[Federal Register Volume 81, Number 18 (Thursday, January 28, 2016)]
[Notices]
[Pages 4917-4921]
[FR Doc No: 2016-01690]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0044]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Recommended
Recordkeeping for Exempt Infant Formula Production

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
February 29, 2016.

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_ADDRESS>All
comments should be identified with the OMB control number 0910--NEW.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Recommended Recordkeeping for Exempt Infant Formula Production--OMB
Control Number 0910--NEW

I. Background

    Section 412(h)(1) (21 U.S.C. 350a(h)(1)) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) exempts an infant formula which is
represented and labeled for use by an infant with an inborn error of
metabolism, low birth weight, or who otherwise has an unusual medical
or dietary problem from the requirements of section 412(a), (b), and
(c) of the FD&C Act (21 U.S.C. 350a(a), (b), and (c)). These formulas
are customarily referred to as ``exempt infant formulas.'' In the
Federal Register of June 10, 2014 (79 FR 33057), we published a final
rule that adopted, with some modifications, an interim final rule
published on February 10, 2014 (79 FR 7934), that established
requirements for quality factors for infant formulas and current good
manufacturing practices (CGMPs), including quality control procedures,
under section 412 of the FD&C Act. The final rule will help prevent the
manufacture of adulterated infant formula, ensure the safety of infant
formula, and ensure that the nutrients in infant formula are present in
a form that is bioavailable.
    In the Federal Register of February 10, 2014 (79 FR 7610), we
published a notice of availability of the draft guidance document
entitled, ``Guidance for Industry: Exempt Infant Formula Production:
Current Good Manufacturing Practices, Quality Control Procedures,
Conduct of Audits, and Records and Reports'' (the draft guidance). The
draft guidance, when finalized, will describe our current thinking on
the manufacturing of exempt infant formula in relation to the
requirements in part 106 (21 CFR part 106) for CGMPs, quality control
procedures, conduct of audits, and records and reports that apply to
nonexempt infant formulas. Persons with access to the Internet may
obtain the draft guidance at http://www.fda.gov/FoodGuidances.

II. Analysis of the Proposed Information Collection

    The proposed information collection seeks OMB approval of the
recordkeeping recommendations of the draft guidance. Our estimate of
the burden of the recordkeeping recommendations includes the one-time
burden of developing production and in-process control systems and the
annual burdens of developing and maintaining production aggregate
production and control records, records pertaining to the distribution
of infant formula, and records pertaining to regularly scheduled
audits. Included in the burden estimate is the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information.
    Description of Respondents: The respondent recordkeepers are
manufacturers of exempt infant formula.
    Description: The records recommended, to the extent practicable, in
the draft guidance include records required by part 106, subparts A, B,
C, D, and F for non-exempt infant formulas. Because the records and
reporting requirements related to part 106 subparts E and G are not
generally applicable to exempt infant formula manufacturers, FDA is not
recommending in the draft guidance that exempt infant formula
manufacturers follow these requirements. As such, the records and
reporting requirements in part 106 subparts E and G are not part of
this new information collection.
    In the Federal Register of March 18, 2015 (80 FR 14134), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received one letter responsive to the
notice, which contained comments.
    (Comment 1) One comment suggested that we clarify the action level
for end-of-shelf-life verification testing and how this testing differs
for exempt infant formulas as compared to non-exempt infant formulas.
    (Response) We appreciate the concerns discussed in the comment.

The exempt infant formula guidance recommends that manufacturers of
exempt infant formulas follow, to the extent practicable, subparts A,
B, C, D, and F of 21 CFR part 106, as amended or established by the
final rule published on June 10, 2014 (79 FR 33057), in the production
of their formula products. We do not plan to establish an action level
for end-of-shelf-life verification testing in the exempt infant formula
guidance. Furthermore, our guidance documents do not establish legally
enforceable requirements and therefore cannot include mandatory
language such as ``shall, must, required, or requirement,'' unless
specific regulatory or statutory requirements are cited.
    To the extent that the comment requests us to engage in rulemaking,
the comment is outside the scope of the comment request on the four
collection of information topics as they relate to the provisions of
the draft guidance document.
    (Comment 2) One comment asserted that we may have underestimated
the time it would take to test weekly for bacteriological contaminants,
as reported in Table 1. The comment noted our estimate of 5 minutes per
test, once a week, for each of three infant formula plants and added
that including the performance of the test would significantly increase
the time needed.
    (Response) We appreciate the information provided in the comment.
However, the comment did not provide us data or information to support
a different estimate. In the absence of such data, we lack a basis on
which to revise our estimates. In addition, we note that our estimate
of 5 minutes per test, once a week, reflects the amount of time needed
to fulfill the recordkeeping burdens associated with this requirement,
not the time needed to conduct the testing that is subject to the
recordkeeping requirement. In preparation for the next regular
information collection request, we will consult with several
establishments to obtain additional data on the recordkeeping burdens
and reevaluate our estimates. We will then publish the revised
estimates for comment and consider additional information submitted in
response.
    FDA estimates the burden of this collection of information as
follows:
    The total one-time estimated burden imposed by this collection of
information is 19,320 hours. The total annual estimated burden imposed
by this collection of information is 6,328.06 hours. There are no
capital costs or operating and maintenance costs associated with this
collection of information. The estimated burden for the draft guidance
is based on ``Evaluation of Recordkeeping Costs for Food
Manufacturers,'' Eastern Research Group Task Order No. 5, Contract No.
223-01-2461. FDA estimates that firms will be able to fulfill
recordkeeping requirements with existing record systems; that is, FDA
estimates that it will not be necessary for infant formula firms to
invest in new recordkeeping systems.
    As of the beginning of 2015, five manufacturers produce exempt
infant formulas that are marketed in the United States. Four out of
these five infant formula manufacturers produce both exempt and non-
exempt infant formulas, with both types of infant formula produced
using the same production lines and equipment. Our experts believe that
manufacturing practices are similar for both exempt and non-exempt
infant formulas. Furthermore, given expert estimations of industry
standard practices, it is estimated that the manufacturer that only
produces exempt infant formula has practices comparable to those
manufacturers producing both exempt and non-exempt infant formulas
(Ref. 1). Together, these 5 manufacturers produce exempt infant formula
at 12 plants.
    The number of recordkeepers in column 3 of Table 1 is based on
FDA's expert estimation of the number of plants that may not already be
adhering to the relevant recordkeeping provisions of the final rule.
The Regulatory Impact Analysis for the final rule (79 FR 33057)
estimated that 25 percent of all infant formula plants manufacturing
non-exempt infant formula were not currently adhering to the
recordkeeping provisions under Sec.  106.100 (21 CFR 106.100). Although
such recordkeeping requirements are now effective for manufacturers of
non-exempt infant formulas, and manufacturers of exempt infant formulas
may have implemented similar procedures for their exempt infant
formulas, it is estimated conservatively that this same proportion (25
percent, or 3 out of 12 plants that manufacture exempt infant formula)
are not currently adhering to the recordkeeping provisions, and unless
otherwise specified, burdens are estimated based on these 3 plants.
Furthermore, we estimate that plants will collect the same information
across the various exempt infant formulas produced by each firm.
    For records pertaining to production and in-process controls, FDA
estimates that, at most, three plants do not currently develop
production records as specified under Sec. Sec.  106.6(c)(5) and
106.100(e)(1) and (3). A team of two senior validation engineers (or
other similarly skilled employees) per plant (2 workers per plant x 3
plants = 6 workers) would each need to work 20 hours to provide
sufficient initial baseline records and documentation to develop
records pertaining to production and in-process controls, for an
industry total of 120 hours (2 workers per plant x 3 plants x 20 hours
per worker = 120 hours), as presented in line 1 of Table 1.
    For the recordkeeping specified under Sec.  106.35(c), in
accordance with Sec.  106.100(f)(5), FDA estimates that a team of 10
senior validation engineers (or other similarly skilled employees) per
plant would need to work full time for the 16 weeks (16 weeks/person x
40 work hours/week = 640 work hours per person) to provide sufficient
initial records and documentation pertaining to controls intended to
prevent adulteration due to automatic equipment. The total burden for
10 senior validation engineers each working 640 hours is 6,400 per
plant in the first year (10 senior validation engineers x 640 hours =
6,400). For three plants, the total one-time hourly burden is 3 plants
x 6,400 hours per plant = 19,200 hours, as presented in line 2 of Table
1.
    For the testing specified under Sec.  106.20(f)(3), manufacturers
of exempt infant formulas should conduct water testing with appropriate
frequency to meet Environmental Protection Agency primary standards for
drinking water (40 CFR parts 9, 141, and 142), but shall conduct these
tests at least annually for chemical contaminants, every 4 years for
radiological contaminants, and weekly for bacteriological contaminants.
FDA estimates that it is part of normal business practice for exempt
infant formula plants to test for chemical contaminants and keep
records of those tests on a regular basis; therefore, this is a new
collection of information that does not present a burden (Ref. 1).
    It is estimated that the recommendation to manufacturers of exempt
infant formulas to test at least every 4 years for radiological
contaminants would represent a new burden for all 12 infant formula
plants (Ref. 1). In addition, it is estimated that collecting water for
this testing takes between 1 and 2 hours (Ref. 1). For the purposes of
this analysis, it is conservatively estimated that water collection
takes, on average, 1.5 hours and that water collection occurs
separately for each type of testing. It is estimated that performing
the test (collecting the information) will take 1.5 hours per test,
every 4 years. Therefore,

1.5 hours per plant x 12 plants = 18 total hours, every 4 years, or 4.5
hours per year, as seen in line 3 of Table 1.
    Furthermore, the draft guidance recommends that manufacturers of
exempt infant formula make and retain records of the frequency and
results of water testing as specified under Sec. Sec.  106.20(f)(4) and
106.100(f)(1). For the 12 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 12
plants = 0.96 hour every four years for the maintenance of records of
radiological testing, or 0.24 hours per year, as seen on line 4 of
Table 1.
    It is estimated that the recommendation to test weekly for
bacteriological contaminants is a new burden for three infant formula
plants. It is estimated that performing the test (collecting the
information) will take 5 minutes per test once a week. Annually, this
burden is 0.08 hour x 52 weeks = 4.16 hours per year per plant, and
4.16 hours per plant x 3 plants = 12.48 total annual hours, as seen on
line 5 of Table 1. Furthermore, for the three 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 per plant x 3 plants = 12.48 annual hours, as seen on line 6 of
Table 1.
    The draft guidance recommends that manufacturers of exempt infant
formulas calibrate certain instruments against a known reference
standard and that records of these calibration activities be made and
retained, as specified in Sec. Sec.  106.30(d)(1) and 106.100(f)(2).
FDA estimates that one senior validation engineer (or other similarly
skilled employee) for each of the three (at most) plants would need to
spend about 13 minutes per week to conduct the ongoing calibration
recordkeeping. Therefore, 3 recordkeepers x 0.21 hours per week per
recordkeeper = 0.63 hours per week; 0.63 hours per week x 52 weeks per
year = 32.76 hours as the total industry annual burden, as presented in
line 7 of Table 1.
    The draft guidance recommends that manufacturers of exempt infant
formula make and retain records of the temperatures of each cold
storage compartment as specified in Sec. Sec.  106.30(e)(3)(iii) and
106.100(f)(3). Based on expert opinion, FDA estimates that three (at
most) plants are not currently conducting recordkeeping, and that at
each of these three plants, conducting this recordkeeping would take
one senior validation engineer (or other similarly skilled employee)
about 13 minutes per week. Therefore, 3 recordkeepers x 0.21 hours per
week per recordkeeper = 0.63 hours per week; 0.63 hours per week x 52
weeks = 32.76 hours as the total industry annual burden, as presented
in line 8 of Table 1.
    The draft guidance recommends the making and retention of records
of ongoing sanitation efforts as specified under Sec. Sec.
106.30(f)(2) and 106.100(f)(4). Based on expert opinion, FDA estimates
that three (at most) plants are not currently making and retaining
these records, and that at each of these three plants, it would take
one senior validation engineer (or other similarly skilled employee)
0.19 hours per week to make and retain these records. Therefore, 3
recordkeepers x 0.19 hours per week per recordkeeper = 0.57 hours per
week; 0.57 hours per week x 52 weeks = 29.64 hours as the total
industry annual burden, as presented in line 9 of Table 1.
    There will be annual recordkeeping associated with recommendations
for preventing adulteration from equipment, as specified under
Sec. Sec.  106.35(c) and 106.100(f)(5). It is estimated that one senior
validation engineer (or other similarly skilled employee) per plant
would need to work 10 hours per week (520 work hours per year) to meet
the ongoing recordkeeping recommendation. For the estimated three (at
most) plants not conducting this recordkeeping, the total annual burden
is 520 hours per plant x 3 plants = 1,560 annual hours, as shown in
line 10 of Table 1. In addition, this guidance recommends that an
infant formula manufacturer revalidate its systems when it makes
changes to automatic equipment. FDA estimates that such changes are
likely to occur twice a year to any aspect of the plant's system, and
that on each of the two occasions, a team of four senior validation
engineers (or other similarly skilled employees) per plant would need
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 adhere to this section. The total 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, 1,280 hours per plant x 3
plants = 3,840 annual hours, as shown on line 11 of Table 1.
    The draft guidance recommends written specifications for
ingredients, containers, and closures, as specified under Sec. Sec.
106.40(g) and 106.100(f)(6). FDA estimates that the exempt infant
formula industry already establishes written specifications for these
components. However, the guidance regarding controls to prevent
adulteration caused by ingredients, containers, and closures may
represent new recordkeeping for three (at most) plants (Ref. 1). It is
not possible to predict how often a specification will not be met or
how often documented reviews of reconditioned ingredients, closures, or
containers will occur. FDA estimates that, on average, one senior
validation engineer per plant would work about 10 minutes a week to
complete this recordkeeping. Therefore, 3 recordkeepers x 0.17 hours
per week per recordkeeper = 0.51 hours per week; 0.51 hours per week x
52 weeks = 26.52 total annual hours, as presented in line 12 of Table
1.
    This draft guidance recommends manufacturers of exempt infant
formula to make and maintain records of controls to prevent
adulteration during manufacturing, as specified in Sec. Sec.  106.50
and 106.100(e). It is not possible to predict how often changes to the
master manufacturing order would be made or how often deviations from
the master manufacturing order would occur. Based on expert opinion,
FDA estimates that each year, three (at most) plants would change a
master manufacturing order and that, on average, one senior validation
engineer for each of the three (at most) plants would spend about 14
minutes per week on recordkeeping pertaining to the master
manufacturing order. Thus, 3 recordkeepers x 0.23 hours per
recordkeeper per week = 0.69 hours per week; 0.69 hours per week x 52
weeks = 35.88 hours as the total annual industry burden, as presented
in line 13 of Table 1.
    The draft guidance recommends manufacturers of exempt infant
formula make and retain records of the testing of infant formula for
microorganisms, as specified in Sec. Sec.  106.55(d) and
106.100(e)(5)(ii) and (f)(7). We estimate that this recordkeeping
represents a new collection of information for, at most, three plants
(Ref. 1) and that one senior validation engineer per plant would spend
15 minutes per week on recordkeeping pertaining to microbiological
testing. Thus, 3 recordkeepers x 0.25 hours per recordkeeper per week =
0.75 hours; 0.75 hours per week x 52 weeks 39 hours as the total annual
industry burden, as presented in line 14 of Table 1.

    The draft guidance recommends that exempt infant formula
manufacturers make and maintain records consistent with the
requirements for the labeling of mixed-lot packages of infant formula
that apply to non-exempt infant formula manufacturers, as specified
under Sec.  106.60(c). We estimate that the draft guidance will result
in infant formula diverters labeling infant formula packaging (such as
packing cases) to facilitate product tracing and to keep specific
records of the distribution of these mixed lot cases. (A diverter is
considered to be a business or individual that purchases food,
including occasionally infant formula, in a geographic area where a
special allowance or deal is being offered and then resells that food
at a lower price to wholesale or retail grocery, drug and mass
merchandise chains in an area where the deal is not being offered.)
There will be some cost associated with this recordkeeping and
labeling, but the Agency estimates that this burden would be minimal as
it is estimated that less than 1 percent of infant formula is handled
by diverters. For the purposes of this analysis, it is estimated that,
for all plants combined, it may take one worker using manual methods 15
minutes, at most, to relabel one case of infant formula one time each
month (0.25 hours per month x 12 months = 3 annual hours), as presented
in line 15 of Table 1.
    The draft guidance recommends nutrient testing for exempt infant
formula manufacturers as specified in Sec.  106.91(a)(1) through (4).
It is estimated that the systems and processes of 100 percent of the
exempt formula industry test in accordance with these provisions.
Therefore, nutrient testing does not represent a new recordkeeping
burden as nutrient testing is estimated to be common business practice
in the exempt infant formula industry. Thus, no burden is estimated for
these recommendations (Ref. 1).
    The draft guidance also recommends on-going stability testing as
specified under Sec.  106.91(b)(1) through (3). It is estimated that
the systems and processes of the infant formula industry partially
adhere to this guidance in that 80 percent of infant formula plants
(about 10 of 12 plants) conduct stability testing as recommended (Ref.
1). For the 20 percent of plants (2 of 12 plants) that do not conduct
stability testing, it is estimated that these plants do conduct initial
stability testing, but may not do so at the intervals specified in this
provision (Ref. 1). For the purposes of this analysis, it is estimated
that the stability testing guidance represents a new information
collection burden of 2 annual hours, per plant. Therefore, 2 hours per
plant x 2 plants = 4 annual hours as shown in line 16 of Table 1.
    The draft guidance recommends recordkeeping for test results as
specified under Sec. Sec.  106.91(d) and 106.100(e)(5)(i). This
represents new information collections for the two plants that are
estimated not to be conducting all of the stability testing specified
in Sec.  106.91(b) (Ref. 1). For the purposes of this analysis, FDA
estimates that one senior validation engineer per plant would spend
about 9 minutes per week maintaining records related to testing. Thus,
2 recordkeepers x 0.15 hours per recordkeeper per week = 0.3 hours per
week x 52 weeks = 15.6 hours as the annual total industry burden, as
presented in lines 17, 18, and 19 of Table 1.
    The draft guidance recommends the creation of audit plans and
procedures, as specified under Sec.  106.94. FDA estimates that all
exempt infant formula manufacturers currently conduct audits, but that
25 percent of infant formula plants (3 of 12 plants) do not conduct
audits that include all elements specified in Sec.  106.94 (Ref. 1). It
is estimated that the ongoing review and updating of audit plans would
require a senior validation engineer 8 hours per year, per plant.
Therefore, 8 hours per year per plant x 3 plants = 24 annual hours to
regularly review and update audit plans as shown in line 20 of Table 1.
    The infant formula final rule does not mandate a frequency of
auditing, therefore, one is not recommended in the draft guidance. For
the purposes of this analysis, FDA estimates that a manufacturer would
choose to audit once per week. Each weekly audit is estimated to
require a senior validation engineer 4 hours, or 52 weeks x 4 hours =
208 hours per plant per year. Therefore, the total annual burden for
the estimated three plants not currently acting in accordance to this
guidance to update audit plans is 208 hours x 3 plants = 624 hours, as
shown in line 21 of Table 1.

                                 Table 1--Estimated Hourly Recordkeeping Burden
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                                                    First year
         21 CFR Section              Number of     frequency of    Total records     Hours per      Total hours
                                   recordkeepers   recordkeeping                      record
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                                            First Year Hourly Burden
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1. Production and In-Process                   6               1               3              40             120
 Control System 106.6(c)(5) and
 106.100(e)(1) and (3)..........
2. Controls to Prevent                        30               1               3           6,400          19,200
 Adulteration Due to Automatic
 (Mechanical or Electronic)
 Equipment 106.35(c) and
 106.100(f)(5)..................
                                 -------------------------------------------------------------------------------
    Total First Year Only Hourly  ..............  ..............  ..............  ..............          19,320
     Recordkeeping Burden.......
----------------------------------------------------------------------------------------------------------------
                                         Recurring Annual Hourly Burden
----------------------------------------------------------------------------------------------------------------
3. Controls to Prevent                        12               1              12             1.5             4.5
 Adulteration Caused by
 Facilities--Testing for
 Radiological Contaminants \1\
 106.20(f)(3)...................
4. Controls to Prevent                        12               1              12            0.08            0.24
 Adulteration Caused by
 Facilities--Recordkeeping of
 Testing for Radiological
 Contaminants \2\ 106.20(f)(4)
 and 106.100(f)(1)..............
5. Controls to Prevent                         3              52             156            0.08           12.48
 Adulteration Caused by
 Facilities--Testing for
 Bacteriological Contaminants
 106.20(f)(3)...................
6. Controls to Prevent                         3              52             156            0.08           12.48
 Adulteration Caused by
 Facilities--Recordkeeping of
 Testing for Bacteriological
 Contaminants 106.20(f)(4) and
 106.100(f)(1)..................

7. Controls to Prevent                         3              52             156            0.21           32.76
 Adulteration by Equipment or
 Utensils 106.30(d)(1) and
 106.100(f)(2)..................
8. Controls to Prevent                         3              52             156            0.21           32.76
 Adulteration by Equipment or
 Utensils 106.30(e)(3)(iii) and
 106.100(f)(3)..................
9. Controls to Prevent                         3              52             156            0.19           29.64
 Adulteration by Equipment or
 Utensils 106.30(f)(2) and
 106.100(f)(4)..................
10. Controls to Prevent                        3              52               3             520           1,560
 Adulteration Due to Automatic
 (Mechanical or Electronic)
 Equipment 106.35(c) and
 106.100(f)(5)..................
11. Controls to Prevent                       12               2               6             640           3,840
 Adulteration Due to Automatic
 (Mechanical or Electronic)
 Equipment 106.35(c) and
 106.100(f)(5)..................
12. Controls to Prevent                        3              52             156            0.17           26.52
 Adulteration Caused by
 Ingredients, Containers, and
 Closures 106.40(g) and
 106.100(f)(6)..................
13. Controls to Prevent                        3              52             156            0.23           35.88
 Adulteration During
 Manufacturing 106.50 and
 106.100(e).....................
14. Controls to Prevent                        3              52             156            0.25              39
 Adulteration From
 Microorganisms 106.55(d),
 106.100(e)(5)(ii), and
 106.100(f)(7)..................
15. Controls to Prevent                        1              12              12            0.25               3
 Adulteration During Packaging
 and Labeling of Infant Formula
 106.60(c)......................
16. General Quality Control-                   2               1               2               2               4
 Testing 106.91(b)(1) through
 (3)............................
17. General Quality Control                    2              52             104            0.15            15.6
 106.91(b)(1) and (d), and
 106.100(e)(5)(i)...............
18. General Quality Control                    2              52             104            0.15            15.6
 106.91(b)(2) and (d), and
 106.100(e)(5)(i)...............
19. General Quality Control                    2              52             104            0.15            15.6
 106.91(b)(3) and (d), and
 106.100(e)(5)(i)...............
20. Audit Plans and Procedures                 3               1               3               8              24
 106.94--Ongoing Review and
 Updating of Audits.............
21. Audit Plans and Procedures                 3              52             156               4             624
 106.94--Regular Audits.........
                                 -------------------------------------------------------------------------------
    Total Recurring               ..............  ..............  ..............  ..............        6,328.06
     Recordkeeping Burden.......
    Total Recordkeeping Burden..  ..............  ..............  ..............  ..............       25,648.06
----------------------------------------------------------------------------------------------------------------
\1\ As noted previously, the burden for making and maintaining such records is expected to occur once every 4
  years. The total hours column reflects the total number of hours averaged over the 4 year period.
\2\ As noted previously, the burden for making and maintaining such records is expected to occur once every four
  years. The total hours column reflects the total number of hours averaged over the four-year period.

III. Reference

    The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.

1. Zink, Don. Statement of Donald L. Zink: Infant Formula
Manufacturing Practices, 2013.

    Dated: January 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01690 Filed 1-27-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 174 (Monday, September 9, 2019)]
[Notices]
[Pages 47275-47276]
[FR Doc No: 2019-19341]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14978-000]

Lock\+TM\ Hydro Friends Fund XXVI, LLC; Notice of Preliminary
Permit Application Accepted for Filing and Soliciting Comments, Motions
To Intervene, and Competing Applications

    On March 6, 2019, Lock\+TM\ Hydro Friends Fund XXVI, LLC, filed an
application for a preliminary permit, pursuant to section 4(f) of the
Federal Power Act (FPA), proposing to study the feasibility of the
Prompton Dam Hydropower Project to be located at the U.S. Army Corps of
Engineers' (Corps) Prompton Dam on the Lackawaxen River in Wayne
County, Pennsylvania. The sole purpose of a preliminary permit, if
issued, is to grant the permit holder priority to file a license
application during the permit term. A preliminary permit does not
authorize the permit holder to perform any land-disturbing activities
or otherwise enter upon lands or waters owned by others without the
owners' express permission.
    The proposed project would consist of the following: (1) A new 30-
foot-long, 30-foot-wide, 160-foot-high Large Frame Module; (2) two
turbine-generator units with a total rated capacity of 1.0 megawatt;
(3) a new 4-foot-long, 4-foot-wide, 3-foot-high pad-mounted
transformer; (4) a new 200-foot-long, 13-kilovolt transmission line
connecting the new transformer to an existing distribution line; and
(5) appurtenant facilities. The proposed project would have an annual
generation of 4,500 megawatt-hours.
    Applicant Contact: Wayne Krouse, Lock\+TM\ Hydro Friends Fund XXVI,
LLC, P.O. Box 43796, Birmingham, AL 35243; phone:<PHONE_NUMBER> ext.
709.
    FERC Contact: Woohee Choi; phone:<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, notices of intent, and competing
applications using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/

ecomment.asp. You must include your name and contact information at the
end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, please send a paper
copy to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE, Washington, DC 20426. The first page of any filing should
include docket number P-14978-000.
    More information about this project, including a copy of the
application, can be viewed or printed on the eLibrary link of the
Commission's website at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14978) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: August 29, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-19341 Filed 9-6-19; 8:45 am]
BILLING CODE 6717-01-P


  MacroButton macIb01 i

EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: Kerry Leifer<PHONE_NUMBER>

TEMPLATE:

Trinseo LLC

[IN-10907]

	EPA has received a pesticide petition (IN-10907) from Trinseo LLC, c/o
Keller and Heckman LLP, 1001 G Street, NW, Suite 500 West, Washington,
DC 20001 requesting, pursuant to section 408(d) of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part
180 to establish an exemption from the requirement of a tolerance for
butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate with an average molecular
weight of greater than 10,000 daltons (CAS Reg. No. 36089-06-2) under 40
CFR §180.960 in or on raw agricultural commodities when used as a
pesticide inert ingredient in pesticide formulations without limitation.
EPA has determined that the petition contains data or information
regarding the elements set forth in section 408 (d)(2) of  FDDCA;
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data supports granting of the petition.
Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. NA-Remove. No specific plant metabolism data is
available, nor is it required for the establishment of a tolerance
exemption.

	2. Analytical method. NA-Remove. An analytical method is not required
for enforcement purposes since the Agency is establishing an exemption
from the requirement of a tolerance without any numerical limitation.

	3. Magnitude of residues. NA-Remove. Information regarding the nature
and magnitude of chemical residues resulting from the use of this inert
ingredient is not required for the establishment of a tolerance
exemption.

B. Toxicological Profile

Butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate is a polymer as defined
by 40 CFR 723.250(b).

Butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate will not become cationic
in an aquatic environment.

Butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate is composed of hydrogen,
oxygen, and carbon: therefore, it meets the criteria of elemental
composition.

Butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate does not contain as an
integral part of its composition, except as impurities, any element
other than those listed in 40 CFR 723.250(d)(2)(ii).

Butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate is not designed nor
reasonably expected to degrade, decompose, or depolymerize under normal
conditions of manufacture, use and disposal.

Butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate is composed of molecules
that are listed on the TSCA Inventory or manufactured under an
applicable TSCA section 5 exemption.

Butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate is not a water absorbing
polymer and cannot absorb its own weight in water.

Butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate does not contain any
perfluoroalkyl moieties consisting of a CF3- or longer chain length as
specified in 40 CFR 723.250(d)(6).

Butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate consists of a number
average molecular weight of greater than 10,000 daltons.

	1. Acute toxicity.  NA-Remove

	2. Genotoxicty. NA-Remove

	3. Reproductive and developmental toxicity. NA-Remove

	4. Subchronic toxicity. NA-Remove

	5. Chronic toxicity. NA-Remove

	6. Animal metabolism. NA-Remove

	7. Metabolite toxicology. NA-Remove

	8. Endocrine disruption. NA-Remove

C. Aggregate Exposure

	1. Dietary exposure. The physical-chemical characteristics of
butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate leads to the conclusion
that there is a reasonably certainty of no harm from exposure to the
polymer from food or drinking water nor from an aggregate exposure.

	i. Food. NA-Remove

	ii. Drinking water. NA-Remove

	2. Non-dietary exposure. The physical-chemical characteristics of
butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate lead to the conclusion
that there is a reasonable certainty of no harm from exposure to the
polymer from non-dietary means.

D. Cumulative Effects

	At this time there is no information to indicate that any toxic effects
produced by butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate would by cumulative with
any other chemical. Given the compound’s categorization as a low risk
polymer, and its proposed use in pesticide formulations, there is no
expectation of increased risk due to cumulative exposure.

E. Safety Determination

	1. U.S. population. Based on the polymer’s physical-chemical
properties, and that it meets or exceeds the polymer exemption criteria
at 40 CFR 723.250 for low-risk polymers, adverse effects are not
expected.

	2. Infants and children. Based on the polymer’s physical-chemical
properties, and that it meets or exceeds the polymer exemption criteria
at 40 CFR 723.250 for low-risk polymers, adverse effects are not
expected.

F. International Tolerances

The Codex Alimentarius Commission (Codex) has not established a MRL for
butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate and there are no maximum
residue limits established for butanedioic acid, 2-methylene-, polymer
with 1,3-butadiene, ethenylbenzene and 2-hydroxyethyl 2-propenoate in or
on crops or commodities of which the petitioner is aware.

4819-9536-0301, v.  1

 PAGE

 PAGE   3


[Federal Register: July 6, 2010 (Volume 75, Number 128)]
[Notices]
[Page 38802]
[DOCID:fr06jy10-60]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR10-43-000]

Copano Pipelines/Upper Gulf Coast, L.P.; Notice of Baseline
Filing

June 28, 2010.
    Take notice that on June 24, 2010, Copano Pipelines/Upper Gulf
Coast, L.P. submitted a baseline filing of its Statement of Operating
Conditions for services provided under section 311 of the Natural Gas
Policy Act of 1978 (NGPA).
    Any person desiring to participate in this rate proceeding must
file a motion to intervene or to protest this filing must file in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211 and 385.214). Protests will be considered
by the Commission in determining the appropriate action to be taken,
but will not serve to make protestants parties to the proceeding. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed on or before the date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern time on Monday, July 12, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-16288 Filed 7-2-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 115 (Friday, June 16, 2017)]
[Rules and Regulations]
[Pages 27616-27618]
[FR Doc No: 2017-12499]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2017-0435]
RIN 1625-AA08

Special Local Regulation; Ohio River, New Martinsville, WV

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary special local
regulation for all navigable waters, surface to bottom, of the Ohio
River miles 127.5 to 128.5. This action is necessary to provide for the
safety of life on these navigable waters near New Martinsville, WV
during a high-speed boat race on June 17, 2017 and June 18, 2017. This
regulation prohibits persons and vessels from being in the regulated
area unless authorized by the Captain of the Port Ohio Valley or a
designated representative.

DATES: This rule is effective from 8:45 a.m. to 6:15 p.m. on June 17,
2017 and June 18, 2017.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2017-0435 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Petty Officer Robert Miller, Marine Safety Unit
Huntington, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

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

II. Background Information and Regulatory History

    On May 11, 2017, the New Martinsville Vintage Regatta notified the
Coast Guard that it will be sponsoring a high-speed boat race from 8:45
a.m. to 6:15 p.m. daily on June 17, 2017 and June 18, 2017 on the Ohio
River miles 127.5 to 128.5 in the vicinity of New Martinsville, WV.
    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b) (B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable. We must
establish this safety zone by June 17, 2017 and lack sufficient time to
provide a reasonable comment period and then consider those comments
before issuing the rule.
    We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for making it effective less than 30
days after publication in the Federal Register. This rule is necessary
for the safety of life during the high-speed boat race on these
navigable waters. It would be impracticable to delay this rule to
provide a full 30 days notice because the event is scheduled, under
contractual obligation and advertised to the local community to take
place on June 17, 2017 and June 18, 2017.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1233. The Captain of the Port Ohio Valley (COTP) has determined that
potential hazards associated with the high-speed boat race to occur on
June 17, 2017 and June 18, 2017, present a safety concern for anyone
within the regulated area. The purpose of this rulemaking is to ensure
the safety of people and property within the regulated area before,
during, and after the scheduled event.

IV. Discussion of Comments, Changes, and the Rule

    This rule establishes a temporary special local regulation from
8:45 a.m. to 6:15 p.m. on June 17, 2017 and June 18, 2017. The
temporary special local regulation will cover all navigable waters,
surface to bottom, from mile 127.5 to 128.5 on the Ohio River in the
vicinity of New Martinsville, WV. The duration of the regulated area is
intended to ensure the safety of vessels and these navigable waters
before,

during, and after the scheduled event. No vessel or person will be
permitted to enter the temporary special local regulation without
obtaining permission from the COTP or a designated representative.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    E.O.s 12866 (``Regulatory Planning and Review'') and 13563
(``Improving Regulation and Regulatory Review'') direct agencies to
assess the costs and benefits of available regulatory alternatives and,
if regulation is necessary, to select regulatory approaches that
maximize net benefits including potential economic, environmental,
public health and safety effects, distributive impacts, and equity.
Executive Order 13563 emphasizes the importance of quantifying both
costs and benefits, of reducing costs, of harmonizing rules, and of
promoting flexibility. Executive Order 13771 (``Reducing Regulation and
Controlling Regulatory Costs''), directs agencies to reduce regulation
and control regulatory costs and provides that ``for every one new
regulation issued, at least two prior regulations be identified for
elimination, and that the cost of planned regulations be prudently
managed and controlled through a budgeting process.''
    The Office of Management and Budget (OMB) has not designated this
rule a significant regulatory action under section 3(f) of Executive
Order 12866. Accordingly, OMB has not reviewed it.
    As this rule is not a significant regulatory action, this rule is
exempt from the requirements of Executive Order 13771. See OMB's
Memorandum titled ``Interim Guidance Implementing Section 2 of the
Executive Order of January 30, 2017 titled `Reducing Regulation and
Controlling Regulatory Costs''' (February 2, 2017).
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the regulated area. Vessel
traffic will be able to safely navigate through the affected area
before and after the scheduled event. The Coast Guard will issue
Broadcast Notice to Mariners via VHF-FM marine channel 16 about the
regulated area and the rule allows vessels to seek permission to enter
the area.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received no comments from the Small Business
Administration on this rulemaking. The Coast Guard certifies under 5
U.S.C. 605(b) that this rule will not have a significant economic
impact on a substantial number of small entities.
    While some owners or operators of vessels intending to transit the
regulated area may be small entities, for the reasons stated in section
V.A. above, this rule will not have a significant economic impact on
any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Public Law 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule involves a temporary special local regulation lasting from 8:45
a.m. to 6:15 p.m. daily on June 17, 2017 and June 18, 2017. It is
categorically excluded from further review under paragraph 34(h) of
Figure 2-1 of the Commandant Instruction. A Record of Environmental
Consideration is available in the docket where indicated under
ADDRESSES.

G. Protest Activities

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

person listed in the FOR FURTHER INFORMATION CONTACT section to
coordinate protest activities so that your message can be received
without jeopardizing the safety or security of people, places or
vessels.

List of Subjects in 33 CFR Part 100

    Marine Safety, Navigation (water), Reporting and Recordkeeping
Requirements, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

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

    Authority:  33 U.S.C. 1233.

0
2. Add temporary Sec.  100.35T08-0435 to read as follows:

 Sec.  100.35T08-0435   Special Local Regulation; Ohio River, New
Martinsville, WV.

    (a) Location. All navigable waters of the Ohio River, surface to
bottom, beginning at mile marker 127.5 and ending at mile marker 128.5
at New Martinsville, WV.
    (b) Periods of enforcement. This rule will be enforced from 8:45
a.m. to 6:15 p.m. daily on June 17, 2017 and June 18, 2017.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  100.801 of this part, entry into this area is prohibited unless
authorized by the Captain of the Port Ohio Valley or a designated
representative.
    (2) Persons or vessels requiring entry into or passage through the
area must request permission from the Captain of the Port Ohio Valley
or a designated representative. U.S. Coast Guard Sector Ohio Valley may
be contacted on VHF Channel 13 or 16, or at 1-800-253-7465.
    (d) Informational Broadcasts. The COTP Ohio Valley or a designated
representative will inform the public through broadcast notices to
mariners of the enforcement period for the special local regulation, as
well as any changes in the dates and times of enforcement.

    Dated: June 12, 2017.
M.B. Zamperini,
Captain, U.S. Coast Guard, Captain of the Port Ohio Valley.
[FR Doc. 2017-12499 Filed 6-15-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 84, Number 176 (Wednesday, September 11, 2019)]
[Rules and Regulations]
[Pages 47882-47884]
[FR Doc No: 2019-19573]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 51, 60, 61, and 63

[EPA-HQ-OAR-2008-0531; FRL-9999-52-OAR]

Stationary Source Audit Program; Notification of Availability and
Request for Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notification of availability, request for comments.

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

SUMMARY: The Environmental Protection Agency (EPA) is providing
notification that one of the two accredited providers

of audit samples for the stationary source audit program has ceased
manufacturing samples. The general provisions require that the owner or
operator of an affected facility required to conduct performance
testing obtain audit samples if the audit samples are ``commercially
available'' and have defined ``commercially available'' to mean that
two or more independent accredited audit sample providers have blind
audit samples available for purchase. Since there are no longer two
providers, the requirement to obtain these audit samples is no longer
in effect until such time as another independent accredited audit
sample provider has audit samples available for purchase. The EPA is
providing a 90-day comment period during which interested persons may
provide comments on the suspension of the stationary source audit
program and the effectiveness of the program prior to its suspension.

DATES: Comments must be received on or before December 10, 2019.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2008-0531, to the Federal eRulemaking Portal: https://www.regulations.gov. Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or withdrawn. The
EPA may publish any comment received to its public docket. Do not
submit electronically any information you consider to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Multimedia submissions (audio, video, etc.) must
be accompanied by a written comment. The written comment is considered
the official comment and should include discussion of all points you
wish to make. The EPA will generally not consider comments or comment
contents located outside of the primary submission (i.e., on the Web,
Cloud, or other file sharing system). For additional submission
methods, the full EPA public comment policy, information about CBI or
multimedia submissions, and general guidance on making effective
comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
    For additional information about the EPA's public docket, visit the
EPA Docket Center homepage at https://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available (e.g., CBI or other information
whose disclosure is restricted by statute). Certain other material,
such as copyrighted material, will be publicly available only in hard
copy. Publicly available docket materials are available either
electronically in www.regulations.gov or in hard copy at the Air and
Radiation Docket and Information Center, EPA/DC, WJC West Building,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the Air
Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Mr. Ned Shappley, Air Quality
Assessment Division, Environmental Protection Agency, Mail code: E143-
02, 109 T.W. Alexander Drive, Research Triangle Park, NC 27709;
telephone number:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On September 13, 2010 (75 FR 55636), EPA promulgated amendments to
the General Provisions of parts 51, 60, 61, and 63 to allow accredited
audit sample providers to supply stationary source audit samples and to
require sources to obtain and use these samples from the accredited
providers instead of from EPA, as was the practice prior to the
promulgation date.
    These amendments included minimum requirements for the audit
samples, the accredited audit sample providers (AASP), and the audit
sample provider accreditor (ASPA). The AASP are the companies that
prepare and distribute the audit samples and the ASPA is a third-party
organization that accredits and monitors the performance of the AASP.
These organizations were required to work through a Voluntary Consensus
Standard Body (VCSB) \1\ using the consensus process to develop
criteria documents that describe how they will function and meet the
EPA regulatory criteria listed in this rule. The AASPs were required to
be accredited by an ASPA according to a technical criteria document
developed by a VCSB and these technical criteria document had to meet
EPA regulations.
---------------------------------------------------------------------------

    \1\ The Federal Office of Management and Budget Circular A-119
defines a VCSB as one having the following attributes: (i) Openness;
(ii) balance of interest; (iii) due process; (iv) an appeals
process; and (v) consensus, which is general agreement, but not
necessarily unanimity, and includes a process for attempting to
resolve objections by interested parties.
---------------------------------------------------------------------------

    These amendments also included language that outlined the
responsibilities of the regulated source owner or operator to acquire
and use an audit sample for all testing conducted to determine
compliance with an air emission limit under the subject parts and
specified that the requirement applies only if there are commercially
available audit samples for the test method used during the compliance
testing. By clarifying the audit sample requirement and expanding audit
sample availability through multiple providers, EPA believed that more
audits would be conducted for compliance tests and the overall quality
of the data used for determining compliance would improve.

II. Public Comment on the Suspension of the SSAP Program

    The EPA suspended the SSAP program effective May 28, 2019, when we
were notified by one of the two AASP that they would no longer be
supplying audit samples. Since we require that audit samples are
``commercially available'' and have defined ``commercially available''
to mean that two or more independent AASP have blind audit samples
available for purchase, EPA was obligated to suspend the program and
provide notification on our website (https://www.epa.gov/emc). The EPA
is seeking comment on whether we should continue the SSAP as currently
defined in the General Provisions to 40 CFR parts 51, 60, 61, and 63.
EPA is also seeking comment regarding if we should redefine
``commercially available'' as it applies to the number of AASPs which
have audit samples available for purchase. The comment period for this
action is 90 days from September 11, 2019.

III. Public Comment on the Effectiveness of the SSAP Program

    Since the privatization of the EPA SSAP, approximately 20,000 audit
samples have been ordered and analyzed with an effective passing rate
of 97 percent for all methods in which audit samples are available. EPA
is requesting comment on effectiveness of the SSAP and whether it has
improved the quality of data produced by performance testing. In
addition, EPA is seeking comment on whether EPA should consider
revisions to the SSAP program to make it a more effective tool for
evaluating quality of a performance test. As indicated previously, the
comment period for this action is 90 days from September 11, 2019.

    Dated: August 20, 2019.
Richard A. Wayland,
Director, Air Quality Assessment Division.
[FR Doc. 2019-19573 Filed 9-10-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 197 (Friday, October 10, 2014)]
[Rules and Regulations]
[Pages 61261-61262]
[FR Doc No: 2014-24219]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

46 CFR Part 67

[Docket No. USCG-2014-0688]
RIN 1625-ZA33

Shipping and Transportation; Technical, Organizational, and
Conforming Amendments

AGENCY: Coast Guard, DHS.

ACTION: Correcting Amendment.

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SUMMARY: The Coast Guard published a final rule in the Federal Register
on September 29, 2014, that made non-substantive corrections throughout
Title 46 of the Code of Federal Regulations. In that final rule, the
Coast Guard revised a paragraph by substituting an incorrect word with
one that was presumed correct. The substitution is actually incorrect,
and the original word was correct. This correction resolves that error
by replacing the word that we incorrectly removed.

DATES: This correction is effective on October 10, 2014.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
correction,

call or email Paul Crissy, Office of Standards Evaluation and
Development, Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing material on
the docket, call Cheryl Collins, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: To view the original final rule document,
visit http://www.gpo.gov/fdsys/granule/FR-2014-09-29/2014-21994.

Background

    On September 29, 2014, the Coast Guard published its annual
technical amendment to make non-substantive changes to Title 46 of the
Code of Federal Regulations. 79 FR 58270.

Need for Correction

    The Coast Guard published a final rule in the Federal Register that
created the need for this correction. The Coast Guard amended Sec.
67.259(b) by removing the word ``effected,'' and adding in its place
the word ``affected.'' This replacement was incorrect, however, as the
word ``effected'' was used correctly. This correction amends paragraph
(b) by replacing the word ``affected'' with the word ``effected.''

List of Subjects in 46 CFR Part 67

    Reporting and recordkeeping requirements, Vessels.

    Accordingly, 46 CFR part 67 is amended by making the following
correcting amendment:

PART 67--DOCUMENTATION OF VESSELS

0
1. The authority citation for part 67 continues to read as follows:

    Authority: 14 U.S.C. 664; 31 U.S.C. 9701; 42 U.S.C. 9118; 46
U.S.C. 2103, 2107, 2110, 12106, 12120, 12122; 46 U.S.C. app. 841a,
876; Department of Homeland Security Delegation No. 0170.1.

Sec.  67.259  [Corrected]

0
2. In Sec.  67.259(b), remove the word ``affected'' and add, in its
place, the word ``effected''.

    Dated: October 6, 2014.
Katia Cervoni,
Chief, Office of Regulations and Administrative Law, U.S. Coast Guard.
[FR Doc. 2014-24219 Filed 10-9-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 84, Number 196 (Wednesday, October 9, 2019)]
[Notices]
[Pages 54266-54267]
[FR Doc No: 2019-22061]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2019-0128]

Washington Meal and Rest Break Rules for Commercial Motor Vehicle
Drivers; Petition for Determination of Preemption

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of petition for determination of preemption; request for
comments.

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SUMMARY: FMCSA requests comments on a petition submitted by the
Washington Trucking Associations, Inc. (WTA) requesting a determination
that the State of Washington's Meal and Rest Break Rules (MRB rules),
as applied to drivers of commercial motor vehicles (CMVs) subject to
FMCSA's hours of service (HOS) regulations, are preempted by Federal
law. FMCSA requests comments in response to this petition.

DATES: Comments must be received on or before November 8, 2019.

ADDRESSES: You may submit comments identified by Federal Docket
Management System (FDMS) Number FMCSA-2019-0128 by any of the following
methods:
     Federal eRulemaking Portal: www.regulations.gov. See the
Public Participation and Request for Comments section below for further
information.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building, Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, between 9 a.m. and 5 p.m.
E.T., Monday through Friday, except Federal holidays.
     Fax: 1-202-493-2251.
    Each submission must include the Agency name and the docket number
for this notice. Note that DOT posts all comments received without
change to www.regulations.gov, including any personal information
included in a comment. Please see the Privacy Act heading below.

FOR FURTHER INFORMATION CONTACT: Tracy M. White, Enforcement and
Litigation Division; FMCSA Office of Chief Counsel; Telephone: (202)
493-0349; email<EMAIL_ADDRESS>If you have questions on viewing
or submitting material to the docket, contact Docket Services,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation and Request for Comments

    FMCSA encourages you to participate by submitting comments and
related materials.

Submitting Comments

    If you submit a comment, please include the docket number for this
notice (FMCSA-2019-0128), indicate the specific section of this
document to which the comment applies, and provide a reason for
suggestions or recommendations. You may submit your comments and
materials online or by fax, mail, or hand delivery, but please use only
one of these means. FMCSA recommends that you include your name and a
mailing address, an email address, or a phone number in the body of
your document so the Agency can contact you if it has questions
regarding your submission.
    To submit your comment online, go to www.regulations.gov and put
the docket number, ``FMCSA-2019-0128'' in the ``Keyword'' box, and
click ``Search.'' When the new screen appears, click on the ``Comment
Now!'' button and type your comment into the text box in the following
screen. Choose whether you are submitting your comment as an individual
or on behalf of a third party and then submit. 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. FMCSA will consider all comments and material received
during the comment period.
    Docket: For access to the docket to read background documents or
comments, go to www.regulations.gov at any time or visit Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday,
except Federal holidays. The online FDMS is available 24 hours each
day, 365 days each year.
    Privacy Act: DOT solicits comments from the public to better inform
its preemption determinations. DOT posts these comments, without edit,
including any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at www.transportation.gov/privacy.

SUPPLEMENTARY INFORMATION:

Background

    On December 21, 2018, FMCSA granted petitions filed by the American
Trucking Associations, Inc. and the Specialized Carriers and Rigging
Association, and determined that California's meal and rest break
rules, as applied to property-carrying CMV drivers subject to FMCSA's
HOS regulations, are preempted under 49 U.S.C. 31141. (Docket No.
FMCSA-2018-0304; 83 FR 67470 (December 28, 2018)). On April 8, 2019,
the WTA submitted a petition to FMCSA seeking a determination that
Washington's MRB rules are also preempted under 49 U.S.C. 31141.
    The WTA's petition states that Washington law requires employers to
provide employees with a meal period of at least 30 minutes for every
5-hour work period and a 10-minute break for every 4-hour work period.
See Petition at 2 (citing Wash. Admin. Code (WAC) 296-126-092). In
addition, the petition states that while ``employees may not waive
their right to a rest period at all,'' employees may waive their right
to a meal break. Id. (citations omitted). However, the WTA contends
that ``a missed [meal] break creates the presumption of a violation,
with the burden on the employer to prove waiver as an affirmative
defense.'' Id. (citations omitted). In its petition, the WTA explains
that ``Washington's rules contemplate a paid, on-duty 30-minute meal
break when the employee is required by the employer to remain on duty
on the premises.'' However, ``even if the 30-minute break is paid
pursuant to that provision,'' the WTA argues that employers remain
obligated to ``make every effort to provide employees with an
uninterrupted meal period'' and to ``continue the meal period until the
employee has received 30 minutes total of mealtime.'' Id. at 2-3.
    In its petition, the WTA alleges that similar to California's
requirements, the Washington MRB rules are ``regulations on commercial
motor vehicle safety

within the meaning of [49 U.S.C. 31141]'' and that they are
``additional to or more stringent than FMCSA's rules.'' Petition at 4-
5. Additionally, the petition states that the Washington MRB rules have
no safety benefit beyond those provided by FMCSA's rules, are
incompatible with the Federal HOS regulations, and impose an
unreasonable burden on interstate commerce. Id. at 5-7. The petition
states, ``Given the similarity between Washington and California meal
and rest break rules, the Agency's analysis of California's rules in
its recent preemption order applies equally to Washington's.'' Id. at
4.

Applicable Law

    Section 31141 of title 49, United States Code, prohibits States
from enforcing a law or regulation on CMV safety that the Secretary of
Transportation (Secretary) has determined to be preempted. To determine
whether a State law or regulation is preempted, the Secretary must
decide whether a State law or regulation: (1) Has the same effect as a
regulation prescribed under 49 U.S.C. 31136, which is the authority for
much of the Federal Motor Carrier Safety Regulations; (2) is less
stringent than such a regulation; or (3) is additional to or more
stringent than such a regulation 49 U.S.C. 31141(c)(1).
    If the Secretary decides that a State law or regulation has the
same effect as a regulation prescribed under 49 U.S.C. 31136, the State
law or regulation may be enforced. 49 U.S.C. 31141(c)(2). If the
Secretary decides that a State law or regulation is less stringent than
a regulation prescribed under 49 U.S.C. 31136, the State law or
regulation may not be enforced. Id. Sec.  31141(c)(3). If the Secretary
decides that a State law or regulation is additional to or more
stringent than a regulation prescribed by the Secretary under 49 U.S.C.
31136, the State law or regulation may be enforced unless the Secretary
decides that the State law or regulation (1) has no safety benefit; (2)
is incompatible with the regulation prescribed by the Secretary; or (3)
would cause an unreasonable burden on interstate commerce. Id. Sec.
31141(c)(4). In deciding whether a State law or regulation will cause
an unreasonable burden on interstate commerce, the Secretary may
consider the cumulative effect that the State's law or regulation and
all similar laws and regulations of other States will have on
interstate commerce. Id. Sec.  31141(c)(5). The Secretary's authority
under 49 U.S.C. 31141 is delegated to the FMCSA Administrator by 49 CFR
1.87(f).

Request for Comments

    Although preemption under 49 U.S.C. 31141 is a legal determination
reserved to the judgment of the Agency, FMCSA seeks comments on any
issues raised in the WTA's petition or otherwise relevant. The Agency
has placed the petition in the docket.

    Issued on: September 27, 2019.
Raymond P. Martinez,
Administrator.
[FR Doc. 2019-22061 Filed 10-8-19; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register: August 5, 2009 (Volume 74, Number 149)]
[Rules and Regulations]
[Page 38916-38918]
[DOCID:fr05au09-13]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2009-0269]
RIN 1625-AA00

Safety Zone; Sea World Labor Day Fireworks, Mission Bay, San
Diego, CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a safety zone on the navigable
waters of Mission Bay in support of the Sea World Labor Day Fireworks.
This safety zone is necessary to provide for the safety of the
participants, crew, spectators, participating vessels, and other
vessels and users of the waterway. Persons and vessels are prohibited
from entering into, transiting through, or anchoring within this safety
zone unless authorized by the Captain of the Port or his designated
representative.

DATES: This rule is effective from 8 p.m. to 10 p.m., each day, from
September 5, 2009 through September 7, 2009.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2009-0269 and are available online
by going to http://www.regulations.gov, selecting the Advanced Docket
Search option on the right side of the screen, inserting USCG-2009-0269
in the Docket ID box, pressing Enter, and then clicking on the item in
the Docket ID column. They are also available for inspection or copying
at two locations: The 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, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays; and at Coast Guard Sector San Diego, 2710 N.
Harbor Drive, San Diego, CA 92101-1064 between 8 a.m. and 3 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail Petty Officer Shane, Waterways
Management, U.S. Coast Guard Sector San Diego, CA; telephone (619) 278-
7262, e-mail<EMAIL_ADDRESS>If you have questions on viewing
the docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because immediate action is necessary to
ensure the safety of vessels, spectators, participants, and others in
the vicinity of the fireworks launching point and delay would be
contrary to the public interest.

Background and Purpose

    Sea World is sponsoring the Sea World Labor Day Fireworks, which
will include a fireworks presentation launched from a barge in Mission
Bay. The safety zone will extend in a 600 foot radius around the barge
at an approximate position of 32[deg]46'03'' N, 117[deg]13'11'' W. This
temporary safety zone is necessary to provide for the safety of the
crew, spectators, participants, and other vessels and users of the
waterway.

Discussion of Rule

    The Coast Guard is establishing a safety zone that will be enforced
from 8 p.m. to 10 p.m., each day, on September 5, 2009 through
September 7, 2009. The safety zone will extend in a 600 foot radius
around the barge at an approximate position of 32[deg]46'03'' N,
117[deg]13'11'' W. The safety zone is necessary to provide for the
safety of the crew, spectators, participants, and other vessels and
users of the waterway. Persons and vessels are prohibited from entering
into, transiting through, or anchoring within this safety zone unless
authorized by the Captain of the Port, or his designated
representative.

Regulatory Analyses

    We developed this 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 rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    We expect the economic impact of this proposed rule to be so
minimal that a full Regulatory Evaluation is unnecessary. This
determination is based on the location, small size, and short duration
of the safety zone, and the fact that vessel traffic will be able to
pass safely around the zone. Commercial vessels will not be hindered by
the safety zone. Recreational vessels will not be allowed to transit
through the designated safety zone during the specified times.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of 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 rule will
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 and operators of vessels intending to
transit or anchor in that portion of Mission Bay covered by the zone.
This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons: Vessel
traffic can pass safely around the safety zone, which is small and will
be effective for a short period. Before the effective period, the Coast
Guard will publish a local notice to mariners (LNM) and will issue
broadcast notice to mariners (BNM) alerts via marine channel 16 VHF
before the safety zone is enforced.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Public Law 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls 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 State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it 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 or more in any
one year. Though this rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will not effect 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 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 rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this 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 rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 5100.1 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 concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded, under figure 2-1, paragraph
(34)(g), of the Instruction because it creates a safety zone. An
environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

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

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  33 U.S.C. 1226, 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;
Public Law 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add temporary Sec.  165.T11-190 to read as follows:

Sec.  165.T11-190  Safety Zone; Sea World Labor Day Fireworks, Mission
Bay, San Diego, California.

    (a) Location. The following area is a safety zone: All waters of
Mission Bay, from surface to bottom, within 600 feet of the barge at an
approximate position of 32[deg]46'03'' N, 117[deg]13'11'' W.
    (b) Enforcement Period. This section will be enforced from 8 p.m.
to 10 p.m., each day, on September 5, 2009 through September 7, 2009.
If the event concludes prior to the scheduled termination time, the
Captain of the Port will cease enforcement of this safety zone and will
announce that fact via Broadcast Notice to Mariners.
    (c) Definitions. The following definition applies to this section:
Designated representative, means any commissioned, warrant, or petty
officers of the Coast Guard on board Coast Guard, Coast Guard
Auxiliary, or local, state, or federal law enforcement vessels who have
been authorized to act on the behalf of the Captain of the Port.
    (d) Regulations. (1) Entry into, transit through or anchoring
within this safety zone is prohibited unless authorized by the Captain
of the Port of San Diego or his designated on-scene representative.
    (2) Mariners requesting permission to transit through the safety
zone may request authorization to do so from the Sector San Diego
Command Center. The Command Center may be contacted on VHF-FM Channel
16.
    (3) All persons and vessels must comply with the instructions of
the Coast Guard Captain of the Port or the designated representative.
    (4) Upon being hailed by U.S. Coast Guard patrol personnel by
siren, radio, flashing light, or other means, the operator of a vessel
must proceed as directed.
    (5) The Coast Guard may be assisted by other federal, state, or
local agencies.

    Dated: July 6, 2009.
T.H. Farris,
Captain, U.S. Coast Guard, Captain of the Port San Diego.
[FR Doc. E9-18629 Filed 8-4-09; 8:45 am]

BILLING CODE 4910-15-P