipment or utensils; Sec.  Sec.
 106.30(f) and 106.100(f)(4)
Controls to prevent adulteration due to                  5               1               5  520                                                    2,600
 automatic (mechanical or electronic)
 equipment; Sec.  Sec.   106.35(c) and
 106.100(f)(5)
Controls to prevent adulteration due to                  5               2              10  640                                                    6,400
 automatic (mechanical or electronic)
 equipment Sec.  Sec.   106.35(c) and
 106.100(f)(5)
Controls to prevent adulteration caused by               5              52             260  0.17 (10 minutes)                                         44
 ingredients, containers, and closures;
 Sec.  Sec.   106.40(d) and 106.100(f)(6)
Controls to prevent adulteration during                  5              52             260  0.23 (14 minutes)                                         60
 manufacturing; Sec.  Sec.   106.50(a)(1)
 and 106.100(e)
Controls to prevent adulteration from                    5              52             260  0.25 (15 minutes)                                         65
 microorganisms; Sec.  Sec.   106.55(d)
 and 106.100(e)(5)(ii) and (f)(7)
Controls to prevent adulteration during                  1              12              12  0.25 (15 minutes)                                          3
 packaging and labeling of infant formula;
 Sec.   106.60(c)
General quality control--testing; Sec.                   4               1               4  2                                                          8
 106.91(b)(1), (2), and (3)
General quality control; Sec.  Sec.                      4              52             208  0.15 (9 minutes)                                          31
 106.91(b)(1) and(d), and 106.100(e)(5)(i)
General quality control; Sec.  Sec.                      4              52             208  0.15 (9 minutes)                                          31
 106.91(b)(2) and (d), and
 106.100(e)(5)(i)
General quality control; Sec.  Sec.                      4              52             208  0.15 (9 minutes)                                          31
 106.91(b)(3) and (d), and
 106.100(e)(5)(i)
Audit plans and procedures; ongoing review               5               1               5  8                                                         40
 and updating of audits; Sec.   106.94
Audit plans and procedures --regular                     5              52             260  4                                                      1,040
 audits; Sec.   106.94
Requirements for quality factors for                     1               1               1  16                                                        16
 infant formulas--written study report;
 Sec.  Sec.   106.96(b) and (d),
 106.100(p)(1) and (q)(1), and 106.121
Requirements for quality factors for                   112               6             672  0.50 (30 minutes)                                        336
 infant formulas--anthropometric data;
 Sec.  Sec.   106.96(b)(2) and (d), and
 106.100(p)(1)
Requirements for quality factors for                   112               6             672  0.25 (15 minutes)                                        168
 infant formulas--formula intake Sec.
 Sec.   106.96(b)(3) and (d), and
 106.100(p)(1)
Requirements for quality factors for                   112               6             672  0.08 (5 minutes)                                          54
 infant formulas--data plotting; Sec.
 Sec.   106.96(b)(4) and (d), and
 106.100(p)(1)
Requirements for quality factors for                   112               6             672  0.08 (5 minutes)                                          54
 infant formulas--data comparison; Sec.
 Sec.   106.96(b)(5) and (d), and
 106.100(p)(1)
Requirements for quality factors--per data               1               1               1  8                                                          8
 collection; Sec.   106.96(f)
Requirements for quality factors--per                    1               1               1  1                                                          1
 written report; Sec.   106.96(f)
Records; Sec.   106.100                                  5              10              50  400                                                   20,000
Records for Exempt Infant Formula; Sec.                  3              10              30  300                                                    9,000
 107.50(c)(3)
                                           -------------------------------------------------------------------------------------------------------------
    Total.................................  ..............  ..............  ..............  ............................................          40,232
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Where necessary, numbers have been rounded to the nearest whole number.
\3\ This testing only occurs every 4 years.

    We estimate that 21 infant formula plants will test at least every
4 years for radiological contaminants. In addition, we estimate that
collecting water for all testing in Sec.  106.20(f)(3) takes between 1
and 2 hours. We estimate that water collection takes an average of 1.5
hours and that water collection occurs separately for each type of
testing. We estimate that performing the test will take 1.5 hours per
test, every 4 years. Therefore, 1.5 hours per plant x 21 plants = 31.5
(rounded to 32) total hours, every 4 years, as seen in row 1 of table
2. Furthermore, Sec. Sec.  106.20(f)(4) and 106.100(f)(1) require firms
to make and retain records of the frequency and results of water
testing. For the 21 plants that are estimated not to currently test for
radiological contaminants, this burden is estimated to be 5 minutes per
record every 4 years. Therefore, 0.08 hour per record x 21 plants =
1.68 (rounded to 2) hours, every 4 years for the maintenance of records
of radiological testing, as seen on row 2 of table 2.
    We estimate that five infant formula plants will test weekly for
bacteriological contaminants. We estimate that performing the test will
take 5 minutes per test once a week. Annually, this burden is 0.08
hours x 52 weeks = 4.16 hours per year, per plant, and 4.16 hours per
plant x 5 plants = 20.8 (rounded to 21) total annual hours, as seen on
row 3 of table 2. Furthermore, for the five plants that are estimated
to not currently test weekly for bacteriological contaminants, this
burden is estimated to be 5 minutes per record, every week. Therefore,
0.08 hour per record x 52 weeks = 4.16 hours per plant for the
maintenance of records of bacteriological testing. Accordingly, 4.16
hours x 5 plants = 20.8 (rounded to 21) annual hours, as seen on row 4
of table 2.
    Sections 106.30(d) and 106.100(f)(2) require that records of
calibrating certain instruments be made and retained. We estimate that
one senior validation engineer for each of the five plants will need to
spend about 13 minutes per week to satisfy the ongoing calibration
recordkeeping requirements. Therefore, 5 recordkeepers x 52 weeks = 260
records; 260 records x 0.22 hour per record = 57 hours as the annual
burden, as presented in row 5 of table 2.
    Sections 106.30(e)(3)(iii) and 106.100(f)(3)) require the
recordkeeping of the temperatures of each cold storage compartment. We
estimate that five plants will each require one senior validation
engineer about 13 minutes per week of recordkeeping. Therefore, 5
recordkeepers x 52 weeks = 260 records; 260 records x 0.22 hours per
record = 57 hours as the annual burden, as presented in row 6 of table
2.
    Sections 106.30(f) and 106.100(f)(4) require the recordkeeping of
ongoing sanitation efforts. We estimate that five plants will each
require one senior validation engineer about 12 minutes

per week of recordkeeping. Therefore, 5 recordkeepers x 52 weeks = 260
records; 260 records x 0.20 hours per record = 52 hours as the annual
burden, as presented in row 7 of table 2.
    For Sec. Sec.  106.35(c) and 106.100(f)(5), we estimate that one
senior validation engineer per plant needs 10 hours per week of
recordkeeping, with the annual burden for this provision being 520
hours per plant x 5 plants = 2,600 annual hours, as shown in row 8 of
table 2. In addition, an infant formula manufacturer revalidates its
systems when it makes changes to automatic equipment. We estimate that
such changes occur twice a year, and that on each of the two occasions,
a team of four senior validation engineers per plant needs to work full
time for 4 weeks (4 weeks x 40 hours per week = 160 work hours per
person) to provide revalidation of the plant's automated systems
sufficient to comply with this section. The annual burden for four
senior validation engineers each working 160 hours twice a year is
1,280 hours ((160 hours x 2 revalidations) x 4 engineers = 1,280 total
work hours) per plant. Therefore, 640 hours x 5 plants x 2 times per
year = 6,400 hours as the annual burden, as shown on row 9 of table 2.
    Sections 106.40(d) and 106.100(f)(6) require written specifications
for ingredients, containers, and closures. We estimate that one senior
validation engineer per plant needs about 10 minutes a week to fulfill
the recordkeeping requirements. Therefore, 5 recordkeepers x 52 weeks =
260 records and 260 records x 0.17 hour = 44 hours as the annual
burden, as shown in row 10 of table 2.
    We estimate that five plants will change a master manufacturing
order and that one senior validation engineer for each of the five
plants spends about 14 minutes per week on recordkeeping pertaining to
the master manufacturing order, as required by Sec. Sec.  106.50(a)(1)
and 106.100(e). Thus, 5 recordkeepers x 52 weeks = 260 records; 260
records x 0.23 hour = 60 hours as the annual burden, as shown in row 11
of table 2.
    Sections 106.55(d), 106.100(e)(5)(ii), and 106.100(f)(7)) require
recordkeeping of the testing of infant formula for microorganisms. We
estimate that five plants each need one senior validation engineer to
spend 15 minutes per week on recordkeeping pertaining to
microbiological testing. Thus, 5 recordkeepers x 52 weeks = 260
records; 260 records x 0.25 hour per record = 65 hours as the annual
burden, as shown in row 12 of table 2.
    Section 106.60 establishes requirements for the recordkeeping and
labeling of mixed-lot packages of infant formula. Section 106.60(c)
requires infant formula distributors to label infant formula packaging
(such as packing cases) to facilitate product tracing and to keep
specific records of the distribution of these mixed lot cases. We
estimate that one worker needs 15 minutes, once a month (0.25 x 12
months) to accomplish this, for an annual burden of 3 hours, as shown
in row 13 of table 2.
    Sections 106.91(b)(1), (2), and (3) provide ongoing stability
testing requirements. We estimate that the stability testing
requirements has a burden of 2 hours per plant. Therefore, 2 hours x 4
plants = 8 hours as the annual burden to fulfill the testing
requirements, as shown in row 14 of table 2.
    Sections 106.91(d) and 106.100(e)(5)(i) provide for recordkeeping
of tests required under Sec.  106.91(b)(1), (2), and (3). We estimate
that one senior validation engineer per plant will spend about 9
minutes per week of recordkeeping to be in compliance. Thus, 4
recordkeepers x 52 weeks = 208 records; 208 records x 0.15 hour per
record = 31.2 (rounded to 31) hours for the annual burden, as shown in
rows 15, 16, and 17 of table 2.
    We estimate that the ongoing review and updating of audit plans
requires a senior validation engineer 8 hours per year, per plant.
Therefore, 8 hours x 5 plants = 40 hours for the annual burden, as
shown in row 18 of table 2.
    We estimate that a manufacturer chooses to audit once per week. We
estimate each weekly audit requires a senior validation engineer 4
hours, or 52 weeks x 4 hours = 208 hours per plant. Therefore, burden
for updating audit plans is calculated as 208 hours x 5 plants = 1,040
hours for the annual burden, as shown in row 19 of table 2.
    We estimate that, as a result of the regulations, the industry as a
whole performs one additional growth study per year, in accordance with
Sec.  106.96. The regulations require that several pieces of data be
collected and maintained for each infant in the growth study. We
estimate that the data collection associated with the growth study is
assembled into a written report and kept as a record in compliance with
Sec. Sec.  106.96(d) and 106.100(p)(1). Thus, we estimate that one
additional growth study report is generated, and that this report
requires one senior scientist to work 16 hours to compile the data into
a study report. Therefore, one growth study report x 16 hours = 16
hours for the annual burden for compliance with Sec. Sec.  106.96(b)
and (d), 106.100(p)(1) and (q)(1), and 106.121 as shown in row 20 of
table 2.
    A study conducted according to the requirements of Sec.
106.96(b)(2) must include the collection of anthropometric measurements
of physical growth and information on formula intake, and Sec. Sec.
106.96(d) and 106.100(p)(1) require that the anthropometric
measurements be made six times during the growth study. We estimate
that in a growth study of 112 infants, 2 nurses or other health
professionals with similar experience need 15 minutes per infant at
each of the required 6 times to collect and record the required
anthropometric measurements. Therefore, 2 nurses x 0.25 hours = 0.50
hour per infant, per visit, and 0.50 hour x 6 visits = 3 hours per
infant. For 112 infants in the study, 3 hours x 112 infants = 336 hours
for the annual burden, as shown in row 21 of table 2. In addition, we
estimate that one nurse needs 15 minutes per infant to collect and
record the formula intake information. That is, 0.25 hour x 6 visits =
1.5 hour per infant, and 1.5 hour per infant x 112 infants = 168 hours
for the annual burden, as shown in row 22 of table 2.
    Section 106.96(b)(4) requires plotting each infant's anthropometric
measurements on the Centers for Disease Control and Prevention-
recommended World Health Organization Child Growth Standards. We
estimate that it takes 5 minutes per infant to record the
anthropometric data on the growth chart at each study visit. Therefore,
112 infants x 6 data plots = 672 data plots, and 672 data plots x 0.08
hour per comparison = 53.75 hours (rounded to 54) for the annual
burden, as shown in row 23 of table 2.
    Section 106.96(b)(5) requires that data on formula intake by the
test group be compared to the intake of a concurrent control group. We
estimate that one nurse or other health care professional with similar
experience needs 5 minutes per infant for each of the six times
anthropometric data are collected. Therefore, 6 comparisons of data x
112 infants = 672 data comparisons and 672 data comparisons x 0.08 hour
per comparison = 53.75 hours (rounded to 54) for the annual burden, as
shown in row 24 of table 2.
    Section 106.96(f) provides that a manufacturer meets the quality
factor of sufficient biological quality of the protein by establishing
the biological quality of the protein in the infant formula when fed as
the sole source of nutrition using an appropriate modification of the
PER rat bioassay. Under Sec.  106.96(g)(1), a manufacturer of infant
formula may be exempt from this requirement if the manufacturer

requests an exemption and provides assurances, as required under Sec.
106.121, that changes made by the manufacturer to an existing infant
formula are limited to changing the type of packaging. A manufacturer
may also be exempt from this requirement under Sec.  106.100(g)(2), if
the manufacturer requests an exemption and provides assurances, as
required under Sec.  106.121, that demonstrate to FDA's satisfaction
that the change to an existing formula does not affect the
bioavailability of the protein. Finally, a manufacturer of infant
formula may be exempt from this requirement under Sec.  106.96(g)(3) if
the manufacturer requests an exemption and provides assurances, as
required under Sec.  106.121(i), that demonstrate that an alternative
method to the PER that is based on sound scientific principles is
available to show that the formula supports the quality factor for the
biological quality of the protein. We estimate that the infant formula
industry submits a total of 35 PER submissions: 34 exemption requests
and the results of 1 PER study.
    A PER study conducted according to the Association of Analytical
Communities Official Method 960.48 is 28 days in duration. We estimate
that there will be 10 rats in the control and test groups (20 rats
total) and that food consumption and body weight will be measured at
day 0 and at 7-day intervals during the 28-day study period (a total of
5 records per rat). We further estimate that measuring and recording
food consumption and body weight will take 5 minutes per rat.
Therefore, 20 rats x 5 records = 100 records; 100 records x 0.08 hour
minutes per record = 8 hours to fulfill the requirements of Sec.
106.96(f). Further, we estimate that a report based on the PER study
will be generated and that this study report will take a senior
scientist 1 hour to generate. Therefore, a total of 9 hours will be
required to fulfill the requirements for Sec.  106.96(f): 8 hours for
the PER study and data collection, and 1 hour for the development of a
report based on the PER study, as shown in rows 25 and 26 of table 2.
    We estimate that five firms will expend approximately 20,000 hours
per year to fully satisfy the recordkeeping requirements in Sec.
106.100 and that three firms will expend approximately 9,000 hours per
year to fully satisfy the recordkeeping requirements in Sec.
107.50(c)(3). Thus, the total recordkeeping burden is 40,232 hours.

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                           21 CFR section                               Number of       disclosures     Total  annual   Average  burden    Total  hours
                                                                       respondents    per  respondent    disclosures    per  disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nutrient labeling; 21 CFR 107.10(a) and 107.20.....................               5               13               65                8              520
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We estimate compliance with our labeling requirements in Sec. Sec.
107.10(a) and 107.20 requires 520 hours annually by five manufacturers.

    Dated: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07147 Filed 4-6-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: October 30, 2006 (Volume 71, Number 209)]
[Notices]
[Page 63298]
[DOCID:fr30oc06-63]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER06-1430-000; ER06-1430-001]

SP Newsprint CO; Notice of Issuance of Order

October 24, 2006.
    SP Newsprint CO (SP Newsprint) filed an application for market-
based rate authority, with an accompanying tariff. The proposed market-
based rate tariff provides for the sale of energy and capacity at
market-based rates. SP Newsprint also requested waivers of various
Commission regulations. In particular, SP Newsprint requested that the
Commission grant blanket approval under 18 CFR part 34 of all future
issuances of securities and assumptions of liability by SP Newsprint.
    On October 20, 2006, pursuant to delegated authority, the Director,
Division of Tariffs and Market Development--West, granted the requests
for blanket approval under part 34. The Director's order also stated
that the Commission would publish a separate notice in the Federal
Register establishing a period of time for the filing of protests.
Accordingly, any person desiring to be heard or to protest the blanket
approvals of issuances of securities or assumptions of liability by SP
Newsprint should file a motion to intervene or protest with the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426, in accordance with Rules 211 and 214 of the Commission's Rules
of Practice and Procedure. 18 CFR 385.211, 385.214 (2004).
    Notice is hereby given that the deadline for filing motions to
intervene or protest is November 24, 2006.
    Absent a request to be heard in opposition by the deadline above,
SP Newsprint is authorized to issue securities and assume obligations
or liabilities as a guarantor, indorser, surety, or otherwise in
respect of any security of another person; provided that such issuance
or assumption is for some lawful object within the corporate purposes
of SP Newsprint, compatible with the public interest, and is reasonably
necessary or appropriate for such purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approvals of SP Newsprint's issuance of securities or
assumptions of liability.
    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also be viewed on the Commission's
Web site at http://www.ferc.gov, using the eLibrary link. Enter the

docket number excluding the last three digits in the docket number
filed to access the document. Comments, protests, and interventions may
be filed electronically via the Internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Magalie R. Salas,
Secretary.
[FR Doc. E6-18135 Filed 10-27-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 95 (Wednesday, May 16, 2012)]
[Rules and Regulations]
[Pages 28766-28767]
[FR Doc No: 2012-11809]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Parts 100 and 165

[Docket No. USCG-2011-0286]
RIN 1625-AA00; 1625-AA08

Eighth Coast Guard District Annual Marine Events and Safety Zones

AGENCY: Coast Guard, DHS.

ACTION: Direct final rule; confirmation of effective date; technical
amendments.

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

SUMMARY: On March 1, 2012, the Coast Guard published a direct final
rule, amending and updating its special local regulations and safety
zones relating to recurring marine parades, regattas, fireworks
displays, and other events that take place in the Eighth Coast Guard
District area of responsibility. No adverse comment or notice of intent
to submit an adverse comment was received. The rule will go into effect
as scheduled. The Coast Guard is also correcting two entries in this
rule through technical amendment. The first correction changes the
event name in one entry and the second reduces the occurrence of an
event and resulting safety zone from annually to biannually.

DATES: The May 30, 2012, effective date for the direct final rule
published March 1, 2012, at 77 FR 12456, is confirmed. The technical
corrections in this document are effective May 30, 2012.

ADDRESSES: Documents mentioned in this preamble are part of docket
USCG-2011-0286. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number (USCG-2011-0286) in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. You may also visit the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Shelley R. Miller, Eighth Coast Guard District Waterways
Management Division,<PHONE_NUMBER> or email,
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION: On March 1, 2012 we published in the Federal
Register this rule as a direct final rule under 33 CFR 1.05-55
expecting no adverse comment (77 FR 12456). The rule updates the
special local regulations and safety zones relating to recurring marine
parades, regattas, fireworks displays, and other events that take place
in the Eighth Coast Guard District area of responsibility. The rule
informs the public of regularly scheduled marine parades, regattas,
fireworks displays, and other annual events. When these special local
regulations and safety zones are enforced, marine traffic is restricted
in specified areas. The purpose of the rule is to reduce administrative
costs involved in producing a separate rule for each individual
recurring event and to provide notice of the known recurring events
requiring a special local regulation or safety zone throughout the
year. The rule also helps to protect event participants and the public
from the hazards associated with the listed events.
    We published the rule as a direct final rule under 33 CFR part
1.05-55 because we considered it noncontroversial and expected no
adverse comment regarding the rulemaking. We notified the public that
the rule would be effective May 30, 2012 unless adverse comment or
notice of intent to submit an adverse comment was received on or before
April 2, 2012. No adverse comment or notice of intent to submit an
adverse comment was received; therefore, this rule is effective May 30,
2012.
    Although we received no adverse comments, the Coast Guard was
informed of two required corrections. These corrections are made
through technical amendment. The first is an event name change and the
second is a change in how often a specific event occurs from annually
to biannually. During the comment period, the Coast Guard posted
supplemental information to the docket, accessible as guided in the
ADDRESSES section, explaining the necessary corrections. No comment or
notice of intent to comment on these corrections was received. The
corrections are as follows:
    (1) For entry no. 5 in Table 1 of 100.801, the ``Spirit of
Morgantown Triathlon'' is now named the ``Mountaineer Triathlon.''
Therefore, the Event/Sponsor column for entry no. 5 in Table 1 of
100.801 requires correction to read ``Mountaineer Triathlon/Greater
Morgantown Convention and Visitors Bureau'' in the final rule. The
triathlon event's date, location, and the resulting special local
regulation remain the same. The next occurrence for this event is the
second Sunday in August, 2012.
    (2) For entry no. 151 in Table 1 of 165.801, the air show requiring
the safety zone takes place biannually, during odd numbered years only,
not every year. Therefore, the ``Date'' column for entry no. 151 in
Table 1 of 165.801, requires correction to read ``Biannually occurring
during odd numbered years; 2 Days; Mid March to end of April'' in the
final rule. This date description properly indicates the resulting
safety zone's occurrence every other year rather than every year. The
time of year, location, and the resulting safety zone requirements
remain the same. The next occurrence for this air show and resulting
safety zone will be 2 days during mid-March to the end of April, 2013.
    Accordingly, 33 CFR parts 100 and 165, as amended March 1, 2012, at
77 FR 12456, and effective May 30, 2012, are corrected through the
following technical amendments:

PART 100--REGATTAS AND MARINE PARADES

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

    Authority: 33 U.S.C. 1233.

0
2. Amend Sec.  100.801 by revising in Table 1 the entry for Table No. 5
to read as follows:

Sec.  100.801  Annual Marine Events in the Eighth Coast Guard District.

* * * * *

              Table 1 of Sec.   100.801--Eighth Coast Guard District Table of Annual Marine Events
----------------------------------------------------------------------------------------------------------------
                    Sector Ohio                                           Sector Ohio Valley
    Table No.         Valley             Date            Event/sponsor          location        Regulated area
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
5...............               5  The second Sunday   Mountaineer         Monongahela River,  Monongahela River,
                                   in August.          Triathlon/Greater   Morgantown, WV.     mile marker 101.0
                                                       Morgantown                              to 102.0,
                                                       Convention and                          Morgantown, WV.
                                                       Visitors Bureau.
----------------------------------------------------------------------------------------------------------------

* * * * *

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
4. Amend Sec.  165.801 by revising in Table 1, the entry for Table No.
151 to read as follows:

Sec.  165.801  Annual Fireworks Displays and other events in the Eighth
Coast Guard District requiring safety zones.

* * * * *

               Table 1 of Sec.   165.801--Eighth Coast Guard District Table of Annual Safety Zones
----------------------------------------------------------------------------------------------------------------
                                                                             Sector Mobile
    Table No.      Sector Mobile         Date            Sponsor/name          location           Safety zone
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
151.............              10  Biannually          Angels Over the     Back Bay Biloxi,    Back Bay Biloxi,
                                   occurring during    Bay/Keesler Air     Biloxi, MS.         Bounded by the
                                   odd numbered        Force Base.                             following
                                   years; 2 Days;                                              coordinates:
                                   Mid-March to end                                           Eastern boundary;
                                   of April.                                                   Latitude
                                                                                30[deg]25'47.6''
                                                                                N, Longitude
                                                                                088[deg]54'13.6''
                                                                                W, to Latitude
                                                                                30[deg]24'43'' N,
                                                                                Longitude
                                                                                088[deg]54'13.6''
                                                                                W.
                                                                                Western Boundary;
                                                                                Latitude
                                                                                30[deg]25'25.6''
                                                                                N, Longitude
                                                                                088[deg]56'9'' W,
                                                                                to Latitude
                                                                                30[deg]24'55'' N,
                                                                                Longitude
                                                                                088[deg]56'9'' W.
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: April 23, 2012.
Roy A. Nash,
Rear Admiral, U.S. Coast Guard, Commander, Eighth Coast Guard District.
[FR Doc. 2012-11809 Filed 5-15-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 65 (Wednesday, April 4, 2012)]
[Proposed Rules]
[Pages 20324-20330]
[FR Doc No: 2012-7964]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Parts 100 and 165

[Docket No. USCG-2012-0111]
RIN 1625-AA00; 1625-AA08

Special Local Regulation and Safety Zones; Marine Events in
Captain of the Port Sector Long Island Sound Zone

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to establish temporary special local
regulations and safety zones for marine events on the navigable waters
within the Captain of the Port (COTP) Sector Long Island Sound zone for
regattas, fireworks displays and swim events. This action is necessary
to provide for the safety of life on navigable waters during the
events. Entering into, transiting through, remaining, anchoring or
mooring within these regulated areas would be prohibited unless
authorized by the COTP Sector Long Island Sound.

DATES: Comments and related material must be received by the Coast
Guard on or before May 4, 2012.
    Requests for public meetings must be received by the Coast Guard on
or before April 25, 2012.

ADDRESSES: You may submit comments identified by docket number USCG-
2012-0111 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or email Petty Officer Joseph Graun, Prevention Department,
Coast Guard Sector Long Island Sound,<PHONE_NUMBER>,
<EMAIL_ADDRESS>If you have questions on viewing or submitting
material to the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2012-0111), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online (via http://www.regulations.gov) or by fax, mail, or hand
delivery, but please use only one of these means. If you submit a
comment online via www.regulations.gov, it will be considered received
by the Coast Guard when you successfully transmit the comment. If you
fax, hand deliver, or mail your comment, it will be considered as
having been received by the Coast Guard when it is received at the
Docket Management Facility. We recommend that you include your name and
a mailing address, an email address, or a telephone number in the body
of your document so that we can contact you if we have questions
regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number USCG-2012-0111 in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with
this rulemaking. If you submit your comments by mail or hand delivery,
submit them in an unbound format, no larger than 8\1/2\ by 11 inches,
suitable for copying and electronic filing. If you submit comments by
mail and would like to know that they reached the Facility, please
enclose a stamped, self-addressed postcard or envelope. We will
consider all comments and material received during the comment period
and may change the rule based on your comments.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number USCG-2012-0111 in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. You may also visit the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. We have an agreement with the Department of Transportation to
use the Docket Management Facility.

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 notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one April 25, 2012 using one of the four methods specified
under ADDRESSES. Please explain why you believe a public meeting would
be beneficial. If we determine that one would aid this rulemaking, we
will hold one at a time and place announced by a later notice in the
Federal Register.

Basis and Purpose

    The legal basis for this temporary rule is 33 U.S.C. 1226, 1231,
1233; 46 U.S.C. Chapters 454, 701, 3306, 3703; 50 U.S.C. 191, 195; 33
CFR 1.05-1, 6.04-1, 6.04-6 and 160.5; Pub. L. 107-295, 116 Stat. 2064;
Department of Homeland Security

Delegation No. 0170.1 which collectively authorize the Coast Guard to
define regulatory special local regulations and safety zones.
    This temporary rule proposes to establish special local regulations
and safety zones in order to provide for the safety of life on
navigable waterways during regattas, fireworks displays and swim
events.

Discussion of Proposed Rule

    This temporary rule proposes special local regulations for two
regattas, and safety zones for thirteen fireworks displays and two
swimming events set to take place within the COTP Sector Long Island
Sound Zone. These events are scheduled to take place between June and
August of 2012.
    A safety zone is proposed for each fireworks display listed in
TABLE 1 to Sec.  165.T01-0111 including all navigable waters within a
1000 foot radius of the launch platform.

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

----------------------------------------------------------------------------------------------------------------
6                                                                            June
----------------------------------------------------------------------------------------------------------------
6.1 Salute to Veterans Fireworks............   Location: Waters of Reynolds Channel West of the loop
                                               parkway Bridge in Hempstead, NY.
----------------------------------------------------------------------------------------------------------------
7                                                                            July
----------------------------------------------------------------------------------------------------------------
7.1 Devon Yacht Club Fireworks..............   Location: Waters of Napeague Bay, in Block Island Sound
                                               off Amagansett, NY.
----------------------------------------------------------------------------------------------------------------
7.2 Dolan Family Fourth Fireworks...........   Location: Water of Oyster Bay Harbor in Long Island Sound
                                               north of the Cove Neck peninsula in Oyster Bay, NY.
----------------------------------------------------------------------------------------------------------------
7.3 Davis Park Fireworks....................   Location: Waters of the Great South Bay north of Davis
                                               Park, NY.
----------------------------------------------------------------------------------------------------------------
7.4 Islip Fireworks.........................   Location: Waters of the Great South Bay off Bay Shore
                                               Manor Park, Islip, NY.
----------------------------------------------------------------------------------------------------------------
7.5 Madison Fireworks.......................   Location: Waters of Long Island Sound off Madison Beach
                                               in Madison, CT.
----------------------------------------------------------------------------------------------------------------
7.6 Stratford Fireworks.....................   Location: Waters of Long Island Sound surrounding Short
                                               Beach Park in Stratford, CT in approximate position
                                               41[deg]09'50.82'' N, 073[deg]6'47.13'' W (NAD 83).
----------------------------------------------------------------------------------------------------------------
7.7 Rowayton Fireworks......................   Location: Waters of Long Island Sound south of Bayley
                                               Beach Park in Rowayton, CT.
----------------------------------------------------------------------------------------------------------------
7.8 Quarentello Wedding Fireworks...........   Location: Waters of the Great South Bay south east of
                                               Brown Point in Sayville, NY.
----------------------------------------------------------------------------------------------------------------
7.9 Niantic Bay Fireworks...................   Location: Waters of Niantic Bay 1500 feet west of the
                                               Niantic River Railroad Bridge in Niantic, CT.
----------------------------------------------------------------------------------------------------------------
8                                                                           August
----------------------------------------------------------------------------------------------------------------
8.1 Shelter Island Yacht Club Fireworks.....   Location: Waters of Dering Harbor north of the Shelter
                                               Island yacht Club in Shelter Island, NY.
----------------------------------------------------------------------------------------------------------------
8.2 Stamford Fireworks......................   Location: Waters of Stamford Harbor, South of Kosciuszco
                                               Park in Stamford, CT.
----------------------------------------------------------------------------------------------------------------
11                                                                         November
----------------------------------------------------------------------------------------------------------------
1 Charles W. Morgan Anniversary Fireworks...   Location: Waters of the Mystic River, north of the Mystic
                                               Seaport Light in Mystic, CT.
----------------------------------------------------------------------------------------------------------------

    A safety zone is proposed for each swim event listed in TABLE 2 to
Sec.  165.T01.0111 including all navigable waters within the defined
swim area.

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

----------------------------------------------------------------------------------------------------------------
1 Waves of Hope Swim........................   Location: All waters of the Great South Bay off
                                               Amityville, NY Bound by Clocks Boulevard to the West, Tanner Park
                                               to the East and shoreward of a line 1000 feet offshore.
----------------------------------------------------------------------------------------------------------------
2 Stonewall Swim............................   Location: All navigable waters of the Great South Bay
                                               within an three miles long and half mile wide rectangle box
                                               connecting the following points. Beginning Snedecor Avenue in
                                               Bayport, NY to Porgie Walk in Fire Island, NY.
----------------------------------------------------------------------------------------------------------------

    A special local regulation is proposed for each regatta listed in
TABLE 1 to Sec.  100.35T01-0111 including all navigable waters
associated with each event's location.

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

----------------------------------------------------------------------------------------------------------------
1 Hartford Dragon Boat Regatta..............   Regulated area: All waters of the Connecticut River in
                                               Hartford, CT between the Bulkeley Bridge and the Wilbur Cross
                                               Bridge.
----------------------------------------------------------------------------------------------------------------
2 Kayak for a Cause Regatta.................   Regulated area: All water of Long Island Sound within a
                                               nine mile long and half mile wide rectangle shaped regatta course
                                               connecting Norwich, CT and Crab Meadow, NY.
----------------------------------------------------------------------------------------------------------------

    Exact locations with coordinates are listed in the regulatory text
below List of Subjects.
    All fireworks events would be enforced from 8:30 p.m. until 10 p.m.
on the date specified in TABLE 1 to Sec.  165.T01-0111. All other
regulated areas will be enforced during the dates and times listed with
the event details in their respective table. In three cases, the Davis
Park Fireworks, Charles W. Morgan Anniversary Fireworks and Waves of
Hope Swim, the event sponsors have not yet determined specific dates
for their events. The event sponsors have provided a range of possible
dates that are listed in the respective tables in the regulatory text
below List of Subjects. The Coast Guard will publish the specific dates
for the events in the final rule.
    Because large numbers of spectator vessels are expected to
congregate around the location of these events, these regulated areas
are necessary to protect both spectators and participants from the
safety hazards created by them; including large numbers of swimmers,
hard to see and unstable small boats, unexpected pyrotechnics
detonation, and burning debris. This proposed rule would temporarily
establish regulated areas to restrict vessel movement around the
location of each event to reduce the safety risks associated with them.
    During the enforcement periods, persons and vessels would be
prohibited from entering, transiting through, remaining, anchoring or
mooring within the regulated areas unless specifically authorized by
the COTP Sector Long Island Sound or designated representative. Persons
and vessels would be able to request authorization to enter, transit
through, remain, anchor or moor within the regulated areas by
contacting the COTP Sector Long Island Sound by telephone at (203) 468-
4401, or designated representative via VHF radio on channel 16. If
authorization to enter, transit through, remain, anchor or moor within
any of the regulated areas is granted, all persons and vessels
receiving authorization would be required to comply with the
instructions of the COTP or designated representative.
    The Coast Guard COTP Sector Long Island Sound or designated
representatives will enforce the regulated areas. These designated
representatives are comprised of commissioned, warrant, and petty
officers of the Coast Guard. The Coast Guard may be assisted by other
federal, state and local agencies in the enforcement of these regulated
areas.
    To aid the public in identifying the launch platforms; fireworks
barges used for these displays will have a sign on their port and
starboard side labeled ``FIREWORKS--STAY AWAY.'' This sign will consist
of 10 inch high by 1.5 inch wide red lettering on a white background.
Shore launch sites will display a sign labeled ``FIREWORKS--STAY AWAY''
with the same dimensions.

Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
as supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders.
    The Coast Guard determined that this rulemaking would not be a
significant regulatory action for the following reasons: The regulated
areas will be of limited duration and cover only a small portion of the
navigable waterways. Furthermore, vessels may transit the navigable
waterways outside of the regulated areas. Persons or vessels requiring
entry into the regulated areas may be authorized to do so by the COTP
Sector Long Island Sound or designated representative.
    Advanced public notifications will also be made to the local
maritime community through the Local Notice to Mariners as well as
Broadcast Notice to Mariners.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered the impact of this proposed rule on small entities. 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. This rule
will affect the following entities, some of which may be small
entities: The owners or operators of vessels intending to enter,
transit, anchor or moor within the regulated areas during the
enforcement periods stated for each event listed below in the List of
Subjects.
    The temporary special local regulations and safety zones will not
have a significant economic impact on a substantial number of small
entities for the following reasons: The regulated areas will be of
limited size and of short duration, vessels that can safely do so may
navigate in all other portions of the waterways except for the areas
designated as regulated areas, and vessels requiring entry into the
regulated areas may be authorized to do so by the COTP Sector Long
Island Sound or designated representative. Additionally, before the
effective period, notifications will be made to the local maritime
community through the Local Notice to Mariners and Broadcast Notice to
Mariners well in advance of the events.
    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.

Assistance for Small Entities

    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 so that they can better
evaluate its effects on them and participate in the rulemaking. 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 Petty Officer Joseph Graun,
Prevention Department, U.S. Coast Guard Sector Long Island Sound, (203)
468-4544<EMAIL_ADDRESS>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.

Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

Federalism

    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 determined that this
rule does not have implications for federalism.

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.

Taking of Private Property

    This proposed rule would not cause a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

Indian Tribal Governments

    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.

Energy Effects

    We have analyzed this proposed rule under Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

Environment

    We have analyzed this proposed 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 (NEPA) (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. A preliminary
environmental analysis checklist supporting this determination is
available in the docket where indicated under ADDRESSES. This rule
appears to be categorically excluded, under figure 2-1, paragraph (34)
(g)&(h), of the Instruction. This rule proposes to establish special
local regulations and safety zones. We seek any comments or information
that may lead to the discovery of a significant environmental impact
from this proposed rule.

List of Subjects

33 CFR Part 100

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

33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR parts 100 and 165 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

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

    Authority:  33 U.S.C. 1233.

    2. Add Sec. 100.35T01-0111 to read as follows:

Sec.  100.35T01-0111  Special Local Regulations; Regattas in the Coast
Guard Sector Long Island Sound Captain of the Port Zone.

    (a) Regulations. (1) The following regulations apply to the marine
events listed in TABLE 1 to Sec.  100.35T01-0111. These regulations
will be enforced for the duration of each event, on the dates
indicated. Notifications will be made to the local maritime community
through all appropriate means such as Local Notice to Mariners or
Broadcast Notice to Mariners well in advance of the events. First Coast
Guard District Local Notice to Mariners can be found at: http://www.navcen.uscg.gov/.
    (b) Definitions. The following definitions apply to this section:

    (1) Designated Representative. A ``designated representative''
is any Coast Guard commissioned, warrant or petty officer of the
U.S. Coast Guard who has been designated by the Captain of the Port
(COTP), Sector Long Island Sound, to act on his or her behalf. The
designated representative may be on an official patrol vessel or may
be on shore and will communicate with vessels via VHF-FM radio or
loudhailer. In addition, members of the Coast Guard Auxiliary may be
present to inform vessel operators of this regulation.
    (2) Official Patrol Vessels. Official patrol vessels may consist
of any Coast Guard, Coast Guard Auxiliary, state, or local law
enforcement vessels assigned or approved by the COTP Sector Long
Island Sound.
    (3) Spectators. All persons and vessels not registered with the
event sponsor as participants or official patrol vessels.

    (c) Vessel operators desiring to enter or operate within the
regulated areas

shall contact the COTP Sector Long Island Sound at<PHONE_NUMBER> (Sector
LIS command center) or the designated representative via VHF channel
16.
    (d) Vessels may not transit the regulated areas without the COTP
Sector Long Island Sound or designated representative approval. Vessels
permitted to transit must operate at a no wake speed, in a manner which
will not endanger participants or other crafts in the event.
    (e) Spectators or other vessels shall not anchor, block, loiter, or
impede the transit of event participants or official patrol vessels in
the regulated areas during the effective dates and times, or dates and
times as modified through the Local Notice to Mariners, unless
authorized by COTP Sector Long Island Sound or designated
representative.
    (f) The COTP Sector Long Island Sound or designated representative
may control the movement of all vessels in the regulated area. When
hailed or signaled by an official patrol vessel, a vessel shall come to
an immediate stop and comply with the lawful directions issued. Failure
to comply with a lawful direction may result in expulsion from the
area, citation for failure to comply, or both. The COTP Sector Long
Island Sound or designated representative may delay or terminate any
marine event in this subpart at any time it is deemed necessary to
ensure the safety of life or property.
    (g) For all regattas listed, vessels not participating in the
event, swimmers, and personal watercraft of any nature are prohibited
from entering or moving within the regulated area unless authorized by
the COTP Sector Long Island Sound or designated representative. Vessels
within the regulated area must be at anchor within a designated
spectator area or moored to a waterfront facility in a way that will
not interfere with the progress of the event.

                    Table 1 to Sec.   100.35T01-0111
------------------------------------------------------------------------

------------------------------------------------------------------------
1 Hartford Dragon Boat Regatta.........   Dates: August 18 and
                                          19, 2012.
                                          Time 8 a.m. until 4:30
                                          p.m. each day.
                                          Regulated area: All
                                          waters of the Connecticut
                                          River in Hartford, CT between
                                          the Bulkeley Bridge
                                          41[deg]46'10.10'' N,
                                          072[deg]39'56.13'' W and the
                                          Wilbur Cross Bridge
                                          41[deg]45'11.67'' N,
                                          072[deg]39'13.64'' W North
                                          American Datum 1983 (NAD 83).
------------------------------------------------------------------------
2 Kayak for a Cause Regatta............   Date: July 21, 2012.
                                          Time: 8 a.m. until 3
                                          p.m.
                                          Regulated area: All
                                          water of Long Island Sound
                                          within a nine mile long and
                                          half mile wide rectangle
                                          shaped regatta course
                                          connecting Norwich, CT and
                                          Crab Meadow, NY. The regulated
                                          area beginning in Norwich CT
                                          east of Shady Beach at
                                          41[deg]5'32.24'' N,
                                          073[deg]23'11.18'' W then
                                          heads south crossing Long
                                          Island Sound to a point east
                                          of Crab Meadow Beach, Crab
                                          Meadow, NY at
                                          40[deg]55'37.21'' N,
                                          073[deg]19'2.14'' W then turns
                                          west connecting to a point
                                          west of Crab Meadow Beach at
                                          40[deg]55'48.3'' N,
                                          073[deg]19'51.88'' W, then
                                          turns north crossing Long
                                          Island Sound to the western
                                          boundary of Calf Pasture Beach
                                          Norwich, CT at
                                          41[deg]4'57.54'' N,
                                          073[deg]23'53.21'' W then
                                          turns east back to its
                                          starting point at
                                          41[deg]5'32.24'' N,
                                          073[deg]23'11.18'' W North
                                          American Datum 1983 (NAD 83).
                                          Additional
                                          stipulations: (1) Spectators
                                          must maintain a minimum
                                          distance of 100 yards from
                                          each event participant and
                                          support vessel. (2) Vessels
                                          that maintain the minimum
                                          required distance from event
                                          participants and support
                                          vessels may transit through
                                          the regatta course.
------------------------------------------------------------------------

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

    3. The authority citation for Part 165 continues to read as
follows:

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapters 454, 701,
3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6 and
160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland
Security Delegation No. 0170.1.

    4. Add Sec.  165.T01-0111 to read as follows:

Sec.  165.T01-0111  Safety Zones; Fireworks Displays and Swim Events in
Captain of the Port Long Island Sound Zone.

    (a) Regulations. (1) The general regulations contained in 33 CFR
165.23 as well as the following regulations apply to the fireworks
displays, air shows, and swim events listed in TABLE 1 and TABLE 2 of
Sec.  165.T01-0111.
    These regulations will be enforced for the duration of each event.
Notifications will be made to the local maritime community through all
appropriate means such as Local Notice to Mariners or Broadcast Notice
to Mariners well in advance of the events. Mariners should consult the
Federal Register or their Local Notice to Mariners to remain apprised
of schedule or event changes. First Coast Guard District Local Notice
to Mariners can be found at http://www.navcen.uscg.gov/.
    (b) Definitions. The following definitions apply to this section:
    (1) Designated Representative. A ``designated representative'' is
any Coast Guard commissioned, warrant or petty officer of the U.S.
Coast Guard who has been designated by the Captain of the Port (COTP),
Sector Long Island Sound, to act on his or her behalf. The designated
representative may be on an official patrol vessel or may be on shore
and will communicate with vessels via VHF-FM radio or loudhailer. In
addition, members of the Coast Guard Auxiliary may be present to inform
vessel operators of this regulation.
    (2) Official Patrol Vessels. Official patrol vessels may consist of
any Coast Guard, Coast Guard Auxiliary, state, or local law enforcement
vessels assigned or approved by the COTP Sector Long Island Sound.
    (3) Spectators. All persons and vessels not registered with the
event sponsor as participants or official patrol vessels.
    (c) Vessel operators desiring to enter or operate within the
regulated areas should contact the COTP Sector Long Island Sound at
203-468-4401 (Sector LIS command center) or the designated

representative via VHF channel 16 to obtain permission to do so.
    (d) Spectators or other vessels shall not anchor, block, loiter, or
impede the transit of event participants or official patrol vessels in
the regulated areas during the effective dates and times, or dates and
times as modified through the Local Notice to Mariners, unless
authorized by COTP Sector Long Island Sound or designated
representative.
    (e) Upon being hailed by a U.S. Coast Guard vessel or the
designated representative, by siren, radio, flashing light or other
means, the operator of the vessel shall proceed as directed. Failure to
comply with a lawful direction may result in expulsion from the area,
citation for failure to comply, or both.
    (f) The COTP Sector Long Island Sound or designated representative
may delay or terminate any marine event in this subpart at any time it
is deemed necessary to ensure the safety of life or property.
    (g) The regulated area for all fireworks displays listed in TABLE 1
to Sec.  165.T01-0111 is that area of navigable waters within a 1000
foot radius of the launch platform or launch site for each fireworks
display, unless otherwise noted in TABLE 1 to Sec.  165.T01-0111 or
modified in USCG First District Local Notice to Mariners at: http://www.navcen.uscg.gov/.
    (h) Fireworks barges used in these locations will also have a sign
on their port and starboard side labeled ``FIREWORKS--STAY AWAY''. This
sign will consist of 10 inch high by 1.5 inch wide red lettering on a
white background. Shore sites used in these locations will display a
sign labeled ``FIREWORKS--STAY AWAY'' with the same dimensions. These
zones will be enforced from 8:30 p.m. to 10:30 p.m. each day a barge
with a ``FIREWORKS--STAY AWAY'' sign on the port and starboard side is
on-scene or a ``FIREWORKS--STAY AWAY'' sign is posted in a location
listed in TABLE 1 to Sec.  165.T01-0111.
    (i) Enforcement period:
    1. Each fireworks display will be enforced from 8:30 p.m. until 10
p.m. on the respective dates listed in Table 1 of Sec.  165.T01-0111.
    2. Each swim event will be enforced during the date and time listed
in Table 2 of Sec.  165.T01-0111.

                                         Table 1 to Sec.   165.T01-0111
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
6                                                                            June
----------------------------------------------------------------------------------------------------------------
6.2 Salute to Veterans Fireworks............   Date: June 23, 2012.
                                               Rain date: June 30, 2012.
                                               Location: Waters of Reynolds Channel off Hempstead, NY in
                                               approximate position 40[deg]35'36.62'' N, 073[deg]35'20.72'' W
                                               (NAD 83).
----------------------------------------------------------------------------------------------------------------
7                                                                            July
----------------------------------------------------------------------------------------------------------------
7.1 Devon Yacht Club Fireworks..............   Date: July 7, 2012
                                               Rain date: July 8, 2012.
                                               Location: Waters of Napeague Bay, in Block Island Sound
                                               off Amagansett, NY in approximate position 40[deg]59'41.4'' N,
                                               072[deg]6'8.7'' W (NAD 83).
----------------------------------------------------------------------------------------------------------------
7.2 Dolan Family Fourth Fireworks...........   Date: July 4, 2012.
                                               Rain date: July 5, 2012.
                                               Location: Waters of Oyster Bay Harbor in Long Island
                                               Sound off Oyster Bay, NY in approximate position
                                               40[deg]53'42.50'' N, 073[deg]30'04.30'' W (NAD 83).
----------------------------------------------------------------------------------------------------------------
7.3 Davis Park Fireworks....................   Date: A single day between the last weekend of June or
                                               first weekend of July 2012 an exact day will be announced in the
                                               final rule.
                                               Location: Waters of the Great South Bay north of Davis
                                               Park, NY in approximate position, 40[deg]41'38.23'' N,
                                               073[deg]00'21.54'' W (NAD 83).
----------------------------------------------------------------------------------------------------------------
7.4 Islip Fireworks.........................   Date: July 4, 2012.
                                               Rain date: July 5, 2012.
                                               Location: Waters of the Great South Bay off Bay Shore
                                               Manor Park, Islip, NY in approximate position 40[deg]42'24'' N,
                                               073[deg]14'24'' W (NAD 83).
----------------------------------------------------------------------------------------------------------------
7.5 Madison Fireworks.......................   Date: July 4, 2012.
                                               Rain date: July 7, 2012
                                               Location: Waters of Long Island Sound off Madison Beach
                                               in Madison, CT in approximate position 41[deg]16'3.93'' N,
                                               072[deg]36'15.97'' W (NAD 83).
----------------------------------------------------------------------------------------------------------------
7.6 Stratford Fireworks.....................   Date: July 3, 2012.
                                               Rain date: July 5, 2012.
                                               Location: Waters of Long Island Sound surrounding Short
                                               Beach Park in Stratford, CT in approximate position
                                               41[deg]09'50.82'' N, 073[deg]6'47.13'' W (NAD 83).
----------------------------------------------------------------------------------------------------------------
7.7 Rowayton Fireworks......................   Date: July 4, 2012.
                                               Rain date: July 5, 2012.
                                               Location: Waters of Long Island Sound south of Bayley
                                               Beach Park in Rowayton, CT in approximate position 41[deg]03'11''
                                               N, 073[deg]26'41'' W (NAD 83).
----------------------------------------------------------------------------------------------------------------
7.8 Quarentello Wedding Fireworks...........   Date: July 21, 2012.
                                               Rain date: None
                                               Location: Waters of the Great South Bay south east of
                                               Brown Point in Sayville, NY in approximate position
                                               40[deg]43'19'' N, 073[deg]03'53'' W (NAD 83).
----------------------------------------------------------------------------------------------------------------
7.9 Niantic Bay Fireworks...................   Date: July 6, 2012.
                                               Rain date: July 7, 2012.

                                               Location: Waters of Niantic Bay 1500 feet west of the
                                               Niantic River Railroad Bridge in Niantic, CT in approximate
                                               position 41[deg]19'22.59'' N, 072[deg]11'3.47'' W (NAD 83).
----------------------------------------------------------------------------------------------------------------
8                                                                           August
----------------------------------------------------------------------------------------------------------------
8.1 Shelter Island Yacht Club Fireworks.....   August 11, 2012.
                                               Rain date: August 12, 2012.
                                               Location: Waters of Dering Harbor north of Shelter Island
                                               Yacht Club in Shelter Island, NY in approximate position
                                               41[deg]05'23.47'' N, 072[deg]21'11.18'' W (NAD 83).
8.2 Stamford Fireworks......................   Date: August 30, 2012.
                                               Rain date: August 31, 2012.
                                               Location: Waters of Stamford Harbor, off Kosciuszco Park
                                               in Stamford, CT in approximate position 41[deg]1'48.46'' N,
                                               073[deg]32'15.32'' W (NAD 83).
----------------------------------------------------------------------------------------------------------------
11                                                                         November
----------------------------------------------------------------------------------------------------------------
1 Charles W. Morgan Anniversary Fireworks...   Date: A single day between November 3, and November 10,
                                               2012 an exact day will be announced in the final rule.
                                               Location: Waters of the Mystic River, north of the Mystic
                                               Seaport Light, Mystic, CT in approximate position
                                               41[deg]21'56.455'' N, 071[deg]57'58.32'' W (NAD 83).
----------------------------------------------------------------------------------------------------------------

                                         Table 2 to Sec.   165.T01-0111
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                                                                         July & August
----------------------------------------------------------------------------------------------------------------
1 Waves of Hope Swim........................   Date: A single weekday during the last week of June or
                                               first two weeks of July 2012 an exact day will be announced in
                                               the final rule.
                                               Time: 10 a.m. until 12:01 p.m.
                                               Location: All waters of the Great South Bay off
                                               Amityville, NY shoreward of a line created by connecting the
                                               following points. Beginning at 40[deg]39'22.38'' N,
                                               073[deg]25'31.63'' W then to 40[deg]39'2.18'' N,
                                               073[deg]25'31.63'' W then to 40[deg]39'2.18'' N,
                                               073[deg]24'03.81'' W, ending at 40[deg]39'18.27'' N,
                                               073[deg]24'03.81'' W North American Datum 1983 ( NAD 83).
----------------------------------------------------------------------------------------------------------------
2 Stonewall Swim............................   Date: August 4, 2012.
                                               Time: 8:30 a.m. until 12:30 p.m.
                                               Location: All navigable waters of the Great South Bay
                                               within an three miles long and half mile wide box connecting
                                               Snedecor Avenue in Bayport, NY to Porgie Walk in Fire Island, NY.
                                               Formed by connecting the following points. Beginning at
                                               40[deg]43'40.24'' N, 073[deg]03'41.5'' W then to 40[deg]43'40''
                                               N, 073[deg]03'13.4'' W, then to 40[deg]40'4.13 N,
                                               073[deg]03'43.81'' W then to 40[deg]40'8.3'' N, 073[deg]03'17.7''
                                               W and ending at the beginning point 40[deg]43'40.24'' N,
                                               073[deg]03'41.5'' W (NAD 83).
----------------------------------------------------------------------------------------------------------------

    Dated: March 12, 2012.
J.M. Vojvodich,
Captain, U.S. Coast Guard, Captain of the Port Sector Long Island
Sound.
[FR Doc. 2012-7964 Filed 4-3-12; 8:45 am]
BILLING CODE 9110-04-P