CONTACT REPORT From: Tom Holloway Date of Contact: September 4 and 19, 2002 Company/ Agency: Schlumberger Malco, Inc. 76 Gwynns Mill Court Owings Mills, MD 21117 Telephone Number: ( 410) 363  1601, ext. 337 Person Contacted: George McDonald CONTACT SUMMARY: Called main number at Schlumberger ( 410 363 1600) on September 4. Was referred to George McDonald; left message. Called Mr. McDonald back on September 19; left message. Mr. McDonald called me back the same day and said that Schlumberger Malco only uses magnetic stripe. It has been 4 yours since they last manufactured magnetic stripe. In response to my question about his supplier, Mr. McDonald called me back later the same day and said that DIC International supplies them with the magnetic tape. DIC International is located at 222 Bridge Plaza South, Fort Lee, NJ 07024. Their telephone number is ( 201) 592 5100. Checked the TRI data base for DIC International, and they have not reported emissions since 1987.


[Federal Register: April 30, 2010 (Volume 75, Number 83)]
[Notices]
[Page 22772-22773]
[DOCID:fr30ap10-61]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL10-61-000]

Cargill Power Markets, LLC, Complainant v. Public Service Company
of New Mexico, Respondent; Notice of Complaint

April 21, 2010.
    Take notice that on April 20, 2010, pursuant to section 206 of the
Federal Energy Regulatory Commission's (Commission) Rules and Practice
and Procedure, 18 CFR 385.206 (2009), and section 206 of the Federal
Power Act (FPA), 16 U.S.C. 824e (2006), Cargill Power Markets, LLC
(Complainant) filed a formal complaint against Public Service Company
of New Mexico (Respondent) alleging that Respondent violated the
requirements of its open access transmission tariff, the North American
Energy Standards Board (NAESB) business practices incorporated by
reference therein, and the non-discrimination requirements of the FPA
by improperly denying Complainant's valid transmission service request
(TSR) that complied with the Respondent's Tariff and NAESB
requirements. Complainant also alleges that Respondent improperly
granted invalid TSRs that did not

comply with the Respondent's Tariff and NAESB requirements. Complainant
requests that the Commission direct Respondent to reprocess its TSRs in
accordance with Respondent's Tariff and the NAESB standards and to
institute an FPA section 206 investigation of Respondent's transmission
and interconnection queue processing practices.
    The Complainant states that a copy of the complaint has been served
on the contacts for the Respondent as listed on the Commission's list
of Corporate Officials.
    Any person desiring 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, 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. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainant.
    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 May 10, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-10056 Filed 4-29-10; 8:45 am]
BILLING CODE 6717-01-P


Report (NDWAC, 2012b) and the docket for this proposed rule. The EPA
carefully considered NDWAC recommendations during the development of a
proposed drinking water rule for perchlorate.
    On May 29, 2012, the EPA sought guidance from the EPA Science
Advisory Board (SAB) on how best to consider and interpret life stage
information, epidemiological and biomonitoring data since the
publication of the National Research Council 2005 report, the Agency's
physiologically-based pharmacokinetic (PBPK) analyses, and the totality
of perchlorate health information to derive a Maximum Contaminant Level
Goal (MCLG) for perchlorate (USEPA, 2012; NRC, 2005). On May 29, 2013,
the EPA received significant input from SAB, summarized in the report,
SAB Advice on Approaches to Derive a Maximum Contaminant Level Goal for
Perchlorate (USEPA, 2013a).
    On July 15, 2013, the EPA responded by stating that the Agency
would consider all the recommendations from the SAB, as it continued
working on the development of the rulemaking process for perchlorate
(USEPA 2013b). To address SAB recommendations, the EPA collaborated
with Food and Drug Administration (FDA) scientists to develop PBPK/
pharmacodynamic (PD), or biologically based dose-response (BBDR),
models that incorporate all available health related information on
perchlorate to predict changes in thyroid hormones in sensitive life
stages exposed to different dietary iodide and perchlorate levels
(USEPA 2017). As recommended by SAB, the EPA developed these models
based upon perchlorate's mode of action (i.e., iodide uptake inhibition
by the thyroid) (USEPA 2013a). Additional details are in section III.C.
of this notice and in the Health Effects of Perchlorate support
document located in the docket for this proposed rule.
    In accordance with SAB recommendations, the EPA developed a two-
stage approach to integrate BBDR model results with data on
neurodevelopmental outcomes from epidemiological studies, this approach
allowed the Agency to link maternal thyroid hormones levels as a result
of low iodine intake and perchlorate exposure, to derive an MCLG that
directly addresses the most sensitive life stage (USEPA 2013a).
    On March 25, 2019, the EPA consulted with the Department of Health
and Human Services (HHS). The EPA provided information to HHS officials
on the draft proposed perchlorate regulation and considered HHS input
as part of the interagency review described in section XVII.A.

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California. Environmental Health Perspectives, 124(6), 861-867.
https://doi.org/10.1289/ehp.1409614.
Sternberg, R.J., Grigorenko, E.L., & Bundy, D.A. (2001). The
predictive value of IQ. Merrill-Palmer Quarterly (1982-), 1-41.
Sun, J., Yao, L., Fang, Y., Chen, Y., et al. (2017). Relationship
between Subclinical Thyroid Dysfunction and the Risk of
Cardiovascular Outcomes: A Systematic Review and Meta-Analysis of
Prospective Cohort Studies. Int J Endocrinol. 2017:8130796.
Taylor, P., Razvi, S., Pearce, S.H., & Dayan, C.M. (2013). Clinical
review: A review of the clinical consequences of variation in
thyroid function within the reference range. J Clin Endocrinol
Metab, 98(9), 3562-3571. doi:10.1210/jc.2013-1315.
The Interstate Technology & Regulatory Council (ITRC) Team. (2008,
March). Technical/Regulatory Guidance: Remediation Technologies for
Perchlorate Contamination in Water and Soil. Retrieved from http://www.eosremediation.com/download/Perchlorate/ITRC%20PERC-2.pdf.
Thompson, W., Russell, G., Baragwanath, G., Matthews, J., Vaidya,
B., & Thompson[hyphen]Coon, J. (2018). Maternal thyroid hormone
insufficiency during pregnancy and risk of neurodevelopmental
disorders in offspring: A systematic review and meta-analysis.
Clinical Endocrinology.

Upadhyaya, G., Kotlarz, N., Togna, P., & Raskin, L. (2015).
Carbohydrate-Based Electron Donor for Biological Nitrate and
Perchlorate Removal From Drinking Water. Journal--American Water
Works Association, 107(12), E674-E684. https://doi.org/10.5942/jawwa.2015.107.0143.
U.S. Census Bureau. (2010). American Community Survey, 5-year
Estimates (2006-2010).
U.S. Census Bureau. (2017a). Annual estimates of the resident
population by single year of age and sex for the United States:
April 1, 2010 to July 1, 2016.
U.S. Census Bureau. (2017b). Average Household Size of Occupied
Housing Units by Tenure. American Community Survey 1-Year Estimates:
Table B25010.
U.S. Department of Defense (U.S. DoD). (2008). Perchlorate Removal,
Destruction, and Field Monitoring Demonstration (Drinking Water--
Pilot Scale) (ESTCP Cost and Performance Report (ER-0312)).
U.S. Department of Defense (U.S. DoD). (2009). Demonstration of a
Full-Scale Fluidized Bed Bioreactor for the Treatment of Perchlorate
at Low Concentrations in Groundwater (Environmental Security
Technology Certification Program (ESTCP) Final Report (ER-0543)).
U.S. Food and Drug Administration (FDA). (2015). Total diet study--
study design. Retrieved from http://www.fda.gov/food/foodscienceresearch/totaldietstudy/ucm184232.htm#.
USEPA. (1991, February). Standardized Monitoring Framework.
USEPA. (1998). Variance Technology Findings for Contaminants
Regulated Before 1996. EPA 815-R-98-003. September.
USEPA. (1999). Revisions to the Unregulated Contaminant Monitoring
Regulation for Public Water Systems; Final Rule. 64 FR 80, p. 50556.
September 17, 1999.
USEPA. (2000a). Arsenic in Drinking Water Economic Analysis. EPA
815-R-00-026.
USEPA. (2000b). Geometries and Characteristics of Public Water
Systems. EPA 815-R-00-024.
USEPA. (2000c). Unregulated Contaminant Monitoring Regulation
Analytical Methods and Quality Control Manual. EPA 815-R-00-006.
USEPA (2000d). Methodology for Deriving Ambient Water Quality
Criteria for the Protection of Human Health. EPA-822-B-00-004.
USEPA. (2002). A review of the reference dose and reference
concentration process.
USEPA (2003). Contaminant Candidate List Regulatory Determination
Support Document for Aldrin and Dieldrin. EPA-815-R-03-010. https://www.epa.gov/sites/production/files/2014-09/documents/support_cc1_aldrin-dieldrin_ccl_regdet.pdf.
USEPA. (2004). The Standardized Monitoring Framework: A Quick
Reference Guide. EPA-816-F-04-010.
USEPA. (2005a). Integrated Risk Information System (IRIS) Chemical
Assessment Summary: Perchlorate (ClO4-) and Perchlorate Salts. USEPA
National Center for Environmental Assessment.
USEPA. (2005b, May). Perchlorate Treatment Technology Update:
Federal Facilities Forum Issue Paper. Office of Solid Waste and
Emergency Response. EPA 542-R-05-015.
USEPA. (2008a). Drinking water: Preliminary regulatory determination
on perchlorate. Federal Register, 73 (198).
USEPA. (2008b, June). Draft Information Collection Request for the
Disinfectants/Disinfection Byproducts, Chemical, and Radionuclides
Rule.
USEPA. (2008c, November 12). National Ambient Air Quality Standards
for Lead. 73 FR 66964, p. 66964-67062. Retrieved from https://www.federalregister.gov/articles/2008/11/12/E8-25654/national-ambient-air-quality-standards-for-lead.
USEPA (2008d). Interim Drinking Water Health Advisory for
Perchlorate. Retrieved from: https://nepis.epa.gov/Exe/ZyPDF.cgi/P1004X7Q.PDF?Dockey=P1004X7Q.PDF.
USEPA. (2008e). Regulatory Determinations Support Document for
Selected Contaminants from the Second Drinking Water Contaminant
Candidate List (CCL 2). EPA-815-R-03-010. https://www.epa.gov/sites/production/files/2014-09/documents/chapter_4_dcpa_mono-_and_di-acid_degradates.pdf.
USEPA. (2009a). Drinking Water: Perchlorate Supplemental Request for
Comments.
USEPA. (2009b). Inhibition of the Sodium-Iodide Symporter By
Perchlorate: An Evaluation of Lifestage Sensitivity Using
Physiologically Based Pharmacokinetic (PBPK) Modeling (Final Report)
(EPA/600/R-08/106A). Washington, DC.
USEPA. (2009c, May). 2006 Community Water System Survey--Volume II:
Detailed Tables and Survey Methodology. Retrieved from https://www.epa.gov/dwstandardsregulations/community-water-system-survey.
USEPA. (2011a). Drinking Water: Regulatory Determination on
Perchlorate. Federal Register Notice. 76 FR No. 29. Pages 7762-7767.
(February 11, 2011) (to be codified at 40 CFR pt. 141). Retrieved
from https://www.federalregister.gov/articles/2011/02/11/2011-2603/drinking-water-regulatory-determination-on-perchlorate.
USEPA. (2011b). Exposure Factors Handbook 2011 Edition (Final
Report) (p. Chapter 8). Retrieved from https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=236252.
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February 28, 2012.
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Effect of Perchlorate on Thyroid Hormones in the Infant, Breast
Feeding Mother, Pregnant Mother, and Fetus: Model Development,
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Schlosser and Santhini Ramasamy, Ed.). Peer Review Draft.
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Drinking Water.
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(2012). Maternal hypothryoxinemia during pregnancy and growth of the
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https://doi.org/10.1177/1933719112450338.
Wang, P., Gao, J., Zhao, S., Guo, Y., Wang, Z., & Qi, F. (2016).
Maternal thyroxine levels during pregnancy and outcomes of cognitive
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https://doi.org/10.1007/s12035-015-9189-z.
Webster, T.D., & Crowley, T.J. (2010, November). Full-Scale
Implementation of a Biological Fluidized Bed Drinking Water
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the 2010 Water Education Foundation Water Quality and Regulatory
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Webster, T.D., & Crowley, T.J. (2016, June). Biological treatment of
perchlorate in groundwater. Presented at the AWWA Annual Conference
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Webster, T.D., & Litchfield, M.H. (2017). Full-scale biological
treatment of nitrate and perchlorate for potable water production.
Journal AWWA, 109(5), 30-40.
Wu, X., & Blute, N.K. (2010, March). Perchlorate Removal Using
Single-Pass Ion Exchange Resin--Pilot Testing Purolite A532E at the
San Gabriel B6 Plant. Presented at the 2010 California-Nevada AWWA
Spring Conference, Hollywood, CA.
Yoon, J., Amy, G., & Yoon, Y. (2005). Transport of target anions,
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List of Subjects

40 CFR Part 141

    Chemicals, Incorporation by reference, Indians--lands,
Intergovernmental relations, Radiation protection, Reporting and
recordkeeping requirements, Water supply.

40 CFR Part 142

    Administrative practice and procedure, Chemicals, Indians--lands,
Radiation protection, Reporting and recordkeeping requirements, Water
supply.

    Dated: May 23, 2019.
Andrew R. Wheeler,
Administrator.

    For the reasons stated in the preamble, the Environmental
Protection Agency proposes to amend 40 CFR parts 141 and 142 as
follows:

PART 141--NATIONAL PRIMARY DRINKING WATER REGULATIONS

0
1. The authority citation for part 141 continues to read as follows:

    Authority:  42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4,
300g-5, 300g-6, 300j-4, 300j-9, and 300j-11.

0
2. Amend Sec.  141.6 by revising paragraph (a) and adding paragraph (l)
to read as follows:

Subpart A--General

Sec.  141.6   Effective dates.

    (a) Except as provided in paragraphs (b) through (l) of this
section the regulations set forth in this part shall take effect on
June 24, 1977.
* * * * *
    (l) The regulations contained in the revisions to Sec. Sec.
141.23(a)(4)(i), 141.23(a)(5), 141.23(c),141.23(f)(1), 141.23(i)(1)-
(2), 141.23(k)(1)-(3), 141.23(k)(3)(ii), 141.51(b), 141.60(b)(5),
141.62(b), 141.62(c), 141.62(e), Appendix A to Subpart O and Appendix A
and B to Subpart Q are effective for the purposes of compliance on
[DATE OF PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER].
0
3. Amend Sec.  141.23 by:
0
a. In paragraph (a)(4)(i) table:
0
i. Revising the table heading; and
0
ii. Adding an entry for ``Perchlorate'' in alphabetical order;
0
b. In paragraph (a)(5), after the text ``nickel,'' adding the text
``perchlorate,'';
0
c. In paragraph (c), after the text ``nickel,'' adding the text
``perchlorate,'';
0
d. Adding paragraph (c)(10);
0
e. In paragraph (f)(1), after the text ``nickel,'' adding the text
``perchlorate,'';
0
f. In paragraphs (i)(1) and (2), after the text ``nickel,'' adding the
text ``perchlorate,'';
0
g. Revising paragraph (i)(3);
0
h. In paragraph (k)(1):
0
i. Revising the introductory text; and
0
ii. In the table, adding the table designation, redesignating entries
21 through 26 as 22 through 27, and adding a new entry 21;
0
i. In paragraph (k)(2):
0
i. In the introductory paragraph, after the text ``nitrite,'' adding
the text ``perchlorate,''; and
0
ii. In the table, adding the table designation and adding, in
alphabetical order, an entry for ``Perchlorate'';
0
j. In paragraph (k)(3):
0
i. In the introductory paragraph, after the text ``nitrite'' adding the
text ``, perchlorate,''; and
0
ii. In paragraph (ii) table, adding the table designation, and adding
in alphabetical order, an entry for ``Perchlorate'';
    The revisions and additions read as follows:

Subpart C--Monitoring and Analytical Requirements

Sec.  141.23   Inorganic chemical sampling and analytical requirements.

* * * * *
    (a) * * *
    (4) * * *
    (i) * * *

                  Table 1 to Paragraph (a)(4)(i)-- Detection Limits for Inorganic Contaminants
                                              [Composited samples]
----------------------------------------------------------------------------------------------------------------
             Contaminant                 MCL  (mg/l)            Methodology            Detection limit  (mg/l)
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Perchlorate..........................           0.056  Ion Chromatography..........  0.00053.
                                                       Inline Column Concentration/  0.00003.
                                                        Matrix Elimination Ion
                                                        Chromatography with
                                                        Suppressed Conductivity
                                                        Detection.
                                                       Two-Dimensional Ion           0.000012-0.000018.
                                                        Chromatography with
                                                        Suppressed Conductivity
                                                        Detection.
                                                       Liquid Chromatography         0.000005 (Tandem Mass
                                                        Electrospray Ionization       Spectrometry [MS/MS])
                                                        Mass Spectrometry.            0.000008 (Selected Ion
                                                                                Monitoring [SIM]).
                                                       Ion Chromatography with       0.00002.
                                                        Suppressed Conductivity and
                                                        Electrospray Ionization
                                                        Mass Spectrometry.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
    (c) * * *
    (10) Community water systems and non-transient non-community water
systems must conduct initial monitoring for perchlorate as follows:
    (i) Community water systems serving greater than 10,000 persons
without acceptable historic data, as defined below, must collect four
consecutive quarterly samples at all sampling points between January 1,
2023 and December 31, 2025.
    (ii) Community water systems serving 10,000 or fewer persons and
non-transient non-community water systems without acceptable historic
data, as defined below, must collect four consecutive quarterly samples
at all

sampling points between January 1, 2026 and December 31, 2028.
    (iii) Grandfathering of data: States may allow historical
monitoring data collected at a sampling point to satisfy the initial
monitoring requirements for that sampling point, for the following
situations.
    (A) To satisfy initial monitoring requirements, community water
systems serving greater than 10,000 persons having only one entry point
to the distribution system may use the monitoring data from the
compliance monitoring period between January 1, 2020 and December 31,
2022. Community water systems serving 10,000 or fewer persons and non-
transient non-community water systems having only one entry point to
the distribution system may use the monitoring data from the compliance
monitoring period between January 1, 2023 and December 31, 2025.
    (B) To satisfy initial monitoring requirements, a system with
multiple entry points and having appropriate historical monitoring data
for each entry point to the distribution system may use the monitoring
data from the compliance monitoring period that began between January
1, 2020 and December 31, 2022, for community water systems serving
greater than 10,000 persons and between January 1, 2023 and December
31, 2025, for community water systems serving 10,000 or fewer persons
and for non-transient non-community water systems.
    (C) To satisfy initial monitoring requirements, a system with
appropriate historical data for a representative point in the
distribution system may use the monitoring data from the compliance
monitoring period between January 1, 2020 and December 31, 2022, for
community water systems serving greater than 10,000 persons and between
January 1, 2023 and December 31, 2025, for community water systems
serving 10,000 or fewer persons and for non-transient non-community
water systems, provided that the State finds that the historical data
satisfactorily demonstrate that each entry point to the distribution
system is expected to be in compliance based upon the historical data
and reasonable assumptions about the variability of contaminant levels
between entry points. The State must make a written finding indicating
how the data conforms to these requirements.
    (iv) The State may waive the final two quarters of initial
monitoring for perchlorate for a sampling point if the results of the
samples from the previous two quarters are below the detection limit.
* * * * *
    (i) * * *
    (3) Compliance with the maximum contaminant level for nitrate,
nitrite and perchlorate is determined based on one sample if the levels
of these contaminants are below the MCLs. If the level of perchlorate
exceeds the MCL in the initial sample, a confirmation sample is
required in accordance with paragraph (f)(1) of this section and
compliance shall be based on the average of the initial and
confirmation sample. If the levels of nitrate and/or nitrite exceed the
MCLs in the initial sample, a confirmation sample is required in
accordance with paragraph (f)(2) of this section and compliance shall
be based on the average of the initial and confirmation sample.
* * * * *
    (k) * * *
    (1) Analysis for the following contaminants shall be conducted in
accordance with the methods in the following table, or the alternative
methods listed in Appendix A to Subpart C of this part, or their
equivalent as determined by the EPA. Criteria for analyzing arsenic,
barium, beryllium, cadmium, calcium, chromium, copper, lead, nickel,
selenium, sodium, and thallium with digestion or directly without
digestion, and other analytical test procedures are contained in
Technical Notes on Drinking Water Methods, EPA-600/R-94-173, October
1994. This document is available from the National Service Center for
Environmental Publications (NSCEP), P.O. Box 42419, Cincinnati, OH
45242-0419 or http://www.epa.gov/nscep/.

                                                               Table 2 to Paragraph (k)(1)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                SM \4\
              Contaminant                       Methodology \13\               EPA         ASTM \3\   (18th, 19th     SM \4\     SM Online      Other
                                                                                ed.)      (20th ed.)      \22\
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
21. Perchlorate........................  Ion Chromatography............      \23\ 314.0
                                         Inline Column Concentration/        \24\ 314.1
                                          Matrix Elimination Ion
                                          Chromatography with
                                          Suppressed Conductivity
                                          Detection.
                                         Two-Dimensional Ion                 \25\ 314.2
                                          Chromatography with
                                          Suppressed Conductivity
                                          Detection.
                                         Liquid Chromatography               \26\ 331.0
                                          Electrospray Ionization Mass
                                          Spectrometry.
                                         Ion Chromatography with             \27\ 332.0
                                          Suppressed Conductivity and
                                          Electrospray Ionization Mass
                                          Spectrometry.

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
\3\ Annual Book of ASTM Standards, ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428, http://www.astm.org.; Annual Book of ASTM
  Standards 1994, Vols. 11.01 and 11.02; Annual Book of ASTM Standards 1996, Vols. 11.01 and 11.02; Annual Book of ASTM Standards 1999, Vols. 11.01 and
  11.02; Annual Book of ASTM Standards 2003, Vols. 11.01 and 11.02.
\4\ Standard Methods for the Examination of Water and Wastewater, American Public Health Association, 800 I Street NW, Washington, DC 20001-3710;
  Standard Methods for the Examination of Water and Wastewater, 18th edition (1992); Standard Methods for the Examination of Water and Wastewater, 19th
  edition (1995); Standard Methods for the Examination of Water and Wastewater, 20th edition (1998).The following methods from this edition cannot be
  used: 3111 B, 3111 D, 3113 B, and 3114 B.

\13\ Because MDLs reported in EPA Methods 200.7 and 200.9 were determined using a 2x preconcentration step during sample digestion, MDLs determined when
  samples are analyzed by direct analysis (i.e., no sample digestion) will be higher. For direct analysis of cadmium and arsenic by Method 200.7, and
  arsenic by Method 3120 B, sample preconcentration using pneumatic nebulization may be required to achieve lower detection limits. Preconcentration may
  also be required for direct analysis of antimony, lead, and thallium by Method 200.9; antimony and lead by Method 3113 B; and lead by Method D3559-
  90D, unless multiple in-furnace depositions are made.
* * * * * * *
\22\ Standard Methods Online, American Public Health Association, 800 I Street NW, Washington, DC 20001, available at http://www.standardmethods.org.
  The year in which each method was approved by the Standard Methods Committee is designated by the last two digits in the method number. The methods
  listed are the only online versions that may be used.
\23\ Determination of Perchlorate in Drinking Water Using Ion Chromatography (Revision 1.0, USEPA, 1999a).
\24\ Determination of Perchlorate in Drinking Water Using Inline Column Concentration/Matrix Elimination Ion Chromatography with Suppressed Conductivity
  Detection (Revision 1.0, USEPA, 2005b).
\25\ Determination of Perchlorate in Drinking Water Using Two-Dimensional Ion Chromatography with Suppressed Conductivity Detection (USEPA, 2008c).
\26\ Determination of Perchlorate in Drinking Water by Liquid Chromatography Electrospray Ionization Mass Spectrometry'' (Revision 1.0, USEPA, 2005c).
\27\ Determination of Perchlorate in Drinking Water by Ion Chromatography with Suppressed Conductivity and Electrospray Ionization Mass Spectrometry''
  (USEPA, Revision 1.0, 2005d).

    The approved compliance methods for determining perchlorate in
drinking water listed in table 1 to paragraph (k) of this section, are
incorporated by reference. The Director of the Federal Register
approves this incorporation by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Copies of the material incorporated by
reference in this paragraph (k) may be inspected at the U.S.
Environmental Protection Agency, EPA Headquarters Library, in the Water
Docket, at the EPA Docket Center (EPA/DC), EPA WJC West, Room 3334,
1301 Constitution Ave. NW, Washington, DC 20460. If you wish to obtain
this material from the EPA Docket Center, call<PHONE_NUMBER>. Copies
of this material also may be inspected at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, call<PHONE_NUMBER>, or go to www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *
    (2) * * *

                                           Table 3 to Paragraph (k)(2)
----------------------------------------------------------------------------------------------------------------
             Contaminant                   Preservative \1\          Container \2\               Time \3\
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Perchlorate \7\......................  4 [deg]C...............  P or G.................  28 days.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ For cyanide determinations samples must be adjusted with sodium hydroxide to pH 12 at the time off
  collection. When chilling is indicated the sample must be shipped and stored at 4 [deg]C or less.
  Acidification of nitrate or metals samples may be with a concentrated acid or a dilute (50% by volume)
  solution of the applicable concentrated acid. Acidification of samples for metals analysis is encouraged and
  allowed at the laboratory rather than at the time of sampling provided the shipping time and other
  instructions in Section 8.3 of EPA Methods 200.7 or 200.8 or 200.9 are followed.
\2\ P = plastic, hard or soft; G = glass, hard or soft.
\3\ In all cases samples should be analyzed as soon after collection as possible. Follow additional (if any)
  information on preservation, containers or holding times that is specified in method.
* * * * * * *
\7\ Sample collection for perchlorate shall be conducted following the requirements specified in the approved
  methods in 141.23(k)(1) or the alternative methods listed in appendix A of subpart C of this part, or their
  equivalent as determined by the EPA.

* * * * *
    (3) * * *
    (ii) * * *

                     Table 4 to Paragraph (k)(3)(ii)
------------------------------------------------------------------------
                                                            Acceptance
                       Contaminant                             limit
------------------------------------------------------------------------

                                * * * * *
Perchlorate.............................................          20% at
                                                            [gteqt]0.004
                                                                   mg/L.

                                * * * * *
------------------------------------------------------------------------

* * * * *
0
4. In Sec.  141.51 amend paragraph (b) by adding a designation to the
table and by adding in alphabetical order, an entry for ``Perchlorate''
to read as follows:

Subpart F--Maximum Contaminant Level Goals and Maximum Residual
Disinfectant Level Goals

Sec.  141.51   Maximum contaminant level goals for inorganic
contaminants.

* * * * *
    (b) * * *

                        Table 1 to Paragraph (b)
------------------------------------------------------------------------
                       Contaminant                         MCLG  (mg/l)
------------------------------------------------------------------------

                                * * * * *
Perchlorate.............................................           0.056

                                * * * * *
------------------------------------------------------------------------

* * * * *
0
5. Amend Sec.  141.60 by adding paragraph (b)(5) to read as follows:

Subpart G--National Primary Drinking Water Regulations: Maximum
Contaminant Levels and Maximum Residual Disinfectant Levels

Sec.  141.60   Effective dates.

* * * * *
    (b) * * *
    (5) The effective date for Sec.  141.62(b)(17) is [DATE OF
PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER].
0
6. Amend Sec.  141.62 by:
0
a. In the table in paragraph (b), adding a designation to the table and
an entry for ``(17) Perchlorate'' at the end of the table;
0
b. In the table in paragraph (c), adding a designation to the table, an
entry for ``Perchlorate'' in alphabetical order, and an entry ``14 =
Biological Treatment'' under the undesignated heading entitled ``Key to
BATs; and

0
c. Adding paragraph (e).
    The revisions and additions read as follows:

Sec.  141.62   Maximum contaminant levels for inorganic contaminants.

* * * * *
    (b) * * *

                        Table 1 to Paragraph (b)
------------------------------------------------------------------------
                       Contaminant                          MCL  (mg/l)
------------------------------------------------------------------------

                                * * * * *
(17) Perchlorate........................................           0.056
------------------------------------------------------------------------

    (c) * * *

 Table 2 to Paragraph (c)--BAT for Inorganic Compounds Listed in Section
                                141.62(B)
------------------------------------------------------------------------
                      Chemical name                           BAT(s)
------------------------------------------------------------------------

                                * * * * *
Perchlorate.............................................       5, 7, 14.

                                * * * * *
------------------------------------------------------------------------

* * * * *

Key to BATs in Table

* * * * *
14 = Biological Treatment
* * * * *
    (e) The Administrator, pursuant to section 1412 of the Act, hereby
identified in the following table the affordable technology, treatment
technique, or other means available to systems serving 10,000 persons
or fewer for achieving compliance with the maximum contaminant level
for perchlorate:

 Table 3 to Paragraph (e)--Small System Compliance Technologies (SSCTS)
                             for Perchlorate
------------------------------------------------------------------------
                                              Affordability for listed
    Small system compliance technology         small system categories
------------------------------------------------------------------------
Ion exchange..............................  All size categories.
Reverse osmosis (point of use)............  All size categories.
------------------------------------------------------------------------

0
7. Amend Appendix A to Subpart O of Part 141 table, under ``Inorganic
contaminants'', by adding an entry for ``Perchlorate'' in alphabetical
order to read as follows:

Subpart O--Consumer Confidence Reports

                                               Appendix A to Subpart O of Part 141--Reguated Contaminants
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                Traditional   To convert
     Contaminant  (units)       MCL in  mg/    for CCR,   MCL in  CCR      MCLG             Major sources in drinking water            Health effects
                                     L       multiply by     units                                                                        language
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
Inorganic contaminants
Perchlorate...................        0.056         1000           56           56  Perchlorate is commonly used in solid rocket    Offspring of
                                                                                propellants, munitions, fireworks, airbag       pregnant women and
                                                                                initiators for vehicles, matches and signal     infants who drink
                                                                                flares. Perchlorate may occur naturally,        water containing
                                                                                particularly in arid regions such as the        perchlorate in
                                                                                southwestern United States and is found as a    excess of the MCL
                                                                                natural impurity in nitrate salts used to       could experience
                                                                                produce nitrate fertilizers, explosives and     delays in their
                                                                                other products.                                 physical or mental
                                                                                development.

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

0
8. Amend Appendix A to Subpart Q of Part 141 table, under ``B.
Inorganic contaminants'', by adding an entry for ``Perchlorate'' in
alphabetical order to read as follows:

Subpart Q--Public Notification of Drinking Water Violations

* * * * *

     Appendix A to Subpart Q of Part 141--NPDWR Violations and Other Situations Requiring Public Notice \1\
----------------------------------------------------------------------------------------------------------------
                                        MCL/MRDL/TT violations \2\            Monitoring & testing  procedure
                                 ----------------------------------------               violations
                                                                         ---------------------------------------
           Contaminant            Tier of public                          Tier of public
                                      notice             Citation             notice             Citation
                                     required                                required
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                          B. Inorganic Chemicals (IOCs)
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
14. Perchlorate.................               1  141.62(b).............               3  141.23(a), (c),
                                                                                141.23(f)(1).

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

    \1\ Violations and other situations not listed in this table (e.g.,
failure to prepare Consumer Confidence Reports), do not require notice,
unless otherwise determined by the primacy agency. Primacy agencies
may, at their option, also require a more stringent public notice tier
(e.g., Tier 1 instead of Tier or Tier 2 instead of Tier 3) for specific
violations and situations listed in this Appendix, as authorized under
141.202(a) and 141.203(a).
    \2\ MCL-Maximum contaminant level, MDRL-Maximum residual
disinfectant level, TT-treatment technique
* * * * *
0
9. Amend Appendix B to Subpart Q of Part 141 table, under ``C.
Inorganic contaminants'', by adding an entry for ``Perchlorate'' in
alphabetical order to read as follows:

          Appendix B to Subpart Q of Part 141--Standard Health Effects Language for Public Notification
----------------------------------------------------------------------------------------------------------------
                                                                   Standard health effects language for public
          Contaminant            MCLG \1\  mg/L   MCL \2\  mg/L                    notification
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                          C. Inorganic Chemicals (IOCs)
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
21. Perchlorate................           0.056           0.056  Offspring of pregnant women and infants who
                                                                  drink water containing perchlorate in excess
                                                                  of the MCL could experience delays in their
                                                                  physical or mental development.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ MCLG--Maximum contaminant level goal.
\2\ MCL--Maximum contaminant level.

PART 142--NATIONAL PRIMARY DRINKING WATER REGULATIONS
IMPLEMENTATION

0
10. The authority citation for part 142 continues to read as follows:

    Authority:  42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4,
300g-5, 300g-6, 300j-4, 300j-9, and 300j-11.

0
11. In Sec.  142.62 amend the table in paragraph (b) by adding a
designation to the table, an entry for ``Perchlorate'' in alphabetical
order; and an entry ``13 = Biological Treatment'' under the
undesignated heading entitled ``Key to BATs''.

Subpart G--Identification of Best Technology, Treatment Techniques
or Other Means Generally Available.

* * * * *

Sec.  142.62   Variances and exemptions from the maximum contaminant
levels for organic and inorganic chemicals.

* * * * *
    (b) * * *

  Table 1 to paragraph (b)--BAT for Inorganic Compounds Listed in Sec.
                                141.62(b)
------------------------------------------------------------------------
               Chemical name                            BAT(s)
------------------------------------------------------------------------

                                 * * * *
Perchlorate................................  5, 7, 14

                                 * * * *
------------------------------------------------------------------------

* * * * *

Key to BATs in Table

* * * * *
13 = Biological Treatment
* * * * *
[FR Doc. 2019-12773 Filed 6-25-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 75, Number 234 (Tuesday, December 7, 2010)]
[Notices]
[Pages 76010-76011]
[FR Doc No: 2010-30583]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0316]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Adverse Event Pilot
Program for Medical Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

DATES: Fax written comments on the collection of information by January
6, 2011.

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 e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0471.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Adverse Event Pilot Program for Medical Products--(OMB Control Number
0910-0471)--Extension

    Under section 519 of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360i), FDA is authorized to require: Manufacturers
to report medical device-related deaths, serious injuries, and
malfunctions; and user facilities to report device-related deaths
directly to manufacturers and FDA, and to report serious injuries to
the manufacturer. Section 213 of the FDA Modernization Act of 1997
(FDAMA) amended section 519(b) of the FD&C Act relating to mandatory
reporting by user facilities of deaths and serious injuries and serious
illnesses associated with the use of medical devices. This amendment
legislated the replacement of universal user facility reporting by a
system that is limited to a ``* * * subset of user facilities that
constitutes a representative profile of user reports'' for device-
related deaths and serious injuries. This amendment is reflected in
section 519(b)(5)(A) of the FD&C Act. The current universal reporting
system remains in place during the pilot stages of the new program and
until FDA implements the new national system by regulation. This
legislation provides FDA with the opportunity to design and implement a
national surveillance network, composed of well-trained clinical
facilities, to provide high-quality data on medical devices in clinical
use. This system is called the Medical Product Safety Network (MedSun).
    FDA is continuing to conduct a pilot of the MedSun system before
the Agency issues regulation to change from universal mandatory
reporting for medical device user facilities to reporting by a
representative sample of facilities. This data collection has been
ongoing since February 20, 2002, and this notice is for continuation of
this data collection.
    FDA is seeking OMB clearance to continue to use electronic data
collection to obtain the information on the 3500A Form related to
medical devices and tissue products from the user facilities
participating in MedSun, to obtain a demographic profile of the
facilities, and to pilot additional questions, which will permit FDA to
better understand the cause of reported adverse events. During the
pilot program, participants will be asked to complete an annual outcome
measures form, as a Customer/Partner Service Survey (approved under OMB
control number 0910-0360) to aid FDA in evaluating the effectiveness of
the program. Participation in this pilot is voluntary and currently
includes 400 facilities. The use of an interactive electronic data
collection system is easier and more efficient for the participating
user facilities to use than the alternative paper system.
    In addition to collecting data on the electronic adverse event
report form, MedSun is proposing to collect additional information from
participating sites about reported problems emerging from the MedSun
hospitals. This data collection is also voluntary and will be collected
on the same Web site as the report information. This will replace the
Device-Safety Exchange (DS-X). The burden to respond to these questions
will take the same time as that used for DS-X: 30 minutes.
    The total burden hours for MedSun and emerging signal questions
equals 6,000 hours (4,500 for MedSun and 1,500 for emerging signals).
The burden estimate for the electronic reporting of adverse events is
based on the number of facilities currently participating in MedSun
(400). FDA estimates an average of 15 reports per site annually. This
estimate is based on MedSun working to promote reporting in general
from the sites, as well as promoting reporting from specific parts of
the hospitals, such as the pediatric intensive care units,
electrophysiology laboratories, and the hospital laboratories. The
burden estimate for the emerging signal portion of MedSun is based on
the assumption that not all sites will use this part of the software
each time questions are asked because not all sites will use the device
in question.
    In the Federal Register of July 9, 2010 (75 FR 39535), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
              Item                   Nunber of     frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
----------------------------------------------------------------------------------------------------------------
MedSun facilities participating              400              15           6,000            0.75           4,500
 in the electronic reporting of
 adverse events program.........
MedSun facilities' electronic                400              10           4,000             0.5           2,000
 responses to Public Health
 Questions (PHQs)...............
                                 -------------------------------------------------------------------------------
    Total hours.................  ..............  ..............  ..............  ..............           6,500
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: December 1, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30583 Filed 12-6-10; 8:45 am]
BILLING CODE 4160-01-P


1 ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [ EPA R06 OAR 2005 TX 0003; FRL  ]

Approval and Promulgation of State Implementation Plans; Texas; Revision to the Rate of Progress Plan for the Beaumont/ Port Arthur Ozone Nonattainment Area AGENCY: Environmental Protection Agency ( EPA).

ACTION: Proposed rule.

SUMMARY: The EPA is proposing to approve revisions to the Texas State Implementation Plan ( SIP) Post 1996 Rate of Progress ( ROP) Plan, the 1990 Base Year Inventory, and the Motor Vehicle Emissions Budgets ( MVEB) established by the ROP Plan, for the Beaumont/ Port Arthur ( BPA) ozone nonattainment area submitted November 16, 2004. The intended effect of this action is to approve revisions submitted by the State of Texas to satisfy the reasonable further progress requirements for 1 hour ozone nonattainment areas classified as serious and demonstrate further progress in reducing ozone precursors. We are approving these revisions in accordance with the requirements of the Federal Clean Air Act ( the Act).

DATE: Written comments should be received on or before [ FEDERAL REGISTER OFFICE:

Insert date 30 days from date of publication in the Federal Register]. 2 ADDRESSES: Comments may be mailed to Mr. Thomas Diggs, Chief, Air Planning Section ( 6PD L), Environmental Protection Agency, 1445 Ross Avenue, Suite 1200, Dallas, Texas 75202 2733. Comments may also be submitted electronically or through hand delivery/ courier by following the detailed instructions in the Addresses section of the direct final rule located in the rules section of this Federal Register.

FOR FURTHER INFORMATION CONTACT: Carl Young, Air Planning Section ( 6PD L),

EPA Region 6, 1445 Ross Avenue, Dallas, Texas 75202 2733, telephone 214 665 6645,

young. carl@ epa. gov.

SUPPLEMENTARY INFORMATION: In the final rules section of this Federal Register,

EPA is approving the State's SIP submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this action, no further activity is contemplated. If EPA receives relevant adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time.

Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. 3 For additional information, see the direct final rule which is located in the rules section of this Federal Register.

Dated: February 6, 2006 Richard E. Greene,

Regional Administrator, Region 6.


[Federal Register: October 6, 2009 (Volume 74, Number 192)]
[Notices]
[Page 51289-51290]
[DOCID:fr06oc09-61]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Pediatric Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Pediatric Advisory Committee.

    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on Tuesday, December 8,
2009, from 8 a.m. to 6 p.m.
    Location: Hilton, Washington, DC/Rockville Executive Meeting
Center, Plaza Ballroom, 1750 Rockville Pike, Rockville, MD 20852.
    Contact Person: Doreen Kezer, Office of Medical and Scientific
Programs (HF-33), Office of the Commissioner, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code<PHONE_NUMBER>. Please call the
Information Line for up-to-date information on this meeting. A notice
in the Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: On December 8, 2009, the Pediatric Advisory Committee will
meet to discuss pediatric-focused safety reviews, as mandated by the
Best Pharmaceuticals for Children Act and the Pediatric Research Equity
Act, for Abilify (aripiprazole), Argatroban (argatroban), Orencia
(abatacept), Humira (adalimumab), Zemuron (rocuronium bromide),
Cancidas (caspofungin acetate), Cardiolite (technetium Tc99 sestamibi),
Evicel--fibrin sealant (human), Artiss--fibrin sealant (human),
Voluven--6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride
injection, Reyataz (atazanavir sulfate), Kaletra (lopinavir/ritonavir),
Aptivus (tipranavir), Zetia (ezetimibe), Vytorin (ezetimibe/
simvastatin), Ventolin HFA (albuterol sulfate). The committee will also
receive a brief update on atypical antipsychotic drugs as requested by
the Pediatric Advisory Committee Meeting on November 18, 2008.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
Tuesday, November 24, 2009. Oral presentations from the public will be
scheduled between approximately 1 p.m. and 2 p.m. Those desiring to
make formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before Monday, November 16, 2009. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by Tuesday, November 17, 2009.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Doreen Kezer at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: October 1, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-24013 Filed 10-5-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 77, Number 45 (Wednesday, March 7, 2012)]
[Notices]
[Pages 13590-13591]
[FR Doc No: 2012-5535]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2310-193]

Pacific Gas and Electric Company; Notice of Extension of Time for
Filing of Motions To Intervene and Protests, Comments, Recommendations,
Preliminary Terms and Conditions, Preliminary Fishway Prescriptions,
Response Comments, and Final License Application Amendments

    As stated in a letter dated February 24, 2012, in this proceeding
by the Director, Division of Hydropower Licensing, the date for filing
of motions to intervene and protests, comments, recommendations,
preliminary terms and conditions, and preliminary fishway
prescriptions, established by the Commission's notice issued on January
19, 2012,\1\ for the Drum-Spaulding Hydroelectric Project No. 2310-193,
has been extended to July 31, 2012, with response comments due by
September 14, 2012. The filing of final

license application amendments has been extended to June 18, 2012.
---------------------------------------------------------------------------

    \1\ Notice of Application Accepted for Filing, Soliciting
Motions to Intervene and Protests, Ready for Environmental Analysis,
and Soliciting Comments, Recommendations, Preliminary Terms and
Conditions, and Preliminary Fishway Prescriptions.

     Dated: February 29, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-5535 Filed 3-6-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 107 (Tuesday, June 4, 2019)]
[Rules and Regulations]
[Pages 25680-25682]
[FR Doc No: 2019-11527]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2018-1098]
RIN 100-AA08

Special Local Regulations; Annual Boyne Thunder Poker Run;
Charlevoix, MI

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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

SUMMARY: The Coast Guard is adding a special local regulation to
increase

safety in the navigable waters of Round Lake and Pine River Channel,
Charlevoix, MI, during the annual Boyne Thunder Poker Run. The
regulation will allow the Coast Guard Patrol Commander to control
vessel traffic during the event in this small and restricted waterway.
The regulation will be enforced during the day of the event. The date
and time will be announced via a Notice of Enforcement.

DATES: This regulation is effective July 13, 2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket go to http://www.regulations.gov. Type the
docket number (USCG-2018-1098) 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 MST2 Blackledge, Waterways Management, Coast Guard Sector
Sault Sainte Marie, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

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

II. Background, Purpose, and Legal Basis

    The Annual Boyne Thunder Poker Run is a charity marine event
occurring in the month of July with a route that runs from Boyne City
out to Lake Michigan and back to Boyne City. This event, occurring
annually for the past 15 years, includes approximately 100 participants
in offshore type power vessels. Round Lake and Pine River Channel are
small restricted waterways that normally have a variety of recreational
users and a commercial ferry that provides service to Beaver Island.
This mix of vessels in close proximity to the event warrants additional
safety measures. In response, the Coast Guard published a notice of
proposed rulemaking (NPRM) on March 11, 2019 (84 FR 8641). There, we
stated why we issued the NPRM, and invited comments on our proposed
regulatory action related to this Special Local Regulation. During the
comment period that ended May 10th 2019, we received no comments.
    The regulation will be enforced during the day of the event. The
date and time will be announced via a Notice of Enforcement published
in the Federal Register.
    The legal basis for this final rulemaking is found at 46 U.S.C.
70041; 33 CFR 1.05-1.

III. Discussion of Proposed Rule

    We received no comments from the NPRM published March 11, 2019.
There are no changes in the regulatory text of this rule from the
proposed rule in the NPRM. The Captain of the Port Sault Sainte Marie
(COTP) has determined that adding the Annual Boyne City Poker Run to
the list of Special Local Regulations in the navigable waters of Round
Lake and Pine River Channel in Charlevoix, MI is the most practical way
to ensure the safety of the boating public.

IV. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, the rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration, and time-of-day for the Special Local Regulation.
Vessel traffic will be able to safely transit through the regulated
area, with the permission of the Patrol Commander, which will impact a
small designated area within the COTP zone for a short duration of
time. Moreover, the Coast Guard will issue Broadcast Notice to Mariners
via VHF-FM marine channel 16 about the special local 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 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
IV.A. above, this rule will not have a significant economic impact on
any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order

13175, Consultation and Coordination with Indian Tribal Governments,
because it would not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes. If you believe this
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 an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Environmental Planning COMDTINST 5090.1
(series), which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a determination that this action is one of a category of actions that
do not individually or cumulatively have a significant effect on the
human environment. This rule prohibits vessels from entering,
transiting through, or anchoring within the regulated area without the
permission of the Coast Guard Patrol Commander. Normally such actions
are categorically excluded from further review under paragraph L61 in
Table 3-1 of U.S. Coast Guard Environmental Planning Implementing
Procedures 5090.1. A Record of Environmental Consideration supporting
this determination is available in the docket where indicated under
ADDRESSES.

G. Protest Activities

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

List of Subjects in 33 CFR Part 100

    Harbors, Marine safety, Navigation (water), Reporting and record
keeping requirements, Security measures, 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:  46 U.S.C. 70041; 33 CFR 1.05-1.

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2. Add Sec.  100.929 to read as follows:

Sec.  100.929  Special Local Regulations; Annual Boyne Thunder Poker
Run; Charlevoix, MI.

    (a) Regulated area. The special local regulations in this section
apply to all U.S. navigable waters of Round Lake and Pine River
Channel, Charlevoix, MI, within an area bordered by a line at the
entrance of the Pine River Channel charted in position 45[deg]19'15''
N, 085[deg]15'55'' W to 45[deg]19'13'' N, 085[deg]15'55'' W to the
southeast end of Round Lake charted in position 45[deg]18'57'' N,
085[deg]14'49'' W to 45[deg]18'56'' N, 085[deg]14'50'' W.
    (b) Special local regulation. The regulations of Sec.  100.901
apply. No vessel may enter, transit through, or anchor within the
regulated area in this section without the permission of the Coast
Guard Patrol Commander.
    (c) Enforcement period. The Coast Guard will issue a Notice of
Enforcement with the exact time and date in July that the regulated
area in this section will be enforced.

    Dated: May 24, 2019.
P.S. Nelson,
Captain, U.S. Coast Guard, Captain of the Port Sault Sainte Marie.
[FR Doc. 2019-11527 Filed 6-3-19; 8:45 am]
BILLING CODE 9110-04-P